Primolut n Bayer medication for hemorrhage due to dysfunction, amenorrhea (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Norethisterone

Ingredient

Composition information	Content
Norethisterone	5mg

Uses

Indications

Treatment of hemorrhage due to dysfunction, amenorrhea and secondary menstrual dysfunction, premenstrate syndrome, cyclical mammary gland, menstruation, endometriosis.

Pharmacokology

Norethisteron is a powerful progestogen. The complete change of endometrium from the proliferation to the period of excretion can be achieved in estrogen-powered women with oral doses of oral norethisteron is 100-150 mg per cycle. The progestogen effects of norethisteron in the endometrium are the basic effects of the treatment of primolut-n for menstrual disorders, amenorrhea and secondary menstruation, endometriosis.

The inhibition of gonadotropine hormone secretion and ovulation inhibitor can also be achieved when using 0.5 mg of daily norethisteron. The positive effect of primolut-n in the treatment of premenstrual symptoms can be seen in the prevention of the ovarian function.

Based on the stable effects of norethisteron in endometrium. Primolut-n can be used as a change of menstruation.

Like progesterone, Norethisteron can generate heat and change the body's body temperature.

pharmacokinetics

absorption:

Norethisteron used by oral is absorbed quickly and completely. The peak concentration in the serum is about 16 ng/mL reached for about 1.5 hours after taking 1 primolut-n tablet. Due to the obvious initial metabolism, the bioavailability of Norethisteron after a dose of about 64%.

Distribution:

Norethisteron is associated with albumin in plasma and globulin associated with sex hormones (SHBG). Only about 3-4% of the total number of drug concentrations in plasma are not containing steroids. Only about 35% associated with SHBG and 61% associated with albumin. The distribution of Norethisteron is 4.4 ± 1.3 l/kg. After taking the oral dose, the time and concentration of the drug in plasma are divided in two stages. The half-life of two corresponding stages is 1-2 and 5-13 hours.

Norethisteron is metabolized into breast milk and the concentration of drugs in breast milk is about 10% compared to serum concentration in women who have just given birth no matter what sugar use. Based on the highest drug concentration in women who give birth is about 16 ng/ml and with the amount of milk produced about 600 ml/day, the highest concentration of the drug is about 1 μg (0.02% of the dose for women who give birth) can affect babies.

Metabolism:

Norethisteron is metabolized mainly through the double bridge saturated process of the A ring and reducing the 3-keto group into a hydroxyl group by combining the root of sulfate and glucuronid. Some of these metabolites are eliminated quite slowly from plasma, with a selling time of about 67 hours. Therefore, when long -term treatment with norethisteron daily orally, these metabolites are accumulated in plasma.

In humans, Norethisteron is partially converted into ethinylelestradiol after the dose of norethisteron or Norethisteron acetate with a dose equivalent to about 4-6 μg of ethinylingiol every 1 mg of Norethisteron/Norethisteron acetate.

Era:

Norethisteron is not excreted in a constant form in a large range. Round A mainly decreased and metabolized hydroxyl as well as its associations (glucuronides and sulfates) were excreted through urine and part at a ratio of about 7: 3. The amount of excretion over the kidney is eliminated in the range of 24 hours with the sale time of about 19h.

Before taking Primolut n Bayer medication for hemorrhage due to dysfunction, amenorrhea (2 blisters x 15 tablets)

How to use

should swallow the pill with a little water. The effect of primolut-n 5mg may be reduced if the user does not take the medicine as directed.

Dosage

Hemorrhage due to dysfunction:

Take 5 mg/time, 3 times/day for 10 days. The majority of cases within 1-3 days will stop cervical bleeding not due to physical damage, but to ensure successful treatment, should take primolut-n for 10 days. About 2-4 days after the end of the treatment process, the phenomenon of hemorrhage due to the drug will occur like normal menstrual periods, in terms of level and time.

Mild bleeding phenomenon during medication:

In some cases, mild bleeding may occur after the end of the first bleeding cycle. In such cases, you should not stop or stop taking the medicine.

Prolonged bleeding, serious bleeding:

If you still take the medication evenly without hemorrhage, it may be due to the cause of physical injuries or non -genital factors (such as polyps, carcinoma in the high position of the cervix or endometrium, fibroids, abortion, ectopic pregnancy, or coagulation disorders). At that time, there should be other measures. This also applies to the case of the first bleeding, the hemorrhage occurs quite seriously while taking the medicine.

Preventing hemorrhage recurrence:

To prevent recurrent hemorrhage due to dysfunction, should be taken with Primolut-N. The dose of 5 mg/time x 1-2 times/day, from the 16th to the 25th day of the cycle (the first day of the cycle is the first day of the last bleeding). After taking the last tablet a few days later, there will be bleeding due to the stop.

amenorrhea and secondary menstruation:

Only conduct hormone treatment for secondary amenorrhea cases when eliminated pregnancy. Before starting to treat amenorrhea and secondary menstrual periods, the presence of the prolactin tumor should be eliminated. It is not possible to rule out the possibility of increasing the size of the general gland when using high doses of estrogen for a long time.

It is necessary to supplement estrogen to the uterus (for example: 14 days) before starting treatment with primolut-n. Then take 5 mg/time x 1-2 times/day for 10 days. Menstrual bleeding may appear in a few days after taking the last tablet.

When sure the patient has produced endogenous estrogen, it is advisable to stop treating with estrogen to create menstrual bleeding by taking 5 mg/time x 2 times/day from 16 to 25 of the cycle.

Pre -menstrual syndrome, mammary gland disease:

Can remove premenstrual symptoms such as headache, depression, water retention, breast tension, by taking 5 mg/time x 1-3 times/day

Sutta:

can delay the phenomenon of monthly menstrual bleeding by using Primolut-N. However, using this method only for women who are not at risk of pregnancy during treatment.

Take 5 mg/time x 2-3 times/day for no more than 10-14 days, starting 3 days before the expected menstruation. Bleeding will occur after a 2-3 days of stopping.

Endometriosis:

Start treatment on the first day until the 5th day of the cycle with 5 mg/time x 2 times/day then increase to 10 mg/time x 2 times/day if there is a little bleeding. When stopping bleeding, the initial dose can be reused.

Minimum treatment time 4-6 months. During treatment, no ovulation and menstruation. After stopping hormone treatment, there will be bleeding due to drug discontinuation.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

What to do when you forget 1 dose?

If to ensure contraceptive purposes, other contraception should be used without hormones (type of barrier).

Side Effects

When using primolut-n, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: headache;

Digestive system: Nausea;

Reproduction system and mammary gland: Uterine/vaginal bleeding abnormally including dotted bleeding, menstruation, amenorrhea;

general disorder: edema.

Uncommon, 1/1000

Nervous system: Migrain migraine.

Rare, ADR

The immune system: Hypersensitivity reaction;

eyes: visual disorders;

Respiratory system, chest and mediastinum: shortness of breath;

Skin and subcutaneous tissue: Rashes, rash.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

contraindicated

Pregnant or suspected pregnancy.

Women who are breastfeeding.

Venous thrombosis is progressing. History or currently there are thrombosis/artery or veins (such as deep veins, pulmonary embolism, myocardial infarction) or stroke.

There is or in a history of artery or cardiovascular disease (for example, myocardial infarction, a stroke, myocardial anemia). Pre -history or current signs of thrombosis (such as fleeting ischemia, angina).

High risk of arterial thrombosis or veins.

History of migraine with local nerve signs.

Diabetes is related to cardiovascular diseases.

History or suffering from serious liver diseases as well as the parameters of the liver's functional evaluation have not returned to normal.

Pre -history or currently suffering from liver tumors (benign or malignant).

There are or suspected tumors depending on the sex hormones.

Hypersensitivity to any ingredients of the drug.

Be cautious when using

circulatory disorders:

Studies on epidemiology have shown that the use of oral estrogen/ progestogen contains ovulation inhibitors associated with increasing risks of thrombotic disease. Therefore, caution should be cautious in patients with a history of this disease.

The risk of venous thrombosis (VTE) includes a personal or family history (siblings or parents from an early age who has been infected with VTE), age, obesity, prolonged immobility, serious surgery or traumatic surgery.

also need to consider the risk of increased thrombosis in the reproductive age.

It is necessary to immediately stop treatment if there are symptoms or suspected signs of artery or veins.

Tumor:

Rarely occurs benign and extremely rare liver tumors in case of malignant liver tumor for hormones like primolut-n. These tumors can be life -threatening due to bleeding inside the abdominal cavity, which should be considered the risk of liver tumor by distinguished diagnostic diagnosis in the case of severe upper abdominal pain, enlargement of the liver or showing signs of bleeding inside the abdominal cavity.

Other conditions:

Be cautious when using drugs with women with diabetes, depression.

Skin melasma can also appear, especially for women with a history of melasma during pregnancy, so stay away from the sun or ultraviolet rays during the use of primolut-n.

Patients with a history of depression must be carefully monitored and stopped immediately if there is a more serious depression.

Medical examination:

It is necessary to fully ask the patient's disease history and conduct gynecological examination before starting treatment or before reuse Primolut-N. Periodically follow the instructions in the contraindication and caution, need to be reminded during the use of this drug. The frequency and properties of this examination need to be based on practical experiences and apply to each specific case, but it must include cervical examination, cervical cytotoxic, abdominal exam, breast and blood pressure.

The reason for stopping the medication immediately:

Migraine occurred for the first time or severe headache or abnormalities, sudden sensory disorders (visual or hearing disorders), the first symptom of thrombosis or symptoms of thrombosis (pain or abnormal swelling, unknown pain when breathing or coughing), pain and chest tightness, in the past 6 weeks) Skin, onset of non -jaundice hepatitis, body itching, blood pressure increased significantly, pregnant.

Other warnings based on partial conversion of Norethisteron into ethinyestradiol

Due to the partial metabolism of Norethisteron into EthinyleLestradiol, the treatment with primolut-n needs to be considered more:

circulatory disorders:

The highest risk of venous thrombosis (VTE) in the first year of use. This rising risk usually appears when starting to use combined contraceptives (COCs) or starting again (after 4 weeks or long medication breaks) of the same type or different types of COCS. VTE may be life-threatening or fatal (1-2%). VTE has manifestations such as deep vein thrombosis (DVT), pulmonary obstruction, all can occur during the use of all COCS.

Symptoms of deep vein thrombosis (DVT) may include: swelling on one leg or along the leg vein, pain or damage can only be felt when standing up or walking, increasing the heat in the legs, red -legged or discolored skin.

Symptoms of pulmonary obstruction (PE) include: Suddenly breathing or breathing rapidly for unknown causes, suddenly coughing up blood, chest pain may increase when deep breathing, anxiety, dizziness, fast or abnormal heartbeat, some symptoms such as cough, shortness of breath are unclear and misunderstand as other low -severe cases such as respiratory infections.

Aortic embolism may include: cerebrovascular lesions, embolism or myocardial infarction (Mi). Symptoms of brain vascular lesions may include: Suddenly numb or weak on the face, arms, legs, especially on one side of the body. Suddenly confused, difficult to say and difficult to understand. Suddenly, partially or completely vision, but. Suddenly difficulty walking, imbalance or coordination, suddenly severe headache or unexplained cause, loss of consciousness or fainting when there is or no epilepsy. Other signs of obstruction may include: pain, swelling, mild blue changes at the head of the limb, acute abdominal pain.

Symptoms of myocardial infarction may include: pain, discomfort, severe, pressure, feeling of pressing or heavy chest, arms and under the breastbone, uncomfortable in the back, jaw, throat, arms, stomach; Flushing, indigestion, breathing feeling, sweating, nausea, vomiting, dizziness, weakness, anxiety, shortness of breath, heart beating fast or irregular.

Cases of artery embolism may threaten life or death.

This risk may increase if the risk factors are listed below. Do not prescribe a COCS if the benefits and risks are not favorable. Risk factors for cases of arterial thrombosis, veins, stroke are:

Age;

Obesity (BMI> 30 kg/m2);

Family history (such as arterial thrombosis, veins in siblings, parents of relatively young age);

Long -term motionless, major surgery, any surgery in the leg, or major lesions. In these cases, the medication should be stopped (if the program surgery, it is advisable to stop the drug 4 weeks) and do not use it again until 2 weeks after fully recovery;

Smoking (the heavier the smoking addiction and the higher the risk, the higher the risk, especially women over 35 years old);

Lipoprotein disorders;

Hypertension;

migraine;

Cardiac disease;

atrial fibrillation.

Other cases of pathology accompanied by an adverse circulatory complications include: diabetes, systemic erythema lupus, hemolytic hyperur syndrome, chronic bowelitis (Crohn's disease or colon ulcer) and sickle cell disease.

Increase the frequency and severity of migraines during the use of COCS (maybe the symptoms of a stroke) should stop the drug.

Note that the risk of thrombosis associated with pregnancy is higher than the risk of low -dose COCS thrombosis ( Tumor:

The most important risk factor for cervical cancer is prolonged HPV infection. Long -term use can contribute to this risk.

The risk gradually disappears over 10 years after stopping using COCS.

Other conditions:

Taking COCS can cause mild hypertension.

The disease may occur or worsened for pregnant people and COCS users are jaundice, itching is related to bile obstruction, gallstones, porphyrin metabolic disorders, systemic erythema lupus, hemolytic hyperur syndrome due to hemolytic dance, Sydenham dance, herpes genital, hearing loss due to fibrous fibrosis.

Patients with genetic angioedema, external estrogen can cause or worsen angioedema symptoms.

Acute or chronic liver dysfunctions must stop using COCS until the liver function returns to normal. The jaundice occurred for the first 3 months of pregnancy or during the use of sex steroids that had to stop using COCS.

Crohn's disease and ulcerative colitis are related to COCS.

The ability to drive and operate machinery

does not affect.

pregnancy

Do not use primolut-n during pregnancy.

Breastfeeding period

Do not use primolut-n during breastfeeding.

Drug interaction

drug interactions can increase the clearance of sex hormones and lead to reduced treatment effect. Long -term treatment with liver fermentation effects (including Phenytoin, Barbiturates, Primidon, Carbamazepin, Rifampicin, Oxcarbazepine, St. Johns World and Rifabutin); Griseofulvin also belongs to the suspected group.

Progestogens may interact with the metabolites of some other drugs. Therefore, the concentration of the drug in serum and in tissues can also be affected (for example cyclosporin).

The use of progestogen may affect the results of tests, including the biochemical indicators of the liver, thyroid, adrenal glands and renal function, the content of proteins (transportation) in plasma such as globulin associated with corticosteroids and lipid/ lipoprotein components, carbohydrate metabolism indicators, blood coagulation index.

Storage

Store at temperatures below 30 ° C.

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