Trazer

Trazer may be available in the countries listed below.

Ingredient matches for Trazer

Itraconazole

Itraconazole is reported as an ingredient of Trazer in the following countries:

• Italy

International Drug Name Search

Naxelan

Naxelan may be available in the countries listed below.

Ingredient matches for Naxelan

Modafinil

Modafinil is reported as an ingredient of Naxelan in the following countries:

• Chile

International Drug Name Search

Cadisozym

Cadisozym may be available in the countries listed below.

Ingredient matches for Cadisozym

Lysozyme

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

• Vietnam

International Drug Name Search

Selesyn

Selesyn may be available in the countries listed below.

Ingredient matches for Selesyn

Selenium

Selenium is reported as an ingredient of Selesyn in the following countries:

• Hungary

International Drug Name Search

Nitroderm Matrix

Nitroderm Matrix may be available in the countries listed below.

Ingredient matches for Nitroderm Matrix

Nitroglycerin

Nitroglycerin is reported as an ingredient of Nitroderm Matrix in the following countries:

• Spain

International Drug Name Search

Dulera

Generic Name: formoterol and mometasone (for MOE ter ol and moe MET a sone)

Brand Names: Dulera

What is formoterol and mometasone?

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

The combination of formoterol and mometasone is used as a maintenance treatment for asthma in adults and children who are at least 12 years old. This medication is not for use in treating an asthma or bronchospasm attack.

Formoterol and mometasone is usually given after other asthma medications have been tried without successful treatment of symptoms.

Formoterol and mometasone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about formoterol and mometasone?

Do not use formoterol and mometasone to treat an asthma attack that has already begun. Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using formoterol and mometasone.

Asthma is often treated with a combination of different drugs. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

What should I discuss with my healthcare provider before using formoterol and mometasone?

You should not use this medication if you are allergic to formoterol (Foradil, Perforomist, Symbicort) or mometasone (Asmanex). Do not use formoterol and mometasone to treat an asthma attack.

To make sure you can safely use this medication, tell your doctor if you have any of the following conditions:

• 
  

  tuberculosis;

  
  


• 
  

  an active infection of any kind;

  
  


• 
  

  herpes infection of the eye;

  
  


• 
  

  heart disease;

  
  


• 
  

  liver disease;

  
  


• 
  

  low bone mineral density;

  
  


• 
  

  glaucoma or cataracts;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether formoterol and mometasone 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 formoterol and mometasone 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. Mometasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. Do not give this medicine to a child younger than 12 years old without the advice of a doctor.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use formoterol and mometasone?

Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using formoterol and mometasone.

This medication comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use formoterol and mometasone to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

The usual dose is 2 inhalations twice each day, morning and evening. Follow your doctor's instructions.

Shake the inhaler canister well before each use.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using the inhaler. Do not swallow.

Asthma is often treated with a combination of different drugs. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Store at room temperature away from moisture and heat.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

What happens if I miss a dose?

Use the medication as soon as you remember, then wait 12 hours before using the medication again. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed 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 nervousness, dry mouth, nausea, sleep problems (insomnia), tremors, muscle cramps, chest pain, fast or pounding heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).

What should I avoid while using formoterol and mometasone?

Do not use a second form of formoterol (such as Foradil, Perforomist, or Symbicort) or use another similar long-acting inhaled bronchodilator (LABA) such as salmeterol (Advair, Serevent) or arformoterol (Brovana).

Mometasone can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Formoterol and mometasone 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 this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  sores or white patches in your mouth or throat;

  
  


• 
  

  wheezing, choking, or other breathing problems after using this medication;

  
  


• 
  

  blurred vision, eye pain, or seeing halos around lights;

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;

  
  


• 
  

  chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;

  
  


• 
  

  increased thirst or hunger, urinating more than usual; or

  
  


• 
  

  worsening asthma symptoms.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  stuffy nose, sinus pain, sore throat;

  
  


• 
  

  changes in menstrual periods;

  
  


• 
  

  hoarseness or deepened voice;

  
  


• 
  

  dizziness, anxiety, headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  back pain, muscle cramps;

  
  


• 
  

  sore throat, dry mouth, cough, stuffy nose; or

  
  


• 
  

  skin rash, 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 formoterol?

Many drugs can interact with formoterol and mometasone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a diuretic (water pill);

  
  


• 
  

  caffeine, diet pills, cold medicine, or a stimulant medication;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  anti-malaria medication;

  
  


• 
  

  heart or blood pressure medication;

  
  


• 
  

  heart rhythm medicine;

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  migraine headache medicine;

  
  


• 
  

  narcotic medication;

  
  


• 
  

  an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), levofloxacin (Levaquin), and others;

  
  


• 
  

  antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal), and others;

  
  


• 
  

  an antidepressant such as amitriptylline (Elavil, Vanatrip), protriptyline (Vivactil), and others;

  
  


• 
  

  an MAO inhibitor such as phenelzine (Nardil), selegiline (Eldepryl, Emsam), tranylcypromine (Parnate), and others; or

  
  


• 
  

  medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran).

  
  

This list is not complete and there are many other drugs that can interact with formoterol and mometasone. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Dulera resources

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

• Dulera Prescribing Information (FDA)


• Dulera Advanced Consumer (Micromedex) - Includes Dosage Information


• Dulera Inhalation Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• Dulera Consumer Overview

Compare Dulera with other medications

• Asthma
• Asthma, Maintenance

Where can I get more information?

• Your pharmacist can provide more information about formoterol and mometasone.

See also: Dulera side effects (in more detail)

Ulcerlmin

Ulcerlmin may be available in the countries listed below.

Ingredient matches for Ulcerlmin

Sucralfate

Sucralfate is reported as an ingredient of Ulcerlmin in the following countries:

• Japan

International Drug Name Search

Daksol

Daksol may be available in the countries listed below.

Ingredient matches for Daksol

Lamotrigine

Lamotrigine is reported as an ingredient of Daksol in the following countries:

• Chile

Secnidazole

Secnidazole is reported as an ingredient of Daksol in the following countries:

• Colombia


• Venezuela

International Drug Name Search

Di-Gel Liquid Suspension

Pronunciation: a-LOO-min-uhm/mag-NEE-zee-uhm/si-METH-i-kone
Generic Name: Aluminum/Magnesium/Simethicone
Brand Name: Examples include Di-Gel Liquid and Mylanta

Di-Gel Liquid Suspension is used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.

Di-Gel Liquid Suspension is an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also causes the gas produced by some foods to remain dissolved, allowing it to be passed through the system more comfortably.

Do NOT use Di-Gel Liquid Suspension if:

• you are allergic to any ingredient in Di-Gel Liquid Suspension


• you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives)

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

Before using Di-Gel Liquid Suspension:

Some medical conditions may interact with Di-Gel Liquid Suspension. 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 preparation, or dietary supplement


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


• if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy


• if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Di-Gel Liquid Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because they may increase the actions and the risk of Di-Gel Liquid Suspension's side effects


• Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Di-Gel Liquid Suspension, especially when taken at the same time as Di-Gel Liquid Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Di-Gel Liquid Suspension 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 Di-Gel Liquid Suspension:

Use Di-Gel Liquid Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Di-Gel Liquid Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Do not use Di-Gel Liquid Suspension within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because their effectiveness may be decreased by Di-Gel Liquid Suspension.


• If you miss a dose of Di-Gel Liquid Suspension 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 and 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 how to use Di-Gel Liquid Suspension.

Important safety information:

• Do NOT take more than the recommended dose or take the maximum dose for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor.


• Di-Gel Liquid Suspension has aluminum and magnesium in it. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see has aluminum or magnesium in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Di-Gel Liquid Suspension while you are pregnant. If you are or will be breast-feeding while you use Di-Gel Liquid Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Di-Gel Liquid Suspension:

All medicines may 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.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

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: Di-Gel 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.

Proper storage of Di-Gel Liquid Suspension:

Store Di-Gel Liquid Suspension between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Di-Gel Liquid Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Di-Gel Liquid Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Di-Gel Liquid Suspension is 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 Di-Gel Liquid Suspension. 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 Di-Gel Liquid resources

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

Compare Di-Gel Liquid with other medications

• Gas
• GERD
• Indigestion

Rivastigmine

In the US, Rivastigmine (rivastigmine systemic) is a member of the drug class cholinesterase inhibitors and is used to treat Alzheimer's Disease and Parkinson's Disease.

US matches:

• Rivastigmine


• Rivastigmine Patch


• Rivastigmine Solution


• Rivastigmine transdermal

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N06DA03

CAS registry number (Chemical Abstracts Service)

0123441-03-2

Chemical Formula

C14-H22-N2-O2

Molecular Weight

250

Therapeutic Categories

Nootropic

Anti-dementia agent

Enzyme inhibitor, acetylcholinesterase

Chemical Name

(-)-m-[(S)-1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate

Foreign Names

• Rivastigminum (Latin)
• Rivastigmin (German)
• Rivastigmine (French)
• Rivastigmina (Spanish)

Generic Names

• Rivastigmine (OS: BAN, DCF, USAN)
• ENA 713 (IS: Sandoz)
• SDZ 212-713 (IS: Sandoz)
• SDZ-ENA 713 (IS: Sandoz)

Brand Names

• Exelon
  Novartis, Switzerland; Novartis, Germany; Novartis, Finland; Novartis, France; Novartis, United Kingdom; Novartis, Croatia (Hrvatska); Novartis, Sweden; Novartis, Tunisia; Novartis, Turkey; Novartis Europharm, Austria



• Prometax
  Novartis, Luxembourg; Novartis, Slovakia



• Remizeral
  Raffo, Argentina



• Rivadem
  Torrent, Myanmar



• Exelon
  Lyfjaver, Iceland; Novartis, Argentina; Novartis, Australia; Novartis, Bangladesh; Novartis, Belgium; Novartis, Bulgaria; Novartis, Bahrain; Novartis, Canada; Novartis, Switzerland; Novartis, Chile; Novartis, China; Novartis, Colombia; Novartis, Czech Republic; Novartis, Denmark; Novartis, Ecuador; Novartis, Spain; Novartis, Finland; Novartis, France; Novartis, United Kingdom; Novartis, Greece; Novartis, Hong Kong; Novartis, Hungary; Novartis, Indonesia; Novartis, Ireland; Novartis, Israel; Novartis, India; Novartis, Iceland; Novartis, Italy; Novartis, Sri Lanka; Novartis, Luxembourg; Novartis, Mexico; Novartis, Malaysia; Novartis, Netherlands; Novartis, Norway; Novartis, New Zealand; Novartis, Oman; Novartis, Philippines; Novartis, Portugal; Novartis, Romania; Novartis, Serbia; Novartis, Russian Federation; Novartis, Sweden; Novartis, Singapore; Novartis, Slovenia; Novartis, Slovakia; Novartis, Thailand; Novartis, Taiwan; Novartis, United States; Novartis, Venezuela; Novartis, South Africa; Novartis Europharm, Austria; Novartis Pharmaceuticals, Peru



• Prometax
  Bial, Portugal; Biofutura, Italy; Biosintética, Brazil; Laboratorios Dr Esteve, Spain; Novartis, Greece; Novartis, Slovakia; Novartis Europharm Ltd., Denmark



• Rivamer
  Sun, Myanmar



• Rivastigmine Tartrate
  Dr. Reddy's, United States; Sun, United States; Watson, United States

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
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.

Gestonette

Gestonette may be available in the countries listed below.

Ingredient matches for Gestonette

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Gestonette in the following countries:

• Denmark

Gestodene

Gestodene is reported as an ingredient of Gestonette in the following countries:

• Denmark

International Drug Name Search

Flunitrazepam L.CH.

Flunitrazepam L.CH. may be available in the countries listed below.

Ingredient matches for Flunitrazepam L.CH.

Flunitrazepam

Flunitrazepam is reported as an ingredient of Flunitrazepam L.CH. in the following countries:

• Chile

International Drug Name Search

Protirelin

In the US, Protirelin (protirelin systemic) is a member of the drug class miscellaneous uncategorized agents.

US matches:

• Protirelin Intravenous

UK matches:

• Protirelin Ampoules (Cambridge Laboratories)
• Protirelin Ampoules (Cambridge Laboratories) (SPC)

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V04CJ02

CAS registry number (Chemical Abstracts Service)

0024305-27-9

Chemical Formula

C16-H22-N6-O4

Molecular Weight

362

Therapeutic Categories

Diagnostic agent

Hypothalamic hormone: Thyrotropin releasing hormone, TRH

Chemical Name

L-Prolinamide, 5-oxo-L-prolyl-L-histidyl-

Foreign Names

• Protirelinum (Latin)
• Protirelin (German)
• Protiréline (French)
• Protirelina (Spanish)

Generic Names

• Protirelin (OS: USAN, JAN, BAN)
• Protirelina (OS: DCIT)
• Protiréline (OS: DCF)
• Abbott 38579 (IS: Abbott)
• Lopremone (IS)
• RU 15077 (IS)
• TRF (IS)
• TRH (IS)
• Tyroliberin (IS)
• Protirelin (PH: BP 2010, JP XIV, Ph. Eur. 6)
• Protiréline (PH: Ph. Eur. 6)
• Protirelinum (PH: Ph. Eur. 6)
• Protirelin Tartrate (OS: JAN)
• Protirelin Tartrate (PH: JP XIV)

Brand Names

• Antepan
  Henning Berlin, Germany; Sanofi-Aventis, Austria; Sanofi-Aventis, Germany



• Protirelin
  Cambridge Laboratories, United Kingdom



• Relefact TRH
  Aventis, Israel; Odan, Canada; Sanofi-aventis, Greece



• Stimu-TSH
  Ferring, France



• TRH Ferring
  Ferring, Argentina; Ferring, Germany; Ferring, Turkey



• TRH Prem
  Novartis Consumer Health, Spain



• TRH
  Ferring, Israel; Tanabe Mitsubishi, Japan; UCB, Luxembourg



• TRH-UCB
  UCB, Luxembourg



• Alhiruto
  Fuji Yakuhin, Japan



• Bognin
  Nichi-Iko PharmaceuticalJMA, Japan



• Hirlok
  Sawai Seiyaku, Japan



• Hirtonin
  Takeda, Japan



• Hishidarin
  Nipro PharmaNipurofama, Japan



• Oriston
  Towa Yakuhin, Japan

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)
SPC	Summary of Product Characteristics (UK)
USAN	United States Adopted Name

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

Callofin

Callofin may be available in the countries listed below.

Ingredient matches for Callofin

Salicylic Acid

Salicylic Acid is reported as an ingredient of Callofin in the following countries:

• Spain

International Drug Name Search

Bicphenin

Bicphenin may be available in the countries listed below.

Ingredient matches for Bicphenin

Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Bicphenin in the following countries:

• Japan

International Drug Name Search

Gyno-Femidazol

Gyno-Femidazol may be available in the countries listed below.

Ingredient matches for Gyno-Femidazol

Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Gyno-Femidazol in the following countries:

• Poland

International Drug Name Search

Metformine HCl Aurobindo

Metformine HCl Aurobindo may be available in the countries listed below.

Ingredient matches for Metformine HCl Aurobindo

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformine HCl Aurobindo in the following countries:

• Netherlands

International Drug Name Search

Enimon

Enimon may be available in the countries listed below.

Ingredient matches for Enimon

Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Enimon in the following countries:

• Greece

International Drug Name Search

Dilex-G 200

Generic Name: dyphylline and guaifenesin (DYE fil in and gwye FEN e sin)

Brand Names: COPD, Difil G, Difil-G Forte, Dilex-G, Dilex-G 200, Dy-G, Dyflex-G, Dyphyllin-GG, Dyphylline GG, Dyphylline GG ES, Jay-Phyl, Lufyllin-GG, Panfil G

What is Dilex-G 200 (dyphylline and guaifenesin)?

Dyphylline is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dyphylline and guaifenesin is used to treat cough and breathing problems caused by bronchial asthma, chronic bronchitis, or emphysema. This medication is not a cure for asthma, bronchitis, or emphysema.

Dyphylline and guaifenesin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dyphylline and Dilex-G 200 (dyphylline and guaifenesin)?

You should not use this medicine if you are allergic to dyphylline or guaifenesin. This medication will not treat an asthma attack.

Before taking this medication, tell your doctor if you have heart disease or a history of heart attack, high blood pressure, overactive thyroid, or a stomach ulcer.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

What should I discuss with my healthcare provider before taking Dilex-G 200 (dyphylline and guaifenesin)?

You should not use this medicine if you are allergic to dyphylline or guaifenesin. This medication will not treat an asthma attack.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  heart disease or a history of heart attack;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  a stomach ulcer.

  
  

FDA pregnancy category C. It is not known whether dyphylline and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Dyphylline and guaifenesin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Dilex-G 200 (dyphylline and guaifenesin)?

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.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take dyphylline and guaifenesin with food if it upsets your stomach.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using dyphylline and guaifenesin.

Store at room temperature away from moisture, heat, and light.

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.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, diarrhea, thirst, sweating, fast or slow heart rate, ringing in your ears, feeling anxious or irritable, and seizure (convulsions).

What should I avoid while taking Dilex-G 200 (dyphylline and guaifenesin)?

Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

Dilex-G 200 (dyphylline and guaifenesin) 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:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  rapid breathing;

  
  


• 
  

  muscle twitching;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  extreme thirst with headache, nausea, vomiting, and weakness.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  mild nausea, vomiting, or stomach pain;

  
  


• 
  

  feeling restless, agitated, or irritable;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  warmth, redness, or tingly feeling under your skin.

  
  

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 dyphylline and guaifenesin ?

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

• 
  

  probenecid (Benemid);

  
  


• 
  

  aminophylline (Phyllocontin, Truphylline); or

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl).

  
  

This list is not complete and other drugs may interact with dyphylline and guaifenesin. 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 Dilex-G 200 resources

• Dilex-G 200 Side Effects (in more detail)
• Dilex-G 200 Use in Pregnancy & Breastfeeding
• Dilex-G 200 Drug Interactions
• Dilex-G 200 Support Group
• 0 Reviews for Dilex-G 200 - Add your own review/rating

• COPD MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilex-G Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Dilex-G 200 with other medications

• Asthma
• Bronchitis

Where can I get more information?

• Your pharmacist can provide more information about dyphylline and guaifenesin.

See also: Dilex-G 200 side effects (in more detail)

Mydripine

Mydripine may be available in the countries listed below.

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Atropine

Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Mydripine in the following countries:

• Bangladesh

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Pharmapar

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Paroxetine

Paroxetine is reported as an ingredient of Pharmapar in the following countries:

• Vietnam

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Micronazol

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Itraconazole

Itraconazole is reported as an ingredient of Micronazol in the following countries:

• Greece

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Felocord

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Felodipine

Felodipine is reported as an ingredient of Felocord in the following countries:

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Conan

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Quinapril

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

• Japan

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Afipran

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Metoclopramide

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

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Nadroparin Calcium

Scheme

Rec.INN

Therapeutic Categories

Anticoagulant agent

Heparin, low molecular weight - LMWH

Chemical Name

Calcium salt of a low molecular weight heparin fraction.

Foreign Names

• Nadroparinum calcicum (Latin)
• Nadroparin calcium (German)
• Nadroparine calcique (French)
• Nadroparina calcica (Spanish)

Generic Names

• Nadroparin Calcium (OS: BAN)
• Nadroparine calcique (OS: DCF)
• CY 216 (IS: Sanofi)
• Heparin, niedermolekular 4-5 calcium (IS)
• Nadroparin Calcium (PH: BP 2010, Ph. Eur. 6)
• Nadroparin-Calcium (PH: Ph. Eur. 6)
• Nadroparine calcique (PH: Ph. Eur. 6)
• Nadroparinum calcicum (PH: Ph. Eur. 6)

Brand Names

• Fraxiforte
  GlaxoSmithKline, Switzerland



• Fraxiparin
  GlaxoSmithKline, Austria; GlaxoSmithKline, Costa Rica; GlaxoSmithKline, Germany; GlaxoSmithKline, Dominican Republic; GlaxoSmithKline, Georgia; GlaxoSmithKline, Guatemala; GlaxoSmithKline, Honduras; GlaxoSmithKline, Israel; GlaxoSmithKline, Nicaragua; GlaxoSmithKline, Panama; GlaxoSmithKline, El Salvador



• Fraxiparina
  Glaxo SmithKline, Spain; GlaxoSmithKline, Italy; GlaxoSmithKline, Portugal



• Fraxiparine
  Glaxo Wellcome, Bulgaria; GlaxoSmithKline, Argentina; GlaxoSmithKline, Belgium; GlaxoSmithKline, Bulgaria; GlaxoSmithKline, Bahrain; GlaxoSmithKline, Canada; GlaxoSmithKline, Switzerland; GlaxoSmithKline, Chile; GlaxoSmithKline, China; GlaxoSmithKline, Czech Republic; GlaxoSmithKline, Ecuador; GlaxoSmithKline, Estonia; GlaxoSmithKline, France; GlaxoSmithKline, Greece; GlaxoSmithKline, Hong Kong; GlaxoSmithKline, Croatia (Hrvatska); GlaxoSmithKline, Hungary; GlaxoSmithKline, Indonesia; GlaxoSmithKline, Lithuania; GlaxoSmithKline, Luxembourg; GlaxoSmithKline, Latvia; GlaxoSmithKline, Mexico; GlaxoSmithKline, Malaysia; GlaxoSmithKline, Netherlands; GlaxoSmithKline, Oman; GlaxoSmithKline, Peru; GlaxoSmithKline, Philippines; GlaxoSmithKline, Poland; GlaxoSmithKline, Romania; GlaxoSmithKline, Serbia; GlaxoSmithKline, Russian Federation; GlaxoSmithKline, Singapore; GlaxoSmithKline, Slovenia; GlaxoSmithKline, Slovakia; GlaxoSmithKline, Thailand; GlaxoSmithKline, Tunisia; GlaxoSmithKline, Turkey; GlaxoSmithKline, Venezuela; GlaxoSmithKline, South Africa; Sanofi-Aventis, Colombia; Sanofi-Aventis, Dominican Republic; Sanofi-Aventis, Taiwan



• Fraxodi
  Euro, Netherlands; GlaxoSmithKline, Belgium; GlaxoSmithKline, Germany; GlaxoSmithKline, France; GlaxoSmithKline, Hungary; GlaxoSmithKline, Italy; GlaxoSmithKline, Luxembourg; GlaxoSmithKline, Netherlands; GlaxoSmithKline, Oman; GlaxoSmithKline, Poland; GlaxoSmithKline, Portugal; GlaxoSmithKline, Tunisia; GlaxoSmithKline, Turkey; Medcor, Netherlands



• Seledie
  Glaxo Allen, Italy



• Seleparina
  Italfarmaco, Italy

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Linvas

Linvas may be available in the countries listed below.

Ingredient matches for Linvas

Lisinopril

Lisinopril is reported as an ingredient of Linvas in the following countries:

• India

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Lexa

Lexa may be available in the countries listed below.

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Levofloxacin

Levofloxacin is reported as an ingredient of Lexa in the following countries:

• Indonesia

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Thilomaxine

Thilomaxine may be available in the countries listed below.

Ingredient matches for Thilomaxine

Tobramycin

Tobramycin is reported as an ingredient of Thilomaxine in the following countries:

• Turkey

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Sodorant

Sodorant may be available in the countries listed below.

Ingredient matches for Sodorant

Aluminium Chlorohydrate

Aluminium Chlorohydrate is reported as an ingredient of Sodorant in the following countries:

• Argentina

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Amixx

Amixx may be available in the countries listed below.

Ingredient matches for Amixx

Amantadine

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

• Germany

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Emplex

Emplex may be available in the countries listed below.

Ingredient matches for Emplex

Methotrexate

Methotrexate is reported as an ingredient of Emplex in the following countries:

• Slovakia

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Levofloxacin Sandoz

Levofloxacin Sandoz may be available in the countries listed below.

Ingredient matches for Levofloxacin Sandoz

Levofloxacin

Levofloxacin hemihydrate (a derivative of Levofloxacin) is reported as an ingredient of Levofloxacin Sandoz in the following countries:

• Switzerland

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Bell Homatropine

Bell Homatropine may be available in the countries listed below.

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Homatropine

Homatropine Hydrobromide is reported as an ingredient of Bell Homatropine in the following countries:

• India

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Novatec

Novatec may be available in the countries listed below.

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Lisinopril

Lisinopril is reported as an ingredient of Novatec in the following countries:

• Luxembourg

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Flox

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Norfloxacin

Norfloxacin is reported as an ingredient of Flox in the following countries:

• Brazil

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Duac

Dosage Form: topical gel
Duac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%

For Dermatological Use Only.

Not for Ophthalmic Use.

Rx Only

Duac Description

Duac® Gel contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate), equivalent to 1% clindamycin, and 5% benzoyl peroxide.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

Clindamycin phosphate is C18H34ClN2O8PS. The structural formula for clindamycin phosphate is represented below:

Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7 - chloro - 6,7,8 - trideoxy - 6 - (1 - methyl - trans - 4 - propyl - L - 2 - pyrrolidinecarboxamido) - 1 - thio - L - threo - α - D - galacto - octopyranoside 2-(dihydrogen phosphate).

Benzoyl peroxide is C14H10O4. It has the following structural formula:

Benzoyl peroxide has a molecular weight of 242.23.

Each gram of Duac® Gel contains 10 mg (1%) clindamycin, as phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.

Duac - Clinical Pharmacology

A comparative study of the pharmacokinetics of Duac® Gel and 1% clindamycin solution alone in 78 patients indicated that mean plasma clindamycin levels during the four week dosing period were < 0.5 ng/ml for both treatment groups.

Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid.

Microbiology

Mechanism of Action

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis.

Benzoyl peroxide is a potent oxidizing agent.

In Vivo Activity

No microbiology studies were conducted in the clinical trials with this product.

In Vitro Activity

The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this is not known.

Drug Resistance

There are reports of an increase of P. acnes resistance to clindamycin in the treatment of acne. In patients with P. acnes resistant to clindamycin, the clindamycin component may provide no additional benefit beyond benzoyl peroxide alone.

Clinical Studies

In five randomized, double-blind clinical studies of 1,319 patients, 397 used Duac® Gel, 396 used benzoyl peroxide, 349 used clindamycin and 177 used vehicle. Duac® Gel applied once daily for 11 weeks was significantly more effective than vehicle, benzoyl peroxide, and clindamycin in the treatment of inflammatory lesions of moderate to moderately severe facial acne vulgaris in three of the five studies (Studies 1, 2, and 5).

Patients were evaluated and acne lesions counted at each clinical visit: weeks 2, 5, 8, 11. The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at week 11. Patients were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily, in the evening before retiring. Percent reductions in inflammatory lesion counts after treatment for 11 weeks in these five studies are shown in the following table:

Mean percent reduction in inflammatory lesion counts

	Study 1 (n=120)	Study 2 (n=273)	Study 3 (n=280)	Study 4 (n=288)	Study 5 (n=358)
Duac® Gel	65%	56%	42%	57%	52%
Benzoyl Peroxide	36%	37%	32%	57%	41%
Clindamycin	34%	30%	38%	49%	33%
Vehicle	19%	-0.4%	29%		29%

The Duac® Gel group showed greater overall improvement in the investigator’s global assessment than the benzoyl peroxide, clindamycin and vehicle groups in three of the five studies (Studies 1, 2, and 5).

Clinical studies have not adequately demonstrated the effectiveness of Duac® Gel versus benzoyl peroxide alone in the treatment of non-inflammatory lesions of acne.

Indications and Usage for Duac

Duac® Gel is indicated for the topical treatment of inflammatory acne vulgaris.

Duac® Gel has not been demonstrated to have any additional benefit when compared to benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

Contraindications

Duac® Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis.

Warnings

ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium difficile AND STOOL ASSAY FOR Clostridium difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Precautions

General

For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs, discontinue use of this medication and take appropriate measures.

Avoid contact with eyes and mucous membranes.

Clindamycin and erythromycin containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

Information for Patients

Patients using Duac® Gel should receive the following information and instructions:

1. Duac® Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.
   


2. This medication should not be used for any disorder other than that for which it was prescribed.
   


3. Patients should not use any other topical acne preparation unless otherwise directed by their physician.


4. Patients should report any signs of local adverse reactions to their physician. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
   


5. Duac® Gel may bleach hair or colored fabric.
   


6. Duac® Gel can be stored at room temperature up to 25°C (77°F) for up to 2 months. Do not freeze. Keep tube tightly closed. Keep out of the reach of small children. Discard any unused product after 2 months.
   


7. Before applying Duac® Gel to affected areas, wash the skin gently, rinse with warm water, and pat dry.
   


8. Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown.

In a 2-year dermal carcinogenicity study in mice, treatment with Duac® Gel at doses up to 8000 mg/kg/day (16 times the highest recommended adult human dose of 2.5 g Duac® Gel, based on mg/m2) did not cause an increase in skin tumors. However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats.

In a 52-week photocarcinogenicity study in hairless mice (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical treatment with Duac® Gel and exposure to ultraviolet radiation.

Genotoxicity studies were not conducted with Duac® Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Studies have not been performed with Duac® Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g Duac® Gel, based on mg/m2) revealed no effects on fertility or mating ability.

Pregnancy

Teratogenic Effects

Pregnancy Category C 

Animal reproduction studies have not been conducted with Duac® Gel or benzoyl peroxide. It is also not known whether Duac® Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Duac® Gel should be given to a pregnant woman only if clearly needed.

Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.

Nursing Women

It is not known whether Duac® Gel is secreted into human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

Adverse Reactions

During clinical trials, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows:

Local reactions with use of Duac® Gel % of patients using Duac® Gel with symptom present Combined results from 5 studies (n=397)

	Before Treatment (Baseline)			During Treatment
	Mild	Moderate	Severe	Mild	Moderate	Severe
Erythema	28%	3%	0	26%	5%	0
Peeling	6%	<1%	0	17%	2%	0
Burning	3%	<1%	0	5%	<1%	0
Dryness	6%	<1%	0	15%	1%	0

(Percentages derived by # subjects with symptom score/# enrolled Duac® Gel subjects, n = 397).

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in post-marketing use with Duac® Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to a drug exposure.

Duac Dosage and Administration

Duac® Gel should be applied once daily, in the evening or as directed by the physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

How is Duac Supplied

Duac® (clindamycin phosphate and benzoyl peroxide), 1.2%/5% Gel is available in:

• 45 gram tube                                  NDC 0145-2371-05

Prior to Dispensing: Store in a cold place, preferably in a refrigerator, between 2°C and 8°C (36°F and 46°F). Do not freeze.

Dispensing Instructions for the Pharmacist: Dispense Duac® Gel with a 60 day expiration date and specify “Store at room temperature up to 25°C (77°F). Do not freeze.”

Keep tube tightly closed. Keep out of the reach of small children.

©2011 Stiefel Laboratories, Inc.

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

DUA:4PI

Rev. July 2011

Duac is a registered trademark of Stiefel Laboratories, Inc.

Principal Display Panel

NDC 0145-2371-05

Duac®

(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%

45 grams

Rx only

For external use only

DEVCOMP-0001937

Principal Display Panel

NDC 0145-5371-61

Duac®

(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%

20 x 5 g

Professional Samples

Rx only

For external use only.

Available in 45 gram tubes

DEVCOMP-0001935

Principal Display Panel

NDC 0145-2367-01

Duac  clindamycin phosphate and benzoyl peroxide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0145-2371 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg  in 1 g BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C   DIMETHICONE   DISODIUM LAURYL SULFOSUCCINATE   EDETATE DISODIUM   GLYCERIN   METHYLPARABEN   POLOXAMER 182   WATER   SILICON DIOXIDE   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0145-2371-05 1 TUBE In 1 CARTON contains a TUBE 1 45 g In 1 TUBE This package is contained within the CARTON (0145-2371-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050741	10/22/2007

Duac  clindamycin phosphate and benzoyl peroxide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0145-5371 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg  in 1 g BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C   DIMETHICONE   DISODIUM LAURYL SULFOSUCCINATE   EDETATE DISODIUM   GLYCERIN   METHYLPARABEN   POLOXAMER 182   WATER   SILICON DIOXIDE   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0145-5371-61 20 TUBE In 1 CARTON contains a TUBE (0145-5371-01) 1 0145-5371-01 5 g In 1 TUBE This package is contained within the CARTON (0145-5371-61)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050741	03/01/2011

Duac  clindamycin phosphate and benzoyl peroxide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0145-2367 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg  in 1 g BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C   DIMETHICONE   DISODIUM LAURYL SULFOSUCCINATE   EDETATE DISODIUM   GLYCERIN   METHYLPARABEN   POLOXAMER 182   WATER   SILICON DIOXIDE   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0145-2367-01 1 TUBE In 1 CARTON contains a TUBE 1 45 g In 1 TUBE This package is contained within the CARTON (0145-2367-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050741	10/22/2007	12/31/2012

Labeler - Stiefel Laboratories Inc (808842343)

Revised: 01/2012Stiefel Laboratories Inc