Coldrex Junior powder, No. 10

Coldrex Junior is used in children from 6 to 12 years old as a remedy for the elimination of cold and flu symptoms, including:

• elevated temperature;

• headache;

• chills;

• joint and muscle pain;

• sinus pain and nasal congestion;

• sore throat.

For oral administration.

Do not exceed the indicated dose!

You should use the smallest dose necessary to achieve the effect during the shortest possible period of treatment!

The minimum interval between doses of Coldrex Junior should be at least 4 hours. Pour the contents of 1 sachet into a mug, pour about 125 ml of hot water, stir until dissolved. Add cold water and sugar if necessary.

Children from 6 to 12 years old: 1 sachet every 4 - 6 hours, but no more than 4 sachets per day. The maximum daily dose should not exceed 4 sachets. The maximum duration of using the drug without consulting a doctor is no more than 3 days.

Do not take with other paracetamol-containing products, decongestants and remedies for the relief of cold and flu symptoms, as well as with ethanol-containing products and drinks.

If, while taking the drug, the symptoms of the disease persist, you should consult a doctor.

If the recommended dose is exceeded, seek immediate medical attention, even if you feel well. Paracetamol overdose can cause liver and kidney failure.

Special patient groups

Patients with impaired renal function:

Before using Coldrex Junior, patients with impaired renal function should first consult a doctor. The limitations associated with the use of drugs containing such a combination of active substances in patients with impaired renal function are mainly associated with the content of paracetamol in the drug.

Patients with impaired liver function:

Before using Coldrex Junior, patients with impaired liver function should first consult a doctor. The restrictions associated with the use of drugs containing this combination of active substances in patients with impaired liver function are mainly associated with the content of paracetamol in the drug.

Active ingredients:

Paracetamol 300.0

Phenylephrine hydrochloride 5.0

Ascorbic acid 20.0

Excipients:

Sodium saccharinate 21.5

Sodium cyclamate 31.5

Anhydrous citric acid 340.0

Sodium citrate 215.0

Dry corn starch 100.0

Sucrose 1862.5

Lemon flavor PHS-163671 100.0

Curcumin (E 100) 3.5 Colloidal silicon dioxide 1.0

Coldrex Junior is not recommended for patients with:

Hypersensitivity to paracetamol, phenylephrine, ascorbic acid (vitamin C) or any other component of the drug;

Severe liver and kidney dysfunctions;

Ј Diseases of the blood system;

Thyrotoxicosis;

Arterial hypertension;

Hyperfunction of the thyroid gland (including thyrotoxicosis);

Ј Heart diseases (with severe stenosis of the aortic orifice, acute myocardial infarction, tachyarrhythmias);

Ј Hyperplasia of the prostate gland;

Ј Diabetes mellitus and diseases associated with hereditary disorders of sugar absorption;

Ј Genetic absence of glucose-6-phosphate dehydrogenase;

Deficiency of sucrase / isomaltase, with fructose intolerance, glucose-galactose malabsorption, because the preparation contains sucrose;

Ј Angle-closure glaucoma;

Ј Simultaneous administration of tricyclic antidepressants, beta-blockers and other antihypertensive drugs, MAO inhibitors, including in the period up to 14 days after their cancellation;

Ј Simultaneous administration of other paracetamol-containing drugs, decongestants, non-narcotic analgesics, non-steroidal anti-inflammatory drugs, drugs to relieve symptoms of 'colds', flu and nasal congestion, appetite-regulating drugs, amphetamine-like psychostimulants, barbiturates, anti-colds. section 'Interaction with other medicinal products');

Ј Simultaneous intake of ethanol-containing drinks and medications;

Ј Children under 6 years of age.

Carefully

If your child has one of the listed diseases / conditions / risk factors, be sure to consult with your doctor before taking the drug:

Ј Benign hyperbilirubinemia.

Ј Dysfunction of the liver and kidneys of mild to moderate severity.

Ј Diseases of the prostate and urinary problems.

Ј Cardiovascular diseases, including high blood pressure, obliterating vascular disease (Raynaud's syndrome).

Glaucoma (excluding angle-closure glaucoma).

Ј Pheochromocytoma.

Ј The presence of severe infections, including sepsis, because taking the drug may increase the risk of metabolic acidosis.

Ј Patients with glutathione deficiency (particularly in severely malnourished patients with anorexia, chronic alcoholism, or patients with a low body mass index).

Coldrex Junior is a combined preparation. It is used in children 6-12 years old to eliminate the symptoms of flu and colds, such as:
Х fever
Х headache
Х chills
Х pain in joints and muscles
Х feeling of nasal congestion
Х pain in the sinuses and throat. *

* Instructions for medical use , RU P N015713 / 01 '

Pharmacodynamics

Combined remedy, the action of which is due to its constituent components. Paracetamol is an analgesic and antipyretic agent. Its mechanism of action is supposedly to suppress the synthesis of prostaglandins, mainly in the central nervous system. Does not affect platelet function and hemostasis.

Paracetamol has practically no effect on the synthesis of prostaglandins in peripheral tissues, it does not change water-electrolyte metabolism and does not damage the mucous membrane of the gastrointestinal tract. Phenylephrine hydrochloride is a sympathomimetic agent, the action of which is aimed at stimulating adrenergic receptors (mainly ?-adrenergic receptors) and vasoconstriction, which leads to a decrease in swelling of the nasal mucosa and facilitates nasal breathing.

Ascorbic acid (vitamin C) replenishes the increased need for vitamin C in case of colds and flu, especially in the initial stages of the disease.

The components of the drug do not cause drowsiness and do not disturb concentration.

Pharmokinetics

Absorption and distribution

Paracetamol: absorption of paracetamol in the gastrointestinal tract is high. Time to reach maximum plasma concentration - 0.5 - 2 hours; the maximum plasma concentration is 5-20 ?g / ml. Communication with blood plasma proteins - 15%. Penetrates the blood-brain barrier.

Phenylephrine hydrochloride is unevenly absorbed in the gastrointestinal tract. The maximum plasma concentration is reached in the range from 45 minutes to 2 hours.

Ascorbic acid is rapidly absorbed in the gastrointestinal tract and is distributed throughout the body. The connection with blood plasma proteins is 25%.

Metabolism

Paracetamol is metabolized mainly in the liver (90 - 95%) in three main ways: 80% enters into conjugation reactions with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergo hydroxylation to form 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug.

Phenylephrine hydrochloride undergoes primary metabolism by monoamine oxidases in the intestine and liver. Thus, with oral administration, the bioavailability of phenylephrine decreases.

Withdrawal

Paracetamol is excreted by the kidneys in the form of metabolites, mainly glucuronide and sulfate conjugates, about 3% is excreted unchanged. The half-life is 1-4 hours.

Phenylephrine hydrochloride is excreted by the kidneys almost completely in the form of sulfate conjugates. The withdrawal period is 2-3 hours.

When used in doses exceeding the body's requirements for ascorbic acid, ascorbic acid is excreted by the kidneys in the form of metabolites

Overdose

The drug should be taken only in the recommended doses!

If you suspect an overdose, even if you feel well, you must stop using the drug and immediately consult a doctor, because there is a risk of delayed serious liver damage and may require hospitalization.

Overdose is usually caused by paracetamol.

Symptoms (due to paracetamol)

In case of an overdose of paracetamol, liver failure may develop, which can lead to the need for liver transplantation or death.

Within 24 hours, it is possible: pallor of the skin, decreased appetite, nausea, vomiting, stomach pain, sweating. Signs of liver dysfunction may appear within 12-48 hours. Signs of impaired glucose metabolism and metabolic acidosis may appear. Clinical signs of liver damage develop, as a rule, after 24 - 48 hours and reach a maximum after 4 - 6 days. In the case of severe poisoning, severe liver failure can develop up to hepatic encephalopathy, the need for a liver transplant, coma and death. Acute renal failure with acute tubular necrosis, diagnosed by severe lumbar pain, hematuria, and proteinuria, can develop without severe liver dysfunction. There have been reports of cases of cardiac arrhythmias and acute pancreatitis with paracetamol overdose.

At the first signs of an overdose, it is necessary to urgently consult a doctor, even in the absence of distinct symptoms of poisoning. In the early period, symptoms may be limited only by nausea and vomiting and may not reflect the severity of the overdose or the degree of risk of damage to internal organs.

Treatment: within the first hour after the alleged overdose, it is advisable to prescribe activated charcoal inside. Four or more hours after the alleged overdose, it is necessary to determine the concentration of paracetamol in the blood plasma (an earlier determination of the concentration of paracetamol may be unreliable). Treatment with acetylcysteine ??can be carried out up to 24 hours after taking paracetamol, however, the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine ??can be administered intravenously. In the absence of vomiting, an alternative option (in the absence of the possibility of quick inpatient care) is to administer methionine by mouth.Treatment of patients with serious liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or a specialized department of liver diseases.

Symptoms (due to phenylephrine)

Symptoms of a phenylephrine overdose are similar to those of side effects. In addition: increased blood pressure, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, seizures, arrhythmias may develop. It should be borne in mind that the appearance of clinically significant symptoms of phenylephrine overdose when taking the drug is always associated with severe liver damage against the background of an overdose of paracetamol.

Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine.

Symptoms (due to ascorbic acid)

High doses of ascorbic acid (over 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances such as nausea and stomach discomfort. It should be borne in mind that the appearance of clinically significant symptoms of an overdose of ascorbic acid when taking the drug is always associated with severe liver damage against the background of an overdose of paracetamol.

Treatment: symptomatic, forced diuresis.

Side effects

Paracetamol

Blood and lymphatic system disorders:

Very rare: thrombocytopenia.

Immune system disorders:

Very rare: anaphylactic shock, skin hypersensitivity reactions, including skin rash, urticaria, angioedema (Quincke's edema), Stevens-Johnson syndrome, toxic epidermal necrolysis.

Respiratory, chest and mediastinal disorders:

Very rare: bronchospasm in patients with hypersensitivity to acetylsalicylic acid and intolerance to other nonsteroidal anti-inflammatory drugs.

Liver and biliary tract disorders:

Very rare: liver dysfunction.

Urinary system disorders:

With prolonged use of the drug in doses exceeding the recommended, the likelihood of nephrotoxic effects increases.

Phenylephrine

Nervous system disorders:

Often: nervousness, irritability, headache, dizziness, insomnia, irritability.

Cardiovascular disorders:

Often: increased blood pressure.

Rarely: tachycardia, palpitations that disappear immediately after discontinuation of the drug.

Violation of the gastrointestinal tract:

Often: nausea, vomiting.

Violations of the organ of vision:

Rare: mydriasis, an acute attack of angle-closure glaucoma in most cases in patients with angle-closure glaucoma.

Immune system disorders:

Rarely: allergic reactions (skin rash, urticaria, allergic dermatitis).

Urinary system disorders:

Rarely: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.

If any of the listed adverse reactions occur, stop taking the drug immediately and consult a doctor as soon as possible.

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

Ћекарственное взаимодействие

ѕарацетамол при приеме в течение длительного времени усиливает эффект непр¤мых антикоагул¤нтов (варфарин и другие кумарины), что увеличивает риск кровотечений. Ёпизодический прием разовой дозы препарата не оказывает значимого вли¤ни¤ на действие непр¤мых антикоагул¤нтов.

»ндукторы ферментов микросомального окислени¤ в печени (барбитураты, дифенин, карбамазепин, рифампицин, зидовудин, фенитоин, этанол, флумецинол, фенилбутазон и трициклические антидепрессанты) повышают риск гепатотоксического действи¤ при передозировках и одновременном приеме с парацетамолом.

»нгибиторы микросомального окислени¤ (циметидин) снижают риск гепатотоксического действи¤. ѕарацетамол снижает эффективность диуретических препаратов.

ћетоклопрамид и домперидон увеличивают, а колестирамин снижает скорость всасывани¤ парацетамола. ѕарацетамол усиливает эффекты ингибиторов ћјќ, седативных препаратов, этанола.

ќдновременный прием парацетамола и алкогольных напитков повышает риск развити¤ поражени¤ печени и острого панкреатита.

‘енилэфрин при приеме с ингибиторами ћјќ может приводить к повышению артериального давлени¤. ‘енилэфрин снижает эффективность действи¤ бета-адреноблокаторов и других гипотензивных препаратов (включа¤ дебризохин, гуанетидин, резерпин, метилдопу), увеличивает риск развити¤ артериальной гипертензии и нарушений со стороны сердечно-сосудистой системы.

“рициклические антидепрессанты (например, амитриптилин) усиливают симпатомиметическое действие фенилэфрина и могут увеличивать риск развити¤ побочных эффектов со стороны сердечно-сосудистой системы.

ќдновременное назначение галотана с фенилэфрином повышает риск развити¤ желудочковой аритмии. ќдновременный прием препарата и алкалоидов спорыньи (эрготамин и метилсергид) увеличивает риск возникновени¤ эрготизма.

јнтидепрессанты, противопаркинсонические средства, антипсихотические средства, фенотиазиновые производные повышают риск развити¤ задержки мочи, сухости во рту, запоров.

ќдновременное применение глюкокортикостероидов с фенилэфрином увеличивает риск развити¤ глаукомы.

ќдновременное применение дигоксина и других сердечных гликозидов повышает риск развити¤ нарушени¤ сердечного ритма и сердечного приступа.

ќдновременное применение фенилэфрина с симпатомиметическими аминами может повышать риск развити¤ побочных эффектов со стороны сердечно-сосудистой системы.

јскорбинова¤ кислота при одновременном применении с препаратами железа, благодар¤ своим восстанавливающим свойствам, переводит трехвалентное железо в двухвалентное, что способствует улучшению его абсорбции. ѕри одновременном применении аскорбинова¤ кислота повышает экскрецию железа у пациентов, получающих дефероксамин.

ѕри одновременном применении с барбитуратами, примидоном повышаетс¤ экскреци¤ аскорбиновой кислоты с мочой. јскорбинова¤ кислота в высоких дозах может снижать рЌ мочи, что при одновременном применении уменьшает канальцевую реабсорбцию амфетамина и трициклических антидепрессантов.

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. With simultaneous use with tetracycline, the excretion of ascorbic acid increases.