Olmesafe-AM 5/20 & 40

ANTIHYPERTENSIVES: Amlodipine Besilate BP & Olmesartan Medoxomil BP

Indication

Treatment of essential hypertension. Olmesafe-AM is indicated in adult patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil or Amlodipine monotherapy.

Contraindication

Hypersensitivity to the active substances, to dihydropyridine derivatives or to any of the excipients, second and third trimesters of pregnancy, severe hepatic insufficiency and biliary obstruction.

Dosage & Administration

Adults: The recommended dosage of Olmesartan Medoxomil and Amlodipine is one tablet per day. Olmesafe-AM may be administered in patients whose blood pressure is not adequately controlled by 40 mg Olmesartan Medoxomil or 5 mg Amlodipine alone. Olmesafe-AM can be taken with or without food.

Elderly (age 65 years or over): No adjustment of the recommended dose is generally required for older people but increase of the dosage should take place with care. If up-titration to the maximum dose of 40 mg Olmesartan Medoxomil daily is required, blood pressure should be closely monitored.

Renal impairment: The maximum dose of Olmesartan Medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 40 mg Olmesartan Medoxomil once daily.

Hepatic impairment: Olmesartan Medoxomil and Amlodipine should be used with caution in patients with mild to moderate hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 40 mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents.

Side Effect

The most commonly reported adverse reactions during treatment with Olmesartan Medoxomil and Amlodipine are peripheral oedema, headache and dizziness. Other common side effects are nausea, fatigue, oedema, hypertriglyceridemia, hyperuricemia, somnolence, abdominal pain, influenza-like symptoms.

Precaution

Symptomatic hypotension may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting, especially after the first dose. Correction of this condition prior to administration of Olmesartan Medoxomil and Amlodipine or close medical supervision at the start of the treatment is recommended.

Drug Interaction

The blood pressure lowering effect of Olmesartan Medoxomil and Amlodipine can be increased by concomitant use of other antihypertensive medicinal products (e.g. alpha blockers, diuretics). Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin, ACE inhibitors) may lead to increases in serum potassium. Concomitant use of Olmesartan Medoxomil and Amlodipine with lithium is not recommended. When angiotensin-II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, concomitant use of angiotensin-II antagonists and NSAIDs may increase the risk of worsening of renal function and may lead to an increase in serum potassium.

Presentation

Olmesafe-AM 5/20 Tablet: Each box contains 3×10’s tablets in Alu-Alu blister.

Olmesafe-AM 5/40 Tablet: Each box contains 3×10’s tablets in Alu-Alu blister.

Use Children

The safety and efficacy of Olmesartan Medoxomil and Amlodipine in children and adolescents below 18 years has not been established. No data are available.

Use Pregnancy Lactation

There are no data about the use of Olmesartan Medoxomil and Amlodipine in pregnant patients. Animal reproductive toxicity studies with Olmesartan Medoxomil and Amlodipine have not been performed. Olmesartan is excreted into the milk of lactating rats. However, it is not known whether Olmesartan passes into human milk. It is not known whether Amlodipine is excreted in breast milk. Similar calcium channel blockers of the dihydropyridine type are excreted in breast milk. Because no information is available regarding the use of Olmesartan and Amlodipine during breast-feeding, Olmesartan Medoxomil and Amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Overdosage

There is no experience of overdose with Olmesartan Medoxomil and Amlodipine. The most likely effects of Olmesartan Medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred. Amlodipine overdosage can be expected to lead to excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia.

Storage

Store in a cool and dry place, protected from light. Keep all medicine out of the reach of children.