Product image of Levosert Single-Handed Inserter (Levonorgestrel) supplied by GNH India

Levosert Single-Handed Inserter

Active Ingredient:
Levonorgestrel
Origin:
EU

Levosert Single-Handed Inserter (Levonorgestrel)

Levonorgestrel, the active ingredient in Levosert Single-Handed Inserter, is a progestogen presented as an intrauterine system (IUS) device for intrauterine use. It provides long‑acting reversible contraception and is also indicated for the management of heavy menstrual bleeding in women of reproductive age.

GNH India supplies Levosert Single-Handed Inserter as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory support for global distribution. It also ensures timely logistics and post‑market surveillance.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levonorgestrel released from the intrauterine system acts on the reproductive hormonal pathway to provide contraception and treat menstrual disorders.

  • Contraception: provides up to several years of highly effective pregnancy prevention for women of reproductive age.
  • Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with excessive bleeding.
  • Endometrial protection: suppresses endometrial proliferation, helping to maintain a thin, stable lining during use.

How It Works

  • Levonorgestrel released from the intrauterine system binds to progesterone receptors in the cervical epithelium, endometrium and hypothalamic‑pituitary axis. This action thickens cervical mucus, creates a hostile environment for sperm, inhibits endometrial growth, and suppresses the mid‑cycle luteinising hormone surge, thereby preventing ovulation and implantation. The device delivers a steady low dose over several years, maintaining local hormone concentrations while minimizing systemic exposure.

Side Effects

Levosert may be associated with a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Irregular bleeding or spotting
  • Prolonged menstrual bleeding
  • Amenorrhea (absence of periods)
  • Breast tenderness

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Device expulsion or displacement
  • Pelvic inflammatory disease or infection

Precautions & Warnings

Prior to insertion and during use, several precautions should be observed to ensure safety and effectiveness.

  • Pregnancy testing: confirm the patient is not pregnant before insertion.
  • Uterine assessment: evaluate cavity size and shape via ultrasound to ensure proper fit.
  • History of pelvic infection: defer insertion if active infection is present.
  • Smoking status: advise cessation, especially in women over 35, to reduce cardiovascular risk.
  • Breastfeeding: discuss benefits and potential hormonal effects with the prescriber.
  • Store at room temperature: keep the device in its original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from an intrauterine system can have its efficacy altered by certain concomitant medications.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort): may reduce contraceptive effectiveness.
  • Antiretroviral protease inhibitors: can lower levonorgestrel levels, increasing risk of unintended pregnancy.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles and some antibiotics: may modestly affect hormone metabolism.
  • Herbal supplements affecting hormone balance (e.g., dong quai): monitor menstrual patterns.
  • Hormonal therapies (e.g., estrogen patches): assess combined hormonal load.

Frequently Asked Questions

Levosert Single-Handed Inserter is an intrauterine system that releases levonorgestrel to provide long‑acting reversible contraception and to treat heavy menstrual bleeding in women of reproductive age.

Levonorgestrel binds to progesterone receptors in the cervix, endometrium and hypothalamic‑pituitary axis, thickening cervical mucus, inhibiting endometrial growth, and suppressing the luteinising hormone surge, which together prevent fertilisation and implantation.

The dose is set by the prescribing clinician based on the approved product specifications. The device delivers a continuous low dose of levonorgestrel over several years; exact dosing details are determined by the manufacturer’s labeling.

Levosert is intended for use in non‑pregnant women. It should not be inserted during an existing pregnancy. Limited data are available for breastfeeding; clinicians should weigh benefits against potential hormonal exposure to the infant.

Enquiries are submitted via the product page on gnhindia.com, where you specify 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 required import documentation.

Both Levosert and Mirena are levonorgestrel‑releasing intrauterine systems, but they may differ in approved duration of use, total hormone load and specific labeling. Clinical efficacy is comparable; selection often depends on regional approvals, pricing and physician preference.

Store the device at room temperature, preferably below 25 °C, in its original sealed packaging. Protect it from moisture, direct sunlight and extreme temperatures to maintain product integrity until insertion.

A trained healthcare professional inserts the device through the cervical canal into the uterine cavity using a single‑handed inserter applicator. The procedure is performed in a clinical setting under aseptic conditions, often after confirming a negative pregnancy test.

Serious risks include uterine perforation during insertion, device expulsion or displacement, and pelvic inflammatory disease. Although rare, these complications require prompt medical evaluation and may necessitate removal or replacement of the system.

Women with active pelvic infection, unexplained vaginal bleeding, uterine anomalies that prevent proper placement, known hypersensitivity to levonorgestrel, or who are currently pregnant should not receive Levosert. Contraindications are detailed in the product’s prescribing information.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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