Dextromethorphan + Paracetamol + Pseudoephedrine (Dextromethorphanum + Paracetamolum + Pseudoephedrinum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Anilides

Included in the formulation
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    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

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    ONLS

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    АТХ:

    N.02.B.E   Anilides

    R.05.D   Antitussives (excluding combinations with expectorants)

    R.01.B.A   Sympathomimetics

    Pharmacodynamics:

    Paracetamol inhibits cyclooxygenase in the central nervous system, resulting in reduced synthesis of prostaglandins, which has an analgesic and antipyretic effect.

    Dextromethorphan blocks glutamatergic NMDA receptors in various structures of the brain, including in the cough center (noncompetitive blockade of the ion channel) of the brainstem, the agonist σ1- and σ2receptors of the brain (a hallucinogenic effect), as a result, suppresses the excitability of the cough center in the brain, inhibiting the cough reflex.

    Pseudophrenia causes vasoconstriction in the pharynx and nasal mucosa, thereby reducing swelling and facilitating breathing.

    Pharmacokinetics:

    It is well absorbed and absorbed, metabolized in the liver, eliminated partially by the kidneys in an unchanged form, partly in the form of metabolites. Half-life 30 hours.

    Paracetamol is evenly distributed in tissues, poorly bound to plasma proteins, metabolized in the liver, eliminated by the kidneys. The elimination half-life is 1-3 hours. Complete elimination of the drug occurs within a day.

    Dextromethorphan is also metabolized in the liver, excreted by the kidneys in an unchanged form and in the form of metabolites, which also have antitussive effects.

    Pseudoephedrine is rapidly absorbed from the gastrointestinal tract, the effect occurs after 15-30 minutes. It reaches a peak concentration in 1-3 hours. The half-life is 5-8 hours. Less than 1% is metabolized in the liver. It is excreted by the kidneys 90% unchanged.

    Indications:

    Colds.

    ICD-10

    X.J00-J06.J06.9   Acute upper respiratory tract infection, unspecified

    X.J10-J18.J10   Influenza caused by an identified influenza virus

    XVIII.R50-R69.R50   Fever of unknown origin

    Contraindications:

    Hypersensitivity; fromangina pectoris; age up to 12 years; chronic kidney / liver diseases; the use of antidepressants, monoamine oxidase inhibitors or zidovudine, antiparkinsonian drugs; lactation; pregnancy; arterial hypertension; cardiac ischemia.

    Carefully:

    Intraocular hypertension; xRandom kidney / liver diseases; Gilbert's syndrome; anemia; thyrotoxicosis; diabetes; elderly age; hyperplasia of the prostate with a delay of urine; attenuated emaciated patients; in persons taking anti-TB drugs; alcoholism.

    Pregnancy and lactation:

    Category Food and Drug Administration (US Food and Drug Administration) - FROM. It is not recommended to prescribe the drug during pregnancy and during lactation (breastfeeding), tk. the safety of its use has not been fully established.

    Dosing and Administration:

    Orally 1-2 tablets (1 dose - paracetamol 325 mg, pseudoeprin 30 mg, dextromethorphan 10 mg) every 6 hours, but not more than 8 doses per day, not more than 4 times a day.

    The interval between receptions should be at least 4 hours. Duration of the drug - no more than 3-5 days.

    Side effects:

    From the circulatory system and hematopoiesis: increased blood pressure, tachycardia, thrombocytopenia, anemia, agranulocytosis, with prolonged use in high doses - hemolytic anemia, aplastic pancytopenia.

    From the gastrointestinal tract: vomiting, epigastric pain, nausea, dry mouth, with prolonged use in high doses - hepatotoxic effect.

    From the central nervous system: sleep disorders, increased nervous excitability, drowsiness, irritability, confusion, headache, toxic psychosis, dizziness.

    From the urinary system: with prolonged use in high doses - renal colic, interstitial nephritis, capillary necrosis.

    Allergic reactions: skin rash, itching, urticaria, angioedema.

    Overdose:

    Symptoms: in patients, especially with impaired renal and hepatic function, an overdose of paracetamol can cause pallor of the skin, anorexia, nausea, vomiting and severe liver damage. A detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver function abnormalities develop rapidly, and can be complicated by renal insufficiency (tubular necrosis). An overdose of pseudoephedrine can cause irritation, increased blood pressure and heart rhythm disturbances. Overdose of dextromethorphan can cause nausea, vomiting, dizziness, drowsiness, visual impairment, blocking, impaired coordination of movements and difficulty breathing.

    The patient should be warned that an accidental overdose should immediately call a doctor.

    Treatment: gastric lavage followed by administration of activated charcoal; if necessary, conduct symptomatic therapy, introduce methionine within 8-9 hours after an overdose, acetylcysteine - within 12 hours.

    Interaction:

    It is not recommended to take other medications that contain paracetamol.

    Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic medicines increase the production of hydroxylated active metabolites, which causes the possibility of severe intoxication even with a slight overdose.

    Long-term use of barbiturates reduces the effectiveness of paracetamol.

    Do not take the drug simultaneously with chloramphenicol, dihydroergotamine, methyldopa or haloperidol.

    The drug increases the effect of anticoagulants.

    Simultaneous reception with drugs that depress the central nervous system leads to the potential for a depressant effect on central nervous system.

    Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

    Diflunizal increases the plasma concentration of paracetamol by 50%, thereby increasing the risk of hepatotoxicity.

    Smoking of tobacco during reception of a preparation can lead to a delay of a secret in respiratory ways.

    In the case of metoclopramide, domperidone, colestyramine and warfarin before starting the drug should consult a doctor.

    With the simultaneous use of pseudoephedrine with monoamine oxidase inhibitors, the development of a hypertensive crisis is possible.

    Propranolol can enhance the pressor effect of pseudoephedrine; pseudoephedrine may reduce the hypotensive effect of reserpine, methyldopa, meqamylamine hydrochloride and the alkaloids of the healer.

    Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, can increase the concentration of dextromethorphan in the blood.

    Special instructions:

    Do not drink alcohol while taking the drug. During the treatment period, the parameters of the peripheral blood and the functional state of the liver are monitored.

    During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

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