PRESCRIBING INFORMATION
Presentation
Anreb Plus : Each film coated tablet contains Losartan Potassium USP 50 mg and Hydrochlorothiazide BP 12.5 mg.
Anreb 100 Plus : Each film coated tablet contains Losartan Potassium USP 100 mg and Hydrochlorothiazide BP 12.5 mg.
Description
This tablet combines an angiotensin II receptor antagonist and a diuretic, Hydrochlorothiazide.
Indication
It is indicated for the treatment of hypertension.
Dosage and Administration
Hypertension
The usual starting dose is one tablet once daily. For patients who do not respond adequately to one tablet the dosage may be increased to two tablets daily. The maximum dose is two tablets daily. In general, the anti-hypertensive effect is attained within three weeks after initiation of therapy. No initial dosage adjustment is necessary for elderly patients. But maximum dose of two tablets of once daily dose should not be used as initial therapy in elderly patients.
Use in patients with renal impairment
The usual regimens of therapy with this may be followed as long as the patients creatinine clearance is > 30ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, Hydrochlorothiazide is not recommended.
Use in patients with hepatic impairment
The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Severe hypertension
The starting dose of this for initial treatment of severe hypertension is one tablet once daily. For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to two tablets daily. The maximum dose is two tablets daily. It may be administered with other anti-hypertensive agents. It may be administered with or without food.
Contraindications
The combination of Losartan Potassium and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of Hydrochlorothiazide, this product is contraindicated in patients with anuria or hypersensitive to other sulfonamide-derived drugs.
Use in Pregnancy and Lactation
Pregnancy : Not recommended.
Nursing mother : Not recommended.
Precautions
* Hypersensitive; Angioedema
* Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
* Hypokalemia may rarely develop, especially with brisk dieresis, when severe cirrhosis is present or after prolonged therapy.
* Impaired renal function and
* Symptomatic hypertension
Side Effects
Generally, it is well tolerated. However few side effects including abdominal pain, swelling, back pain, dizziness, rash and cough may occur in rare cases.
Drug Interactions
Losartan Potassium
No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II of its effects, concomitant use of Potassium-sparing diuretics, Potassium supplements, or salt substitutes containing Potassium may lead to increase in serum Potassium. As with other anti-hypertensive agents, the anti-hypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug indomethacin.
Hydrochlorothiazide
When administered concurrently, the following drugs may interact with thiazide diuretics- alcohol, barbiturates or narcotics - potentiation of orthostatic hypotension may occur. Anti-diabetic drug (oral agents and insulin) - dosage adjustment of anti-diabetic drug may be required. Other anti-hypertensive drugs-additive effect or potentiation. Cholestyramine and Colestipol resins-absorption of Hydrochlorothiazide is impaired in presence of anionic exchange resins.
Storage Conditions
Store in cool and dry place, away from light and out of children's reach.
Commercial Pack
Anreb Plus : Each box contains 3 blister packs of 10 tablets.
Anreb 100 Plus : Each box contains 2 blister packs of 10 tablets.
