Norethindrone

FDA label

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Renal Undefined

Hepatic Contraindicated with benign or malignant liver tumors or acute liver disease

Instructions

• Must be taken exactly as directed: one tablet every day at the same time
• Administration is continuous, with no interruption between pill packs
• Diarrhea and/or vomiting may reduce hormone absorption and decrease serum concentrations

Contraindications

• Known or suspected pregnancy
• Known or suspected carcinoma of the breast
• Undiagnosed abnormal genital bleeding
• Benign or malignant liver tumors
• Acute liver disease

Cautions

• Cigarette smoking greatly increases risk of heart attack/stroke with oral contraceptives — strongly advise not to smoke
• Ectopic pregnancy: up to 10% of pregnancies on POPs are extrauterine — consider in lower abdominal pain
• Delayed follicular atresia / ovarian cysts (usually resolve spontaneously; rarely twist or rupture)
• Irregular genital bleeding common — rule out infection, malignancy, or pregnancy if suggestive or amenorrhea prolonged
• No protection against HIV or other STDs
• Monitor prediabetic and diabetic women (slight deterioration in glucose tolerance possible)
• Discontinue and evaluate for recurrent, persistent, or severe new-pattern headache/migraine

Adverse reactions

• Menstrual irregularity (most frequent)
• Frequent and irregular bleeding
• Amenorrhea (less common)
• Headache
• Breast tenderness
• Nausea
• Dizziness
• Androgenic effects (acne, hirsutism, weight gain) — rare

Pregnancy Contraindicated in known/suspected pregnancy; studies found no fetal-development effects of contraceptive-dose oral progestins — rule out pregnancy before starting

Lactation Small amounts of progestin pass into breast milk (infant plasma 1–6% of maternal levels); isolated reports of decreased milk production and, very rarely, infant jaundice