Valsartan - Angiotensin II Receptor Antagonists- (FDC- List )- (Dec 2001)
Drug Interaction:
Angiotensin II Receptor Antagonists-
Candesartan, Eposartan, Irbestan, Losartan metabolite, Olmesartan, Telmistran, Valsartan
Pot sparing diuretics
Potassium supplements
Salt substitutes
Indication:
Following myocardial infraction in clinically stable patients with left ventricular failure or systolic dysfunction
Angiotensin II Receptor Antagonists-
Candesartan, Eposartan, Irbestan, Losartan metabolite, Olmesartan, Telmistran, Valsartan
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Valsartan Anti-hypertensive 10-12-2001
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Valsartan 80mg/160mg/160mg + 18-03-2003
HCTZ 12.5mg/12.5mg/12.5mg/25mg tablet
For the treatment of mild to moderate hypertension
2. Valsartan 80mg + 1-11-2003
S(-) Amlodipine as besylate 2.5mg capsules
For the treatment of hypertension
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Valsartan Cardiovascular Novartis Group 21-03-2012
Adverse Reaction:
Angiotensin II Receptor Antagonists-
Candesartan, Eposartan, Irbestan, Losartan metabolite, Olmesatran, Telmistran, Valsartan
Adverse Reactions-
VALSARTAN
CNS - Dizziness >1% ,Insomnia >0.2%, Headache >1% ,Fatigue 2%
Anxiety/nervousness > 0.2%
GI - Diarrhea >1% Dyspepsia/heartburn >0.2% Nausea/voming >1%
Abdomnal pain 2%
Musculoskeletal- Arthalgia >1% Pain >0.2% Muscle cramp >0.2% Myalgia >0.2%
Respiratory - Upper Respiratory tract infn > 1% Cough >1% Sinusitis >1%
Pharyngitis >1% Rhinitis >1%
Miscellaneous - Viral infection 3% Edema >1% Rash > 0.2%
Contra-Indications:
Severe hepatic impairment
Cirrhosis, biliary obstruction,
Pregnancy, lactation
Special precautions-
Mild to moderate hepatic impairment renal impairment
Monitor renal renal function, renal artery stenosis
Cardiac insufficiency
Post - MI patients
Hypotension
Monitor serum K in elderly and renally impaired if taking K supplements
Dosages/ Overdosage Etc:
Date of Approval December 2001
Indication-
Following myocardial infraction in clinically stable patients with left ventricular failure
or systolic dysfunction
Dosage-
Initially 20 mg daily twice daily starting as early as 12 hours post MI
Titrsate gradually over next few weeks to 160mg twice daily according to tolerance
Not recommended for Children
Pharmacology/ Pharmacokinetics:
Angiotensin II Receptor Antagonists-
Candesartan, Eposartan, Irbestan, Losartan metabolite, Olmesartan, Telmistran, Valsartan
Pregnancy and lactation:
Contraindicated during pregnancy and lactation