NAVELA 1.5 MG 28 1 TAB

Indications

Approved Uses

Emergency contraception to prevent pregnancy after unprotected intercourse or known/suspected contraceptive failure; intended for use as soon as possible within 72 hours (effectiveness decreases with time).

Dosage & Administration

Dosing by Condition

Emergency contraception: 1.5 mg (one tablet) orally as a single dose as soon as possible within 72 hours of unprotected intercourse/contraceptive failure (earlier is more effective).

Initial Dose

One 1.5 mg tablet taken as soon as possible within 72 hours of unprotected intercourse.

Maintenance Dose

Not applicable - single-dose regimen

Maximum Dose

1.5 mg per emergency contraceptive episode

Children's Dosage

Approved for use in women of childbearing potential. Available over-the-counter for women 17 years and older in some regions, and by prescription for those younger.

Dose Adjustment Notes

No routine dose adjustment for renal/hepatic impairment is recommended; efficacy may be reduced with severe malabsorption or with CYP3A4 enzyme-inducing drugs-prefer a non-interacting emergency contraception option (e.g., copper IUD or ulipristal where appropriate) rather than empiric dose doubling.

How to Take

Take 1 tablet (levonorgestrel 1.5 mg) orally as soon as possible after unprotected intercourse/contraceptive failure (preferably within 12-24 hours; no later than 72 hours); swallow with water, with or without food; if vomiting occurs within 3 hours, take another 1.5 mg tablet.

Side Effects

Common Side Effects

Nausea, vomiting, abdominal/pelvic pain, headache, dizziness, fatigue, breast tenderness, and menstrual changes (spotting/irregular bleeding, earlier or delayed next period).

Side Effect Frequency

Very common (≥10%): nausea, abdominal/lower abdominal pain, fatigue, headache, menstrual changes/irregular bleeding. Common (1-10%): vomiting, dizziness, breast tenderness, diarrhea. Rare/uncommon: hypersensitivity reactions; ectopic pregnancy is a clinical risk if the method fails (not a typical adverse drug reaction frequency category).

Safety & Warnings

Contraindications

Hypersensitivity to levonorgestrel or any excipient; pregnancy is not a contraindication but the product is not effective if already pregnant/after implantation.

Warnings & Precautions

Not effective after implantation/does not terminate pregnancy; does not protect against STIs; not for routine contraception or repeated use in the same cycle; consider ectopic pregnancy if severe abdominal pain occurs or if pregnancy suspected; if vomiting occurs within 3 hours, repeat the dose; if menses delayed >7 days or abnormal bleeding occurs, perform pregnancy test/seek care.

Age Restriction

Intended for post‑menarchal females; not indicated for pre‑menarchal children; no specific upper age limit (use in women of childbearing potential).

Driving Warning

No specific driving warning; may cause dizziness or fatigue.

Drug Interactions

Drug Interactions

Efficacy reduced by strong enzyme inducers (CYP3A4) such as rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital/primidone, topiramate, some antiretrovirals (e.g., efavirenz, ritonavir-boosted regimens), griseofulvin, and St John’s wort.

Interaction Severity

MAJOR: Strong CYP3A4 enzyme inducers (e.g., rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital/primidone, St. John’s wort; some antiretrovirals such as efavirenz) may reduce efficacy; MODERATE: certain antiretrovirals can lower levonorgestrel exposure; routine antibiotics are not considered to reduce levonorgestrel EC efficacy (except rifamycins).

Food Interaction

No restriction.

Special Populations

Pregnancy

Not indicated if already pregnant; does not increase risk of birth defects if pregnancy occurs after use.

Children

Approved for use in women of childbearing potential. Available over-the-counter for women 17 years and older in some regions, and by prescription for those younger.

Elderly

Not applicable - indicated for women of reproductive age only

Kidney Impairment

No adjustment needed.

Liver Impairment

No established dose adjustment; use with caution/seek medical advice in severe hepatic impairment.

Storage & Patient Advice

Missed Dose

Not applicable (single-dose); take as soon as possible after unprotected intercourse (within 72 hours). If vomiting occurs within 3 hours, repeat the full 1.5 mg dose.

Stopping the Medicine

Not applicable-single 1.5 mg oral dose; no tapering or discontinuation plan required.

Overdose

Likely symptoms: nausea, vomiting, dizziness, breast tenderness, and possible vaginal bleeding; no antidote-manage symptomatically/supportively and seek medical attention/poison center advice if significant overdose.

Patient Counseling

Take 1 tablet (levonorgestrel 1.5 mg) by mouth as soon as possible after unprotected intercourse; effectiveness is highest the sooner it is taken and it should be taken within 72 hours (3 days). If vomiting occurs within 3 hours, take another 1.5 mg tablet as soon as possible. This is emergency contraception (not for routine contraception) and it will not terminate an established pregnancy. Use condoms/abstain until the next menses and consider starting/continuing regular contraception (backup for 7 days if starting hormonal contraception). Expect possible nausea, headache, fatigue, abdominal pain, breast tenderness, and menstrual changes; if the next period is >7 days late or unusually light/heavy, take a pregnancy test. Seek urgent care for severe/persistent lower abdominal pain 3-5 weeks after use (possible ectopic pregnancy if failure). No protection against STIs. Check for interacting medicines that reduce efficacy (e.g., enzyme inducers such as certain antiepileptics, rifampicin/rifabutin, some antiretrovirals, St John’s wort); consider copper IUD or ulipristal if relevant.

Monitoring Requirements

No routine monitoring; perform a pregnancy test/seek evaluation if the next menses is >7 days late, unusually light/heavy, or if pregnancy symptoms occur; seek care for severe lower abdominal pain (rule out ectopic pregnancy).

Pharmacology

Mechanism of Action

Primarily delays or inhibits ovulation (by preventing/attenuating the LH surge); it is not effective once ovulation has occurred and does not disrupt an established pregnancy.

Onset of Action

Begins working as soon as absorbed; levonorgestrel reaches peak levels in ~1-2 hours, and effectiveness is highest when taken immediately after intercourse.

Duration of Effect

Single-episode emergency contraception only; it does not provide ongoing contraception for subsequent intercourse-use/continue a regular contraceptive method and use backup as advised.

Half-Life

Approximately 24-32 hours

Bioavailability

Approximately 100%.

Metabolism

Extensive hepatic metabolism mainly by reduction and hydroxylation followed by conjugation (glucuronide/sulfate); CYP3A4 contributes and enzyme inducers can increase clearance and reduce efficacy.

Protein Binding

Highly protein bound (~97-99%), primarily to sex hormone-binding globulin (SHBG) and albumin.

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: 1.5 mg levonorgestrel

Generic Availability

Yes

OTC Alternatives

Other OTC levonorgestrel emergency contraceptive tablets (including generic 1.5 mg single-dose products and some 0.75 mg two-tablet regimens, depending on market availability).

Hormone Type

Progesterone

Method

Oral

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