Generic: Olmesartan Medoxomil Hydrochlorothiazide  |  Dosage Form: Tablet  |  Manufacturer: Renata PLC

Indications

This combination tablet is indicated for the treatment of hypertension.

Dosage & Administration

Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.

Interaction

Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.

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.
• Corticosteroids, ACTH.
• Lithium.

Contraindications

The combination of Olmesartan and Hydrochlorothiazide 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.

Side Effects

The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.

Precautions & Warnings

• Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
• Hyperuricemia may occur in certain patients receiving thiazide therapy.
• Impaired renal function.

Overdose Effects

Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.

Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

Therapeutic Class

Combined antihypertensive preparations

Storage Conditions

Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.