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Nifedipine (Nifedipine)

Trade Name : Nifedipine

Actavis Pharma, Inc.

CAPSULE, LIQUID FILLED

Strength 10 mg/1

NIFEDIPINE Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]

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Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nifedipine (Nifedipine) which is also known as Nifedipine and Manufactured by Actavis Pharma, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Nifedipine (Nifedipine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 40-9173
  • Revised u2014 June 2015
  • Rx only
  • Nifedipine, USPu00a0is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2, 6-dimethyl -4-(2-nitrophenyl)-, dimethyl ester, CHN0and has the structural formula:
  • Nifedipine, USPu00a0is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine capsules are formulated as soft gelatin capsules for oral administration, each containing 10 mg or 20 mg nifedipine.
  • Inactive Ingredients:n
  • 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 processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Nifedipine selectively inhibits calcium ion influx across the cell membrane of cardiac muscle and vascular smooth muscle without changing serum calcium concentrations.
  • No data
  • Known hypersensitivity reaction to nifedipine.
  • No data
  • No data
  • In multiple-dose United States and foreign controlled studies in which adverse reactions were reported spontaneously, adverse effects were frequent but generally not serious and rarely required discontinuation of therapy or dosage adjustment. Most were expected consequences of the vasodilator effects of nifedipine.
  • There is also a large uncontrolled experience in over 2100 patients in the United States.
  • Most of the patients had vasospastic or resistant angina pectoris, and about half had concomitant treatment with beta-adrenergic blocking agents. The most common adverse events were:
  • Experience with nifedipine overdosage is limited. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, and judicious use of calcium infusion, pressor agents, and fluids. Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.
  • The dosage of nifedipine needed to suppress angina and that can be tolerated by the patient must be established by titration. Excessive doses can result in hypotension.
  • Therapy should be initiated with the 10 mg capsule. The starting dose is one 10 mg capsule, swallowed whole, 3 times/day. The usual effective dose range is 10 to 20 mg three times daily. Some patients, especially those with evidence of coronary artery spasm, respond only to higher doses, more frequent administration, or both. In such patients, doses of 20 to 30 mg three or four times daily may be effective. Doses above 120 mg daily are rarely necessary. More than 180 mg per day is not recommended.
  • In most cases, nifedipine titration should proceed over a 7 to 14 day period so that the physician can assess the response to each dose level and monitor the blood pressure before proceeding to higher doses.
  • If symptoms so warrant, titration may proceed more rapidly provided that the patient is assessed frequently. Based on the patientu2019s physical activity level, attack frequency, and sublingual nitroglycerin consumption, the dose of nifedipine may be increased from 10 mg three times a day. to 20 mgu00a0three times a dayu00a0and then to 30 mgu00a0three times a dayu00a0over a three-day period.
  • In hospitalized patients under close observation, the dose may be increased in 10 mg increments over four- to six-hour periods as required to control pain and arrhythmias due to ischemia. A single dose should rarely exceed 30 mg.
  • Avoid coadministration of nifedipine with grapefruit juice (see and ).
  • No u201crebound effectu201d has been observed upon discontinuation of nifedipine. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
  • Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See , for information on coadministration of nifedipine with beta blockers or long-acting nitrates.
  • 10 mg u2014 Each yellow, opaque, capsule-shaped soft gels imprinted with and 497 with black ink contains 10 mg of nifedipine USP. Capsules are supplied in bottles of 100 (NDC 0228-2497-10).
  • 20 mg u2014 Each reddish-brown, opaque, capsule-shaped soft gels imprinted with and 530 with black ink contains 20 mg of nifedipine USP. Capsules are supplied in bottles of 100 (NDC 0228-2530-10).
  • Storage
  • PREVENT FREEZING, CAPSULES ARE LIQUID FILLED.
  • PROTECT CAPSULES FROM LIGHT AT ALL TIMES.
  • PROTECT CAPSULES FROM MOISTURE AND HUMIDITY.
  • REPLACE CAP TIGHTLY AFTER EACH OPENING.
  • Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Encapsulated by:Catalent Pharma Solutions, LLC.St. Petersburg, FL 33716
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • 40-9173
  • Revised u2014 June 2015
  • NDC 0228-2497-10
  • NIFEdipine Capsules, USP 10 mg
  • 100 Capsules
  • Rx Only
  • Actavis
  • NDC 0228-2530-10
  • NIFEdipine Capsules, USP 20 mg
  • 100 Capsules
  • Rx Only
  • Actavis

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