GNH USA

Europe — EMA

Levosert

GNH USA supplies Levosert (Levonorgestrel), a progestogen intrauterine system for contraception and heavy menstrual bleeding.

Levonorgestrel

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What is Levonorgestrel?

Levonorgestrel, the active ingredient in Levosert, is a progestogen presented as a 52 mg intrauterine system for intrauterine use. It provides hormonal contraception and can be used to manage heavy menstrual bleeding in women of reproductive age.

GNH USA supplies Levosert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Levonorgestrel used for?

Levosert, a levonorgestrel‑releasing intrauterine system, is indicated for hormonal contraceptive and menstrual‑related indications.

Contraception: provides up to five years of highly effective birth control for women of reproductive age. Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with excessive bleeding.

What are the side effects of Levonorgestrel?

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

Common Side Effects: - Irregular bleeding or spotting - Amenorrhea (absence of periods) - Cramping or pelvic pain after insertion - Headache - Breast tenderness - Mood changes

Serious or Rare Side Effects: - Uterine perforation during insertion - Expulsion of the device - Pelvic inflammatory disease - Ectopic pregnancy if contraception fails - Ovarian cyst formation - Severe allergic reaction to device components

What precautions apply to Levonorgestrel?

Before insertion, clinicians should assess patient suitability and counsel on potential risks. - Confirm non‑pregnancy: verify negative pregnancy test before placement. - Screen for active pelvic infection: avoid insertion in presence of PID or severe cervicitis. - Review uterine anatomy: ensure appropriate cavity size and position. - Counsel on bleeding changes: inform patients about possible spotting or amenorrhea. - Assess contraindications: avoid in women with known levonorgestrel hypersensitivity or liver disease. - Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levosert may interact with systemic agents that alter steroid metabolism.

Major Interactions (Avoid): - Rifampin and other strong enzyme inducers: may reduce levonorgestrel efficacy. - Certain antiepileptic drugs (e.g., carbamazepine, phenytoin): can lower hormone levels. - Antifungal azoles (e.g., ketoconazole): may increase levonorgestrel concentrations.

Moderate Interactions (Monitor Closely): - St. John's wort: potential reduction in hormone effect, monitor for breakthrough bleeding. - Protease inhibitors used in HIV therapy: may affect levonorgestrel metabolism, consider alternative contraception.

Frequently asked questions

What is Levosert used for?+
Levosert is a levonorgestrel‑releasing intrauterine system indicated for hormonal contraception up to five years and for the medical management of heavy menstrual bleeding in women of reproductive age. It provides a localized, steady release of progestogen to prevent pregnancy and reduce menstrual blood loss.
How does levonorgestrel work in Levosert?+
Levonorgestrel released from the intrauterine system acts on the endometrium, cervical mucus and ovary. It suppresses ovulation, thickens cervical mucus to impede sperm passage, and induces endometrial atrophy, creating an environment that prevents implantation and reduces menstrual bleeding.
What is the usual dose of Levosert?+
The dosing regimen of Levosert is determined by the prescribing clinician. The device contains 52 mg of levonorgestrel and releases approximately 20 µg per day for up to five years; the prescriber decides insertion timing and follow‑up schedule based on individual patient needs.
Is Levosert safe during pregnancy or breastfeeding?+
Levosert is classified as pregnancy category X; it must not be used in women who are pregnant or who intend to become pregnant. Breastfeeding is not a contraindication after insertion, but women should discuss any concerns with their healthcare provider, as hormonal exposure may affect milk production.
How do I order Levosert from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Levosert compare with other hormonal contraceptives?+
Compared with combined oral contraceptives, Levosert offers a “set‑and‑forget” approach with continuous low‑dose levonorgestrel release, eliminating daily adherence. Unlike copper IUDs, it reduces menstrual bleeding and may improve anemia, but it does not protect against sexually transmitted infections.
How should Levosert be stored and handled?+
Store Levosert at room temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture and direct sunlight. Do not attempt to open or manipulate the intrauterine system before insertion by a qualified healthcare professional.
How is Levosert administered?+
Levosert is inserted into the uterine cavity by a trained clinician using a specialized inserter. The procedure is performed in a clinical setting under aseptic conditions, typically during the early follicular phase of the menstrual cycle. Once placed, the device remains effective for up to five years without further dosing.
What are the most serious risks associated with Levosert?+
Serious but uncommon risks include uterine perforation during insertion, expulsion of the device, pelvic inflammatory disease, and ectopic pregnancy if contraception fails. Users should seek immediate medical attention for severe abdominal pain, abnormal bleeding, or signs of infection.
Who should not use Levosert?+
Levosert is contraindicated in women who are pregnant, have current or suspected pelvic infection, unexplained vaginal bleeding, known or suspected uterine malignancy, or a history of severe allergic reaction to levonorgestrel. It should also be avoided in individuals with active liver disease or known hypersensitivity to the device components.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Levonorgestrel
Route
Intrauterine Use
Manufacturer
Gedeon Richter Plc.
Origin
EU

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