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Generic Diovan Hct Valsartan-hydrochlorothiazide 80mg + 12.5/160mg + 12.5mg

Check with your doctor before combining Diovan with salt substitutes that contain potassium, or with diuretics that leave potassium in the body, including the following: Amiloride Spironolactone Triamterene The hydrochlorothiazide in Diovan HCT may interact with a variety of drugs. Drugs such as Diovan and Diovan HCT can cause injury or even death to the unborn child when used during the last 6 months of pregnancy. As soon as you find out that you're pregnant, stop taking the drug and call your doctor. The maximum recommended dose is 320 milligrams a day. Heart Failure The usual starting dose is 40 milligrams taken twice a day. The doctor may increase the dose to 80 or 160 milligrams twice daily depending on your tolerance for the drug.

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Warnings

In rabbits, fetotoxicity (i.e., resorptions, litter loss, abortions, and low body weight) associated with maternal toxicity (mortality) was observed at doses of 5 and 10 mg/kg/day. The no observed adverse effect doses of 600, 200 and 2 mg/kg/day in mice, rats and rabbits represent 9, 6 and 0.1 times, respectively, the maximum recommended human dose on a mg/m basis. These doses of hydrochlorothiazide in mice and rats represent 608 and 405 times, respectively, the maximum recommended human dose on a mg/m basis. (Calculations assume an oral dose of 25 mg/day and a 60-kg patient.), Excessive reduction of blood pressure was rarely seen (0.7%) in patients with uncomplicated hypertension treated with Diovan HCT in controlled trials.

Precautions

In other patients, one or the other effect may be dominant. Musculoskeletal: Arthralgia, back pain, muscle cramps, myalgia, and pain in extremity. Nervous system: Dizziness postural, paraesthesia, and somnolence. Psychiatric: Anxiety and insomnia. Renal and urinary: Pollakiuria. In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, hydrochlorothiazide, or lisinopril were 20%, 19%, 69% respectively (p less than 0.001). CYP 450 Interactions: The enzyme(s) responsible for valsartan metabolism have not been identified but do not seem to be CYP 450 isozymes.

Adverse Reactions

In clinical trials, the opposite effects of valsartan (80, 160 or 320 mg) and hydrochlorothiazide (12.5 mg) on serum potassium approximately balanced each other in many patients. The overall frequency of adverse experiences was neither dose-related nor related to gender, age or race. In controlled clinical trials, discontinuation of therapy due to side effects was required in 2.3% of valsartan-hydrochlorothiazide patients and 3.1% of placebo patients. The most common reasons for discontinuation of therapy with Diovan HCT were headache and dizziness. The only adverse experience that occurred in controlled clinical trials in at least 2% of patients treated with Diovan HCT and at a higher incidence in valsartan- hydrochlorothiazide (n=4372) than placebo (n=262) patients was nasopharyngitis (2.4% vs 1.9%).

Drug Interactions

The following additional adverse reactions have been reported in post-marketing experience: Hypersensitivity: There are rare reports of angioedema; Digestive: Elevated liver enzymes and very rare reports of hepatitis. Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin. If symptomatic hypotension should occur, supportive treatment should be instituted.