Composition: Each Film Coated Tablet contains. Active Ingredients: Valsartan 80 mg + Hydrochlorothiazide 12.5 mg / Valsartan 160 mg + Hydrochlorothiazide 12.5 mg / Valsartan 160 mg + Hydrochlorothiazide 25 mg
Indications And Usage: Valsatens plus is indicated for treatment of Hypertension.
Contraindications: Valsatens plus is contraindicated in patients who are hypersensitive to any component of this product Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Warnings : In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of Valsartan, or the treatment should start under close medical supervision Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction patients.
Dosage & Administration: Hypertension: The recommended starting dose of Valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily, and can be given at doses of 12.5 mg to 25 mg. Valsatens plus tablets contain valsartan and hydrochlorothiazide, 80/12.5 mg, 160/12.5 mg and 160/25 mg. A patient whose blood pressure is not adequately controlled with valsartan monotherapy may add hydrochlorothiazide (valsartan 80 mg/hydrochlorothiazide12.5 mg or valsartan 160 mg/hydrochlorothiazide 12.5 mg) once daily. if blood pressure remains uncontrolled after 3-4 weeks of therapy, the dose may be titrated up to a maximum of valsartan 320mg/hydrochlorothiazide 25 mg. Warnings : In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of Valsartan, or the treatment should start under close medical supervision Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction patients.
Drug Interactions: Valsartan: No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. Hydrochlorothiazide: When administered concurrently the following drugs may interact with thiazide diuretics:Alcohol, barbiturates, or narcotics : Potentiation of orthostatic hypotension may occur. Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs: Additive effect or potentiation. Cholestyramine and colestipol resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43% respectively. Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia. Pressor amines (e.g.,norepinephrine): Possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible increased responsiveness to the muscle relaxant. Lithium: Should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with Valsatens plus. Non-steroidal anti-inflammatory Drugs:In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Valsatens plus and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: There were no notable differences in efficacy or safety between older and younger patients.
Precautions: Hydrochlorothiazide :All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting. In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Impaired Hepatic Function: Valsartan: 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 (higher AUCs). Care should be exercised in administering valsartan to these patients.Renal artery stenosis in a solitary kidney or bilateral renal artery stenosis.Valsartan: Uses of ACE inhibitors in hypertensive patients with unilateral or bilateral renal artery stenosis are associated with increase in serum creatinine or blood urea nitrogen, similar outcome should be expected with valsartan . Impaired Renal Function: Valsartan: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death.Similar outcomes have been reported with Valsatens plus. Hydrochlorothiazide: Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Pregnancy & Lactation: Warning: Use In Pregnancy : When used in pregnancy,.drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Valsatens plus should be discontinued as soon as. possible.
Adverse Effects: It may include hypotension, headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia, allergic reaction and asthenia ، palpitations ، pruritus and rash, constipation, dry mouth, dyspepsia, and flatulence, back pain, muscle cramps, and myalgia, anxiety, insomnia, paresthesia, and somnolence , dyspnea, vertigo, impotence. Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia,vomiting, and angioedema.