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ETC / RX - Cardiovascular system - LodiMax 5, 10

COMPOSITION:

Amlodipine: 5 mg, 10 mg.
Per each film coated caplet.


INDICATIONS:

Treatment of hypertension: Amlodipine can be used as the single therapy or in combination with other antihypertensive agents to control blood pressure.
Treatment of coronary artery diseases: stable angina and Prinzmetal’s or variant angina.


ADMINISTRATION AND DOSAGE:

The usual initial dose is 5 mg once daily, which may be increased to a maximum dose of 10 mg depending on the individual patient’s response under physician’s advice.


CONTRAINDICATIONS:

In patients with a known hypersensitivity to amlodipine and other agents in dihydropiridines group.

Do not use for patients with heart failure who are not treated stably.


WARNINGS AND PRECAUTIONS:

Amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Therefore, amlodipine should be used with caution in these patients.

Use during pregnancy: Calcium channel blockers carry the potential to produce foetal hypoxia associated with maternal hypotension. Accordingly, they should not be used in pregnant women unless the potential benefit outweighs the potential risk to the foetus.

Use during lactation: It is not known whether amlodipine is excreted in human milk. Therefore, breast-feeding should be discontinued during treatment with amlodipine.

Use in children: No experience is available on use of amlodipine in children.

Use with caution in patients with heart failure.

Effects on driving and operating machine: Take care when driving or operating machinery until you know how amlodipine effects you.


SIDE EFFECTS:

Amlodipine is well tolerated.
Common: headache, flushing, dizziness, swelling of ankles, fatigue, asthenia, palpitation and nausea.
Rare: Over-hypotension, tachycardia, chest pain, muscular pain, rash and pruritus.


INTERACTIONS:

Amlodipine has been safely administered with thiazide diuretics, beta-blocker, angiotensin-converting enzyme inhibitors, nitrate derivatives and oral hypoglycemic drugs.

In vitro data indicates that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin

Non-steroidal anti-inflammatory drugs (NSAIDs), especially indomethacin may reduce the antihypertensive effects of amlodipine by inhibiting renal prostaglandin synthesis and/or causing sodium and fluid retention).

Anesthetic drugs increases antihypertensive effects of amlodipine.


PRESENTATION:

Box of 2 blisters x 10 film-coated caplets.