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‑acting reversible contraception for 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 used for prevention of pregnancy.
  • Long‑acting reversible contraception: provides up to five years of pregnancy prevention.
  • Contraception for women seeking intrauterine method: offers high efficacy and convenience.
  • Prevention of unintended pregnancy: reduces risk of pregnancy in sexually active women.

How It Works

  • Levosert releases levonorgestrel locally at approximately 20 µg per day, which thickens cervical mucus, impairs sperm motility and viability, suppresses endometrial proliferation, and may occasionally inhibit ovulation, thereby preventing fertilisation and implantation.

Side Effects

Levosert may cause local and systemic adverse reactions.

Common Side Effects

  • Irregular bleeding: spotting or changes in menstrual pattern.
  • Pelvic pain or cramping: discomfort after insertion.
  • Headache: mild to moderate.
  • Breast tenderness: soreness or swelling.
  • Acne: mild skin eruptions.

Serious or Rare Side Effects

  • Uterine perforation: rare injury during insertion.
  • Device expulsion: loss of the intrauterine system.
  • Infection: pelvic inflammatory disease.
  • Ectopic pregnancy: pregnancy occurring outside the uterus.

Precautions & Warnings

  • Before insertion, clinicians should assess eligibility and counsel patients on possible outcomes.
  • Eligibility assessment: confirm non‑pregnant status and absence of uterine anomalies.
  • Contraindications review: avoid in women with active pelvic infection or known hypersensitivity to levonorgestrel.
  • Insertion timing: place within 5 days of menstrual onset or after a negative pregnancy test.
  • Follow‑up evaluation: schedule check after insertion to ensure correct placement.
  • Patient counseling: discuss possible changes in bleeding patterns and signs of complications.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert can interact with other medicines that affect hormone metabolism.

Major Interactions (Avoid)

  • Enzyme inducers (e.g., rifampicin, carbamazepine): may reduce levonorgestrel efficacy.
  • Antifungal azoles (e.g., ketoconazole): may increase levonorgestrel levels, risk of side effects.

Moderate Interactions (Monitor Closely)

  • Antibiotics (e.g., tetracycline): possible slight reduction in contraceptive effect.
  • Herbal supplements (e.g., St. John’s wort): may decrease hormone levels.
  • Antiretrovirals (e.g., protease inhibitors): may alter hormone metabolism.

Frequently Asked Questions

Levosert is a hormonal intrauterine system that provides long‑acting reversible contraception for women of reproductive age. After insertion, it prevents pregnancy for up to five years by delivering a steady low dose of levonorgestrel directly within the uterus, offering a highly effective, maintenance‑free birth control option.

Levonorgestrel released from Levosert at about 20 µg per day acts locally to thicken cervical mucus, making it difficult for sperm to enter the uterus. It also impairs sperm motility and viability, suppresses growth of the endometrial lining, and may occasionally inhibit ovulation, together preventing fertilisation and implantation.

The dose is fixed within the device; each Levosert contains 52 mg of levonorgestrel that releases roughly 20 µg per day. The prescribing clinician determines whether the device is appropriate for a patient and decides the timing of insertion. No patient‑adjusted dosing or daily administration is 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 exist for breastfeeding; clinicians typically advise caution and may consider alternative contraceptive methods for nursing mothers.

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

Levosert releases levonorgestrel, which can reduce menstrual bleeding and cause fewer cramping episodes compared with copper IUDs that often increase bleeding. Both provide high efficacy for up to five years, but the hormonal IUS offers additional benefits such as lighter periods, whereas copper devices are non‑hormonal and suitable for women who prefer a hormone‑free option.

Levosert should be stored at room temperature, below 25 °C, in its original sealed packaging. The device must be protected from moisture, extreme heat and direct sunlight to maintain the integrity of the levonorgestrel reservoir until insertion.

Levosert is a T‑shaped intrauterine system inserted by a trained healthcare professional through the cervical canal into the uterine cavity. Insertion is performed in a clinical setting using a sterile inserter, and the device remains in place for up to five years without any daily user action.

Serious but rare risks include uterine perforation during insertion, expulsion of the device, pelvic infection such as pelvic inflammatory disease, and the possibility of ectopic pregnancy if contraception fails. Prompt medical evaluation is required if severe abdominal pain, abnormal bleeding or signs of infection occur.

Levosert is contraindicated in women who are currently pregnant, have active pelvic infections, known hypersensitivity to levonorgestrel, uterine anomalies that preclude device placement, or a history of breast cancer. It should also be avoided in individuals with unexplained vaginal bleeding until the underlying cause is identified.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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