CAMILA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CAMILA (CAMILA).
Progestin-only oral contraceptive. Norethindrone suppresses gonadotropins (primarily LH and FSH), preventing follicular maturation and ovulation. It also increases viscosity of cervical mucus and alters endometrial morphology.
| Metabolism | Primarily hepatic via reduction and conjugation; CYP3A4 is the primary cytochrome P450 enzyme involved. |
| Excretion | Renal: ~40% as unchanged drug and metabolites; biliary/fecal: ~60% as metabolites. |
| Half-life | Terminal elimination half-life: 36 hours (range 20-60 hours); allows once-daily dosing, steady-state achieved by 8 days. |
| Protein binding | 90-95% bound, primarily to sex hormone-binding globulin (SHBG) and albumin. |
| Volume of Distribution | 4-5 L/kg, indicating extensive distribution into body tissues including breast tissue and adipose. |
| Bioavailability | Oral: ~70% (first-pass effect reduces systemic exposure). |
| Onset of Action | Oral: 2-4 hours for plasma concentration effect; full contraceptive effect after 7 days of continuous dosing. |
| Duration of Action | Contraceptive protection persists for 24 hours; reversal of effects occurs within 1-2 days after discontinuation. |
0.35 mg orally once daily at the same time each day without interruption.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl >=30 mL/min). Not studied in severe renal impairment (CrCl <30 mL/min); use not recommended. |
| Liver impairment | Contraindicated in acute hepatic disease or uncompensated cirrhosis. No specific Child-Pugh adjustments; use not recommended in severe impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients (<18 years). |
| Geriatric use | No specific dose adjustment. Use with caution due to potential for decreased renal function and comorbidities; monitor thromboembolic risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CAMILA (CAMILA).
| Breastfeeding | Norethindrone is excreted into breast milk in small amounts (estimated infant dose <1% of maternal weight-adjusted dose, M/P ratio not established). No adverse effects on infant growth or development have been reported. It may decrease milk production, especially in early postpartum period. Considered compatible with breastfeeding per the Academy of Breastfeeding Medicine. |
| Teratogenic Risk | Camila (norethindrone) is a progestin-only contraceptive. Based on data from progestin-only pills, there is no evidence of teratogenicity in human pregnancies when inadvertently taken during early pregnancy. However, it is not recommended during pregnancy as it is indicated for contraception. The FDA assigns pregnancy category X for combined oral contraceptives, but progestin-only pills are not known to cause fetal harm. First trimester: No increased risk of congenital anomalies reported. Second and third trimesters: No known adverse effects, but use is not indicated. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from oral contraceptive use. Women who use oral contraceptives should be strongly advised not to smoke.
| Serious Effects |
["Hypersensitivity to any component","Known or suspected pregnancy","Hepatic disease (e.g., acute hepatitis, hepatocellular carcinoma)","Undiagnosed abnormal genital bleeding","Known or suspected carcinoma of the breast"]
| Precautions | ["Thromboembolic disorders","Cigarette smoking and cardiovascular risk","Hepatic neoplasia","Ocular lesions","Gallbladder disease","Carbohydrate and lipid effects","Ectopic pregnancy","Depression","Menstrual irregularities"] |
| Food/Dietary | No significant food interactions. Grapefruit juice may minimally affect metabolism but not clinically relevant. |
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| Fetal Monitoring | No specific fetal monitoring required. Monitor for pregnancy if patient misses pills or has breakthrough bleeding. Routine pregnancy testing if pregnancy suspected. No requirement for ultrasound or fetal monitoring beyond standard obstetric care. |
| Fertility Effects | Norethindrone does not impair long-term fertility. After discontinuation, ovulation resumes typically within 1-2 cycles. It may delay return to fertility while taking, but no permanent effects. No known adverse effect on oocyte quality or future pregnancy outcomes. |
| Clinical Pearls | Camila (norethindrone) is a progestin-only oral contraceptive. It must be taken at the same time daily (±3 hours) to maintain efficacy. Amenorrhea is common; rule out pregnancy if no withdrawal bleed. Drug interactions include rifampin and certain anticonvulsants (e.g., phenytoin, carbamazepine) which reduce efficacy. Use barrier contraception during CYP3A4 inducer therapy. |
| Patient Advice | Take one tablet at the same time every day, without missing any. · If you are late by more than 3 hours, use backup contraception (condoms) for the next 48 hours. · Irregular bleeding or amenorrhea is common; do not stop taking if bleeding occurs. · Camila does not protect against HIV or other STIs. · Tell your doctor if you become pregnant or plan to breastfeed. · Check for drug interactions with other medications, especially seizure medicines or rifampin. |