VALZAN 80


Product Name:

VALZAN 80

Composition:

Valsartan 80 mg.

Pharmaceutical Form:

Capsules

Packing:

20 Caps.

Pharmacologic Category:

Cardiac

Properties:

Valsartan is an oral selective angiotensin П - AT1 subtype receptor blockers.

Protein binding: 94 % to 97 %.
Metabolism: it is metabolized to an inactive metabolite.
Bioavailability: 23 %.
Average elimination half-life: 6 hours.
Maximum concentration in blood serum: after 2 hours (maximum effect: 4 - 6 hours).

Excretion: 13 %and 83% excreted in the urine or stool respectively as an unconverted drug.

Indications:

- It is indicated either alone or in combination with other hypotensives in treating essential hypertension.

- It is used in CHF as a substitute to ACE-I in patients intolerant to ACE-I (Val-HeFT).

Contraindications:

- Hypersensivity to Valsartan or one of its components.

Use during pregnancy:
Categories C (first trimester) and D (second and third trimesters).
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, VALZAN should be discontinued as soon as possible.

Nursing Mothers:
It is not known whether valsartan is excreted in human milk, but valsartan was excreted in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Children:
The safety and efficacy of treatment in children has not been investigated.

Side Effects:

- On the central nervous system: headache, dizziness, drowsiness.
- Gastro-intestinal tract: Diarrhea, abdominal pain, nausea, abnormal taste.
- Neuro-muscular and skeletal: Arthralgia and myalgia.
- Respiratory system: Cough.
- Elevation in creatinine, potassium and hepatic function in the blood serum.

Precautions:

- Caution must be taken with patients of mild to moderate hepatic failure (adjusted dosage), sodium/ water depleted (high diuretic doses),elderly.

- Use with caution in patients with arotic / mirtal valve stenosis and coronary artery insufficiency.

- Increase the primary aldosterone.

- Bilateral renal artery stenosis.

Drug Interactions:

- No drug interactions are reported in shared treatment with Amlodipin, Atenolol, Cimetidine, Dijoxin, Furosemide, Indomethacin.

- Using Valsartan with Warfarin didn\\\'t change the pharmacokinetic of Valsartan nor of Warfarin.

Dosage:

The recommended starting dose of Valsartan is 80 mg once daily when used as monotherapy in patients who are not volum-depleted.Valsartan may be used over a dose range of 80 mg to 320 mg daily, administrated once-a- day.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks.

If additional antihypertensive effect is required, the dosage may be increased to 160 mg or 320 mg or a diuretic may be added. No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Valsartan in patients with hepatic or severe renal impairment.
Valsartan may be administrated with other antihypertensive agents.
Valsartan may be administrated with or without food.

NOTES:
- Before using Valsartan it is advised to have tests for electrolytes, renal and hepatic functions, urinalysis, blood pressure, hypersensitivity to the drug and these tests must be held periodically.

- Treatment should be stopped gradually under medical supervision.

- If any allergic reactions or side effects occurred, the physician should be informed immediately.

Over Dosage:

Reports had indicated to some mild toxicity cases (hypotension, bradycrdia, hyperkalemia) after intaking large doses of Valsartan ; no deathes are reported, symptomatic treatment is indicated in this case (by giving fluids and intravenous infusion of saline solution).

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