Nemestran (Nemestran)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceGestrinoneGestrinone
Similar drugsTo uncover
  • Nemestran
    capsules inwards 
    Aventis Pharma Co., Ltd.     India
    • Dosage form: & nbspcapsules
    Composition:

    One capsule contains:

    active substance: gestrinone 2.5 mg;

    Excipients: corn starch, lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, talc.

    The capsule shell consists of titanium dioxide and gelatin.

    Description:

    Opaque hard gelatin capsules # 4, consisting of a body and a lid of white color. On both halves of the capsule is the logo of the company Roussel. The capsule contains a yellowish powder.

    Pharmacotherapeutic group:gestagen
    ATX: & nbsp

    G.03.X.A.02   Gestrinone

    Pharmacodynamics:

    Synthetic steroid hormone, which is a derivative of 19-nortestosterone. Depending on the model tested, it exhibits both antiprogestin and progestin activity. Has antigonadotropic, antiestrogenic and weak androgenic effect.

    Gestrinone has an inhibitory effect on endometrial tissue. It is believed that its action is associated with a direct suppression of the mechanism of synthesis and release of pituitary gonadotropins and with a direct antagonistic effect on endometrial tissue.

    Pharmacokinetics:

    After taking 2.5 mg gestrinone, the maximum concentration of the drug in the blood is 19 mol / ml and is achieved on average after 2 hours.

    The half-life of the drug from the plasma is approximately 27 hours.

    The volume of distribution is 67 liters (with iv introduction in men).

    Metabolism is carried out in the liver through hydroxylation, leading to the formation of 3 basic conjugated metabolites. It is excreted on 40-45% by kidneys (1% - in the form of a free steroid) and by 30-35% with feces.

    Indications:Endometriosis.
    Contraindications:

    - BVariability;

    - lactation period;

    - acute heart failure;

    - renal or hepatic insufficiency;

    - metabolic disorders and / or history of thrombophlebitis when treated with preparations containing estrogens and / or progestogens;

    - hypersensitivity to any component of the drug Nemestran.

    Carefully:Migraine.
    Pregnancy and lactation:

    Nemestran is absolutely contraindicated in pregnancy and during lactation. If pregnancy is detected, taking the drug should be interrupted, as it has been shown in animal experiments that the drug has an embryotoxic effect, although at doses significantly exceeding the doses used in clinical practice.

    Dosing and Administration:

    For use inside.

    The first dose (2.5 mg) is taken on the first day of the menstrual cycle after receiving negative pregnancy test results. The second dose should be taken on the fourth day.The usual scheme of admission - 2 times a week, strictly on the same days. The number of capsules can be increased to three per week, especially with uterine bleeding during the intermenstrual period. The duration of treatment is 6 months without interruption.

    If you missed taking one dose, the capsule should be taken the next day, keeping in the future the usual weekly schedule of taking the drug. If two or more doses of Nemestran are omitted, the treatment should be discontinued and resumed on the first day of the next menstrual cycle according to the usual schedule.

    Side effects:

    The occurrence of uterine bleeding at the beginning of therapy, especially if the first dose did not coincide with the first day of the menstrual cycle.

    Acne, seborrhea, fluid retention, hirsutism, hair loss, voice change, reduction of breast size.

    Changes in libido, weight gain, "hot flashes", headache, increased nervous excitability, depression, dyspepsia, hyperpigmentation of the skin, increased activity of "liver" transaminases, arthralgia, convulsions.

    Rarely - benign intracranial hypertension.

    Overdose:

    No information is available.

    In cases of taking a large amount of the drug, it is necessary to rinse the stomach.

    Interaction:

    Simultaneous administration of antiepileptic drugs or rifampicin can lead to an accelerated metabolism of gestrinone.

    Special instructions:

    Before starting treatment, pregnancy should be excluded.

    In some women, Nemestran in the recommended dose can suppress ovulation, but the possibility of pregnancy during treatment is preserved. This means that Nemestran can not be considered a contraceptive.

    Since the simultaneous administration of hormonal contraceptives can affect the activity of Nemestran, barrier methods of contraception must be used throughout the treatment period.

    Treatment should begin strictly from the first day of the menstrual cycle. To ensure maximum effectiveness, it is necessary to adhere strictly to the treatment regimen.

    In connection with the possible delay of fluid in the treatment of Nemestrian patients with cardiac and renal insufficiency require special observation.

    It is recommended that levels ACT, ALT and lipids in patients with hyperlipidemia, as well as blood sugar in patients with diabetes mellitus.

    Form release / dosage:Capsules, 2.5 mg.
    Packaging:

    For 8 capsules in a blister pack of PVC / aluminum foil.

    1 blister pack together with instructions for use and a "calendars-disk" designed to regulate the frequency of taking the drug are placed in a cardboard box.

    Storage conditions:In a place protected from light and inaccessible to children, at a temperature of no higher than 25 ° C.
    Shelf life:

    3 years.

    After the expiration date, the drug should not be used.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016291 / 01
    Date of registration:24.03.2010
    The owner of the registration certificate:Aventis Pharma Co., Ltd.Aventis Pharma Co., Ltd. India
    Manufacturer: & nbsp
    PATHEON UK, Ltd. United Kingdom
    Representation: & nbspAventis Pharma Co., Ltd.Aventis Pharma Co., Ltd.India
    Information update date: & nbsp16.01.2016
    Illustrated instructions
      Instructions
      Up