Av-Sartan Tablet 5/80mg

Pregnancy

• Av-Sartan 5/80mg in pregnancy. Lactation: Caution advised or effect undetermined. Contraindications: Biliary cirrhosis or cholestasis, severe hepatic impairment, dialysis. Severe hypotension, shock, left ventricular outflow obstruction, unstable heart failure following MI. Primary hyperaldosteronism. Precautions: Mild to moderate hepatic impairment, biliary obstruction, salt or volume depletion, aortic or mitral stenosis, malignant hyperthermia, hypertensive crisis. Moderate to severe renal impairment, renal artery stenosis; monitor serum potassium and creatinine levels. Heart failure or post MI; monitor renal function. Elderly.

Indications

• Essential hypertension.

Dosage

• Adults: 1 tab daily. Children: Not recommended.

Advice to Patient

• Take with or without meals.

Pharmacokinetics

• VALSARTAN: Onset of action: Approx. 2 hrs. Duration: 24 hrs. Metabolism: To inactive metabolite. Bioavailability: Tab: 25%. Susp: Approx. 40%. Half-life elimination: Children 1-5 yrs. Approx. 4 hrs, 6-16 yrs: Approx. 5 hrs. Adults: Approx. 6 hrs. Time to peak, serum: Children 1-16 yrs: Oral susp: 2 hrs. Adults: 2-4 hrs. Excretion: Faeces (83%). Urine (13%). AMLODIPINE: Onset of action: Antihypertensive effect: Significant reductions in blood pressure at 24-48 hrs after first dose. Duration: Antihypertensive effect: At least 24 hrs. Discontinuation after 6-7 wks of treatment: Duration extends to at least 72 hrs. Absorption: Well absorbed. Metabolism: Hepatic. Bioavailability: 64%-90%. Half-life elimination: Terminal (biphasic): 30-50 hrs. Time to peak, plasma: 6-12 hrs. Excretion: Urine.

Interactions

• k supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that may increase k levels (heparin, etc.), other antihypertensives, lithium, heparin, NSAIDs, simvastatin, ritonavir, rifampicin, dantrolene, cyclosporin, grapefruit juice, CYP3A4 inhibitors or inducers.

Adverse effects

• Nasopharyngitis, flu. Headache. Oedema (pitting, facial, peripheral), fatigue, flushing, asthaenia, hot flush, hypokalaemia, hot flushes, somnolence, dizziness, palpitations, abdominal pain, nausea. Reports of angioedema (discontinue).