Clinical use:
Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (>65 years of age): No data is available to Health Canada. Therefore, caution should be exercised in this population, and close monitoring is warranted. Evidence from experience suggests that the use of Lidocaine in the geriatric population is associated with differences in safety.
Contraindications:
- 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
- Do not use in large quantities
Most serious warnings and precautions:
Methemoglobinemia: Seaford Nifedipine and Lidocaine Hydrochloride Cream can cause a rare, but serious, blood disorder called methemoglobinemia. It can appear up to two hours after you use Seaford Nifedipine and Lidocaine Hydrochloride Cream. Stop using Seaford Nifedipine and Lidocaine Hydrochloride Cream and talk to your healthcare professional immediately if you get any of the following symptoms: weakness, confusion, headache, difficulty breathing, pale, grey or blue coloured skin.
Other relevant warnings and precautions:
- Avoid contact with eyes
- Risks of excessive dosage or short intervals between doses
- Monitoring of arterial pressure
- Carcinogenesis and mutagenesis
- Cardiovascular risks including concomitant use with beta-adrenergic blockers or antihypertensive drugs, excessive hypotension in patients with angina, increased risk of angina and/or myocardial infarction, beta-blocker withdrawal, caution in patients with severe aortic stenosis, risk of hypotension and a compensatory increase in heart rate, risk of peripheral edema, caution in patients with bradycardia or impaired cardiovascular function, caution in patients in severe shock, caution in patients with partial or complete heart block
- Driving and operating machinery
- Caution in diabetic patients
- Caution in patients with hepatic insufficiency or hepatic disease
- Peri-operative considerations
- Caution in patients with renal insufficiency
- Reproductive health: female and male potential
- Risk of allergic reactions, including delayed allergic reactions
- Risk of local skin reactions, local hyperemia and bleeding
- Caution in patients with sepsis and/or severely injured mucosa and phlogosis in the area to treat
Please see the Product Monograph at https://health-products.canada.ca/dpd-bdpp/ for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.
The Product Monograph is also available by calling us at 1-888-292-3192.