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MYLAN-NIFEDIPINE EXTENDED RELEASE is a brand name for Nifedipine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations MYLAN-NIFEDIPINE EXTENDED RELEASE is only marketed in the 30 mg and 60 mg strengths. Dosage should be individualized depending on patient tolerance and response. 2 Recommended Dose and Dosage Adjustment In general, titration steps should proceed over a 7-14 day period so that the physician can assess the response to each dose level before proceeding to higher doses.
Since steady-state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided that the patient is closely monitored. Chronic Stable Angina MYLAN-NEFIDIPINE EXTENDED RELEASE Page 6 of 51 Therapy with MYLAN-NIFEDIPINE EXTENDED RELEASE should normally be initiated with 30 mg once daily.
Experience with doses greater than 90 mg daily in patients with angina is limited, therefore, doses greater than 90 mg daily are not recommended. Angina patients controlled on nifedipine capsules alone or in combination with beta blockers may be safely switched to MYLAN-NIFEDIPINE EXTENDED RELEASE tablets at the nearest equivalent daily dose.
Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Hypertension Therapy should normally be initiated with 20 mg* or 30 mg once daily. The usual maintenance dose is 30 mg to 60 mg once daily.
Doses greater than 90 mg daily are not recommended. No "rebound effect" has been observed upon discontinuation of nifedipine extended-release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually under close physician supervision.
Pediatrics (< 18 years of age) Health Canada has not authorized an indication for pediatric use. Patients with Hepatic Impairment In patients with mild impaired liver function, careful monitoring should be performed and a dose reduction may be necessary.
3 Pharmacokinetics - Special Populations and Conditions, Hepatic Insufficiency). Patients with Diabetes MYLAN-NIFEDIPINE EXTENDED RELEASE may produce hyperglycemia and lead to loss of glucose control. 1 Special Populations). 4 Drug-Drug Interactions).
*Note: MYLAN-NIFEDIPINE EXTENDED RELEASE is only marketed in the 30 mg and 60 mg strengths. 4 Administration For oral use. MYLAN-NIFEDIPINE EXTENDED RELEASE (nifedipine extended-release tablets) must be swallowed whole and should not be chewed or divided.
5 Missed Dose If a dose of MYLAN-NIFEDIPINE EXTENDED RELEASE is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. However, if it is almost time for the next dose, the missed dose should not be taken and the patient should take his/her next dose as scheduled.
The patient should not take two doses together to make up for the missed dose.
). These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment and may be more likely in patients on concomitant beta blockers. If excessive hypotension occurs, dosage should be lowered or the drug should be discontinued (see 2 CONTRAINDICATIONS).
Severe hypotension and/or increased fluid volume requirements have been reported in patients receiving nifedipine, with a beta blocker, who underwent coronary artery bypass surgery using high-dose fentanyl anesthesia. The interaction with high-dose fentanyl appears to be due to the combination of nifedipine and a beta blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl in other surgical procedures, or with other narcotic analgesics cannot be ruled out.
In nifedipine-treated patients where surgery using high-dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems, and if the patient’s condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery.
The following information should be taken into account in those patients who are being treated for hypertension as well as angina. Increased Angina and/or Myocardial Infarction Rarely, patients, particularly those who have severe obstructive coronary artery disease have developed well-documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting nifedipine or at the time of dosage increase.
The mechanism of the response is not established. Since there has not been a study of nifedipine extended-release tablets in acute myocardial infarction reported, similar effects of nifedipine extended-release tablets to that of immediate- release nifedipine cannot be excluded.
Immediate-release nifedipine is contraindicated in acute myocardial infarction. Beta-Blocker Withdrawal MYLAN-NEFIDIPINE EXTENDED RELEASE Page 10 of 51 Patients with angina recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines.
). Hypertension MYLAN-NIFEDIPINE EXTENDED RELEASE indicated in the management of mild to moderate essential hypertension. Combination of nifedipine extended-release tablets with a diuretic has been found compatible and has shown added antihypertensive effect.
Concurrent administration of low doses of nifedipine extended-release tablets and enalapril has been shown to produce an enhanced antihypertensive effect with no additional safety concerns when compared to that observed with either of the monotherapies.
Safety of concurrent use of nifedipine extended-release tablets with other antihypertensive agents has not been established. 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 MYLAN-NIFEDIPINE EXTENDED RELEASE (nifedipine extended-release tablets) is contraindicated in: • Pregnancy, and in women of childbearing potential. Fetal malformations and adverse effects on pregnancy have been reported in animals.
(see 16 NON-CLINICAL TOXICOLOGY - Reproductive and Developmental Toxicology). • Breastfeeding • Patients who are hypersensitive to nifedipine, or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING • Patients with a known hypersensitivity to other dihydropyridines calcium antagonists, because of the theoretical risk of cross-reactivity.
• Patients with severe hypotension or cardiovascular shock. • Combination with rifampicin because effective plasma levels of nifedipine may not be achieved due to induction of the enzyme metabolizing nifedipine. • Patients with a Kock pouch (ileostomy after proctocolectomy).
• Patients with moderate or severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). • Patients with severe gastrointestinal (GI) obstructive disorders (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations MYLAN-NIFEDIPINE EXTENDED RELEASE is only marketed in the 30 mg and 60 mg strengths.
5 Missed Dose 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 12 8 ADVERSE REACTIONS ................................................................................................
15 9 DRUG INTERACTIONS ................................................................................................ 27 10 CLINICAL PHARMACOLOGY .......................................................................................
29 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 31 PART II: SCIENTIFIC INFORMATION .......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nifedipine in Canada.
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Initiation of treatment with nifedipine extended-release tablets will not prevent this occurrence and might be expected to exacerbate it by provoking reflex catecholamine release. There have been occasional reports of increased angina in a setting of beta-blocker withdrawal and initiation of nifedipine.
It is important to taper beta blockers if possible, rather than stopping them abruptly before beginning MYLAN-NIFEDIPINE EXTENDED RELEASE. Patients with Heart Failure There have been isolated reports of severe hypotension and lowering of cardiac output following administration of nifedipine to patients with severe heart failure.
Thus, MYLAN- NIFEDIPINE EXTENDED RELEASE should be used cautiously in patients with severe heart failure. Rarely have patients receiving a beta-blockers developed heart failure after beginning nifedipine therapy. In patients with severe aortic stenosis, nifedipine will not produce its usual afterload reducing effects, and there is a possibility that an unopposed negative inotropic action of the drug may produce heart failure if the end-diastolic pressure is raised.
Caution should therefore be exercised when using MYLAN-NIFEDIPINE EXTENDED RELEASE in patients with these conditions. Hypotension/Heart Rate Because MYLAN-NIFEDIPINE EXTENDED RELEASE (nifedipine extended-release tablets) is an arterial and arteriolar vasodilator, hypotension, and a compensatory increase in heart rate may occur.
Thus, blood pressure and heart rate should be monitored carefully during nifedipine therapy. Close monitoring is especially recommended for patients who are prone to develop hypotension, those with a history of cerebrovascular insufficiency, and those who are taking medications that are known to lower blood pressure.
Peripheral Edema Mild to moderate peripheral edema, typically associated with arterial vasodilation and not due to left ventricular dysfunction, has been reported to occur in patients treated with nifedipine extended-release tablets (see 8 ADVERSE REACTIONS).
This edema occurs primarily in the lower extremities and may respond to diuretic therapy. With patients whose angina or hypertension is complicated by congestive heart failure, care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction.
Driving and Operating Machinery Reactions to the drug, which vary in intensity from individual to individual, can impair the ability to drive or to operate machinery, particularly at the start of the treatment, upon changing the medication, or in combination with alcohol.
MYLAN-NEFIDIPINE EXTENDED RELEASE Page 11 of 51 Gastrointestinal Patients with Pre-existing Gastrointestinal Narrowing Since the MYLAN-NIFEDIPINE EXTENDED RELEASE delivery system contains a non-deformable material, caution should be used when administering MYLAN-NIFEDIPINE EXTENDED RELEASE in patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of nifedipine extended-release tablets. In single cases, obstructive symptoms have been described without known history of gastrointestinal disorders.
Bezoars can occur in very rare cases and may require surgical intervention. MYLAN- NIFEDIPINE EXTENDED RELEASE should be used with caution in patients with inflammatory bowel disease, Crohn's disease, or with a history of gastrointestinal obstruction, esophageal obstruction, or with decreased diameter of the gastrointestinal lumen.
When the GI narrowing is severe, the MYLAN-NIFEDIPINE EXTENDED RELEASE tablet may become obstructed within the GI tract. Therefore, MYLAN-NIFEDIPINE EXTENDED RELEASE is contraindicated in these patients (see 2 CONTRAINDICATIONS) When doing barium […]
Dosage should be individualized depending on patient tolerance and response. 2 Recommended Dose and Dosage Adjustment In general, titration steps should proceed over a 7-14 day period so that the physician can assess the response to each dose level before proceeding to higher doses.
Since steady-state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided that the patient is closely monitored. Chronic Stable Angina MYLAN-NEFIDIPINE EXTENDED RELEASE Page 6 of 51 Therapy with MYLAN-NIFEDIPINE EXTENDED RELEASE should normally be initiated with 30 mg once daily.
Experience with doses greater than 90 mg daily in patients with angina is limited, therefore, doses greater than 90 mg daily are not recommended. Angina patients controlled on nifedipine capsules alone or in combination with beta blockers may be safely switched to MYLAN-NIFEDIPINE EXTENDED RELEASE tablets at the nearest equivalent daily dose.
Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Hypertension Therapy should normally be initiated with 20 mg* or 30 mg once daily. The usual maintenance dose is 30 mg to 60 mg once daily.
Doses greater than 90 mg daily are not recommended. No "rebound effect" has been observed upon discontinuation of nifedipine extended-release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually under close physician supervision.
Pediatrics (< 18 years of age) Health Canada has not authorized an indication for pediatric use. Patients with Hepatic Impairment In patients with mild impaired liver function, careful monitoring should be performed and a dose reduction may be necessary.
3 Pharmacokinetics - Special Populations and Conditions, Hepatic Insufficiency). Patients with Diabetes MYLAN-NIFEDIPINE EXTENDED RELEASE may produce hyperglycemia and lead to loss of glucose control. 1 Special Populations). 4 Drug-Drug Interactions).
*Note: MYLAN-NIFEDIPINE EXTENDED RELEASE is only marketed in the 30 mg and 60 mg strengths. 4 Administration For oral use. MYLAN-NIFEDIPINE EXTENDED RELEASE (nifedipine extended-release tablets) must be swallowed whole and should not be chewed or divided.
5 Missed Dose If a dose of MYLAN-NIFEDIPINE EXTENDED RELEASE is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. However, if it is almost time for the next dose, the missed dose should not be taken and the patient should take his/her next dose as scheduled.
The patient should not take two doses together to make up for the missed dose. 5 OVERDOSAGE There are several well-documented cases of nifedipine extended-release tablets overdosage. The following symptoms are observed in cases […]
32 13 PHARMACEUTICAL INFORMATION ............................................................................ 32 14 CLINICAL TRIALS ........................................................................................................
34 15 MICROBIOLOGY ........................................................................................................ 37 16 NON-CLINICAL TOXICOLOGY .....................................................................................
37 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 42 PATIENT MEDICATION INFORMATION .................................................................................. 43 MYLAN-NEFIDIPINE EXTENDED RELEASE Page 4 of 51 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MYLAN-NIFEDIPINE EXTENDED RELEASE is only marketed in the 30 mg and 60 mg strengths.
MYLAN-NIFEDIPINE EXTENDED RELEASE (nifedipine extended-release tablets) is indicated for: Chronic Stable Angina MYLAN-NIFEDIPINE EXTENDED RELEASE (nifedipine extended-release tablets) is indicated in the […]