Duokold powder for pr-ra packets (day + night) lemon, No. 9 + No. 3

Duokold powder for pr-ra packets (day + night) lemon, No. 9 + No. 3; 'Symptomatic treatment of infectious and inflammatory diseases: ARVI (acute respiratory viral infection), including flu and' cold accompanied by fever, chills, headache, joint and muscle pain, runny nose, nasal congestion, sneezing and sore throat and sinuses.

Inside. Dissolve the contents of the sachet in one glass (200 ml) of hot, but not boiling, water. Consume immediately after dissolving. Stir the solution before use. Adults and children over 12 years of age take 1 sachet 'Day' every 4-6 hours during the daytime, but no more than 3 times a day, and 1 sachet 'Night' in the evening before bedtime (no more than 1 day) no more than 3 days. If no relief of symptoms is observed within 3 days after starting the drug, you should consult a doctor.

Patients with hepatic impairment

Patients with impaired liver function or Gilbert's syndrome need to reduce the dose or increase the interval between doses of the drug.

Patients with renal impairment

In the presence of acute renal failure (creatinine clearance less than 10 ml / min), the interval between doses of the drug should be at least 8 hours.

Elderly patients

In elderly patients, no dose adjustment is necessary.

Powder for preparation of 'Day' oral solution from light yellow to yellow, with a characteristic odor, with the presence of white crystals; blotches of bright yellow color and lumps, easily crumbling when pressed, are allowed.

1 pack.

paracetamol 325 mg

ascorbic acid 200 mg

calcium gluconate monohydrate 200 mg

rutoside 20 mg

phenylephrine hydrochloride 10 mg

Excipients: mannitol, sodium citrate, lemon flavor, citric acid monohydrate, aspartame, povidone K30.

Powder for preparation of solution for oral administration 'Night' from light yellow to yellow, with a characteristic odor, with the presence of white crystals; blotches of bright yellow color and lumps, easily crumbling when pressed, are allowed.

1 pack.

paracetamol 500 mg

ascorbic acid 200 mg

calcium gluconate monohydrate 200 mg

rutoside 20 mg

pheniramine maleate 20 mg

phenylephrine hydrochloride 10 mg

Excipients: mannitol, sodium citrate, lemon flavor, citric acid monohydrate, aspartame, povidone K30.

• Hypersensitivity to paracetamol, rutoside, phenylephrine, pheniramine, ascorbic acid and other components that make up the drug;

• simultaneous administration of paracetamol-containing drugs;

• concomitant use of tricyclic antidepressants, beta-blockers, and other sympathomimetic drugs;

• simultaneous or during the previous 2 weeks taking monoamine oxidase inhibitors (MAO);

• severe cardiovascular disease;

• arterial hypertension;

• angle-closure glaucoma;

• tendency to thrombosis;

• pheochromocytoma, hyperthyroidism;

• portal hypertension;

• alcoholism;

• diabetes;

• pregnancy, breastfeeding period;

• phenylketonuria;

• children under 12 years of age;

• hypercalcemia (calcium concentration should not exceed 12 mg%);

• severe hypercalciuria; nephrourolithiasis (calcium);

• simultaneous intake of cardiac glycosides (risk of arrhythmias).

  With caution expressed atherosclerosis of the coronary arteries; cardiovascular diseases; acute hepatitis; hemolytic anemia; severe liver or kidney disease; prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy; blood diseases; deficiency of glucose-6-phosphate dehydrogenase; congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes); bronchial asthma; chronic malnutrition (deficit in consumed calories) and dehydration? EdTableAlig; pyloroduodenal obstruction; stenosing ulcer of the stomach and / or duodenum; epilepsy; simultaneous administration of drugs that can adversely affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes).

Pharmacodynamics

The combined drug, the action of which is due to its constituent components, has antipyretic, anti-inflammatory, analgesic, antiallergic, angioprotective and vasoconstrictor effects. Eliminates cold symptoms. Narrows the vessels of the nose, eliminates swelling of the nasal mucosa.

Ascorbic acid (vitamin C) - replenishes the increased need for vitamin C in colds and flu, especially in the initial stages of the disease. Increases the body's resistance to infectious diseases, participates in the regulation of redox processes, promotes normal capillary permeability, blood clotting, tissue regeneration.

Calcium gluconate - replenishes the deficiency of calcium ions necessary for the transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial activity, bone formation, blood coagulation. Has antiallergic effect, prevents the development of increased permeability and fragility of blood vessels, causing hemorrhagic processes in influenza and acute respiratory viral infections (ARVI).

Paracetamol is a non-narcotic analgesic that blocks the structural enzyme cyclooxygenase-1 (COX-1) and an inducible enzyme (COX-2) mainly in the central nervous system, affecting the centers of pain and thermoregulation. It has an analgesic and antipyretic effect. Reduces headaches and muscle pains, fever phenomena. Does not affect platelet function and hemostasis.

Rutozid is an angioprotective agent. Reduces capillary permeability, swelling and inflammation, strengthens the vascular wall. Prevents the development of increased permeability and fragility of blood vessels, causing hemorrhagic processes. Rutoside is involved in redox processes, has antioxidant properties, prevents oxidation and promotes the deposition of ascorbic acid in tissues.

Phenylephrine is a symptomatic agent, stimulates postsynaptic alpha1-adrenergic receptors, has a moderate vasoconstrictor effect, reduces edema and hyperemia of the nasal mucosa, restores free breathing, lowers pressure in the paranasal cavities and middle ear. Pheniramine - is an anti-allergic agent - a blocker of H1-histamine receptors. Reduces the feeling of nasal congestion, sneezing, watery eyes, itching and redness of the eyes. Moderately sedative.

Pharmacokinetics

Vitamin C

Suction

After oral administration, ascorbic acid is completely absorbed from the gastrointestinal tract.

Distribution

It is widely distributed in body tissues. The time to reach the maximum plasma concentration (TCmax) after oral administration is 4 hours. Communication with blood plasma proteins - 25%. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and plasma. It crosses the placenta and passes into breast milk.

Metabolism and excretion

It is metabolized mainly in the liver to deoxyascorbic acid and then to oxalic acid and ascorbate-2-sulfate. It is excreted by the kidneys unchanged and in the form of metabolites.

Calcium gluconate

Approximately 1 / 5-1 / 3 part of orally administered calcium gluconate is absorbed in the small intestine, this process depends on the presence of vitamin D, pH, diet and the presence of factors that can bind calcium ions. The absorption of calcium ions increases with its deficiency and the use of a diet with a reduced content of calcium ions. About 20% is excreted by the kidneys, the rest (80%) - by the intestines.

Paracetamol

Suction

After oral administration, paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is reached within 10-60 minutes after ingestion.

Distribution

Paracetamol is distributed in most body tissues, crosses the placenta, and is present in breast milk. In therapeutic concentrations, binding to blood plasma proteins is insignificant, increasing with increasing concentration.

Metabolism

It undergoes primary metabolism in the liver, excreted mainly by the kidneys in the form of glucuronide and sulfate compounds. The half-life is 1-3 hours.

Rutoside

When taken orally, 10-15% of the dose is absorbed, the maximum concentration in the blood plasma is reached after 1-9 hours, the half-life is 10-25 hours; excreted mainly in the bile.

Phenylephrine

Absorption and metabolism

It is absorbed from the gastrointestinal tract and undergoes primary metabolism in the intestines and liver. The maximum concentration in blood plasma is reached in the interval from 45 minutes to 2 hours.

Withdrawal

It is excreted by the kidneys almost completely in the form of sulfate compounds. The half-life is 2-3 hours.

Pheniramine

Distribution

After oral administration, the maximum concentration in blood plasma is reached after 1-2.5 hours. The half-life in the final phase is 16-19 hours.

Withdrawal

It is excreted by the kidneys (70-83%) as an unchanged substance or metabolites.

Side effects

Disturbances from the blood and lymphatic system: very rarely - thrombocytopenia, agranulocytosis, leukopenia, pancytopenia. Immune system disorders: rarely - hypersensitivity reactions (rash, shortness of breath, anaphylactic shock), angioedema; frequency unknown - anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis. Mental disorders: rarely - hyperexcitability, sleep disturbance (when taking the contents of Den sachets). Disturbances from the nervous system: often - drowsiness (when taking the contents of the 'Night' sachets); rarely - dizziness, headache. Violations of the organ of vision: rarely - mydriasis, paresis of accommodation, increased intraocular pressure. Heart disorders: rarely - tachycardia, palpitations. Vascular disorders:rarely - increased blood pressure. Gastrointestinal disorders: often - nausea, vomiting; rarely - dryness of the oral mucosa, constipation, abdominal pain, diarrhea. Violations of the liver and biliary tract: rarely - increased activity of hepatic enzymes. Violations of the skin and subcutaneous tissues: rarely - rash, itching, erythema, urticaria. Disorders of the kidneys and urinary tract: rarely - difficulty urinating. General disorders and reactions at the injection site: rarely - malaise.Disorders of the kidneys and urinary tract: rarely - difficulty urinating. General disorders and reactions at the injection site: rarely - malaise.Disorders of the kidneys and urinary tract: rarely - difficulty urinating. General disorders and reactions at the injection site: rarely - malaise.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Interaction

Effect of ascorbic acid

With simultaneous use with barbiturates, primidone, tetracycline, the excretion of ascorbic acid in the urine increases. With the simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. It is possible to increase the concentration of ethinyl estradiol in the blood plasma with its simultaneous use as part of contraceptives for oral administration. When used simultaneously with iron preparations, ascorbic acid, due to its regenerating properties, converts trivalent iron into bivalent, which helps to improve its absorption. Ascorbic acid in high doses can lower urine pH, which, when used simultaneously, reduces tubular reabsorption of amphetamine and tricyclic antidepressants.With the simultaneous use of acetylsalicylic acid, it reduces the absorption of ascorbic acid by about a third. With simultaneous use with warfarin, it is possible to reduce the effects of warfarin.

Effect of calcium gluconate

With the simultaneous use of calcium gluconate inside, it slows down the absorption of tetracyclines, digoxin, oral iron preparations (the interval between their doses should be at least 2 hours). With simultaneous use under the influence of cholestyramine, the absorption of calcium from the gastrointestinal tract is reduced. Calcium gluconate with simultaneous use reduces the hypotensive effect of calcium channel blockers (intravenous administration of calcium gluconate before and after verapamil reduces its hypotensive effect). During treatment with cardiac glycosides, parenteral administration of calcium gluconate is not recommended (possibly increased cardiotoxicity). Simultaneous use with quinidine may slow down intraventricular conduction and increase the toxicity of quinidine. When combined with thiazide diuretics, calcium gluconate may increase hypercalcemia,reduce the effect of calcitonin in hypercalcemia, reduces the bioavailability of phenytoin.

Influence of paracetamol

Enhances the effects of MAO inhibitors, sedatives, ethanol. The risk of hepatotoxic action of paracetamol increases with the simultaneous administration of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes. The anticoagulant properties of warfarin and other coumarins can be enhanced with long-term regular use of paracetamol, increasing the risk of bleeding. A single dose of paracetamol does not have this effect. Metoclopramide increases the rate of absorption of paracetamol and increases the concentration of paracetamol in blood plasma to the maximum. Likewise, domperidone can increase the absorption rate of paracetamol. With the combined use of chloramphenicol and paracetamol, the half-life of chloramphenicol may increase.Paracetamol can reduce the bioavailability of lamotrigine with a possible decrease in its action due to the induction of its hepatic metabolism. The absorption of paracetamol can be reduced when taken simultaneously with cholestyramine, but this can be avoided by taking cholestyramine an hour later than paracetamol. Regular use of paracetamol with zidovudine can cause neutropenia and increase the risk of liver damage. Probenecid affects the metabolism of paracetamol. In patients taking probenecid at the same time, the dose of paracetamol should be reduced. The hepatotoxicity of paracetamol can be exacerbated by chronic or excessive alcohol consumption. Paracetamol may interfere with the uric acid test using the phosphotungstate precipitating reagent.Effect of rutoside Ascorbic acid enhances the effects of rutoside.

Effect of phenylephrine

The drug is contraindicated in patients who have taken or have taken MAO inhibitors within the past two weeks. MAO inhibitors, tricyclic antidepressants (for example, amitriptyline), ergot alkaloids, sympathomimetics increase the pressor effect, and the latter also increase the arrhythmogenicity of phenylephrine. Phenylephrine can reduce the effectiveness of beta-blockers and other antihypertensive drugs (eg, debrisoquine, guanethidine, reserpine, methyldopa). The risk of arterial hypertension increases. The simultaneous use of phenylephrine with digoxin and other cardiac glycosides may increase the risk of developing arrhythmias or myocardial infarction. Thyroid hormones (mutually) increase the risk of coronary insufficiency (especially in coronary atherosclerosis). Alpha blockers (phentolamine), phenothiazines,furosemide and other diuretics inhibit vasoconstriction.

Effect of pheniramine

The effect of other substances on the central nervous system may increase (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers and drugs). Pheniramine can inhibit the action of anticoagulants.

Overdose

The most dangerous symptoms of drug overdose can be caused by paracetamol.

Paracetamol

Symptoms (appear after a single dose of 7.5-10 g of paracetamol): in severe cases of overdose, paracetamol has a hepatotoxic effect, including it can cause liver necrosis. Also, overdose can cause nephropathy with irreversible liver failure. The severity of the overdose depends on the dose, therefore it is necessary to warn patients about the prohibition of the simultaneous use of paracetamol-containing drugs. The risk of poisoning is especially high in elderly patients, in children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition (calorie deficit) and in patients taking inducers of microsomal oxidation in the liver. Paracetamol overdose can lead to liver failure, encephalopathy, coma, and death.

Symptoms of a paracetamol overdose in the first 24 hours: pallor of the skin, nausea, vomiting, anorexia, convulsions. Abdominal pain can be the first sign of liver damage and usually does not appear in the first 24-48 hours and can sometimes appear later, after 4-6 days, on average after 72-96 hours after taking the drug. Disorders of glucose metabolism and metabolic acidosis may also occur. Even in the absence of liver damage, acute renal failure and acute tubular necrosis can develop. Cases of cardiac arrhythmia and the development of pancreatitis have been reported with an overdose of paracetamol.

Ћечение: введение ацетилцистеина внутривенно или перорально в качестве антидота, промывание желудка, прием внутрь метионина могут иметь положительный эффект по крайней мере в течение первых 48 часов после передозировки. –екомендован прием активированного угл¤, мониторинг дыхани¤ и кровообращени¤. ¬ случае развити¤ судорог возможно назначение диазепама.

јскорбинова¤ кислота

—имптомы: при приеме более 1 г в день возможны изжога, диаре¤, затрудненное мочеиспускание или окрашивание мочи в красный цвет, гемолиз (у пациентов с дефицитом глюкозо-6-фосфатдегидрогеназы).

 альци¤ глюконат

—имптомы: развитие гиперкальциемии: тошнота, рвота, резка¤ слабость, жажда, сонливость, нарушение ориентации, помрачение сознани¤, почечна¤ недостаточность. ћаксимальна¤ суточна¤ доза дл¤ взрослых и детей старше 12 лет Ц 9 г.

Ћечение: кальцитонин внутривенно капельно 5-10 ћ?/кг в сутки (препарат развести в 500 мл изотонического раствора натри¤ хлорида, вводить в течение 6 часов).

‘енирамин и фенилэфрин (симптомы передозировки объединены из-за риска взаимного потенцировани¤ парасимпатолитического эффекта фенирамина и симпатомиметического эффекта фенилэфрина в случае передозировки препарата).

—имптомы: сонливость, к которой в дальнейшем присоедин¤етс¤ беспокойство (особенно у детей), зрительные нарушени¤, сыпь, тошнота, рвота, головна¤ боль, повышенна¤ возбудимость, головокружение, бессонница, нарушение кровообращени¤, кома, судороги, изменени¤ поведени¤, повышение или снижение артериального давлени¤, брадикарди¤. ѕри передозировке фенирамина сообщалось о случа¤х атропиноподобного Ђпсихозаї.

Ћечение.

There is no specific antidote. Routine care is needed, including activated charcoal, saline laxatives, cardiac and respiratory support. Psychostimulants (methylphenidate) should not be prescribed due to the risk of seizures. With hypotension, it is possible to use vasopressor drugs. In case of an increase in blood pressure, intravenous administration of alpha-adrenergic blockers is possible, since phenylephrine is a selective agonist of alpha1-adrenergic receptors, therefore, the hypertensive effect in case of an overdose of phenylephrine should be treated by blocking alpha-adrenergic receptors. If seizures develop, use diazepam.