Molecule Info

Content & description

Olmesartan Medoxomil INN 20mg + Hydrochlorothiazide BP 12. 5mg Tablet.

This product is a combination of two antihypertensive drugs.

Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme, 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 . In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT1 receptor. Olmesartan does not inhibit ACE .

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing 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.

Indication & dosage

This combination is indicated for the treatment of hypertension and should not be used as initial therapy.

The usual recommended starting dose of Olmesartan Medoxomil is 20mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40mg. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment or with moderate to marked hepatic dysfunction.  Hydrochlorothiazide is effective in doses between 12. 5mg and 50mg once daily.

Replacement Therapy: This combination may be substituted for its titrated components.

Dose Titration by Clinical Effect: The dose of this combination is one tablet once daily. This combination 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 combination 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. 5mg and later titrated to 25mg once daily.

If a patient is taking Hydrochlorothiazide, Olmesartan may be added starting with a dose of 20mg once daily and titrated to 40mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding Olmesartan or switching to combination tablet, as marked decreases in blood pressure may occur. Consideration should be given to reducing the dose of Hydrochlorothiazide to 12. 5mg before adding Olmesartan. The antihypertensive effect of this combination is related to the dose of both components

over the range of 10mg/12. 5mg to 40mg/25mg.

Patients with Renal Impairment:

The usual regimens of therapy with This combination may be followed provided the patient's creatinine clearance>30 ml/min. In patients with more severe renal impairment, loop

diuretics are preferred to thiazides, so this combination tablet is not recommended.

Patients with Hepatic Impairment: No dosage adjustment is necessary with hepatic impairment.

Precautions

Fetal/Neonatal morbidity and mortality: When pregnancy is detected, this combination drug should be discontinued as soon as possible.

Hypotension in volume- or salt-depleted patients: Symptomatic hypotension may occur after initiation of therapy.

Vasodilation: Exercise caution, when administering this combination, particularly in patients with severe aortic stenosis.

Patients with Severe Obstructive Coronary Artery Disease: Patients may develop increased frequency, duration, or severity of angina or acute MI on starting calcium channel blocker therapy or at the time of dosage increase.

Patients with Congestive Heart Failure: Calcium channel blocker should be used with caution.

Patients with Impaired Renal Function / Hepatic Impairment: Should be used with caution

Pregnancy / lactation

Pregnancy: Category C  and D .

Lactation: 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.

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.

Children: The safety and effectiveness in pediatric patients have not been established.

Side effects

This combination tablet has been evaluated for safety in 1,243 hypertensive patients. It was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of this combination tablet. Some common side effects include: headache, urinary tract infection, chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhoea, increased SGOT & SGPT, hyperlipemia, creatine phosphokinase increased, hyperglycemia, arthritis, arthralgia, myalgia, coughing, rash etc.

Contraindications

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.

Drug interactions

Olmesartan Medoxomil

No significant drug interactions were reported in studies in which Olmesartan Medoxomil was coadministered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers.

Hydrochlorothiazide

When administered concurrently the following drugs may interact with thiazide diuretics: alcohol, barbiturates or narcotics, antidiabetic drugs, other antihypertensive drugs, cholestyramine and colestipol resins, corticosteroids, pressor amines, skeletal muscle relaxants, lithium, NSAIDs etc.

Overdosage

Olmesartan Medoxomil

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic  stimulation occurs.

Hydrochlorothiazide

The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion  and dehydration resulting from excessive diuresis.

mph Class

Combined anti-hypertensive drugs.

   

Brand/Product Info


Total Products : 5     
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ABETIS Plus 20 ACI Ltd. Olmesartan Medoxomil INN 20mg+ Hydrochlorothiazide BP 12.5mg Tablet (film-coated) 30's: 240.90 MRP
OLMETIC Plus Drug International Ltd Olmesartan Medoxomil INN 20mg+ Hydrochlorothiazide BP 12.5mg Tablet (film-coated) 30's: 240.00 MRP
OLMEZEST H20 Sun Pharmaceutical (Bangladesh) Ltd. Olmesartan Medoxomil INN 20mg+ Hydrochlorothiazide BP 12.5mg Tablet (film-coated) 30's: 255.00 MRP
OLSART HZ Opsonin Pharma Limited Olmesartan Medoxomil INN 20mg+ Hydrochlorothiazide BP 12.5mg Tablet (film-coated) 30's: 240.00 MRP
XYOTIL 20 Plus Incepta Pharmaceuticals Limited Olmesartan Medoxomil INN 20mg+ Hydrochlorothiazide BP 12.5mg Tablet 30's: 240.00 MRP