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 progestogen (progestin) presented as an intrauterine system (IUS) for intrauterine use. It delivers levonorgestrel locally to provide long‑acting reversible contraception and to reduce 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, with distribution channels that meet EU regulatory standards and rigorous quality‑assurance processes.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levosert Shi, a levonorgestrel‑releasing intrauterine system, is indicated for the following clinical uses:

  • Long‑acting reversible contraception: provides effective contraception for up to five years.
  • Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with excessive bleeding.

How It Works

  • Levosert Shi releases levonorgestrel directly into the uterine cavity, where the hormone binds to progesterone receptors, thickening cervical mucus, inhibiting sperm motility and function, inducing endometrial atrophy, and suppressing ovulation, thereby preventing pregnancy and reducing menstrual bleeding.

Side Effects

Levosert Shi may cause a range of adverse reactions. Monitoring and patient counseling are recommended.

Common Side Effects

  • Irregular bleeding or spotting: unpredictable menstrual patterns.
  • Amenorrhea: absence of periods after initial adjustment.
  • Pelvic or cramping pain: discomfort during the first months.
  • Breast tenderness: mild hormonal effect on breast tissue.
  • Headache: occasional tension‑type headache.
  • Acne or skin changes: mild hormonal skin response.

Serious or Rare Side Effects

  • Uterine perforation: rare injury during insertion.
  • Device expulsion: loss of the IUS from the uterine cavity.
  • Pelvic infection: potential for bacterial infection post‑insertion.
  • Ectopic pregnancy: pregnancy occurring outside the uterus if contraception fails.
  • Severe allergic reaction: anaphylaxis or hypersensitivity to device components.
  • Thromboembolic events: rare clotting disorders linked to systemic hormone exposure.

Precautions & Warnings

Prior to insertion, clinicians should assess patient suitability and counsel on expected changes.

  • Contraindications: pregnancy, suspected pregnancy, active pelvic infection, unexplained vaginal bleeding, uterine anomalies, or known malignancy.
  • Insertion by trained professional: ensure correct placement to minimize perforation risk.
  • Follow‑up evaluation: schedule visits to confirm device position and address adverse symptoms.
  • Menstrual changes: inform patients that spotting or amenorrhea are common early effects.
  • Interaction with hormonal therapies: review concurrent hormonal medications.
  • Store at room temperature below 25°C: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert Shi may interact with medications that alter hormone metabolism or affect bleeding risk.

Major Interactions (Avoid)

  • Enzyme inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort): may reduce levonorgestrel effectiveness.
  • Antifungal agents (e.g., griseofulvin): can lower hormone levels.
  • Certain antiretrovirals (e.g., efavirenz): may diminish contraceptive efficacy.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): may increase bleeding tendency.
  • NSAIDs (e.g., ibuprofen): can exacerbate spotting.
  • Hormonal therapies (e.g., estrogen‑containing pills): may alter bleeding patterns.
  • Antidepressants (e.g., SSRIs): occasional reports of increased spotting.
  • Herbal supplements (e.g., ginseng): potential modest effect on hormone metabolism.

Frequently Asked Questions

Levosert Shi is a levonorgestrel‑releasing intrauterine system indicated for long‑acting reversible contraception and for the management of heavy menstrual bleeding in women of reproductive age.

Levonorgestrel is released locally within the uterus, where it thickens cervical mucus, impairs sperm motility, induces endometrial atrophy, and suppresses ovulation, thereby preventing pregnancy and reducing menstrual blood loss.

Levosert Shi contains a fixed amount of levonorgestrel that provides therapeutic levels for up to five years. The prescribing clinician determines suitability and inserts the device; no patient‑controlled dosing is required.

Levosert Shi is not intended for use during pregnancy and should be removed if pregnancy occurs. Limited data exist for breastfeeding; generally the device is not recommended until after the postpartum period and after a healthcare professional’s assessment.

Submit an enquiry on the product page at gnhindia.com, specifying 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.

Compared with copper IUDs, Levosert Shi provides hormonal benefits such as reduced menstrual bleeding and lighter periods. Compared with other levonorgestrel IUS products, it offers similar efficacy and duration but may differ in size or release rate; selection depends on clinician preference and patient anatomy.

Store Levosert Shi at room temperature below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. Do not expose the device to extreme temperatures or humidity before insertion.

Levosert Shi is inserted by a trained healthcare professional into the uterine cavity through a sterile procedure. Once placed, the device remains in situ for up to five years, after which it can be removed or replaced.

Serious risks include uterine perforation during insertion, device expulsion, pelvic infection, ectopic pregnancy if contraception fails, and rare severe allergic reactions. Prompt medical attention is required if any of these events are suspected.

Women who are currently pregnant, suspect pregnancy, have active pelvic infections, unexplained vaginal bleeding, uterine anomalies, known or suspected uterine or breast cancer, or severe liver disease should not use Levosert Shi.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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