7 Interactions found for:

The following applies to the ingredients: Glipizide

Professional Content

Use only if clearly needed and the benefit outweighs the risk

AU TGA pregnancy category: C
US FDA pregnancy category: C (immediate-release); Not assigned (extended-release)

Risk Summary: Drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes have not been identified with use of this drug during pregnancy, however, this drug crosses the placenta and has been associated with neonatal adverse reactions such as hypoglycemia; poorly controlled diabetes in pregnancy is associated with risks to the mother and fetus.

Comments:
-Insulin is recommended during pregnancy to maintain blood glucose levels as normal as possible.
-If this drug is used during pregnancy, it should be discontinued at least 2 to 4 weeks before the expected delivery date.

In rat reproductive studies, mild fetotoxic effects were observed at dose levels from 5 to 50 mg/kg. This perinatal effect is believed to be directly related to the hypoglycemic action of the drug. No teratogenic effects were found in rats and rabbits. Data from published data and postmarketing experience have not identified drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes, however, neonates born to mothers receiving a sulfonylurea at the time of delivery have experienced prolonged severe hypoglycemia, especially with those having prolonged half-lives. Poorly controlled diabetes during pregnancy is associated with risks to the mother and fetus. In women with pre-gestational diabetes and a HbA1c greater than 7, an estimated background risk of major birth defects of 6% to 10% has been shown, and for women with a HbA1c greater than 10, this has been shown to be as high as 20% to 25%. Sulfonylureas may not be suitable for the treatment of diabetes during pregnancy as significant metabolic changes occurring during this time make control of blood sugar difficult. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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: Sitagliptin (found in Januvia)

Professional Content

Use is not recommended unless the benefit outweighs the risk to the fetus

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

Risk Summary: Limited data available with this drug in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes during pregnancy.

Comments: In the US, Merck Sharp & Dohme Corporation maintains a pregnancy registry to monitor pregnancy outcomes of women exposed to this drug while pregnant; health care providers are encouraged to report any prenatal exposure (1-800-989-8999).

Studies in rats and rabbits with doses approximately 30 and 20-times the maximum recommended human dose (MRHD), respectively did not adversely affect developmental outcomes. At doses up to 100 times MRHD, an increase in the incidence of rib malformations was observed. Placental transfer was observed in pregnant rats and rabbits. There are no adequate and well-controlled studies in pregnancy women.

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: Glipizide

Professional Content

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-If diet alone is inadequate for controlling blood glucose, insulin should be considered as alternative therapy.
-Breastfed infants should be monitored closely for signs of hypoglycemia; if there is a concern, blood glucose monitoring is advisable.

Limited data suggests low levels of this drug are present in breast milk. Based on milk concentrations in 2 women, it is estimated that the maximum dose a fully breastfed infant would receive is less than 27% of the weight-adjusted maternal dose. Due to the potential for hypoglycemia in the nursing infant, the manufacturer suggests women who are not able to manage their blood sugar on diet alone consider insulin therapy while breastfeeding.

The following applies to the ingredients: Sitagliptin (found in Januvia)

Professional Content

US: Use caution
AU and UK: Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown

This drug is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. Pups of rats administered this drug at 1000 mg/kg/day from gestation day 6 through lactation day 20 showed reduced birth weight and postnatal weight gain (observed prior to and after weaning). No functional or behavioral toxicity was observed. Due to lack of human data, an alternate drug may be preferred.