Information about Valsartic

Composition:
Each film coated tablet contains: Valsartan and Hydrochlorothiazide.
80/12.5 mg, 160/12.5 mg and 160/25 mg. 
Pharmacokinetics:
Valsartan:
Valsartan peak plasma concentration is reached 2 to 4 hours after dosing.
Absolute bioavailability for the capsule formulation is about 25%.
and peak plasma concentration (Cmax) by about 50%.
Hydrochlorothiazide:
The estimated absolute bioavailability of hydrochlorothiazide after oral administration is about 70%. Peak plasma hydrochlorothiazide concentrations (Cmax) are reached within 2 to 5 hours after oral administration. There is no clinically significant effect of food on the
bioavailability of hydrochlorothiazide.
Hydrochlorothiazide binds to albumin (40% to 70%) and distributes into erythrocytes. Following oral administration, plasma hydrochlorothiazide concentrations decline bi-exponentially, with a mean distribution half-life of about 2 hours and an elimination half-life of about 10 hours.
Distribution:
Valsartan is highly bound to serum proteins (95%), mainly serum albumin.
Metabolism:
Valsartan: The primary metabolite, accounting for about 9% of dose, is valeryl 4-hydroxy valsartan.
Hydrochlorothiazide: Is not metabolized.
Excretion:
Valsartan: Valsartan, is primarily recovered in feces (about 83% of dose) and urine (about 13% of dose).
Hydrochlorothiazide: About 70% of an orally administered dose of hydrochlorothiazide is eliminated in the urine as unchanged drug.
Indications:
VALSARTAN /HYDROCHLOROTHIAZIDE is indicated for the treatment of essential hypertension. This fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy 
Contraindications:
VALSARTAN /HYDROCHLOROTHIAZIDE is contraindicated in patients who are hypersensitive to any component of this product.
Because of the presence of hydrochlorothiazide, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Do not coadminister aliskiren with valsartan and hydrochlorothiazide in patients with diabetes.
Adverse reactions:
Palpitations and tachycardia, Tinnitus and vertigo, Dyspepsia, diarrhea, flatulence, dry mouth, nausea, abdominal pain, abdominal pain upper, and vomiting, Asthenia, chest pain, fatigue, peripheral edema and pyrexia, Bronchitis, bronchitis acute, influenza, gastroenteritis, sinusitis, upper respiratory tract infection and urinary tract infection, Blood urea increased, Arthralgia, back pain, muscle cramps, myalgia, and pain in extremity, Dizziness postural, paraesthesia, and somnolence ,Anxiety and insomnia,
Pollakiuria, Erectile dysfunction, Dyspnea, cough, nasal congestion, pharyngolaryngeal pain and sinus congestion, Hyperhidrosis and rash, Hypotension , Loss of appetite, mild nausea and vomiting, Postural hypotension, Hyponatraemia, hypomagnesaemia, hyperuricaemia, Hypokalaemia, blood lipids increased (mainly at higher doses).
Storage conditions:
Store below 30°C.
Packaging: 
Carton pack contains 30 F.C. Tablets in blisters for all strengths.