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Norethisterone

NA

DRUG STATUS

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Approvals

UK(BNF)

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Essential Medicine

YES

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Teratogenicity

Unlisted

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Pharmaceutical Class

NA

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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 the treatment of dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, metropathia haemorrhagia, pre-menstrual syndrome, and postponement of menstruation at low doses. At higher doses, it is used for disseminated carcinoma of the breast. It is also used for managing endometriosis and related symptoms.

How does Norethisterone work?

Norethisterone works by suppressing ovulation through its effect on the pituitary gland, reducing the production of endogenous estrogens and progesterones. It converts the endometrium to a decidua-like state, which helps manage symptoms of hormonal imbalances and certain cancers. This action is beneficial in treating conditions like dysfunctional uterine bleeding and endometriosis.

Is Norethisterone effective?

Norethisterone is effective in treating various conditions due to its ability to suppress ovulation and convert the endometrium to a decidua-like state. It is used for dysfunctional uterine bleeding, endometriosis, and postponement of menstruation, among other conditions. Its effectiveness is supported by its pharmacodynamic properties, which include pituitary inhibition and direct action on tumor deposits in carcinoma cases.

How does one know if Norethisterone is working?

The benefit of Norethisterone is evaluated by monitoring the patient's response to treatment, including the resolution of symptoms such as uterine bleeding or endometriosis-related pain. Regular follow-ups with a healthcare provider are essential to assess the effectiveness and adjust the dosage if necessary. Any adverse effects should also be reported and managed accordingly.

Directions for Use

What is the usual dose of Norethisterone?

For adults, the usual daily dose of Norethisterone varies depending on the condition being treated. For dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea, and metropathia haemorrhagia, 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. For postponement of menstruation, it's 1 tablet three times daily starting three days before the expected onset. For disseminated breast carcinoma, the starting dose is 8 tablets (40mg) per day. The content does not provide dosing information for children.

How do I take Norethisterone?

Norethisterone is taken orally, and the instructions do not specify whether it should be taken with or without food. There are no specific food restrictions mentioned in the provided content. However, patients should follow their healthcare provider's instructions and report any adverse effects or concerns regarding food interactions.

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 of menstruation. The duration for other conditions like breast carcinoma may vary based on the patient's response and doctor's advice.

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 timeframe. The onset of action may vary depending on the condition being treated and individual patient response. Patients should consult their healthcare provider for specific guidance based on their treatment plan.

How should I store Norethisterone?

Norethisterone should be stored in its original package at a temperature not exceeding 25°C. It should be kept in a dry place, away from direct sunlight and moisture, to maintain its efficacy and shelf life. Always ensure that the medication is stored out of reach of children.

Warnings and Precautions

Who should avoid taking Norethisterone?

Important warnings and contraindications for Norethisterone include hypersensitivity to the active substance, pregnancy, venous thromboembolism, arterial thromboembolic disease, liver function disturbances, and undiagnosed irregular vaginal bleeding. Patients should be aware of the risk of fluid retention and thromboembolic complications, and therapy should be discontinued if jaundice, significant blood pressure increase, or migraine-type headaches occur.

Can I take Norethisterone with other prescription drugs?

Norethisterone's metabolism may be increased by drugs that induce cytochrome P450 enzymes, such as anticonvulsants and certain anti-infectives. It may also interact with cyclosporin, leading to altered plasma levels. Herbal preparations like St John's wort can reduce progestogen levels. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions.

Can I take Norethisterone with vitamins or supplements?

The provided content does not specifically mention interactions between Norethisterone and vitamins or supplements. However, patients should inform their healthcare provider about all supplements they are taking, as some may affect the metabolism of Norethisterone or interact with its effects. St John's wort, for example, is known to induce the metabolism of progestogens.

Can Norethisterone be taken safely while pregnant?

Norethisterone is contraindicated during pregnancy due to potential risks to the fetus. The provided content does not specify evidence from human studies on fetal harm, but it is generally advised to avoid using this medication during pregnancy. Women of childbearing age should use effective contraception while taking Norethisterone and consult their healthcare provider if they become pregnant.

Can Norethisterone be taken safely while breastfeeding?

The provided content does not specifically address the use of Norethisterone while breastfeeding. However, as with any medication, it is important to consult a healthcare provider to weigh the benefits and potential risks to the nursing infant. The provider may suggest alternative treatments or advise on the timing of medication to minimize exposure to the infant.

Is Norethisterone safe for the elderly?

The provided content does not specifically mention recommendations or warnings for the use of Norethisterone in the elderly. However, as with any medication, elderly patients should use Norethisterone under the guidance of a healthcare provider, considering potential age-related changes in drug metabolism and the presence of other medical conditions.

Is it safe to exercise while taking Norethisterone?

The provided content does not specifically mention any limitations on exercise due to Norethisterone. However, since Norethisterone can cause side effects like fatigue and dizziness, these may indirectly affect one's ability to exercise. Individuals should listen to their bodies and consult with a healthcare provider if they experience any concerning symptoms while exercising.

Is it safe to drink alcohol while taking Norethisterone?

The provided content does not specifically mention the effects of alcohol on the safety or effectiveness of Norethisterone. However, it is generally advisable to consult with a healthcare provider regarding alcohol consumption while taking any medication, as alcohol can potentially interact with medications and affect their metabolism or efficacy.