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VALZID 80

Product Name:
VALZID 80
Composition:

Valsartan 80 mg. Hydrochlorothiazide 12.5 mg.

Pharmaceutical Form:

Tablets

Packing:

30 F.C. Tabs.

Public Price:

 325 sp

Pharmacist Price:

 272 sp

Pharmacologic Category:

Cardiac

Properties:

Valsartan is a specific angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide is a diuretic.

Mechanism of action:
Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20.000-fold) for the AT1 receptor than for the AT2 receptor. Because valsartan does not inhibit ACE (kininase II) it does not affect the response to bradykinin.

Hydrochlorothiazide is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazides is unknown. Hydrochlorothiazide reduces plasma volume, increases aldosterone secretion, and causes an increase in urinary potassium loss, and decrease in serum potassium.

Coadministration of valsartan with hydrochlorothiazide is additive in its hypertensive effect and reverses the potassium loss associated with these diuretics.

Indications:

Valzid is indicated for the treatment of hypertension.

Contraindications:

1- Valzid is contraindicated in patients who are hypersensitive to any component of this product.

2- Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Side Effects:

They are generally rare, mild, and independent of race, age, and gender: Dizziness, viral infection, fatigue, pharyngitis, cough, diarrhea, electrolyte disturbances (e.g., hypokalemia, hyponatremia, hypomagnesemia), hyperuricemia.

Symptomatic hypotension may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretic).

Precautions:

It is not recommended for patients with severe renal impairment.
Arrhythmias. Postsympathectomy. Diabetes. Gout. Asthma. Renal artery stenosis. SLE.

Pregnant and nursing mothers: not recommended.
Use extreme caution and adjust doses in patients with mild to moderate hepatic dysfunction.

Drug Interactions:

1- Valzid may cause hyperkalemia with K -sparing diuretics or K supplements.
2- Hypokalemia happens with corticosteroids and ACTH.
3- NSAIDs decrease the effect of Valzid.
4- Orthostatic hypotension may be potentiated by alcohol, barbiturates, narcotics, antihupertensives.
5- Potentiates nondepolarizing muscle relaxants.
6- Antagonizes norepinephrine.
7- The dosage of antidiabetic medications should be adjusted when used with Valzid.
8- May increase toxicity of lithium.
9- May interfere with parathyroid tests.

Dosage:

Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once-a-day. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

Dose titration by clinical effect: Valzid (valsartan 80 mg/hydrochlorothiazide 12.5 mg) is initiated once daily. If blood pressure remains uncontrolled after about 3-4 weeks of therapy, either valsartan or both components may be increased depending on clinical response.

There are no studies evaluating doses of valsartan greater than 160 mg in combination with hydrochlorothiazide 25 mg.

A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to Valzid (valsartan 80 mg/hydrochlorothiazide
12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response.

The maximal antihypertensive effect is attained about 4 weeks after initiation of therapy.
Patients with Renal Impairment: The usual regimens of therapy with Valzid may be followed as long as the patient\\\'s creatinine clearance is >30 mL/min.

In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Valzid is not recommended.
Patients with Hepatic Impairment: Care should be exercised with dosing of Valzid in patients with hepatic impairment.

Other: No initial dosage adjustment is required for elderly patients.
Valzid may be administered with other antihypertensive agents.
Valzid may be administered with or without food.