Generic Name
Olmesartan Medoxomil + HydrochlorothiazideTherapeutic Class: Cardiovascular / Combined antihypertensive preparations
Indications:
Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus is indicated for the treatment of hypertension.
Presentation:
Each tablet contains Olmesartan Medoxomil INN 20 mg and Hydrochlorothiazide BP 12.5 mg.
Description:
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 AT1 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 the AT1 receptor. Olmesartan does not inhibit ACE (kinase II, 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.
Dosage & Administration:
Hypertension
The usual starting dose of Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus is 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.
Patients with Renal Impairment:
The usual regimens of therapy with Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus may be followed provided the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, Xyotil 20 Plus is not recommended.
Patients with Hepatic Impairment:
No dosage adjustment is necessary with hepatic impairment.
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:
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
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:
Olmesartan:
Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus is indicated for the treatment of hypertension.
Presentation:
Each tablet contains Olmesartan Medoxomil INN 20 mg and Hydrochlorothiazide BP 12.5 mg.
Description:
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 AT1 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 the AT1 receptor. Olmesartan does not inhibit ACE (kinase II, 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.
Dosage & Administration:
Hypertension
The usual starting dose of Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus is 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.
Patients with Renal Impairment:
The usual regimens of therapy with Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus may be followed provided the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, Xyotil 20 Plus is not recommended.
Patients with Hepatic Impairment:
No dosage adjustment is necessary with hepatic impairment.
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:
- 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.
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
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 or potentiation.
- Corticosteroids, ACTH.
- Lithium.
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.
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.
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.