GNH USA

Europe — EMA

Levosert

GNH USA supplies Levosert (Levonorgestrel), a hormonal contraceptive intrauterine system for long‑acting birth control and treatment of heavy menstrual

Levonorgestrel

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What is Levonorgestrel?

Levonorgestrel, the active ingredient in Levosert, is a Progestin (levonorgestrel) intrauterine system presented as a 52 mg intrauterine system for intrauterine use. It provides long‑acting reversible contraception and can be used to treat heavy menstrual bleeding.

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‑bleeding management pathways.

- Contraception: provides highly effective, long‑acting reversible birth control for up to five years. - Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with excessive bleeding. - Endometrial suppression: helps prevent endometrial overgrowth during prolonged use.

What are the side effects of Levonorgestrel?

Levosert may cause a range of adverse reactions. Most are mild and resolve with continued use.

Common Side Effects: - Irregular bleeding or spotting - Amenorrhea (absence of periods) - Pelvic or abdominal cramping - Hormonal acne - Breast tenderness - Headache

Serious or Rare Side Effects: - Uterine perforation during insertion - Expulsion of the device - Pelvic inflammatory disease or infection - Ectopic pregnancy if contraception fails - Allergic reaction to levonorgestrel or device materials - Migration of the IUS to adjacent organs

What precautions apply to Levonorgestrel?

Before insertion and during use, certain precautions should be observed.

- Pregnancy testing: confirm non‑pregnant status prior to insertion. - Uterine evaluation: assess for fibroids, septum, or other anomalies that may impede placement. - Infection risk: treat any active pelvic infection before device insertion. - Breast cancer history: avoid use in current or past estrogen‑dependent breast cancer. - Medication review: assess concomitant drugs that could alter bleeding patterns. - Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levosert may interact with systemic medications that affect levonorgestrel metabolism or bleeding patterns.

Major Interactions (Avoid): - Rifampicin and other strong CYP3A4 inducers: may reduce contraceptive efficacy. - Antiepileptic enzyme inducers (carbamazepine, phenytoin, phenobarbital): may lower levonorgestrel levels.

Moderate Interactions (Monitor Closely): - Certain antibiotics (e.g., tetracycline, metronidazole): may slightly affect bleeding patterns. - Antifungal azoles (ketoconazole): may increase levonorgestrel exposure. - Concurrent estrogen‑containing hormonal therapies: may increase overall hormonal load and affect side‑effect profile.

Frequently asked questions

What is Levosert used for?+
Levosert is a levonorgestrel‑releasing intrauterine system indicated for long‑acting reversible contraception and for the treatment of heavy menstrual bleeding. It provides up to five years of birth control while also reducing menstrual blood loss in women who experience excessive bleeding.
How does levonorgestrel work in Levosert?+
Levonorgestrel released from Levosert acts locally in the uterus to thicken cervical mucus, impair sperm motility, suppress the growth of the endometrium, and occasionally inhibit ovulation. These combined actions create an environment that prevents fertilisation and implantation.
What is the usual dose of Levosert?+
Levosert is supplied as a single intrauterine device that releases approximately 20 µg of levonorgestrel per day for up to five years. The exact dosing regimen, including timing of insertion and removal, is determined by the prescribing healthcare professional.
Is Levosert safe to use during pregnancy or breastfeeding?+
Levosert is contraindicated in pregnancy (Category X) and must not be inserted in a pregnant woman. For breastfeeding women, insertion after delivery is generally considered safe, but patients should discuss any concerns with their healthcare provider.
How do I order Levosert from GNH USA?+
To order Levosert, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and required import documentation.
How does Levosert compare with copper IUDs?+
Levosert releases levonorgestrel, offering hormonal contraception, reduced menstrual bleeding and potential improvement of dysmenorrhoea, whereas copper IUDs provide non‑hormonal contraception and may increase menstrual flow. Both are highly effective, but the choice depends on a woman's preference for hormonal versus non‑hormonal methods and her bleeding profile.
How should Levosert be stored and handled?+
Levosert should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and physical damage until it is inserted 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 after confirming the patient is not pregnant and that the uterus is suitable for device placement.
What are the most serious risks to watch for with Levosert?+
Serious risks include uterine perforation during insertion, expulsion of the device, pelvic inflammatory disease, ectopic pregnancy if contraception fails, allergic reactions to device components, and migration of the IUS to adjacent organs. Prompt medical evaluation is required if any of these events are suspected.
Who should not use Levosert?+
Levosert should not be used by women who are pregnant, have known or suspected uterine anomalies (e.g., large fibroids, septate uterus), have active pelvic infection, have a history of breast cancer that is estrogen‑dependent, or have severe liver disease. Contraindications are confirmed by the prescribing clinician.
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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