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NIFEDIPINE is a brand name for Nifedipine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NIFEDIPINE (nifedipine capsules) is indicated for: • Management of angina resulting from coronary artery spasm. • Management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Dosage should be individualized depending on patient tolerance and response. 2 Recommended Dose and Dosage Adjustment The starting dose of NIFEDIPINE 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. A maximum daily dose of 120 mg should not be exceeded.
In general there should be an interval of at least three days between increases in dose in order to adequately assess the response to a particular dose level. In hospitalized patients under close observation the titration phase may proceed more rapidly.
3 Pediatrics). 4 Geriatrics). Patients with Hepatic Impairment In patients with impaired liver function, careful monitoring should be performed and a dose reduction may be necessary. g. in elderly patients and patients with hepatic impairment.
4 Administration NIFEDIPINE capsules must be swallowed whole. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the NIFEDIPINE (Nifedipine Capsules) Page 6 of 36 regular dosing schedule.
Do not take a double dose to make up for the forgotten dose.
0%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. A safety analysis from the world literature (controlled and open studies) was carried out in a heterogeneous group of 7146 patients who were treated with nifedipine.
5% of patients. As a part of the above analysis, a more comprehensive safety evaluation (controlled and open studies) was carried out in 3074 patients, some of whom were severely ill and were receiving a variety of concomitant drugs, such as beta-blockers, nitrates, antiarrhythmics, cardiac glycosides, diuretics and anti-platelet drugs, etc.
01% and ≤1%), and possibly due to tachycardia, nifedipine has been reported to have precipitated an angina pectoris attack. In addition, more serious events were occasionally observed, not readily distinguishable from the natural history of the disease in these patients.
It remains possible, however, that some or many of these events were drug related. These events include myocardial infarction, congestive heart failure or pulmonary edema, and ventricular arrhythmias or conduction disturbances. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Laboratory Tests Rarely, mild to moderate transient elevations of enzymes such as alkaline phosphatase, Creatine phosphokinase (CPK), Lactate dehydrogenase (LDH), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) have been noted after treatment with nifedipine.
, Cardiovascular). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics). 2 CONTRAINDICATIONS NIFEDIPINE is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • Patients with a known hypersensitivity to other dihydropyridines calcium antagonists, because of the theoretical risk of cross-reactivity. • Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception (see 7 WARNINGS AND PRECAUTIONS and 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
• Nursing women (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology). NIFEDIPINE (Nifedipine Capsules) Page 5 of 36 • Combination with rifampicin because effective plasma levels of nifedipine may not be achieved due to induction of the enzyme metabolizing nifedipine.
• Patients with acute myocardial infarction (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Patients with Myocardial Infarction). • Patients with cardiovascular shock. • Patients with severe hypotension. 1 Dosing Considerations • Dosage should be individualized depending on patient tolerance and response.
2 Recommended Dose and Dosage Adjustment The starting dose of NIFEDIPINE 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. A maximum daily dose of 120 mg should not be exceeded. In general there should be an interval of at least three days between increases in dose in order to adequately assess the response to a particular dose level.
NIFEDIPINE is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
• Patients with a known hypersensitivity to other dihydropyridines calcium antagonists, because of the theoretical risk of cross-reactivity. • Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception (see 7 WARNINGS AND PRECAUTIONS and 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
• Nursing women (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology). NIFEDIPINE (Nifedipine Capsules) Page 5 of 36 • Combination with rifampicin because effective plasma levels of nifedipine may not be achieved due to induction of the enzyme metabolizing nifedipine.
• Patients with acute myocardial infarction (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Patients with Myocardial Infarction). • Patients with cardiovascular shock. • Patients with severe hypotension.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These laboratory abnormalities have rarely been associated with clinical symptoms, however, cholestasis with or without jaundice has been reported. Infrequent reversible elevations in Blood Urea Nitrogen (BUN) and serum creatinine have been reported in patients with pre-existing chronic renal insufficiency taking nifedipine.
01% and ≤1%). Rare instances of allergic hepatitis and cholestasis with or without jaundice have been reported in patients treated with nifedipine. Gingival hyperplasia similar to that caused by diphenylhydantoin has been reported in patients treated with nifedipine.
The lesions usually regressed on discontinuation of the drug. However, on occasion gingivectomy was necessary. Gynecomastia has been observed rarely in older men on long-term therapy, but has so far always regressed completely on discontinuation of the drug.
Isolated cases of angioedema have been reported. Angioedema may be accompanied by breathing difficulty. Anaphylaxis has been reported rarely. In post marketing experience, there have been rare reports of exfoliative dermatitis and Stevens-Johnson Syndrome.
Gastrointestinal irritation and gastrointestinal bleeding were also reported; however, the causal relationship is uncertain. The following adverse events were identified only during post marketing experience with a frequency that could not be estimated: agranulocytosis, epidermal photosensitivity allergic reaction, eye pain, gastro esophageal sphincter insufficiency, hyperglycemia, hypoesthesia, jaundice, leukopenia, toxic epidermal necrolysis, somnolence, toxic palpable purpura, intestinal obstruction, bezoars.
NIFEDIPINE (Nifedipine Capsules) Page 14 of 36
In hospitalized patients under close observation the titration phase may proceed more rapidly. 3 Pediatrics). 4 Geriatrics). Patients with Hepatic Impairment In patients with impaired liver function, careful monitoring should be performed and a dose reduction may be necessary.
g. in elderly patients and patients with hepatic impairment. 4 Administration NIFEDIPINE capsules must be swallowed whole. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the NIFEDIPINE (Nifedipine Capsules) Page 6 of 36 regular dosing schedule.
Do not take a double dose to make up for the forgotten dose. 5 OVERDOSAGE There are several well documented cases of nifedipine immediate-release overdosage. The following symptoms are observed in cases of severe nifedipine intoxication: disturbance of consciousness to the point of coma, a drop in blood pressure, tachycardia/bradycardia, hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema.
As far as treatment is concerned, elimination of the active substance and the restoration of stable cardiovascular conditions have priority. After oral ingestion, thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine.
Hemodialysis serves no purpose, as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution). Clinically significant hypotension calls for active cardiovascular support including monitoring of cardiac and respiratory function including elevation of extremities and attention to circulating fluid volume and urine output.
Hypotension as a result of arterial vasodilation can also be treated with calcium (10 mL of 10% calcium gluconate solution administered slowly via intravenous route and repeated if necessary). As a result, the serum calcium can reach the upper normal range to slightly elevated levels.
If an insufficient increase in blood pressure is achieved with calcium, vasoconstricting sympathomimetics such as dopamine or noradrenaline are additionally administered as a last resort only in patients without cardiac arrhythmia or ischemic heart disease and when other safer measures have failed.
The dosage of these drugs is determined solely by the effect obtained. Additional liquid or volume must be administered with caution because of the danger of overloading the heart. Bradycardia and/or bradyarrhythmias have been observed in some cases of nifedipine overdosage.
Appropriate clinical measures, according to the nature and severity of the symptoms, should be applied. For management of a suspected drug overdose, contact your regional poison control centre. NIFEDIPINE (Nifedipine Capsules) Page 7 of 36 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsules 5 mg, 10 mg of nifedipine Benzyl alcohol, FD&C yellow #6, gelatin, glycerin, iron oxide yellow, lemon oil, mannitol, […]