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Pharmacological properties

The pharmacological activity of the drug is due to the properties of paracetamol, caffeine, phenylephrine hydrochloride and chlorpheniramine maleate, which are part of the drug. paracetamol has an antipyretic, analgesic and anti-inflammatory effect. the mechanism of action is associated with inhibition of prostaglandin synthesis.

Caffeine has a stimulating effect on the central nervous system, mainly on the cerebral cortex, respiratory and vasomotor centers, increases mental and physical performance, reduces drowsiness, a feeling of tiredness and weakens the effects of central nervous system depressants.

Phenylephrine hydrochloride has a vasoconstrictor effect, reduces swelling of the nasal mucosa and sinuses.

Chlorphenamine has an antihistamine and anticholinergic effect. Blocking H1-receptors, has an antiallergic effect, reduces vascular permeability of the mucous membrane of the upper respiratory tract, reduces lacrimation, itching in the eyes and nose.

Indications

Symptomatic treatment of colds and flu, which are accompanied by fever, chills, headache, runny nose and nasal congestion, sneezing, aching and pain in the body.

Application

Adults and children over the age of 12 are prescribed 1 tablet every 3-4 hours, but no more than 4 tablets per day.

The course of treatment is usually 3 days, but not more than 5 days.

Contraindications

Hypersensitivity to the components of the drug, other derivatives of xanthines (theophylline, theobromine). severe cardiovascular diseases, including conduction disturbance, severe atherosclerosis, severe coronary artery disease. severe impaired liver and kidney function. congenital hyperbilirubinemia, severe ag; prostate adenoma with difficulty urinating; bladder neck obstruction; blood diseases, severe anemia, leukopenia, hyperthyroidism, pyloroduodenal obstruction, diabetes mellitus, BA, glaucoma, glucose-6-phosphate dehydrogenase deficiency, alcoholism, increased irritability, sleep disturbance, concomitant treatment with MAO inhibitors and for 2 weeks after stopping their use. elderly age.

Side effects

On the part of the skin and subcutaneous tissue: skin rashes, itching, urticaria, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the immune system: hypersensitivity reactions, including anaphylactic shock, angioedema.

Neurological disorders: headache, dizziness, psychomotor agitation and disorientation, anxiety, nervous irritability, fear, irritability, sleep disturbance, insomnia, drowsiness, confusion, hallucinations, depressive states, tremors, tingling and heaviness in the limbs, noise in ears, in some cases - coma, cramps, dyskinesia, behavior changes, general weakness.

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

From the side of the organ of vision: impaired vision and accommodation, mydriasis, increased intraocular pressure, dry eyes.

From the gastrointestinal tract: nausea, vomiting, heartburn, dry mouth, discomfort and pain in the epigastric region, diarrhea, hypersalivation, decreased appetite.

On the part of the hepatobiliary system: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (with high doses).

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

On the part of the blood system and lymphatic system: anemia, including hemolytic, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain).

From the kidneys and urinary system: nephrotoxicity, interstitial nephritis, papillary necrosis, urination disorders, dysuria, urinary retention.

From the cardiovascular system: hypertension, tachycardia or reflex bradycardia, arrhythmia, shortness of breath, heart pain.

special instructions

Do not exceed the indicated dose.

The simultaneous use of other drugs intended for the symptomatic treatment of colds and flu, medicines containing paracetamol should be avoided. This drug is not recommended for use simultaneously with sedatives, sleeping pills or drinks containing alcohol.

The drug is prescribed by a doctor only after assessing the risk / benefit ratio in the following cases: AH; epilepsy; prostate adenoma; heart rhythm disturbances; pheochromocytoma; urination disorders. If, on the recommendation of a doctor, the drug is used for a long period, it is necessary to monitor the functional state of the liver and the picture of peripheral blood.

When using the drug, excessive consumption of coffee, strong tea, other tonic drinks and medicines containing caffeine should be avoided. This can cause sleep problems, tremors, tension, irritability, and palpitations.

Use during pregnancy and lactation. Contraindicated.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. During the treatment period, you should avoid driving, working with machinery, and other hazardous activities.

Children. The drug is used to treat children over the age of 12 years.

Interactions

Paracetamol absorption rate may increase when used with metoclopramide and domperidone and may decrease with cholestyramine. with simultaneous prolonged use, the anticoagulant effect of coumarins (e.g. warfarin) is enhanced. barbiturates reduce the severity of the antipyretic effect of paracetamol. anticonvulsants (phenytoin, barbiturates, carbamazepine), stimulating microsomal liver enzymes, and isoniazid can increase the hepatotoxicity of paracetamol. paracetamol reduces the effectiveness of diuretics.

The interaction of phenylephrine hydrochloride with MAO inhibitors causes a hypertensive effect, with tricyclic antidepressants (amitriptyline) - increases the risk of cardiovascular side effects, with digoxin and cardiac glycosides - leads to arrhythmias and heart attack. Phenylephrine with other sympathomimetics increases the risk of adverse cardiovascular reactions, may reduce the effectiveness of β-adrenergic receptor blockers and other antihypertensive drugs (reserpine, methyldopa) with an increased risk of hypertension and adverse cardiovascular reactions.

The simultaneous use of the drug with hypnotics, barbiturates, sedatives, antipsychotics, tranquilizers, anesthetics, narcotic analgesics, and alcohol can significantly increase the severity of the inhibitory effect of chlorpheniramine maleate. Chlorphenamine enhances the anticholinergic effect of atropine, antispasmodics, tricyclic antidepressants, antiparkinsonian drugs.

Caffeine enhances the effect (improves bioavailability) of antipyretic analgesics, potentiates the effects of xanthine derivatives, α- and β-adrenergic agonists, and psychostimulants.

Cimetidine, hormonal contraceptives, isoniazid enhance the effect of caffeine.

Caffeine reduces the effect of opioid analgesics, anxiolytics, sleeping pills and sedatives, is an antagonist of drugs for anesthesia and other drugs that depress the central nervous system, a competitive antagonist of adenosine, ATP.With the simultaneous use of caffeine with ergotamine, the absorption of ergotamine in the gastrointestinal tract improves, with thyrotropic drugs, the thyroid effect increases. Caffeine reduces the concentration of lithium in the blood.

Overdose

With an overdose of paracetamol, pallor of the skin, nausea, vomiting, anorexia, and abdominal pain are noted in the first 24 hours. when taking high doses, orientation disturbances, agitation, dizziness, sleep disturbance, heart rhythm, and pancreatitis may occur. in rare cases, it was reported that there is a seizure with tubular necrosis, which is manifested by pain in the lower back, hematuria, proteinuria; nephrotoxicity (renal colic, interstitial nephritis).

Admission to adults of 10 g or more of paracetamol, especially simultaneously with alcohol, and children over 150 mg of paracetamol per kg of body weight can lead to hepatocellular necrosis with the development of encephalopathy, hepatic coma and death. The first clinical signs of hepatonecrosis may appear 12–48 hours after an overdose. Impaired glucose metabolism and metabolic acidosis may occur. With prolonged use of high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia are possible.

With an overdose of phenylephrine hydrochloride, hyperhidrosis, psychomotor agitation or depression of the central nervous system, headache, dizziness, drowsiness, impaired consciousness, arrhythmias, tremors, hyperreflexia, convulsions, nausea, vomiting, irritability, anxiety, and hypertension occur.

With an overdose of chlorpheniramine maleate, atropine-like symptoms are possible: mydriasis, photophobia, dry skin and mucous membranes, fever, intestinal atony. Inhibition of the central nervous system, which is accompanied by respiratory disorders and disorders of the cardiovascular system (decreased heart rate, decreased blood pressure, up to vascular insufficiency).

High doses of caffeine can cause pain in the epigastric region, vomiting, rapid diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, effects on the central nervous system (dizziness, insomnia, nervous excitement, irritability, affect state, anxiety, tremor, convulsions).

Treatment: During the first 6 hours after a suspected overdose, gastric lavage is necessary, followed by hospitalization of the patient.

During the first 8 hours after an overdose - the use of methionine orally or the introduction of cysteamine or N-acetylcysteine; symptomatic therapy; in severe hypertension - the use of blockers of α-, β-adrenergic receptors.

Storage conditions

In a dry, dark place and out of the reach of children at a temperature of no higher than 25 ° c.

Tags: Flucold-N