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Feminine
Generic Name: Norethisterone
Therapeutic Category: Endocrine-Metabolic Agent.
Pharmacological Class: Progestin
Composition: Each uncoated tablet contains Norethisterone BP 5 mg
Pregnancy Category: X
Presentation: Available in the pack size as 14 tablets X 20 blisters

What is Feminine and what is it used for?

Feminine contains Norethisterone 5 mg in tablet form. Norethisterone is a synthetic and potent progestogen hormone which is used in:

  • Dysfunctional Uterine Bleeding (DUB)
  • Premenstrual syndrome (PMS)
  • Painful periods
  • Endometriosis
  • Menopausal syndrome (in combination with estrogen)
  • To postpone period.

 

How does it work?

Feminine is a man-made version of the female sex hormone progesterone. It works by mimicking the effects of your natural progesterone. Your progesterone levels naturally fluctuate throughout your monthly menstrual cycle. As progesterone levels increase your womb lining flourishes, ready to receive a fertilised egg. If you don’t get pregnant the levels fall again, causing your womb lining to be shed as a period. If you do get pregnant your progesterone levels remain high to help maintain a healthy womb lining for the ongoing pregnancy.

 

How to take Feminine?

This medication must be taken orally.

 

  • Dysfunctional uterine bleeding: 5mg three times daily for ten days.

Bleeding is arrested usually within one to three days. A withdrawal bleeding resembling normal menstruation occurs within two to four days after discontinuing treatment.

 

  • Pre-menstrual syndrome: 10 – 15mg daily for 1week.

Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom free for a number of months.

 

  • Endometriosis: 2 tablets a day starting on the 5th day of your cycle.

If continue having small bleeds (“spotting”), the dosage may be increased to 4 to 5 tablets a day. Once bleeding has stopped the dosage may be reduced.

 

  • To postpone a period: 5mg three times daily, starting three days before the expected onset of menstruation.

A normal period should occur two to three days after the patient has stopped taking tablets.

 

  • Dysmenorrhea: 5mg three times daily for 20 days, starting on the fifth day of the cycle.

Treatment should be maintained for three to four cycles followed by treatment-free cycles.  A further course of therapy may be employed if symptoms return.

 

  • Menorrhagia: 5mg two to three times a day for 7 to 10 days

Emergency treatment to rapidly stop heavy bleeding: A dose of 5 mg three times daily for 10 days is the usual treatment.

 

  • Bleeding usually stops within 24-48 hours of starting treatment.
  • If bleeding is exceptionally heavy then 10 mg three times daily may be given.
  • This should then be tapered down to 5 mg three times daily for a week, once your bleeding has stopped.

 

What if you miss a dose?

If you miss a dose do not worry, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

                                                                                             

What to do in case of overdose?

If you accidentally take too many Feminine tablets, contact your doctor or hospital immediately. Overdosage may be manifested by nausea, vomiting, breast enlargement and later vaginal bleeding. There is no specific antidote and treatment should be symptomatic.

What do you need to know before you take Feminine?

Do not take Feminine in case of:

  • Hypersensitivity to the active substance or any of the excipients
  • Pregnancy
  • Previous idiopathic or current venous thromboembolism
  • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
  • Disturbance of liver function
  • History during pregnancy of idiopathic jaundice
  • Severe pruritus or pemphigoid gestationis
  • Undiagnosed irregular vaginal bleeding
  • Porphyria

 

Warning and Precautions

  • Therapy should be discontinued if the following occur:
    • Jaundice or deterioration in liver function
    • Significant increase in blood pressure
    • New onset of migraine-type headache

 

  • Progestogens may cause fluid retention. Special care should be taken when prescribing norethisterone in patients with conditions which might be aggravated by this factor: Epilepsy, Migraine, Asthma, Cardiac dysfunction, Renal dysfunction
  • Any patient who develops an acute impairment of vision migraine headache should be carefully evaluated ophthalmologically before continuing medication.

 

Feminine and other medications

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

 

Pregnancy and breast-feeding

Feminine must not be administered by pregnant of lactating women.

 

Driving and using machines

Feminine has no influence on the ability to drive and use machines.

 

What are thae possible side effects?

  • The most commonly reported side effect is facial swelling
  • Other include as acne, hirsutism, and voice changes.
  • Menstrual cycle changes, breast tenderness, dizziness, nausea, headaches

Mechanism of action:

Progestins diffuse freely into target cells and bind to the progesterone receptor. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH surge.

 

Pharmacokinetic properties:

Absorption: The Cmax of norethisterone following oral administration of a single dose ranges from 5.39 to 7.36 ng/mL with a Tmax of 1-2 hour. The oral bioavailability of norethisterone is approximately 64%.

 

Volume of distribution: The volume of distribution of norethisterone is approximately 4 L/kg. Sulfated metabolites of norethisterone, as well as small quantities of parent drug, have been shown to distribute into breast milk.

 

Protein binding: Norethisterone is 38% bound to sex hormone-binding globulin and 61% bound to albumin.

 

Metabolism:  Norethisterone is extensively metabolized, primarily in the liver, to a number of metabolites via partial and total reduction of its A-ring.

 

Route of elimination: Following administration of radio-labeled norethisterone, slightly more than 50% of the administered dose was eliminated in the urine and 20-40% was eliminated in the feces.

 

Half–life: The half-life of norethisterone has been variably estimated as 8-10 hours.

 

Drug Interactions

  • The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz, tetracyclines, ampicillin, oxacillin and cotrimoxazole)
  • Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John’s wort (Hypericum perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore be reduced.
  • Aminoglutethimide has been reported to decrease plasma levels of some progestogens.
  • Concurrent administration of cyclosporin and norethisterone has been reported to lead to increased plasma cyclosporin levels and/or decreased plasma norethisterone levels.
  • When used in combination with cytotoxic drugs, it is possible that progestogens may reduce the haematological toxicity of chemotherapy.
  • Special care should be taken when progestogens are administered with other drugs which also cause fluid retention, such as NSAIDs and vasodilators.

 

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