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Opioids can cross both the placental and blood-brain barriers, which poses risks to fetuses and newborns exposed to these drugs before birth. This exposure to opioids during pregnancy can lead to potential obstetric complications, including spontaneous abortion, abruption of the placenta, pre-eclampsia, prelabor rupture of membranes, and fetal death.
Buprenorphine has been used in the treatment of the neonatal abstinence syndrome, [119] a condition in which newborns exposed to opioids during pregnancy demonstrate signs of withdrawal. [120] In the United States, use currently is limited to infants enrolled in a clinical trial conducted under an FDA-approved investigational new drug (IND ...
Topical nicotinamide and topical zinc are safe, however, there are no FDA pregnancy category ratings. [27] [28] Topical salicylic acid and topical dapsone are classified as FDA pregnancy category C. [23] [28] Acne medications to avoid during pregnancy include oral isotretinoin and topical tazarotene as there have been reports of birth defects.
Buprenorphine/naloxone, sold under the brand name Suboxone among others, is a fixed-dose combination medication that includes buprenorphine and naloxone. [3] It is used to treat opioid use disorder , and reduces the mortality of opioid use disorder by 50% (by reducing the risk of overdose on full-agonist opioids such as heroin or fentanyl ).
Buprenorphine/naloxone, methadone, and naltrexone are approved by the U.S. Food and Drug Administration (FDA) for medication-assisted treatment (MAT). [117] In the U.S., the Substance Abuse and Mental Health Services Administration (SAMHSA) certifies opioid treatment programs (OTPs), where methadone can be dispensed at methadone clinics. [118]
The treatment of withdrawal in people with opioid use disorder also relies on symptomatic management and tapering with medications that replace typical opioids, including buprenorphine and methadone. The principle of managing the syndrome is to allow the concentration of drugs in blood to fall to near zero and reverse physiological adaptation.
The Drug Addiction Treatment Act of 2000 (DATA 2000), Title XXXV, Section 3502 of the Children's Health Act, permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the Food and Drug Administration for that indication.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.