7 Interactions found for:

The following applies to the ingredients: Metformin

Professional Content

Benefit should outweigh risk

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Data are not sufficient to inform a drug-associated risk for major birth defects or miscarriage; published studies have not reported an increased risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Maternal glucose levels should be well controlled prior to conception and throughout pregnancy to avoid maternal and fetal diabetes-associated risks.
-Premenopausal women should understand the potential for unintended pregnancy with use of this drug as ovulation may occur in some anovulatory women.

Animal studies do not indicate harmful effects with respect to pregnancy, embryo or fetal development, birth or postnatal development. Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled maternal diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Published evidence suggests this drug has a good safety profile in women with no increased long-term effects in offspring up to 18 months; however, much of the evidence is from observational, small, and/or nonrandomized studies, and therefore data must be interpreted cautiously.

Many experts continue to recommend insulin as the drug of choice for type 1, type 2, and gestational diabetes when diet alone is unsuccessful in controlling blood sugars. The estimated background risk for major birth defects in women with pre-gestational diabetes mellitus with an HbA1C greater than 7 is 6% to 10% and for women with a HbA1C greater than 10, this risk has been reported to be as high as 20% to 25%. In the US, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated risk of miscarriage for pregnant women with diabetes is unknown. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Insulin Glargine (found in Lantus)

Professional Content

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Published studies of insulin glargine use during pregnancy have not reported a clear association with adverse developmental outcomes; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential.

For rats and rabbits, dosed at 50 and 10 times the human subcutaneous dose during organogenesis, respectively, the effects of insulin glargine did not differ greatly from those observed with regular human insulin. In rabbits, 5 fetuses from 2 high-dosed litters exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal. In published human pregnancy reports, no specific adverse effects of insulin glargine on pregnancy and no specific malformations nor fetal or neonatal toxicity has been reported. These studies are not definitive in ruling out the absence of risk due to methodological limitations. The estimated background risk of major birth defects in women with pregestational diabetes with an HbA1c greater than 7 is 6% to 10%; in women with a HbA1c greater than 10, it has been reported to be as high as 20% to 25%. There are no controlled data in human pregnancy.

Clinical Considerations:
-Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications.
-Poorly controlled diabetes during pregnancy increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Metformin

Professional Content

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Available data have not reported adverse effects in breastfed infants, however, this data is limited.
-Due to this limited data, product manufacturers recommend a decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.
-Published data suggest this drug is compatible with breastfeeding; they recommend caution when nursing a newborn or premature infant, and those with renal impairment.

Drug levels are expected to be 0.5% (range 0.11% to 1%) of the mother's weight-adjusted dosage and milk/plasma ratio range between 0.13 and 1. Since milk levels are expected to be relatively constant, timing of breastfeeding with drug administration is expected to be of little benefit. One large prospective study found no adverse effects in breastfed infants. Low detectable serum levels were found in some breastfed infants.

The following applies to the ingredients: Insulin Glargine (found in Lantus)

Professional Content

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes

Comments: Women who are breastfeeding may require adjustments in insulin dose and diet.

Exogenous insulins, including the newer biosynthetic insulins (i.e. aspart, detemir, glargine, glulisine, lispro) appear to be excreted into breast milk. Insulin is a protein that is inactivated if taken by mouth. If absorbed, it would be destroyed in the digestive tract of the infant.

Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production.