5X

• Approved Indication:
• Emergency contraception to prevent pregnancy following unprotected sexual intercourse or contraceptive failure (e.g., condom rupture, missed oral contraceptives).
• Important Off-Label Uses:
• Treatment of uterine fibroids to reduce symptoms and fibroid size prior to surgery (off-label and less common).

• Adults and Adolescents (≥15 years):
• Single oral dose of 30 mg as soon as possible, up to 120 hours (5 days) after unprotected intercourse.
• Pediatrics (<15 years):
• Safety and efficacy not established; use under medical supervision.
• Elderly:
• Not applicable.
• Special Populations:
• No dose adjustment recommended in mild to moderate hepatic or renal impairment.
• Route:
• Oral administration, with or without food.
• Repeat Use:
• Not recommended within the same menstrual cycle.
• Additional Instructions:
• Use effective contraception immediately after administration until the next menstrual period.

Ulipristal Acetate is a selective progesterone receptor modulator. It binds competitively to progesterone receptors, delaying or inhibiting ovulation even after the luteinizing hormone surge has started. It also induces changes in the endometrium that may prevent implantation. These combined effects prevent pregnancy when taken within 120 hours after unprotected intercourse.

• Absorption:
• Rapidly absorbed with peak plasma concentration within 0.5 to 3 hours.
• Bioavailability:
• Nearly 100% oral bioavailability.
• Distribution:
• Highly protein bound (~98%).
• Metabolism:
• Primarily metabolized by CYP3A4 in the liver to active and inactive metabolites.
• Elimination:
• Half-life approximately 32 hours.
• Excreted mainly via feces (~84%) and urine (~6%).

• Pregnancy:
• Contraindicated if pregnancy is confirmed. No conclusive evidence of teratogenicity but not recommended during pregnancy.
• Lactation:
• Excreted in breast milk in small quantities. Breastfeeding is generally not recommended for one week after intake. If breastfeeding continues, monitor infant for adverse effects.
• Note:
• Limited data available; caution advised.

• Selective Progesterone Receptor Modulator (SPRM)
• Emergency contraceptive agent

• Known hypersensitivity to Ulipristal Acetate or excipients
• Confirmed or suspected pregnancy
• Severe hepatic impairment
• Use of hormonal contraception within 5 days prior to administration
• Unexplained vaginal bleeding before ruling out pregnancy or other causes

• Not intended for routine contraception use.
• Delay of menstruation over 7 days after intake requires pregnancy testing.
• May cause menstrual irregularities.
• Avoid repeat doses in the same menstrual cycle.
• Caution in patients with severe liver disease.
• Drug interactions with CYP3A4 inducers may reduce effectiveness.
• Does not protect against sexually transmitted infections.
• Advise immediate use of effective contraception after administration.

• Common:
• Headache
• Nausea
• Abdominal pain
• Fatigue
• Dizziness
• Breast tenderness
• Menstrual changes (spotting or delayed menses)
• Less Common:
• Vomiting
• Back pain
• Serious/Rare:
• Allergic reactions (rash, pruritus, anaphylaxis)
• Severe abdominal pain (may indicate ectopic pregnancy)

• CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John’s Wort) may reduce drug levels and efficacy.
• CYP3A4 inhibitors may increase drug levels, clinical relevance uncertain.
• Avoid concurrent hormonal contraceptives within 5 days before or after Ulipristal administration.
• No significant interaction with food or alcohol reported.

• Approved for use up to 120 hours after unprotected intercourse, extending previous 72-hour window.
• Recommended as first-line emergency contraception by WHO and FDA where available.
• Emphasis on counseling for immediate initiation of regular contraception post-use.
• Repeated dosing within one cycle discouraged.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in original packaging until use.
• No refrigeration required.
• Keep out of reach of children.
• Avoid freezing.