ECINQ 30MG 1 TABLET

Indications

Approved Uses

Emergency contraception within 120 hours (5 days) after unprotected intercourse or contraceptive failure.

Off-Label Uses

None recommended for this 30 mg emergency contraception product; do not cite fibroids/AUB/endometriosis indications for this product.

Dosage & Administration

Dosing by Condition

Emergency Contraception: One 30mg tablet taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.

Initial Dose

30mg as a single dose

Maintenance Dose

Not applicable - single-dose regimen

Maximum Dose

30mg as a single dose per episode; do not repeat within the same menstrual cycle

Children's Dosage

Not approved for use before menarche; post-menarchal adolescents may use the same adult dose of 30mg

Dose Adjustment Notes

No routine dose adjustment; if vomiting occurs within 3 hours, repeat the 30 mg dose. Avoid use with strong CYP3A4 inducers; no dose increase is recommended for high BMI or body weight.

How to Take

Swallow one tablet whole with water as soon as possible, within 120 hours (5 days) of unprotected intercourse or contraceptive failure. Can be taken with or without food.

Side Effects

Common Side Effects

Headache, nausea, abdominal pain, dysmenorrhea, fatigue, dizziness; menstrual changes (e.g., delayed/early period, irregular bleeding) may occur.

Side Effect Frequency

Very common (≥10%): headache, nausea, abdominal pain. Common (1-10%): dysmenorrhea, fatigue, dizziness (and other menstrual-related effects such as delayed menses).

Safety & Warnings

Contraindications

Known or suspected pregnancy; hypersensitivity to ulipristal acetate or any excipient; severe hepatic impairment (avoid/not recommended).

Warnings & Precautions

Not for routine contraception; does not protect against STIs; if vomiting occurs within 3 hours repeat dose; if menses is >7 days late or abnormal, rule out pregnancy and assess for ectopic pregnancy if pain occurs; avoid starting/using progestogen-containing hormonal contraception immediately-use barrier contraception until effective; efficacy may be reduced with high body weight/BMI (evidence inconsistent).

Age Restriction

Not indicated before menarche; intended for women of reproductive potential (not indicated post‑menopause).

Drug Interactions

Drug Interactions

Efficacy reduced by strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St John’s wort); avoid co-administration with progestogen-containing contraceptives around the time of use (mutual reduction in effect); drugs that increase gastric pH (PPIs/antacids) may reduce absorption; strong CYP3A4 inhibitors may increase ulipristal exposure (clinical significance uncertain for single dose).

Interaction Severity

MAJOR: Strong CYP3A4 inducers (e.g., rifampicin/rifampin, carbamazepine, phenytoin, St John’s wort) reduce ulipristal exposure and efficacy-avoid; MODERATE/CLINICALLY IMPORTANT: Progestogen-containing hormonal contraception may reduce ulipristal effect-delay starting/resuming hormonal contraception for 5 days and use condoms until hormonal method effective; MODERATE: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) increase exposure.

Food Interaction

Can be taken with or without food.

Special Populations

Pregnancy

Category X (contraindicated in known or suspected pregnancy)

Breastfeeding

Caution

Children

Not approved for use before menarche; post-menarchal adolescents may use the same adult dose of 30mg

Elderly

Not applicable - emergency contraception is not indicated in post-menopausal women

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

Not applicable (single-dose); take as soon as possible within 120 hours. If vomiting occurs within 3 hours, take another 30 mg tablet.

Stopping the Medicine

Single-dose product (one 30 mg tablet) - no discontinuation/tapering protocol; if vomiting occurs within 3 hours, repeat the dose.

Overdose

Limited overdose experience; single doses up to 200 mg have been given without serious adverse reactions; manage with symptomatic/supportive care and seek medical attention.

Patient Counseling

Take 1 tablet (30 mg) as soon as possible and within 120 hours of unprotected sex. If vomiting occurs within 3 hours, take another tablet. This is not regular contraception and does not protect from STIs. After ulipristal, wait 5 days before starting/resuming hormonal contraception and use condoms until the hormonal method becomes effective; if the next period is >7 days late or abnormal, take a pregnancy test.

Monitoring Requirements

No routine monitoring required; follow-up recommended if next menstrual period is more than 7 days late to exclude pregnancy

Pharmacology

Mechanism of Action

Selective progesterone receptor modulator (SPRM) that primarily delays or inhibits ovulation; endometrial effects may occur but EC efficacy is mainly via ovulation delay.

Onset of Action

Begins working soon after ingestion by delaying/inhibiting ovulation if ovulation has not yet occurred; effectiveness depends on cycle timing and is highest when taken as soon as possible.

Duration of Effect

Single-dose emergency contraception for the episode of unprotected intercourse; it can be taken up to 120 hours after intercourse (it does not provide ongoing contraception).

Half-Life

Terminal half-life ~32 hours for ulipristal acetate; active mono-demethylated metabolite ~27 hours.

Bioavailability

Oral bioavailability: not reliably established/quantified in standard labeling; describe as orally absorbed with peak concentrations occurring within a few hours.

Metabolism

Extensively hepatic metabolism, predominantly via CYP3A4, forming active mono-demethylated and further didemethylated metabolites.

Excretion

Primarily excreted via feces; minor renal (urinary) excretion.

Protein Binding

>94% protein bound (mainly to high density lipoprotein, alpha-1-acid glycoprotein, and albumin).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 30mg ulipristal acetate

Generic Availability

Yes

OTC Alternatives

Levonorgestrel 1.5 mg single-dose emergency contraceptive tablet (most effective within 72 hours; can be used up to 120 hours with decreasing efficacy).

Hormone Type

Progesterone

Method

Oral

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