Indications

1.Chronic stable angina pectoris (effort angina)

2.Vasospastic angina pectoris (Prinzmetal’s angina, variant angina)

3.Essential hypertension

Dosage and Administration

Usage: Oral use

Dosage:

1. Nifedipine dosage should be adjusted gradually according to different patient tolerance and angina control condition. Overdose of nifedipine may cause hypotension.

2. Patients should start taking medicine from small dose, normally from 10mg/time, 3 times/day per os. The common maintenance dose is orally administrated, 10-20mg/time, 3 times/day Part of patients with obvious coronary spasm cantake 20-30mg/time, 3-4 times/day. The maximum dosage shall not be more than 120mg/day. In case of emergency disease condition, chew up or sublingually take 10mg/time, and decide to dose again according to the patients' reaction to medication.

3. The recommended starting dose of Nifedipine is 10 mg every 12 hours swallowed with water with subsequent titration of dosage according to response. Nifedipine permit titration of the initial dosage, which may be adjusted to 40 mg every 12 hours, to a maximum daily dose of 80 mg. Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all.

Precautions & Warning:

1.Nifedipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blocker preferably over 8-10 days

2.Nifedipine may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. Nifedipine will not prevent possible rebound effects after cessation of other antihypertensive therapy.

3.Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg).

4.Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. Nifedipine should be reserved for women with severe hypertension who are unresponsive to standard therapy.

Contraindications:

1.Nifedipine must not be administered to patients with known hypersensitivity to nifedipine, or to other dihydropyridines because of the theoretical risk of cross-reactivity, or to any of theexcipients.

2.Nifedipine must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within 4 weeks of a myocardial infarction. Nifedipine should not be used for the treatment of acute attacks of angina. The safety of Nifedipine in malignant hypertension has not been established. Nifedipine should not be used for secondary prevention of myocardial infarction. Nifedipine should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction.

Adverse Reactions:

1.Headache

2.Oedema (incl. Peripheral oedema) Vasodilatation

3.Constipation

4.Feeling unwell

Drug interactions:

Grapefruit juice inhibits the cytochrome P450 3A4 system. Administration of nifedipine together with grapefruit juice thus results in elevated plasma concentrations and prolonged action of nifedipine due to a decreased first pass metabolism or reduced clearance. As a consequence, the blood pressure lowering effect of nifedipine may be increased. After regular intake of grapefruit juice, this effect may last for at least three days after the last ingestion of grapefruit juice. Ingestion of grapefruit/grapefruit juice is therefore to be avoided while taking nifedipine.

Storage instructions:

Store below 30°C, protect from light and moisture.