DESCRIPTION
MISAR H (Telmisartan +hydrochlorothiazide) is a combination of Telmisartan, an orally active angiotensin ll antagonist, and hydrochlorothiazide, a diuretic.
COMPOSITION
1. Misar H 40/12. 5mg tablets: Each tablet contains Telmisartan U.S.P. 40mg and Hydrochlorothiazide B.P.12.5mg.
2. Misar H 80/12. 5mg tablets: Each tablet contains Telmisartan U.S.P. 80mg and Hydrochlorothiazide B.P.12.5mg.
3. Misar H 80/25. 5mg tablets: Each tablet contains Telmisartan U.S.P. 40mg and Hydrochlorothiazide B.P.12.25mg.
CLINICAL PHARMACOLOGY
Telimisartan
Antagonizes the effect of angiotensin ll ( vasoconstriction and aldosterone secretion) by blocking the angiotensin ll (AT 1 receptor) in vescular smooth muscle and the adrenal gland, producing decreased BP.
Hydrochlothiazide Increases chloride, sodium and water excretion by interfering with transport of sodium ions across renal tubular epithelium.
INDICATIONS
For the treatment of hypertension.
DOSAGE AND ADMINISTRATION
Patients whose BP is not adequately controlled with telmisartan 80 mg monotherapy may be switched to telmisartan 80 mg/hydrochlorothiazide 12.5 mg once daily, and finally titrated up to 160/25 mg, if necessary.
Patient whose BP is inadequately controlled by hydrochlorothiazide 25 mg once daily may be switched to telmistran 80 mg/hydrochlorothiazide 12.5 mg or telmisartan 80 mg/hydrochlorothiazide 25 mg once daily. If BP remains uncontrolled after 2 to 4 wk or therapy, the dose may be titrated up to telmisartan 160 mg/hydrochlorothiazide 25 mg, if necessary. Those patients controlled by hydrochlorothiazide 25 mg but who experience hypokalemia with this regimen may be switched to telmistaran 80mg/hydrochlorothiazide 12.5 mg once daily.
Hepatic function impairment:
Patients with billary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision using the 40/12.5 mg combination.
ADVERSE REACTIONS
Cardiovascular:
Postural hypotension, tachycardia (less than 2%) atrial fibrillation,bradycardia,CHF, hypertension, hypertension aggravated, hypotension,MI, syncope.
Central Nervous System:
Dizziness (5%); fatigue (3%): asthenia, headache, weakness.
Dermatologic:
Rash (less than 2%) drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), erythema, sweating increased urticaria.
CONTRAINDICATIONS
Anuria; hypersensivity to sulfonamide-derived drugs or any component of this product.
PRECAUTIONS & WARNINGS
Correct volume and/or salt depletion before initiating therapy. Observe all patients foe clinical signs of fluid or electrolyte imbalance. Evaluate hepatic and renal function and measure serum electrolytes before starting therapy and periodically thereafter. Monitor BP and pulse on a regular basis. Monit blood glucose in diabetic patients when the drug is started or dose is changed. Hypersensivity may occur in patients with or without history of allergy or bronchial asthma; cross-sensivity with sulfonamides also may occur. Safety and efficacy not established in children and it is to be used in elderly with caution.
PREGNANCY & LACTATION
The use of Misar H is not recommend in pregnancy and lactation.
OVERDOSAGE
Symptoms include bradycardia, dehhdration, dizziness, electrolyte depletion (eg, hypochloremia, hypokalemia, hyponatremia), hypotension, tachycardia. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and creatinine should be placed in a supine position, with salt and volume replacement given quickly.
PRESENTAION
1. Misar H 40 /12.5 mg tablets: Blister Pack of 2×7's tablets.
2. Misar H 80 / 12.5 mg tablets: Blister Pack of 2×7's tablets.
3. Misar H 80 / 25 mg tablets: Blister Pack of 2×7's tablets.
MISAR H (Telmisartan +hydrochlorothiazide) is a combination of Telmisartan, an orally active angiotensin ll antagonist, and hydrochlorothiazide, a diuretic.
COMPOSITION
1. Misar H 40/12. 5mg tablets: Each tablet contains Telmisartan U.S.P. 40mg and Hydrochlorothiazide B.P.12.5mg.
2. Misar H 80/12. 5mg tablets: Each tablet contains Telmisartan U.S.P. 80mg and Hydrochlorothiazide B.P.12.5mg.
3. Misar H 80/25. 5mg tablets: Each tablet contains Telmisartan U.S.P. 40mg and Hydrochlorothiazide B.P.12.25mg.
CLINICAL PHARMACOLOGY
Telimisartan
Antagonizes the effect of angiotensin ll ( vasoconstriction and aldosterone secretion) by blocking the angiotensin ll (AT 1 receptor) in vescular smooth muscle and the adrenal gland, producing decreased BP.
Hydrochlothiazide Increases chloride, sodium and water excretion by interfering with transport of sodium ions across renal tubular epithelium.
INDICATIONS
For the treatment of hypertension.
DOSAGE AND ADMINISTRATION
Patients whose BP is not adequately controlled with telmisartan 80 mg monotherapy may be switched to telmisartan 80 mg/hydrochlorothiazide 12.5 mg once daily, and finally titrated up to 160/25 mg, if necessary.
Patient whose BP is inadequately controlled by hydrochlorothiazide 25 mg once daily may be switched to telmistran 80 mg/hydrochlorothiazide 12.5 mg or telmisartan 80 mg/hydrochlorothiazide 25 mg once daily. If BP remains uncontrolled after 2 to 4 wk or therapy, the dose may be titrated up to telmisartan 160 mg/hydrochlorothiazide 25 mg, if necessary. Those patients controlled by hydrochlorothiazide 25 mg but who experience hypokalemia with this regimen may be switched to telmistaran 80mg/hydrochlorothiazide 12.5 mg once daily.
Hepatic function impairment:
Patients with billary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision using the 40/12.5 mg combination.
ADVERSE REACTIONS
Cardiovascular:
Postural hypotension, tachycardia (less than 2%) atrial fibrillation,bradycardia,CHF, hypertension, hypertension aggravated, hypotension,MI, syncope.
Central Nervous System:
Dizziness (5%); fatigue (3%): asthenia, headache, weakness.
Dermatologic:
Rash (less than 2%) drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), erythema, sweating increased urticaria.
CONTRAINDICATIONS
Anuria; hypersensivity to sulfonamide-derived drugs or any component of this product.
PRECAUTIONS & WARNINGS
Correct volume and/or salt depletion before initiating therapy. Observe all patients foe clinical signs of fluid or electrolyte imbalance. Evaluate hepatic and renal function and measure serum electrolytes before starting therapy and periodically thereafter. Monitor BP and pulse on a regular basis. Monit blood glucose in diabetic patients when the drug is started or dose is changed. Hypersensivity may occur in patients with or without history of allergy or bronchial asthma; cross-sensivity with sulfonamides also may occur. Safety and efficacy not established in children and it is to be used in elderly with caution.
PREGNANCY & LACTATION
The use of Misar H is not recommend in pregnancy and lactation.
OVERDOSAGE
Symptoms include bradycardia, dehhdration, dizziness, electrolyte depletion (eg, hypochloremia, hypokalemia, hyponatremia), hypotension, tachycardia. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and creatinine should be placed in a supine position, with salt and volume replacement given quickly.
PRESENTAION
1. Misar H 40 /12.5 mg tablets: Blister Pack of 2×7's tablets.
2. Misar H 80 / 12.5 mg tablets: Blister Pack of 2×7's tablets.
3. Misar H 80 / 25 mg tablets: Blister Pack of 2×7's tablets.
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