7 Interactions found for:

The following applies to the ingredients: Bupropion

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This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Smoking cessation without the use of medications is advisable during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g.,. respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).

High dose animal studies have failed to reveal evidence of specific teratogenic effects. Low dose animal studies in rabbits have reported a slightly increased incidence of fetal malformations and skeletal variations. Epidemiological studies of pregnant women exposed to bupropion in the first trimester show no increased risk of congenital malformations overall.

Data from the international bupropion pregnancy register (675 trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) and a case-control study from the National Birth Defects Prevention Study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) did not show an increased risk for malformations overall after bupropion exposure during the first trimester. A retrospective database of infants (n=7005) whose mothers were exposed to bupropion in the first trimester and outside of the first trimester also failed to reveal an increased risk for congenital malformation, especially cardiovascular malformation. Study findings on the risk for left ventricular outflow tract obstruction and ventricular septal defect after first trimester exposure to bupropion are inconclusive.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

The following applies to the ingredients: Amphetamine (found in Adderall)

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Use only if the benefit justifies the risk to the fetus

US FDA pregnancy category: Not Assigned

Risk Summary: There are insufficient data to determine a drug-associated risk of major congenital malformations or miscarriages; long-term neurochemical and behavioral effects have been reported in published animal developmental studies using clinically relevant doses of amphetamine.

Comments:
-Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight; these infants should be monitored for feeding difficulties, irritability, agitation, excessive drowsiness and other withdrawal symptoms.
-Pregnancy exposure registry monitors pregnancy outcomes in women exposed to psychostimulants during pregnancy; National Pregnancy Registry for Psychostimulants 1-866-961-2388 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/

In animal studies, no effects on morphological development were seen in rats and rabbits exposed to doses 2 and 12 times the maximum recommended human dose (MRHD) during organogenesis, respectively. However, long-term neurochemical and behavioral effects (e.g., learning and memory deficits, altered locomotor activity, changes in sexual function) have been reported in published animal development studies at clinically relevant doses. Fetal malformations and death as well as severe maternal toxicity were observed in mice following parenteral administration of d-amphetamine doses approximately 10 times the MRHD. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mother's dependent on amphetamines. This drug and others within the amphetamine class may cause vasoconstriction of placental blood vessels and increase the risk for intrauterine growth restriction. There are no controlled human data in pregnancy.

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: Dextroamphetamine (found in Adderall)

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UK: Use is contraindicated during pregnancy.
AU and US: Use is not recommended during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-Infants born to mothers dependent on amphetamine drugs have an increased risk of premature delivery and low birth weight, and may experience withdrawal symptoms including dysphoria, agitation, hyperexcitabilitiy, and significant lassitude.
-Females of reproductive potential should be advised to avoid pregnancy during treatment.

Although there are no controlled data in human pregnancy, the use of amphetamine drugs during early pregnancy has been associated with an increased risk of congenital malformations. Additionally, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (Vater association) in an infant whose mother took this drug with lovastatin during the first trimester of pregnancy.

Some animal studies have revealed evidence of embryotoxicity, teratogenicity, and reproductive toxicity. Animal data also showed developmental delays, behavioral sensitization, and increased motor activity in animal offspring due to prenatal exposures at dose levels comparable to human therapeutic dose levels.

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 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.

The following applies to the ingredients: Amphetamine-Dextroamphetamine (found in Adderall)

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Use is recommended during pregnancy only if the potential benefit justifies the possible risk to the fetus.

US FDA pregnancy category: C

Comments: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight, and may experience withdrawal symptoms (e.g., dysphoria, agitation and significant lassitude).

In the enantiomer ratio present in this drug, some animal studies show amphetamine had no apparent effects on embryofetal morphological development or survival while other data offspring effects (e.g., decreased survival, increased locomotor activity, reduced body weight) in addition to maternal effects (e.g., hyperactivity and decreased weight gain). Animal studies also reveal long-term neurochemical and behavioral effects with exposure to amphetamine (d- or d-,l-isomers) at doses similar to those used clinically. There has been one report of severe congenital bony deformity, trachea-esophageal fistula, and anal atresia (vater association) in an infant whose mother took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. There are no reported effects on fertility.

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.

The following applies to the ingredients: Bupropion

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A decision should be made to discontinue nursing or discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother.
-Some experts recommend: Use with caution.

Excreted into human milk: Yes

Comment: Another drug may be preferred, particularly when breastfeeding a newborn or preterm infant.

There is limited information that maternal bupropion at oral doses up to 300 mg daily produces low levels in breastmilk. It is not generally expected to cause adverse effects in breastfed infants; however, there are case reports of possible seizure in partially breastfed 6-month-olds. Alternate drugs that may be considered in place of bupropion include nortriptyline, paroxetine, and sertraline.

One case report has suggested that bupropion accumulates in human breast milk in concentrations much greater than in maternal plasma. At least two metabolites of bupropion are also detectable in human milk. However, in the plasma of one nursing infant whose mother took bupropion, neither bupropion nor its metabolites could be detected.

Data from a lactation study in 10 women showed breastmilk levels of 45.2 mcg/L for bupropion, and 104.6 mcg/mL, 72.1 mcg/mL, and 459 mcg/mL for it metabolites hydroxybupropion, erythrohydroxybupropion, and threohydroxybupropion, respectively. The authors of this study estimated that an exclusively breastfed infant would receive an average of 0.2% of the maternal weight-adjusted dose of bupropion and an average of 2% of the maternal weight-adjusted dosage of bupropion plus metabolites.

The following applies to the ingredients: Amphetamine (found in Adderall)

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Not recommended

Excreted into human milk: Yes

Comments:
-The effect on the neurological development of the breastfed infant has not been well studied.
-Large dosages might interfere with milk production, especially in women whose lactation is not well established.

Based on limited data, this drug is estimated to be present in human milk at approximately 2% to 13.8% of the maternal weight-adjusted dose (milk/plasma ratio 1.9 to 7.5). This drug does not appear to effect breastfeeding infants adversely in doses prescribed for medical indications, however, the effects on neurological development have not been well studied. Manufacturers recommend against breastfeeding while taking this drug due to the potential for serious adverse reactions in nursing infants. Breastfeeding should be avoided in women who are actively abusing amphetamines.

The following applies to the ingredients: Dextroamphetamine (found in Adderall)

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UK: Use is contraindicated during breastfeeding.
AU and US: Breastfeeding is not recommended during treatment.

Excreted into human milk: Yes

Comments:
-The effect of this drug in milk on the neurological development of a breastfed infant has not been well studied.
-Large dosages of this drug might interfere with milk production, especially in women whose lactation is not well established.

-Blood levels of this drug in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg per day of this drug had no adverse effects and showed normal progress with weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, this drug reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose produced a sustained suppression of serum prolactin by 40%.

The following applies to the ingredients: Amphetamine-Dextroamphetamine (found in Adderall)

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Breastfeeding is not recommended during treatment.

Excreted into human milk: Yes

Comments:
-The effect of amphetamine and dextroamphetamine in milk on the neurological development of a breastfed infant has not been well studied.
-Large dosages of amphetamine and/or dextroamphetamine might interfere with milk production, especially in women whose lactation is not well established.

Level 2:
-The urinary excretion in 2 breastfed infants whose mothers took amphetamine 20 to 35 mg/day ranged from 0.1% to 2.1% of the mothers' excretion; these infants showed no signs of abnormal development.
-Dextroamphetamine blood levels in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg/day dextroamphetamine had normal progress, no adverse effects, and weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, dextroamphetamine reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.