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 placement. It releases a low, continuous dose of levonorgestrel directly into the uterine cavity, providing effective, long‑acting reversible contraception for women of reproductive age and reducing the need for daily oral dosing.

GNH India supplies Levosert One as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality and regulatory compliance across global markets to meet local health authority requirements.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levonorgestrel is a progestogen used in hormonal contraception to prevent pregnancy.

  • Contraception: Provides long‑acting reversible contraception for up to several years when placed intrauterinely.
  • Unintended pregnancy prevention: Reduces the risk of unintended pregnancy in sexually active women.
  • Menstrual regulation: Can lead to lighter, more predictable menstrual bleeding in many users.

How It Works

  • Levonorgestrel binds to progesterone receptors in the endometrium, cervical mucus, and hypothalamic‑pituitary axis. This inhibits ovulation, thickens cervical mucus to impede sperm passage, and induces endometrial changes that make implantation unlikely, delivering continuous progestogenic activity directly from the intrauterine system.

Side Effects

Levosert One may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Irregular bleeding or spotting: unpredictable menstrual bleeding patterns.
  • Amenorrhea: absence of menstrual periods.
  • Pelvic or abdominal cramping: discomfort in the lower abdomen.
  • Device expulsion: partial or complete displacement of the IUS.
  • Headache: mild to moderate intensity.
  • Breast tenderness: soreness or swelling of breast tissue.

Serious or Rare Side Effects

  • Uterine perforation: rare injury to the uterine wall during insertion.
  • Pelvic infection: severe infection requiring medical treatment.
  • Ectopic pregnancy: pregnancy occurring outside the uterus.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Hormonal migraine: intense migraine linked to hormonal changes.
  • Heavy vaginal discharge: persistent, foul‑smelling discharge.

Precautions & Warnings

Before using Levosert One, clinicians should assess patient suitability and counsel on potential risks.

  • Contraindications: Do not insert in women with active pelvic infection, unexplained vaginal bleeding, or known uterine anomalies.
  • Pregnancy testing: Ensure the patient is not pregnant before insertion.
  • Follow‑up: Schedule a post‑insertion check to confirm correct placement.
  • Medication review: Evaluate concurrent use of drugs that may affect levonorgestrel levels.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel levels can be altered by other medicines, requiring monitoring.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, phenytoin): may significantly reduce contraceptive efficacy.
  • Simultaneous use of another hormonal IUD: increases risk of hormonal side effects.

Moderate Interactions (Monitor Closely)

  • Antibiotics such as rifampin: may lower levonorgestrel concentrations.
  • Antifungal agents (e.g., ketoconazole): can increase levonorgestrel exposure.
  • Herbal supplements like St. John’s wort: may decrease effectiveness.
  • Antiretroviral drugs (e.g., efavirenz): may reduce contraceptive reliability.

Frequently Asked Questions

Levosert One is an intrauterine system that delivers levonorgestrel to provide long‑acting reversible contraception. It is intended for women of reproductive age who seek a highly effective, low‑maintenance birth control method that does not require daily dosing.

Levonorgestrel binds to progesterone receptors, suppressing ovulation, thickening cervical mucus to block sperm, and altering the endometrium to prevent implantation. The intrauterine system releases a steady, low dose directly into the uterus, maintaining these effects over several years.

The dose of levonorgestrel released by Levosert One is set by the manufacturer and the device is inserted by a qualified health professional. The prescribing clinician determines suitability and duration of use based on the patient’s medical profile.

Levosert One is contraindicated in pregnancy (Category X) and must not be inserted in a pregnant woman. Women who become pregnant after insertion should discontinue use. Limited data exist for breastfeeding; clinicians should evaluate risks and benefits before use.

To order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Compared with daily oral progestogen pills, Levosert One offers continuous low‑dose delivery, eliminating the need for daily adherence. Unlike injectable depots, it provides reversible contraception for several years without repeated visits, and it avoids systemic peaks associated with some hormonal implants.

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 the integrity of the levonorgestrel reservoir until insertion.

Levosert One is inserted into the uterine cavity by a trained healthcare professional using a sterile insertion kit. The procedure is performed in a clinical setting, typically after confirming a negative pregnancy test and ruling out uterine abnormalities.

Serious risks include uterine perforation during insertion, pelvic infection, and the rare possibility of ectopic pregnancy if contraceptive failure occurs. Prompt medical evaluation is essential if severe abdominal pain, fever, or abnormal bleeding develop after insertion.

Women with active pelvic infection, unexplained vaginal bleeding, known uterine anomalies, or a history of breast cancer should avoid Levosert One. It is also contraindicated in pregnancy and in individuals who are allergic to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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