Sicca-Stulln

Sicca-Stulln may be available in the countries listed below.

Ingredient matches for Sicca-Stulln

Hypromellose

Hypromellose is reported as an ingredient of Sicca-Stulln in the following countries:

• Germany

International Drug Name Search

Compesolon

Compesolon may be available in the countries listed below.

Ingredient matches for Compesolon

Prednisolone

Prednisolone is reported as an ingredient of Compesolon in the following countries:

• Taiwan

International Drug Name Search

Hebdo'pil

Hebdo'pil may be available in the countries listed below.

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

Ingredient matches for Hebdo'pil

Medroxyprogesterone

Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Hebdo'pil in the following countries:

• France

International Drug Name Search

Buprenorphine

Pronunciation: byoo-pre-NOR-feen
Generic Name: Buprenorphine
Brand Name: Buprenex

Buprenorphine is used for:

Treating moderate to severe pain.

Buprenorphine is a narcotic analgesic. It works by working in the brain and nervous system to decrease pain.

Do NOT use Buprenorphine if:

• you are allergic to any ingredient in Buprenorphine


• you are taking sodium oxybate (GHB)

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

Before using Buprenorphine:

Some medical conditions may interact with Buprenorphine. 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 a history of blood or electrolyte problems, breathing or lung problems (eg, chronic obstructive pulmonary disease), underactive thyroid, adrenal gland problems (eg, Addison disease), liver or kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, gallbladder problems, or stomach problems


• if you have a history of recent head injury, growths in the brain (eg, tumor), or increased pressure in the brain, or muscle problems (eg, myasthenia gravis)


• if you have a history of mental or mood problems, drug or alcohol abuse, or if you have a physical dependence on narcotic medicines (eg, morphine) or other opiates (eg, heroin)

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

• Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because the side effects of Buprenorphine may be increased


• Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of severe drowsiness, severe breathing problems, and seizures may be increased


• Naltrexone or rifampin because the effectiveness of Buprenorphine may be decreased


• Methadone because effectiveness may be decreased by Buprenorphine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Buprenorphine 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 Buprenorphine:

Use Buprenorphine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Buprenorphine is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Buprenorphine at home, carefully follow the injection procedures taught to you by your health care provider.


• If Buprenorphine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Buprenorphine, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Buprenorphine.

Important safety information:

• Buprenorphine may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Buprenorphine. Using Buprenorphine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Buprenorphine. Buprenorphine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Buprenorphine may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.


• Buprenorphine may cause withdrawal symptoms if you have a physical dependence on narcotic medicines (eg, morphine) or other opiates (eg, heroin). Talk with your doctor if you are dependent on narcotic medicines or other opiates.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Buprenorphine.


• LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Buprenorphine with caution in the ELDERLY because they may be more sensitive to its effects, especially decreased breathing and drowsiness.


• Use Buprenorphine with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Buprenorphine, discuss with your doctor the benefits and risks of using Buprenorphine during pregnancy. Buprenorphine is excreted in breast milk. Do not breast-feed while taking Buprenorphine.

When used for long periods of time or at high doses, some people develop a need to continue taking Buprenorphine. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Buprenorphine, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Buprenorphine:

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; dizziness; drowsiness; headache; nausea; sweating; vomiting;

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); anxiety or nervousness; dark urine; fast or irregular heartbeat; mental or mood changes (eg, depression); pale stools; pain, redness, or swelling at the injection site; slow or shallow breathing; unusual weakness; vision changes; yellowing of eyes or skin.

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: Buprenorphine 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 excessive drowsiness; severe dizziness; very slow and shallow breathing; very small pupils.

Proper storage of Buprenorphine:

Buprenorphine is usually handled and stored by a health care provider. If you are using Buprenorphine at home, store Buprenorphine as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Buprenorphine, please talk with your doctor, pharmacist, or other health care provider.


• Buprenorphine 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 Buprenorphine. 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 Buprenorphine resources

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

• buprenorphine Injection Advanced Consumer (Micromedex) - Includes Dosage Information


• Buprenex Prescribing Information (FDA)


• Buprenorphine Hydrochloride Monograph (AHFS DI)


• Butrans Advanced Consumer (Micromedex) - Includes Dosage Information


• Butrans Consumer Overview


• Subutex Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Buprenorphine with other medications

• Opiate Dependence
• Pain

Cardival

Cardival may be available in the countries listed below.

Ingredient matches for Cardival

Valsartan

Valsartan is reported as an ingredient of Cardival in the following countries:

• Bangladesh

International Drug Name Search

Convulex Meyer

Convulex Meyer may be available in the countries listed below.

Ingredient matches for Convulex Meyer

Carbamazepine

Carbamazepine is reported as an ingredient of Convulex Meyer in the following countries:

• Venezuela

International Drug Name Search

Convermin M

Convermin M may be available in the countries listed below.

Ingredient matches for Convermin M

Betahistine

Betahistine dimesilate (a derivative of Betahistine) is reported as an ingredient of Convermin M in the following countries:

• Japan

International Drug Name Search

Coopers Tick Grease

Coopers Tick Grease may be available in the countries listed below.

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

Ingredient matches for Coopers Tick Grease

Deltamethrin

Deltamethrin is reported as an ingredient of Coopers Tick Grease in the following countries:

• South Africa

Piperonyl Butoxide

Piperonyl Butoxide is reported as an ingredient of Coopers Tick Grease in the following countries:

• South Africa

International Drug Name Search

Colirio Llorens Fluorvas

Colirio Llorens Fluorvas may be available in the countries listed below.

Ingredient matches for Colirio Llorens Fluorvas

Fluorometholone

Fluorometholone is reported as an ingredient of Colirio Llorens Fluorvas in the following countries:

• Spain

Tetryzoline

Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Colirio Llorens Fluorvas in the following countries:

• Spain

International Drug Name Search

Acetaminophen/Diphenhydramine/Phenylephrine Suspension

Pronunciation: a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin
Generic Name: Acetaminophen/Diphenhydramine/Phenylephrine
Brand Name: Tylenol Children's Plus Cold and Allergy

Acetaminophen/Diphenhydramine/Phenylephrine Suspension is used for:

Relieving symptoms such as pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Acetaminophen/Diphenhydramine/Phenylephrine Suspension is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Acetaminophen/Diphenhydramine/Phenylephrine Suspension if:

• you are allergic to any ingredient in Acetaminophen/Diphenhydramine/Phenylephrine Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Acetaminophen/Diphenhydramine/Phenylephrine Suspension:

Some medical conditions may interact with Acetaminophen/Diphenhydramine/Phenylephrine 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, plan 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 a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, chronic bronchitis, emphysema); trouble breathing when you sleep (apnea): adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; the blood disease porphyria; an overactive thyroid; severe kidney problems; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Acetaminophen/Diphenhydramine/Phenylephrine Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-o-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Acetaminophen/Diphenhydramine/Phenylephrine Suspension's side effects


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Acetaminophen/Diphenhydramine/Phenylephrine Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Acetaminophen/Diphenhydramine/Phenylephrine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Diphenhydramine/Phenylephrine 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 Acetaminophen/Diphenhydramine/Phenylephrine Suspension:

Use Acetaminophen/Diphenhydramine/Phenylephrine Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Diphenhydramine/Phenylephrine Suspension by mouth with or without food.


• Shake well before each use.


• Use the dosing cup that comes with Acetaminophen/Diphenhydramine/Phenylephrine Suspension 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 Acetaminophen/Diphenhydramine/Phenylephrine Suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Diphenhydramine/Phenylephrine Suspension.

Important safety information:

• Acetaminophen/Diphenhydramine/Phenylephrine Suspension may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Diphenhydramine/Phenylephrine Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Diphenhydramine/Phenylephrine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Acetaminophen/Diphenhydramine/Phenylephrine Suspension without checking with you doctor.


• Acetaminophen/Diphenhydramine/Phenylephrine Suspension has acetaminophen, diphenhydramine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has these or similar medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• If you have a fever that becomes worse or lasts for more than 3 days, contact your doctor.


• Contact your doctor if you have a sore throat that becomes severe, last for more than 2 days, or occurs with fever, headache, rash, nausea, or vomiting.


• Acetaminophen/Diphenhydramine/Phenylephrine Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Acetaminophen/Diphenhydramine/Phenylephrine Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Acetaminophen/Diphenhydramine/Phenylephrine Suspension may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Diphenhydramine/Phenylephrine Suspension. Talk to your doctor before you take Acetaminophen/Diphenhydramine/Phenylephrine Suspension or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Acetaminophen/Diphenhydramine/Phenylephrine Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Acetaminophen/Diphenhydramine/Phenylephrine Suspension for a few days before the tests.


• Tell your doctor or dentist that you take Acetaminophen/Diphenhydramine/Phenylephrine Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use Acetaminophen/Diphenhydramine/Phenylephrine Suspension with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Acetaminophen/Diphenhydramine/Phenylephrine Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Acetaminophen/Diphenhydramine/Phenylephrine Suspension should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Diphenhydramine/Phenylephrine Suspension while you are pregnant. Acetaminophen/Diphenhydramine/Phenylephrine Suspension is found in breast milk. Do not breast-feed while taking Acetaminophen/Diphenhydramine/Phenylephrine Suspension.

Possible side effects of Acetaminophen/Diphenhydramine/Phenylephrine 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; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); dark urine; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; pale stools; seizures; severe drowsiness; severe or persistent dizziness, nervousness, lightheadedness, or headache; severe or persistent trouble sleeping; stomach pain; tremor; vision changes; yellowing of 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: Acetaminophen/Diphenhydramine/Phenylephrine 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Acetaminophen/Diphenhydramine/Phenylephrine Suspension:

Store Acetaminophen/Diphenhydramine/Phenylephrine Suspension at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Diphenhydramine/Phenylephrine Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Diphenhydramine/Phenylephrine Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Acetaminophen/Diphenhydramine/Phenylephrine 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 Acetaminophen/Diphenhydramine/Phenylephrine 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 Acetaminophen/Diphenhydramine/Phenylephrine resources

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

Compare Acetaminophen/Diphenhydramine/Phenylephrine with other medications

• Cold Symptoms

Rabbit Fever (Tularemia) Medications

Definition of Rabbit Fever: Tularemia is an infection common in wild rodents caused by the organism

Drugs associated with Rabbit Fever

The following drugs and medications are in some way related to, or used in the treatment of Rabbit Fever. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Rabbit Fever (Tularemia)

Medical Encyclopedia:

• Tularemia

Drug List:

Chloromycetin-Oral-Intravenous-Injection

Chloromycetin-Sodium-Succinate

Cipro

Cipro-I-V

Cipro-Xr-Extended-Release-Tablets

Doryx-Delayed-Release-Capsules

Doxy-100

Doxy-200

Garamycin-Solution

Monodox

Nebcin

Ocudox-Convenience-Kit

Oraxyl

Tobi-Solution

Vibra-Tabs

Vibramycin

Tanderil

Tanderil may be available in the countries listed below.

Ingredient matches for Tanderil

Betamethasone

Betamethasone is reported as an ingredient of Tanderil in the following countries:

• Colombia

International Drug Name Search

Edason

Edason may be available in the countries listed below.

Ingredient matches for Edason

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Edason in the following countries:

• Greece

International Drug Name Search

Glicerolo Sella

Glicerolo Sella may be available in the countries listed below.

Ingredient matches for Glicerolo Sella

Glycerol

Glycerol is reported as an ingredient of Glicerolo Sella in the following countries:

• Italy

International Drug Name Search

Colistine

Colistine may be available in the countries listed below.

Ingredient matches for Colistine

Colistin Sulfate

Colistine (DCF) is known as Colistin Sulfate in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

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

Mycoral

Mycoral may be available in the countries listed below.

Ingredient matches for Mycoral

Ketoconazole

Ketoconazole is reported as an ingredient of Mycoral in the following countries:

• Indonesia


• Sri Lanka

International Drug Name Search

Fortical

Fortical is a brand name of calcitonin, approved by the FDA in the following formulation(s):

FORTICAL (calcitonin salmon recombinant - spray, metered; nasal)

• 
  Manufacturer: UPSHER SMITH
  
  Approval date: August 12, 2005
  
  Strength(s): 200 IU/SPRAY ^[RLD]

Has a generic version of Fortical been approved?

No. There is currently no therapeutically equivalent version of Fortical available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Fortical. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Nasal calcitonin formulations
  Patent 6,440,392
  Issued: August 27, 2002
  Inventor(s): William; Stern
  Assignee(s): Unigene Laboratories, Inc.
  A liquid pharmaceutical composition is disclosed comprising calcitonin or an acid addition salt thereof and citric acid or salt thereof in a concentration from about to about 50 mM, said composition being in a form table for nasal administration.
  
  Patent expiration dates:
  
  
  • February 2, 2021
    
    ✓ 
    Patent use: NASAL ADMINISTRATION
    ✓ 
    Drug product
  
  



• 
  Nasal calcitonin formulation
  Patent RE40812
  Issued: June 30, 2009
  Inventor(s): Stern; William
  Assignee(s): Unigene Laboratories Inc.
  A liquid pharmaceutical composition is disclosed comprising calcitonin or an acid addition salt thereof and citric acid or salt thereof in a concentration from about to about 50 mM, said composition being in a form table for nasal administration. A liquid pharmaceutical composition is provided for nasal administration of calcitonin or an acid addition salt thereof. The nasal pharmaceutical formulations contain a component selected from the group consisting of citric acid, citric acid salt and a combination thereof.
  
  Patent expiration dates:
  
  
  • February 2, 2021
    
    ✓ 
    Drug product
  
  

See also...

• Fortical Consumer Information (Drugs.com)
• Fortical Spray Consumer Information (Wolters Kluwer)
• Fortical Consumer Information (Cerner Multum)
• Fortical Nasal Advanced Consumer Information (Micromedex)
• Fortical Parenteral Advanced Consumer Information (Micromedex)
• Calcitonin Salmon Spray Consumer Information (Wolters Kluwer)
• Calcitonin-Salmon Consumer Information (Wolters Kluwer)
• Calcitonin injection Consumer Information (Cerner Multum)
• Calcitonin nasal Consumer Information (Cerner Multum)
• Calcitonin (salmon) Nasal Advanced Consumer Information (Micromedex)
• Calcitonin Injection Advanced Consumer Information (Micromedex)
• Calcitonin Nasal Advanced Consumer Information (Micromedex)
• Calcitonin Parenteral Advanced Consumer Information (Micromedex)
• Calcitonin AHFS DI Monographs (ASHP)

Solanax

Solanax may be available in the countries listed below.

Ingredient matches for Solanax

Alprazolam

Alprazolam is reported as an ingredient of Solanax in the following countries:

• Japan

International Drug Name Search

Arcyl

Arcyl may be available in the countries listed below.

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

Ingredient matches for Arcyl

Arsanilic Acid

Arsanilic Acid is reported as an ingredient of Arcyl in the following countries:

• Australia

International Drug Name Search

Uveitis, Anterior Medications

Topics under Uveitis, Anterior

• Infectious Anterior Uveitis (0 drugs in 2 topics)

• Iridocyclitis (27 drugs)

Learn more about Uveitis, Anterior

Micromedex Care Notes:

• Iritis

Medical Encyclopedia:

• Uveitis

Drug List:

Alprazolam Sigma Tau

Alprazolam Sigma Tau may be available in the countries listed below.

Ingredient matches for Alprazolam Sigma Tau

Alprazolam

Alprazolam is reported as an ingredient of Alprazolam Sigma Tau in the following countries:

• Italy

International Drug Name Search

Androcal

Androcal may be available in the countries listed below.

Ingredient matches for Androcal

Bicalutamide

Bicalutamide is reported as an ingredient of Androcal in the following countries:

• Germany

International Drug Name Search

Conucol

Conucol may be available in the countries listed below.

Ingredient matches for Conucol

Thiamphenicol

Thiamphenicol is reported as an ingredient of Conucol in the following countries:

• Indonesia

International Drug Name Search

Fominoben Hydrochloride

Fominoben Hydrochloride may be available in the countries listed below.

Ingredient matches for Fominoben Hydrochloride

Fominoben

Fominoben Hydrochloride (JAN) is also known as Fominoben (Rec.INN)

International Drug Name Search

Glossary

JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Rosadan Cream

Generic Name: metronidazole

Dosage Form: cream
Rosadan™

Metronidazole Topical Cream, 0.75%

FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Rx only

Rosadan Cream Description

Rosadan™ (metronidazole) Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

Rosadan Cream - Clinical Pharmacology

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

Indications and Usage for Rosadan Cream

Rosadan™ (metronidazole) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Contraindications

Rosadan™ (metronidazole) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

Precautions

General

Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug Interactions

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy

Teratogenic effects

Pregnancy category B

There are no adequate and well-controlled studies with the use of Rosadan™ (metronidazole) Topical Cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, 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 in pediatric patients have not been established.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of topical metronidazole cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.

The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

Rosadan Cream Dosage and Administration

Apply and rub in a thin layer of Rosadan™ (metronidazole) Topical Cream twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Rosadan™ (metronidazole) Topical Cream.

How is Rosadan Cream Supplied

Rosadan™ (metronidazole) Topical Cream, 0.75% is supplied in a 45 g tube - NDC 43538-180-45.

Storage conditions

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Manufactured for:

MEDIMETRIKS

PHARMACEUTICALS, INC.

363 Route 46 West

Fairfield, NJ 07004-2402 USA

www.medimetriks.com

Manufactured by:

G&W Laboratories, Inc.

South Plainfield, NJ 07080

IP019

8-0633MDM1

Issued 02/11

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

MEDIMETRIKS

PHARMACEUTICALS, INC.

NDC 43538-180-45

RX Only

Rosadan™

Metronidazole Topical Cream, 0.75%

NET WT 45 g

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-181-45

RX Only

Rosadan™

Metronidazole Topical Cream, 0.75%

CREAM KIT

CONTENTS:

1-Rosadan™ Metronidazole Topical Cream, 0.75% Tube (Net wt. 45 g)

1-Rehyla™ Wash Moisturizing Daily Wash Bottle (16 fl. oz.)

MEDIMETRIKS

PHARMACEUTICALS, INC.

ROSADAN  metronidazole  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-180 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength sorbitol   glycerin   isopropyl palmitate   benzyl alcohol   lactic acid   sodium hydroxide   water

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-180-45 45 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077549	08/30/2011

ROSADAN  metronidazole  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-181 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength sorbitol   glycerin   isopropyl palmitate   benzyl alcohol   lactic acid   sodium hydroxide   water

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-181-45 1 TUBE In 1 KIT contains a TUBE 1 45 g In 1 TUBE This package is contained within the KIT (43538-181-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077549	08/30/2011

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Establishment
Name	Address	ID/FEI	Operations
G&W Laboratories		001271188	MANUFACTURE

Revised: 08/2011Medimetriks Pharmaceuticals, Inc.

More Rosadan Cream resources

• Rosadan Cream Use in Pregnancy & Breastfeeding
• Rosadan Cream Drug Interactions
• Rosadan Cream Support Group
• 15 Reviews for Rosadan - Add your own review/rating

Compare Rosadan Cream with other medications

• Bacterial Vaginitis
• Perioral Dermatitis
• Rosacea

Sertraline Generichealth

Sertraline Generichealth may be available in the countries listed below.

Ingredient matches for Sertraline Generichealth

Sertraline

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

• Australia

International Drug Name Search

Indométacine

Indométacine may be available in the countries listed below.

Ingredient matches for Indométacine

Indometacin

Indométacine (DCF) is also known as Indometacin (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Benadryl Cream

Pronunciation: DYE-fen-HYE-dra-meen
Generic Name: Diphenhydramine
Brand Name: Examples include Benadryl and Dermarest

Benadryl Cream is used for:

Temporarily relieving pain and itching associated with insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, and rashes caused by poison ivy, poison oak, and poison sumac.

Benadryl Cream is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Benadryl Cream if:

• you are allergic to any ingredient in Benadryl Cream


• you use any other medicine that contains diphenhydramine, unless your doctor tells you to

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

Before using Benadryl Cream:

Some medical conditions may interact with Benadryl Cream. 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 porphyria

Some MEDICINES MAY INTERACT with Benadryl Cream. Because little, if any, of Benadryl Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Benadryl Cream 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 Benadryl Cream:

Use Benadryl Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Benadryl Cream is for external use only. Avoid contact with the eyes. Do not swallow Benadryl Cream.


• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Apply to the affected area not more than 3 to 4 times a day.


• Wash your hands immediately after using Benadryl Cream.


• If you miss a dose of Benadryl Cream and you are using it regularly, use 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.

Ask your health care provider any questions you may have about how to use Benadryl Cream.

Important safety information:

• Benadryl Cream may cause harm if it is swallowed. If you have taken it by mouth, contact your poison control center or emergency room right away.


• If your symptoms do not get better within 7 days, if they get worse, or if they come back, stop using Benadryl Cream and check with your doctor.


• Do not use on chickenpox, measles, or on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered, or oozing skin, unless advised to do so by your doctor.


• Benadryl Cream has diphenhydramine in it. Before you start any new medicine, including one used on the skin, check the label to see if it has diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Benadryl Cream should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Benadryl Cream while you are pregnant. Benadryl Cream is found in breast milk. If you are or will be breast-feeding while you use Benadryl Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Benadryl Cream:

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:

Skin irritation.

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).

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.

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. Benadryl Cream may be harmful if swallowed. Symptoms after swallowing Benadryl Cream may include confusion, hallucinations, or loss of consciousness.

Proper storage of Benadryl Cream:

Store Benadryl Cream at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep Benadryl Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Benadryl Cream, please talk with your doctor, pharmacist, or other health care provider.


• Benadryl Cream 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 Benadryl Cream. 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 Benadryl resources

• Benadryl Use in Pregnancy & Breastfeeding
• Benadryl Drug Interactions
• Benadryl Support Group
• 0 Reviews for Benadryl - Add your own review/rating

Compare Benadryl with other medications

• Pain
• Pruritus

Neomycin Sulfate

Neomycin Sulfate TABLETS USP, 500 MG

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets USP and other antibacterial drugs. Neomycin Sulfate Tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNINGS: SYSTEMIC ABSORPTION OF NEOMYCIN OCCURS FOLLOWING ORAL ADMINISTRATION AND TOXIC REACTIONS MAY OCCUR. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use. NEUOROTOXICITY (INCLUDING OTOTOXICITY AND NEPHROTOXICITY) FOLLOWING THE ORAL USE OF Neomycin Sulfate HAVE BEEN REPORTED, EVEN WHEN USED IN RECOMMENDED DOSES. THE POTENTIAL FOR NEPHROTOXICITY, PERMANENT BILATREAL AUDITORY OTOTOXICITY AND SOMETIMES VESTIBULAR TOXICITY IS PRESENT IN PATIENTS WITH NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/OR FOR LONGER PERIODS THAN RECOMMENDED. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). THE RISK OF NEPHROTOXICITY AND OTOTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued

Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary.

Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive.

Other factors which increase the risk of toxicity are advanced age and dehydration. The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue.

Neomycin Sulfate Description

Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. Structurally, Neomycin Sulfate may be represented as follows:

Chemically, it is O-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→  3)-O-β-D-ribofuranosyl-(1→5)-O-[2,6-diamino-2, 6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the α-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl.

Each tablet contains 500 mg Neomycin Sulfate (equivalent to 350 mg neomycin base).

Inactive Ingredients: Calcium Stearate, Colloidal Silicon Dioxide, Povidone.

Neomycin Sulfate - Clinical Pharmacology

Neomycin Sulfate is poorly absorbed from the normal gastrointestinal tract. The small absorbed fraction is rapidly distributed in the tissues and is excreted by the kidney in keeping with the degree of kidney function. The unabsorbed portion of the drug (approximately 97%) is eliminated unchanged in the feces.

Growth of most intestinal bacteria is rapidly suppressed following oral administration of Neomycin Sulfate, with the suppression persisting for 48 to 72 hours. Nonpathogenic yeasts and occasionally resistant strains of Enterobacter aerogenes (formerly Aerobacter aerogenes) replace the intestinal bacteria.

As with other aminoglycosides, the amount of systemically absorbed neomycin transferred to the tissues increases cumulatively with each repeated dose administered until a steady state is achieved. The kidney functions as the primary excretory path as well as the tissue binding site, with the highest concentrations found in the renal cortex.  With repeated dosings, progressive accumulation also occurs in the inner ear.  Release of tissue-bound neomycin occurs slowly over a period of several weeks after dosing has been discontinued.

Protein binding studies have shown that the degree of aminoglycoside protein binding is low and, depending upon the methods used for testing, this may be between 0% and 30%.

Microbiology: In vitro tests have demonstrated that neomycin is bactericidal and acts by inhibiting the synthesis of protein in susceptible bacterial cells. It is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. Neomycin is active in vitro against Escherichia coli and the Klebsiella-Enterobacter group. Neomycin is not active against anaerobic bowel flora.

If susceptibility testing is needed, using a 30 mcg disc, organisms producing zones of 16 mm or greater are considered susceptible. Resistant organisms produce zones of 13 mm or less. Zones greater than 13 mm and less than 16 mm indicate intermediate susceptibility.

Indications and Usage for Neomycin Sulfate

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets USP and other antibacterial drugs, Neomycin Sulfate Tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Suppression of Intestinal Bacteria:  Neomycin Sulfate Tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION Section).

Hepatic Coma (Portal-Systemic Encephalopathy):  Neomycin Sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

Contraindications

Neomycin Sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction other aminoglycosides may have a cross-sensitivity to neomycin.

Neomycin Sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

Warnings

(see boxed WARNINGS)

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.The risk of hearing loss continues after drug withdrawal.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Precautions

General

Prescribing Neomycin Sulfate Tablets USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide beneï¬t to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of oral neomycin may result in overgrowth of non-susceptible organisms, particularly fungi.  If this occurs, appropriate therapy should be instituted.

Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical ï¬elds with minute quantities of neomycin.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with the oral use of neomycin. If renal insufï¬ciency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for the patient

Patients should be counseled that antibacterial drugs including Neomycin Sulfate Tablets USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Neomycin Sulfate Tablets USP are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.  Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Neomycin Sulfate Tablets USP or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory tests

Patients with renal insufï¬ciency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufï¬ciency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased speciï¬c gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity and neomycin (see boxed WARNINGS).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate Neomycin Sulfate’s neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral Neomycin Sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Neomycin Sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

(see WARNINGS section).

Nursing Mothers

It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides 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

The safety and efï¬cacy of oral Neomycin Sulfate in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

Adverse Reactions

The most common adverse reactions to oral Neomycin Sulfate are nausea, vomiting and diarrhea.  The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

Overdosage

Because of low absorption, it is unlikely that acute overdosage would occur with oral Neomycin Sulfate. However, prolonged administration could result in sufï¬cient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Neomycin Sulfate from the blood.

Neomycin Sulfate Dosage and Administration

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

1. Withdraw protein from diet. Avoid use of diuretic agents.


2. Give supportive therapy, including blood products, as indicated.


3. Give Neomycin Sulfate Tablets USP in doses of 4 to 12 grams of Neomycin Sulfate per day (eight to 24 tablets) in divided doses.  Treatment should be continued over a period of ï¬ve to six days, during which time protein should be returned incrementally to the diet.


4. If less potentially toxic drugs cannot be used for chronic hepatic insufï¬ciency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The beneï¬ts to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Neomycin Sulfate (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m., and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

How is Neomycin Sulfate Supplied

Neomycin Sulfate Tablets USP, 500 mg (equivalent in activity to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed "ZYNOVA" and "01", in bottles of 100 tablets (NDC-51991-738-01).

Store at controlled room temperature between 20º and 25ºC (68º and 77ºF) (see USP).

Dispense in tight containers as deï¬ned in the USP/NF.

Address medical inquiries to Breckenridge Pharmaceutical: (800) 367-3395

Manufactured by:

OMAN PHARMACEUTICAL PRODUCTS CO. L.L.C.

Salalah, Sultanate of Oman

Distributed by:

Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487

Iss. D 08/2010

PRINCIPAL DISPLAY PANEL

Neomycin Sulfate TABLETS USP, 500 MG

NDC 51991-738-01

Neomycin Sulfate  Neomycin Sulfate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-738 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Neomycin Sulfate (NEOMYCIN) Neomycin Sulfate 500 mg

Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE   SILICON DIOXIDE   POVIDONE

Product Characteristics Color WHITE (OFF WHITE) Score no score Shape ROUND Size 12mm Flavor Imprint Code ZYNOVA;01 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-738-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065468	01/03/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Oman Pharmaceutical Products Co. LLC		534770578	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nutra Med		022004902	PACK

Revised: 12/2010Breckenridge Pharmaceutical, Inc.

More Neomycin Sulfate resources

• Neomycin Sulfate Dosage
• Neomycin Sulfate Use in Pregnancy & Breastfeeding
• Drug Images
• Neomycin Sulfate Drug Interactions
• Neomycin Sulfate Support Group
• 0 Reviews for Neomycin Sulfate - Add your own review/rating

• Neomycin Sulfate Monograph (AHFS DI)


• Neomycin MedFacts Consumer Leaflet (Wolters Kluwer)


• Mycifradin Concise Consumer Information (Cerner Multum)


• Neo-Fradin Advanced Consumer (Micromedex) - Includes Dosage Information


• Neo-Fradin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Neomycin Sulfate with other medications

• Bowel Preparation
• Diarrhea
• Hepatic Coma
• Hepatic Encephalopathy