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Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/ kg/ day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons. Pregnancy Teratogenic Effects: Pregnancy Category B. Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.
Because animal reproduction studies are not always predictive of human response, GLUCOPHAGE and GLUCOPHAGE XR should not be used during pregnancy unless clearly needed. Text Continues Below
There are no adequate and well-controlled studies in pregnant women with GLUCOPHAGE or GLUCOPHAGE XR. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/ kg/ day. This represents an exposure of about two and six times the maximum recom-mended human daily dose of 2000 mg based on body surface area comparisons for rats and rab-bits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin. Nursing Mothers Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to dis-continue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If GLUCOPHAGE or GLUCOPHAGE XR is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered. Pediatric Use The safety and effectiveness of GLUCOPHAGE for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of GLUCOPHAGE in this age group is supported by evi-dence from adequate and well-controlled studies of GLUCOPHAGE in adults with additional data from a controlled clinical study in pediatric patiens ages 10-16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults. (See CLINICAL PHAR-MACOLOGY: Pediatric Clinical Studies.) In this study, adverse effects were similar to those described in adults. (See ADVERSE REACTIONS: Pediatric Patients.) A maximum daily dose of 2000 mg is recommended. (See DOSAGE AND ADMINISTRATION: Recommended Dosing Schedule: Pediatrics.) Safety and effectiveness of GLUCOPHAGE XR in pediatric patients have not been established. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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