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 progestogen presented as a 52 mg intrauterine system for intrauterine use. It delivers a steady low dose of levonorgestrel to the uterine cavity, providing highly effective, 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, ensuring regulatory‑approved quality and reliable global distribution to meet local health authority requirements and support reproductive health programs through established logistics networks.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

  • Levosert, a levonorgestrel‑based intrauterine system, is used for hormonal contraception.
  • Contraception (long‑acting reversible contraceptive): provides >99% effective prevention of pregnancy for up to five years.
  • Heavy menstrual bleeding: reduces menstrual blood loss and may improve anemia.
  • Endometriosis‑associated pain: alleviates dysmenorrhea and related pelvic discomfort.

How It Works

  • Levosert releases levonorgestrel directly into the uterine cavity at approximately 20 µg per day. The progestogen binds to progesterone receptors in the endometrium, causing glandular atrophy and thickening of cervical mucus, which impedes sperm penetration. It also suppresses the hypothalamic‑pituitary‑ovarian axis, reducing the frequency of ovulation. The localized delivery minimizes systemic exposure while maintaining contraceptive efficacy.

Side Effects

Levosert may be associated with local and systemic adverse reactions, most of which are mild and self‑limiting.

Common Side Effects

  • Irregular bleeding or spotting: unpredictable uterine bleeding patterns, especially during the first months.
  • Amenorrhea: absence of menstrual periods after prolonged use.
  • Pelvic or abdominal pain: mild cramping or discomfort.
  • Headache: occasional tension‑type headaches.

Serious or Rare Side Effects

  • Uterine perforation: rare injury to the uterine wall during insertion.
  • Expulsion of the device: unexpected loss of the IUS requiring re‑evaluation.
  • Pelvic inflammatory disease: infection that may develop after insertion.

Precautions & Warnings

Before prescribing Levosert, clinicians should evaluate the following precautions to ensure safe use.

  • Contraindications: active pelvic infection, unexplained vaginal bleeding, or known hypersensitivity to levonorgestrel.
  • Pregnancy status: must be negative before insertion; pregnancy category X indicates it should not be used during pregnancy.
  • Breastfeeding: consider risk‑benefit; levonorgestrel is excreted in breast milk in low amounts.
  • Uterine abnormalities: avoid in women with fibroids, uterine malformations, or significant cervical stenosis that may impede placement.
  • Future fertility: fertility typically returns promptly after removal, but patients should be counseled.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert can interact with other medicines that affect hormonal pathways or hepatic metabolism.

Major Interactions (Avoid)

  • Antiepileptic enzyme inducers (e.g., carbamazepine, phenytoin, rifampicin): may reduce levonorgestrel levels and contraceptive efficacy.
  • Antiretroviral drugs (e.g., efavirenz, nevirapine): can lower hormone concentrations, increasing risk of unintended pregnancy.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole): may increase levonorgestrel exposure, requiring monitoring for side effects.
  • St. John’s wort: may modestly decrease hormone levels.
  • Hormonal therapies (e.g., estrogen‑containing contraceptives): concurrent use may alter bleeding patterns.

Frequently Asked Questions

Levosert is an intrauterine system that provides long‑acting reversible contraception. It is indicated for women of reproductive age who desire a highly effective, hormone‑based method that can prevent pregnancy for up to five years without daily dosing.

Levonorgestrel released from Levosert binds to progesterone receptors in the endometrium, causing thinning of the uterine lining and thickening of cervical mucus. It also suppresses the hypothalamic‑pituitary‑ovarian axis, reducing the likelihood of ovulation, thereby preventing fertilisation.

Levosert contains 52 mg of levonorgestrel and releases approximately 20 µg per day. The exact duration of use and any replacement schedule are determined by the prescribing clinician based on the patient’s clinical needs and regulatory guidelines.

Levosert is contraindicated in pregnancy (category X) and must not be inserted in a pregnant woman. While low levels of levonorgestrel are excreted in breast milk, clinicians weigh the benefits against potential risks before recommending use during breastfeeding.

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 any necessary import documentation.

Levosert and Mirena both deliver levonorgestrel locally, but they differ in approved duration, dosage strength and regulatory labeling. Levosert is approved in the EU for up to five years with a 52 mg load, whereas Mirena typically offers a three‑year duration with a 52 mg load. Clinical efficacy is comparable, while individual choice may depend on local approvals and provider preference.

Levosert should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and physical damage. Do not attempt to open or modify the system before insertion by a qualified health professional.

Levosert is inserted by a trained clinician into the uterine cavity through the cervical canal using a specialized inserter. The procedure is performed in a clinical setting under aseptic conditions, and the device remains in place for the prescribed duration unless removal is required.

The most serious risks include uterine perforation during insertion, expulsion of the device, and pelvic inflammatory disease. These events are rare but require prompt medical evaluation. Patients should be instructed to seek care if they experience severe abdominal pain, abnormal bleeding or signs of infection.

Levosert should not be used by women with active pelvic infection, unexplained vaginal bleeding, known hypersensitivity to levonorgestrel, significant uterine abnormalities (e.g., large fibroids, malformations), or those who are currently pregnant. A thorough medical assessment is essential before insertion.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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