AjiKOLD: Instructions for use: Description of the drug: Price for EUROLAB

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Manufacturers: Agio Pharmaceuticals (India)

Active ingredients

Caffeine
Paracetamol
Phenylephrine

Disease class

Not indicated. See instructions

Clinical and pharmacological group

Not indicated. See instructions

Pharmacological action

Not indicated. See instructions

Pharmacological group

Anilides in combinations

AgiCOLD tablets

Instructions for medical use of the drug

Indications for use

Colds, accompanied by a runny nose, a feeling of nasal congestion, headache, fever, chills, pain in the joints and muscles.

Release form

pills; blister 4, cardboard envelope 1. tablets; blister 4, cardboard envelope 25. tablets; blister 10, cardboard envelope 1.

Pharmacodynamics

Combined drug. Paracetamol has an antipyretic and analgesic effect, inhibits the synthesis of prostaglandins and reduces the excitability of the thermoregulation center of the hypothalamus. Phenylephrine hydrochloride has a vasoconstrictor effect, thereby helping to relieve nasal congestion and reduce nasal discharge. Chlorpheniramine maleate has an antiallergic and anti-edematous effect, reduces vascular permeability, eliminates swelling and hyperemia of the nasal mucosa, suppresses the symptoms of allergic rhinitis, making breathing easier. Caffeine has a stimulating effect on the central nervous system, which leads to a decrease in fatigue and drowsiness, and an increase in mental and physical performance.

Pharmacokinetics

Paracetamol is quickly absorbed from the gastrointestinal tract and binds to blood plasma proteins. T1/2 in plasma is 1-4 hours. Metabolized in the liver to form paracetamol sulfate glucuronide. Metabolism is carried out by the microsomal enzyme system in the liver and by general clearance. Penetrates through the placenta. Paracetamol glucuronidation products have hepato- and nephrotoxicity, toxic effects develop after 1-2 days. Excreted by the kidneys mainly in the form of conjugation products, less than 5% is excreted unchanged. Phenylephrine hydrochloride is poorly absorbed from the gastrointestinal tract after oral administration. Metabolized with the participation of monoamine oxidase in the intestinal wall and during the “first pass” through the liver. The main biotransformation pathways are the formation of sulfated derivatives, which leads to the formation of phenylephrine 3-O-sulfate, and deamination. The bioavailability of phenylephrine is low. After topical application, it is subject to systemic absorption. Chlorpheniramine maleate is quickly and completely absorbed and distributed into tissues after oral administration. About 70% binds to blood plasma proteins. The half-life of elimination is approximately 8 hours. Metabolized in the liver. Slowly absorbed from the gastrointestinal tract, reaching peak plasma concentrations 2.5 to 6 hours after oral administration. It is excreted in the urine in partially unchanged form and in the form of dimethylated metabolites. The rate of excretion depends on the pH of the urine. Caffeine is easily absorbed when taken orally, with peak concentrations ranging from 5 to 90 minutes. after reception. It is quickly destroyed in the cells of the body and penetrates the placental and blood-brain barrier. Approximately 17–36% is bound to plasma proteins. In the adult body, it is rapidly metabolized in the liver to form 1-methyluric acid, 1-methylxanthine and 7-methylxanthine. The main metabolic products of demethylation in the body are the 1,3- and 7-demethylated forms of theobromine, paraxanthine and theophylline, respectively. All three methylated products are found in plasma. The plasma distribution of each of the demethylated products is 84% paraxanthine, 12% theobromine and 4% theophylline. Each of the monomethylated products further undergoes intense biotransformation. The half-life in plasma averages 4.9 hours, with a possible range from 1.9 to 12.2. hour. Well absorbed in the intestine, T1/2 in plasma is 1-4 hours; excreted by the kidneys mainly in the form of metabolites. Only about 1% of caffeine metabolites are excreted unchanged by the kidneys. Pharmacokinetic studies have not been conducted in the neonatal period.

Contraindications for use

- hypersensitivity to the components of the drug; - simultaneous use of other drugs containing substances included in AjiKOLD; - simultaneous use of tricyclic antidepressants, monoamine oxidase inhibitors, beta-blockers; — pregnancy, lactation period; - children under 6 years of age; - with caution in case of: glucose-6-phosphate dehydrogenase deficiency, blood diseases, liver and/or kidney failure, angle-closure glaucoma, benign prostatic hyperplasia, Gilbert's syndrome, arterial hypertension, thyroid diseases, diabetes mellitus, bronchial asthma.

Side effects

- allergic reactions (skin rash, itching, urticaria, angioedema); - dizziness, sleep disturbance, increased excitability, headache; - nausea, dry mouth, pain in the epigastric region; - anemia, thrombocytopenia, agranulocytosis; - increased blood pressure, difficulty falling asleep; - mydriasis, accommodation paresis, increased intraocular pressure; - urinary retention. With long-term use in large doses: - hepatotoxic effect; - hemolytic or aplastic anemia, methemoglobinemia, pancytopenia; - nephrotoxicity (renal colic, glycosuria, interstitial nephritis, papillary necrosis).

Directions for use and doses

Adults: 2 tablets 1-4 times a day. Children 6-12 years old: 1 tablet 1-4 times a day.

Storage conditions

List B: In a dry place, protected from light, at a temperature not exceeding 25 °C.

Best before date

36 months

ATX classification:

N Nervous system

N02 Analgesics

N02B Analgesics and antipyretics

N02BE Anilides

N02BE71 Paracetamol in combination with psychotropic drugs

AgiCold®

In case of overdose, consult a doctor immediately. Prompt medical attention is critical, even if you do not experience any signs or symptoms.

Caffeine

Symptoms of acute overdose: abdominal pain, vomiting, flushing of the face, fever, chills, agitation, insomnia, irritability, loss of appetite, weakness, tremor, increased muscle tone, state of altered consciousness, delirium, hallucinations, increased blood pressure followed by its decrease, tachycardia, tachypnea, increased diuresis, hypokalemia, hyponatremia, hyperglycemia, metabolic acidosis, convulsions, myoclonus and rhabdomyolysis, supraventricular and ventricular arrhythmias.

Symptoms of chronic caffeine intoxication - “caffeineism”: irritability, insomnia, anxiety, emotional lability, chronic abdominal pain.

Chlorphenamine

Symptoms: central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, intestinal paresis), tachycardia, decreased blood pressure, increased blood pressure, nausea, vomiting, agitation, disorientation, hallucinations, psychosis, seizures, arrhythmias.

Rarely, patients with agitation, seizures, or comatose patients develop rhabdomyolysis and renal failure.

Phenylephrine

Symptoms: nausea, vomiting, irritability, agitation, insomnia, psychosis, convulsions, palpitations, tachycardia, increased blood pressure, reflex bradycardia.

Paracetamol

Symptoms of liver dysfunction may appear 12-48 hours after an overdose: increased activity of “liver” transaminases, hepatonecrosis. In severe cases - liver failure with progressive encephalopathy, coma. Rarely, liver failure develops rapidly and can be complicated by renal failure (tubular necrosis).

The overdose threshold may be lowered in elderly patients and children; in patients taking certain medications (eg, liver microsomal enzyme inducers), alcohol, or who are malnourished.

Treatment: gastric lavage, administration of activated carbon in the first 6 hours after an overdose, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and acetylcysteine after 12 hours. The need for additional therapeutic measures (further administration of methionine and acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time elapsed after its administration. Symptomatic therapy.

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AjiCold tablet 30 mg+500 mg+10 mg+2 mg x10

ATX code: N02BE71 (Paracetamol in combination with psycholeptics)

Dosage form

Adzhikold

Tabletkireg. No.: LP-001522 dated 02/16/12 - Valid

Release form, packaging and composition of the drug Adzhicold

Tablets from orange to light orange in color with orange inclusions, round, flat, with a score line on one side.

1 tab.

paracetamol 500 mg

phenylephrine hydrochloride 10 mg

chlorphenamine maleate 2 mg

caffeine 30 mg

Excipients: sodium carboxymethyl starch 10 mg, povidone 5 mg, propylene glycol 2 mg, corn starch 32 mg, methyl parahydroxybenzoate 1 mg, propyl parahydroxybenzoate 0.1 mg, sunset yellow dye 0.9 mg, talc 1 mg, microcrystalline cellulose 5 mg, magnesium stearate 5 mg, water up to 604 mg.

Clinical-pharmacological group: Drug for the symptomatic treatment of acute respiratory diseases Pharmaco-therapeutic group: Drug for eliminating the symptoms of acute respiratory infections and “colds”

pharmachologic effect

Combined drug. Paracetamol is an analgesic-antipyretic. It has an antipyretic and analgesic effect, chlorpheniramine has an antiallergic and anti-edematous effect. Reduces vascular permeability, eliminates swelling and hyperemia of the nasal mucosa, suppresses the symptoms of allergic rhinitis, making breathing easier. Phenylephrine has a vasoconstrictor effect, thereby helping to relieve nasal congestion and reduce nasal discharge. Caffeine has a stimulating effect on the central nervous system, which leads to a decrease in fatigue and drowsiness, and an increase in mental and physical performance.

Pharmacokinetics Data on the pharmacokinetics of the drug Adzhicold are not provided.

Indications for the drug Adjicold

symptomatic treatment of colds, flu, ARVI, accompanied by rhinorrhea, fever, pain in joints and muscles. ICD-10 codes

ICD-10 code Indication

J00 Acute nasopharyngitis (runny nose)

J06 Acute upper respiratory tract infections of multiple and unspecified localization

J10 Influenza caused by an identified seasonal influenza virus

J11 Influenza, virus not identified

Dosage regimen

Adults: 1-2 tablets 3-4 times a day. The maximum daily dose is 4 tablets.

Children 6-12 years old: 1 tablet 1-4 times a day.

Side effect

When taking the drug in recommended doses, side effects rarely occur.

If side effects occur, they can manifest themselves in the form of allergic reactions, dizziness, sleep disturbances, increased excitability, nausea, headache, dry mouth.

Contraindications for use

hypersensitivity to the components of the drug, simultaneous use of other drugs containing substances included in Adjicold, simultaneous use of tricyclic antidepressants, MAO inhibitors, beta-blockers, pregnancy, lactation, children (up to 6 years).

With caution: with glucose-6-phosphate dehydrogenase deficiency, blood diseases, liver and/or kidney failure, closed-angle glaucoma, benign prostatic hyperplasia, Gilbert's syndrome, arterial hypertension, thyroid diseases, diabetes mellitus, bronchial asthma.

Use during pregnancy and lactation Contraindicated during pregnancy and lactation.

Use for liver dysfunction Use with caution in liver failure.

Use for impaired renal function Use with caution in case of renal failure.

Use in children Contraindicated in children under 6 years of age.

special instructions

During the treatment period you should refrain from drinking alcohol. Care must be taken when performing work that requires concentration, speed of motor and mental reactions. Adjicold is not recommended for children under 6 years of age, pregnant women and nursing mothers.

Adjikold should not be taken together with other drugs containing paracetamol.

Overdose

The drug should be taken only in recommended doses. Overdose is usually caused by paracetamol.

Possible: pallor of the skin, anorexia, nausea, vomiting, hepatonecrosis, increased activity of liver transaminases, increased prothrombin index. In case of overdose, consult a doctor immediately.

Treatment: gastric lavage followed by the administration of activated charcoal, symptomatic therapy.

Drug interactions

Enhances the effects of MAO inhibitors, sedatives, ethanol.

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

Glucocorticosteroids increase the risk of developing glaucoma.

Paracetamol reduces the effectiveness of diuretics.

Chlorpheniramine combined with MAO inhibitors and furazolidone can lead to hypertensive crisis, agitation, and hyperpyrexia.

Tricyclic antidepressants enhance their sympathomimetic effect; simultaneous administration of halothane increases the risk of developing ventricular arrhythmia.

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

Storage conditions for the drug Adzhicold

In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.

Shelf life of the drug Adjicold Shelf life - 3 years.

Terms of sale Without a prescription.

Adjicold tab No. 10

Compound

Active ingredients:

paracetamol - 500 mg;
phenylephrine hydrochloride - 10 mg;
chlorphenamine maleate - 2 mg;
caffeine - 30 mg.

Pharmacokinetics

Data on the pharmacokinetics of the drug Adjicold are not provided.

Indications for use

Symptomatic treatment of colds, acute respiratory viral infections, including influenza (fever, pain, rhinorrhea).

Contraindications

Severe atherosclerosis of the coronary arteries;
arterial hypertension; portal hypertension; diabetes; simultaneous use of tricyclic antidepressants, monoamine oxidase inhibitors (MAO), beta-blockers; hypersensitivity to paracetamol and other components included in the drug; taking other drugs containing substances included in the drug AjiCold®; pregnancy, breastfeeding period; children under 15 years of age; alcoholism. Carefully:

For hyperthyroidism, pheochromocytoma; bronchial asthma; chronic obstructive pulmonary disease; emphysema; chronic bronchitis; deficiency of glucose-6-phosphate dehydrogenase; hemolytic anemia; blood diseases; acute hepatitis; congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes); liver and/or kidney failure; simultaneous use of drugs that can adversely affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes); pyloroduodenal obstruction; stenosing ulcer of the stomach and/or duodenum; closed-angle form of glaucoma; epilepsy; prostatic hyperplasia; and also by persons with a deficit of caloric intake from food, AjiCold® can be used with caution after consultation with a doctor.

Directions for use and doses

Inside.
Adults and children over 15 years old - 1 tablet 3-4 times a day. The maximum daily dose is 4 tablets.

The course of treatment is no more than 5 days.

Storage conditions

Store out of the reach of children, at a temperature not exceeding 25°C.

Best before date

3 years. Do not use after the expiration date stated on the package.

special instructions

During the treatment period, you should refrain from taking alcohol, sleeping pills and anxiolytic (tranquilizers) medications.
Do not take with other medicines containing paracetamol.

If symptoms worsen or persist after 5 days of using the drug, you should stop taking it and consult your doctor.

The drug may cause drowsiness.

If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street! Place it in a bag and place it in the trash. These measures will help protect the environment!

Description

A drug for the symptomatic treatment of acute respiratory diseases.

Dosage form

Tablets from orange to light orange in color with orange inclusions, round, flat, with a score line on one side.

Use in children

Contraindicated for children under 15 years of age.

Pharmacodynamics

Combined drug.
Paracetamol

has an antipyretic and analgesic effect: reduces the pain syndrome observed during colds - sore throat, headache, muscle and joint pain, reduces high temperature.

Phenylephrine

has a vasoconstrictor effect - reduces swelling and hyperemia of the mucous membranes of the upper respiratory tract and paranasal sinuses.

Chlorphenamine

has an antiallergic effect: eliminates itching of the eyes, nose and throat, swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, reduces exudative manifestations.

Caffeine

has a stimulating effect on the central nervous system (CNS), which leads to a decrease in fatigue and drowsiness, and an increase in mental and physical performance.

Side effects

From the immune system: skin rash, itching, urticaria, angioedema, anaphylactic shock.
From the blood and lymphatic system: anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, leukopenia.

From the nervous system: headache, dizziness, drowsiness, difficulty falling asleep, increased excitability.

From the organ of vision: mydriasis, paresis of accommodation, increased intraocular pressure.

From the heart: tachycardia, palpitations.

From the side of blood vessels: increased blood pressure.

From the respiratory system, chest and mediastinal organs: bronchospasm.

From the gastrointestinal tract: nausea, vomiting, epigastric pain, diarrhea, dry oral mucosa, hepatotoxic effect.

From the skin and subcutaneous tissues: very rarely - serious skin reactions:

acute generalized exanthematous pustulosis (AGEP). Acute condition with the development of pustular rashes. It is characterized by fever and diffuse erythema, accompanied by burning and itching. Swelling of the face, hands and mucous membranes may occur;

Stevens-Johnson syndrome (SJS) (erythema malignant exudative). A severe form of erythema multiforme, in which blisters appear on the mucous membrane of the mouth, throat, eyes, genitals, and other areas of the skin and mucous membranes;

toxic epidermal necrolysis (TEN, Lyell's syndrome). The syndrome is a consequence of extensive apoptosis of keratinocytes, which leads to detachment of large areas of skin at the dermoepidermal junction. The affected skin looks like it has been scalded by boiling water.

From the kidneys and urinary tract: nephrotoxicity (renal colic, glycosuria, interstitial nephritis, papillary necrosis), difficulty urinating.
If you notice one of the side effects described above, you should stop taking the drug and consult a doctor immediately.

Use during pregnancy and breastfeeding

Due to the lack of clinical data, the safety of the drug during pregnancy and breastfeeding has not been established, therefore the use of the drug in this category of patients is contraindicated.

Interaction

Enhances the effects of MAO inhibitors, sedatives, ethanol.
Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.
Glucocorticosteroids increase the risk of developing glaucoma.
Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.
Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.
Paracetamol reduces the effectiveness of uricosuric drugs.
When used simultaneously with barbiturates, diphenin, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes, the risk of developing the hepatotoxic effect of paracetamol increases.
When chloramphenicol and paracetamol are used together, the half-life of chloramphenicol may be increased.
In most patients taking warfarin long-term, infrequent use of paracetamol usually has little or no effect on the international normalized ratio (INR).
However, with prolonged regular use, paracetamol enhances the effect of indirect anticoagulants (warfarin and other coumarin derivatives), which increases the risk of bleeding.
A single dose of caffeine increases lithium excretion by the kidneys. Abrupt cessation of caffeine may result in increased serum lithium concentrations.
Chlorphenamine simultaneously with MAO inhibitors and furazolidone can lead to hypertensive crisis, agitation, and hyperpyrexia.
Concomitant use of phenylephrine with digoxin and other cardiac glycosides may increase the risk of arrhythmia and myocardial infarction.
Phenylephrine when taken with MAO inhibitors can lead to increased blood pressure.
Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs.
Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine; simultaneous use of halothane increases the risk of developing ventricular arrhythmia.
Reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenomimetic activity of phenylephrine.

Overdose

In case of overdose, consult a doctor immediately. Prompt medical attention is critical, even if you do not experience any signs or symptoms.

Caffeine

Chlorphenamine

Phenylephrine

Symptoms: nausea, vomiting, irritability, agitation, insomnia, psychosis, convulsions, palpitations, tachycardia, increased blood pressure, reflex bradycardia.

Paracetamol

Symptoms appear after taking more than 7.5-10 g: during the first 24 hours after taking - pallor of the skin;
nausea, vomiting, anorexia, abdominal pain; increase in prothrombin time; impaired glucose metabolism, metabolic acidosis (including lactic acidosis). Symptoms of liver dysfunction may appear 12-48 hours after an overdose: increased activity of “liver” transaminases, hepatonecrosis. In severe cases - liver failure with progressive encephalopathy, coma. Rarely, liver failure develops rapidly and can be complicated by renal failure (tubular necrosis).

The overdose threshold may be lowered in elderly patients and children; in patients taking certain medications (eg, liver microsomal enzyme inducers), alcohol, or who are malnourished.

Symptomatic therapy.

Impact on the ability to drive vehicles and operate machinery

The drug may cause drowsiness. During the treatment period, it is necessary to refrain from driving vehicles and machinery and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.