Pretomanid

پرتومانید

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🦠 Antiinfectives For Systemic UseNitroimidazooxazine (antimycobacterial)

Market / country: 🇺🇸 USA

Pretomanid (US)

🧮 Dose calculator

Tuberculosis · Regimen source: FDA Pretomanid · 2.2

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🛡️ Safety & information

Contraindications

Warnings

  • • Hepatotoxicity; myelosuppression; peripheral and optic neuropathy; QT prolongation; lactic acidosis; male reproductive effects. FDA Pretomanid · 5

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Pretomanid · 8.1

    “Risk Summary There are no studies or available data on pretomanid use in pregnant women to inform any drug-associated risks.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Pretomanid · 8.2

    “Risk Summary There is no information regarding the presence of pretomanid in human milk, or its effects on milk production or the breastfed infant.”
  • 👶 ChildrenSafety not established

    Label: safety and effectiveness in children have not been established. FDA Pretomanid · 8.4

    “Safety and effectiveness of Pretomanid Tablets in pediatric patients have not been established.”
  • 👴 Older adultsUse with caution

    Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Pretomanid · 8.5

    “Clinical studies of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Pretomanid · 8.3

    “Infertility Males Reduced fertility and/or testicular toxicity were observed in male rats and mice treated with oral pretomanid.”

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