Primolut N (Generic Norethisterone Tablets)

Primolut N (Generic Norethisterone Tablets)
© The Swiss Pharmacy

Primolut N (Generic Norethisterone Tablets) can be used in
several different circumstances to treat irregular, painful or
heavy periods, Dysfuntional uterine bleeding, Polymenorrhoea,
Menorrhagia, Metropathia, Haemorrhagia, to treat
endometriosis (where tissue from the lining of the womb is
present in places where it is not normally found), to treat
premenstrual syndrome (also known as premenstrual tension,
PMS or PMT) and to delay periods.
At high dose Primolut N tablets are used to treat disseminated
carcinoma of the breast.

Primolut N Tablets are manufactured
by Zydus Cadila Healthcare Limited,
India in the strength of 5 mg.

Chemical Structure

The active ingredient contained in Primolut N
tablets is Norethisterone.
Each Primolut N tablet contains 5 mg of
Norethisterone.

Uses of Primolut N 5mg Tablets:
Primolut N (Generic Norethisterone Tablets) is usedfor the treatment of
secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to
hormonal imbalance in theabsence of organic pathology, such as submucous
fibroids or uterine cancer.
Norethisterone mimics the effects of your natural progesterone and so can help
regulate the healthy growth and normal shedding of the womb lining. It may be
used in the treatment of menstrual disorders such as irregular or painful
menstrual periods, premenstrual syndrome and endometriosis. It may also be
used to delay the onset of menstruation for special circumstances, such as if
travelling or taking part in a sporting event.
Norethindrone acetate is not intended, recommended or approved to be used with
concomitant estrogen therapy in postmenopausal women for endometrial
protection.

Recommended Adult Dosage
The dose of Primolut N (Generic Norethisterone Tablets) for
various indications is given below:
Metropathia Haemorrhagica (Dysfunctional Uterine Bleeding): 1
tablet 3 times daily for 10 days. Bleeding is arrested usually within 1 to 3
days. A withdrawal bleeding resembling normal menstruation occurs
within 2 to 4 days after discontinuing treatment. One tablet twice daily
from the 19th to the 26th day of the two subsequent cycles should be
given to prevent recurrence of the condition.
To ensure treatment success, Primolut N must be taken for the full 10
days. Occasionally, slight bleeding may occur after the initial suspension
of bleeding.

Premenstrual Syndrome (Including Premenstrual Mastalgia): Premenstrual
symptoms such as headache, migraine, breast discomfort, water retention,
tachycardia, and psychological disturbances may be relieved by the administration
of 1 to 3 tablets daily from the 19th to the 26th day of the cycle. Treatment should
be repeated for several cycles. When treatment is stopped, the patient may remain
symptom-free for a number of months.
Postponement Of Menstruation: In cases of too frequent menstrual bleeding, and
in special circumstances (e.g. operations, travel, sports) the postponement of
menstruation is possible. The dosage is 1 tablet of Primolut N three times daily,
starting 3 days before the expected onset of menstruation and continuing for not
longer than 10 to 14 days. A normal period should occur 2 to 3 days after the
patient has stopped taking tablets. This method should be restricted to users who
are not at risk of pregnancy during the treatment cycle.

Endometriosis (Pseudo-Pregnancy Therapy): Treatment should
begin between the first and 5th day of the cycle with 1 of tablet
Primolut N twice daily. In the event of spotting, the dose can be
increased to 2 tablets twice daily. If bleeding ceases, dose reduction
to the initial dose should be considered. Treatment is to be
continued for at least 4 to 6 months. With uninterrupted daily
intake, ovulation and menstruation do not usually occur.
Menorrhagia (Hypermenorrhoea): 1 tablet 2 to 3 times a day from
the 19th to the 26th day of the cycle (counting the first day of
menstruation as day 1).

Dysmenorrhoea: Functional or primary dysmenorrhoea is
almost invariably relieved by the suppression of ovulation.
1 tablet three times daily for 20 days, starting on the fifth
day of the cycle (the first day of menstruation counting as
day 1).
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.

Contraindications
➔
Primolut N is contraindicated in patients with a known hypersensitivity to
Norethisterone or any component of the tablet.
➔
Lactation
➔
Presence or a history of venous or arterial thrombotic/thromboembolic
events (e.g. deep venous thrombosis, pulmonary embolism, myocardial
infarction) or of a cerebrovascular accident
➔
Presence or a history of prodromi of a thrombosis (e.g. transient ischaemic
attack, angina pectoris)
➔
A high risk of venous or arterial thrombosis
➔
History of migraine with focal neurological symptoms

Contraindications
➔
Diabetes mellitus with vascular involvement
➔
Presence or history of severe hepatic disease as long as liver function
values have not returned to normal
➔
Presence or history of liver tumours (benign or malignant)
➔
Known or suspected sex hormone-dependent malignancies
➔
Hypersensitivity to the active substances or to any of the excipients.
➔
Dubin-Johnson syndrome

Contraindications
➔
Rotor syndrome
➔
Missed abortion
➔
Undiagnosed vaginal or urinary bleeding
➔
Undiagnosed breast pathology
➔
Undiagnosed genital bleeding
➔
Untreated endometrial hyperplasia.
➔
History during pregnancy of idiopathic jaundice or severe pruritus.

Storage Instructions
Primolut N (Generic Norethisterone Tablets) have to be
stored at controlled room temperature i.e. from 20°C to
25°C (68°F to 77°F) with excursions permitted between
15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
A complete personal and family medical history should be taken for each
woman. Physical examination should be guided by this and by the
contraindications and warnings for Primolut N (Generic Norethisterone
Tablets).
Therapy should be discontinued immediately if the following occur: New onset
of migraine-type headaches or more frequent occurrence of unusually severe
headaches, Sudden perceptual disorders (e.g. disturbances of vision or hearing),
First signs of thrombophlebitis or thromboembolic symptoms, feeling of pain and
tightness in the chest, Pending operations (six weeks beforehand),
immobilisation (e.g. after accidents), Onset of jaundice or deterioration in liver
function, anicteric hepatitis, general pruritus, Significant increase in blood
pressure and Pregnancy.

Warnings
Circulatory disorders: It has been concluded from epidemiological surveys
that the use of oral Oestrogen / Progestogen containing ovulation inhibitors is
associated by an increased incidence of thromboembolic diseases. Therefore,
one should keep the possibility of an increased thromboembolic risk in mind,
particularly where there is a history of thromboembolic diseases. A patient
who develops symptoms suggestive of thromboembolic complications should
stop treatment immediately. The need for treatment should be reassessed
before continuing therapy.
Known Hyperlipidaemias: Women with hypertriglyceridemia, or a family
history thereof, may be at increased risk of pancreatitis when using COCs.
Women with hyperlipiaedmia are at increased risk of arterial disease.
However, routine screening of women on COCs is not appropriate.

Warnings
Tumours: In rare cases, benign liver tumours, and even more rarely, malignant
liver tumours have been reported in users of hormonal substances such as the one
contained in Primolut N. In isolated cases, these tumours have led to life-
threatening intra-abdominal haemorrhages. If severe upper abdominal
complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a
liver tumour should be included in the differential diagnosis and, if necessary, the
medicine must be stopped.
Primolut-N can influence carbohydrate metabolism. Parameters of carbohydrate
metabolism should be examined carefully in all diabetics before and regularly
during treatment.
Chloasma may occasionally occur, especially in women with a history of chloasma
gravidarum. Women with a tendency to chloasma should minimise exposure to
the sun or ultraviolet radiation when taking Primolut N.

Warnings
Patients who have a history of depression should be carefully
observed and the drug discontinued if the depression recurs to a
serious degree.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should
not take this medicine.
Any patient who develops an acute impairment of vision, proptosis,
diplopia or migraine headache should be carefully evaluated
ophthalmologically to exclude papilloedema or retinal lesions
before continuing medication.

Warnings
Progestogens may cause fluid retention. Special care should be taken when
prescribing Norethisterone in patients with conditions which might be
aggravated by this factor. These conditions include Epilepsy,Migraine, Asthma,
Cardiac dysfunction and Renal dysfunction.
If menstrual bleeding should fail to follow a course of Primolut N, or if the
patient wishes to postpone menstruation in special circumstances, the possibility
of pregnancy must be excluded before a further course is given.
Due to the partial conversion of Norethisterone to Ethinylestradiol,
administration of Primolut N is expected to result insimilar pharmacological
effects as seen with COCs.

Possible Side Effects
Side effects are more common during the first months after start of intake
of Primolut preparations, and subside with duration of treatment. The
frequencies are based on reporting rates from postmarketing experience
and literature.
Very common: Uterine/ Vaginal bleeding including Spotting,
Hypomenorrhoea
Common: Headache, Nausea, Amenorrhoea, Oedema
Uncommon: Migraine
Rare: Hypersensitivity reactions, Urticaria, Rash,
Very rare: Visual disturbances, Dyspnoea
Frequency (not known): Dizziness, Depression aggravated, Abdominal
pain, Cholestasis, Jaundice.

Possible Side Effects
The following events listed in order of seriousness rather than frequency of occurrence,
have been associated with the use of progestogens:
Hypersensitivity: Anaphylaxis and anaphylactoid-like reactions.
Thromboembolic disease: Thrombophlebitis and pulmonary embolism.
Central nervous system: Nervousness, insomnia, somnolence, fatigue, depression,
dizziness and tremor. Some patients may complain of pre-menstrual type depression.
Dermatological: Urticaria, pruritus, rash, acne, hirsutism, alopecia and sweating.
Genitourinary: Irregular uterine bleeding, spotting and amenorrhoea
Breast: Tenderness and galactorrhoea
Cervix: Changes in excretions and secretions.
Other: Hyperpyrexia, Cushing’s syndrome, weight gain. Moderate elevation of blood
pressure, transient elevation of alkaline phosphatase and/or serum transaminase
activities, elevations of serum calcium and potassium levels, and increases in white cell and
platelet counts

Primolut N Tablets Overdosage
Overdosage may be manifested by nausea, vomiting,
breast enlargement and later vaginal bleeding. There is
no specific antidote and treatment should be
symptomatic.
Gastric lavage may be employed if the overdosage is
large and the patient is seen sufficiently early (within
four hours).

Primolut N Tablets During Pregnancy
Primolut N (Generic Norethisterone Tablets) has been classified by
the US FDA as Pregnancy Category X.
Norethisterone (Primolut N) is contraindicated during pregnancy
as it may cause fetal harm when administered to pregnant women.
Several reports suggest an association between intrauterine
exposure to progestational drugs in the first trimester of pregnancy
and congenital abnormalities in male and female fetuses.
Studies on reproduction toxicology performed with Norethisterone
Acetate as well as Norethisterone Enantate led to signs of
masculinisation in female fetuses when administered in high doses
at the time of the development of the external genitalia.

Primolut N Tablets During Pregnancy
Since epidemiological studies show that this effect is relevant for
humans after high dosages, it is to be stated that Primolut N may
provoke signs of virilisation in female fetuses if administered
during the hormone-sensitive stage of somatic sexual
differentiation (day 45 of pregnancy onwards).
Apart from this, no indications of teratogenic effects were obtained
from the studies.
During animal studies, maternal administration of high doses of
synthetic oestrogens produced urogenital malformations in the
offspring.

Primolut N Tablets are manufactured by Zydus
Cadila Healthcare Limited, India.
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Primolut N (Generic Norethisterone Tablets)

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