OLMETIC

Olmesartan Medoxomil BP

Composition : Olmesartan Medoxomil BP 20 mg Tablet.

Indication : Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Dosage and administration : Olmetic : Adults: Dosage must be individualized. The usual recommended starting dose of Olmesartan Medoxomil is 10 to 20 mg once daily when used as monotherapy. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan Medoxomil may be increased to 20 to 40 mg. Maximum recommended daily dose is 40mg. Elderly and renal impairment: The maximum dose in elderly and patients with mild to moderate renal impairment is 20mg daily. Children and adolescents: The safety and efficacy have not been established in children and adolescents up to 18 years of age. Patients with Hepatic Impairment : No dosage adjustment is necessary with hepatic impairment. Or, as directed by the registered physicians.

Use in pregnancy and lactation : Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether Olmesartan Medoxomil is excreted in human milk. Mothers must not breast-feed if they are taking Olmesartan Medoxomil. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, this drug should be discontinued as soon as possible.

Packing : Olmetic : 3 x 10's tablets in blister pack.

PRESCRIBING DESCRIPTION

Composition : Olmesartan Medoxomil 20mg Tablet. Indications : Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Dosage and administration : Olmetic : Adults: Dosage must be individualized. The usual recommended starting dose of Olmesartan Medoxomil is 10 to 20mg once daily when used as monotherapy. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan Medoxomil may be increased to 20 to 40 mg. Maximum recommended daily dose is 40mg. Elderly and renal impairment: The maximum dose in elderly and patients with mild to moderate renal impairment is 20mg daily. Children and adolescents: The safety and efficacy have not been established in children and adolescents up to 18 years of age. Patients with Hepatic Impairment : No dosage adjustment is necessary with hepatic impairment. Or as directed by the registered physicians. Contraindication : This tablet is contraindicated in patients who are hypersensitive to any components of this product. Side effects : The most frequent side effects related to olmesartan are chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhoea, SGOT increased, GGT increased, SGPT increased, hyperlipemia, creatine phosphokinase increased, hyperglycemia, arthritis, arthralgia, myalgia, coughing, rash, hematuria. Precautions : Angiotensin II receptor antagonist should be used with caution in patients with severe renal impairment (creatinine clearance<20ml/min) and patients with sever congestive heart failure. Due to limited experience, the use of Olmesartan Medoxomil is not recommended in patients with hepatic impairment. All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia. Serum and urine electrolyte determinations are important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Use in pregnancy and lactation : Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether Olmesartan Medoxomil is excreted in human milk. Mothers must not breast-feed if they are taking Olmesartan Medoxomil. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, this drug should be discontinued as soon as possible. Drug interactions : Olmesartan medoxomill: No significant drug interactions were reported in studies in which Olmesartan was co administered with Hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Packing : Olmetic : 3 x 10's tablets in blister pack.