7 Interactions found for:

The following applies to the ingredients: Doxycycline

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Use is not recommended unless clearly needed. Use should be avoided during the second and third trimesters of pregnancy.
-According to some authorities: Use of most oral formulations is contraindicated; use of the 40 mg capsule formulation is contraindicated during the second and third trimesters.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: Use of this drug in pregnant women may cause fetal harm. Use during the second and third trimesters may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth.

Comments:
-According to some authorities: Tetracyclines are considered safe for use during the first 18 weeks of pregnancy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of embryofetal toxicity, including toxic effects on skeletal formation. Animal studies indicate this drug crosses the placenta and is found in fetal tissues. There are no controlled data in human pregnancy.

Most reported human experience was short-term, first trimester exposure but no human data are available assessing long-term therapy during pregnancy (e.g., regimen for anthrax exposure). An expert review of data regarding use of this drug during pregnancy by the Teratogen Information System (TERIS) concluded that substantial teratogenic risk from therapeutic doses during pregnancy is unlikely (data quantity and quality limited to fair); insufficient data to state there is no risk.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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: Duloxetine (found in Cymbalta)

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This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Risk summary: Observational study data have not produced clear drug-associated risks regarding adverse events or major birth defects.

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.
-Women who discontinued antidepressant use during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant use.

Animal studies have revealed increased perinatal toxicity and fetotoxicity at doses potentially correlated with maternal toxicity. There are no controlled data in human pregnancy.

Some neonates exposed to SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors) late in the third trimester had clinical findings including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. This clinical picture is consistent with either direct toxic effect of SSRIs and SNRIs, drug discontinuation syndrome, or serotonin syndrome.

A less than 2-fold increase in postpartum hemorrhage was determined by observational data in patients exposed to the drug within 1 month before birth.

A study of women with a history of major depression who were euthymic at the beginning of pregnancy, showed women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

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/

Healthcare providers are encouraged to register patients receiving Cymbalta by calling the Cymbalta Pregnancy Registry at 1-866-814-6975 or by visiting www.cymbaltapregnancyregistry.com.

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: Doxycycline

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LactMed: Short-term use is considered acceptable; as a precaution (theoretical), prolonged or repeat courses should be avoided throughout breastfeeding.
-IV: The manufacturer makes no recommendation regarding use during lactation.
-Oral: According to some authorities and manufacturers, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother; according to other authorities and manufacturers, use is contraindicated. Use of the 40 mg capsule formulation is not recommended.

Excreted into human milk: Yes

Comments:
-According to at least 1 manufacturer: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for the drug; potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.
-The effects in the nursing infant are unknown; the infant should be monitored for rash and possible effects on the gastrointestinal flora (e.g., diarrhea or candidiasis [thrush, diaper rash]).
-Tetracycline, a related drug, is considered compatible with breastfeeding by the American Academy of Pediatrics.

Tetracyclines have been considered contraindicated during breastfeeding due to possible staining of infants' dental enamel or bone deposition of tetracyclines; however, a close review of available literature suggests harmful effects are unlikely with short-term use of this drug during lactation as milk levels are low and infant absorption is inhibited by the calcium in breast milk.

According to some experts, this drug is compatible for short courses (e.g., 10 days) if alternative therapy is not appropriate; diarrhea may occur in the nursing infant.

The extent of drug absorption by breastfed infants is unknown. Short-term use in lactating women is not explicitly contraindicated by most manufacturers, but the effects of prolonged drug exposure via breast milk are unknown. Long-term or repeat courses are not recommended during nursing as a theoretical precaution. Theoretical risks of dental staining and inhibition of bone growth in nursing infants are considered unlikely by most experts.

After 2 oral doses (200 mg followed by 100 mg 12 hours later) in 15 nursing mothers, milk drug levels 3 and 24 hours after dosing averaged 0.77 mg/L (range: 0.4 to 1.4 mg/L) and 0.38 mg/L (range: 0.12 to 0.85 mg/L), respectively.

This drug (100 mg/day) was given orally to 10 mothers. On day 2, milk drug levels 3 and 24 hours after dosing averaged 0.82 mg/L (range: 0.37 to 1.24 mg/L) and 0.46 mg/L (range: 0.3 to 0.91 mg/L), respectively. Using peak and trough milk level averages in this study, the estimated intake of an infant only fed breast milk averaged about 6% of the maternal weight-adjusted dose.

Peak milk levels averaged 0.96 mg/L after a single 100 mg dose (n=3) and 1.8 mg/L after a single 200 mg dose (n=3). After 100 mg orally twice a day for 5 days, milk drug levels were about 3.6 mg/L.

In another study, in the immediate postpartum period, peak milk levels were 0.6 mg/L after oral doses of 100 mg (n=3) and averaged 1.1 mg/L after 200 mg (n=11).

After a single 200 mg dose (n=2), milk levels 2, 4, and 6 hours after dosing averaged 0.8, 0.7, and 0.4 mg/L, respectively.

The following applies to the ingredients: Duloxetine (found in Cymbalta)

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Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some experts state that a more thoroughly studied alternative agent (e.g., nortriptyline, paroxetine, sertraline) may be preferred while breastfeeding premature or neonates.
-The American Academy of Pediatrics classifies other antidepressants as agents for which the effect on nursing infants is unknown but may be of concern.
-Exposed infants should be monitored for developmental milestones, feeding, sedation, weight gain, especially in younger infants who are exclusively breastfed and/or when breastfed infants are exposed to multiple antipsychotropic agents.

The estimated neonatal dose is approximately 0.1% to 0.3% of the maternal dose.