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Cocaine nasal Pregnancy and Breastfeeding Warnings

Cocaine nasal Pregnancy Warnings

Animal studies have revealed anophthalmia, cleft palate, cryptorchidism, delayed and incomplete ossification, exencephaly, hemorrhage, hydrocephalus, hydronephrosis, and limb anomalies at 1.7 times the human reference dose (HRD) of 58 mg based on body surface area. Human studies examining the effect of chronic cocaine abuse during pregnancy have revealed reduced fetal growth. There are no controlled data in human 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.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: No data exists regarding use of this drug in pregnant women. Adverse maternal and fetal/neonatal outcomes have been observed in women with chronic cocaine abuse during pregnancy.

Comments: Advise pregnant women of the potential risk to a fetus.

See references

Cocaine nasal Breastfeeding Warnings

Breastfeeding immediately after administration of this drug could result in infant plasma concentrations that are approximately half the anticipated maximum maternal plasma concentrations at the clinical dose of 160 mg.

Breastfeeding is not recommended during use of this drug; pump and discard breastmilk for 48 hours after use of this drug.

Excreted into human milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Cocaine Hydrochloride Nasal (cocaine nasal)." Genus Lifesciences Inc., Allentown, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Cocaine Hydrochloride Nasal (cocaine nasal)." Genus Lifesciences Inc., Allentown, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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