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 provides long‑term contraception for up to five years and prevents pregnancy in women of reproductive age.

GNH India supplies Levosert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

  • Levosert, a hormonal intrauterine contraceptive, is indicated for the following clinical uses:
  • Long‑term contraception: Provides up to five years of reliable birth control for women of reproductive age.
  • Prevention of pregnancy: Acts as a primary method to prevent fertilisation and implantation.

How It Works

  • Levonorgestrel released from the intrauterine system binds to progesterone receptors in the endometrium, suppresses the mid‑cycle LH surge to inhibit ovulation, thickens cervical mucus to impede sperm passage, and induces endometrial changes that reduce the likelihood of implantation, all while delivering a low systemic hormone dose.

Side Effects

Levosert may cause a range of adverse reactions. Monitoring and reporting are recommended.

Common Side Effects

  • Irregular vaginal bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or abdominal discomfort after insertion
  • Breast tenderness or enlargement
  • Mood changes or headache
  • Vaginal discharge

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Device expulsion or displacement
  • Pelvic inflammatory infection
  • Ectopic pregnancy if contraceptive failure occurs
  • Severe allergic reaction to device components

Precautions & Warnings

  • Before insertion of Levosert, certain precautions should be observed.
  • Screen for pregnancy: Confirm the patient is not pregnant prior to insertion.
  • Assess uterine anatomy: Evaluate for fibroids, septa, or other anomalies that may affect placement.
  • Monitor for infection: Observe for signs of pelvic infection after the procedure.
  • Avoid use in active pelvic infection: Do not insert in the presence of untreated sexually transmitted infections.
  • Contraindicated in known or suspected pregnancy: The device must not be placed in pregnant women.
  • Store at room temperature: Keep in the original packaging, protect from moisture and direct sunlight, and store below 25 °C.

Avoid Interactions

Levosert may interact with other medications that affect hormone metabolism.

Major Interactions (Avoid)

  • Enzyme‑inducing antiepileptics (e.g., carbamazepine, phenytoin): May reduce contraceptive efficacy.
  • Rifampicin or other strong CYP3A4 inducers: Can lower levonorgestrel levels.
  • Certain antiretroviral protease inhibitors: May increase hormone concentrations leading to side effects.

Moderate Interactions (Monitor Closely)

  • Antibiotics such as tetracycline: May slightly affect hormone levels, though clinical impact is minimal.
  • Herbal supplements containing St. John’s wort: Potential to reduce contraceptive effectiveness.

Frequently Asked Questions

Levosert is a hormonal intrauterine system containing levonorgestrel, indicated for long‑term contraception up to five years and for preventing pregnancy in women of reproductive age. It provides continuous birth control without daily user action.

Levonorgestrel is a synthetic progestin that suppresses ovulation, thickens cervical mucus to block sperm, and alters the endometrium to make implantation unlikely. Delivered via an intrauterine system, it releases a low, steady hormone dose directly to the uterus, maintaining contraceptive efficacy while limiting systemic exposure.

Each Levosert device contains a fixed 52 mg of levonorgestrel, releasing about 20 µg of hormone per day for up to five years. The prescribing clinician determines the insertion timing, follow‑up schedule, and any additional care required.

Levosert is contraindicated in pregnancy (Category X) and must not be inserted in a pregnant woman. If pregnancy occurs while the device is in place, it should be removed promptly. Limited data suggest low systemic hormone levels are generally compatible with breastfeeding, but removal is advised if concerns arise.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Levosert. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any temperature control) and the necessary import documentation.

Compared with copper IUDs, Levosert releases levonorgestrel, often resulting in reduced menstrual bleeding and relief of dysmenorrhea while offering similar pregnancy‑prevention efficacy. Compared with other hormonal IUS such as Mirena, Levosert contains a comparable amount of levonorgestrel and provides up to five years of use with a similar safety profile.

Levosert should be stored at room temperature, below 25 °C, in its original sealed packaging. It must be protected from moisture, direct sunlight, and extreme temperature fluctuations. The device should remain in a controlled environment until insertion to preserve the hormone reservoir’s integrity.

Levosert is inserted into the uterine cavity by a trained healthcare professional using a specialized inserter. The procedure is performed in a clinical setting after confirming the patient is not pregnant and after appropriate cervical preparation. Once placed, the device remains in situ for up to five years without further user action.

Serious but rare complications include uterine perforation during insertion, device expulsion, pelvic infection, and ectopic pregnancy if contraception fails. Users should seek immediate medical attention for severe abdominal pain, abnormal bleeding, fever, or signs of infection, as early detection can prevent further complications.

Levosert is contraindicated in women who are currently pregnant, have known or suspected uterine anomalies, active pelvic infection, unexplained vaginal bleeding, or a history of breast cancer. It should also be avoided in individuals with hypersensitivity to levonorgestrel or any component of the device. Consultation with a healthcare provider is essential before use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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