Alka-Prim® (Alka-Prim®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAcetylsalicylic acid + GlycineAcetylsalicylic acid + Glycine
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  • Alka-Prim®
    pills inwards 
    Pharmaceutical factory "POLFARMA" JSC     Poland
    • Dosage form: & nbsptablets, effervescent
    Composition:Active substances: acetylsalicylic acid - 330.0 mg; glycine-100.0 mg; auxiliary substances: citric acid - 685.0; sodium bicarbonate-1685.0.
    Description:Round plain cylindrical tablets of white color, with a facet on both sides, dissolve in water with a strong hiss, forming a transparent colorless solution.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    N.02.B.A.51   Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Combined drug, the effect of which is determined by the components that make up its composition.

    Acetylsalicylic acid indiscriminately inhibits cyclooxygenase-1 and cyclooxygenase-2, altering the metabolism of arachidonic acid, reducing the synthesis of prostaglandins. Has a strong analgesic, antipyretic and anti-inflammatory effect. Aminoacetic acid (glycine) - a replaceable amino acid, a central neurotransmitter of the inhibitory type of action. Improves metabolic processes in the brain tissues, providing an antidepressant and sedative effect.It has glycine- and GABA -ergic, alpha1-adrenoblocking, antioxidant and antitoxic effects. Regulates activity of glutamate (NMDA) receptors, due to which reduces psychoemotional stress, improves mood, increases mental performance, reduces the severity of vegetative-vascular disorders and toxic effect of ethanol on the central nervous system. Reduces the acidity of gastric juice to a pH of 6-7 and reduces the irritating effect of acetylsalicylic acid on the mucosa of the gastrointestinal tract.

    Pharmacokinetics:

    After ingestion, the drug is rapidly absorbed from the gastrointestinal tract. It starts to act after 30 minutes from the moment of admission, and the maximum effect is manifested after 1-4 hours and is kept for 3-6 hours after applying a single dose.

    In patients with normal renal function, 80-100% of a single dose is excreted by the kidneys within 24-72 hours.

    Indications:

    - Alcoholic (hangover) withdrawal syndrome.

    - Moderately or mildly expressed pain syndrome of various origin (head pain, muscle pain, toothache, migraine, menstruation pain, neuralgia, arthralgia).

    - Elevated body temperature for colds and other infectious and inflammatory diseases.

    Contraindications:

    - Hypersensitivity to acetylsalicylic acid and other NSAIDs or any of the components of the drug;

    - Combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid;

    - Hemorrhagic diathesis (hemophilia, von Willebrand's disease, telangiectasia, hypoprothrombinemia, thrombocytopenia, thrombocytopenic purpura);

    - Erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

    - Pronounced violations of the liver and kidneys;

    - Simultaneous reception of methotrexate in a dose of 15 mg per week or more;

    - Pregnancy (I-III trimester);

    - Lactation period.

    The drug is not prescribed as an antipyretic agent for children under 15 with acute respiratory infections caused by viral infections, because of the risk of developing Reye's syndrome (encephalopathy and acute fatty liver disease with the development of liver failure).

    Carefully:Gout, hyperuricemia, peptic ulcer and duodenal ulcer or gastrointestinal hemorrhage (history), bronchial asthma, chronic obstructive pulmonary disease, hay fever, nasal polyposis, drug allergy,simultaneous reception of methotrexate in a dose less than 15 mg / week, pregnancy (II trimester).
    Pregnancy and lactation:

    It is not recommended to use the drug during pregnancy, especially during the last three months (III trimester), due to possible malformations of the fetus and complications during childbirth.

    If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.
    Dosing and Administration:

    Effervescent tablets should be dissolved in a glass of water and a drink.

    Adults and children over 12 years: usually 1-2 tablets 2-4 times a day with an interval of at least 4 hours.

    The maximum single dose is 1 g (3 tablets). The maximum daily intake for adults, which is not recommended to exceed - 3 g (9 tablets).

    Do not use the drug for more than 7 days, as an analgesic and more than 3 days, as an antipyretic agent without medical supervision.

    Side effects:

    Allergic reactions: skin rash, bronchospasm, angioedema.

    Formation on the basis of the hapten mechanism of the "aspirin triad" (combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance of acetylsalicylic acid and preparations of pyrazolone series).

    From the gastrointestinal tract: nausea, vomiting, pain in the epigastric region, diarrhea;

    On the part of the hematopoiesis system: Thrombocytopenia, anemia, leukopenia, hemorrhagic syndrome (nasal bleeding, bleeding gums), lengthening of clotting time.

    With prolonged use in large doses, there may be erosive and ulcerative lesions of the gastrointestinal tract, bleeding, black "tarry" stool, general weakness, interstitial nephritis, prerenal azotemia with increasing levels creatinine and hyperkalemia, bronchospasm, papillary necrosis, acute renal failure, nephrotic syndrome, increased activity of "liver" transaminases, aseptic meningitis, increased symptoms of chronic heart failure, edema.

    When such symptoms appear, it is recommended to stop taking the drug and immediately consult a doctor.

    Overdose:

    Overdose of moderate severity: dizziness, hearing and vision impairment, nausea, vomiting, confusion. These symptoms occur after the drug is discontinued.

    Overdose of severe severity: fever, hyperventilation, ketoacidosis, respiratory alkalosis, metabolic acidosis,depression of consciousness down to coma, cardiogenic shock, respiratory failure, severe hypoglycemia. Severe intoxication is observed when taking the drug at doses above 200 mg / kg body weight.

    Treatment: hospitalization, vomiting or gastric lavage, administration of activated carbon, monitoring of acid-base balance, alkalinization of urine in order to obtain a pH of 7.5-8 (forced alkalization of urine is considered to be achieved if the concentration of salicylic acid in the blood plasma is more than 500 mg / L (3.6 mmol / L) in adults or 300 mg / L (2.2 mmol / L) in children), hemodialysis, fluid loss compensation, symptomatic therapy.
    Interaction:

    Strengthens the effect of oral anticoagulants and hypoglycemic drugs, insulin, methotrexate, other non-steroidal anti-inflammatory drugs, glucocorticosteroids, valproic acid.

    Weaken the effect of sulfinpyrazone, diflunizal, fenoprofen, ibuprofen, indomethacin, piroxicam, naproxen, sulindac, as well as drugs that block tubular secretion.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    Applying the drug under medical supervision is recommended for people suffering from allergic diseases (bronchial asthma, allergic rhinitis, urticaria, skin itching, swelling of the nasal mucosa).

    When using acetylsalicylic acid, patients receiving antidiabetic drugs should regularly monitor the level of glucose in the blood plasma.

    Careful observation requires the combined use of the drug with glucocorticoids, antihypertensive and diuretics.

    Antacid preparations containing magnesium hydroxide or aluminum should be taken no earlier than two hours after taking acetylsalicylic acid.

    With prolonged use of the drug should periodically do a general clinical analysis of blood and monitor the presence of blood in the stool.

    Effect on the ability to drive transp. cf. and fur:

    Data on the negative impact of Alka-prima® on the ability to drive and perform work requiring increased attention have not been identified.

    Form release / dosage:

    The tablets are effervescent.

    Packaging:

    For 2 or 10 tablets in foil strips aluminum, laminated paper and polyethylene.

    1 or 5 strips with 2 tablets, or 1 strip with 10 tablets together with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013287 / 01
    Date of registration:10.10.2011 / 07.09.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Pharmaceutical factory "POLFARMA" JSCPharmaceutical factory "POLFARMA" JSC Poland
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp16.07.2017
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