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

Levosert Shi

Active Ingredient:
Levonorgestrel
Origin:
EU

Levosert Shi (Levonorgestrel)

Levonorgestrel, the active ingredient in Levosert Shi, is a progestin presented as an intrauterine system for intrauterine use. It provides long‑acting hormonal contraception and is also indicated for the management of heavy menstrual bleeding in women of reproductive age.

GNH India supplies Levosert Shi 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 Shi is a levonorgestrel‑based intrauterine system that acts on the hormonal regulation of the menstrual cycle and uterine environment.

  • Contraception: offers highly effective, reversible birth control for up to several years.
  • Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with menorrhagia.
  • Menstrual regulation: helps normalize irregular uterine bleeding patterns in women seeking hormonal management.

How It Works

  • Levonorgestrel released from the intrauterine system diffuses locally into the endometrium and cervical mucus. It suppresses ovulation, thickens cervical mucus to impede sperm passage, and induces endometrial atrophy, creating an environment that prevents implantation and reduces menstrual blood loss.

Side Effects

Levosert Shi may be associated with a range of adverse reactions.

Common Side Effects

  • Irregular bleeding or spotting, especially during the first months.
  • Amenorrhea (absence of periods) after prolonged use.
  • Pelvic or uterine cramping.
  • Breast tenderness or enlargement.
  • Ovarian cyst formation, usually asymptomatic.
  • Headache or mild nausea.

Serious or Rare Side Effects

  • Uterine perforation during insertion.
  • Device expulsion or displacement.
  • Pelvic inflammatory disease or severe infection.
  • Ectopic pregnancy if contraception fails.
  • Severe allergic reaction to device components.
  • Thromboembolic events, though rare with progestin‑only systems.

Precautions & Warnings

Before insertion, clinicians should evaluate patient suitability and counsel on potential risks.

  • Pregnancy screening: confirm the patient is not pregnant before insertion.
  • Uterine assessment: exclude fibroids, congenital anomalies, or active infection.
  • Infection risk: avoid insertion during untreated pelvic infection.
  • Bleeding counseling: inform about possible changes in menstrual pattern.
  • Follow‑up: schedule post‑insertion checks to verify placement.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel IUS may have pharmacokinetic interactions that affect contraceptive efficacy.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) that may lower levonorgestrel levels.
  • Concurrent use of uterine‑acting devices that could displace the system.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., efavirenz, St. John's wort) requiring efficacy monitoring.
  • Antifungal agents such as ketoconazole that may increase levonorgestrel exposure.
  • Certain antiretrovirals (e.g., protease inhibitors) that could alter hormone metabolism.

Frequently Asked Questions

Levosert Shi is an intrauterine system that delivers levonorgestrel locally. It is prescribed for long‑term contraception and for the management of heavy menstrual bleeding, helping to reduce menstrual blood loss and improve related anemia.

Levonorgestrel released from the device acts on the endometrium and cervical mucus. It suppresses ovulation, thickens cervical mucus to block sperm, and induces endometrial thinning, creating conditions that prevent implantation and lessen menstrual bleeding.

The dose of levonorgestrel delivered by Levosert Shi is set by the prescribing clinician based on the approved product specifications. The device is inserted once and provides continuous hormone release for the approved duration.

Levosert Shi is intended for use in women who are not pregnant. It should not be inserted in a pregnant patient. Breastfeeding women should discuss risks and benefits with their healthcare provider, as levonorgestrel can be excreted in breast milk.

To place an 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 necessary import documentation.

Compared with oral progestins or combined pills, Levosert Shi offers a once‑inserted, long‑acting solution that avoids daily adherence. Its local hormone release minimizes systemic exposure, and it also provides therapeutic benefit for heavy menstrual bleeding, which many oral options do not address.

Levosert Shi should be stored at room temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme temperatures to maintain its integrity until insertion.

Levosert Shi is a sterile intrauterine system that must be inserted by a qualified healthcare professional into the uterine cavity using a dedicated inserter. The procedure is performed in a clinical setting under aseptic conditions.

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

Women with active pelvic infection, known or suspected uterine abnormalities (e.g., large fibroids, congenital malformations), a history of uterine perforation, or who are currently pregnant should not receive Levosert Shi. Contraindications are assessed by the prescribing clinician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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