PRIMOLUT N 5/MG TAB 30/TAB

Indications

Approved Uses

Treatment of menstrual disorders such as dysfunctional uterine bleeding/menorrhagia (including irregular or heavy periods), secondary amenorrhea (to induce withdrawal bleeding), endometriosis, premenstrual syndrome, dysmenorrhea, and postponement of menstruation.

Off-Label Uses

Cycle scheduling in assisted reproduction/IVF protocols and other specialist-directed menstrual suppression regimens (off-label depending on local labeling).

Dosage & Administration

Dosing by Condition

Postponement of menstruation: 5 mg three times daily starting 3 days before expected menses, continue until postponement no longer required (withdrawal bleed usually follows after stopping). Dysfunctional uterine bleeding/menorrhagia (acute control): 5 mg three times daily for 10 days. Premenstrual syndrome/dysmenorrhea: 5 mg two to three times daily from day 19 to 26 of the cycle. Endometriosis: typically 5 mg two to three times daily (e.g., 15 mg/day) started early in the cycle and continued for several months per specialist direction.

Initial Dose

5 mg once to three times daily depending on indication

Maintenance Dose

Varies by indication; for endometriosis, 5mg three times daily. For cycle control, 5mg once or twice daily during the luteal phase.

Maximum Dose

15 mg/day (typically 5 mg three times daily) is the usual maximum for endometriosis; some references allow up to 20-25 mg/day in selected indications under specialist supervision.

Children's Dosage

Not approved for use in pre-pubertal children; use in adolescents only after menarche under specialist supervision

How to Take

Swallow the 5 mg tablet whole with water (with or without food) and take exactly as prescribed; if multiple daily doses are prescribed, space them evenly and try to take doses at the same times each day.

Safety & Warnings

Warnings & Precautions

Assess and monitor thromboembolic risk (higher with smoking and other risk factors); discontinue and evaluate if new/worsening migraine, sudden visual/perceptual disturbances, or symptoms of thrombosis occur; use caution in diabetes, hypertension, epilepsy, asthma, and history of depression; possible fluid retention and androgenic effects; periodic clinical/gynecologic review; not a reliable contraceptive at 5 mg treatment regimens.

Age Restriction

Not indicated/should not be used before menarche (pre‑pubertal girls).

Drug Interactions

Food Interaction

No restriction.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Children

Not approved for use in pre-pubertal children; use in adolescents only after menarche under specialist supervision

Elderly

Not typically indicated post-menopause for contraception; if used for other indications (e.g., endometrial protection), standard adult dosing applies with caution regarding cardiovascular and thromboembolic risk

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

May be stopped when the prescribed course is completed; withdrawal bleeding typically occurs about 2-4 days after stopping; if used long‑term, discontinuation should be clinician‑directed (not abruptly self‑stopped).

Overdose

Likely symptoms: nausea, vomiting, breast tenderness/enlargement, and vaginal bleeding; management: no specific antidote-supportive/symptomatic care and medical assessment if significant ingestion.

Pharmacology

Mechanism of Action

A synthetic progestogen that produces progestational effects on the endometrium (converts proliferative to secretory endometrium), suppresses gonadotropins at sufficient doses (reducing follicular maturation/ovulation), and can thicken cervical mucus.

Duration of Effect

Clinical effect is maintained only while taking the tablets; withdrawal bleeding typically occurs about 2-4 days after stopping.

Bioavailability

Approximately 64%.

Metabolism

Primarily hepatic metabolism with significant first-pass effect; biotransformation mainly via reduction/oxidation (including hydroxylation) followed by conjugation (glucuronidation/sulfation), with enterohepatic recirculation contributing.

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: 5 mg norethisterone

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Hormone Type

Progesterone

Method

Oral

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