5 Interactions found for:

The following applies to the ingredients: Prednisone

Professional Content

This drug should only be used during pregnancy if the benefit outweighs the potential risk to the fetus

AU TGA pregnancy category: A
US FDA pregnancy category: C
US FDA pregnancy category: D (delayed-release tablets)

Comments:
-Observe for signs and symptoms of hypoadrenalism in infants exposed to this drug in utero.
-Women who become pregnant while using this drug should be apprised of the potential fetal risks.
-The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or newborn infant.

Teratogenicity including increased incidence of cleft palate have occurred in animal studies. A number of cohort and case controlled studies in humans suggest maternal corticosteroid use in the first trimester produces a slight increased risk of cleft lip with or without cleft palate (increased from 1 out of 1000 to 3 to 5 out of 1000 infants). Reduced placental and birth weight have been recorded in animals and humans after long term treatment. There is the possibility of adrenal cortex suppression in the newborn with long term use in the mother; however the short term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant. Maternal pulmonary edema has been reported with inhibition of uterine contractions and fluid overload. There are no adequate and well controlled studies in pregnant women.

Use of prednisolone (active metabolite) at high doses for an extended period of time (30 mg/day for a minimum of 4 weeks) has caused reversible disturbances of spermatogenesis that persisted for several months after discontinuation.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

The following applies to the ingredients: Pregabalin (found in Lyrica)

Professional Content

This drug should only be given during pregnancy when there are no alternatives and benefit outweighs risk

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

Risk Summary: There are no adequate and well-controlled studies in pregnant women; animal reproduction studies have shown increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity.

Comment:
-Patients should be advised of the potential risk to a fetus.
-Women of childbearing potential should be encouraged to use reliable contraception during treatment.
-Physicians should encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; toll free 1-888-233-2334 or http://www.aedpregnancyregistry.org/

Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity including skeletal malformations, retarded ossification, and decreased fetal body weight have been observed in rat and rabbit offspring receiving this drug at 18 times or greater the maximum recommended dose during organogenesis. Lethality, growth retardation, and nervous and reproductive system functional impairment have been observed in rat offspring receiving this drug during gestation and lactation. Rat offspring tested as adults, showed neurobehavioral abnormalities (decreased auditory startle responding). There are no controlled data in human pregnancy.

A clinical trial in healthy male subjects found that 3 months of taking this drug at 600 mg/day did not effect sperm motility. Adverse reproductive and developmental effects have been observed in male rats.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

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: Pregabalin (found in Lyrica)

Professional Content

Breastfeeding is not recommended

Excreted into human milk: Yes

Comment:
-Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment.

Limited data have shown the estimated average daily infant dose expected from breast milk is about 7% of the maternal weight adjusted dose. An unexpectedly high incidence of hemangiosarcoma was observed in standard preclinical in vivo lifetime carcinogenicity studies in 2 different strains of mice. The clinical significance of this finding is unknown.

The following applies to the ingredients: Prednisone

Professional Content

This drug should be used only if clearly needed

Excreted into human milk: Yes

Comments:
-If this drug is necessary, the lowest dose should be prescribed; theoretically, if high maternal doses are necessary, the dose the infant receives may be minimized by avoiding breastfeeding for 4 hours following dosing and using prednisolone instead of prednisone.

Amounts of glucocorticoids excreted into breast milk are low with a total infant daily dose calculated to be up to 0.23% of the maternal daily dose. For doses up to 10 mg/day, the amount of drug an infant receives via breast milk is undetectable; however the milk/plasma ratio increases with doses above 10 mg/day (e.g., 25% of the serum concentration is found in breast milk when dose is 80 mg/day). If this drug is necessary, the lowest dose should be prescribed as high doses of corticosteroids for long periods could produce infant growth and development problems and interfere with endogenous corticosteroid production. High doses might occasionally cause temporary loss of milk supply.