Losan Plus ®: Each film-coated tablet contains 50 mg Losartan Potassium USP and 12.5 mg Hydrochlorothiazide BP.

BP

Angiotensin Receptor Blockers

Losan Plus ® is indicated in the treatment of hypertension.

This combination 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.

The usual starting dose is Losan Plus ® one tablet once daily. More than two tablets of Losan Plus ® once daily is not recommended. Maximum Antihypertensive effect is attained about three weeks after initiation of therapy. Patients whose blood pressure is not adequately controlled with losartan or hydrochlorothiazide monotherapy, may be switched to Losan Plus once daily. If blood pressure remains uncontrolled after about three weeks of therapy, the dose may be increased to two tablets of Losan Plus ® once daily or as directed by the physician.

The combination of Losartan Potassium and Hydrochlorothiazide is generally well tolerated. However, few side effects including abdominal pain, edema/swelling, palpitation, back pain, dizziness, cough, sinusitis, upper respiratory tract infection, rash.

• Hypersensitivity: Angioedema.

• Hydrochlorothiazide therapy is associated with electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

• Hyperglycemia may occur with thiazide diuretics. In diabetic patients, dosage adjustments of insulin or oral hypoglycemic agents may be required.

• Impaired renal function.

• Symptomatic hypotension.

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 or its effects, concomitant use of potassium-sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive 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. Antidiabetic drugs (oral agents and insulin): dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs: additive effect or potentiation. Skeletal muscle relaxants: possible increased responsiveness to the muscle relaxant. NSAIDS: In some patients the administration of a non-steroidal anti-inflammatory agent can reduce the antihypertensive effects of thiazide diuretics.

Each box contains 3 x 10 tablets in blister strips.<span class="\&quot;Apple-tab-span\&quot;" style="\&quot;white-space:" pre;\"="">

Safety and effectiveness of Losan Plus ® in pediatric patients have not been established.

Not recommended

Store in a cool and dry place, at below 30 ºC temperature and protected from light.

Keep all medicines out of the reach of children.