Coldrex sachets instructions for use. Coldrex Hotrem - instructions for use. The Coldrex line of drugs includes the following options:

Drug for symptomatic therapy acute respiratory diseases

Active ingredients

Release form, composition and packaging

Powder for oral solution (lemon) light yellow color, with a characteristic lemon smell; the prepared solution is yellow in color, with a characteristic lemon smell.

* in the form of ascorbic acid coated with ethylcellulose - 61.5 mg (contains 1.5 mg of ethylcellulose).

Excipients: sucrose - 2904.42 mg, sodium citrate dihydrate - 500 mg, lemon acid anhydrous - 600 mg, sodium saccharinate - 40 mg, lemon flavor P0551 - 50 mg, lemon flavor 52293/TP0551 - 83.33 mg, quinoline yellow dye (E104) - 0.75 mg.

5 g - laminate bags (5) - cardboard packs.
5 g - laminate bags (10) - cardboard packs.

pharmachologic effect

A combined drug whose effect is determined by its constituent components.

Paracetamol is an analgesic and antipyretic agent. The mechanism of its action is presumably to suppress the synthesis of prostaglandins, mainly in the central nervous system. Paracetamol has an extremely small effect on the synthesis of prostaglandins in peripheral tissues; it does not change water-electrolyte metabolism and does not damage the gastrointestinal mucosa. This property of paracetamol makes the drug particularly suitable for patients with a history of gastrointestinal diseases (for example, patients with gastrointestinal bleeding history or elderly patients) or patients taking concomitant drug treatment, in which suppression of peripheral prostaglandin synthesis may be undesirable.

Phenylephrine hydrochloride- a sympathomimetic agent, the action of which is aimed at stimulating adrenergic receptors (mainly α-adrenergic receptors), which leads to a reduction in swelling of the nasal mucosa and easier nasal breathing.

Ascorbic acid () replenishes the increased need for vitamin C during colds and flu, especially during initial stages diseases.

The components included in the drug do not cause drowsiness and do not impair concentration.

Pharmacokinetics

Suction and distribution

Paracetamol quickly and almost completely absorbed from the gastrointestinal tract. Binding to blood proteins is minimal when used at therapeutic concentrations.

Phenylephrine hydrochloride unevenly absorbed from the gastrointestinal tract.

Ascorbic acid quickly absorbed from the gastrointestinal tract and distributed throughout the body. Plasma protein binding is 25%.

Metabolism

Paracetamol metabolized primarily in the liver.

Phenylephrine hydrochloride undergoes primary metabolism of MAO in the intestines and liver. Thus, when oral administration the bioavailability of phenylephrine is reduced.

Removal

Paracetamol excreted by the kidneys in the form of metabolites, mainly glucuronide and sulfate conjugates, less than 5% of the dose taken is excreted unchanged.

Phenylephrine hydrochloride excreted almost completely by the kidneys in the form of sulfate conjugates.

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

Indications

In adults (including elderly patients) and children over 12 years of age to eliminate symptoms of acute respiratory infections and flu, including:

- increased body temperature;

headache;

- pain in joints and muscles;

- pain in the sinuses;

- nasal congestion;

- a sore throat.

Contraindications

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

- severe liver and kidney dysfunction;

arterial hypertension;

- hyperfunction thyroid gland(including thyrotoxicosis);

— diseases of the blood system;

- heart disease (severe stenosis of the aortic mouth, acute heart attack myocardium, tachyarrhythmia);

- hyperplasia prostate gland;

- angle-closure glaucoma;

- diseases accompanied by portal hypertension;

diabetes;

— chronic alcoholism;

- diseases associated with hereditary disorder sugar absorption - each sachet contains about 4 g of sugar;

- genetic absence of glucose-6-phosphate dehydrogenase;

- sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, because the drug contains sucrose;

- simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors, incl. within a period of up to 14 days after their cancellation;

- simultaneous use of other paracetamol-containing drugs medicines, decongents, non-narcotic analgesics, NSAIDs, medicines to relieve symptoms of colds, flu and nasal congestion, drugs that regulate appetite, amphetamine-like psychostimulants, barbiturates, rifampicin, chloramphenicol;

- simultaneous intake of ethanol-containing drinks and medications;

- age up to 12 years.

Carefully

Benign hyperbilirubinemia.

Mild to moderate liver and kidney dysfunction.

Alcoholic liver disease.

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

Pheochromocytoma.

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

Patients with glutathione deficiency (in particular, extremely malnourished patients suffering from anorexia, chronic alcoholism or patients with a low BMI).

Concomitant use of antihypertensive drugs.

Pregnancy.

Breastfeeding period.

If the patient has one of the listed diseases/conditions/risk factors, he should consult a doctor before taking the drug.

Dosage

For oral administration.

Do not exceed the indicated dose.

The smallest dose necessary to achieve effect should be used.

The minimum interval between doses of Coldrex HotRem should be 4 hours.

Place the contents of one sachet in a mug and pour half of the mug hot water. Stir until dissolved. Add cold water, if necessary, and sugar to taste.

Adults (including elderly) and children over 12 years of age: single dose - 1 sachet. Repeated use of the drug is possible no earlier than after 4-6 hours and no more than 4 times a day. Maximum daily dose should not exceed 4 sachets.

The maximum duration of use of the drug without consulting a doctor is no more than 5 days.

Do not take simultaneously with other paracetamol-containing products, decongestants and cold and flu relief products, as well as ethanol-containing products and drinks.

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

patients with impaired renal function You must first consult your doctor. Restrictions associated with the use of drugs containing this combination active substances, in patients with impaired renal function are predominantly associated with the paracetamol content of the drug.

Before using Coldrex HotRem patients with liver dysfunction You must first consult your doctor. Restrictions associated with the use of drugs containing this combination of active substances in patients with impaired liver function are mainly associated with the paracetamol content of the drug.

Side effects

The following adverse reactions were detected spontaneously during post-registration use of the drug.

Adverse reactions are classified according to body systems and according to the frequency of development. Frequency determination side effects: very often (≥1/10), often (≥1/100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000), очень редко (≥1/100 000 и <1/10 000), частота неизвестна (частота не может быть оценена, исходя из имеющихся данных).

Paracetamol

Paracetamol rarely has side effects.

very rarely - thrombocytopenia, leukopenia, agranulocytosis.

From the immune system: very rarely - anaphylactic shock, skin hypersensitivity reactions, including skin rash, urticaria, angioedema (Quincke's edema), Stevens-Johnson syndrome; frequency unknown - toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis.

From the respiratory system: very rarely - bronchospasm in patients with hypersensitivity to and intolerance to other NSAIDs.

From the liver and biliary tract: very rarely - liver dysfunction; frequency unknown - increased activity of liver enzymes.

with long-term use of the drug in doses exceeding the recommended one, the likelihood of nephrotoxicity increases.

Phenylephrine

From the nervous system: very rarely - nervousness, irritability, headache, dizziness, insomnia.

From the cardiovascular system: very rarely - increased blood pressure, tachycardia, palpitations.

very rarely - nausea, vomiting.

From the side of the organ of vision: very rarely - mydriasis, an acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

From the immune system: very rarely - allergic reactions (skin rash, urticaria, allergic dermatitis).

From the urinary system: very rarely - dysuria, urinary retention in patients with obstruction of the bladder outlet due to prostatic hypertrophy.

Ascorbic acid

The frequency of side effects has not been established.

From the immune system: allergic reactions (skin rash, skin hyperemia).

From the digestive system: irritation of the gastrointestinal mucosa.

From the blood and lymphatic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

When taking ascorbic acid more than 600 mg/day, moderate pollakiuria is possible.

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

If any of the above adverse reactions worsen, or the patient notices other adverse reactions, he should inform the doctor.

Overdose

If you suspect an overdose, even if you feel well, you must stop using the drug and consult a doctor immediately, because there is a risk of delayed serious liver damage. Overdose is usually caused by paracetamol.

Symptoms caused by paracetamol: liver failure may develop, which may lead to the need for liver transplantation or death.

Within 24 hours it is possible: pale skin, anorexia, nausea, vomiting, abdominal pain. Signs of liver dysfunction may appear within 12-48 hours. Signs of impaired glucose metabolism and metabolic acidosis (including lactic acidosis) may appear. Toxic effects in adults are possible after taking more than 10 g of paracetamol. In cases of severe poisoning, severe liver failure may develop, including hepatic encephalopathy, the need for a liver transplant, coma and death.

Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without severe impairment of liver function. There have been reports of cases of cardiac arrhythmia, hypokalemia and pancreatitis following an overdose of paracetamol.

Taking 5 g or more of paracetamol may cause liver damage in patients with the following risk factors:

Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort preparations, or other drugs that stimulate liver enzymes;

Regular consumption of alcohol in excess quantities;

Glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).

Treatment: At the first signs of an overdose, you should immediately consult a doctor, even in the absence of clear symptoms of poisoning. In the early period, symptoms may be limited only to nausea and vomiting and may not reflect the severity of the overdose or the risk of damage to internal organs.

During the first hour after the expected overdose, it is advisable to administer activated carbon orally. 4 or more hours after the expected overdose, it is necessary to determine the concentration of paracetamol in the blood plasma (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 this, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine ​​can be administered intravenously. In the absence of vomiting, an alternative option (if it is not possible to quickly obtain hospital care) is to prescribe methionine orally. Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department.

Symptoms caused by phenylephrine: Symptoms of phenylephrine overdose are similar to side effects. In addition: irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, convulsions, and 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 due to an overdose of paracetamol.

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

Symptoms caused by ascorbic acid: when using 1000 mg or more ascorbic acid, headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the gastrointestinal mucosa, inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosuria), hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).

High doses of ascorbic acid (more than 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 due to an overdose of paracetamol.

Treatment: symptomatic, forced diuresis.

Drug interactions

Paracetamol when taken for a long time, it enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Occasional administration of a single dose of the drug does not have a significant effect on the effect of indirect anticoagulants.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in overdoses and concomitant use with paracetamol.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of diuretics.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.

Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol.

Phenylephrine when taken with MAO inhibitors, it can lead to an increase in blood pressure.

Phenylephrine reduces the effectiveness of beta-blockers and (including debrisoquine, guanethidine, reserpine and methyldopa), increases the risk of developing hypertension and cardiovascular disorders.

Concomitant use of phenylephrine with sympathomimetic amines may increase the risk of adverse cardiovascular effects.

Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine and may increase the risk of side effects from the cardiovascular system.

Concomitant use of halothane with phenylephrine increases the risk of developing ventricular arrhythmia.

Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenergic stimulating activity of phenylephrine.

Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.

The simultaneous administration of GCS with phenylephrine increases the risk of developing glaucoma.

When used simultaneously with digoxin and cardiac glycosides, the risk of developing heart rhythm disturbances or a heart attack may increase.

Ascorbic acid increases the risk of developing crystalluria during treatment with salicylates and short-acting sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), and reduces the concentration of oral contraceptives in the blood.

Ethanol contributes to the development of acute pancreatitis.

Myelotoxic drugs enhance the hematotoxicity of the drug.

special instructions

The drug should not be taken simultaneously with other paracetamol-containing drugs, as well as other non-narcotic analgesics, metamizole sodium, NSAIDs (including acetylsalicylic acid, ibuprofen), drugs to eliminate the symptoms of colds and flu, sympathomimetics (decongestants, drugs that regulate appetite , amphetamine-like psychostimulants), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

To avoid toxic liver damage, the drug should not be combined with ethanol-containing drugs and drinks, or taken by people prone to chronic alcohol consumption.

Concomitant liver disease increases the risk of further liver damage while taking the drug. When taking the drug in patients with non-alcoholic cirrhosis of the liver, there is a high risk of overdose.

Patients with glutathione deficiency due to an eating disorder, dietary fibrosis, HIV infection, starvation, malnutrition are susceptible to overdose, so precautions must be taken and it is recommended to consult a doctor before taking the drug. Cases of liver failure/impaired liver function have been reported with a small overdose of paracetamol (5 g or more) in patients with low glutathione levels, in particular in extremely malnourished patients suffering from anorexia, chronic alcoholism or patients with a low BMI.

Use of the drug in patients with low levels of glutathione, for example, with sepsis, may increase the risk of developing metabolic acidosis, accompanied by symptoms of rapid, difficult breathing (feeling short of breath, shortness of breath), nausea, vomiting, loss of appetite. If these symptoms occur simultaneously, you should immediately consult a doctor.

The drug is not recommended for patients suffering from phenylketonuria, because it contains aspartame, which is a source of phenylalanine.

Before taking Coldrex HotRem, the patient should consult a doctor if using the following medications:

Warfarin or other indirect anticoagulants to reduce blood clotting;

Metoclopramide, domperidone (used to relieve nausea and vomiting), or cholestyramine, used to lower blood cholesterol;

If necessary, follow a hyposodium diet.

When conducting tests to determine uric acid and blood glucose levels, the patient must inform the doctor about the use of the drug Coldrex HotRem, because the drug may distort the results of laboratory tests assessing the concentration of glucose and uric acid.

Impact on the ability to drive vehicles and machinery

The drug may cause dizziness. If dizziness occurs, it is not recommended to drive vehicles or operate machinery.

Pregnancy and lactation

Pregnancy

The drug should not be used during pregnancy without first consulting a doctor.

Experimental studies in animals and clinical studies in humans have not shown any risk of using paracetamol during pregnancy or adverse effects on fetal development.

There are no sufficient data on the effect of drugs containing phenylephrine on the course of pregnancy.

The maximum daily dose of ascorbic acid during pregnancy is 2000 mg, which significantly exceeds the maximum daily dose of the drug, so taking the drug in pregnant women is presumably not associated with the risk of side effects from ascorbic acid.

Breastfeeding period

The drug should not be used during breastfeeding without first consulting a doctor.

Paracetamol penetrates the placental barrier and is excreted in breast milk. Clinical studies in humans have not shown any negative effects on the baby's body during breastfeeding.

Phenylephrine may be excreted in breast milk.

The maximum daily dose of ascorbic acid during breastfeeding is 2000 mg, which significantly exceeds the maximum daily dose of the drug, so taking the drug in women during breastfeeding is not associated with side effects from ascorbic acid.

Fertility

There is no sufficient data on the effect of the drug on fertility.

Content

Respiratory diseases are easier to treat at the first manifestations. If you notice symptoms of a cold or infection, you can use Coldrex. Each of its forms is freely sold in pharmacies. Therapy with this drug, if the dosage regimen and manufacturer's instructions are followed, does not cause negative reactions. To avoid adverse health effects, consult your doctor.

Instructions for use of Coldrex

The drug Coldrex is in most cases well tolerated by patients, so doctors often recommend it at the first manifestations of respiratory ailments. For therapy to be effective, the drug must be taken in strict accordance with the instructions. Deviations from the recommended dosage regimen or use in the presence of contraindications can cause a number of negative consequences.

Composition of Coldrex

The drug is available in the form of tablets, syrup or water-soluble powder. Each form of medicine has a specific composition:

Name

Release form

Active ingredients

Excipients

Coldrex

Pills

Phenylephrine, caffeine, vitamin C, paracetamol.

Corn starch, povidone, sodium lauryl sulfate, stearic acid, potassium sorbate, color.

Coldrex Hotrem

Paracetamol, ascorbic acid, phenylephrine hydrochloride.

Citric acid, sucrose, sodium cyclamate, corn starch, sodium citrate, flavoring, sodium saccharin.

Coldrex Maxgripp

Vitamin C, paracetamol, phenylephrine.

Flavouring, sodium citrate, citric acid, sodium saccharinate, corn starch, sodium cyclamate, color, colloidal silicon dioxide, sucrose.

Coldrex Broncho

Guaifenesin

Molasses, dextrose, glacial acetic acid, sodium cyclamate, macrogol 300, coloring, sodium benzoate, red pepper tincture, flavoring, sodium metabisulfite, acesulfame K, star anise seed oil, xanthan gum, levomenthol, racemic camphor, water.

Coldrex Knight

Paracetamol, promethazine hydrochloride, dextromethorphan hydrobromide.

Ethanol (96%), sodium cyclamate, liquid dextrose, macrogol 300, flavor oil, acesulfame K, sodium acid citrate, color, sodium benzoate, water.

Pharmacodynamics and pharmacokinetics

The peculiarities of the action of the drug are determined by its composition. The active components of the drug have the following pharmacodynamics and pharmacokinetics:

  • Paracetamol is an analgesic whose effect is based on inhibition of the synthesis of prostaglandins in the central nervous system. The substance affects the hypothalamus and has an antipyretic effect. Paracetamol is absorbed in the gastrointestinal tract, its biosynthesis occurs in the liver. The substance is excreted in the urine.
  • Ascorbic acid - replenishes the lack of vitamin C, characteristic of the initial stages of infectious diseases, normalizes capillary permeability, strengthens the body's immune system. Absorption of the substance occurs in the gastrointestinal tract, after which it is quickly transported through the tissues. Residues of ascorbic acid are excreted during urination.
  • Caffeine has a stimulating effect on the central nervous system and the secretory function of the stomach, helps reduce platelet aggregation, dilate blood vessels, enhance the analgesic effect of paracetamol, and increase diuresis. After oral administration, the substance is easily absorbed. The maximum concentration of caffeine in blood plasma occurs after 60 minutes. The half-life of the substance is 3.5 hours.
  • Phenylephrine helps ease breathing and relieve swelling of the nasal mucosa. Absorption occurs unevenly in the gastrointestinal tract. The bioavailability of the substance when taken orally is reduced. Phenylephrine is excreted in the urine.

Indications for use

The drug is prescribed to relieve symptoms of colds and flu. According to the instructions for use, the medication fights several manifestations of diseases:

  • pain in muscles and joints;
  • high body temperature;
  • nasal congestion;
  • headache;
  • chills;
  • pain in the throat, sinuses.

Directions for use and dosage

All forms of Coldrex must be taken orally in the manner indicated in the instructions. The recommended course duration and dosage of the drug should be carefully observed to reduce the risk of side effects. If it is necessary to increase the duration of therapy or if unwanted symptoms are detected, you should contact a specialist.

Coldrex tablets

Children over 12 years of age and adults are prescribed 2 Coldrex tablets 4 times a day. A child aged 6-12 years is recommended to take 1 pill four times a day. It is prohibited to exceed the recommended dose of the drug. The maximum duration of treatment for colds and flu using tablets is 5 days. If symptoms persist, it is necessary to consult a specialist to change the treatment strategy or increase the course of medication.

Syrup

As an expectorant that promotes the production of secretions from the bronchial glands, Broncho syrup is prescribed to elderly patients, adults and children over 12 years of age, 10 ml 1-3 times a day. The viscous liquid must be poured into a measuring cup to the desired level and drunk. For children from 3 to 6 years old, the permitted single dose is 5 ml. Knight syrup is recommended to be taken 1 time/day before bedtime. Adult patients are prescribed 4 scoops (20 ml). It is recommended to give 10 ml of medicine to children under 12 years of age.

Coldrex powder

The contents of the Hotrem or Maxigrip sachets must be filled with a 200 ml glass of hot water and stirred until the powder is completely dissolved. Adults are recommended to take 1 sachet every 4-6 hours. Maximum quantity – 4 sachets per day. Children over 12 years of age are recommended to drink the drink every 6 hours. You should not drink more than 3 sachets per day. The drug should not be used for more than 5 days.

special instructions

Patients taking the drug should avoid drinking alcohol during therapy to avoid toxic liver damage. Patients who are dependent on alcohol are prohibited from using the medication. The drug can cause dizziness, so during treatment you should avoid activities that require increased concentration and rapid psychomotor reactions (driving a car, operating complex and dangerous mechanisms).

During pregnancy

The period of bearing a child and breastfeeding is a contraindication to the use of the medication. A doctor must decide on the possibility of using medication for the treatment of colds and viral diseases during pregnancy. If treatment is necessary for a woman during lactation, it is recommended to stop breastfeeding, since paracetamol entering the child’s body can cause a toxic effect.

Coldrex for children

The drug in children should be taken strictly according to the instructions. The line of medications includes Coldrex Junior. It is prescribed to children aged 6 to 12 years. The product is a powder that should be dissolved in 125 ml of hot water. It is recommended to drink 1 sachet every 4 hours. In this case, the maximum dose of medication per day should not exceed 4 sachets. Therapy is allowed to continue for no more than 5 days. If the symptoms of the disease do not disappear, you should consult a doctor.


Drug interactions

Experts do not recommend simultaneous use of the drug with beta-blockers, monoamine oxidase inhibitors, and tricyclic antidepressants. There should be a break of at least 2 weeks between the use of these medications. The combined use of Coldrex with the following drugs can have an adverse effect on the body:

  • Cholestyramine - the rate of absorption of paracetamol is reduced.
  • Rifampicin, barbiturates, zidovudine, carbamazepine, and other inducers of microsomal liver enzymes increase the possibility of developing a hepatotoxic effect.
  • Isoniazid, Cimetidine, hormonal contraceptives - the activity of caffeine increases, which can cause nervous excitement, anxiety, and rapid heartbeat.
  • Indirect anticoagulants, Heparin, diuretics - the effectiveness of these drugs is reduced.
  • Metoclopramide, domperidone - paracetamol is absorbed too quickly.

Side effects

When taking the recommended doses, the drug is well tolerated by patients. Long-term therapy may cause nephrotoxic or hepatotoxic effects. During treatment, it is not recommended to drink coffee or strong tea, as there is a risk of increasing the negative effects of caffeine. Coldrex tablets rarely cause adverse reactions:

  • bronchospasm (if the patient is sensitive to non-steroidal anti-inflammatory drugs);
  • thrombocytopenia;
  • cardiopalmus;
  • dizziness, nervous tension, irritability, headache, insomnia;
  • nausea, vomiting, liver dysfunction;
  • skin rash, Quincke's edema, dermatitis, urticaria, anaphylactic shock, Stevens-Johnson syndrome;
  • disturbances in the process of urine excretion;
  • attack of glaucoma.

Overdose

If the patient has exceeded the recommended dose of the drug, the medication should be stopped even if the condition does not worsen, then go to the hospital. An overdose of Coldrex can be manifested by nausea, pallor of the skin, hepatonecrosis, impaired liver function, vomiting, and a decrease in the intensity of the feeling of hunger.

In adult patients, the toxic effects of paracetamol are detected after taking 10-15 g of the substance. In this case, an increase in the activity of liver transaminases is possible. For treatment, gastric lavage, sorbents, administration of N-acetylcysteine, and SH-group donors are prescribed. Exceeding the dose of terpinhydrate can provoke gastrointestinal disorders - the patient will require symptomatic therapy.

An overdose of caffeine is manifested by increased urination, arrhythmia, pain in the epigastric region, sleep disturbance, vomiting, increased nervous excitability, anxiety, tachycardia, convulsions, and tremor. If severe arterial hypertension occurs, the patient requires treatment with alpha blockers. Consuming excess amounts of ascorbic acid can cause abdominal pain, nausea, and diarrhea. A patient with an overdose of vitamin C is prescribed forced diuresis and symptomatic therapy.

Coldrex contraindications

  • leukopenia;
  • individual intolerance to one or more substances included in the medication;
  • diseases of the circulatory system;
  • impaired renal and liver function;
  • diseases of the cardiovascular system of organic origin;
  • thrombophlebitis;
  • epilepsy;
  • insomnia;
  • severe atherosclerosis;
  • decompensated heart failure;
  • glaucoma;
  • alcoholism;
  • cardiac ischemia;
  • severe anemia;
  • prostate hypertrophy;
  • pregnancy and lactation;
  • hyperthyroidism;
  • severe arterial hypertension;
  • thrombosis;
  • acute pancreatitis;
  • the presence of a tendency to vascular spasms;
  • poor cardiac conduction;
  • severe diabetes mellitus.

Terms of sale and storage

The drug is approved as an over-the-counter product. The medicine must be stored in a dry place at room temperature and should be kept away from children. The shelf life of the medicine depends on the form of release and is 2-4 years from the date of manufacture.

Analogs

If the product is not available on pharmacy shelves, it can be replaced with other medications. There are several medications similar to Coldrex in composition or properties:

  • Aurora Hot Sip is a drug for the treatment of colds. Available in the form of a powder intended for preparing a solution. The Coldrex analogue is well tolerated by patients. The medication has a number of contraindications, so before use you must carefully study the instructions. Drink a hot solution prepared from the contents of an Aurora Hot Sip sachet and water 4 times a day, avoiding consumption on an empty stomach.
  • Adzhikold - tablets designed to eliminate the symptoms of respiratory infections. The active ingredients of the product are: paracetamol, caffeine, phenylephrine hydrochloride. The tablets have analgesic, antipyretic, decongestant and antiallergic effects. Adjikold has a small list of contraindications - its use is prohibited for children under 6 years of age, pregnant and lactating women, and people with hypersensitivity to the components of the medicine. Adults are prescribed 1-2 pills 3-4 times/day, children – 1 tablet 1-4 times/day.
  • Coldrin - helps cope with febrile syndrome, acute rhinitis during colds and infectious diseases. Available in the form of tablets, which contain caffeine, paracetamol, chlorphenamine, phenylephrine. The drug has many contraindications - it is recommended to consult a doctor before use. Adults need to take 1-2 pills every 4-6 hours. The maximum dose is 12 tablets per day. Children – 1 pill every 4 hours (no more than 5 pieces/day). The maximum duration of therapy is 1 week.
  • Glycodin is a drug that has an expectorant effect. The product is dispensed in the form of syrup. The composition of Glycodin is represented by levomenthol, terpin hydrate, dextromethorphan hydrobromide. The drug has a minimum of contraindications. People with bronchial asthma should take it with caution. The recommended dose for children is 1/4-1/2 tsp. 3 times/day. Adults need to take 5 ml four times a day.
  • Coldkur Plus - tablets for the symptomatic treatment of colds and flu, contain phenylephrine, acetaminophen, caffeine, chlorphenylamine. The drug has antipyretic, analgesic, and vasoconstrictor effects. The medicine cannot be used for arterial hypertension, during pregnancy, lactation, or in case of individual intolerance to the components. Adults are advised to take 1 pill three times a day. Children need to drink 1/2 tablet 3-4 times a day. The maximum duration of therapy is 5 days.
  • Neogrip is an elongated tablet used for colds. They have anti-inflammatory, antiallergic, vasoconstrictor effects, and relieve fever. Adults are advised to take 1-2 pills 3-4 times a day. The dosage for children should be determined by a doctor.
  • Gripout is an effective anti-inflammatory drug for the treatment of respiratory diseases. It is recommended to take no more than 4 pills per day, the maximum duration of therapy is 5 days. The product has a large number of contraindications and side effects.
  • Maxicold - available in the form of tablets and powder. Ingredients: phenylephrine, paracetamol, vitamin C. Maxicold is indicated for patients with flu and colds to relieve pain, fever, and runny nose. It is recommended to take 1-2 pills four times a day. Maxicold has many contraindications; prior consultation with a specialist is required.
  • Flukold - sachets and pills that have antihistamine, analgesic, antipyretic effects. The medication relieves nasal swelling, myalgia, and fever. The contents of the sachet should be dissolved in water and taken no more than 4 times per day. Flukold tablets should be taken 1 pc. three times a day, swallowing whole.
  • Idrink is a combination remedy against the symptoms of respiratory ailments. The active ingredients are paracetamol and phenylephrine. It is necessary to take 1 sachet 3-4 times in 24 hours. The contents of the sachet should be diluted with hot water.
  • Vicks Active - available in the form of powder, syrup, balm, nasal spray, effervescent tablets. Each type of medicine has a specific composition and properties. Vicks Active is developed for the symptomatic treatment of influenza and colds. It is necessary to carefully follow the recommendations for use specified in the instructions.
  • Lemsip Max - used for high fever, chills, headache, nasal congestion, rhinitis. Should be taken orally, after dissolving in a glass of hot water. The recommended daily amount is 4 sachets.
  • Paralen – contains caffeine and paracetamol. The medication relieves pain and fever, improves well-being during colds. The maximum daily dose of Paralen is 8 tablets. The course of treatment is up to 10 days.
  • Amicitron is an analgesic, antipyretic, vasoconstrictor powder for the treatment of influenza and acute respiratory viral infections. It is allowed to take no more than 3 sachets in 24 hours, after diluting the contents with hot water. It is necessary to strictly follow the instructions, since Amicitron has a large list of side effects.
  • Axagrip - contains paracetamol, guaifenesin, phenylephrine. The medication is intended to reduce fever, headache and muscle pain, and nasal congestion. Adults are recommended to take no more than 8 tablets per 24 hours with water. It is necessary to strictly follow the instructions in order to prevent overdose and side effects.
  • Grippocitron is used to treat patients suffering from viral diseases. The medication relieves swelling, fever, fights sneezing, itchy nose, and headache. From the powder contained in the bags, you need to prepare a drink by mixing it with hot water. The resulting liquid must be consumed every 4-6 hours.
  • Multigrip is a combined anti-influenza drug containing paracetamol, ascorbic acid, phenylephrine. Eliminates headaches and muscle pain, runny nose, nasal congestion, reduces body temperature. It is recommended to drink no more than 3 doses of the drug per day. To prepare the drink, the powder is dissolved in hot, but not boiling water.
  • Theraflu - its components effectively fight fever, allergic manifestations, swelling, pain during ARVI. The medication has vasoconstrictor, sedative, and antitussive effects. The powder is consumed orally by preparing a hot solution. The interval between doses is 4 hours (no more than 4 sachets/day).

Coldrex: instructions for use and reviews

Latin name: Coldrex

ATX code: N02BE51

Active substance: caffeine + paracetamol + ascorbic acid + terpinihydrate + phenylephrinum (coffeinum + paracetamolum + acidum ascorbinicum + terpini hydras + phenylephrinum)

Manufacturer: GlaxoSmithKline Dungarvan, Ltd., Ireland

Updating the description and photo: 27.07.2018

Coldrex is a drug with decongestant, expectorant, analgesic and antipyretic effects, used for the symptomatic treatment of influenza and colds.

Release form and composition

Coldrex is produced in the form of tablets: capsule-shaped, two-layer, orange-white, the orange layer may contain white inclusions, with “Coldrex” embossed on one side (5, 6, 8, 12 pieces in blisters, 1 or 2 blisters in a cardboard box).

1 tablet contains the following active ingredients:

  • Caffeine – 25 mg;
  • Paracetamol – 500 mg;
  • Terpinhydrate – 20 mg;
  • Phenylephrine hydrochloride – 5 mg;
  • Vitamin C (ascorbic acid) – 30 mg.

Auxiliary components in Coldrex: talc, soluble and corn starch, dye, povidone, potassium sorbate, stearic acid, sodium lauryl sulfate.

Pharmacological properties

Pharmacodynamics

Coldrex is a combination drug, the components of which have the following effects on the body:

  • paracetamol is an analgesic that inhibits the synthesis of prostaglandins in the central nervous system and affects the thermoregulation center located in the hypothalamus;
  • phenylephrine is a sympathomimetic that eliminates swelling of the nasal mucosa and facilitates breathing;
  • ascorbic acid compensates for vitamin C deficiency, which causes the development of viral infections, and also strengthens the immune system and normalizes capillary permeability;
  • caffeine, which belongs to the group of methylxanthines, intensively stimulates the activity of the central nervous system, increases diuresis, promotes dilation of the lumen of blood vessels, enhances the analgesic effect of paracetamol, stimulates the secretory function of the stomach, reduces platelet aggregation;
  • Terpin hydrate is an expectorant and enhances bronchial secretions.

Pharmacokinetics

Paracetamol is almost completely absorbed from the gastrointestinal tract. It undergoes biotransformation in the liver and is excreted in the urine.

Ascorbic acid is absorbed from the gastrointestinal tract at high speed and transported to all tissues of the body. The degree of its binding to plasma proteins is about 25%. The remaining amount of ascorbic acid is excreted in the urine.

Caffeine is absorbed very easily after oral administration. The maximum content of the substance in plasma is recorded 1 hour after entering the body. The half-life is approximately 3.5 hours.

Phenylephrine is absorbed unevenly from the gastrointestinal tract. When taken orally, its bioavailability decreases significantly. Almost 100% of the administered dose of phenylephrine is excreted in the urine.

Indications for use

According to the instructions, Coldrex is prescribed to eliminate symptoms of flu and colds, such as:

  • Headache;
  • Fever;
  • Chills;
  • Feeling of nasal congestion;
  • Sore throat and sinuses;
  • Muscle and joint pain.

Contraindications

  • Diseases of the circulatory system;
  • Arterial hypertension;
  • Severe functional disorders of the kidneys or liver;
  • Diabetes;
  • Thyrotoxicosis;
  • Genetic absence of glucose-6-phosphate dehydrogenase;
  • Simultaneous use with other drugs containing paracetamol;
  • Hypersensitivity to the components of the drug.

Nursing and pregnant women, as well as children under 6 years of age, can take Coldrex only after medical consultation.

Instructions for use of Coldrex: method and dosage

Coldrex tablets are taken orally.

The dosage regimen is determined by age:

  • Adults and children over 12 years old – 2 tablets;
  • Children 6-12 years old – 1 tablet.

Frequency of administration – up to 4 times a day.

It is not recommended to take Coldrex for longer than 5 days without consulting a doctor. If symptoms persist, you should consult a doctor.

Side effects

Possible side effects that occur during administration are determined by the components included in Coldrex.

Paracetamol may cause the following disorders:

  • Sometimes: allergic reactions (angioedema, urticaria, skin rash);
  • Rarely: blood picture disturbances.

With prolonged use of doses exceeding the recommended ones, hepatotoxic and nephrotoxic effects may develop.

The use of phenylephrine can lead to disorders of certain body systems:

  • Digestive system: nausea;
  • Cardiovascular system: headache, slight increase in blood pressure; rarely – palpitations (symptoms disappear after discontinuation of the drug).

Overdose

In case of an overdose of Coldrex, it is recommended to immediately consult a doctor, even if the patient feels well. Its symptoms include cardiac arrhythmias, pain in the stomach, nausea, vomiting, pale skin, and excessive sweating. 1-2 days after taking high doses of the drug, signs of liver damage are often observed. In complicated cases, acute liver failure and coma may develop.

special instructions

Excessive consumption of coffee or tea during therapy can lead to the development of irritability and nervous tension.

To avoid toxic liver damage, patients should refrain from drinking alcohol. For chronic alcoholism, taking Coldrex tablets is not recommended.

Impact on the ability to drive vehicles and complex mechanisms

If dizziness occurs while taking the drug, it is necessary to avoid engaging in potentially hazardous activities that require increased concentration and immediate psychomotor reactions (driving a car and other vehicles, working with complex moving mechanisms, etc.).

Drug interactions

When Coldrex is used simultaneously with certain medications, undesirable effects may occur:

  • Diphenin, barbiturates, rifampicin, carbamazepine, zidovudine and other inducers of microsomal liver enzymes: increased risk of hepatotoxicity;
  • Domperidone, metoclopramide: increase the rate of absorption of paracetamol;
  • Cholestyramine: decreased rate of absorption of paracetamol.

The simultaneous use of Coldrex with beta-blockers, tricyclic antidepressants and monoamine oxidase inhibitors is not recommended. Between doses of drugs, a break of at least 14 days should be observed.

Analogs

An analogue of Coldrex is Flucoldex forte.

Terms and conditions of storage

Store in a dry place, out of reach of children.

Shelf life – 4 years.

Sodium citrate, corn starch, sodium saccharin, caramel SCS (E150), and lemon, honey or currant flavoring.

Release form

Powder, which is contained in sachets of 5 or 10 g.

pharmachologic effect

Coldrex Hotrem powder is used for colds.

Pharmacodynamics and pharmacokinetics

The medication has sympathomimetic , antipyretic , immunostimulating And analgesic action. The features of its action depend on the properties of the components included in the composition.

The active components are excreted mainly in the urine. In addition, a certain amount ascorbic acid may be excreted in bile. Half-life – 2-3 hours, and paracetamol – 1-4 hours.

Indications for use

Medicine is used to relieve symptoms And : hyperthermia , chills , sore throat and nose, , nasal congestion, pain in joints and muscles.

Contraindications

The powder is contraindicated for use in case of a negative reaction to its components, diseases of the circulatory system, , lack of glucose-6-phosphate dehydrogenase, liver dysfunction And kidney , arterial hypertension .

Side effects

When used according to the instructions, the medicine is well tolerated without side effects. In rare cases, the following negative reactions have been observed:

  • digestive system and liver: increased liver activity , vomiting, nausea, , anorexia , dry mouth;
  • nervous system: , , irritability, tinnitus, , ;
  • : , rash, , , Lyell's syndrome , ;
  • SSS: heart rhythm disturbance, leukopenia , thrombocytopenia , , arterial hypertension , neutropenia , anemia , pancytopenia ;
  • urinary system: oliguria , nephrotoxic effect , ;
  • other: , change in glucose content in .

Instructions for use of Coldrex Hotrem (Method and dosage)

For those taking Coldrex Hotrem powder, the instructions for use recommend using a sachet approximately every 4 hours. The maximum daily dosage is 6 sachets.

The instructions for Coldrex Hotrem say that the powder should be poured into a glass of warm water, stir until it is completely dissolved, and add cool water.

The maximum duration of use of the medication is 5 days.

Overdose

The dose of the drug indicated in the instructions cannot be exceeded. In case of overdose, you should definitely consult a doctor, even if there are no pronounced negative symptoms, as there is a possibility of serious liver damage, , And metabolic .

In case of an overdose, nausea, headache, loss, vomiting, pallor, pain in the epigastric region . In addition, in severe cases it is possible arterial hypertension And hepatotoxic effect of the drug. Manifestations toxic reactions due to overdose paracetamol usually appear within 12-48 hours. In this case, the use of And .

In case of overdose it is also possible gastric lavage and application enterosorbents . Treatment is symptomatic.

Interaction

When combined with barbiturates , , , , and other inducers of microsomal liver enzymes, taking the drug may cause hepatotoxic effect .

Coldrex Hotrem should not be taken together with other products containing paracetamol . In addition, use with MAO inhibitors , tricyclic antidepressants And beta blockers , as well as within 14 days after their cancellation.

Terms of sale

Coldrex Hotrem powder is available without a prescription.

COLDREX is a water-soluble powdery drug. Medicine for internal use.

Composition, release form, packaging

Active ingredients of COLDREX:

Excipients:

  • Citric acid gives a pleasant taste.
  • Corn starch is added as a vitamin and mineral supplement.
  • Sugar substitute.
  • Sodium cyclamate (sweetener).
  • Colloidal silicon dioxide (reduces the risk of allergies).
  • Flavors and dyes.

Packaging: 5 or 10 multilayer vacuum bags in a cardboard box + annotation for the drug.

Manufacturer

Ireland. Company "GLAXOSMITHKLINE"

Indications

It is used to eliminate (reduce the severity) of viral and various cold symptoms in respiratory infections:

  • and swelling of the sinuses.
  • Fever.
  • Joint pain.
  • Muscle spasms.

Contraindications

  • Hypersensitivity () to one or more components of the drug.
  • Blood diseases.
  • Diabetes.
  • Pregnancy and lactation.
  • Cirrhosis of the liver.
  • Intraocular pressure.
  • Thyrotoxicosis (excessive production of thyroid hormones).
  • Pathologies of the prostate gland.

About the drug Coldrex, more details in our video:

Mechanism of action

  1. - anti-inflammatory drug. It has an effective and strong analgesic effect.
  2. Ascorbic acid stimulates metabolic processes well and has a mild antiviral effect.
  3. Phenylephrine reduces painful swelling of the airways. Also relieves burning sensation. Reduces rhinorrhea (runny nose).

Instructions for use

The powder from the package must be completely dissolved in warm or hot water (1 package - approximately 250 ml). Take the medicine regardless of your meal schedule.

The dosage and duration of the course should be checked with your doctor; they are individual for everyone.

Usually, for colds, 1 packet is prescribed one to four times a day. It is advisable to maintain a minimum interval of at least 4 hours between doses.

5 packets is the maximum acceptable daily dose. The duration of the general course is no more than 5 days.

When using COLDREX for more than one week, monitoring the functional state of the liver is already necessary.

Side effects

  • Increased thirst.
  • Attacks of vomiting.
  • Diarrhea.
  • Decreased hemoglobin.
  • Changes in blood composition.
  • Agranulocytosis (decreased white blood cells).
  • Long.
  • Pancytopenia (decreased normal blood circulation).
  • Seizures
  • Alcoholic drinks during therapy increase intoxication.
  • Expectant mothers must consult a doctor.

Drug interactions

  • COLDREX is not prescribed simultaneously with antidepressants and any beta blockers. After their cancellation, the medicine is also not used for two weeks.
  • The undesirable effects of the components of paracetamol may increase when taking sleeping pills simultaneously.
  • Cholestyramine significantly reduces the rate of absorption of paracetamol components. Metoclopramide and domperidone tablets increase it.