Primolut n Bayer medication for hemorrhage due to dysfunction, amenorrhea (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Norethisterone

Ingredient

Composition informationContent
Norethisterone5mg

Uses

Indications

Primolut - N drugs are indicated in the following cases:

  • Hemorrhage due to dysfunction, amenorrhea and secondary menstrual dysfunction, premenopause syndrome, cycle mammary gland disease, menstruation, endometriosis. The complete change of endometrium from the proliferation to the period of excretion can be achieved in estrogenic 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, amateur 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 premium symptoms can be seen in the prevention of the ovarian function.

    Based on the stable effects of norethisteron in the endometrium, Primolut - N can be used as a change of menstrual period.

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

    pharmacokinetic

    absorption

    Norethistron used by oral is absorbed quickly and completely. The peak concentration in the serum is about 16 ng/mL achieved for about 1.5 hours after taking 1 tablet of Primolut - N. Due to the obvious initial metabolic effect, the bioavailability of Norethisteron after an oral dose reaches 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 the plasma are not containing steroids, only about 35% are 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% of the 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 drug is about 1 µg (0.02% the dose for women who give birth) can affect infants.

    Metabolism

    Norethisteron is metabolized mainly through the double bridge saturated process of ring A and reducing group 3 - Keto 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 ethinylelestradiol every 1 mg of norethisteron/norethisteron acetate.

    Elimination

    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 fertilizer at a ratio of about 7: 3.

  • Before taking Primolut n Bayer medication for hemorrhage due to dysfunction, amenorrhea (3 blisters x 10 tablets)

    How to use

    Primolut - N drugs are taken orally. Should swallow the whole pill with a little water.

    Dosage

    The effect of Primolut - N can be reduced if the user forgot to take the medication as directed.

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

    Hemorrhage due to functional disorders

    Take one Primolut - N 5 mg. 3 times a day. In 10 days. Most cases within 1-3 days will stop cervical bleeding not due to physical damage, but to ensure successful treatment. 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 stopping bleeding, it may be due to the cause of physical damage or genital factors (for example, 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.

    Watch out for recurrence

    To prevent recurrent hemorrhage due to dysfunction, should take backup with Primolut - N. (1 tablet Primolut - N 5 mg, 1-2 times/day, from the 16th to the 25th day of the cycle (the first day of the cycle = the first day of the last hemorrhage).

    amenorrhea and secondary menstrual period

    Only conduct hormone treatment for secondary amenorrhea cases when eliminated pregnancy. Before the beginning of the treatment of amenorrhea and secondary menstrual periods, the presence of the prolactin secretion 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. Additional estrogen supplements for the uterus (e.g. 14 days) before starting treatment with Primolut - N.

    Then take 1 Primolut - N 1-2 times a day for 10 days. Menstrual bleeding may appear for a few days after taking the last tablet. When sure that the patient has produced endogenous estrogen, should stop treating with estrogen to create menstrual bleeding by taking 1 tablet Primolut-N twice a day from 16 to 25 of the cycle.

    Pre -menstrual syndrome, mammary gland disease

    Can remove premenstrual symptoms such as headache, depression, water retention, feeling of breast tightness, by taking primol - - n tablets 1 to 3 times.

    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.

    Dosage: Take 1 tablet of Primolut - N 5 mg, 2-3 times a day for no more than 10-14 days, starting 3 days before the expected menstrual period. Bleeding will occur after stopping the drug 2-3 days.

    Endometriosis

    Start treatment on the first day until the 5th day of the cycle with Primolut - N twice a day, 1 tablet each time, increase 2 times a day, 2 tablets each time 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 overdose?

    What to do when forgetting a dose?

    Side Effects

    When using Primolut - N, you may experience unwanted effects (ADR).

    Very common, ADR ≥ 1/10)

  • Reproductive disorders and mammary glands: Uterine/vaginal bleeding abnormally including dotted bleeding*, menstruation*.
  • Nervous system disorders: headache.
  • Disorders of the digestive system: nausea.
  • Reproductive and mammary disorders: amenorrhea*.
  • Systemic disorders and on -site use.
  • Not usually 1/1000 ≤ ADR

  • Nervous disorders: Migrain migraine.
  • The immune system disorder: Hypersensitivity reaction.
  • Skin disorders and subcutaneously: Rashes, rashes.
  • Very rare ADR

  • eye disorders: visual disorders.
  • Respiratory system, chest and mediastinum: Difficulty breathing.
  • *: In endometriosis.

    Most Medra terms are used to describe an adverse or synonymous reaction or related conditions.

    Instructions on how to handle ADR

    Notify the doctor with unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Primolut - N drugs in the following cases:

    Do not use Primolut - N In case of any of the following phenomena, this information is listed from products that contain only progestogen and combined contraceptive. It is necessary to stop the drug immediately if any symptoms are listed below in the first use of Primolut - N.

  • 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.

    Precautions when using

    In case of the following conditions or risk factors are listed below, analyzing risk benefits for each individual should be done before starting or continuing to use Primolut - N.

    circulatory disorders

    Studies on epidemiology have shown the use of oral estrogen/progestogen containing ovulation inhibitors associated with increasing risks of thrombotic disease, thus paying attention to the possibility of increased risk of thrombosis, especially for patients with a history of blood vessels.

    In general, it is necessary to identify the risks of venous thrombosis (VTE) including 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.

    tumors

    It has also been noted in some rare cases, benign liver tumors and extremely rare cases of malignant liver tumors for women who use hormones such as hormones contained in primolut - n. Some special cases, these tumors may be life -threatening due to bleeding inside the abdomen, need to consider the risk of tumor in the liver by abdominal pain in severe abdominal pain, enormous signs For women who are using primol - n.

    Other conditions

    Need to closely monitor women with diabetes during treatment.

    Melasma can also appear, especially for women with a history of melasma during pregnancy. Women tend to have melasma should 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 stop taking the drug immediately if there is a more serious sign of depression.

    Medical examination

    It is necessary to fully ask the patient's disease history and conduct gynecological examination before starting or before reuse Primolut - N, periodically follow the instructions in the anti -contraindication and warning section, need to be reminded during the time of using Primolut - N. The frequency and properties of this examination need to be based on practical experience and apply for specific cases of cervical and cervical examination Abdominal examination, 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 (such as visual or hearing disorders), the first symptom of thrombophlebitis or symptoms of thrombotic embolism (such as pain or abnormal leg swelling, unknown pain when breathing or coughing), pain and chest, in the next 6 weeks, in the next 6 weeks) jaundice, hepatitis without jaundice, body itching, blood pressure increased significantly, pregnant.

    Other warnings based on partialization of Norethisteron into Ethinyestradiol

    After taken, Norethisteron is partially converted into ethinylestradiol with a dose equivalent to about 4 - 6 ig ethinylelestradiol every 1 mg of norethisteron/norethisteron acetate oral (see them in "pharmacokinetic properties").

    Due to the partial conversion of Norethisteron into ethinylelestradiol. Primolut treatment must be estimated at the same pharmacological effect as in combined contraceptive pill. Therefore, the common warnings related to the use of the following contraceptive pill should be considered further.

    circulatory disorders

    The risk of venous thrombosis (VTE) is the highest in the first year of use. This increasing risk is present at the beginning of the first use of combined oral contraceptives (COCS) or starting again (after 4 weeks or long -term medication) of the same type or different type or COCS type. Data from a large system study, salvation with 3 branches suggested that this increasing risk mainly appeared in the first 3 months.

    In general, the risk of venous thrombosis (VTE) in COCS user with low doses of estrogen (

    VTE may be life -threatening or fatal (in 1-2% of cases).

    vte, manifested as deep vein thrombosis, pulmonary obstruction may occur during the use of all COCS.

    Very rarely reported in other blood vessels such as liver, hanging, kidneys, veins and retinal arteries or brain. There is no consensus of the view even though the appearance of these cases is related to the use of COCS.

    Symptoms of deep vein thrombosis (DVT) may include:

    Swelling on one side or along the leg veins, pain or damage can only be felt when standing up or walking, increasing the heat in the legs, red -legged skin or discoloration.

    Symptoms of pulmonary embolism (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 can be misunderstood as other less serious cases (such as respiratory infections).

    A arterial embolism may include:

    Brain vessel 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, hands and under the uncomfortable breastbone in the back, jaw, throat, arms, stomach; bloating, indigestion, suffocating 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 be higher than the pure risk of one factor. Do not prescribe a COCS if the benefits and risks are not favorable. (See the "contraindication" section). The risk of arterial embolism, venous/thrombotical embolism of the stroke increases with:

  • Age.
  • Obesity (body mass index of over 30 kg/m2).

    There is a family history (such as arterial thrombosis, veins in siblings, parents at relatively young age). If the genetic tendency is known or suspicious, the woman should be instructed in a specialty for advice before deciding to use COCS.

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

  • Smoking (smoking addiction and the higher the age, the higher the risk, especially women over 35 years old).
  • Lipoprotein disorders.
  • Hypertension.
  • migraine.
  • Cardiac disease.
  • atrial fibrillation.

    There is no unity of viewpoint of varicose veins and agricultural veins due to thrombosis in VTE.

    Other cases of pathology accompanied by an adverse circulatory complications include:

    Diabetes, systemic lupus erythematosus, hyper Urea syndrome due to hemolytic, chronic bowelitis (Crohn's disease or ulcerative colitis) and sickle blood cells.

    Increase the frequency and severity of migraine pain during the use of COCS (maybe millions of stroke) may also be one reason to immediately stop COCS.

    When considering the benefits and risks, doctors should pay attention to the full treatment of the condition that can minimize the risk of thrombosis and also note that the risk of thrombosis associated with pregnancy is higher than the risk of thrombosis associated with low -dose COCs (

    tumor

    The most important risk factor for cervical cancer is prolonged HPV infection. An epidemiological study indicates that the long -term use of COCS may contribute to this risk, but continue to have contradictory opinions about these results due to interference factors such as cervical screening and sexual behavior, including the use of barrier contraception.

    A gross analysis from 54 epidemiological studies reports that there is a slight increase in the relative risk of breast cancer (RR = 1.24) among women currently using COCS. The risk of excess gradually disappears over 10 years after stopping using COCS. Because breast cancer is very rare in women under 40 years old, the number of excessive cancer has been diagnosed in recent people and is using COCs is small compared to the risk of breast cancer in general.

    These studies do not provide evidence of the cause. How to record an increase in the risk of breast cancer may be because COCS users are diagnosed earlier, or due to the biological effects of COCS or combine both. The diagnosis of breast cancer in people who have used COCs tends to progress less clinically than cancer diagnosed on people who have never used COCS.

    Malignant tumors can threaten life or death.

    Other conditions

    Although blood pressure increased slightly, it was reported on women who drink COCs, but rarely saw clinical increases, however, if hypertension is clinically significant during COCS, the doctor should be cautious to stop using COCS and treat hypertension. When appropriate, COCS can be reused if possible to achieve normal blood pressure by treating hypertension.

    The following diseases are reported or evolved during pregnancy and COCS user, but there is no definitive evidence of a combination with COCS: jaundice and/or itching related to biliary obstruction; The formation of gallstones; Porphyrin metabolic disorders, systemic lupus erythematosus, hemolytic hyperur syndrome, Sydenham, genital herpes; Hearing loss due to fibrous fibers.

    In genetic angi angiema women, external estrogen can cause or exacerbate the symptoms of angioedema.

    Acute or chronic liver dysfunction requires stop using COCS until the liver function returns to normal. Jaundice has occurred for the first 3 months of pregnancy or during the use of previous sex steroids that require stop use of COCS.

    The ability to drive and operate machinery

    No.

    Pregnancy

    Do not use primolut-n during pregnancy.

    Breastfeeding period

    Do not use primol - n during breastfeeding.

    Drug interaction

    drug interactions can increase the clearance of sex hormones and lead to reduced treatment effect. This is shown when long -term treatment with liver fermentation drugs (including Phenytoin, Barbiturates, Primidon, Carbamazepin, Rifampicin, Oxcarbazepin, 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).

    Note: It should be noted the information of the drugs used simultaneously to determine the risks of drug interaction.

    Interaction with subclinical test results

    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 and bleeding indicators. These changes are usually within the permitted limits of these tests.

    Storage

    Store at temperatures below 30 ° C.

    Other drugs

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    count views

    Popular Keywords