Maxikold - instructions for use, dose, side effects, contraindications

Excipients: core: croscarmellose sodium - 28.00 mg, calcium hydrophosphate - 82.62 mg, ethyl cellulose - 0.20 mg, giprolase (hydroxypropyl cellulose) 35.00 mg, magnesium stearate - 7.00 mg, talc - 7.00 mg, dye sunset yellow sunset (E 110) - 0.18 mg;

shell: hypromellose (hydroxypropyl methylcellulose) - 13,200 mg, giprolose (hydroxypropyl cellulose) - 7,701 mg, talc - 6,300 mg, titanium dioxide 2,750 mg, dye sunset yellow sunset (E 110) - 0.049 mg or OUADRA 20A230018 Orange (OPADRY 20A230018 Orange) - 30,00 mg [Hypromellose (hydroxypropylmethylcellulose) - 13,200 mg, giprolose (hydroxypropyl cellulose) - 7,701 mg, talc - 6,300 mg, titanium dioxide 2,750 mg, dye sunset yellow sunset (E 110) 0.049 mg].

Description:

Tablets covered with a film membrane pinkish-orange color, oval biconvex with a risk. On the cross-section the tablet is pinkish-orange with white and orange impregnations.

Pharmacotherapeutic group:Means for eliminating the symptoms of acute respiratory infections (ARI) and "colds" (analgesic non-narcotic means + alpha-adrenomimetic + vitamin)

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Combined drug, has antipyretic and analgesic effect, is intended to relieve the symptoms of "colds" and flu.

The effect of the drug is due to the properties of its constituent components.

Paracetamol - non-narcotic analgesic, has an antipyretic and analgesic effect due to blockade of cyclooxygenase in the central nervous system and exposure to pain centers and thermoregulation. Reduces headache and muscle pain, fever.

Phenylephrine - alpha 1-adrenostimulant, little effect on the beta-adrenoreceptors of the heart; is not catecholamine. Causes narrowing of arterioles, due to which reduces edema and flushing of the mucous membrane of the nasal cavity, facilitates breathing through the nose.

Ascorbic acid - increases the resistance of the body to infections, replenishes the increased need for vitamin C for colds and flu.

Pharmacokinetics:

Paracetamol: well absorbed in the intestine, time to reach maximum concentration (Tmah) - 0.5-2 hours; communication with plasma proteins - 15%. Metabolised in the liver with the formation of both active and inactive metabolites. The half-life (T1 / 2) is 1-4 hours. Primarily excreted by the kidneys in the form of metabolites - glucuronides and sulfates, 3% - unchanged.

Phenylephrine: After oral administration phenylephrine poorly absorbed from the gastrointestinal tract (GIT). Metabolized with the participation of monoamine oxidase (MAO) in the intestinal wall and at the "first passage" through the liver. Bioavailability of phenylephrine is low.

Ascorbic acid: Absorbed in the digestive tract (mainly in the jejunum). Tmah after ingestion of -4 hours. Easily penetrates into leukocytes, platelets, and then - into all tissues; the greatest concentration is achieved in glandular organs, leukocytes, liver and lens of the eye; penetrates the placenta. Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic acid and ascorbate-2-sulfate. It is excreted by the kidneys, through the intestines, with sweat, breast milk in unchanged form and in the form of metabolites.

Indications:Symptomatic treatment of infectious and inflammatory diseases (including influenza and other acute respiratory viral infections (ARVI)), accompanied by fever,chills, stuffy nose, headache, pain in the bones and muscles, in the throat and sinuses of the nose.

Contraindications:

Hypersensitivity to any component of the drug; marked renal / hepatic impairment; hyperthyroidism (including thyrotoxicosis); heart disease (pronounced stenosis of the aortic aorta, acute myocardial infarction, tachyarrhythmias); arterial hypertension; pheochromocytoma; pregnancy; the period of breastfeeding; simultaneous administration of tricyclic antidepressants, beta-adrenoblockers, monoamine oxidase inhibitors, incl. in the period of 14 days after cancellation; simultaneous administration of other paracetamol-containing drugs and agents to relieve the symptoms of "colds", flu and nasal congestion; hyperplasia of the prostate; angle-closure glaucoma; children's age (up to 9 years, as well as children with body weight less than 30 kg).

Carefully:

With a deficiency of glucose-6-phosphate dehydrogenase, with benign hyperbilirubinemia, during pregnancy and lactation, in old age.

Pregnancy and lactation:It is not recommended to use the drug during pregnancy and breast-feeding due to the lack of data on the safe use of the drug.

Dosing and Administration:

Inside, before meals or 1-2 hours after eating, squeezed large amounts of liquid.

Adults and children over 12 years of age (body weight over 40 kg): 1 -2 tablets every 4-6 hours. Multiplicity of reception no more than 4 times a day with an interval of at least 4 hours.

Children aged 9 to 12 years (body weight over 30 kg): 1 tablet every 4-6 hours. Multiplicity of reception no more than 4 times a day with an interval of at least 4 hours.

The drug is not recommended for more than 5 days as an anesthetic and 3 days as an antipyretic agent without consulting a doctor. If symptoms persist, consult a physician.

DO NOT EXCEED THE INDICATED DOSE.

Side effects:

Allergic reactions are possible (skin rash, skin hyperemia, hives, angioedema, edema).

Paracetamol: hemopoiesis disorders (anemia, thrombocytopenia, methemoglobinemia).

Phenylephrine: headache, nausea, or vomiting; stenocardia, bradycardia, dyspnea, increased or decreased blood pressure, palpitation, tachycardia, ventricular arrhythmia (especially when used in high doses), irritability, motor anxiety, allergic reactions.

Ascorbic acid: may cause irritation of the gastrointestinal mucosa, with prolonged use of large doses - nausea, vomiting, diarrhea, hyperacid gastritis, ulceration of the gastrointestinal mucosa; decreased capillary permeability (possibly deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies). It is also possible the occurrence of thrombocytosis, hyperprotrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria, oppression of the insular pancreas function.

With prolonged use at doses much higher than recommended, the probability of impaired renal function increases (moderate pollakiuria, hyperoxaluria, nephrolithiasis, damage to glomerular renal apparatus), increased central nervous system excitability, headache, insomnia.

In case of adverse reactions, consult a physician.

Overdose:

In case of an overdose, seek medical help immediately, even if you are feeling well, as there is a risk of delayed signs of severe liver damage.

In overdose, symptoms are usually due to exposure to high doses of paracetamol.

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Hepatotoxic effect in adults is manifested when taking 10 g or more.

Treatment: introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine for 8-9 hours after an overdose and acetylcysteine-for 8 hours. The need for additional therapeutic measures (further introduction of methionine, iv injection of acetylcysteine) is determined in depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

The drug enhances the effects of monoamine oxidase inhibitors, sedatives, ethanol.

The risk of hepatotoxic action of paracetamol increases with the simultaneous administration of ethanol, hepatotoxic drugs, inducers of microsomal oxidation enzymes in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, etc.).

The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver). Paracetamol reduces the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. Inhibitors of enzymes of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects of paracetamol.

Simultaneous administration of ethanol and paracetamol promotes the development of acute pancreatitis. Long-term combined use of paracetamol and 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. Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity. Myelotoxic drugs increase the manifestation of hematotoxicity of paracetamol.

Phenylephrine reduces the hypotensive effect of diuretics and hypotensive drugs (including methyldopy, mekamilamin, guanadrel, guanetidine), reduces the antianginal effect of nitrates.

Phenothiazines, alpha-adrenoblockers (phentolamine), furosemide and other diuretics reduce the hypertensive effect of phenyramine. Inhibitors of monoamine oxidase (incl. furazolidone, procarbazine, selegiline), oxytocin, ergot alkaloids, tricyclic antidepressants, methylphenidate, adrenostimulants increase the vasoconstrictive effect and arrhythmogenicity of phenylephrine, against the background of reserpine, hypertension is possible. Ergometrine, ergotamine, methylergomethrin, oxytocin, doxapram increase the severity of the vasoconstrictor effect of phenyramine.

Inhalation anesthetics (including chloroform, enflurane, halothane, isoflurane, methoxyflurane) increase the risk of severe atrial and ventricular arrhythmias. Thyroid hormones increase (mutually) the effect of phenylephrine and the associated risk of coronary insufficiency (especially in coronary atherosclerosis).

Ascorbic acid increases the concentration in the blood of benzylpenicillin and tetracyclines, reduces the effectiveness of heparin and indirect anticoagulants, increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body, reduces the therapeutic effect of antipsychotic drugs - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

With simultaneous use with acetylsalicylic acid, urinary excretion of ascorbic acid increases and the excretion of acetylsalicylic acid decreases. Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drink reduce the absorption and absorption of ascorbic acid.

Ascorbic acid improves the absorption of iron in the intestine; increases the risk of developing crystalluria in the treatment of salicylates andsulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration in the blood of oral contraceptives, reduces the chronotropic effect of isoprenaline. With long-term use or use in high doses, it can interfere with the interaction of disulfiram and ethanol, in high doses increases the excretion of mexiletine by the kidneys.

Drugs quinoline series, calcium chloride, salicylates, glucocorticoids with prolonged use deplete the stores of ascorbic acid. Barbiturates and primidon increase the excretion of ascorbic acid in the urine.

Special instructions:

Before taking the drug, a doctor should be consulted in case of concomitant use of metoclopramide, domperidone, colestyramine (due to the fact that metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol), anticoagulants (because concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs).

Acceptance of the drug distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the plasma.

When using the drug for more than 5-7 days, it is necessary to monitor the peripheral blood and the functional state of the liver.

TO AVOID TOXIC LIVER DISEASE PREPARATION SHOULD NOT BE CONSIDERED WITH RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TO TAKE PERSONS WITH CHRONIC ALCOHOLISM.

Effect on the ability to drive transp. cf. and fur:The drug does not adversely affect the performance of potentially hazardous activities requiring special attention and rapid reactions.

Form release / dosage:

Film-coated tablets.

Packaging:

By 2, 10 or 12 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1 or 2 contourcell packs with instructions for use in a pack of cardboard.

Storage conditions:

In a dry place 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 printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000077

Date of registration:10.12.2010 / 11.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp30.03.2018

Illustrated instructions

Instructions

Maxcold® (Maxicold®)