Product image of Levosert One (Levonorgestrel) supplied by GNH India

Levosert One

Active Ingredient:
Levonorgestrel
Origin:
EU

Levosert One (Levonorgestrel)

Levonorgestrel, the active ingredient in Levosert One, is a progestogen presented as an intrauterine system (IUS) for intrauterine use. It provides long‑acting reversible contraception by releasing levonorgestrel directly into the uterine cavity, suitable for women of reproductive age seeking reliable birth control. It is approved for up to five years of continuous use.

GNH India supplies Levosert One as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑approved products to meet global demand.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levosert One, containing levonorgestrel, is used within the hormonal contraceptive pathway for preventing pregnancy.

  • Contraception: provides continuous pregnancy prevention for up to five years of use, eliminating the need for daily pills.
  • Menstrual bleeding reduction: may decrease the volume and duration of menstrual bleeding, helping women with heavy periods.
  • Endometrial protection: creates a hostile environment that prevents implantation of a fertilized egg, contributing to contraceptive efficacy.
  • User convenience: requires only a single insertion by a qualified provider, reducing the need for frequent clinic visits.

How It Works

  • Levonorgestrel released from the intrauterine system acts locally on the endometrium and cervical mucus. It binds to progesterone receptors, causing the cervical mucus to become thick and impermeable to sperm, suppresses the mid‑cycle luteinizing hormone surge to inhibit ovulation, and induces endometrial atrophy, thereby preventing implantation. The high local concentration minimizes systemic exposure, allowing effective contraception with a favorable safety profile.

Side Effects

Levosert One may be associated with a range of adverse reactions. Most users experience mild, transient effects that typically resolve without intervention, while rare serious events require medical attention.

Common Side Effects

  • Irregular vaginal bleeding, especially during the first months after insertion
  • Amenorrhea (absence of menstrual periods) after several months of use
  • Pelvic or lower abdominal pain that may be mild to moderate
  • Headache, often transient and responsive to simple analgesics

Serious or Rare Side Effects

  • Uterine perforation, a rare event that may require surgical management
  • Device expulsion, where the IUS partially or completely exits the uterine cavity
  • Ectopic pregnancy, a rare pregnancy occurring outside the uterus despite device use

Precautions & Warnings

Before prescribing Levosert One, clinicians should consider several precautionary measures to ensure safe and effective use.

  • Pregnancy testing: confirm the patient is not pregnant prior to insertion.
  • Uterine anomalies: evaluate for fibroids, septum or other structural abnormalities that may affect placement.
  • Active infection: screen for pelvic inflammatory disease and treat any infection before device insertion.
  • Bleeding disorders: assess coagulation status and advise caution in patients with thrombocytopenia or anticoagulant therapy.
  • Device monitoring: schedule follow‑up visits to verify correct IUS position and address any symptoms.
  • Store at room temperature: keep the device in its original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert One can interact with other medicines that affect hormone levels or hepatic metabolism.

Major Interactions (Avoid)

  • Enzyme inducers: drugs such as rifampin, carbamazepine, phenytoin may lower levonorgestrel effectiveness.
  • Antifungal azoles: ketoconazole and itraconazole can increase systemic levonorgestrel levels and risk of side effects.

Moderate Interactions (Monitor Closely)

  • Antibiotics: some, like tetracycline, may slightly reduce contraceptive efficacy.
  • Antiepileptics: valproic acid and lamotrigine may require monitoring of hormonal effects.
  • Herbal supplements: St. John’s wort may induce metabolism and diminish contraceptive protection.
  • Hormonal therapies: concurrent use of other progestins or estrogen may lead to additive hormonal effects.

Frequently Asked Questions

Levosert One is an intrauterine system that provides long‑acting reversible contraception. It releases levonorgestrel directly into the uterus to prevent pregnancy for up to five years, offering a convenient alternative to daily oral contraceptives.

Levonorgestrel released from the device binds to progesterone receptors in the cervical mucus and endometrium. This thickens the mucus, inhibits the luteinizing hormone surge that triggers ovulation, and creates an endometrial environment that is unsuitable for implantation.

Levosert One is a fixed‑dose intrauterine system; the amount of levonorgestrel released is pre‑determined by the manufacturer. The prescribing clinician selects the product based on approved guidelines, and no patient‑specific dosing adjustments are required.

Levosert One must not be inserted in a woman who is already pregnant, and it is intended for use only in non‑pregnant individuals. Limited data exist for breastfeeding; most guidelines consider it compatible, but clinicians should evaluate each case individually.

Enquiries are submitted on the product page at gnhindia.com where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Levosert One and other levonorgestrel‑releasing IUDs share a similar mechanism and efficacy. Differences may lie in the approved duration of use, size, and specific regulatory labeling. Clinicians choose based on patient anatomy, desired duration, and local availability.

Store at room temperature: keep the intrauterine system in its original packaging, protect it from moisture and direct sunlight, and avoid exposure to temperatures above 25 °C to maintain device integrity.

Levosert One is inserted by a trained healthcare professional into the uterine cavity using a sterile inserter. The procedure is performed in a clinical setting, typically after confirming a negative pregnancy test and evaluating uterine anatomy.

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

Women who are pregnant, have active pelvic infections, unexplained vaginal bleeding, certain uterine abnormalities (e.g., large fibroids, septate uterus), or known hypersensitivity to levonorgestrel should avoid using Levosert One. A thorough clinical assessment is essential before placement.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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