Duocold oral solution powder set lemon, 9pcs/night 3pcs

Composition

Powder for the preparation of a solution for oral use “Day”: One packet of ” Day ” contains:

active ingredients: paracetamol-325 mg, ascorbic acid-200 mg, calcium gluconate monohydrate-200 mg, rutoside-20 mg, phenylephrine hydrochloride-10 mg; excipients: mannitol, sodium citrate, Lemon or cranberry flavor, citric acid monohydrate, aspartame, povidone K-30.

Powder for the preparation of a solution for oral use “Night”: One sachet of “Night” contains:

active ingredients: paracetamol 500 mg, ascorbic acid 200 mg, calcium gluconate monohydrate – 200 mg, rutin 20 mg, feniramina maleate 20 mg, phenylephrine hcl is a 10 mg;

excipients: mannitol, sodium citrate, flavor, Lemon, or Cranberry, citric acid monohydrate, aspartame, povidone K-30.

Pharmacological properties

Pharmacotherapeutic group

Acute respiratory infections and “colds” symptoms remedy (vitamin+calcium-phosphorus metabolism regulator+analgesic non-narcotic agent+angioprotector+alpha-adrenomimetic+H1-histamine receptor blocker)

ATX code:  N02BE51

Pharmacological properties

Pharmacodynamics

The combined drug, the action of which is due to the components included in its composition, has antipyretic, anti-inflammatory, analgesic, anti-allergic, angioprotective and vasoconstrictor effects. Eliminates the symptoms of the “common cold”. Narrows the vessels of the nose, eliminates swelling of the nasal mucosa.

Ascorbic acid (vitamin C) – makes up for 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, and tissue regeneration.

Calcium gluconate-makes up for the lack of calcium ions necessary for the transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial activity, bone formation, blood clotting. It has an anti-allergic 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 the induced enzyme (COX-2) mainly in the central nervous system, affecting the centers of pain and thermoregulation. It has analgesic and antipyretic effects. Reduces headache and muscle aches, fever symptoms. It does not affect platelet function and hemostasis.

Rutoside-is an angioprotector. Reduces capillary permeability, swelling and inflammation, and 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 drug that stimulates postsynaptic alpha-1-adrenergic receptors, has a moderate vasoconstrictive effect, reduces swelling and hyperemia of the nasal mucosa, restores free breathing, lowers pressure in the paranasal cavities and middle ear.

Phenyramine-is an anti-allergic agent-a blocker of H1-histamine receptors. Reduces nasal congestion, sneezing, watery eyes, itching and redness. It has a moderate sedative effect.

Pharmacokinetics

Ascorbic acid

Suction

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

Distribution

is widely distributed in the body’s tissues. The time to reach the maximum concentration in blood plasma (TMAX) after oral use is 4 hours. Binding to plasma proteins is 25%. The concentration of ascorbic acid in white blood cells and platelets is higher than in red blood cells and in plasma. It passes through the placenta and enters breast milk.

Metabolism and elimination

It is mainly metabolized 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 of orally administered calcium gluconate is absorbed in the small intestine, this process depends on the presence of vitamin D, pH, dietary characteristics, 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 remaining amount (80%) – by the intestines.

Paracetamol

Suction

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

Distribution

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

Metabolism

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

Rutoside

When taken orally,10-15% of the dose is absorbed, the maximum concentration in blood plasma is reached in 1-9 hours, the half-life is 10-25 hours; it is 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 range from 45 minutes to 2 hours.

Deduction

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

Phenyramine

Distribution

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

Deduction

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

Indications

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.

Use during pregnancy and lactation

The drug is not recommended for use during pregnancy and lactation, due to the lack of data on the safe use of the drug in these individuals.

Contraindications

• hypersensitivity to paracetamol, the rutin, fenilefrina, Pheniramine, ascorbic acid and other components included in the composition of the drug;
• simultaneous reception of parazitologiia therapy;
• concomitant use of tricyclic antidepressants, beta-blockers, other sympathomimetic drugs;
• simultaneous or within the preceding 2 weeks inhibitors of monoamine oxidase (MAO);
• severe cardiovascular disease;
• hypertension;
• angle-closure glaucoma;
• the tendency to thrombosis;
• pheochromocytoma, hyperthyroidism;
• portal hypertension;
• alcoholism;
• diabetes mellitus;
• pregnancy the period of breastfeeding;
• phenylketonuria;
• children up to age 12 years;
• hypercalcemia (calcium concentration should not exceed 12 mg%);
• severe hypercalciuria;
• nefrourolitiaz (calcium);
• simultaneous reception of cardiac glycosides (risk of arrhythmias).

Caution

• pronounced coronary atherosclerosis;
• cardiovascular disease;
• acute hepatitis;
• hemolytic anemia;
• severe liver disease or kidney disease;
• enlargement of the prostate gland, difficulty urinating due to prostate hypertrophy;
• blood disease;
• deficiency of glucose-6-phosphate dehydrogenase;
• congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor);
• bronchial asthma;
• chronic malnutrition (deficiency of calories consumed) and dehydration;
• pyloroduodenal obstruction;
• stenosing ulcer of the stomach and/or duodenum;
• epilepsy;
• concomitant use of drugs that can adversely affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes).

Side effects

The frequency of side effects is mainly dose-dependent. Classification of the frequency of side effects (WHO): very common ≥1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100; rare ≥ 1/10000 to < 1/1000;very rare

In therapeutic doses, the drug is usually well tolerated, but the following side effects may occur.

Disorders of 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 – increased excitability, sleep disturbance (when taking the contents of Day bags).

Nervous system disorders: often-drowsiness (when taking the contents of “Night” sachets); rarely-dizziness, headache.

Visual disorders: rarely-mydriasis, paresis of accommodation, increased intraocular pressure.

Cardiac disorders: rarely-tachycardia, palpitation sensation.

Vascular disorders: rarely-increased blood pressure.

Gastrointestinal disorders: often – nausea, vomiting; rarely-dryness of the oral mucosa, constipation, abdominal pain, diarrhea.

Disorders of the liver and biliary tract: rarely-increased activity of liver enzymes. Skin and subcutaneous tissue disorders: rarely-rash, pruritus, erythema, urticaria.

Kidney and urinary tract disorders: rarely-difficulty urinating.

General disorders and reactions at the injection site: rarely-malaise.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Effect of ascorbic acid

When used concomitantly with barbiturates, primidone, tetracycline, the excretion of ascorbic acid in the urine increases.

With 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 blood plasma when it is used simultaneously as part of oral contraceptives.

When used concomitantly with iron preparations, ascorbic acid, due to its reducing properties, converts trivalent iron into divalent iron, which improves its absorption.

Ascorbic acid in high doses can reduce the pH of urine, which, when used simultaneously, reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

When used concomitantly, acetylsalicylic acid reduces the absorption of ascorbic acid by about a third.

When used concomitantly with warfarin, the effects of warfarin may be reduced.

Effect of calcium Gluconate

When administered orally at the same time, calcium gluconate slows down the absorption of tetracyclines, digoxin, and oral iron preparations (the interval between their use should be at least 2 hours).

When used simultaneously under the influence of colestyramine, the absorption of calcium from the gastrointestinal tract decreases.

Calcium gluconate concomitantly reduces the hypotensive effect of calcium channel blockers (intravenous use of calcium gluconate before and after verapamil reduces its hypotensive effect).

During treatment with cardiac glycosides, parenteral use of calcium gluconate is not recommended (it may increase the cardiotoxic effect). Simultaneous use with quinidine may slow 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, and reduce the bioavailability of phenytoin.

The effect of paracetamol

Enhances the effects of MAO inhibitors, sedatives, and ethanol.

The risk of hepatotoxic effects of paracetamol increases with simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes.

The anticoagulant properties of warfarin and other coumarins may be enhanced with prolonged 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 the blood plasma to the maximum. Similarly, domperidone may increase the rate of absorption of paracetamol.

With the combined use of chloramphenicol and paracetamol, the half-life of chloramphenicol may increase.

Paracetamol may reduce the bioavailability of lamotrigine with a possible reduction in its action due to the induction of its hepatic metabolism. Absorption of paracetamol may be reduced when co-administered with colestyramine, but this can be avoided if colestyramine is taken one hour later than paracetamol.

Regular use of paracetamol concomitantly with zidovudine may cause neutropenia and increase the risk of liver damage. Probenecid affects the metabolism of paracetamol. In patients taking probenecid concomitantly, the dose of paracetamol should be reduced.

The hepatotoxicity of paracetamol may increase with chronic or excessive alcohol consumption. Paracetamol may affect the results of a uric acid test using the precipitating reagent phosphoframate.

Effect of rutoside

Ascorbic acid enhances the effects of rutoside.

Effect of phenylephrine

The drug is contraindicated in patients who take or have taken MAO inhibitors in the last 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 may reduce the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisoquine, guanethidine, reserpine, methyldopa). The risk of arterial hypertension increases.

Concomitant use of phenylephrine with digoxin and other cardiac glycosides may increase the risk of arrhythmia or myocardial infarction.

Thyroid hormones increase (mutually) the risk of coronary insufficiency (especially in coronary atherosclerosis).

Alpha-blockers (phentolamine), phenothiazines, furosemide and other diuretics prevent vasoconstriction.

Effect of phenyramine

Other substances may have an increased effect on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers, and narcotic drugs). Phenyramine may inhibit the action of anticoagulants.

How to take, course of use and dosage

Inside. Dissolve the contents of the sachet in one glass (200 ml) of hot, but not boiling, water. Use immediately after dissolution. Stir the solution before use.

Adults and children over 12 years of age should take 1 Day sachet every 4-6 hours, but no more than 3 times a day, and 1 Night sachet in the evening before going to bed (no more than 1 time a day) for no more than 3 days. If there is no relief of symptoms within 3 days after starting taking the drug, you should consult a doctor.

Patients with hepatic insufficiency

Patients with impaired liver function or Gilbert’s syndrome should reduce the dose or increase the interval between doses of the drug.

Patients with renal insufficiency

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, there is no need to adjust the dose.

Overdose

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

Paracetamol

Symptoms (occur after a single dose of 7.5-10 g of paracetamol): in severe cases of overdose, paracetamol has hepatotoxic effects, including liver necrosis. Also, overdose can cause nephropathy with irreversible liver failure.

The severity of overdose depends on the dose, so patients should be warned about the prohibition of simultaneous use of paracetamol-containing drugs. The risk of poisoning is particularly high in elderly patients, in children, in patients with liver diseases, in cases of chronic alcoholism, in patients with chronic malnutrition (lack of calories consumed) and in patients taking inducers of microsomal oxidation in the liver.

An overdose of paracetamol can lead to liver failure, encephalopathy, coma, and death.

Symptoms of 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,4-6 days later, on average 72-96 hours after taking the drug. There may also be a violation of glucose metabolism and metabolic acidosis. Even in the absence of liver damage, acute renal failure and acute tubular necrosis may develop. Cases of cardiac arrhythmia and pancreatitis have been reported with paracetamol overdose.

Treatment: use of acetylcysteine intravenously or orally as an antidote, gastric lavage, oral methionine may have a positive effect for at least the first 48 hours after overdose.

It is recommended to take activated charcoal, monitor respiration and blood circulation. In case of convulsions, diazepam may be prescribed.

Ascorbic acid

Symptoms: if you take more than 1 g per day, you may experience heartburn, diarrhea, difficulty urinating or reddening the urine, and hemolysis (in patients with glucose-6-phosphate dehydrogenase deficiency).

Calcium Gluconate

Symptoms: development of hypercalcemia: nausea, vomiting, severe weakness, thirst, drowsiness, disorientation, confusion, kidney failure. The maximum daily dose for adults and children over 12 years of age is 9 g.

Treatment: calcitonin intravenously drip 5-10 IU / kg per day (the drug is diluted in 500 ml of isotonic sodium chloride solution, administered within 6 hours).

Phenyramine and phenylephrine (overdose symptoms are combined due to the risk of mutual potentiation of the parasympatholytic effect of phenyramine and the sympathomimetic effect of phenylephrine in the case of drug overdose).

Symptoms: drowsiness, which is later accompanied by anxiety (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disorders, coma, convulsions, behavior changes, increased or decreased blood pressure, bradycardia. Cases of atropine-like “psychosis”have been reported with phenyramine overdose.

Treatment. There is no specific antidote. Routine care measures are needed, including the use of activated charcoal, saline laxatives, and cardiac and respiratory support measures. Psychostimulants (methylphenidate) should not be prescribed because of the risk of seizures. With hypotension, vasopressors may be used.

In case of increased blood pressure, intravenous use of alpha-blockers is possible, since phenylephrine is a selective agonist of alpha-1-adrenergic receptors, therefore, the hypertensive effect of an overdose of phenylephrine should be treated by blocking alpha-adrenergic receptors. If seizures develop, use diazepam.

Description

Powder from light yellow to yellow color with a characteristic smell with the presence of white crystals. Flecks of bright yellow color and lumps that easily crumble when pressed are allowed.

Appearance of the drug solution. Clear or opalescent solution of light yellow color with a characteristic smell. Undissolved yellow particles are allowed.

Special instructions

To avoid toxic liver damage, the drug should not be combined with the use of alcoholic beverages.

Patients should consult a doctor if::

• bronchial asthma, emphysema, or chronic bronchitis is present;
• symptoms persist for 5 days or are accompanied by severe fever lasting for 3 days, rash, or persistent headache.

These may be signs of more serious disorders.

The drug contains 200 mg of sodium citrate per sachet. This should be taken into account by patients following a sodium-rich diet.

Do not use the drug from damaged sachets.

Do not take the drug at the same time as other medications containing paracetamol.

Influence on the ability to drive vehicles and mechanisms

Phenyramine, which is part of the contents of the “Night” sachet, can cause drowsiness, so during treatment it is not recommended to drive a car or engage in other activities that require concentration of attention and a high rate of psychomotor reactions.

Form of production

A set of powders for preparing a solution for oral use with lemon flavor, cranberry flavor.

5 g each in heat-sealed bags made of multi-layer combined material.

3 sachets of powder for preparation of oral solution “Day” and 1 sachet of powder for preparation of oral solution “Night”,6 sachets of powder for preparation of oral solution “Day” and 2 sachets of powder for preparation of oral solution “Night”,9 bags of powder for preparation of oral solution “Day” and 3 sachets of powder for preparation of oral solution “Night, ” 12 sachets of powder for preparation of oral solution “Day” and 4 sachets of powder for preparation of oral solution “Night” or 15 bags of powder for preparation of oral solution “Day” and 5 sachets of powder for preparation of oral solution “Night” together with the application instruction in a cardboard pack.

Storage conditions

In a dark place at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Ascorbic Acid, Calcium Gluconate, Paracetamol, Rutoside, Phenylephrine

Dosage form

oral solution