Irbesartan - Angiotensin II Receptor Antagonists- (FDC- List )- (June 2000)
Drug Interaction:
Angiotensin II Receptor Antagonists- Candesartan, Eposartan, Irbestan, Losartan metabolite, Olmesatran, Telmistran, Valsartan
Aspirin,NSAIDs, K -Sparing diuretics, K -supplements, lithium,
Indication:
Hypertension
Renal disease in hypertensive Type ll diabetes
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Irbesatran Anti-Hypertensive 26-06-2000
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Irbesartan 150mg/300mg + 31-01-2001
Hydrochlorthiazide 12.5mg /25mg tablet
For mild to moderate hypertension
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Irbesatran Cardiovascular Sanofi 20-03-2011
Adverse Reaction:
Angiotensin II Receptor Antagonists-
Candesartan, Eprosartan, Irbestan, Losartan metabolite, Olmesatran, Telmistran, Valsartan
Adverse Reactions-
IRBESARTAN
CNS -
Dizziness, Headache > 1%,Fatigue 4%, Anxiety/nervousness >1% Depression < 1%
GI -
Diarrhea 3%, Dyspepsia /heartburn 2%, Nausea/vomiting >1% Abdominal pain >1%
Musculoskeletal-
Pain >1%Trauma 2%
Respiratory -
Upper Res tract infn 9% Cough 3% Sinus disorder >1% Pharyngitis >1% Rhinitis >1%
Influnz symptoms >1%
Miscellaneous -
Edema >1% Chest pain >1% Rash >1% Tacycardia >1% Urinary tract infn >1%
Contra-Indications:
Pregnancy, lactation primary aldosteronism
Special precautions- Correct volume and or salt fdepletion before starting therapy Renovascular hypertension
Renal impairment
Heart failure
Monitor serum potassium and creatinine levels
Aortic or mitral valve stenosis, Ventricular dysfunction, cardiac arrhythmias, severe hepatic impairment,
Obstructive hypertrophic cardiomyopathy
Recent kidney transplant, haemodialysis.
Renal artery stenosis
Elderly
Type ll diabetes with renal disease
Dosages/ Overdosage Etc:
Indication-
Hypertension
Renal disease in hypertensive Type ll diabetes
Dosage
Initially 150mg once daily
Lower starting dose in volume/sodium depletion, haemodialysis increase if necessary to 300mg once daily or add other antihypertensives agent
Elderly over 75 years- Initially 75mg once daily then titrate according to responses
Renal disease -Initially 150mg once daily, titrate to 300mg once daily for maintenance
Pharmacology/ Pharmacokinetics:
Angiotensin II Receptor Antagonists-
Candesartan, Eposartan, Irbestan, Losartan metabolite, Olmesatran, Telmistran, Valsartan
Pregnancy and lactation:
Contra-indicated in pregnancy and lactation