Norfloxacin

In some countries, this medicine may only be approved for veterinary use.

In the US, Norfloxacin (norfloxacin systemic) is a member of the drug class quinolones and is used to treat Bladder Infection, Campylobacter Gastroenteritis, Epididymitis - Non-Specific, Gonococcal Infection - Uncomplicated, Kidney Infections, Prostatitis, Salmonella Enteric Fever, Salmonella Gastroenteritis, Shigellosis, Small Bowel Bacterial Overgrowth, Traveler's Diarrhea and Urinary Tract Infection.

US matches:

• Norfloxacin


• Norfloxacin ophthalmic

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

J01MA06,S01AX12

CAS registry number (Chemical Abstracts Service)

0070458-96-7

Chemical Formula

C16-H18-F-N3-O3

Molecular Weight

319

Therapeutic Category

Antibacterial: Gyrase inhibitor

Chemical Name

3-Quinolinecarboxylic acid, 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-

Foreign Names

• Norfloxacinum (Latin)
• Norfloxacin (German)
• Norfloxacine (French)
• Norfloxacino (Spanish)

Generic Names

• Norfloxacin (OS: USAN, JAN, BAN)
• Norfloxacina (OS: DCIT)
• Norfloxacine (OS: DCF)
• AM 715 (IS: Kyorin)
• MK 0366 (IS)
• Norfloxacin (PH: BP 2010, Ph. Eur. 6, USP 32, JP XIV)
• Norfloxacine (PH: Ph. Eur. 6)
• Norfloxacinum (PH: Ph. Eur. 6)
• Norfloxacin pivoxil (IS)

Brand Names

• Alenbit
  Chrispa, Greece



• Ambigram
  Bussié, Colombia; Bussié, Dominican Republic; Bussié, Guatemala; Bussié, Honduras; Bussié, Nicaragua; Bussié, Panama; Bussié, El Salvador



• Amicrobin
  Quimifar, Spain



• Ampliron
  Roemmers, Peru



• Apiflox
  Amman Pharmaceutical Industries Co., Oman



• Apirol
  Merck Sharp & Dohme, Israel



• Apo-Norflox
  Apotex, Canada; Apotex, Guyana



• Arrow Norfloxacin
  Arrow, New Zealand



• Asudufe
  Yoshindo, Japan



• Azo Uroflam
  Sherfarma, Peru



• Baccidal
  Kyorin, Japan



• Bacfamil
  Nisshin Seiyaku - Yamagata, Japan



• Bacteriotal
  Mediproducts, Guatemala; Mediproducts, Nicaragua; Mediproducts, El Salvador



• Bactracid
  Apogepha, Germany



• Bafurokisaru
  Tsuruhara Seiyaku, Japan



• Barazan
  Teofarma, Germany



• Barocul
  Nagase Iyakuhin, Japan



• Basteen
  Zensei Yakuhin, Japan



• Baxicin
  Taiwan Biotech, Taiwan



• Bexinor
  Beacons, Singapore



• Bio Tarbun
  Duncan, Argentina



• Biofloxin
  Biochem, India



• Biscolet
  Fuji Yakuhin, Japan



• Blemalart
  Choseido Pharmaceutical, Japan



• Chemmart Norfloxacin
  Apotex, Australia



• Chibroxin
  Merck, United Arab Emirates; Merck, Bahrain; Merck, Egypt; Merck, Iraq; Merck, Iran; Merck, Jordan; Merck, Kuwait; Merck, Peru; Merck, Qatar; Merck, Saudi Arabia; Merck, Sudan; Merck, Syria; Merck, Yemen; Merck Sharp & Dohme, Poland; MSD, Lebanon; Thea, Spain; Théa, Germany



• Chibroxine
  Merck Sharp & Dohme, Bahrain; Merck Sharp & Dohme, Sri Lanka; Merck Sharp & Dohme, Tunisia; Théa, France



• Chibroxol
  Laboratoires Théa, Netherlands; Thea, Luxembourg; Thea, Portugal



• CO Norfloxacin
  Cobalt, Canada



• Constilax
  Bros, Greece



• Danilon
  Biotech, Venezuela



• Effectsal
  Shin Poong, Singapore



• Epinor
  E.I.P.I.C.O., Romania



• Esclebin
  Alacan, Spain



• Espeden
  Qualigen, Spain



• Fada Norfloxacina
  Fada, Argentina



• Firin
  Schwarz, Germany



• Flobarl
  Mylan Pharmaceutical, Japan



• Flocidal
  VPP, Taiwan



• Flossac
  Caber, Italy



• Flox
  Hexal, Brazil



• Floxacin
  Medix, Mexico; Stada, Austria



• Floxamed
  Unimed, Tunisia



• Floxamicin
  Biotenk, Argentina



• Floxatral
  Austral, Argentina



• Floxatrat
  Luper, Brazil



• Floxen
  Ebewe, Hong Kong



• Floxin
  Be-Tabs Pharmaceuticals, South Africa



• Floxinol
  Millet Roux, Brazil



• Fluseminal
  Anfarm, Greece; Anfarm, Malta; Anfarm Hellas, Romania



• Foxgoria
  Nida, Singapore



• Fulgram
  Labomed, Chile



• GenRX Norfloxacin
  Apotex, Australia



• Grenis
  Genepharm, Greece; Genepharm, Romania



• Gyrablock
  Medochemie, Bahrain; Medochemie, Cyprus; Medochemie, Czech Republic; Medochemie, Iraq; Medochemie, Jordan; Medochemie, Sudan; Medochemie, Singapore; Medochemie, Slovakia; Medochemie, Yemen; Schering, Ethiopia



• H-Norfloxacin
  Helcor, Romania



• Janacin
  Biolab, Hong Kong



• Lemorcan
  Leovan, Greece



• Lexiflox
  Duopharma, Hong Kong



• Lexinor
  AstraZeneca, Philippines; AstraZeneca, Thailand



• Lorcamin
  Coup, Greece



• Loxone
  Brown & Burk, Sri Lanka; Brown & Burk, Myanmar



• Mariotton
  Tsuruhara Seiyaku, Japan



• Memento NF
  Merck, Argentina



• Menorox (veterinary use)
  Ceva Animal Health, South Africa



• Microxin
  Rayere, Mexico



• Mitatonin
  Kyorin Rimedio, Japan



• N.F.S.
  Chen Ho, Taiwan



• Naflox
  Farmigea, Italy



• Nalion
  Sandoz, Spain



• Negaflox
  Cadila, Eritrea; Cadila, Kenya; Cadila, Sri Lanka; Cadila, Nigeria; Cadila, Tanzania; Cadila, Uganda; Cadila, Zambia; Cadila, Zimbabwe; Zydus Cadila, Myanmar



• Negalflex
  Cadila Health Care, Ethiopia



• Neofloxin
  Alexandria Company, Ethiopia



• N-Flox
  LCG, Peru



• Niterat
  Apotecarium, Colombia



• Noflo
  Banyu Seiyaku, Japan



• Nofloxan
  Nichi-Iko PharmaceuticalJMA, Japan



• Nofocin
  Srbolek, Serbia



• Nofxan
  Taisho Yakuhin, Japan



• Nolicin
  Krka, Bosnia & Herzegowina; Krka, Czech Republic; Krka, Estonia; Krka, Georgia; Krka, Croatia (Hrvatska); Krka, Hungary; Krka, Lithuania; Krka, Latvia; Krka, Poland; Krka, Romania; Krka, Serbia; Krka, Russian Federation; Krka, Slovenia; Krka, Slovakia



• Noprose
  California, Colombia



• Nor
  Intas Pharmaceuticals, Ethiopia



• Noracin
  Bosnalijek, Bosnia & Herzegowina; Saiph, Tunisia



• Norax
  United Pharmaceutical, United Arab Emirates; United Pharmaceutical, Bahrain; United Pharmaceutical, Iraq; United Pharmaceutical, Jordan; United Pharmaceutical, Libya; United Pharmaceutical, Qatar; United Pharmaceutical, Saudi Arabia; United Pharmaceutical, Sudan; United Pharmaceutical, Yemen



• Noraxin
  Standard, Taiwan



• Norbactin
  Ranbaxy, Sri Lanka; Ranbaxy, Lithuania; Ranbaxy, Latvia; Ranbaxy, Oman; Ranbaxy, Peru; Ranbaxy, Singapore; Solus, India



• Norcozine
  Iwaki Seiyaku, Japan



• Norfacin
  Shreya, Russian Federation



• Norfen
  Cadila, Eritrea; Cadila, Kenya; Cadila, Nigeria; Cadila, Tanzania; Cadila, Uganda; Cadila, Zambia; Cadila, Zimbabwe; Cadila Health Care, Ethiopia



• Norflocin-Mepha
  Mepha Pharma, Switzerland



• Norflodal
  CCPC, Taiwan



• Norflogen
  Genamerica, Ecuador



• Norflohexal
  Hexal, Germany; Sandoz, Australia



• Norflok
  Inkeysa, Spain; Inkeysa, Latvia



• Norflol
  Oriental, Argentina



• Norflomax
  Generifar, Nicaragua



• Norflosal
  TAD, Germany; TAD, Luxembourg



• Norflostad
  Eurogenerics, Luxembourg



• Norflox
  Biomedica Foscama, Italy; Cipla, India; Cipla, Latvia; Cipla, Oman; Cipla, Romania



• Norflox-1A Pharma
  1A Pharma, Germany



• Norfloxacin AbZ
  AbZ, Germany



• Norfloxacin Adico
  Adico Pharma, Switzerland



• Norfloxacin AL
  Aliud, Germany



• Norfloxacin Helvepharm
  Helvepharm, Switzerland



• Norfloxacin Heumann
  Heumann, Germany



• Norfloxacin Krka
  Krka, Sweden



• Norfloxacin Sandoz
  Sandoz, Austria; Sandoz, Finland; Sandoz, Sweden



• Norfloxacin STADA
  Stada, Germany; Stada, Sweden



• Norfloxacin
  Antibiotice, Romania; GAMA, Georgia; Genepharm, Australia; Kwang Mayung Pharma, Ethiopia; Laropharm, Romania



• Norfloxacina ABC
  ABC, Italy



• Norfloxacina Actavis
  Actavis, Italy



• Norfloxacina Alter
  Alter, Italy



• Norfloxacina Best
  Best, Colombia



• Norfloxacina Cinfa
  Cinfa, Portugal



• Norfloxacina Craveri
  Craveri, Argentina



• Norfloxacina EG
  EG, Italy



• Norfloxacina Fabra
  Fabra, Argentina



• Norfloxacina Jet
  Jet, Italy



• Norfloxacina Klonal
  Klonal, Argentina



• Norfloxacina La Santé
  La Santé, Colombia



• Norfloxacinã LPH
  Labormed Pharma, Romania



• Norfloxacina MK
  McKesson, Ecuador; MK, Colombia



• Norfloxacina Northia
  Northia, Argentina



• Norfloxacina Ratiopharm
  Ratiopharm, Portugal



• Norfloxacina Richet
  Richet, Argentina



• Norfloxacina Sandoz
  Sandoz, Italy



• Norfloxacina
  AZ Pharma, Colombia; Elter - Medicamentos Genéricos, Venezuela; Genéricos Venezolanos, Venezuela; OFA, Venezuela; Spefar, Venezuela; Synthesis, Colombia



• Norfloxacinã
  Arena, Romania



• Norfloxacine A
  Apothecon, Netherlands



• Norfloxacine Actavis
  Actavis, Netherlands



• Norfloxacine Arrow
  Arrow, France



• Norfloxacine Biogaran
  Biogaran, France



• Norfloxacine CF
  Centrafarm, Netherlands



• Norfloxacine CristerS
  CristerS, France



• Norfloxacine EG
  EG Labo, France; Eurogenerics, Belgium



• Norfloxacine Merck
  Mylan, Netherlands



• Norfloxacine Mylan
  Mylan, France



• Norfloxacine PCH
  Pharmachemie, Netherlands



• Norfloxacine Qualimed
  Qualimed, France



• Norfloxacine Ranbaxy
  Ranbaxy, France



• Norfloxacine Ratiopharm
  Ratiopharm, France; Ratiopharm, Netherlands



• Norfloxacine Sandoz
  Sandoz, France; Sandoz, Netherlands



• Norfloxacine Teva
  Teva, Belgium; Teva Santé, France



• Norfloxacine Winthrop
  Sanofi-Aventis, France



• Norfloxacine-EG
  Eurogenerics, Luxembourg



• Norfloxacine-Sandoz
  Sandoz, Luxembourg



• Norfloxacin-Helcor
  Helcor, Hungary



• Norfloxacino Acost
  Acost, Spain



• Norfloxacino Bexal
  Bexal, Spain



• Norfloxacino Cinfa
  Cinfa, Spain



• Norfloxacino Cinfamed
  Cinfa, Spain



• Norfloxacino Fmndtria
  Farmindustria, Peru



• Norfloxacino Generix
  GNR, Spain



• Norfloxacino Genfar
  Genfar, Colombia; Genfar, Ecuador; Genfar, Peru



• Norfloxacino Induquimica
  Induquimica, Peru



• Norfloxacino Iqfarma
  Iqfarma, Peru



• Norfloxacino MF
  Marfan, Peru



• Norfloxacino MK
  Bonima, Belize; Bonima, Costa Rica; Bonima, Dominican Republic; Bonima, Guatemala; Bonima, Honduras; Bonima, Nicaragua; Bonima, Panama; Bonima, El Salvador



• Norfloxacino Normon
  Normon, Costa Rica; Normon, Dominican Republic; Normon, Spain; Normon, Guatemala; Normon, Honduras; Normon, Nicaragua; Normon, Panama; Normon, El Salvador



• Norfloxacino Ranbaxy
  Ranbaxy, Spain



• Norfloxacino Sandoz
  Sandoz, Spain



• Norfloxacino Stada
  Stada, Spain



• Norfloxacino
  Britania, Peru; Farmachif, Peru; Farmo Andina, Peru; G&R, Peru; Hersil, Peru; La Sante, Peru; Labofar, Peru; Pentacoop, Colombia; Pentacoop, Peru; Quilab, Peru; UQP, Peru



• Norfloxacin-ratiopharm
  Ratiopharm, Austria; Ratiopharm, Belgium; Ratiopharm, Germany; Ratiopharm, Finland; Ratiopharm, Hungary; Ratiopharm, Luxembourg



• Norfloxacin-Teva
  Teva Pharma, Switzerland



• Norfloxatin-Ratiopharm
  Ratiopharm, Czech Republic



• Norflox-CT
  CT Arzneimittel, Germany



• Norflox-Sandoz
  Sandoz, Germany



• Norfluxx
  Ruhrpharm, Germany



• Norilet
  Biofarma, Venezuela; Dr Reddys, Sri Lanka; Dr Reddys, Myanmar; Dr. Reddy's, Peru



• Normax
  Ipca, India; Ipca, Sri Lanka; Ipca, Russian Federation



• Norocin
  Vianex / BIANEΞ, Greece



• Noroxin
  Merck, Peru; Merck, United States; Merck Sharp & Dhome, Oman; Merck Sharp & Dohme, Netherlands Antilles; Merck Sharp & Dohme, Argentina; Merck Sharp & Dohme, Australia; Merck Sharp & Dohme, Aruba; Merck Sharp & Dohme, Barbados; Merck Sharp & Dohme, Bahamas; Merck Sharp & Dohme, Belize; Merck Sharp & Dohme, Ethiopia; Merck Sharp & Dohme, Italy; Merck Sharp & Dohme, Jamaica; Merck Sharp & Dohme, Cayman Islands; Merck Sharp & Dohme, Sri Lanka; Merck Sharp & Dohme, Mexico; Merck Sharp & Dohme, Netherlands; Merck Sharp & Dohme, Portugal; Merck Sharp & Dohme, Turkey; Merck Sharp & Dohme, Trinidad & Tobago; Merck Sharp & Dohme, Venezuela; Merck Sharp & Dome, Dominican Republic; MSD, Switzerland; Sharp Dohme, Spain; Thea, Iceland



• Noroxine
  Finadiet, Argentina; Merck Sharp & Dohme, France



• Norsol
  Finadiet, Argentina; Sandoz, Switzerland



• Norzen
  FDC, Sri Lanka



• Notler
  Sandoz, Japan



• Noxacin
  Gentle, Taiwan; Wakamoto, Japan



• Nufloxib
  Alphapharm, Australia



• Oranor
  AF, Mexico



• Ovinol
  Norma, Greece



• Parcetin
  Denver, Argentina



• Pharex Norfloxacin
  Pascual, Philippines



• Pistofil
  Rafarm, Greece



• Renor
  Aurobindo Pharma, Ethiopia



• Renoxacin
  B&G, Italy



• Respexil
  Merck Sharp & Dohme, Brazil



• Rexacin
  Unison, Myanmar; Unison, Thailand



• Ritromine
  Hexa, Argentina



• Roxin
  Sigma, Australia



• Sebercim
  GlaxoSmithKline, Italy



• Senro
  Biosarto, Spain



• Setanol
  Vilco, Greece



• Shinun
  Tatsumi Kagaku, Japan



• Sinobid
  Biospray, Greece



• Sofasin
  Faran Laboratories, Greece



• Stbanil
  Taiyo Pharmaceutical, Japan



• Steinaclox-Medichrom
  Medichrom, Greece



• Taflox
  Faribérica, Portugal



• Terry White Chemists Norfloxacin
  Apotex, Australia



• Theanorf
  Thea-F, Italy



• Trizolin
  Remedica, Cyprus



• Unasera
  Isei, Japan



• Uricin
  Slaviamed, Serbia



• Uriflox
  Flamingo Pharmacueticals, Ethiopia



• Uritracin
  Biofemme, Philippines



• Uritrat
  Libbs, Brazil



• Urobacid
  Biochemie, United Arab Emirates; Biochemie, Bahrain; Biochemie, Cyprus; Biochemie, Jordan; Biochemie, Kuwait; Biochemie, Lebanon; Biochemie, Qatar; Biochemie, Saudi Arabia; Biochemie, Sudan; Biochemie, Yemen; Novartis, Greece; Sandoz, Philippines



• Urobiotic
  Iqfarma, Peru



• Uroctal
  Almirall, Burkina Faso; Almirall, Benin; Almirall, Congo; Almirall, Cote D'ivoire; Almirall, Cameroon; Almirall, Egypt; Almirall, Spain; Almirall, Gabon; Almirall, Ghana; Almirall, Guinea; Almirall, Madagascar; Almirall, Mali; Almirall, Mauritania; Almirall, Mauritius; Almirall, Niger; Almirall, Oman; Almirall, Senegal; Almirall, Togo; Almirall, Tanzania; Almirall, Zambia; Almirall Prodesfarma, Hong Kong; Boehringer Ingelheim, Sudan; Bristol-Myers Squibb, Kenya



• Urodixil
  Magma, Peru



• Urodol
  Dimerpharma, Peru



• Uroflox
  Bial, Portugal; Farmion, Brazil; Torrent, India; Torrent Pharmaceuticals, Ethiopia



• Urofos
  Panalab, Argentina



• Uro-Linfol
  Omega, Argentina



• Uronovag
  Gobbi, Argentina



• Uro-Plus
  Medco, Peru



• Uroquin
  Bios Peru®, Peru



• Uroseptal
  Bagó, Argentina; Bagó, Ecuador



• Urospes-N
  Specifar, Greece



• Urotem
  Temis-Lostalo, Argentina



• Uroxacin
  Lazar, Argentina



• Uroxin
  Julphar, Oman



• Utibid
  Lupin, Ethiopia



• Uticina
  So.Se., Italy



• Utin-400
  Cipla Medpro, South Africa



• Utinor
  Merck Sharp & Dohme, United Kingdom; Merck Sharp & Dohme, Malta; Neopharmed, Italy



• Vefloxa (veterinary use)
  Formevet, Italy



• Vetamol
  Viofar, Greece



• Wenflox
  Asofarma, Argentina



• Xaflor
  Sawai Seiyaku, Japan



• Xasmun
  VP, Spain



• Zoroxin
  Merck Sharp & Dohme, Austria; Merck Sharp & Dohme, Belgium; Merck Sharp & Dohme, Costa Rica; Merck Sharp & Dohme, Honduras; Merck Sharp & Dohme, Luxembourg; Merck Sharp & Dohme, Nicaragua; Merck Sharp & Dohme, Panama; Merck Sharp & Dohme, El Salvador; Thea, Austria



• Quinabic (veterinary use)
  Novartis Animal Health, South Africa



• Diperflox
  Francia, Italy

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Sélénifer

Sélénifer may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Sélénifer

Sodium Selenite

Sodium Selenite is reported as an ingredient of Sélénifer in the following countries:

• France

Tocopherol, α-

Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Sélénifer in the following countries:

• France

International Drug Name Search

Cardura XL

Generic Name: doxazosin (dox AY zo sin)

Brand Names: Cardura, Cardura XL

What is Cardura XL (doxazosin)?

Doxazosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Doxazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Doxazosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cardura XL (doxazosin)?

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

What should I discuss with my doctor before taking Cardura XL (doxazosin)?

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

If you have liver disease or a history of prostate cancer, you may need a dose adjustment or special tests to safely take doxazosin.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

FDA pregnancy category C. It is not known whether doxazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether doxazosin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Cardura XL (doxazosin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure or prostate will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking Cardura XL (doxazosin)?

Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of doxazosin.

Cardura XL (doxazosin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  fast or pounding heartbeats, fluttering in your chest;

  
  


• 
  

  trouble breathing;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  penis erection that is painful or lasts 4 hours or longer.

  
  

Less serious side effects may include:

• 
  

  mild dizziness;

  
  


• 
  

  tired feeling, drowsiness;

  
  


• 
  

  headache;

  
  


• 
  

  nausea; or

  
  


• 
  

  runny nose.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cardura XL (doxazosin)?

Tell your doctor about all other medications you use, especially:

• 
  

  sildenafil (Viagra, Revatio)

  
  


• 
  

  tadalafil (Cialis);

  
  


• 
  

  vardenafil (Levitra); or

  
  


• 
  

  other blood pressure medications, including diuretics (water pills).

  
  

This list is not complete and other drugs may interact with doxazosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cardura XL resources

• Cardura XL Side Effects (in more detail)
• Cardura XL Use in Pregnancy & Breastfeeding
• Cardura XL Drug Interactions
• Cardura XL Support Group
• 1 Review for Cardura XL - Add your own review/rating

• Cardura XL Prescribing Information (FDA)


• Cardura XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardura XL Advanced Consumer (Micromedex) - Includes Dosage Information


• Doxazosin Prescribing Information (FDA)


• Cardura MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardura Prescribing Information (FDA)


• Cardura Monograph (AHFS DI)


• Cardura Consumer Overview

Compare Cardura XL with other medications

• Benign Prostatic Hyperplasia

Where can I get more information?

• Your pharmacist can provide more information about doxazosin.

See also: Cardura XL side effects (in more detail)

Hydrocortisone Na Succin.

Hydrocortisone Na Succin. may be available in the countries listed below.

Ingredient matches for Hydrocortisone Na Succin.

Hydrocortisone

Hydrocortisone 21-(sodium succinate) (a derivative of Hydrocortisone) is reported as an ingredient of Hydrocortisone Na Succin. in the following countries:

• Romania

International Drug Name Search

Nafti-ratiopharm

Nafti-ratiopharm may be available in the countries listed below.

Ingredient matches for Nafti-ratiopharm

Naftidrofuryl

Naftidrofuryl oxalate (a derivative of Naftidrofuryl) is reported as an ingredient of Nafti-ratiopharm in the following countries:

• Germany

International Drug Name Search

Cinryze

Generic Name: c1 esterase inhibitor, human (Intravenous route)

C1 ES-ter-ase in-HIB-i-ter, HUE-man

Commonly used brand name(s)

In the U.S.

• Berinert


• Cinryze

Available Dosage Forms:

• Powder for Solution

Uses For Cinryze

C1 esterase inhibitor is used to treat or prevent hereditary angioedema (HAE), which is a rare disease that causes swelling of the face, hands, feet, throat, stomach, bowels, or sexual organs. People who have HAE have low levels of C1 esterase inhibitor in their body. This medicine works by improving your immune system and clotting system.

This medicine is available only with your doctor's prescription.

Before Using Cinryze

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of C1 esterase inhibitor in children 12 years of age and younger. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of C1 esterase inhibitor in the geriatric population. Safety and efficacy have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots, history of—Use with caution. May make this condition worse.

Proper Use of c1 esterase inhibitor, human

This section provides information on the proper use of a number of products that contain c1 esterase inhibitor, human. It may not be specific to Cinryze. Please read with care.

A nurse or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins.

This medicine may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

Make sure family members or other people you are with know how to inject the medicine in case you are unable to do it yourself during an HAE attack.

Use a new needle and syringe each time you inject your medicine.

Carry this medicine with you at all times for emergency use in case you have an HAE attack.

This medicine comes with a patient information leaflet. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For hereditary angioedema:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by a doctor. The usual dose is 20 units per kilogram (kg) of body weight injected into a vein.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Keep the medicine in the original carton until ready to use. You may store the vial of Berinert® powder in the refrigerator. Do not freeze.

You may store the mixed liquid at room temperature and use it within 8 hours. Do not refrigerate or freeze the mixed liquid.

Check the injection kits regularly to make sure that the powder or liquid has not changed its color. Do not use this medicine if the powder or liquid has changed its color, or if there are solids in the mixed liquid.

Do not reuse the remaining portion of the medicine that is left in the vial. Throw away the vial after you have used it.

Precautions While Using Cinryze

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

HAE attack is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you or your child have a rash; itching; hives; hoarseness; chest tightness; lightheadedness, dizziness, or fainting; wheezing; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach; chest pain; shortness of breath; loss of sensation; confusion; or problems with muscle control or speech.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Cinryze Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Chest pain


• chills


• cough


• ear congestion or pain


• fever


• head congestion


• headache


• hoarseness or other voice changes


• nasal congestion


• pain or tenderness around the eyes and cheekbones


• rash


• runny nose


• shortness of breath or troubled breathing


• sneezing


• sore throat


• stuffy or runny nose


• tightness of the chest or wheezing

Incidence not known

• Dark urine


• difficulty with swallowing


• dizziness


• fast heartbeat


• general tiredness and weakness


• hives


• itching


• light-colored stools


• nausea and vomiting


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• diarrhea


• muscle spasms


• pain

Less common

• Change in taste


• loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Cinryze side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Cinryze resources

• Cinryze Side Effects (in more detail)
• Cinryze Use in Pregnancy & Breastfeeding
• Cinryze Support Group
• 3 Reviews for Cinryze - Add your own review/rating

• Cinryze Prescribing Information (FDA)


• Cinryze Monograph (AHFS DI)


• Cinryze MedFacts Consumer Leaflet (Wolters Kluwer)


• Cinryze Consumer Overview


• Berinert Prescribing Information (FDA)


• Berinert MedFacts Consumer Leaflet (Wolters Kluwer)


• Berinert Consumer Overview

Compare Cinryze with other medications

• Hereditary Angioedema

Nitrogen Mustard N-oxide Hydrochloride

Nitrogen Mustard N-oxide Hydrochloride may be available in the countries listed below.

Ingredient matches for Nitrogen Mustard N-oxide Hydrochloride

Mechlorethamine Oxide

Nitrogen Mustard N-oxide Hydrochloride (JAN) is also known as Mechlorethamine Oxide

International Drug Name Search

Glossary

JAN	Japanese Accepted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Ibuprofeno Medifarma

Ibuprofeno Medifarma may be available in the countries listed below.

Ingredient matches for Ibuprofeno Medifarma

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofeno Medifarma in the following countries:

• Peru

International Drug Name Search

Children's Motrin Drops

Pronunciation: EYE-bue-PROE-fen
Generic Name: Ibuprofen
Brand Name: Examples include Children's Advil and Children's Motrin

Children's Motrin Drops are a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Children's Motrin Drops for a long time. Do not use Children's Motrin Drops right before or after bypass heart surgery.

Children's Motrin Drops may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Children's Motrin Drops are used for:

Treating minor aches and pains caused by the common cold, flu, sore throat, headaches, or toothaches. It may be used to reduce fever. It may also be used for other conditions as determined by your doctor.

Children's Motrin Drops are an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Children's Motrin Drops if:

• you are allergic to any ingredient in Children's Motrin Drops


• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)


• you have recently had or will be having bypass heart surgery


• you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Children's Motrin Drops:

Some medical conditions may interact with Children's Motrin Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal product, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, persistent or returning stomach pain or heartburn)


• if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases


• if you are dehydrated or have low fluid volume (eg, caused by diarrhea, vomiting, not drinking fluids)


• if you have poor health, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Children's Motrin Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased


• Probenecid because it may increase the risk of Children's Motrin Drops's side effects


• Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Children's Motrin Drops


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Children's Motrin Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Children's Motrin Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Children's Motrin Drops:

Use Children's Motrin Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Children's Motrin Drops comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Children's Motrin Drops refilled.


• Take Children's Motrin Drops by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.


• Shake well before each use.


• Use the dropper that comes with Children's Motrin Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Children's Motrin Drops and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of Children's Motrin Drops.

Important safety information:

• Children's Motrin Drops may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Children's Motrin Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Serious stomach ulcers or bleeding can occur with the use of Children's Motrin Drops. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Children's Motrin Drops with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Do NOT take more than the recommended dose or use for longer than 10 days without checking with your doctor.


• If stomach pain or upset gets worse or does not get better, check with the doctor. If pain or fever gets worse or lasts for more than 3 days, check with your doctor.


• If a child using Children's Motrin Drops does not get any relief within 24 hours, contact the child's doctor.


• Children's Motrin Drops has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Children's Motrin Drops unless your doctor tells you to.


• Diabetes patients - Children's Motrin Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use Children's Motrin Drops with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.


• Different brands of Children's Motrin Drops may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: Children's Motrin Drops may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Children's Motrin Drops while you are pregnant. It is not known if Children's Motrin Drops are found in breast milk. Do not breast-feed while taking Children's Motrin Drops.

Possible side effects of Children's Motrin Drops:

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Children's Motrin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Children's Motrin Drops:

Store Children's Motrin Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Children's Motrin Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Children's Motrin Drops, please talk with your doctor, pharmacist, or other health care provider.


• Children's Motrin Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Children's Motrin Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Children's Motrin resources

• Children's Motrin Side Effects (in more detail)
• Children's Motrin Use in Pregnancy & Breastfeeding
• Children's Motrin Drug Interactions
• Children's Motrin Support Group
• 2 Reviews for Children's Motrin - Add your own review/rating

Compare Children's Motrin with other medications

• Fever
• Pain
• Spondylolisthesis

Bectam

Bectam may be available in the countries listed below.

Ingredient matches for Bectam

Paroxetine

Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Bectam in the following countries:

• Chile

International Drug Name Search

Cafatine

Generic Name: caffeine and ergotamine (oral/rectal) (KAF een and er GOT a meen)

Brand Names: Cafergot, Migergot

What is caffeine and ergotamine?

Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).

Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.

The combination of caffeine and ergotamine is used to treat or prevent a migraine type headache.

This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.

Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Caffeine and ergotamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about caffeine and ergotamine?

This medication can harm an unborn baby or a nursing baby. Do not use caffeine and ergotamine if you are pregnant or breast-feeding. Do not use this medication if you are allergic to caffeine and ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection. Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Never use more than your prescribed dose of caffeine and ergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. An overdose of caffeine and ergotamine can be fatal.

What should I discuss with my healthcare provider before using caffeine and ergotamine ?

Do not use this medication if you are allergic to caffeine or ergotamine, or other ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use caffeine and ergotamine if you are pregnant or breast-feeding, or if you have:

• 
  

  a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;

  
  


• 
  

  coronary artery disease or "hardening of the arteries";

  
  


• 
  

  uncontrolled high blood pressure;

  
  


• severe liver disease;


• severe kidney disease; or


• 
  

  a serious infection called sepsis.

  
  

Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use caffeine and ergotamine if you are also using any of the following medications:

• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);

  
  


• 
  

  an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or

  
  


• 
  

  HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

  
  

Caffeine and ergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using caffeine and ergotamine, tell your doctor if you have:

• 
  

  breathing problems;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

  
  

FDA pregnancy category X. This medication can cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using caffeine and ergotamine. Caffeine and ergotamine passes into breast milk and may be harmful to a nursing infant. Do not use caffeine and ergotamine without telling your doctor if you are breast-feeding a baby.

How should I use caffeine and ergotamine?

Use this medication exactly as prescribed by your doctor. Never use more than your prescribed dose of caffeine and ergotamine. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Caffeine and ergotamine is not for daily use.

To use caffeine and ergotamine tablets: Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.

If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed. If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.

If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.

To use caffeine and ergotamine rectal suppositories: Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun. If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Try to empty your bladder just before using the suppository. Remove the outer wrapper from the suppository and insert it gently into the rectum, pointed tip first. Avoid handling the suppository too long or it will melt in your hands.

For best results, lie down after inserting the suppository and hold it in for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days. Do not give this medication to anyone else, even if they have the same headache symptoms you have. Caffeine and ergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches. Store caffeine and ergotamine at room temperature away from moisture, heat, and light. Do not use any stored caffeine and ergotamine if the expiration date on the label has passed.

What happens if I miss a dose?

Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.

Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week. Do not use more than 2 suppositories per headache or 5 suppositories per week.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.

Overdose can cause vomiting, confusion, drowsiness, weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes, fainting, and seizure (convulsions).

What should I avoid while using caffeine and ergotamine?

Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:

• 
  

  dihydroergotamine (D.H.E. 45, Migranal), caffeine and ergotamine (Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), methysergide (Sansert); or

  
  


• 
  

  almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).

  
  

Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Caffeine and ergotamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  fast or slow heart rate;

  
  


• 
  

  muscle pain in your arms or legs;

  
  


• 
  

  leg weakness;

  
  


• 
  

  numbness or tingling and a pale or blue-colored appearance in your fingers or toes;

  
  


• 
  

  severe pain in your stomach or lower back;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  painful sores on your rectum after using the rectal suppositories;

  
  


• 
  

  swelling or itching in any part of your body;

  
  


• 
  

  cough with stabbing chest pain and trouble breathing; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, spinning sensation;

  
  


• 
  

  weakness;

  
  


• 
  

  nausea, vomiting; or

  
  


• 
  

  mild itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect caffeine and ergotamine?

Many drugs can interact with caffeine and ergotamine. Below is just a partial list. Talk with your doctor before using caffeine and ergotamine if you are also taking:

• 
  

  birth control pills;

  
  


• 
  

  zileuton (Zyflo);

  
  


• 
  

  cold or allergy medications;

  
  


• 
  

  nicotine (Nicoderm, Nicorette);

  
  


• 
  

  diet pills, stimulants, or medication to treat ADHD (such as Ritalin or Adderall);

  
  


• 
  

  an antidepressant such fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), and others;

  
  


• 
  

  nitroglycerin or other nitrate medicines such as isosorbide (Isordil, Dilatrate, Imdur, Monoket); or

  
  


• 
  

  heart or blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

This list is not complete and there may be other drugs that can interact with caffeine and ergotamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cafatine resources

• Cafatine Side Effects (in more detail)
• Cafatine Use in Pregnancy & Breastfeeding
• Cafatine Drug Interactions
• Cafatine Support Group
• 0 Reviews for Cafatine - Add your own review/rating

• Cafergot Advanced Consumer (Micromedex) - Includes Dosage Information


• Cafergot MedFacts Consumer Leaflet (Wolters Kluwer)


• Cafergot Prescribing Information (FDA)


• Migergot Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cafatine with other medications

• Cluster Headaches
• Migraine

Where can I get more information?

• Your pharmacist can provide more information about caffeine and ergotamine.

See also: Cafatine side effects (in more detail)

Campral

acamprosate calcium

Dosage Form: tablet, delayed release
Campral® (acamprosate calcium) Delayed-Release Tablets

Rx Only

DESCRIPTION

Campral® (acamprosate calcium) is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.48. Its structural formula is:

Acamprosate calcium is a white, odorless or nearly odorless powder. It is freely soluble in water, and practically insoluble in absolute ethanol and dichloromethane.

Each Campral tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Campral tablets include: crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, talc, propylene glycol and Eudragit® L 30 D or equivalent. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.

CLINICAL PHARMACOLOGY

Pharmacodynamics

The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. In vitro and in vivo studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that acamprosate restores this balance.

Pharmacodynamic studies have shown that acamprosate calcium reduces alcohol intake in alcohol-dependent animals in a dose-dependent manner and that this effect appears to be specific to alcohol and the mechanisms of alcohol dependence.

Acamprosate calcium has negligible observable central nervous system (CNS) activity in animals outside of its effects on alcohol dependence, exhibiting no anticonvulsant, antidepressant, or anxiolytic activity.

The administration of acamprosate calcium is not associated with the development of tolerance or dependence in animal studies.

Campral is not known to cause alcohol aversion and does not cause a disulfiram-like reaction as a result of ethanol ingestion.

Pharmacokinetics

Absorption

The absolute bioavailability of Campral after oral administration is about 11%. Steady-state plasma concentrations of acamprosate are reached within 5 days of dosing. Steady-state peak plasma concentrations after Campral doses of 2 x 333 mg tablets three times daily average 350 ng/mL and occur at 3-8 hours post-dose. Coadministration of Campral with food decreases bioavailability as measured by Cmax and AUC, by approximately 42% and 23%, respectively. The food effect on absorption is not clinically significant and no adjustment of dose is necessary.

Distribution

The volume of distribution for acamprosate following intravenous administration is estimated to be 72-109 liters (approximately 1 L/kg). Plasma protein binding of acamprosate is negligible.

Metabolism

Acamprosate does not undergo metabolism.

Elimination

After oral dosing of 2 x 333 mg of Campral, the terminal half-life ranges from approximately 20 - 33 hours. Following oral administration of Campral, the major route of excretion is via the kidneys as acamprosate.

Special Populations

Gender: Campral does not exhibit any significant pharmacokinetic differences between male and female subjects.

Age: The pharmacokinetics of Campral have not been evaluated in a geriatric population. However, since renal function diminishes in elderly patients and acamprosate is excreted unchanged in urine, acamprosate plasma concentrations are likely to be higher in the elderly population compared to younger adults.

Pediatrics: The pharmacokinetics of Campral have not been evaluated in a pediatric population.

Renal Impairment: Peak plasma concentrations after administration of a single dose of 2 x 333 mg Campral tablets to patients with moderate or severe renal impairment were about 2-fold and 4-fold higher, respectively, compared to healthy subjects. Similarly, elimination half-life was about 1.8-fold and 2.6-fold longer, respectively, compared to healthy subjects. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate. A dose of 1 x 333 mg Campral, three times daily, is recommended in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min, see also PRECAUTIONS).

Patients with severe renal impairment (creatinine clearance ≤30 mL/min) should not be given Campral (see also CONTRAINDICATIONS).

Hepatic Impairment: Acamprosate is not metabolized by the liver and the pharmacokinetics of Campral are not altered in patients with mild to moderate hepatic impairment (groups A and B of the Child-Pugh classification). No adjustment of dosage is recommended in such patients.

Alcohol-dependent subjects: A cross-study comparison of Campral at doses of 2 x 333 mg three times daily indicated similar pharmacokinetics between alcohol-dependent subjects and healthy subjects.

Drug-Drug Interactions

Acamprosate had no inducing potential on the cytochrome CYP1A2 and 3A4 systems, and in vitro inhibition studies suggest that acamprosate does not inhibit in vivo metabolism mediated by cytochrome CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4. The pharmacokinetics of Campral were unaffected when co-administered with alcohol, disulfiram or diazepam. Similarly, the pharmacokinetics of ethanol, diazepam and nordiazepam, imipramine and desipramine, naltrexone and 6-beta naltrexol were unaffected following co-administration with Campral. However, co-administration of Campral with naltrexone led to a 33% increase in the Cmax and a 25% increase in the AUC of acamprosate. No adjustment of dosage is recommended in such patients.

CLINICAL STUDIES

The efficacy of Campral in the maintenance of abstinence was supported by three clinical studies involving a total of 998 patients who were administered at least one dose of Campral or placebo as an adjunct to psychosocial therapy. Each study was a double-blind, placebo-controlled trial in alcohol-dependent patients who had undergone inpatient detoxification and were abstinent from alcohol on the day of randomization. Study durations ranged from 90 days to 360 days. Campral proved superior to placebo in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment.

In a fourth study, the efficacy of Campral was evaluated in alcoholics, including patients with a history of polysubstance abuse and patients who had not undergone detoxification and were not required to be abstinent at baseline. This study failed to demonstrate superiority of Campral over placebo.

INDICATIONS AND USAGE

Campral is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.

The efficacy of Campral in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral treatment. The efficacy of Campral in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

CONTRAINDICATIONS

Campral is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components.

Campral is contraindicated in patients with severe renal impairment (creatinine clearance ≤30 mL/min).

PRECAUTIONS

Use of Campral does not eliminate or diminish withdrawal symptoms.

General

Renal Impairment: Treatment with Campral in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) requires a dose reduction. Patients with severe renal impairment (creatinine clearance of ≤30 mL/min) should not be given Campral (see also CONTRAINDICATIONS).

Suicidality: In controlled clinical trials of Campral, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in Campral-treated patients than in patients treated with placebo (1.4% vs. 0.5% in studies of 6 months or less; 2.4% vs. 0.8% in year-long studies). Completed suicides occurred in 3 of 2272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1962 patients (0.10%) in the placebo group. Adverse events coded as "depression" were reported at similar rates in Campral-treated and placebo-treated patients. Although many of these events occurred in the context of alcohol relapse, no consistent pattern of relationship between the clinical course of recovery from alcoholism and the emergence of suicidality was identified. The interrelationship between alcohol dependence, depression and suicidality is well-recognized and complex. Alcohol-dependent patients, including those patients being treated with Campral should be monitored for the development of symptoms of depression or suicidal thinking. Families and caregivers of patients being treated with Campral should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's health care provider.

Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Campral.

Any psychoactive drug may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Campral therapy does not affect their ability to engage in such activities.

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

Patients should be advised to notify their physician if they are breast-feeding.

Patients should be advised to continue Campral therapy as directed, even in the event of relapse and should be reminded to discuss any renewed drinking with their physician.

Patients should be advised that Campral has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support.

Drug Interactions

The concomitant intake of alcohol and Campral does not affect the pharmacokinetics of either alcohol or acamprosate.

Pharmacokinetic studies indicate that administration of disulfiram or diazepam does not affect the pharmacokinetics of acamprosate. Co-administration of naltrexone with Campral produced a 25% increase in AUC and a 33% increase in the Cmax of acamprosate. No adjustment of dosage is recommended in such patients.

The pharmacokinetics of naltrexone and its major metabolite 6-beta-naltrexol were unaffected following co-administration with Campral.

Other concomitant therapies: In clinical trials, the safety profile in subjects treated with Campral concomitantly with anxiolytics, hypnotics and sedatives (including benzodiazepines), or non-opioid analgesics was similar to that of subjects taking placebo with these concomitant medications. Patients taking Campral concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.

Carcinogenicity, Mutagenicity and Impairment of Fertility

Dietary administration of acamprosate calcium for 2 years to Sprague-Dawley rats at doses of 25, 100 and 400 mg/kg/day (up to 3 times the MRHD on an AUC basis) and CD-1 mice at doses of 400, 1200 and 3600 mg/kg/day (up to 25 times the MRHD on an AUC basis) showed no evidence of increased tumor incidence.

Acamprosate calcium was negative in all genetic toxicology studies conducted. Acamprosate calcium demonstrated no evidence of genotoxicity in an in vitro bacterial reverse point mutation assay (Ames assay) or an in vitro mammalian cell gene mutation test using Chinese Hamster Lung V79 cells. No clastogenicity was observed in an in vitro chromosomal aberration assay in human lymphocytes and no chromosomal damage detected in an in vivo mouse micronucleus assay.

Acamprosate calcium had no effect on fertility after treatment for 70 days prior to mating in male rats and for 14 days prior to mating, throughout mating, gestation and lactation in female rats at doses up to 1000 mg/kg/day (approximately 4 times the maximum recommended human daily oral dose on a mg/m2 basis). In mice, acamprosate calcium administered orally for 60 days prior to mating and throughout gestation in females at doses up to 2400 mg/kg/day (approximately 5 times the maximum recommended human daily oral dose on a mg/m2 basis) had no effect on fertility.

Pregnancy Category C

Teratogenic effects: Acamprosate calcium has been shown to be teratogenic in rats when given in doses that are approximately equal to the human dose (on a mg/m2 basis) and in rabbits when given in doses that are approximately 3 times the human dose (on a mg/m2 basis). Acamprosate calcium produced a dose-related increase in the number of fetuses with malformations in rats at oral doses of 300 mg/kg/day or greater (approximately equal to the maximum recommended human daily oral dose on a mg/m2 basis). The malformations included hydronephrosis, malformed iris, retinal dysplasia, and retroesophageal subclavian artery. No findings were observed at an oral dose of 50 mg/kg/day (approximately one-fifth the maximum recommended human daily oral dose on a mg/m2 basis). An increased incidence of hydronephrosis was also noted in Burgundy Tawny rabbits at oral doses of 400 mg/kg/day or greater (approximately 3 times the maximum recommended human daily oral dose on a mg/m2 basis). No developmental effects were observed in New Zealand white rabbits at oral doses up to 1000 mg/kg/day (approximately 8 times the maximum recommended human daily oral dose on a mg/m2 basis). The findings in animals should be considered in relation to known adverse developmental effects of ethyl alcohol, which include the characteristics of fetal alcohol syndrome (craniofacial dysmorphism, intrauterine and postnatal growth retardation, retarded psychomotor and intellectual development) and milder forms of neurological and behavioral disorders in humans. There are no adequate and well controlled studies in pregnant women. Campral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic effects: A study conducted in pregnant mice that were administered acamprosate calcium by the oral route starting on Day 15 of gestation through the end of lactation on postnatal day 28 demonstrated an increased incidence of still-born fetuses at doses of 960 mg/kg/day or greater (approximately 2 times the maximum recommended human daily oral dose on a mg/m2 basis). No effects were observed at a dose of 320 mg/kg/day (approximately one-half the maximum recommended human daily dose on a mg/m2 basis).

Labor and Delivery

The potential for Campral to affect the duration of labor and delivery is unknown.

Nursing Mothers

In animal studies, acamprosate was excreted in the milk of lactating rats dosed orally with acamprosate calcium. The concentration of acamprosate in milk compared to blood was 1.3:1. It is not known whether acamprosate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Campral is administered to a nursing woman.

Pediatric Use

The safety and efficacy of Campral have not been established in the pediatric population.

Geriatric Use

Forty-one of the 4234 patients in double-blind, placebo-controlled, clinical trials of Campral were 65 years of age or older, while none were 75 years of age or over. There were too few patients in the ≥65 age group to evaluate any differences in safety or effectiveness for geriatric patients compared to younger patients.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION).

Adverse Reactions

The adverse event data described below reflect the safety experience in over 7000 patients exposed to Campral for up to one year, including over 2000 Campral-exposed patients who participated in placebo-controlled trials.

Adverse Events Leading to Discontinuation

In placebo-controlled trials of 6 months or less, 8% of Campral-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both the placebo-treated and the Campral-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Campral-treated vs. 0.7% of placebo-treated patients). Other events, including nausea, depression, and anxiety, while accounting for discontinuation in less than 1% of patients, were nevertheless more commonly cited in association with discontinuation in Campral-treated patients than in placebo-treated patients.

Common Adverse Events Reported in Controlled Trials

Common, non-serious adverse events were collected spontaneously in some controlled studies and using a checklist in other studies. The overall profile of adverse events was similar using either method. Table 1 shows those events that occurred in any Campral treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events. The reported frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed, without regard to the causal relationship of the events to the drug.

Table 1. Events Occurring at a Rate of at Least 3% and Greater than Placebo in any Campral Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events

Body System/Preferred Term	Number of Patients (%) with Events
	Campral 1332 mg/day	Campral 1998 mg/day1	Campral Pooled2	Placebo
*includes events coded as “fracture” by sponsor; **includes events coded as “nervousness” by sponsor
1 includes 258 patients treated with acamprosate calcium 2000 mg/day, using a different dosage strength and regimen.
2 includes all patients in the first two columns as well as 83 patients treated with acamprosate calcium 3000 mg/day, using a different dosage strength and regimen.
Number of patients in Treatment Group	397	1539	2019	1706
Number (%) of patients with an AE	248 (62%)	910 (59%)	1231 (61%)	955 (56%)
Body as a Whole	121 (30%)	513 (33%)	685 (34%)	517 (30%)
Accidental Injury*	17 ( 4%)	44 ( 3%)	70 ( 3%)	52 ( 3%)
Asthenia	29 ( 7%)	79 ( 5%)	114 ( 6%)	93 ( 5%)
Pain	6 ( 2%)	56 ( 4%)	65 ( 3%)	55 ( 3%)
Digestive System	85 (21%)	440 (29%)	574 (28%)	344 (20%)
Anorexia	20 ( 5%)	35 ( 2%)	57 ( 3%)	44 ( 3%)
Diarrhea	39 (10%)	257 (17%)	329 (16%)	166 (10%)
Flatulence	4 ( 1%)	55 ( 4%)	63 ( 3%)	28 ( 2%)
Nausea	11 ( 3%)	69 ( 4%)	87 ( 4%)	58 ( 3%)
Nervous System	150 (38%)	417 (27%)	598 (30%)	500 (29%)
Anxiety**	32 ( 8%)	80 ( 5%)	118 ( 6%)	98 ( 6%)
Depression	33 ( 8%)	63 ( 4%)	102 ( 5%)	87 ( 5%)
Dizziness	15 ( 4%)	49 ( 3%)	67 ( 3%)	44 ( 3%)
Dry mouth	13 ( 3%)	23 ( 1%)	36 ( 2%)	28 ( 2%)
Insomnia	34 ( 9%)	94 ( 6%)	137 ( 7%)	121 ( 7%)
Paresthesia	11 ( 3%)	29 ( 2%)	40 ( 2%)	34 ( 2%)
Skin and Appendages	26 ( 7%)	150 (10%)	187 ( 9%)	169 (10%)
Pruritus	12 ( 3%)	68 ( 4%)	82 ( 4%)	58 ( 3%)
Sweating	11 ( 3%)	27 ( 2%)	40 ( 2%)	39 ( 2%)

Other Events Observed During the Premarketing Evaluation of Campral

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with Campral in 20 clinical trials (4461 patients treated with Campral, 3526 of whom received the maximum recommended dose of 1998 mg/day for up to one year in duration). This listing does not include those events already listed above; events for which a drug cause was considered remote; event terms which were so general as to be uninformative; and events reported only once which were not likely to be acutely life-threatening.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the summary of adverse events in controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole –Frequent: headache, abdominal pain, back pain, infection, flu syndrome, chest pain, chills, suicide attempt; Infrequent: fever, intentional overdose, malaise, allergic reaction, abscess, neck pain, hernia, intentional injury; Rare: ascites, face edema, photosensitivity reaction, abdomen enlarged, sudden death.

Cardiovascular System –Frequent: palpitation, syncope; Infrequent: hypotension, tachycardia, hemorrhage, angina pectoris, migraine, varicose vein, myocardial infarct, phlebitis, postural hypotension; Rare: heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis, shock.

Digestive System –Frequent: vomiting, dyspepsia, constipation, increased appetite; Infrequent: liver function tests abnormal, gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, liver cirrhosis, esophagitis, hematemesis, nausea and vomiting, hepatitis; Rare: melena, stomach ulcer, cholecystitis, colitis, duodenal ulcer, mouth ulceration, carcinoma of liver.

Endocrine System –Rare: goiter, hypothyroidism.

Hemic and Lymphatic System –Infrequent: anemia, ecchymosis, eosinophilia, lymphocytosis, thrombocytopenia; Rare: leukopenia, lymphadenopathy, monocytosis.

Metabolic and Nutritional Disorders –Frequent – peripheral edema, weight gain; Infrequent: weight loss, hyperglycemia, SGOT increased, SGPT increased, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia; Rare: alkaline phosphatase increased, creatinine increased, hyponatremia, lactic dehydrogenase increased.

Musculoskeletal System –Frequent – myalgia, arthralgia; Infrequent: leg cramps; Rare: rheumatoid arthritis, myopathy.

Nervous System –Frequent –somnolence, libido decreased, amnesia, thinking abnormal, tremor, vasodilatation, hypertension; Infrequent: convulsion, confusion, libido increased, vertigo, withdrawal syndrome, apathy, suicidal ideation, neuralgia, hostility, agitation, neurosis, abnormal dreams, hallucinations, hypesthesia; Rare: alcohol craving, psychosis, hyperkinesia, twitching, depersonalization, increased salivation, paranoid reaction, torticollis, encephalopathy, manic reaction.

Respiratory System –Frequent: rhinitis, cough increased, dyspnea, pharyngitis, bronchitis; Infrequent: asthma, epistaxis, pneumonia; Rare: laryngismus, pulmonary embolus.

Skin and Appendages –Frequent: rash; Infrequent: acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis, vesiculobullous rash; Rare: psoriasis.

Special Senses –Frequent: abnormal vision, taste perversion; Infrequent: tinnitus, amblyopia, deafness; Rare: ophthalmitis, diplopia, photophobia.

Urogenital System –Frequent: impotence; Infrequent – metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormal, urinary incontinence, vaginitis; Rare: kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria, urinary urgency.

Serious Adverse Events Observed During the Non-US Postmarketing Evaluation of Campral (acamprosate calcium)

Although no causal relationship to Campral has been found, the serious adverse event of acute kidney failure has been reported to be temporally associated with Campral treatment in at least 3 patients and is not described elsewhere in the labeling.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class

Acamprosate calcium is not a controlled substance.

Physical and Psychological Dependence

Campral did not produce any evidence of withdrawal symptoms in patients in clinical trials at therapeutic doses. Post marketing data, collected retrospectively outside the U.S., have provided no evidence of Campral abuse or dependence.

OVERDOSAGE

In all reported cases of acute overdosage with Campral (total reported doses of up to 56 grams of acamprosate calcium), the only symptom that could be reasonably associated with Campral was diarrhea. Hypercalcemia has not been reported in cases of acute overdose. A risk of hypercalcemia should be considered in chronic overdosage only. Treatment of overdose should be symptomatic and supportive.

DOSAGE AND ADMINISTRATION

The recommended dose of Campral is two 333 mg tablets (each dose should total 666 mg) taken three times daily. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested as an aid to compliance in those patients who regularly eat three meals daily. A lower dose may be effective in some patients.

Treatment with Campral should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Campral should be used as part of a comprehensive psychosocial treatment program.

Dosage in Renal Impairment: For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Patients with severe renal impairment (creatinine clearance of ≤30 mL/min) should not be given Campral.

HOW SUPPLIED

Campral 333 mg tablets are enteric-coated, white, round, biconvex tablets, identified with “333” debossed on one side.

Opaque HDPE bottles of 180-NDC #0456-3330-01

Dose Pak of 180-NDC #0456-3330-60

10 X 10 Unit Dose-NDC #0456-3330-63

Storage:

Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF).

Manufactured by:

Merck Santé s.a.s.

Subsidiary of Merck KGaA, Darmstadt, Germany

37, rue Saint-Romain

69008 Lyon, France

Manufactured for:

Forest Pharmaceuticals, Inc.

Subsidiary of Forest Laboratories, Inc.

St. Louis, MO 63045

Revised: 12/2010

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 333 MG LABEL

Rx Only

NDC 0456-3330-01

Campral®

(acamprosate calcium)

Delayed-Release Tablets

333 mg

180 Tablets

FOREST PHARMACEUTICALS, INC.

Campral  acamprosate calcium  tablet, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0456-3330 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acamprosate calcium (acamprosate) acamprosate calcium 333 mg

Inactive Ingredients Ingredient Name Strength crospovidone   cellulose, microcrystalline   magnesium silicate   sodium starch glycolate type a potato   silicon dioxide   magnesium stearate   talc   propylene glycol   methacrylic acid - ethyl acrylate copolymer (1:1) type a

Product Characteristics Color WHITE (WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 333 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0456-3330-01 180 TABLET In 1 BOTTLE None 2 0456-3330-60 180 TABLET In 1 DOSE PACK None 3 0456-3330-63 100 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021431	01/11/2005

Labeler - Forest Laboratories, Inc. (001288281)

Establishment
Name	Address	ID/FEI	Operations
Merck Sante s.a.s.		384668112	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Anderson Packaging, Inc.		053217022	PACK

Establishment
Name	Address	ID/FEI	Operations
Forest Laboratories, Inc.		867188724	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Sharp Corporation		002346625	PACK

Establishment
Name	Address	ID/FEI	Operations
Merck Sante s.a.s.		384953134	MANUFACTURE

Revised: 01/2011Forest Laboratories, Inc.

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