GNH USA

Europe — EMA

Levosert

GNH USA supplies Levosert (Levonorgestrel), a hormonal intrauterine contraceptive for up to five years of pregnancy prevention.

Levonorgestrel

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What is Levonorgestrel?

Levonorgestrel, the active ingredient in Levosert, is a progestin presented as a 52 mg intrauterine system for intrauterine use. It provides long‑term hormonal contraception and may also 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 is a hormonal intrauterine system that acts on the reproductive tract to prevent pregnancy and treat menstrual disorders. - Contraception (prevention of pregnancy): offers up to five years of highly effective reversible birth control. - Heavy menstrual bleeding: reduces menstrual blood loss and improves cycle regularity. - Endometrial protection: suppresses endometrial proliferation, helping to manage hormone‑related uterine conditions.

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 vaginal bleeding or spotting. - Amenorrhea (absence of periods) after initial months. - Pelvic or uterine cramping. - Breast tenderness or enlargement. - Ovarian cyst formation. - 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. - Allergic reaction to device materials. - Severe abdominal pain requiring medical evaluation.

What precautions apply to Levonorgestrel?

Before insertion and during use, certain precautions should be observed to ensure safety and effectiveness. - Pregnancy testing: confirm the patient is not pregnant prior to insertion. - Uterine abnormalities: evaluate for fibroids, congenital anomalies, or scarring that may affect placement. - Active infection: defer insertion if pelvic infection or sexually transmitted disease is present. - Bleeding disorders: assess coagulation status and advise on potential increased bleeding. - Hormone‑sensitive conditions: avoid use in known breast cancer or severe liver disease. - Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levosert has limited systemic exposure, but certain drugs can affect levonorgestrel levels.

Major Interactions (Avoid): - Rifampicin and other strong CYP3A4 inducers: may markedly reduce contraceptive efficacy. - St. John's wort (hypericum perforatum): can lower levonorgestrel concentrations.

Moderate Interactions (Monitor Closely): - Antiretroviral protease inhibitors (e.g., ritonavir): may alter hormone metabolism. - Certain anticonvulsants (e.g., carbamazepine, phenytoin): may modestly decrease effectiveness. - Antifungal agents (e.g., ketoconazole): could increase levonorgestrel exposure, requiring monitoring.

Frequently asked questions

What is Levosert used for?+
Levosert is a levonorgestrel‑releasing intrauterine system indicated for long‑term contraception, providing up to five years of pregnancy prevention, and for the management of heavy menstrual bleeding in women of reproductive age.
How does levonorgestrel work in Levosert?+
Levonorgestrel released from the device thickens cervical mucus, reduces sperm motility, suppresses endometrial growth, and often inhibits ovulation, creating multiple barriers that prevent fertilisation and implantation.
What is the usual dose of Levosert?+
The dosage of Levosert is fixed; it contains 52 mg of levonorgestrel that releases about 20 µg per day. The prescribing clinician determines suitability and insertion timing based on individual patient needs.
Is Levosert safe to use during pregnancy or breastfeeding?+
Levosert is contraindicated in pregnancy (Category X) and should not be inserted in pregnant women. Women who become pregnant while using the device should seek medical advice. Limited data exist for breastfeeding, and clinicians should evaluate risks versus benefits.
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 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.
How does Levosert compare with other intrauterine contraceptives?+
Levosert delivers a consistent low‑dose levonorgestrel release over five years, similar to other hormonal IUDs such as Mirena. Compared with copper IUDs, it may cause less menstrual bleeding but carries hormone‑related side effects. Choice depends on patient preference, medical history and desired duration of use.
What are the storage and handling requirements for Levosert?+
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 the time of insertion.
How is Levosert administered?+
Levosert is inserted by a qualified healthcare professional into the uterine cavity using a specialized inserter. The procedure is performed in a clinical setting after confirming the patient is not pregnant and has no active pelvic infection.
What are the most serious risks associated with Levosert?+
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.
Who should not use Levosert?+
Levosert is contraindicated in women who are pregnant, have known or suspected uterine anomalies, active pelvic infection, untreated cervical cancer, breast cancer, severe liver disease, or a history of thromboembolic disorders. A thorough medical assessment is essential before insertion.
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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