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  • Manufacturer BAYER PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Levonorgestrel

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Levonorgestrel, the active ingredient in the Levonorgestrel Device, acts primarily by inhibiting ovulation. It achieves this through its strong progestational effects, which suppress the mid-cycle surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). By preventing this surge, the device effectively inhibits ovulation, thereby preventing fertilization. Additionally, levonorgestrel alters the cervical mucus, making it thicker and creating a barrier that impedes sperm penetration. It may also affect the endometrium, reducing the likelihood of implantation if fertilization does occur. This multi-faceted mechanism of action contributes to the device's effectiveness in emergency contraception and other reproductive health applications.

  • Ingredients

    Levonorgestrel
  • Drug Class

    Intrauterine contraceptive

  • Dosage Form

    device

  • Uses

    The following are the uses of Levonorgestrel Device:

    • Used for emergency contraception, providing a backup option after unprotected intercourse.
    • Used for long-term birth control, offering a hormonal alternative for up to 5 years.
    • Used for managing heavy menstrual bleeding, reducing flow and associated symptoms.
    • Used for endometrial protection during hormone therapy, maintaining uterine health.
    • Used for treating endometriosis pain, providing relief and potential symptom management.
    • Used for regulating irregular periods, helping to establish a more predictable cycle.
    • Used for adolescent contraception, offering a discreet and effective method for young users.
  • In case of Overdose

    In the case of an overdose of Levonorgestrel Device, it is important to remain calm and seek medical advice promptly. While this medication is generally safe, an overdose may lead to increased side effects such as nausea, abdominal pain, and dizziness. Do not induce vomiting unless advised by a healthcare professional. Contact a doctor or poison control center for guidance on managing symptoms and determining the appropriate next steps for treatment.

  • Missed Dose

    In the case of a missed dose of Levonorgestrel Device, it is important to act quickly. If you realize you have missed inserting the device within the first 72 hours after unprotected intercourse, insert it as soon as possible. However, if more than 72 hours have passed, the device may not be as effective, and you should contact your healthcare provider for further guidance. It is crucial to use a backup method of contraception, such as condoms, until you can discuss the missed dose with your doctor and determine the best course of action.

  • How To Use

    To use the Levonorgestrel Device, insert the device deeply into the vagina, ensuring it is positioned correctly, and leave it in place for the duration of the recommended time, typically 48 hours, without removing or replacing it.

  • When Not to Use

    Following are the conditions or situations when Levonorgestrel Device should not be used:

    • Not to be used if the patient has a known allergy or hypersensitivity to levonorgestrel or any of the device components.
    • Contraindicated in women who are already pregnant or suspect they might be pregnant.
    • Should not be used in individuals with a history of ectopic pregnancy.
    • Not suitable for individuals with severe liver disease or liver impairment.
    • Should not be used in patients with a history of breast cancer or suspected breast cancer.
    • Contraindicated in individuals with unexplained vaginal bleeding or genital tract pathology.
    • Not recommended for individuals with a history of blood clots or thromboembolic disorders.
    • Should not be used if the patient has a history of stroke or heart attack.
    • Contraindicated in individuals with severe uncontrolled hypertension.
    • Not suitable for women with a history of ovarian cysts or ovarian cancer.
  • Side Effects

    The side effects of Levonorgestrel Device may include:

    • Irregular menstrual cycles
    • Breakthrough bleeding or spotting
    • Nausea and vomiting
    • Headaches or dizziness
    • Breast tenderness or pain
    • Mood changes, including depression or irritability
    • Abdominal pain or cramps
    • Diarrhea or constipation
  • Precautions & Warnings

    Following are the precautions and warnings for Levonorgestrel Device:

    • Not suitable for those with known allergies or hypersensitivity to Levonorgestrel or any of the device's components.
    • Individuals with a history of blood clots, stroke, or heart attack should exercise caution and consult a healthcare professional before using this device.
    • Caution is advised for patients with high blood pressure, as it may increase the risk of hypertension-related complications.
    • Not recommended for individuals with severe liver impairment, as it may affect the device's effectiveness and increase the risk of side effects.
    • Patients should be aware that Levonorgestrel Device does not protect against sexually transmitted infections and HIV/AIDS.
    • This device is not intended for long-term use as a primary contraceptive method and should not be used as a substitute for regular contraception.
    • Women who experience severe abdominal pain, persistent nausea, or any other concerning symptoms after insertion should seek immediate medical attention.
  • Drug Interactions

    Following are the drug interactions for Levonorgestrel Device:

    • Levonorgestrel may decrease the effectiveness of enzyme inducers like rifampin, phenytoin, and carbamazepine, potentially reducing the contraceptive effect.
    • Can interact with other hormonal contraceptives, including combined oral contraceptive pills, potentially affecting hormone levels.
    • Antibiotics such as rifampin and rifabutin may reduce levonorgestrel blood levels, impacting contraceptive efficacy.
    • St. John's Wort may decrease the effectiveness of levonorgestrel, increasing the risk of unintended pregnancy.
    • HIV protease inhibitors (e.g., ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine) may reduce levonorgestrel levels, requiring alternative contraceptive methods.
    • Griseofulvin, a medication used to treat fungal infections, may also decrease levonorgestrel blood levels.
    • Caution is advised when using levonorgestrel with drugs that affect the liver, as this may alter its metabolism and effectiveness.
  • Food Interactions

    Following are the food interactions for Levonorgestrel Device:

    • Alcohol consumption may lead to increased levels of Levonorgestrel in the blood, potentially enhancing its side effects. It is advisable to avoid or limit alcohol intake while using this medication.
    • Grapefruit and grapefruit juice should be avoided as they can interfere with the metabolism of Levonorgestrel, leading to increased blood levels and potential side effects.
    • High-fat meals can delay the absorption of Levonorgestrel, potentially affecting its effectiveness. It is best to take the medication on an empty stomach or with a light meal.
    • Dairy products like milk, cheese, and yogurt may interact with Levonorgestrel, reducing its absorption. It is recommended to separate these foods by at least 2 hours when taking the medication.
    • Certain vegetables like broccoli, Brussels sprouts, and cabbage contain compounds that can affect the metabolism of Levonorgestrel. It is advisable to maintain a consistent intake of these vegetables to avoid fluctuations in medication levels.
    • Herbs like St. John's Wort can reduce the effectiveness of Levonorgestrel by inducing its metabolism. It is best to consult a healthcare professional before taking any herbal supplements.
    • Vitamin C supplements may interfere with the absorption of Levonorgestrel. It is advisable to separate the intake of high-dose vitamin C supplements and the medication by a few hours.
    • Caffeine intake should be monitored as it can affect hormone levels and potentially interact with Levonorgestrel, although the interaction is not well established.
  • Storage/Disposal

    The Levonorgestrel Device should be stored in a secure and designated area, away from direct sunlight, heat, and moisture. Maintain a consistent room temperature, ideally between 68°F and 77°F (20°C and 25°C), to ensure the stability of the device. Keep it in its original packaging until ready for use, ensuring the packaging remains intact and free from damage. Once the device is no longer needed or has reached its expiration date, proper disposal is crucial. Do not discard it in regular household trash or pour it down the drain. Contact your local waste management authorities or healthcare provider for guidance on appropriate disposal methods, ensuring compliance with environmental regulations. Keep the device out of the reach of children and pets to prevent accidental exposure.

  • Quick Tips, if any

    Following are the quick tips for Levonorgestrel Device:

    • Consult a healthcare professional for instructions on proper usage.
    • Ensure you understand the insertion and removal process before using the device.
    • Wash your hands thoroughly before handling the device to maintain hygiene.
    • Check the expiration date and inspect the device for any damage before use.
    • Insert the device as instructed, ensuring it is placed correctly for maximum effectiveness.
    • If you experience discomfort or have difficulty removing the device, seek medical advice promptly.
    • Do not reuse the device; it is designed for one-time use only.
    • Store the device in a cool, dry place, away from direct sunlight and moisture.

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