Piracetam MK

Piracetam MK may be available in the countries listed below.

Ingredient matches for Piracetam MK

Piracetam

Piracetam is reported as an ingredient of Piracetam MK in the following countries:

• Colombia

International Drug Name Search

Simvastatina Cuve

Simvastatina Cuve may be available in the countries listed below.

Ingredient matches for Simvastatina Cuve

Simvastatin

Simvastatin is reported as an ingredient of Simvastatina Cuve in the following countries:

• Spain

International Drug Name Search

Clozapin-biomo

Clozapin-biomo may be available in the countries listed below.

Ingredient matches for Clozapin-biomo

Clozapine

Clozapine is reported as an ingredient of Clozapin-biomo in the following countries:

• Germany

International Drug Name Search

Neriderm

Neriderm may be available in the countries listed below.

Ingredient matches for Neriderm

Diflucortolone

Diflucortolone 21-valerate (a derivative of Diflucortolone) is reported as an ingredient of Neriderm in the following countries:

• Israel

International Drug Name Search

Rimantadine Hydrochloride

Ingredient matches for Rimantadine Hydrochloride

Rimantadine

Rimantadine Hydrochloride (BANM, USAN) is known as Rimantadine in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

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

Fluvimil

Fluvimil may be available in the countries listed below.

Ingredient matches for Fluvimil

Fluvastatin

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

• Switzerland

International Drug Name Search

Flutam

Flutam may be available in the countries listed below.

Ingredient matches for Flutam

Flutamide

Flutamide is reported as an ingredient of Flutam in the following countries:

• Hungary

International Drug Name Search

Spasmodol

Spasmodol may be available in the countries listed below.

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

Ingredient matches for Spasmodol

Tiemonium Iodide

Tiemonium Iodide is reported as an ingredient of Spasmodol in the following countries:

• France

International Drug Name Search

Aprazol

Aprazol may be available in the countries listed below.

Ingredient matches for Aprazol

Lansoprazole

Lansoprazole is reported as an ingredient of Aprazol in the following countries:

• Turkey

International Drug Name Search

Tums

Ingredient matches for Tums

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Tums in the following countries:

• Canada


• Colombia


• Israel


• Philippines


• Portugal


• Slovakia


• United States

Magnesium Carbonate

Magnesium Carbonate heavy (a derivative of Magnesium Carbonate) is reported as an ingredient of Tums in the following countries:

• Slovakia

International Drug Name Search

Selvet Vet

Selvet Vet may be available in the countries listed below.

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

Ingredient matches for Selvet Vet

Sodium Selenite

Sodium Selenite pentahydrate (a derivative of Sodium Selenite) is reported as an ingredient of Selvet Vet in the following countries:

• Finland

Tocopherol, α-

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

• Finland

International Drug Name Search

Flectron

Flectron may be available in the countries listed below.

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

Ingredient matches for Flectron

Cypermethrin

Cypermethrin is reported as an ingredient of Flectron in the following countries:

• France


• Germany


• Ireland


• Portugal


• United Kingdom

International Drug Name Search

Super Concentrate Teat Dip or Spray

Super Concentrate Teat Dip or Spray may be available in the countries listed below.

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

Ingredient matches for Super Concentrate Teat Dip or Spray

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Super Concentrate Teat Dip or Spray in the following countries:

• United Kingdom

International Drug Name Search

Easprin

In the US, Easprin (aspirin systemic) is a member of the following drug classes: platelet aggregation inhibitors, salicylates and is used to treat Angina, Angina Pectoris Prophylaxis, Ankylosing Spondylitis, Antiphospholipid Syndrome, Aseptic Necrosis, Back Pain, Fever, Heart Attack, Ischemic Stroke, Ischemic Stroke - Prophylaxis, Juvenile Rheumatoid Arthritis, Kawasaki Disease, Myocardial Infarction - Prophylaxis, Niacin Flush, Osteoarthritis, Pain, Prosthetic Heart Valves, Prosthetic Heart Valves - Mechanical Valves, Revascularization Procedures - Prophylaxis, Rheumatic Fever, Rheumatoid Arthritis, Sciatica, Systemic Lupus Erythematosus and Thromboembolic Stroke Prophylaxis.

US matches:

• Easprin

Ingredient matches for Easprin

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Easprin in the following countries:

• United States

International Drug Name Search

Glicerolo + Sodio Cloruro NovaSelect

Glicerolo + Sodio Cloruro NovaSelect may be available in the countries listed below.

Ingredient matches for Glicerolo + Sodio Cloruro NovaSelect

Glycerol

Glycerol is reported as an ingredient of Glicerolo + Sodio Cloruro NovaSelect in the following countries:

• Italy

International Drug Name Search

Esophageal Variceal Hemorrhage Prophylaxis Medications

Drugs associated with Esophageal Variceal Hemorrhage Prophylaxis

The following drugs and medications are in some way related to, or used in the treatment of Esophageal Variceal Hemorrhage Prophylaxis. 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 Esophageal Variceal Hemorrhage Prophylaxis

Medical Encyclopedia:

• Bleeding esophageal varices

Drug List:

Corgard

Tenormin

Bosnyl

Bosnyl may be available in the countries listed below.

Ingredient matches for Bosnyl

Sulpiride

Sulpiride is reported as an ingredient of Bosnyl in the following countries:

• Bosnia & Herzegowina

International Drug Name Search

Multiderm

Multiderm may be available in the countries listed below.

Ingredient matches for Multiderm

Betamethasone

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

• Peru

International Drug Name Search

Lafayette Cimetidine

Lafayette Cimetidine may be available in the countries listed below.

Ingredient matches for Lafayette Cimetidine

Cimetidine

Cimetidine is reported as an ingredient of Lafayette Cimetidine in the following countries:

• Philippines

International Drug Name Search

Tab Ciprox

Tab Ciprox may be available in the countries listed below.

Ingredient matches for Tab Ciprox

Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Tab Ciprox in the following countries:

• Bangladesh

International Drug Name Search

Sohobal

Sohobal may be available in the countries listed below.

Ingredient matches for Sohobal

Mecobalamin

Mecobalamin is reported as an ingredient of Sohobal in the following countries:

• Indonesia

International Drug Name Search

Pentoxifilina L.CH.

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

Ingredient matches for Pentoxifilina L.CH.

Pentoxifylline

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

• Chile

International Drug Name Search

Betametasona Lafedar

Betametasona Lafedar may be available in the countries listed below.

Ingredient matches for Betametasona Lafedar

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Betametasona Lafedar in the following countries:

• Argentina

Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Betametasona Lafedar in the following countries:

• Argentina

Betamethasone 21-acetate and 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Betametasona Lafedar in the following countries:

• Argentina

International Drug Name Search

Disodium Pamidronate Bioren

Disodium Pamidronate Bioren may be available in the countries listed below.

Ingredient matches for Disodium Pamidronate Bioren

Pamidronic Acid

Pamidronic Acid disodium salt (a derivative of Pamidronic Acid) is reported as an ingredient of Disodium Pamidronate Bioren in the following countries:

• Switzerland

International Drug Name Search

Allcut

Allcut may be available in the countries listed below.

Ingredient matches for Allcut

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Allcut in the following countries:

• Japan

International Drug Name Search

Integrilin

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

INTEGRILIN (eptifibatide - injectable; injection)

• 
  Manufacturer: SCHERING
  
  Approval date: May 18, 1998
  
  Strength(s): 2MG/ML ^[RLD], 75MG/100ML ^[RLD]

Has a generic version of Integrilin been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Integrilin. 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.

• 
  Platelet aggregation inhibitors
  Patent 5,686,570
  Issued: November 11, 1997
  Inventor(s): Scarborough; Robert M. & Wolf; David Lawrence & Charo; Israel F.
  Assignee(s): COR Therapeutics, Inc.
  An assay for screening snake venom for the presence or absence of platelet aggregation inhibitors (PAIs) based on specific receptor binding is described. Using this assay, the identification and characterization of PAIs in a wide range of snake venom samples was accomplished. The isolated and purified PAI from several of these active snake venoms is described and characterized. In addition, PAIs lacking the Arg-Gly-Asp (RGD) adhesion sequence but containing K*-(G/Sar)-D wherein K* is a modified lysyl residue of the formula EQU R.sup.1.sub.2 N(CH.sub.2).sub.4 CHNHCO-- wherein each R.sup.1 is independently H, alkyl(1-6C) or at most one R.sup.1 is R.sup.2 --C.dbd.NR.sup.3 wherein R.sup.2 is H, alkyl(1-6C), phenyl or benzyl, or is NR.sup.4.sub.2 in which each R.sup.4 is independently H or alkyl(1-6C) and R.sup.3 is H, alkyl(1-6C), phenyl or benzyl, or R.sup.2 --C.dbd.NR.sup.3 is a radical selected from the group consisting of: ##STR1## where m is an integer of 2-3, and each R.sup.5 is independently H or alkyl(1-6C); and wherein one or two (CH.sub.2) may be replaced by O or S provided said O or S is not adjacent to another heteroatom are prepared and shown to specifically inhibit the binding of fibrinogen or von Willebrand Factor to GP IIb-IIIa.
  
  Patent expiration dates:
  
  
  • November 11, 2014
    
  
  



• 
  Stable polypeptide composition
  Patent 5,747,447
  Issued: May 5, 1998
  Inventor(s): Swift; Robert L. & Du Mee; Charles P. & Randolph; Anne
  Assignee(s): COR Therapeutics
  A (injectable biologically active) polypeptide is stabilized by dissolving said polypeptide forming a liquid solution in citrate buffer of about pH 5.0-5.5.
  
  Patent expiration dates:
  
  
  • May 5, 2015
    
  
  



• 
  Platelet aggregation inhibitors
  Patent 5,756,451
  Issued: May 26, 1998
  Inventor(s): Scarborough; Robert M. & Wolf; David Lawrence & Charo; Israel F.
  Assignee(s): COR Therapeutics, Inc.
  This invention relates to a group of peptides which are, or are related to, platelet aggregation inhibitors isolated and purified from various snake venoms. The instant platelet aggregation inhibitors inhibit (a) binding of Fg or vWF to GPIIb-IIIa more than (b) binding of vitronectin to vitronectin receptor or fibronectin to fibronectin receptor. The peptides are useful as therapeutic agents for the treatment of, and prevention of, platelet-associated ischemic disorders.
  
  Patent expiration dates:
  
  
  • November 11, 2014
    
  
  



• 
  Platelet aggregation inhibitors
  Patent 5,807,825
  Issued: September 15, 1998
  Inventor(s): Scarborough; Robert M. & Wolf; David Lawrence & Charo; Israel F.
  Assignee(s): COR Therapeutics, Inc.
  An assay for screening snake venom for the presence or absence of platelet aggregation inhibitors (PAIs) based on specific receptor binding is described. Using this assay, the identification and characterization of PAIs in a wide range of snake venom samples was accomplished. The isolated and purified PAI from several of these active snake venoms is described and characterized. In addition, PAIs lacking the Arg-Gly-Asp (RGD) adhesion sequence but containing K*-(G/Sar)-D wherein K* is a modified lysyl residue of the formula EQU R.sup.1.sub.2 N(CH.sub.2).sub.4 CHNHCO-- wherein each R.sup.1 is independently H, alkyl(1-6C) or at most one R.sup.1 is R.sup.2 --C.dbd.NR.sup.3 wherein R.sup.2 is H, alkyl(1-6C), phenyl or benzyl, or is NR.sup.4.sub.2 in which each R.sup.4 is independently H or alkyl(1-6C) and R is H, alkyl(1-6C), phenyl or benzyl, or R.sup.2 --C.dbd.NR.sup.3 is a radical selected from the group consisting of: ##STR1## where m is an integer of 2-3, and each R.sup.5 is independently H or alkyl(1-6C); and wherein one or two (CH.sub.2) may be replaced by O or S provided said O or S is not adjacent to another heteroatom are prepared and shown to specifically inhibit the binding of fibrinogen or von Willebrand Factor to GP IIb-IIIa.
  
  Patent expiration dates:
  
  
  • September 15, 2015
    
    ✓ 
    Patent use: PLATELET AGGREGATION INHIBITORS
  
  



• 
  Platelet aggregation inhibitors
  Patent 5,968,902
  Issued: October 19, 1999
  Inventor(s): Scarborough; Robert M. & Wolf; David Lawrence & Charo; Israel F.
  Assignee(s): COR Therapeutics, Inc.
  The isolated and purified PAI from several active snake venoms is described and characterized. In addition, PAIs lacking the Arg-Gly-Asp (RGD) adhesion sequence but containing K* -(G/Sar)-D wherein K* is a modified lysyl residue of the formula EQU R.sup.1.sub.2 N(CH .sub.2).sub.4 CHNHCO-- wherein each R.sup.1 is independently H, alkyl(1-6C) or at most one R.sup.1 is R.sup.2 --C.dbd.NR.sup.3 wherein R.sup.2 is H, alkyl(1-6C), phenyl or benzyl, or is NR.sup.4 .sub.2 in which each R.sup.4 is independently H or alkyl(1-6C) and R.sup.3 is H, alkyl(1-6C), phenyl or benzyl, or R.sup.2 --C.dbd.NR.sup.3 is a radical selected from the group consisting of: ##STR1## where m is an integer of 2-3, and each R.sup.5 is independently H or alkyl(1-6C); and wherein one or two (CH.sub.2) may be replaced by O or S provided said O or S is not adjacent to another heteroatom are prepared and shown to specifically inhibit the binding of fibrinogen or von Willebrand Factor to GP IIb-IIIa.
  
  Patent expiration dates:
  
  
  • June 2, 2015
    
    ✓ 
    Patent use: TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS
  
  

See also...

• Integrilin Consumer Information (Drugs.com)
• Integrilin Consumer Information (Wolters Kluwer)
• Integrilin Consumer Information (Cerner Multum)
• Integrilin Advanced Consumer Information (Micromedex)
• Integrilin AHFS DI Monographs (ASHP)
• Eptifibatide Consumer Information (Wolters Kluwer)
• Eptifibatide Consumer Information (Cerner Multum)
• Eptifibatide Intravenous Advanced Consumer Information (Micromedex)
• Eptifibatide AHFS DI Monographs (ASHP)

Ultralan

Ultralan may be available in the countries listed below.

Ingredient matches for Ultralan

Fluocortolone

Fluocortolone 21-caproate and 21-pivalate (a derivative of Fluocortolone) is reported as an ingredient of Ultralan in the following countries:

• Austria


• Luxembourg

Fluocortolone monohydrate and 21-caproate (a derivative of Fluocortolone) is reported as an ingredient of Ultralan in the following countries:

• Austria

International Drug Name Search

Vomiz

Vomiz may be available in the countries listed below.

Ingredient matches for Vomiz

Ondansetron

Ondansetron is reported as an ingredient of Vomiz in the following countries:

• Oman

International Drug Name Search

Cardiloc

Cardiloc may be available in the countries listed below.

Ingredient matches for Cardiloc

Bisoprolol

Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Cardiloc in the following countries:

• Israel

International Drug Name Search

Licostrata

Licostrata may be available in the countries listed below.

Ingredient matches for Licostrata

Hydroquinone

Hydroquinone is reported as an ingredient of Licostrata in the following countries:

• Spain

International Drug Name Search

Diafen

Diafen may be available in the countries listed below.

Ingredient matches for Diafen

Baclofen

Baclofen is reported as an ingredient of Diafen in the following countries:

• Peru

International Drug Name Search

Soluprick

Soluprick may be available in the countries listed below.

Ingredient matches for Soluprick

Histamine

Histamine dihydrochloride (a derivative of Histamine) is reported as an ingredient of Soluprick in the following countries:

• Estonia


• Finland


• Latvia

International Drug Name Search

Cytomel

In the US, Cytomel (liothyronine systemic) is a member of the drug class thyroid drugs and is used to treat Hypothyroidism - After Thyroid Removal, Myxedema, Myxedema Coma, Thyroid Suppression Test, TSH Suppression and Underactive Thyroid.

US matches:

• Cytomel

Ingredient matches for Cytomel

Liothyronine

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

• Canada


• Luxembourg


• Netherlands


• United States

International Drug Name Search

Spironolactone Minsheng Pharm

Spironolactone Minsheng Pharm may be available in the countries listed below.

Ingredient matches for Spironolactone Minsheng Pharm

Spironolactone

Spironolactone is reported as an ingredient of Spironolactone Minsheng Pharm in the following countries:

• China

International Drug Name Search

Sprol

Sprol may be available in the countries listed below.

Ingredient matches for Sprol

Cetylpyridinium

Cetylpyridinium chloride monohydrate (a derivative of Cetylpyridinium) is reported as an ingredient of Sprol in the following countries:

• Japan

International Drug Name Search

Xelcard

Xelcard may be available in the countries listed below.

Ingredient matches for Xelcard

Amlodipine

Amlodipine is reported as an ingredient of Xelcard in the following countries:

• Bangladesh

International Drug Name Search

Omniscan

gadodiamide

Dosage Form: intravenous injection
FULL PRESCRIBING INFORMATION

WARNING: NOT FOR INTRATHECAL USE

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents increase the risk for NSF in patients with:

• acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), or


• acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration [(See Warnings and Precautions (5.2)].

Indications and Usage for Omniscan

CNS (Central Nervous System)

Omniscan is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1)].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

Omniscan is a gadolinium-based contrast agent indicated for intravenous use to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2)].

Omniscan Dosage and Administration

CNS (Central Nervous System)

Adults: The recommended dose of Omniscan is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. An additional 0.4 mL/kg (0.2 mmol/kg) can be given within 20 minutes of the first dose [see Dosage and Administration (2.3)].

Pediatric Patients (2-16 years): The recommended dose of Omniscan is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3)].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of Omniscan is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of Omniscan is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3)].

Dosage Chart

BODY WEIGHT		PEDIATRIC		ADULTS
		0.05	0.1	0.05	0.1	0.2
kg	lb	(mmol/kg)		(mmol/kg)
		VOLUME (mL)		VOLUME (mL)
* The heaviest patient in clinical studies weighed 136 kg.
12	26	1.2	2.4	-	-	-
14	31	1.4	2.8	-	-	-
16	35	1.6	3.2	-	-	-
18	40	1.8	3.6	-	-	-
20	44	2.0	4.0	-	-	-
22	48	2.2	4.4	-	-	-
24	53	2.4	4.8	-	-	-
26	57	2.6	5.2	-	-	-
28	62	2.8	5.6	-	-	-
30	66	3.0	6.0	-	-	-
40	88	4.0	8.0	4.0	8.0	16.0
50	110	5.0	10.0	5.0	10.0	20.0
60	132	6.0	12.0	6.0	12.0	24.0
70	154	7.0	14.0	7.0	14.0	28.0
80	176	8.0	16.0	8.0	16.0	32.0
90	198	-	-	9.0	18.0	36.0
100	220	-	-	10.0	20.0	40.0
110	242	-	-	11.0	22.0	44.0
120	264	-	-	12.0	24.0	48.0
130*	286	-	-	13.0	26.0	52.0

Dosing Guidelines

Inspect Omniscan visually for particulate matter and discoloration before administration, whenever solution and container permit.

Do not use the solution if it is discolored or particulate matter is present.

Draw Omniscan into the syringe and use immediately. Discard any unused portion of Omniscan Injection.

To ensure complete delivery of the desired volume of contrast medium, follow the injection of Omniscan with a 5 mL flush of 0.9% sodium chloride. Complete the imaging procedure within 1 hour of administration of Omniscan.

A physician with the prerequisite training and knowledge of the procedure to be performed should supervise diagnostic procedures involving the use of gadolinium-based contrast agents.

Directions for Proper Use of Omniscan Pharmacy Bulk Package

1. Use only a suitable work area, such as a laminar flow hood, to withdraw Omniscan Injection doses from the Pharmacy Bulk Package.


2. Penetrate the Pharmacy Bulk Package container closure only once using a suitable transfer device and aseptic technique.


3. Once the closure is penetrated, withdraw the container contents without delay. If delay is unavoidable, complete the fluid transfer as soon as possible within a maximum time of 8 hours.


4. Once the closure is penetrated, keep the Pharmacy Bulk Package container in the aseptic area and at room temperature (do not exceed 30°C).


5. Following withdrawal of any dose from the Pharmacy Bulk Package, immediately label the dose with the supplied peel-off label that identifies the dose contents as Omniscan and that Omniscan is not for intrathecal use.


6. Use each individual dose of Omniscan Injection immediately following withdrawal from the Pharmacy Bulk Package container; discard any unused portion of the Omniscan Injection dose not used immediately.


7. Discard any unused Omniscan doses remaining in the Pharmacy Bulk Package 8 hours after the penetration of the container closure.

Repeat Dosing

Sequential use during the same diagnostic session has been studied in adult CNS use only. If the physician determines repeat dosing is required in non-CNS imaging in adults or pediatric patients, renal function should be normal and the time interval between repeat doses should be at least 7 hours to allow for clearance of the drug from the body [see Clinical Pharmacology (12.3)].

Dosage Forms and Strengths

Sterile aqueous solution for intravenous injection; 287 mg/mL.

Contraindications

None.

Warnings and Precautions

Hypersensitivity Reactions

Anaphylactoid and anaphylactic reactions, with cardiovascular, respiratory and/or cutaneous manifestations, resulting in death have occurred. If such a reaction occurs, stop Omniscan Injection and immediately begin appropriate therapy. Observe patients closely, particularly those with a history of drug reactions, asthma, allergy or other hypersensitivity disorders, during and up to several hours after Omniscan Injection.

Nephrogenic Systemic Fibrosis

[see BOXED WARNING]

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2) and in patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced MRI. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a gadolinium-based contrast agent in order to enhance the contrast agent's elimination. The usefulness of hemodialysis in the prevention of NSF is unknown.

Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a gadolinium-based contrast agent and the degree of renal function impairment at the time of exposure.

Post-marketing reports have identified the development of NSF following single and multiple administrations of gadolinium-based contrast agents. These reports have not always identified a specific agent. Where a specific agent was identified, the most commonly reported agent was gadodiamide (Omniscan™), followed by gadopentetate dimeglumine (Magnevist®) and gadoversetamide (OptiMARK®). NSF has also developed following sequential administrations of gadodiamide with gadobenate dimeglumine (MultiHance®) or gadoteridol (ProHance®). The number of post-marketing reports is subject to change over time and may not reflect the true proportion of cases associated with any specific gadolinium-based contrast agent.

The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents. Published reports are limited and predominantly estimate NSF risks with gadodiamide. In one retrospective study of 370 patients with severe renal insufficiency who received gadodiamide, the estimated risk for development of NSF was 4% (J Am Soc Nephrol 2006;17:2359). The risk, if any, for the development of NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown.

Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent prior to any readministration. [See Clinical Pharmacology (12.2) and Dosage and Administration (2)].

Acute Renal Failure

In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred, mostly within 48 hours of Omniscan Injection. The risk of renal failure may increase with increasing dose of gadolinium contrast. Use the lowest necessary dose of contrast and evaluate renal function in patients with renal insufficiency. Acute renal failure was observed in <1% of patients in Omniscan clinical studies [see Adverse Reactions (6.0)].

Omniscan is cleared by glomerular filtration. Hemodialysis also enhances Omniscan clearance [see Use in Specific Populations (8.5), (8.6)].

Not for Intrathecal Use

Inadvertent intrathecal use of Omniscan has occurred and caused convulsions, coma, sensory and motor neurologic deficits.

Impaired Visualization of Lesions Detectable with Noncontrast MRI

Paramagnetic contrast agents such as Omniscan might impair the visualization of lesions which are seen on the noncontrast MRI. This may be due to effects of the paramagnetic contrast agent, or imaging parameters. Exercise caution when Omniscan MRI scans are interpreted in the absence of a companion noncontrast MRI.

Laboratory Test Findings

Asymptomatic, transitory changes in serum iron have been observed. The clinical significance is unknown.

Omniscan interferes with serum calcium measurements with some colorimetric (complexometric) methods commonly used in hospitals, resulting in serum calcium concentrations lower than the true values. In patients with normal renal function, this effect lasts for 12-24 hours. In patients with decreased renal function, the interference with calcium measurements is expected to last during the prolonged elimination of Omniscan. After patients receive Omniscan, careful attention should be used in selecting the type of method used to measure calcium.

Adverse Reactions

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience (Adults)

In clinical studies 1160 patients were exposed to Omniscan. The most frequent adverse reactions were nausea, headache, and dizziness that occurred in 3% or less of the patients. The majority of these adverse reactions were of mild to moderate intensity.

The following adverse reactions occurred in 1% or less of patients:

Application Site Disorders: Injection site reaction.

Autonomic Nervous System Disorders: Vasodilation.

Body as a Whole-General Disorders: Anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms), fever, hot flushes, rigors, fatigue, malaise, pain, syncope.

Cardiovascular Disorders: Cardiac failure, rare arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease, flushing, chest pain, deep thrombophlebitis.

Central and Peripheral Nervous System Disorders: Convulsions including grand mal, ataxia, abnormal coordination, parethesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), aggravated migraine.

Gastrointestinal System Disorders: Abdominal pain, diarrhea, eructation, dry mouth/vomiting, melena.

Hearing and Vestibular Disorders: Tinnitus.

Liver and Biliary System Disorders: Abnormal hepatic function.

Musculoskeletal System Disorders: Arthralgia, myalgia.

Respiratory System Disorders: Rhinitis, dyspnea.

Skin and Appendage Disorders: Pruritus, rash, erythematous rash, sweating increased, urticaria.

Special Senses, Other Disorders: Taste loss, taste perversion.

Urinary System Disorders: Acute reversible renal failure.

Vision Disorders: Abnormal vision.

Clinical Studies Experience (Pediatrics)

In the 97 pediatric patients in CNS studies with Omniscan [see Clinical Studies (14.1)] and the 144 pediatric patients in published literature, the adverse reactions were similar to those reported in adults.

Postmarketing Experience

Because postmarketing 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 drug exposure.

The following adverse reactions have been identified during the postmarketing use of Omniscan:

Nervous System Disorders: Inadvertent intrathecal use causes seizures, coma, paresthesia, paresis.

Drug Interactions

Specific drug interaction studies have not been conducted.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C

Omniscan has been shown to have an adverse effect on embryo-fetal development in rabbits at dosages as low as 0.5 mmol/kg/day for 13 days during gestation (approximately 0.6 times the human dose based on a body surface area comparison). These adverse effects are observed as an increased incidence of flexed appendages and skeletal malformations which may be due to maternal toxicity since the body weight of the dams was reduced in response to Omniscan administration during pregnancy. In rat studies, fetal abnormalities were not observed at doses up to 2.5 mmol/kg/day for 10 days during gestation (1.3 times the maximum human dose based on a body surface area comparison); however, maternal toxicity was not achieved in these studies and a definitive conclusion about teratogenicity in rats at doses above 2.5 mmol/kg/day cannot be made. Adequate and well controlled studies in pregnant women have not been conducted. Omniscan should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when administering Omniscan to a nursing woman.

Pediatric Use

The safety and efficacy of Omniscan at a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients over 2 years of age based on adequate and well controlled studies of Omniscan in adults, a pediatric CNS imaging study, and safety data in the scientific literature. However, the safety and efficacy of doses greater than 0.1 mmol/kg and of repeated doses have not been studied in pediatric patients.

Pharmacokinetics of Omniscan have not been studied in pediatrics. The glomerular filtration rate of neonates and infants is much lower than that of adults. The pharmacokinetics volume of distribution is also different. Therefore, the optimal dosing regimen and imaging times in patients under 2 years of age have not been established.

Geriatric Use

In clinical studies of Omniscan, 243 patients were between 65 and 80 years of age while 15 were over 80. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Omniscan is substantially excreted by the kidney, and the risk of toxic reactions to Omniscan may be greater in patients with impaired renal function. [see Warnings and Precautions (5.3)] Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to assess renal function before Omniscan use.

Renal/Hepatic Impairment

Dose adjustments in renal or hepatic impairment have not been studied. Caution should be exercised in patients with impaired renal insufficiency [see Warnings and Precautions (5.2,5.3)].

Overdosage

Clinical consequences of overdose with Omniscan have not been reported. The minimum lethal dose of intravenously administered Omniscan in rats and mice is greater than 20 mmol/kg (200 times the recommended human dose of 0.1 mmol/kg; 67 times the cumulative 0.3 mmol/kg dose). Omniscan is dialyzable.

Omniscan Description

Omniscan (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. Omniscan is administered by intravenous injection.

Omniscan is provided as a sterile, clear, colorless to slightly yellow, aqueous solution in Pharmacy Bulk Package. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. Omniscan contains no antimicrobial preservative. Omniscan is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9•xH2O, and the following structural formula:

Pertinent physicochemical data for Omniscan are noted below:

PARAMETER

Osmolality (mOsmol/kg water)	@ 37°C	789
Viscosity (cP)	@ 20°C @ 37°C	2.0 1.4
Density (g/mL)	@ 25°C	1.14
Specific gravity	@ 25°C	1.15

Omniscan has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.

Omniscan - Clinical Pharmacology

Pharmacodynamics

In magnetic resonance imaging, visualization of normal and pathologic tissue depends in part on variations in the radiofrequency signal intensity. These variations occur due to: changes in proton density; alteration of the spin-lattice or longitudinal relaxation time (T1); and variation of the spin-spin or transverse relaxation time (T2). Omniscan is a paramagnetic agent with unpaired electron spins which generate a local magnetic field. As water protons move through this local magnetic field, the changes in magnetic field experienced by the protons reorient them with the main magnetic field more quickly than in the absence of a paramagnetic agent.

By increasing the relaxation rate, Omniscan decreases both the T1 and T2 relaxation times in tissues where it is distributed. At clinical doses, the effect is primarily on the T1 relaxation time, and produces an increase in signal intensity. Omniscan does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that do not have an abnormal blood-brain barrier (e.g., cysts, mature postoperative scars, etc). However, disruption of the blood-brain barrier or abnormal vascularity allows accumulation of Omniscan in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetic parameters of Omniscan in various lesions are not known.

Pharmacokinetics

The pharmacokinetics of intravenously administered gadodiamide in normal subjects conforms to an open, two-compartment model with mean distribution and elimination half-lives (reported as mean ± SD) of 3.7 ± 2.7 minutes and 77.8 ± 16 minutes, respectively.

Gadodiamide is eliminated primarily in the urine with 95.4 ± 5.5% (mean ± SD) of the administered dose eliminated by 24 hours. The renal and plasma clearance rates of gadodiamide are nearly identical (1.7 and 1.8 mL/min/kg, respectively), and are similar to that of substances excreted primarily by glomerular filtration. The volume of distribution of gadodiamide (200 ± 61 mL/kg) is equivalent to that of extracellular water. Gadodiamide does not bind to human serum proteins in vitro.

Metabolism

There is no detectable biotransformation or decomposition of gadodiamide.

Special Populations

Pharmacokinetic and pharmacodynamic studies have not been systematically conducted to determine the optimal dose and imaging time in patients with abnormal renal function or renal failure, in the elderly, or in pediatric patients with immature renal function.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies have not been performed to evaluate the carcinogenic potential of gadodiamide. The results of the following genotoxicity assays were negative: in vitro bacterial reverse mutation assay, in vitro CHO/HGPRT forward mutation assay, in vitro Chinese Hamster Ovary chromosome aberration assay, and the in vivo mouse micronucleus assay at intravenous doses of 27 mmol/kg (approximately 7 times the maximum human dose based on a body surface area comparison). Impairment of male or female fertility was not observed in rats after intravenous administration three times per week at the maximum dose tested of 1.0 mmol/kg (approximately 0.5 times the maximum human dose based on a body surface area comparison).

Clinical Studies

CNS (Central Nervous System)

Omniscan (0.1 mmol/kg) contrast enhancement in CNS MRI was evident in a study of 439 adults. In a study of sequential dosing, 57 adults received Omniscan 0.1 mmol/kg followed by 0.2 mmol/kg within 20 minutes (for cumulative dose of 0.3 mmol/kg). The MRIs were compared blindly. In 54/56 (96%) patients, Omniscan contrast enhancement was evident with both the 0.1 mmol/kg and cumulative 0.3 mmol/kg Omniscan doses relative to noncontrast MRI.

In comparison to the noncontrast MRI, increased numbers of brain and spine lesions were noted in 42% of patients who received Omniscan at any dose. In comparisons of 0.1 mmol/kg versus 0.3 mmol/kg, the results were comparable in 25/56 (45%); in 1/56 (2%) Omniscan 0.1 mmol/kg dose provided more diagnostic value and in 30/56 (54%) the cumulative Omniscan 0.3 mmol/kg dose provided more diagnostic value.

The usefulness of a single 0.3 mmol/kg bolus in comparison to the cumulative 0.3 mmol/kg (0.1 mmol/kg followed by 0.2 mmol/kg) has not been established.

Omniscan as a single 0.1 mmol/kg dose was evaluated in 97 pediatric patients with a mean age of 8.9 (2-18) years referred for CNS MRI. Postcontrast MRI provided added diagnostic information, diagnostic confidence, and new patient management information in 76%, 67%, and 52%, respectively, of pediatrics.

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

Omniscan was evaluated in a controlled trial of 276 patients referred for body MRI. These patients had a mean age of 57 (9-88) years. Patients received 0.1 mmol/kg Omniscan for imaging the thorax (noncardiac), abdomen, and pelvic organs, or a dose of 0.05 mmol/kg for imaging the kidney. Pre- and post-Omniscan images were evaluated blindly for the degree of diagnostic value rated on a scale of "remarkably improved, improved, no change, worse, and cannot be determined." The postcontrast results showed "remarkably improved" or "improved" diagnostic value in 90% of the thorax, liver, and pelvis patients, and in 95% of the kidney patients.

In a dose ranging study 258 patients referred for body MRI received Omniscan 0.025, 0.05, 0.1 mmol/kg. The lowest effective dose of Omniscan for the kidney was 0.05 mmol/kg.

How Supplied/Storage and Handling

Omniscan (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide supplied in the following sizes:

50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-71)

100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-70)

SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES.

DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.

Protect polymer bottles of Omniscan from strong daylight and direct exposure to sunlight. Do not freeze. Do not use if the product is inadvertently frozen.

Store Omniscan at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].

Patient Counseling Information

1. Patients receiving Omniscan should be instructed to inform their physician if they:
   
   • are pregnant or breast feeding, or
   
   
   • have a history of renal disease, convulsions, asthma or allergic respiratory disorders, or recent administration of gadolinium-based contrast.
   
   


2. Patients with impaired renal function who receive repetitive administrations of a gadolinium-containing contrast agent may have an increased risk for the development of nephrogenic systemic fibrosis if the time interval between the administrations precludes clearance of the contrast agent from the body. In these situations, patients should contact their physician if they develop burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain deep in the hip bones or ribs; or muscle weakness.

Distributed by GE Healthcare Inc.

Princeton, NJ

Manufactured by GE Healthcare Ireland

Cork, Ireland

Omniscan is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.

OptiMARK® is a registered trademark of Mallinckrodt Inc.

Magnevist® is a registered trademark of Verlex Laboratories, Inc.

MultiHance® is a registered trademark of Bracco International B.V.

ProHance® is a registered trademark of Bracco Diagnostics Inc.

Omniscan  gadodiamide  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0407-0690 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Gadodiamide (Gadodiamide) Active 287 MILLIGRAM  In 1 MILLILITER Caldaimide sodium Inactive 12 MILLIGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0407-0690-71 10 BOTTLE In 1 BOX contains a BOTTLE, PLASTIC 1 50 mL (MILLILITER) In 1 BOTTLE, PLASTIC This package is contained within the BOX (0407-0690-71) 2 0407-0690-70 10 BOTTLE In 1 BOX contains a BOTTLE, PLASTIC 2 100 mL (MILLILITER) In 1 BOTTLE, PLASTIC This package is contained within the BOX (0407-0690-70)

Revised: 09/2007GE Healthcare Pharmacovigilance

More Omniscan resources

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

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Daunorubicin

Pronunciation: daw-noe-ROO-bi-sin
Generic Name: Daunorubicin
Brand Name: Cerubidine

Daunorubicin can cause tissue damage if it is injected by a route other than through the vein. Notify your doctor immediately if redness, pain, and swelling occur at or around the injection site. Daunorubicin may cause heart problems, including heart failure, or bone marrow depression, making it hard to fight off infection. Notify your doctor immediately if you develop chest pain, an irregular heartbeat, trouble breathing, swelling of the hands or feet, easy bruising or bleeding, or signs of infection, such as fever, unusual fatigue, or persistent sore throat. Tell your doctor if you have liver or kidney problems before starting treatment with Daunorubicin. You may require smaller doses.

Daunorubicin is used for:

Treating certain types of cancer. It may be used in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Daunorubicin is a cytotoxic agent. It works by preventing the cancer cell from reproducing, which results in death of the cancer cell.

Do NOT use Daunorubicin if:

• you are allergic to any ingredient in Daunorubicin

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

Before using Daunorubicin:

Some medical conditions may interact with Daunorubicin. 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 bone marrow depression, heart disease, gout, or liver or kidney problems, or if you have taken Daunorubicin before

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

• Certain medicines that act upon the liver (eg, methotrexate) or cyclosporine because the actions and side effects of Daunorubicin may be increased


• Trastuzumab because the risk of heart problems may be increased


• Hydantoins (eg, phenytoin) because the effectiveness may be decreased and the risk of seizures may be increased by Daunorubicin

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

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

• Daunorubicin is usually administered as an injection at your doctor's office, hospital, or clinic.


• If Daunorubicin 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 Daunorubicin, contact your doctor as soon as possible.

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

Important safety information:

• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• If you get Daunorubicin on your skin, wash thoroughly with soap and water.


• Daunorubicin may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• Daunorubicin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Daunorubicin causes the urine to turn red. This is harmless and not a cause for concern.


• Check with your doctor before having vaccinations while you are using Daunorubicin.


• LAB TESTS, including blood cell counts; heart, liver, and kidney function tests; and uric acid levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Daunorubicin with caution in CHILDREN because they may be more sensitive to its effects, such as heart problems.


• PREGNANCY and BREAST-FEEDING: Daunorubicin may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Daunorubicin during pregnancy. It is unknown if Daunorubicin is excreted in breast milk. Do not breast-feed while taking Daunorubicin.

Possible side effects of Daunorubicin:

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:

Diarrhea; hair loss; loss of appetite; mouth pain; nausea; sore throat; stomach pain; tiredness; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the stools; chest pain; chills; cough or sore throat; excessive bleeding; fever; flushing; irregular heartbeat; pain, redness, or swelling at the injection site; shortness of breath; sores on the mouth or lips; unusual bruising or bleeding.

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.

Proper storage of Daunorubicin:

Daunorubicin is usually handled and stored by a health care provider. If you are using Daunorubicin at home, store Daunorubicin as directed by your pharmacist or health care provider. Keep Daunorubicin out of the reach of children and away from pets.

General information:

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


• Daunorubicin 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 Daunorubicin. 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.

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• Daunorubicin Support Group
• 0 Reviews for Daunorubicin - Add your own review/rating

• Daunorubicin Prescribing Information (FDA)


• Cerubidine Prescribing Information (FDA)


• daunorubicin Concise Consumer Information (Cerner Multum)


• daunorubicin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• daunorubicin citrate Monograph (AHFS DI)

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