Levonorgestrel Tablets (box of 1 tablets)
Levonorgestrel Tablets (blister of 1 tablet)
Levonorgestrel Tablets (box of 1 tablets)
Levonorgestrel Tablets (blister of 1 tablet)
*Packaging color may differ according to distribution region.

Levonorgestrel Tablets

PreventaCare™
Levonorgestrel Tablets are a hormonal emergency contraceptive drug. AdvaCare Pharma manufactures this drug in its ISO/GMP-compliant facilities which undergo routine inspections to ensure the highest quality and safety standards are met.

Dosage

Packaging

What is Levonorgestrel?

Therapeutic Class:

Active Ingredients: Levonorgestrel

Levonorgestrel Tablets are a hormonal emergency contraceptive drug intended to prevent pregnancy after a known or suspected contraceptive failure or unprotected intercourse. When taken within 72 hours of unprotected sex, levonorgestrel can reduce the risk of a successful pregnancy by up to 89%.

Levonorgestrel Tablets may also be referred to as a 'morning-after pill' or 'Plan B'. It is considered a safe and effective emergency contraceptive option that is well-tolerated by most patients. This medication is not intended to be used as a regular form of birth control. Levonorgestrel is not an abortifacient and will not end an already existing pregnancy.

Levonorgestrel is classified as a synthetic progestin, which acts as a progesterone agonist by mimicking the effects of the hormone progesterone within the body. This drug binds to serum albumin and sex hormone-binding globulin (SHBG) and works to suppress the release of gonadotropins from the pituitary gland. This effect leads to decreased levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

As a post-coital contraceptive, levonorgestrel works by delaying or preventing ovulation and the thickening of cervical mucus. By altering the cervical mucus, the sperm is less able to move throughout the cervix to reach the egg. Levonorgestrel is also known to change the uterine lining, which reduces the chance of embryo implantation.

Levonorgestrel is found in many types of hormonal contraception, including birth control pills, intrauterine devices (IUDs), and emergency contraception. As an emergency contraceptive, levonorgestrel is available in either 1.5mg or 0.75mg tablets. Pharmacies, healthcare providers, and online pharmacies often stock these tablets to ensure individuals can quickly access the drug when needed.

AdvaCare Pharma is a manufacturer and supplier of Levonorgestrel Tablets. Every part of our supply chain is thoroughly vetted to ensure it meets health, safety, and environmental standards. This medication is produced in our GMP-certified facilities in China, India, and the USA.

Why are we a trusted Levonorgestrel manufacturer?

We are a Levonorgestrel manufacturer engaged in the global distribution of 200+ oral solid pharmaceutical products in tablet dosage form.

As an American-owned and operated company, we are devoted to the manufacture and supply of superior quality, yet cost-effective pharmaceuticals to improve access to healthcare solutions worldwide. AdvaCare Pharma manufactures Levonorgestrel Tablets, and over 500 other pharmaceutical treatments, according to strict GMP regulations as part of our global commitment to bring efficacious medicines to pharmaceutical distributors, hospitals, pharmacies and other medical institutions.

Uses

What is Levonorgestrel used for?

It is used as an emergency contraceptive pill to prevent pregnancy after a known or suspected contraceptive failure or unprotected intercourse. Levonorgestrel helps to prevent pregnancy before it occurs by inhibiting fertilization or implantation.

How should Levonorgestrel Tablets be used?

This medication is intended to be taken orally. The tablets should be taken with a glass of water. Do not crush or chew the tablet.

How should Levonorgestrel Tablets be stored?

The tablets should be kept in their original packaging until use. The medicine should be stored in a cool, dry location.

What happens if a dose is missed?

If the second dose of the treatment is missed, it should be taken as soon as possible.

What dose should be taken and for how long?

For emergency contraception, in order to obtain optimal results, the first tablet (1.5mg) should be taken as soon as possible within 72 hours (3 days) of intercourse. Alternatively, a dose of 0.75mg should be taken with a second pill 12 hours later. The medication is more effective the sooner it is taken after sexual intercourse. If vomiting occurs within 2 hours of treatment, a repeated dose may be necessary.

Refer to a doctor or pharmacist for guidelines on dosage. Do not exceed the advisable dosage.

Who can use Levonorgestrel?

Levonorgestrel can be administered to postmenarchal females, but caution is advised for specific groups of patients.

Pregnant This medicine should not be used for patients who are already pregnant. It should be noted that levonorgestrel will not terminate a pregnancy that has already begun. Based on limited human data, there is no known risk of teratogenicity during early pregnancy. There are no existing clinical data for the effects on the fetus for doses greater than 1.5mg. Animal experiments with this drug have shown fetal defects at high doses.

Nursing Levonorgestrel is considered safe for breastfeeding women, with some special considerations as this medicine is secreted into the milk. Breastfeeding should be avoided for 3-4 hours after treatment with levonorgestrel. Some studies show that women should avoid nursing for 8 hours after taking this medicine. Levonorgestrel has been reported to slow breast milk production in some women. The long-term use of progestin-only contraception has been shown to result in detectable levels of steroids in the plasma of the infant.

Children The safety and efficacy are expected to be equal for adolescents who have reached puberty. This drug is not intended for use in premenarcheal individuals.

Elderly This drug is not intended for use in postmenopausal women.

Does Levonorgestrel protect against sexually transmitted infections (STIs)?

No, Levonorgestrel Tablets do not offer protection from sexually transmitted diseases (STDs) and infections (STIs), including HIV infection.

Does taking Levonorgestrel have an impact on future fertility?

No, using Levonorgestrel as an emergency contraception does not affect fertility. However, treatment with levonorgestrel may temporarily disrupt a patient's regular menstrual cycle. There are reported cases of individuals with irregular bleeding or spotting after treatment. Most individuals return to their normal menstrual cycles and long-term fertility should not be affected. An individual's period should be expected at its usual time or with a 5-7 day delay. If after a week, there has been a period, pregnancy should be considered and a pregnancy test should be performed.

Is Levonorgestrel 100% effective against pregnancy?

When used correctly, levonorgestrel tablets are considered an effective form of emergency contraceptive; however, factors like timing of administration or individual patient situations may affect the effectiveness of the treatment. When used as emergency contraception, levonorgestrel can reduce the risk of a successful pregnancy by up to 87% when used as directed within 3 days of unprotected sex. When used within 24 hours, this medicine is more effective. The effectiveness of treatment decreases as time passes after unprotected sex. The tablet should be taken as soon as possible for maximum efficacy.

Other warnings or considerations

Levonorgestrel tablets are intended for emergency use. They are considered safe for occasional use, but they are not intended to be used as a regular form of contraception. If a patient is already taking combination birth control pills, emergency contraception may not be necessary.

Recent research suggests that the effectiveness of levonorgestrel may be impacted by body weight, particularly in patients with a higher body mass index (BMI). Recent studies have shown a reduced efficacy in women weighing more than 75kg.

Altered gastrointestinal motility may impact how levonorgestrel is absorbed or processed in the body. If a patient with this condition vomits or has diarrhea after taking levonorgestrel, additional doses may be necessary.

If pregnancy occurs after taking levonorgestrel, ectopic pregnancy should be considered. Though the absolute risk is low, an ectopic pregnancy may continue in spite of uterine bleeding.

Side Effects

As with all pharmaceuticals, some unwanted effects can occur from the use of Levonorgestrel Tablets.

Common side effects include, but may not be limited to:

  • nausea
  • abdominal pain
  • fatigue
  • headache
  • irregular menstrual bleeding
  • dizziness
  • breast tenderness
  • vomiting
  • diarrhea

Severe side effects are not common, but may include:

  • hypersensitivity or allergic reactions
  • blood clots
  • high blood pressure

In the event of severe pain in the lower stomach or side, emergency help or a doctor should be contacted. This could be a sign of an ectopic or tubal pregnancy.

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.

Precautions

Do NOT use Levonorgestrel Tablets if:

  • You are allergic to any of the ingredients.
  • You are pregnant or breastfeeding.
  • You have undiagnosed vaginal bleeding.
  • You have any type of bleeding in your brain or the retina of your eyes.

Before treatment, consult your doctor regarding any medications you are taking to address potential drug interactions.Certain medications, such as barbiturates (e.g. primidone), bosentan, anticonvulsants (e.g. carbamazepine, felbamate, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, topiramate) specific antibiotics (rifampin), efavirenz, and herbal supplements (Hypericum perforatum/St. John's Wort), may reduce the effectiveness of levonorgestrel as an emergency form of contraception. Levonorgestrel may also increase the risk of cyclosporine toxicity due to possible inhibition of cyclosporine metabolism.

This medication may not be suitable for people with certain conditions, so it is important to consult with a doctor if you have any health conditions. Some known conditions that may need special consideration include gastrointestinal disorders or malabsorption syndromes (e.g. Crohn's disease), hormone disorders (e.g. polycystic ovary syndrome / PCOS), and certain thyroid disorders.

Levonorgestrel tablets are contraindicated for patients who are already pregnant or have undiagnosed vaginal bleeding.

Levonorgestrel is not recommended for patients at risk of ectopic pregnancy (history of ectopic pregnancy or salpingitis) or severe hepatic dysfunction.

Patients with pre-existing reproductive health conditions, including uterine fibroids, endometriosis, or menstrual irregularities, should be warned that tablets may have an impact on their condition.

References

A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception

This is a systematic review that discusses the available evidence of levonorgestrel which is a commonly used progestin for emergency contraception.

It is a randomized, double-blind trials were sought, evaluating healthy women with regular menstrual cycles, who requested emergency contraception within 72 hours of unprotected coitus. The following three regimens were used: 1.5mg single dose levonorgestrel, two doses of 0.75mg levonorgestrel given 12 hours apart, or two doses of 0.75mg levonorgestrel given 24 h apart.

The results revealed that a single dose of levonorgestrel 1.5mg for emergency contraception supports its safety and efficacy profile. If two doses of levonorgestrel 0.75mg are intended for administration, the second dose can safely be taken 12–24 h after the first dose without compromising its contraceptive efficacy. There were no significant side effects after the use of levonorgestrel.

The findings indicate that emergency contraceptive regimens are efficacious for emergency contraception and prevent a high proportion of pregnancies if taken within 72 hours of unprotected coitus.

*Regulatory compliance may vary according to production standard, import requirements and/or manufacturing origin.

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