5 Interactions found for:

The following applies to the ingredients: Prednisone

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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: Acetaminophen (found in Tylenol)

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Benefit should outweigh risk

AU TGA pregnancy category: A
US FDA pregnancy category: Not Assigned

Risk Summary: A clear association of drug use and birth defects, miscarriage, or adverse maternal or fetal outcomes has not been shown with human use; animal studies have demonstrated adverse events at clinically relevant doses.

In pregnant rats receiving oral drug at doses up to 0.85 times maximum human daily dose (MHDD) during organogenesis, fetotoxicity and dose-related increases in bone variations (reduced ossification and rudimentary rib changes) were observed. Areas of necrosis in both the liver and kidney of pregnant rats and fetuses were observed when pregnant rats were given oral drug throughout gestation at doses 1.2 times the maximum human daily dose. Animal studies using the IV formulation have not been performed. In humans, this drug and its metabolites cross the placental barrier. Large cohort studies have not found an association between maternal use in the first trimester and either adverse pregnancy outcomes or congenital malformations. Some evidence of increased risk of neurodevelopmental disorders (e.g., attention deficit hyperactivity disorder [ADHD]), respiratory illness (e.g., asthma) and reproductive toxicity (e.g., androgen disruption) has been suggested in epidemiologic studies. However, extrapolating causation from pharmaco-epidemiological studies to humans is tricky considering various confounders and biases inherent in the study design. Associations seen in clinical cohort studies need clarification with randomized clinical trials (RCTs), which would be difficult to perform ethically in pregnant populations. The mechanism by which this drug or its metabolites affect neurological development, asthma, or endocrine/reproductive toxicity is poorly understood. It is important to factor in the risk of untreated febrile illness in mother and child when evaluating risks and benefits of using this drug. There are no controlled data in human pregnancy.

Epidemiologic data, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took this drug as either an over the counter or prescription product at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. In a prospective birth cohort study (Avon Longitudinal Study or Parents and Children [ALSPAC]) maternal drug exposure was assessed by questionnaire at 18 and 32 weeks, children were assessed at 61 months. Mothers were questioned about behavioral problems in their children at 7 years old; children's behavioral problems were assessed using the Strengths and Difficulties Questionnaire (SDQ). A number of confounders were evaluated although a limitation of the study was lack of information for drug use. The authors suggest there may be an association between drug use during pregnancy and behavioral problems in childhood that may be due to an intrauterine mechanism. Further studies are needed to test alternatives to a causal explanation.

According to published animal studies, this drug may cause reduced fertility in both males and females described as decreased testicular weights, reduced spermatogenesis, reduced fertility; and reduced implantation sites, respectively.

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 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: Acetaminophen (found in Tylenol)

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Caution is recommended.

Excreted into human milk: Yes

Comments;
-This drug has been used without apparent harmful effects.
-This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.

This drug is excreted into breast milk in very small amounts. Published reports reveal peak levels occur 1 to 2 hours after dosing and are undetectable after 12 hours. Reports have also shown infants ingesting 90 mL of breast milk every 3 hours would receive an average of 0.14% (range 0.04% to 0.23%) of the mother's dose; calculated to be a maximum maternal weight-adjusted dose of around 2%. Other studies have shown similar calculated maximal maternal weight adjusted doses (1.1% to 3.6%); these doses are about 0.5% of the lowest recommended infant dose of this drug. A single case of a maculopapular rash has been reported in a 2-month old nursing infant; the rash recurred on rechallenge.

The following applies to the ingredients: Prednisone

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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.