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 progestin presented as a hormonal intrauterine system for intrauterine use. It provides long‑acting reversible contraception by continuously releasing levonorgestrel within the uterus.

GNH India supplies Levosert Single-Handed Inserter 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 Single-Handed Inserter, containing levonorgestrel, acts within the hormonal contraceptive pathway to prevent pregnancy.
  • Long‑acting reversible contraception: provides up to five years of highly effective pregnancy protection.
  • Prevention of unintended pregnancy: reduces the risk of conception for women of reproductive age.
  • Management of heavy menstrual bleeding: can lessen menstrual blood loss and improve cycle regularity.

How It Works

  • Levonorgestrel released from the intrauterine system binds to progesterone receptors in the endometrium, cervical mucus and hypothalamic‑pituitary axis. This progestogenic activity thickens cervical mucus, suppresses ovulation in some cycles, and induces endometrial atrophy, creating an environment that prevents sperm penetration and implantation.

Side Effects

Levosert may be associated with a range of adverse reactions, most of which are related to the intrauterine device and local hormone exposure.

Common Side Effects

  • Irregular vaginal bleeding or spotting
  • Amenorrhea (absence of periods) after initial months
  • Pelvic or cramping pain at insertion
  • Discomfort or soreness at the insertion site

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Expulsion of the intrauterine system
  • Pelvic inflammatory disease or infection
  • Ectopic pregnancy if contraception fails

Precautions & Warnings

  • Before prescribing Levosert, clinicians should consider several precautionary measures to ensure patient safety.
  • Screen for contraindications: confirm absence of active pelvic infection, uterine anomalies, or current pregnancy.
  • Assess thromboembolic risk: avoid in women with a history of clotting disorders unless benefits outweigh risks.
  • Monitor bleeding patterns: counsel patients about possible changes in menstrual flow after insertion.
  • Verify device position: schedule follow‑up examination if abnormal symptoms such as pain or missing strings occur.
  • Store at ambient temperature: 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)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may markedly reduce levonorgestrel levels and contraceptive efficacy.
  • Rifampicin or rifampin‑containing regimens: can lower hormone concentrations, increasing risk of unintended pregnancy.

Moderate Interactions (Monitor Closely)

  • Antibiotics such as tetracycline: may slightly diminish hormonal effect; advise additional contraceptive method.
  • Azole antifungals (e.g., ketoconazole): may increase levonorgestrel exposure, potentially enhancing side effects.
  • Herbal supplements like St. John’s wort: can accelerate hormone metabolism, reducing effectiveness.

Frequently Asked Questions

Levosert Single-Handed Inserter is a levonorgestrel‑releasing intrauterine system indicated for long‑acting reversible contraception and for preventing unintended pregnancy in women of reproductive age.

Levonorgestrel binds to progesterone receptors in the cervix, endometrium and hypothalamic‑pituitary axis, thickening cervical mucus, suppressing ovulation in some cycles, and causing endometrial atrophy, thereby blocking sperm penetration and implantation.

The device is pre‑loaded with a fixed amount of levonorgestrel that releases a low, continuous dose over several years. The exact dosing regimen is determined by the prescriber based on the approved product specifications.

Levosert must not be inserted in a woman who is already pregnant. It is contraindicated during pregnancy. Limited data are available for breastfeeding; clinicians should weigh benefits against potential risks and follow local guidelines.

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 necessary import documentation.

Both Levosert and Mirena are levonorgestrel‑releasing intrauterine systems offering up to five years of contraception. Differences may include device dimensions, insertion device design, and specific regulatory approvals, but the core hormonal mechanism and efficacy are comparable.

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 until it is inserted by a qualified healthcare professional.

Levosert is inserted into the uterine cavity by a trained clinician using a single‑handed inserter device. The procedure is performed in a clinical setting under aseptic conditions, and the device remains in place for the approved duration.

Serious risks include uterine perforation during insertion, expulsion of the device, pelvic inflammatory disease, and, in the rare event of contraceptive failure, ectopic pregnancy. Prompt medical evaluation is required if severe pain, abnormal bleeding or signs of infection occur.

Women with current pregnancy, active pelvic infection, unexplained vaginal bleeding, uterine anomalies (e.g., bicornuate uterus), known or suspected breast cancer, or a history of thromboembolic disorders should avoid using Levosert unless a specialist determines it is appropriate.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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