Pentalgin®-H (Pentalginum®-N)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppills
Composition:

Composition per one tablet:

Active substances: metamizole sodium (analgin) 300 mg, naproxen 100 mg, caffeine 50 mg, codeine or codeine phosphate in terms of codeine 8 mg, phenobarbital 10 mg.

Excipients: potato starch - 242 mg, povidone low molecular weight (polyvinylpyrrolidone low molecular weight medical) - 9 mg, sodium citrate - 4 mg, magnesium stearate - 7 mg.

Description:

tablets white or white with a yellowish or kremovatym color shade, flat-cylindrical. On one side of the tablet, the abbreviated name "PENT-H" is applied by embossing.

Pharmacotherapeutic group:Analgesic agent (analgesic opioid + non-steroidal anti-inflammatory drug + psychostimulant + barbiturate)
ATX: & nbsp
  • Metamizole sodium in combination with psycholeptics
    • Pharmacodynamics:

    Combined drug, has analgesic, anti-inflammatory and antipyretic effect.

    Naproxen and metamizol sodium - have analgesic and anti-inflammatory effects.

    Codeine stimulates opiate receptors in various departments of the central nervous system, which leads to the activation of the antinotseptive system and changes in the emotional perception of pain. Phenobarbital and codeine increase the analgesic effectiveness of metamizole sodium and naproxen.

    Caffeine causes the expansion of the blood vessels of skeletal muscles, brain,heart, kidney; increases mental and physical performance, helps to eliminate fatigue and drowsiness; increases the permeability of histohematological barriers and increases the bioavailability of non-narcotic analgesics, thereby contributing to the enhancement of the therapeutic effect.

    Pharmacokinetics:

    The components of the drug are well absorbed in the gastrointestinal tract.

    Metamizol sodium: in the intestinal wall hydrolyses to form an active metabolite, 4-methyl-amino-antipyrine, which in turn is metabolized to 4-formyl-amino-antipyrine and other metabolites. The level of binding of the active metabolite with proteins is 50-60%. Excretion of metabolites passes through the kidneys. In addition, metabolites are excreted in breast milk.

    Naproxen: bioavailability is 95%. It binds to blood proteins. The half-life is 12-15 hours. It is excreted in the urine mainly in the form of a metabolite (dimethylnaproxen), in small amounts - with bile.

    Caffeine: well absorbed in the intestine, half-life -5h (sometimes - up to 10 hours). It is excreted mainly by kidneys in the form of metabolites, about 10% - in unchanged form.

    Codeine: slightly binds to plasma proteins. It is subject to biotransformation in the liver (10% by demethylation passes into morphine). Excreted by the kidneys (5-15% - unchanged).

    Phenobarbital: bioavailability is 80%. In plasma it binds to proteins by 50%, it penetrates well through the placenta. Biotransformatsya in the liver. The main metabolite does not have pharmacological activity. It is excreted by the kidneys, including 20-25% - unchanged.

    Indications:

    Accepted with a mild and moderately expressed pain syndrome of different genesis (including pain in the joints, muscles, radiculitis, menstrual pains, neuralgia, as well as headache, migraine, toothache). Can be used for fever, colds and other diseases, accompanied by pain syndrome and inflammation.

    Contraindications:

    Hypersensitivity, severe hepatic and / or renal failure, gastric ulcer and duodenal ulcer in the acute stage, bronchial asthma, bronchospasm. Conditions accompanied by respiratory depression. Deficiency of glucose-6-phosphate dehydrogenase; anemia, leukopenia; state,accompanied by respiratory depression; craniocerebral trauma, acute myocardial infarction; arrhythmias, severe arterial hypertension, alcoholic intoxication, glaucoma, children's age (under 12 years).

    Carefully:Peptic ulcer of the stomach and duodenum (in remission), advanced age, mild hypertension of light and moderate severity.
    Pregnancy and lactation:
    The drug is contraindicated for use in pregnancy.
    If it is necessary to use the drug during lactation, it is necessary to solve the problem of stopping breastfeeding.

    Dosing and Administration:

    The drug is usually taken 1 tablet 1-3 times a day. The maximum daily dose is 4 tablets. The drug should not be taken more than 5 days as an anesthetic and more than 3 days as an antipyretic agent without prescribing a doctor.

    Side effects:Dyspeptic disorders (nausea, vomiting, constipation), skin allergic reactions (rash, itching, urticaria), epigastric pain, dizziness, drowsiness, palpitations are possible. Rarely is the oppression of hematopoiesis (leukopenia, granulocytopenia, agranulocytosis).With prolonged admission in high doses, it is possible that the liver and kidney function is impaired.
    Overdose:

    Symptoms: nausea, vomiting, stomach pain, tachycardia, cardiac arrhythmias, weakness, drowsiness, delirium, respiratory depression.

    Treatment: induction of vomiting, over-the-horizon gastric lavage, the appointment of adsorbents (activated charcoal), symptomatic therapy aimed at maintaining vital functions.

    Interaction:Simultaneous use of the drug with other non-narcotic analgesics may lead to an increase in toxic effects. Tricyclic antidepressants, oral contraceptives, allopurinol increase the toxicity of metamizole sodium (analgin), which is part of the drug. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium (analgin). Simultaneous use of metamizole sodium (analgin) with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers increase the analgesic effect of the drug.
    Special instructions:

    If you use more than 5 days, you need to monitor the picture of peripheral blood and the functional state of the liver.

    Due to the presence of codeine and phenobarbital in the formulation, it is possible to obtain positive results when using test systems, including during doping control.

    It is difficult to establish a diagnosis for acute abdominal pain syndrome.

    In patients with atopic bronchial asthma, pollinosis, there is an increased risk of developing hypersensitivity reactions.

    Effect on the ability to drive transp. cf. and fur:In connection with the possibility of developing sedative action, during the treatment it is not recommended to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention, speed of psychomotor and motor reactions.
    Form release / dosage:

    pills.

    Packaging:

    For 10 tablets in a planar cell package.

    1 or 2 contour squares with instructions for use in a pack of cardboard.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.


    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002271
    Date of registration:17.06.2010 / 25.05.2015
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp2016-01-28
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