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 (IUS) for intrauterine use. Approved in the European Union, it delivers a steady low dose of hormone to provide long‑acting reversible contraception for women of reproductive age, reducing the need for daily pills.

GNH India supplies Levosert as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies, and clinics worldwide under strict quality‑assured conditions. All shipments follow WHO‑GMP guidelines and are supported by a dedicated regulatory affairs team.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levosert, containing levonorgestrel, is used as a hormonal contraceptive to prevent pregnancy.

  • Contraception: Provides up to five years of highly effective reversible birth control.
  • Post‑abortion contraception: Offers immediate, reliable contraception following surgical or medical abortion.
  • Family planning: Enables long‑term pregnancy prevention without daily pill adherence.

How It Works

  • Levonorgestrel released from the intrauterine system binds to progesterone receptors in the hypothalamus and pituitary, suppressing the luteinizing hormone surge and thereby inhibiting ovulation. The hormone also induces thickening of cervical mucus, creating a barrier to sperm penetration, and causes endometrial atrophy, reducing the likelihood of implantation. The low, continuous local dose maintains these effects while minimizing systemic exposure through localized delivery.

Side Effects

Levosert may be associated with a range of adverse reactions, most of which are mild and resolve without intervention.

Common Side Effects

  • Irregular bleeding: Unpredictable spotting or changes in menstrual pattern.
  • Amenorrhea: Absence of menstrual bleeding.
  • Pelvic pain: Discomfort in the lower abdomen.
  • Headache: Mild to moderate tension‑type headaches.
  • Breast tenderness: Sensitivity or swelling of the breasts.
  • Mood changes: Slight fluctuations in mood or irritability.

Serious or Rare Side Effects

  • Uterine perforation: Rare injury to the uterine wall during insertion.
  • Ectopic pregnancy: Occurs if contraception fails and implantation is outside the uterus.
  • Infection: Pelvic inflammatory disease following insertion.
  • Allergic reaction: Severe hypersensitivity requiring medical attention.
  • Device expulsion: Partial or complete loss of the IUS from the uterine cavity.

Precautions & Warnings

Before using Levosert, clinicians should evaluate patient history and follow recommended safety measures.

  • Pregnancy status: Confirm the patient is not pregnant before insertion.
  • Uterine abnormalities: Assess for fibroids, septum, or scarring that may impede placement.
  • Infection risk: Treat active pelvic infections prior to insertion.
  • Breastfeeding: Consider alternative contraception during early lactation if advised.
  • Smoking: Advise cessation in women over 35 who smoke, due to increased cardiovascular risk.
  • Storage: Store at ambient temperature below 25 °C: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert can interact with other medicines that affect hormone metabolism or uterine environment.

Major Interactions (Avoid)

  • Antiepileptic enzyme inducers (e.g., carbamazepine, phenytoin): May reduce levonorgestrel efficacy.
  • Rifampin and other strong antibiotics: Potentially decrease hormone levels.

Moderate Interactions (Monitor Closely)

  • Hormonal therapies (e.g., estrogen‑containing contraceptives): May increase overall hormone exposure.
  • Antifungal azoles (e.g., ketoconazole): Can increase levonorgestrel concentrations.
  • Herbal supplements (e.g., St. John’s wort): May modestly lower effectiveness.

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, eliminating the need for daily oral contraceptives and offering a convenient, low‑maintenance option for women of reproductive age.

Levonorgestrel from the IUS binds to progesterone receptors, suppressing the luteinizing hormone surge and preventing ovulation. It also thickens cervical mucus to block sperm entry and induces endometrial atrophy, making the uterine lining unsuitable for implantation.

Levosert contains a total of 52 mg of levonorgestrel, released at a low, steady rate that provides contraceptive efficacy for up to five years. The exact dosing schedule and insertion timing are determined by the prescribing clinician based on individual patient needs.

Levosert is classified as pregnancy category X and must not be used in women who are pregnant or suspect pregnancy. While limited data exist for breastfeeding, many guidelines advise using alternative methods during early lactation, and clinicians should assess risks versus benefits for each patient.

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 (including any cold‑chain requirements) and the necessary import documentation.

Levosert and other levonorgestrel IUS products such as Mirena share a similar mechanism but differ in hormone load and approved duration. Levosert’s 52 mg load is designed for up to five years of use, whereas some alternatives contain higher doses for longer or shorter durations. Choice depends on patient preference, clinical profile and regulatory approval in the target market.

Levosert should be stored at ambient temperature below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. The device must be handled by trained healthcare professionals using aseptic technique during insertion to maintain sterility and ensure proper placement.

Levosert is inserted by a qualified clinician into the uterine cavity using a specialized inserter. The procedure is performed in a clinical setting under sterile conditions, typically after confirming the patient is not pregnant and that the uterine cavity is suitable for IUS placement.

Serious but rare risks include uterine perforation during insertion, ectopic pregnancy if contraception fails, and pelvic infection following the procedure. Patients should be counseled to seek immediate medical attention for severe abdominal pain, abnormal bleeding, or signs of infection.

Levosert is contraindicated in women who are pregnant, have known or suspected uterine anomalies (e.g., large fibroids, septate uterus), active pelvic infection, unexplained vaginal bleeding, or a history of breast cancer. It is also not recommended for women with severe liver disease or those who are hypersensitive to levonorgestrel.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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