In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day DALIRESP during the period of organogenesis and lactation. DALIRESP induced stillbirth and decreased pup viability at doses corresponding to approximately 16 and 49 times, respectively, the MRHD (on a mg/m 2 basis at maternal doses >2 mg/kg/day and 6 mg/kg/day, respectively). DALIRESP induced delivery retardation in pregnant mice at doses greater or equal to approximately 16 times the MRHD (on a mg/m basis at maternal doses >2 mg/kg/day). DALIRESP decreased pup rearing frequencies at approximately 49 times the MRHD (on a mg/m 2 basis at a maternal dose of 6 mg/kg/day) during pregnancy and lactation. DALIRESP also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at approximately 97 times the MRHD (on a mg/m 2 basis at a maternal dose of 12 mg/kg/day).
Glucophage should be given in divided doses with meals while Glucophage XR should generally be given once daily with the evening meal. Glucophage or Glucophage XR should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. Glucophage should not be given to a child younger than 10 years old. Glucophage XR should not be given to a child younger than 17 years old. The FDA classifies Glucophage as a class-B drug during pregnancy , which means that there have not been enough studies to determine the safety of its use in pregnant women, so Glucophage and Glucophage XR should not be used during pregnancy unless clearly needed. Safety studies have also not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Glucophage and Glucophage XR may interact with furosemide, nifedipine, cimetidine, ranitidine, amiloride, triamterene, digoxin, morphine, procainamide, quinidine, quinine, trimethoprim, vancomycin, isoniazid, diuretics (water pills), steroids, heart or blood pressure medications, niacins, phenothiazines, thyroid medicines, birth control pills and other hormones, seizure medicines, and diet pills or medicines to treat asthma , colds or allergies. Tell your doctor all medications and supplements you use.
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