PROCARDIA XL Extended release tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

0069-2650 0069-2660 0069-2670

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1. Description

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ...

2. Clinical Pharmacology

Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle. The contractile ...

3. Indications and Usage

I. Vasospastic Angina PROCARDIA XL is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, ...

4. Contraindications

Known hypersensitivity reaction to nifedipine.

5. Warnings

Excessive Hypotension Although in most angina patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These ...

6. Precautions

Other Interactions Grapefruit Juice Co-administration of nifedipine with grapefruit juice resulted in approximately a doubling in nifedipine AUC and C<sub>max</sub> with no change in half-life. The increased ...

6.1. General

Hypotension Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of nifedipine is suggested. Close observation ...

6.2. Information for Patients

PROCARDIA XL Extended Release Tablets should be swallowed whole. Do not chew, divide or crush tablets. Do not be concerned if you occasionally notice in your stool something that looks like a tablet. In ...

6.3. Laboratory Tests

Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT and SGPT have been noted. The relationship to nifedipine therapy is uncertain in ...

6.4. Drug Interactions

Beta-adrenergic blocking agents (see INDICATIONS AND USAGE and WARNINGS) Experience in over 1400 patients with PROCARDIA capsules in a noncomparative clinical trial has shown that concomitant administration ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Nifedipine was administered orally to rats for two years and was not shown to be carcinogenic. When given to rats prior to mating, nifedipine caused reduced fertility at a dose approximately 5 times the ...

6.7. Pregnancy

Nifedipine has been shown to produce teratogenic findings in rats and rabbits, including digital anomalies similar to those reported for phenytoin. Digital anomalies have been reported to occur with other ...

6.9. Nursing Mothers

Nifedipine is transferred through breast milk. PROCARDIA XL should be used during breast-feeding only if the potential benefit justifies the potential risk.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Age appears to have a significant effect on the pharmacokinetics of nifedipine. The clearance is decreased resulting in a higher AUC in the elderly. These changes are not due to changes in renal function ...

7. Adverse Reactions

Over 1000 patients from both controlled and open trials with PROCARDIA XL Extended Release Tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported ...

9. Overdosage

Experience with nifedipine overdosage is limited. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support, including monitoring of cardiovascular ...

10. Dosage and Administration

Dosage must be adjusted according to each patients needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. PROCARDIA XL Extended Release Tablets should be swallowed ...

11. How Supplied

PROCARDIA XL Extended Release Tablets are supplied as 30 mg, 60 mg and 90 mg round, biconvex, rose-pink, film-coated tablets in: Bottles of 100: 30 mg (NDC 0069-2650-66) 60 mg (NDC 0069-2660-66) ...

12. Storage and Handling

Store below 86°F (30°C). Protect from moisture and humidity.