Registered Zambia · ZAMRA

Unipill 1.5mg

Levonorgesterel

ZAMRA-HM-26-147 Prolonged release tablets

What it does

Levonorgestrel is a hormonal medication used mainly for birth control and to manage certain menstrual issues.

Commonly used for: emergency contraception, irregular menstrual cycles

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
ZAMRA-HM-26-147
Registration date
2026-04-12
Expiry date
2031-04-11
Status
Registered/Compliant
Active ingredient
Levonorgesterel
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Hll Lifecare
Applicant / LTR
HLL Lifecare Limited
Country of origin
India
Manufacturer location
Hll Infra Tech Services, B 14A, Block B, Industrial Area, Sector 62, Noida, Uttar Pradesh 201309, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-04-14 14:02:07 · updated 2026-09-24 03:38:53

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About this medicine

Levonorgestrel is a hormonal medication used mainly for birth control and to manage certain menstrual issues.

What it treats

  • emergency contraception
  • irregular menstrual cycles

How it works

Levonorgestrel helps prevent pregnancy by stopping ovulation and making it harder for sperm to fertilize an egg.

Who it's for

This medication is for individuals seeking to prevent pregnancy or manage menstrual problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: levonorgesterel

Levonorgestrel is a synthetic progestogen, a type of hormone that mimics the action of natural progesterone. It is primarily used in contraceptive applications, both in emergency contraceptive pills and as a component of various hormonal contraceptives. Levonorgestrel is effective in preventing ovulation, inhibiting fertilization, and altering the endometrium to prevent implantation of a fertilized egg. Its use is widespread in family planning and reproductive health.

Indications

  • Emergency contraception
  • Hormonal contraception (combined with estrogens or as a progestin-only method)
  • Management of menstrual disorders
  • Endometrial protection in hormone replacement therapy

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations and guidance.

Adults: Refer to specific guidelines for dosing based on the indication; typically, for emergency contraception, a single dose of 1.5 mg is administered as soon as possible after unprotected intercourse.

Mechanism of action

Levonorgestrel works by binding to progesterone receptors in the body, leading to the inhibition of ovulation and alterations in the cervical mucus and endometrial lining. This hormonal action prevents sperm from reaching the egg and reduces the likelihood of implantation of a fertilized egg.

Pharmacodynamics

Levonorgestrel exhibits progestational activity, which influences the menstrual cycle and alters the endometrium. It helps in thickening the cervical mucus, making it less permeable to sperm. The drug also affects the hypothalamic-pituitary-gonadal axis, leading to reduced secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby inhibiting ovulation.

Pharmacokinetics

Levonorgestrel is well absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism in the liver. Its bioavailability is approximately 100% when administered as an intrauterine device (IUD) or through injection. The drug has a half-life of about 24 hours, with peak plasma concentrations occurring within 1 to 2 hours after oral administration. Levonorgestrel is primarily metabolized in the liver, with metabolites excreted mainly in urine and feces.

Contra-indications

  • Known or suspected pregnancy
  • Severe liver disease
  • History of thromboembolic disorders
  • Undiagnosed genital bleeding
  • Hypersensitivity to levonorgestrel or any component of the formulation

Adverse effects

  • Nausea
  • Vomiting
  • Fatigue
  • Headache
  • Dizziness
  • Breast tenderness
  • Abdominal pain
  • Changes in menstrual bleeding patterns

Interactions

  • Anticonvulsants (e.g., phenytoin, carbamazepine) may reduce effectiveness
  • Rifampicin and other rifamycins can decrease levonorgestrel plasma levels
  • Certain herbal supplements (e.g., St. John's Wort) may affect metabolism

Precautions

  • Monitor for signs of ectopic pregnancy
  • Consider alternative contraceptive methods for individuals with gastrointestinal issues affecting absorption
  • Use with caution in patients with a history of depression

Pregnancy

Levonorgestrel is not indicated during pregnancy and is contraindicated if pregnancy is confirmed.

Breast-feeding

Levonorgestrel is excreted in breast milk, but is considered safe for use during breastfeeding. Monitoring for adverse effects in infants is advisable.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Oral tablet
  • Intrauterine device (IUD)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.