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Primolut-n

Primolut-n contains norethisterone, a progestogen classified within the endocrine therapy and endocrine-metabolic agent category, and is registered in 14 countries. The brand sits in a mid-range international footprint, familiar in parts of Western Europe, the Nordics, South and Southeast Asia, and the Southern Hemisphere, but absent from a number of major markets where norethisterone circulates under different brand names instead.

The medication is prescribed across a relatively broad set of gynaecological indications, including dysmenorrhea, premenstrual syndrome, endometriosis, uterine fibroids, endometrial hyperplasia, abnormal uterine bleeding, and certain hormone-responsive cancers including uterine cancer. The structured indication list further down this page sets out, in detail, the registered uses recognised by regulators in each market where Primolut-n is sold.

Markets where Primolut-n is registered include the United Kingdom, Australia, India, Norway, South Africa, and Vietnam, among others. A traveller or expatriate moving between these countries will usually find the brand familiar, but someone relocating to a market outside this list — much of continental Europe outside the Nordics, most of the Americas — is more likely to encounter norethisterone under a different brand name, or as a component of a combined hormonal preparation. A local pharmacist is generally the right person to translate between brand names in this situation.

Other medications in the broader endocrine therapy class are sold internationally under various molecules and brand names, with meaningfully different clinical positioning between them. Hormonal therapy is highly individual, and any decision about initiating, continuing, or substituting Primolut-n belongs in a conversation with a healthcare provider who knows the patient's history.

Countries
Australia Finland Iceland India Ireland Netherlands New Zealand Norway Philippines South Africa Thailand Turkey United Kingdom Vietnam
Diseases
Cancer Dysmenorrhea Premenstrual syndrome Endometriosis Uterine fibroids Endometrial hyperplasia Cancer,uterine Abnormal uterine bleeding Uterine bleeding
Ingredients
Norethisteron
Drug Actions
Endocrine therapy Endocrine-metabolic agent

Drugs with the same active ingredients

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Overdose

No information provided.

Contraindications

  • Known or suspected pregnancy. There is no indication for AYGESTIN in pregnancy. (See PRECAUTIONS.)
  • Undiagnosed vaginal bleeding Known, suspected or history of cancer of the breast
  • Active deep vein thrombosis, pulmonary embolism or history of these conditions
  • Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
  • Impaired liver function or liver disease
  • As a diagnostic test for pregnancy
  • Hypersensitivity to any of the drug components

Undesirable effects

See WARNINGS and PRECAUTIONS.

The following adverse reactions have been observed in women taking progestins:

  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Edema
  • Changes in weight (decreases, increases)
  • Changes in the cervical squamo-columnar junction and cervical secretions
  • Cholestatic jaundice
  • Rash (allergic) with and without pruritus
  • Melasma or chloasma
  • Clinical depression
  • Acne
  • Breast enlargement/tenderness
  • Headache/migraine
  • Urticaria
  • Abnormalities of liver tests (i.e., AST, ALT, Bilirubin)
  • Decreased HDL cholesterol and increased LDL/HDL ratio
  • Mood swings
  • Nausea
  • Insomnia
  • Anaphylactic/anaphylactoid reactions
  • Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism)
  • Optic neuritis (which may lead to partial or complete loss of vision)

Therapeutic indications

AYGESTIN (norethindrone acetate tablets USP) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. AYGESTIN (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopaus al women for endometrial protection.

Pharmacokinetic properties

Absorption

Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate is rapidly absorbed from AYGESTIN tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of AYGESTIN in 29 healthy female volunteers are summarized in Table 1.

Table 1: Pharmacokinetic Parameters after a Single Dose of AYGESTIN® in Healthy Women

  AYGESTIN®
(n = 29)
Arithmetic Mean ± SD
Norethindrone (NET)
AUC (0-inf)(ng/ml*h) 166.90 ± 56.28
Cmax (ng/ml) 26.19 ± 6.19
tmax (h) 1.83 ± 0.58
t½ (h) 8.51 ± 2.19
AUC = area under the curve,
Cmax = maximum plasma concentration,
tmax = time at maximum plasma concentration,
t½ = half-life,
SD = standard deviation

Figure 1: Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions

Effect Of Food

The effect of food administration on the pharmacokinetics of AYGESTIN has not been studied.

Distribution

Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is about 4 L/kg.

Metabolism

Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

Excretion

Plasma clearance value for norethindrone is approximately 0.4 L/hr/kg. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following a single dose administration of AYGESTIN is approximately 9 hours.

Name of the medicinal product

Primolut-N

Qualitative and quantitative composition

Norethisteron

Special warnings and precautions for use

WARNINGS Cardiovascular Disorders

Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

Visual Abnormalities

Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

PRECAUTIONS General
  • Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, require careful observation.
  • In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.
  • Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
  • Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism. The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy.
  • The pathologist should be advised of progestin therapy when relevant specimens are submitted.
Information For The Patient

Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe AYGESTIN.

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established.

Pregnancy Category X

Norethindrone acetate 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. Some progestational drugs induce mild virilization of the external genitalia of female fetuses.

Nursing Mothers

Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman.

Pediatric Use

AYGESTIN tablets are not indicated in children.

Dosage (Posology) and method of administration

Therapy with AYGESTIN must be adapted to the specific indications and therapeutic response of the individual patient.

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology

2.5 to 10 mg AYGESTIN may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing AYGESTIN therapy. Patients with a past history of recurrent episodes of abnormal uterine bleedingmay benefit from planned menstrual cycling with AYGESTIN.

Endometriosis

Initial daily dosage of 5 mg AYGESTIN for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of AYGESTIN is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

Frequently asked questions

What conditions does Primolut-n treat?

Primolut-n is prescribed across a range of gynaecological indications, including dysmenorrhea, premenstrual syndrome, endometriosis, uterine fibroids, endometrial hyperplasia, abnormal uterine bleeding, and certain hormone-responsive cancers including uterine cancer. As an endocrine therapy, it acts on hormonal pathways relevant to the female reproductive system. The structured indication block further down this page lists the registered uses recognised in each market where the brand is sold.

What is the active ingredient in Primolut-n?

Primolut-n contains norethisterone, a progestogen classified within the endocrine therapy and endocrine-metabolic agent category. Norethisterone is a long-established molecule that circulates internationally under several different brand names, and is also incorporated into a range of combined hormonal preparations. The same active ingredient may therefore appear on a pharmacy shelf abroad under packaging quite different from Primolut-n.

In how many countries is Primolut-n available?

Primolut-n is registered in 14 countries spread across several regions, including the United Kingdom, Australia, India, South Africa, Thailand, Norway, and Vietnam. The footprint mixes Western Europe, the Nordics, parts of Asia, and the Southern Hemisphere, but leaves many large markets uncovered. If your country is not represented in the list, a local pharmacist can confirm whether norethisterone is sold there under another brand name.

Are there other medications with the same active ingredient as Primolut-n?

Norethisterone is sold under several brand names worldwide, both as a single-ingredient progestogen and as a component of combined hormonal products. Other medications within the broader endocrine therapy class also exist, although they are not interchangeable without medical guidance — molecules in this category differ meaningfully in their clinical positioning. To identify a local norethisterone-containing product, search the active ingredient on Pill2Trip or speak with a pharmacist.

Should I consult a doctor before taking Primolut-n?

Yes. Primolut-n is a prescription medication, and hormonal therapy is calibrated to a patient's individual gynaecological history, concurrent medications, and personal circumstances. Prescription rules, available brand names, and even the specific indications recognised by regulators vary considerably between countries, which matters particularly for travellers and people relocating. Any decision to start, stop, switch, or substitute norethisterone should be made with a healthcare provider familiar with the patient.

Primolut-n

Available in 14 countries