ABETIS PLUS TAB

Indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

Angiotensin Receptor Blocker

Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin). Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume with consequent increases in plasma renin activity, increases Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

The dose is one tablet once daily. It may be administered with other antihypertensive agents. A patient whose blood pressure is inadequately controlled by Olmesartan or Hydrochlorothiazide alone may be switched to once daily tablet. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks. If blood pressure is not controlled by Olmesartan alone, Hydrochlorothiazide may be added starting with a dose of 12.5 mg & later titrated to 25 mg once daily. If a patient is taking Hydrochlorothiazide, Olmesartan may be added starting with a dose of 20 mg once daily & titrated to 40 mg for inadequate blood pressure control. If large doses of Hydrochlorothiazide have been used as monotherapy & volume depletion or hyponatremia is present, caution should be used when adding Olmesartan or switching to tablet, as marked decreases in blood pressure may occur. Consideration should be given to reducing the dose of Hydrochlorothiazide to 12.5 mg before adding Olmesartan. The antihypertensive effect of this tablet is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg.

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.

This combination tablet 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.

Some common side Effects include: headache, urinary tract infection, chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhoea, SGOT increased, GGT increased, SGPT increased, hyperlipemia, creatine phosphokinase increased, hyperglycemia, arthritis, arthralgia, myalgia, coughing, rash etc.

Pregnancy Categories D. This combination drug should not be used during pregnancy. It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse Effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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.

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