Norethisterone

NA

Drug Status

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Government Approvals

UK(BNF)

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WHO Essential Medicine

YES

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Known Teratogen

NO

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Pharmaceutical Class

Progestin

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Controlled Drug Substance

NO

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Drug Ingredient

Norethisterone

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Summary

  • Norethisterone is used to treat conditions such as dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, metropathia haemorrhagia, premenstrual syndrome, and to delay menstruation. At higher doses, it is used for disseminated carcinoma of the breast and to manage endometriosis and related symptoms.

  • Norethisterone works by suppressing ovulation and converting the endometrium to a state similar to pregnancy. This helps manage symptoms associated with hormonal imbalances and certain cancers.

  • The usual daily dose of Norethisterone varies depending on the condition. For most conditions, the dose is 1 tablet (5mg) three times daily for 10 days. For endometriosis, it's 1 tablet three times daily for at least six months. It is taken orally.

  • Common side effects of Norethisterone include breakthrough bleeding, spotting, amenorrhoea, nausea, headache, dizziness, and fatigue. Serious adverse effects may include thromboembolic disorders, liver function disturbances, and hypersensitivity reactions.

  • Norethisterone should not be used if you have hypersensitivity to the active substance, pregnancy, venous thromboembolism, arterial thromboembolic disease, liver function disturbances, and undiagnosed irregular vaginal bleeding. Be aware of the risk of fluid retention and thromboembolic complications.

Indications and Purpose

What is Norethisterone used for?

Norethisterone is indicated for treating various menstrual disorders, including dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea, and metropathia haemorrhagia. It is also used for endometriosis, pre-menstrual syndrome, and postponement of menstruation. At higher doses, it is used for treating disseminated breast carcinoma. Always consult a healthcare provider for appropriate use and dosing for these conditions.

How does Norethisterone work?

Norethisterone works by suppressing ovulation through its effect on the pituitary gland. It also alters the uterine lining, converting it to a decidua similar to that of pregnancy, which helps manage menstrual disorders. In cases of breast carcinoma, it may act by inhibiting pituitary function or directly affecting tumor deposits, helping to control cancer progression.

Is Norethisterone effective?

Norethisterone is effective in treating various menstrual disorders and conditions like dysfunctional uterine bleeding, endometriosis, and pre-menstrual syndrome. It works by suppressing ovulation and altering the uterine lining, which helps manage symptoms. Its effectiveness in treating disseminated breast carcinoma is due to its ability to inhibit pituitary function or act directly on tumor deposits. Clinical use and studies support its efficacy in these conditions.

How does one know if Norethisterone is working?

The benefit of Norethisterone is evaluated by monitoring the improvement of symptoms related to the conditions it treats, such as reduced menstrual bleeding, alleviation of pre-menstrual syndrome symptoms, or regression of endometriosis. Regular follow-up appointments with a healthcare provider help assess the effectiveness and adjust the treatment as needed. Patients should report any persistent or worsening symptoms to their doctor for further evaluation.

Directions for Use

What is the usual dose of Norethisterone?

For adults, the usual dose of Norethisterone varies based on the condition being treated. For dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea, and metropathia haemorrhagia, the typical dose is 1 tablet (5mg) three times daily for 10 days. For endometriosis, it's 1 tablet three times daily for at least six months. For postponement of menstruation, it's 1 tablet three times daily starting three days before the expected onset. For pre-menstrual syndrome, it's 1 tablet daily from days 16 to 25 of the menstrual cycle. For disseminated breast carcinoma, the starting dose is 8 tablets (40mg) per day, increasing to 12 tablets (60mg) if needed. There is no specific dosage information for children in the provided content. Always follow a doctor's advice for dosing.

How do I take Norethisterone?

Norethisterone should be taken orally, and it can be taken with or without food. There are no specific food restrictions mentioned in the provided content. However, it is always best to follow your doctor's instructions regarding the use of this medication. If you have any concerns about food interactions, consult your healthcare provider for personalized advice.

For how long do I take Norethisterone?

The duration of use for Norethisterone depends on the condition being treated. For dysfunctional uterine bleeding and related conditions, it is typically used for 10 days. For endometriosis, the treatment period is a minimum of six months. For postponement of menstruation, it is used for a few days before the expected onset. For pre-menstrual syndrome, it is used for 10 days each cycle. Always follow your doctor's instructions regarding the duration of use.

How long does it take for Norethisterone to start working?

Norethisterone typically starts working within 48 hours for conditions like dysfunctional uterine bleeding, where bleeding usually stops within this time frame. For other conditions, such as endometriosis or pre-menstrual syndrome, the effects may take longer to become noticeable. Always follow your doctor's guidance and report any concerns about the effectiveness of the treatment.

How should I store Norethisterone?

Store Norethisterone in its original package at a temperature not exceeding 25°C. Ensure the container is tightly closed and kept away from moisture and direct sunlight. Keep it out of reach of children and pets to prevent accidental ingestion. Follow any additional storage instructions provided by your pharmacist or healthcare provider.

Warnings and Precautions

Who should avoid taking Norethisterone?

Important warnings for Norethisterone include the risk of venous thromboembolism, especially in patients with a history of thromboembolic disorders. It is contraindicated in pregnancy, liver dysfunction, and undiagnosed vaginal bleeding. Patients with conditions like epilepsy, migraine, asthma, cardiac or renal dysfunction should use it cautiously due to potential fluid retention. If symptoms like jaundice, significant blood pressure increase, or migraine-type headaches occur, discontinue use and consult a doctor.

Can I take Norethisterone with other prescription drugs?

Norethisterone's metabolism can be increased by drugs that induce liver enzymes, such as anticonvulsants (e.g., phenobarbital, phenytoin) and anti-infectives (e.g., rifampicin). This may reduce its effectiveness. Concurrent use with cyclosporin can increase cyclosporin levels. Herbal supplements like St John's wort may also reduce Norethisterone levels. Always inform your doctor about all medications and supplements you are taking to avoid interactions.

Can I take Norethisterone with vitamins or supplements?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Can Norethisterone be taken safely while pregnant?

Norethisterone is contraindicated during pregnancy due to potential risks to the fetus. There is no strong evidence from human studies provided in the content, but it is generally advised to avoid its use during pregnancy. If you become pregnant while taking Norethisterone, consult your doctor immediately for guidance and alternative treatment options.

Can Norethisterone be taken safely while breastfeeding?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Is Norethisterone safe for the elderly?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Is it safe to exercise while taking Norethisterone?

Norethisterone does not directly limit the ability to exercise. However, some side effects like fatigue, dizziness, or headaches might affect your ability to perform physical activities. If you experience any of these symptoms, it is advisable to rest and avoid strenuous exercise until you feel better. Always consult your doctor if you have concerns about exercising while on this medication.

Is it safe to drink alcohol while taking Norethisterone?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.