AROVAN

Valsartan

Description:

Arovan (Valsartan) is a nonpeptide orally active and angiotensin II receptor antagonist acting on the AT₁ receptor subtype.

Composition:

Arovan-80: Each capsule contains Valsartan INN 80 mg.

Pharmacology:

Valsartan is an angiotensin II receptor (type AT₁) antagonist. Angiotensin II (formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme) is a potent vasoconstrictor, the primary vasoactive hormone of the renin angiotensin system and an important component in the pathophysiology of hypertension.

Pharmacokinetics:

Bioavailability               25%

Plasma bound               95%

Volume of distribution    17L

Terminal half life        ~ 6 hours

Renal clearance          ~ 0.62 L/hr

Indications:

Valsartan is indicated in the following indications

a)      Treatment of hypertension alone or in combination with other anti-hypertensive agents

b)      In the treatment of heart failure.

Dosage & administration:

Usually 80 mg once daily (elderly over 75 years, mild to moderate hepatic impairment, moderate to severe renal impairment, intravascular volume depletion initially 40 mg once daily); if necessary increased after at least 4 weeks to 160 mg daily (80 mg daily in hepatic impairment).

Contraindications:

Valsartan is contraindicated in-patients with severe hepatic impairment, cirhhosis, or billiary obstruction.

Adverse reaction:

In general, treatment with valsartan is well tolerated. Some adverse reaction such as dizziness, insomnia, headache, fatigue, diarrhoea, dyspepsia, nausea, abdominal pain, sinusitis, etc. may be observed.

Precautions:

Impaired hepatic function: As the majority of valsartan is eliminated in the bile, patients with mild to moderate hepatic impairment including patients with biliary obstructive disorders, showed lower valsartan clearance, care should be exercised in administering valsartan to these patients.

Impaired renal function: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosteron system (e.g. patients with congestive heart failure), treatment with angiotensin converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria.

High Risk Groups:

Use in pregnancy:

Drugs that act directly on the renin angiotensin system can cause fetal and neonetal morbidity and when administered to pregnant women mortality valsartan should be discontinued as soon as possible when pregnancy is defected. .

Use in Lactation:

It is not known if AIIRAs are excreted in human breast milk. Because of the potential for adverse effects on the nursing effect on the nursing infants, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Use in Children:

Safety and efficacy in-patients <18 years of age have not been established.

Drug interactions:

No clinically significant pharmacokinetics interactions were observed when valsartan was co-administered with amlodipine, atenolol, cimetidine, digoxin, furosemide, hydroclorothiazide, or indomethacin.

Overdosage:

The most manifestation of overdosage with an AIIRA would be hypotension, dizziness, and tachycardia.

Storage:

Store in a cool and dry place protected from light. Keep out of the reach of children.

Packing:

Arovan-80: Each box contains 3x10's capsules in blister pack.