GNH USA

Europe — EMA

Levosert

GNH USA supplies Levosert (Levonorgestrel), a progestogen hormonal contraceptive for long‑acting reversible birth control and up to five years of pregnancy

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 long‑acting reversible contraception for women of reproductive age, preventing pregnancy for up to five years by locally releasing hormone directly within the uterus.

GNH USA supplies Levosert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory conformity across global markets.

What is Levonorgestrel used for?

Levosert, containing levonorgestrel, is used as a hormonal contraceptive delivered via an intrauterine system.

- Contraception (long‑acting reversible contraceptive): provides continuous pregnancy prevention for up to five years. - Family planning: offers a reversible, hormone‑based method for women seeking long‑term birth control. - Management of heavy menstrual bleeding: may reduce the duration and volume of menstrual bleeding in eligible users.

What are the side effects of Levonorgestrel?

Levosert may be associated with 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 abdominal cramping. - Breast tenderness or enlargement.

Serious or Rare Side Effects: - Uterine perforation during insertion. - Device expulsion or displacement. - Pelvic inflammatory disease or severe infection.

What precautions apply to Levonorgestrel?

Prior to insertion of Levosert, clinicians should evaluate several safety considerations.

- Pregnancy testing: confirm the patient is not pregnant before device placement. - Uterine abnormalities: assess for fibroids, septa, or congenital malformations that may affect insertion. - Active infection: defer insertion if pelvic infection or sexually transmitted disease is present. - Bleeding disorders: review history of coagulopathy or anticoagulant use to mitigate excessive bleeding risk. - Medication review: consider drugs that may reduce contraceptive effectiveness, such as enzyme‑inducing agents. - Store at ambient temperature: keep the device in its original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levosert can interact with other medicines that alter hormone metabolism or affect uterine environment.

Major Interactions (Avoid): - Enzyme‑inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital): may lower levonorgestrel levels and reduce efficacy. - Rifampicin or other strong hepatic inducers: can decrease hormone concentration, increasing risk of unintended pregnancy.

Moderate Interactions (Monitor Closely): - Antifungal azoles (e.g., ketoconazole, itraconazole): may increase levonorgestrel exposure, requiring monitoring for side effects. - Certain antiretrovirals (e.g., ritonavir): may modestly affect hormone levels. - Herbal supplements such as St. John’s wort: can induce metabolism and potentially lower contraceptive effectiveness.

Frequently asked questions

What is Levosert used for?+
Levosert is a levonorgestrel‑containing intrauterine system that provides long‑acting reversible contraception. It is inserted into the uterus to prevent pregnancy for up to five years and may also help reduce heavy menstrual bleeding in some women.
How does levonorgestrel work in Levosert?+
Levonorgestrel released from the intrauterine system thickens cervical mucus, impairs sperm motility, suppresses the growth of the uterine lining, and can 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 52 mg intrauterine device that provides continuous hormone release for up to five years. The exact dosing regimen, including timing of insertion and follow‑up, is determined by the prescribing clinician based on individual patient needs.
Is Levosert safe during pregnancy or breastfeeding?+
Levosert is contraindicated in pregnancy (Category X) and should not be used by women who are or may become pregnant. While limited data exist for breastfeeding, most guidelines advise caution and recommend discussing alternative contraception with a healthcare professional.
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 necessary import documentation.
How does Levosert compare with other hormonal IUS devices?+
Levosert contains 52 mg of levonorgestrel and is approved for up to five years of use, similar to other IUS products such as Mirena. Differences may include device dimensions, release rate, and regulatory approvals in specific regions. Clinical efficacy and safety profiles are comparable, but selection often depends on physician preference and patient characteristics.
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 extreme temperatures to maintain its integrity until the time of insertion.
How is Levosert administered?+
Levosert is inserted by a trained 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 evaluating uterine anatomy. Once placed, the device remains in situ for up to five years without the need for daily action.
What are the most serious risks associated with Levosert?+
Serious risks include uterine perforation during insertion, device expulsion or displacement, and pelvic inflammatory disease or severe infection. Early detection and prompt medical attention are essential if symptoms such as severe abdominal pain, abnormal bleeding or signs of infection occur.
Who should not use Levosert?+
Levosert is not recommended for women who are currently pregnant, have active pelvic infections, untreated cervical or uterine malignancies, unexplained vaginal bleeding, or certain uterine abnormalities such as large fibroids or congenital malformations that could impede 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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