Coldrex HotRem

The drug should be taken only in recommended doses!

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 and hospitalization may be required. Overdose is usually caused by paracetamol.

Paracetamol

Symptoms

An overdose of paracetimol may cause liver failure, which may lead to the need for liver transplantation or death.

Within 24 hours the following are possible: pale skin, loss of appetite, nausea, vomiting, abdominal pain, sweating. Clinical signs of liver damage develop, as a rule, after 24-8 hours and reach a maximum after 4-6 days. Signs of impaired glucose metabolism and metabolic acidosis may occur. Toxic effects in adults are possible after taking more than 10 g of paracetamol: increased activity of “liver” transaminases. Acute pancreatitis has been observed, usually with liver dysfunction and liver toxicity.

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 are reports of cases of cardiac arrhythmia with 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).

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.

Treatment

During the first hours after an 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.

Phenylephrine

Symptoms

Symptoms of a phenylephrine overdose are similar to those of side effects. In addition: irritability, headache, dizziness, insomnia, increased excitability, increased blood pressure, nausea, vomiting, 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.

Ascorbic acid

Symptoms

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.

Coldrex

Coldrex is a combination drug widely known in our country from a British pharmaceutical company, used for the symptomatic treatment of acute respiratory viral infections (ARVI). The key characteristic of ARVI is the species diversity of their pathogens, including influenza viruses, parainfluenza, rhinoviruses, adenoviruses, etc. Such etiological polymorphism greatly complicates the development of methods for specific treatment of these diseases. In this regard, the main emphasis must be placed on symptomatic therapy, whose action is aimed at eliminating the most unpleasant symptoms of viral infections: runny nose, cough, nasal congestion, headache and sore throat, myalgia, weakness and fever. All these facts make it advisable to use combination drugs in the drug therapy of ARVI, the components of which have different mechanisms of action, but therapeutically complement each other, providing pharmacological synergism. One of these drugs is Coldrex, which includes five active substances: paracetamol, phenylephrine, caffeine, terpene hydrate and ascorbic acid. Its composition is selected in such a way as to influence all parts of the pathological process of ARVI. The main “driving force” of Coldrex is highly purified paracetamol. Its analgesic and antipyretic properties have been mercilessly exploited by doctors for almost four decades. Unlike aspirin, it does not have an ulcerogenic (ulcerating) effect, and, unlike analgin, it does not cause blood side effects (granulocytopenia, granulocytosis). The pharmacological effect of paracetamol is due to the blockade of the synthesis of prostaglandins, mediators of pain and inflammation, however, unlike aspirin and a number of other non-steroidal anti-inflammatory drugs, this effect is not systemic, but is believed to manifest itself mainly at the level of the central nervous system, due to which the drug realizes its antipyretic effect . The analgesic effect of the drug is more complex in its development mechanism and involves not only central, but also peripheral pain pathways.

Phenylephrine is a direct beta-agonist. Causes a decrease in the lumen of arterioles, thereby relieving swelling, reducing excess formation and secretion of mucus, and relieving congestion in the nasal passages. Caffeine reinforces the analgesic potential of paracetamol, has a general tonic effect, invigorates and improves well-being. Terpin hydrate is a time-tested expectorant. It dilutes bronchial secretions and promotes their freer separation, protects the respiratory tract from blockage and makes breathing easier. It has, among other things, a weak anti-inflammatory effect. Ascorbic acid stimulates the immune system, normalizes tissue respiration processes and increases the body’s resistance to invasion by various pathogens (as is known, a bacterial infection is often “layered” on top of a viral infection).

One of the main advantages of Coldrex over its pharmacological “brothers” is the presence “under one roof” of all the medicinal ingredients required for the complex treatment of ARVI, which significantly simplifies the administration of the drug to patients. In addition, a thoughtful combination of active substances in Coldrex allows you to reduce the doses of each of them, and, therefore, reduce the risk of side effects. If you start taking Coldrex in a timely manner, the duration of the manifestation of acute symptoms of ARVI is significantly reduced. In fact, cough and increased secretion of mucus from the nose are eliminated already in the first days of the disease, creating the preconditions for further suppression of the pathological process in the respiratory tract. Taking Coldrex at the first alarming pathogenetic “bells” prevents the development of the acute phase of ARVI, thereby stopping the acute inflammatory reaction at the preclinical stage. As a result, a milder course of the disease is ensured and the negative manifestations of temperature and catarrhal reactions are leveled out. In conclusion, it should be noted that Coldrex is well tolerated by patients and rarely causes clinically significant side effects.

Coldrex maxgripp 10 pcs. powder for solution for oral administration lemon 1/10

pharmachologic effect

Combined drug for the symptomatic treatment of colds and other infectious and inflammatory diseases.
Paracetamol has an antipyretic and analgesic effect. The content of paracetamol in the drug corresponds to the maximum single dose allowed for over-the-counter use.

Phenylephrine is a vasoconstrictor, relieves nasal congestion (constricts blood vessels in the nasal mucosa and paranasal sinuses) and facilitates breathing.

Ascorbic acid replenishes the increased need for vitamin C during colds and flu.

The active components of the drug do not cause drowsiness.

Composition and release form Coldrex maxgripp 10 pcs. powder for solution for oral administration lemon 1/10

Powder for preparing a solution for oral administration - 1 pack:

Active ingredients: paracetamol - 1000 mg; phenylephrine hydrochloride - 10 mg; ascorbic acid - 40 mg;
Excipients: sucrose - 3725 mg, citric acid - 680 mg, sodium citrate - 430 mg, corn starch - 200 mg, lemon flavor - 200 mg, sodium cyclamate - 79 mg, sodium saccharinate - 54 mg, curcumin dye (E100) - 7 mg, colloidal silicon dioxide - 2 mg.

6.427 g - multilayer bags, cardboard packs.

Description of the dosage form

Powder for preparing a solution for oral administration (lemon) is light yellow in color, with the smell of lemon; the prepared solution is cloudy, yellowish-green in color, with the smell of lemon, without surface foam and solid inclusions.

Directions for use and doses

Adults are recommended to take 1 sachet every 4-6 hours, but no more than 4 sachets within 24 hours. The interval between doses should be at least 4 hours.

The contents of 1 sachet should be poured into a mug half filled with hot water, stir until completely dissolved and add cold water or sugar as desired.

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

Pharmacokinetics

Paracetamol

Quickly and almost completely absorbed from the gastrointestinal tract, distribution in body fluids is relatively even.

Metabolized primarily in the liver with the formation of several metabolites.

T1/2 when taking a therapeutic dose is 2-3 hours. The main amount of the drug is excreted after conjugation in the liver. No more than 3% of the received dose of paracetamol is excreted unchanged.

Phenylephrine

It is poorly absorbed from the gastrointestinal tract and undergoes “first pass” metabolism in the intestines and liver under the influence of MAO. When phenylephrine is taken orally, the bioavailability of the drug is limited.

It is excreted almost entirely in the urine as a sulfuric acid conjugate.

Ascorbic acid

Well absorbed from the gastrointestinal tract, binding to plasma proteins is 25%. Distribution in body tissues is wide.

Metabolized in the liver, excreted in the urine in the form of oxalate and unchanged.

Ascorbic acid, taken in excessive quantities, is quickly excreted unchanged in the urine.

Indications for use Coldrex maxgripp 10 pcs. powder for solution for oral administration lemon 1/10

Relieving cold and flu symptoms:

increased body temperature;
headache;
chills;
pain in joints and muscles;
nasal congestion;
sore throat;
pain in the sinuses.

Contraindications

hypersensitivity to the components of the drug;
severe liver disease;
severe kidney disease;
diseases of the hematopoietic system;
thyrotoxicosis;
arterial hypertension;
heart disease (severe stenosis of the aortic mouth, acute myocardial infarction, tachyarrhythmias);
prostatic hyperplasia;
angle-closure glaucoma;
diabetes;
diseases associated with hereditary malabsorption of sugar, because each sachet contains 4 g of sucrose;
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 and a period of up to 14 days after their discontinuation;
pregnancy;
lactation (breastfeeding);
children and adolescents up to 18 years of age.

The drug should be used with caution in cases of benign hyperbilirubinemia, pheochromocytoma, vasospastic diseases (Raynaud's syndrome), diseases of the cardiovascular system, and concomitant use with other antihypertensive drugs.

Application of Coldrex maxgripp 10 pcs. powder for the preparation of a solution for oral administration lemon 1/10 during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and breastfeeding. Contraindication: children and adolescents under 18 years of age.

special instructions

The patient should be informed that if symptoms of the disease persist after 5 days of using the drug, they should stop taking it and consult a doctor.

The drug should be taken only in recommended doses.

The drug should not be taken concomitantly with other drugs containing paracetamol, as well as other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsants, rifampicin and chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants , amphetamine-like psychostimulants), with other drugs to relieve cold and flu symptoms.

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

Before taking Coldrex® MaxGrip, you should consult a doctor if:

Overdose

In case of an overdose of Coldrex® MaxGrip (even if you feel well), the risk of delayed signs of serious liver damage should be taken into account.

Overdose is usually caused by paracetamol. Liver damage in adults is possible when taking ≥ 10 g of paracetamol.

Taking ≥ 5 g 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).

Symptoms (due to paracetamol): pale skin, nausea, vomiting, anorexia, abdominal pain are possible within 24 hours; within 12-48 hours, signs of liver dysfunction, signs of impaired glucose metabolism and metabolic acidosis may appear. In cases of severe poisoning, severe liver failure may occur, including hepatic encephalopathy, 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 are reports of cases of cardiac arrhythmia and pancreatitis with an overdose of paracetamol.

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.

Treatment: within the first hour after the expected overdose, it is advisable to administer activated carbon orally. 4 or more hours after the suspected overdose, it is necessary to determine the concentration of paracetamol in plasma (earlier determination of paracetamol concentration may be unreliable). The antidote is acetylcysteine. 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 toxicology center or a specialized liver disease department.

At the first signs of an overdose, you should immediately seek medical help, even in the absence of clear symptoms of poisoning.

Symptoms caused by phenylephrine: 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. An overdose of phenylephrine can cause symptoms similar to side effects.

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

Symptoms caused by ascorbic acid: when using more than 1 g - 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, glugocosuria), 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).

Ascorbic acid in high doses (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea and stomach discomfort.

Manifestations of an overdose of ascorbic acid can be classified as those caused by severe liver damage as a result of an overdose of paracetamol.

Treatment: symptomatic, forced diuresis.

Side effects of Coldrex maxgripp 10 pcs. powder for solution for oral administration lemon 1/10

Determination of the frequency of side effects: very often (≥1/10), often (≥1/100 and less than 1/10), infrequently (≥1/1000 and less than 1/100), rarely (≥1/10,000 and less than 1 /1000), very rare (≥1/100,000 and less than 1/10,000).

At recommended doses, the drug is usually well tolerated.

Paracetamol rarely has side effects.

From the hematopoietic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis.

Allergic reactions: very rarely - anaphylactic shock, skin rash, urticaria, angioedema, Stevens-Johnson syndrome.

From the respiratory system: very rarely - bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

From the liver and biliary tract: very rarely - impaired liver function.

From the urinary system: with prolonged use in excess of the recommended dose, nephrotoxic effects may be observed.

Phenylephrine

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

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

From the digestive system: very rarely - nausea, vomiting.

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

Allergic reactions: very rarely - 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 incidence of side effects has not been established.

Allergic reactions: skin rash, skin hyperemia.

From the digestive system: irritation of the gastrointestinal mucosa.

From the hematopoietic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis.

Other: hypokalemia.

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

If side effects occur, the patient should immediately stop taking the drug and consult a doctor as soon as possible.

If any of the above side effects worsen, or any other side effects occur, the patient should inform the doctor.

Drug interactions

Paracetamol, when taken for a long time, 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 can lead to an increase in blood pressure.

Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of developing arterial hypertension and disorders of the cardiovascular system.

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.