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SEAFORD NIFEDIPINE AND LIDOCAINE HYDROCHLORIDE is a brand name for Nifedipine, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Seaford Nifedipine and Lidocaine Hydrochloride Cream is indicated in adults for the management of chronic primary anal fissure unresponsive to stool softeners and topical anesthetic agents. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Geriatrics (> 65 years of age): Evidence from experience suggests that use in the geriatric population is associated with differences in safety. (see 4. 2 RECOMMEND DOSE AND DOSAGE ADJUSTMENT and 7. WARNINGS AND PRECAUTIONS-Geriatrics).
Assessment of blood pressure and heart rate should be considered before initiation of the treatment and during therapy, especially in those at higher risk of systemic effects. Discontinue use if a significant hypotension or change in heart rate is observed.
Pregnancy should be ruled out prior to treatment initiation (See 2. CONTRAINDICATIONS). 5-3 grams of cream) administered up to 1 cm inside the anus (and , if needed, around the anus (periannally)), twice daily for 3 weeks. 5-3 grams of cream) administered up to 1 cm inside the anus (and if needed, around the anus (periannally)), twice daily for 3 weeks.
5 mg to 45 mg of lidocaine. - Geriatrics (> 65 years of age): Elderly patients should be closely monitored as they may be more sensitive to systemic effects due to increased blood levels of lidocaine following repeated doses. - Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use.
4 Administration For application inside or around the anus.
Administer up to 1 cm inside the anus (and around the anus if needed):
Lie down on the left side, remove the cap of the tube and fix the applicator (cannula). 7 cm apart. Squeeze out a small quantity of cream to lubricate the cannula and introduce it into the anus (up to 1 cm inside the anus). 5-3 grams of cream).
Remain on the left side for 3-5 minutes after application. 5 Missed Dose If you forgot to take this medicine at the designated time, do not take a double dose. Wait until it is time for the next dose which should be taken at the usual time.
Adhere to the treatment regimen as recommended by the doctor.
1 Adverse Reaction Overview Lidocaine Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by overdosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
Serious adverse experiences are generally systemic in nature. Nifedipine Because drugs containing nifedipine have a vasodilating effect, hypotension, tachycardia, or syncope may occur. Safety data supporting the use of Seaford Nifedipine and Lidocaine Hydrochloride Cream have been collected from clinical studies conducted on patients with anal fissure and patients with damaged anorectal mucosa.
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. In study P001/98, in 55 patients with chronic anal fissures treated with Seaford Nifedipine and Lidocaine Hydrochloride Cream twice daily for three weeks, the average diastolic blood pressure was not significantly different from pretreatment levels.
In study Antro-0206, conducted in 135 patients with damaged anorectal mucosa (following anorectal surgery) treated twice daily with Seaford Nifedipine and Lidocaine Hydrochloride Cream for two weeks, one case of headache led to drug discontinuation.
No deaths or serious adverse reactions related to Seaford Nifedipine and Lidocaine Hydrochloride Cream were reported. The following table includes adverse reactions more frequently reported with Seaford Nifedipine and Lidocaine Hydrochloride Cream as compared to a galenic Lidocaine ointment.
Please see 3. 5% w/w / Each gram of cream contains 3 mg of Nifedipine and 15 mg of Lidocaine HCl Cetostearyl alcohol – Type A, Glycerol monostearate, Macrogol stearate, Paraffin, white soft, Propyl parahydroxybenzoate, Propylene glycol, Purified water, Sodium methyl parahydroxybenzoate, Triglycerides, medium- chain.
SEAFORD NIFEDIPINE AND LIDOCAINE HYDROCHLORIDE CREAM Page 9 of 40 General Avoid contact with eyes; if this happens, rinse thoroughly with water. Excessive dosage or short intervals between doses of Seaford Nifedipine and Lidocaine Hydrochloride Cream, can result in high plasma levels of nifedipine, lidocaine and/or their metabolites, which could lead to serious or life-threatening adverse effects.
Patients should be instructed to strictly adhere to the recommended dosage, discontinue the treatment and to consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, grey or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to two (2) hours after use.
It is suggested to monitor arterial pressure at the beginning and periodically during the treatment. In case of treatment failure of Seaford Nifedipine and Lidocaine Hydrochloride Cream (absence of improvement or worsening of the anal fissure or symptoms) the treatment must be stopped.
Seaford Nifedipine and Lidocaine Hydrochloride Cream should be used with caution in patients with sepsis and/or severely injured mucosa and phlogosis (inflammation) in the area to treat since this may cause excessive and/or rapid absorption of the active substances, and possibly increase the risk of systemic toxic effects.
The management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs (see 5. OVERDOSAGE). KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN. Carcinogenesis and Mutagenesis Genotoxicity tests with lidocaine or nifedipine showed no evidence of mutagenic potential.
Seaford Nifedipine and Lidocaine Hydrochloride Cream is contraindicated in: • Patients with a known history of hypersensitivity to lidocaine and/or local anesthetics of the amide type or to other components of the cream including any non-medicinal ingredient.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with a known hypersensitivity to nifedipine or other dihydropyridines calcium antagonists, because of the theoretical risk of cross-reactivity.
• Pregnancy or women planning to become pregnant, and women breastfeeding. • Patients with congenital or idiopathic methemoglobinemia, and patients with glucose-6- phosphate dehydrogenase deficiency which are more susceptible to drug-induced methemoglobinemia.
• Severe hypotension. • Cardiac insufficiency. • Cardiovascular shock. • Recent myocardial infarction (in the previous month). • Unstable angina. • Concomitant use of diltiazem See 7. WARNINGS AND PRECAUTIONS and 9. DRUG INTERACTIONS. • Do not use in large quantities.
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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5% lidocaine cream. 1 Clinical Trial Adverse Reactions – Pediatrics No safety data is available in the pediatric population. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings No clinical laboratory evaluations have been conducted in the safety studies.
Vital Signs, Physical Findings, and Other Observations Related to Safety Only slight but non-significant variations of blood pressure and heart rate were reported. 5 Post-Market Adverse Reactions Hypersensitivity reactions due to the drug such as Urticaria and edema has been reported.
The following are adverse reactions mostly from published studies. 01%) including isolated reports.
A metabolite of lidocaine, 2,6-xylidine, showed weak evidence of activity in some genotoxicity tests. See 16. NON-CLINICAL TOXICOLOGY for more information on carcinogenicity of 2,6-xylidine. Cardiovascular • Nifedipine Seaford Nifedipine and Lidocaine Hydrochloride Cream is contraindicated in patient with cardiac insufficiency, severe hypotension, recent myocardial infarction (in the previous month), unstable angina, or cardiovascular shock.
It is also contraindicated for concomitant use with diltiazem. (See 2. CONTRAINDICATIONS). The use of Seaford Nifedipine and Lidocaine Hydrochloride Cream in patients being treated with beta- adrenergic blockers or antihypertensive drugs should be supervised by the physician.
Caution should be exercised due to increased risks of severe hypotension, exacerbation of angina, or congestive heart failure. 4 Drug-Drug Interactions. Excessive Hypotension in Patients with Angina Since oral nifedipine lowers peripheral vascular resistance and blood pressure, nifedipine should be used cautiously in patients with angina who are prone to develop hypotension and those with a history of cerebrovascular insufficiency.
Occasionally, excessive and poorly tolerated hypotension, and syncope have been reported (see 8. ADVERSE REACTIONS), usually 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, the drug should be discontinued (see 2. CONTRAINDICATIONS). SEAFORD NIFEDIPINE AND LIDOCAINE HYDROCHLORIDE CREAM Page 10 of 40 Severe hypotension and/or increased fluid volume requirements have been reported in patients receiving oral 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 oral nifedipine and a beta blocker, but the possibility that it may occur with oral nifedipine alone, with low doses of fentanyl in other surgical procedures, or with other narcotic analgesics cannot be ruled out.
When 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.
Increased Angina and/or Myocardial Infarction SEAFORD Nifedipine and Lidocaine Hydrochloride Cream is contraindicated in patients with recent myocardial infarction (in the previous month). Rarely, patients, particularly those who have severe obstructive coronary artery disease have developed increased frequency, duration and/or severity of angina or acute myocardial infarction on starting oral nifedipine or at the time of dosage increase.
Nifedipine should not be used before the patient has stabilized. Nifedipine may increase the risk of reinfarction and worsen survival in patients treated early after myocardial infarction. SEAFORD Nifedipine and Lidocaine Hydrochloride Cream is contraindicated in patients with unstable angina, due to increased risk of myocardial infarction and recurrent ischemia.
Beta-blocker Withdrawal Patients with angina recently withdrawn from beta-blockers may develop a withdrawal syndrome with increased angina, at the initiation of treatment with nifedipine. It is important to taper beta-blockers if possible, rather than stopping them abruptly before starting nifedipine.
Patients with Heart Failure SEAFORD Nifedipine and Lidocaine Hydrochloride Cream is contraindicated in patients with cardiac insufficiency. Severe hypotension and lowering of cardiac output following administration of oral nifedipine have been reported in patients […]