📌 COMPOSITION

Each tablet contains: Amlodipine Besilate B.P. Equivalent to Amlodipine 5 mg, 10 mg.

📌 DESCRIPTION

Amlodura is a calcium antagonist that inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle. The exact mechanism by which amlodipine relieves angina has not been fully determined, but amlodipine reduces the total ischaemic burden by the following two actions:

• In exertional angina: Amlodipine reduces the peripheral resistance (afterload) against which the heart works, and reduces the rate pressure product, and thus myocardial energy consumption and oxygen requirement.
• In patients with Prinzmetal's or variant angina: Amlodipine dilates the main coronary arteries and coronary arterioles, both in normal and ischaemic regions; this dilatation increases myocardial oxygen delivery.

Amlodipine is well absorbed and not affected by consumption of food. Peak blood concentrations occur after 6-12 hours. It has a prolonged terminal elimination half‑life of 30-50 hours, and steady‑state plasma concentrations are achieved after 7-8 days of administration. Amlodipine is extensively metabolised in the liver to inactive metabolites, and 90% of metabolites are excreted in the urine.

📌 INDICATIONS

Amlodura is indicated for:

• Treatment of hypertension. It can be used alone or in combination with other antihypertensive agents.
• Treatment of chronic stable angina. It may be used alone or in combination with other antianginal agents.
• Treatment of vasospastic angina (Prinzmetal's or variant angina). It may be used alone or in combination with other antianginal drugs.

📌 DOSAGE & ADMINISTRATION

• The usual initial dose for both hypertension and angina is 5 mg amlodipine once daily, which may be increased to a maximum dose of 10 mg depending on the individual patient's response.
• Renal failure patients use a normal dose of amlodipine.
• Elderly patients or patients with hepatic insufficiency can start with 2.5 mg once daily, and can combine amlodipine with other antihypertensive drugs.

📌 RESTRICTIONS ON USE

Contraindications

Amlodipine is contraindicated in the following cases:

• Hypersensitivity to amlodipine or dihydropyridine.
• Unstable angina and for 8 days after myocardial infarction.

Precautions

Caution should be exercised when administering amlodipine in patients with severe aortic stenosis, heart failure or severe hepatic impairment.

Pregnancy and Lactation

Use in pregnancy is only recommended if the potential benefit justifies the potential risk to the fetus. It is not recommended to use amlodipine for nursing mothers.

📌 DRUG INTERACTIONS

Amlodipine can be administered with other antihypertensives, NSAIDs, nitrates, antibiotics, digoxin and oral hypoglycaemic drugs.

📌 ADVERSE REACTIONS

The most commonly observed side effects were headache, oedema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitations and dizziness.

📌 STORAGE INSTRUCTIONS

Store between 15-30°C in a dry place, protect from light.

📌 PHARMACEUTICAL FORMS

• Amlodura 5: Pack of 30 tablets and hospital packs of different sizes.
• Amlodura 10: Pack of 10 or 30 tablets and hospital packs of different sizes.

📌 INSTRUCTIONS TO THE PATIENT

• Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
• Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament.
• The doctor and the pharmacist are experts in medicine, its benefits and risks.
• Do not by yourself interrupt the period of treatment prescribed for you.
• Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

012-06-072 3/16 | Council of Arab Health Ministers | Union of Arab Pharmacists | Mfd. By: Shiba Pharma P.O. Box: 4265 Sana'a / Yemen