Ambloc Special Precautions

Carcinogenicity/Mutagenicity: No evidence of carcinogenicity was found in rats or mice given dosages of 0.5, 1.25, and 2.5 mg per kg of body weight (mg/kg) per day for 2 years. No mutagenicity was found in studies at either the gene or chromosome level.
Pharmacogenetic differences with Amlodipine: In clinical trials there was a greater incidence of edema, flushing and palpitations seen in women than in men.
Dental: Gingival enlargement is a rare side effect that has been reported with Amlodipine, Diltiazem, Felodipine, Nifedipine, and Verapamil. It usually starts as gingivitis or gum inflammation in the first 1 to 9 months of treatment. A strictly enforced program of teeth cleaning by a professional combined with plaque control by the patient will minimize growth rate and severity of gingival enlargement. Periodontal surgery may be indicated in some cases, and should be followed careful plaque control to inhibit recurrence of gum enlargement.
Use in Children: Although appropriate studies on the relationship of age to the effects of Calcium-channel blocking agents have not been performed in the pediatric population, pediatrics-specific problems that would limit the usefulness of Calcium-channel blocking agents in children are not expected.
Use in Elderly: Due to a decreased clearance of Amlodipine with a resulting increase in AUC of 40 to 60%, a lower initial dose may be required.