Product image of Levosert (Levonorgestrel) supplied by GNH India

Levosert

Active Ingredient:
Levonorgestrel
Origin:
EU

Levosert (Levonorgestrel)

Levonorgestrel, the active ingredient in Levosert, is a progestin presented as a 52 mg intrauterine system for intrauterine use. It delivers continuous levonorgestrel release to provide long‑acting reversible contraception for women of reproductive age. The device is designed for up to five years of continuous use, eliminating the need for daily dosing and offering a highly effective contraceptive option.

GNH India supplies Levosert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for global distribution.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levosert, a levonorgestrel‑releasing intrauterine system, is used within the hormonal contraceptive pathway for long‑term birth control.

  • Contraception: Provides up to five years of highly effective reversible birth control for women of reproductive age.

How It Works

  • Levosert releases levonorgestrel locally within the uterine cavity at approximately 20 µg per day. The hormone thickens cervical mucus, impairs sperm motility and viability, suppresses endometrial proliferation, and may inhibit ovulation, collectively preventing fertilisation and implantation while offering sustained contraceptive effect.

Side Effects

Levosert may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Irregular bleeding or spotting: changes in menstrual pattern are frequent during the first months.
  • Amenorrhea: absence of periods may develop with continued use.
  • Pelvic or abdominal pain: mild cramping is reported after insertion.
  • Ovarian cysts: functional cysts may form and resolve spontaneously.
  • Breast tenderness: mild discomfort may occur.
  • Mood changes: some users notice alterations in mood or libido.

Serious or Rare Side Effects

  • Uterine perforation: a rare event during insertion that may require surgical management.
  • Device expulsion: the IUS may be expelled partially or completely, reducing efficacy.
  • Pelvic infection: severe infection can develop if pre‑existing infection is present at insertion.
  • Ectopic pregnancy: occurs if contraception fails; it is a medical emergency.
  • Severe allergic reaction: anaphylaxis or hypersensitivity to levonorgestrel or device components.

Precautions & Warnings

Before insertion, clinicians should evaluate individual risk factors and counsel patients on expected outcomes.

  • Pregnancy contraindication: the device must not be used in women who are pregnant.
  • Active pelvic infection: defer insertion until infection is fully treated.
  • Uterine abnormalities: assess for fibroids, septa, or malformations that could impede placement.
  • Breast cancer history: avoid use in women with current or past estrogen‑sensitive malignancies.
  • Hormonal sensitivity: discuss potential mood or bleeding changes with patients.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert’s hormonal component can be affected by other medicines that alter steroid metabolism.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may reduce contraceptive efficacy.
  • Rifampin and other strong CYP450 inducers: can lower levonorgestrel levels, increasing risk of pregnancy.

Moderate Interactions (Monitor Closely)

  • St. John’s wort (hypericum perforatum): may decrease hormone effectiveness.
  • Azole antifungals (e.g., ketoconazole): can increase levonorgestrel concentrations, potentially enhancing side effects.
  • Protease inhibitor antiretrovirals: may raise hormone levels, requiring clinical observation.

Frequently Asked Questions

Levosert is a levonorgestrel‑releasing intrauterine system indicated for long‑acting reversible contraception. It provides up to five years of highly effective birth control for women of reproductive age, eliminating the need for daily hormonal pills.

Levonorgestrel released from the intrauterine device thickens cervical mucus, impairs sperm motility and viability, suppresses the growth of the endometrium, and may inhibit ovulation. These combined actions prevent fertilisation and implantation, delivering sustained contraceptive protection.

Levosert contains 52 mg of levonorgestrel that releases approximately 20 µg per day. The exact dosing regimen, including timing of insertion and replacement, is determined by the prescribing clinician based on individual patient needs.

Levosert is contraindicated in pregnancy and must not be inserted in a pregnant woman. For breastfeeding mothers, the device is generally considered safe after insertion, but patients should discuss any concerns with their healthcare provider.

To order Levosert, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and necessary import documentation.

Levosert delivers levonorgestrel, a hormonal method, whereas copper IUDs provide non‑hormonal contraception. Compared with other levonorgestrel IUS devices such as Mirena, Levosert releases a similar daily dose but is marketed primarily in the EU and offers a five‑year duration of use.

Levosert should be stored at ambient temperature below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. No refrigeration is required, and the device should be kept out of reach of children.

Levosert is inserted by a trained healthcare professional using a dedicated inserter. The device is placed through the cervical canal into the uterine cavity during a brief office procedure, after which the inserter is removed and the IUS remains in place.

Serious risks include uterine perforation during insertion, device expulsion, pelvic infection, and ectopic pregnancy if contraceptive failure occurs. Patients should seek immediate medical attention if they experience severe abdominal pain, abnormal bleeding, or signs of infection.

Levosert should not be used by women who are pregnant, have active pelvic infections, known uterine anomalies, a history of breast cancer, severe liver disease, or known hypersensitivity to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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