Trade name of the drug: Romidon

Active ingredients (INN): paracetamol, chlorpheniramine maleate, phenylephrine hydrochloride, caffeine.

Dosage form: tablets

Composition:

Each tablet contains:

active substances: paracetamol 500 mg, caffeine 30 mg, phenylephrine hydrochloride 5 mg, chlorpheniramine maleate 2 mg;

excipients: corn starch, povidone, microcrystalline cellulose, sodium metabisulfite, purified talc, magnesium stearate, sodium starch glycolate, aerosil, purified water, Ponceau 4R dye.

Description : pink, round, uncoated tablet with a dividing line on one side.

Pharmacotherapeutic group: remedies for eliminating the symptoms of acute respiratory infections and colds.

ATX code: N02BE51

 

Pharmacological properties

Pharmacodynamics

Combined drug, the action of which is due to the properties of its constituent components.

Paracetamol

It has an analgesic and antipyretic effect. The mechanism of action is associated primarily with the ability to inhibit the synthesis of prostaglandins in the central nervous system and, to a lesser extent, the effect on thermoregulation in the hypothalamus.

Chlorine eniramine maleate

Blocker of histamine H ₁ -receptors. Has antiallergic effect, reduces exudation phenomena. Narrows the vessels of the nose, eliminates swelling and hyperemia of the mucous membrane of the nasal cavity , nasopharynx and paranasal sinuses .

Phenylephrine a hydrochloride

It is a stimulant of α-adrenergic receptors of blood vessels, has little effect on the receptors of the heart. It causes narrowing of arterioles and an increase in systemic blood pressure (with possible reflex bradycardia). Promotes pupil dilation (without affecting accommodation) and can lower intraocular pressure in open-angle forms of glaucoma.

Caffeine

It stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, reduces headaches (including migraines), eliminates drowsiness and fatigue, and increases physical and mental performance.

Pharmacokinetics

Paracetamol

It is rapidly absorbed from the gastrointestinal tract, mainly in the small intestine, mainly by passive transport. The half-life (T _1/2 ) is 1-4 hours. It is metabolized in the liver. It is excreted mainly by the kidneys.

Chlorine eniramine maleate

After oral administration, the maximum concentration (C _m ah ) in the blood plasma reaches after 1-2.5 hours. T _1/2 in the final phase is 16-19 hours. It is excreted in the urine (70-83%) as unchanged metabolites.

Phenylephrine hydrochloride

After oral administration, it is poorly absorbed from the gastrointestinal tract. It is metabolized with the participation of MAO in the intestinal wall and “first pass” through the liver. Bioavailability is low.

Caffeine

It is well absorbed in the intestine, T _1/2 in plasma is 5-10 hours. Excreted by the kidneys mainly in the form of metabolites.

 

Indications for use

Symptomatic therapy of infectious and inflammatory diseases (ARVI, rhinitis, colds, flu), accompanied by fever, fever, headache and muscle pain, runny nose, nasal congestion and sneezing.

 

Method of administration and dosage

Inside.

Adults: 1 tablet 3-4 times a day.

Children: 2 to 6 years old: 1/4 tablet 3-4 times a day,

from 6 to 12 years old: 1/2 tablet 3-4 times a day.

The course of treatment should not exceed 7 days.

If there is no relief of symptoms within 3 days after starting the drug, you should see your doctor.

 

Side effects

The drug is usually well tolerated. However, sometimes it is possible:

From the nervous system: dizziness , sleep disturbance, irritability.

From the side of the cardiovascular system: increased blood pressure , tachycardia , arrhythmia, bradycardia.

From the digestive system: nausea , vomiting , epigastric pain , constipation, dry mouth, hepatotoxic effect .

 

Contraindications

– Hepatic and / or renal failure;

– deficiency of glucose-6-phosphate dehydrogenase;

– thyrotoxicosis, arterial hypertension and blood dyscrasia;

– simultaneous intake of beta-blockers, tricyclic antidepressants and MAO inhibitors;

– the period of pregnancy and lactation;

– children under 2 years old;

– hypersensitivity to the components of the drug.

 

Drug interactions

Paracetamol, with simultaneous use, reduces the effectiveness of uricosuric drugs, enhances the effects of MAO inhibitors, sedatives, ethanol. Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention , dry mouth, constipation, aglucocorticosteroids – the risk of glaucoma .

With simultaneous use with inducers of microsomal liver enzymes, agents with hepatotoxic action, there is a risk of increased hepatotoxic action of paracetamol, with anticoagulants – a slight or moderate increase in prothrombin time, with diazepam – a decrease in the excretion of diazepam, with metoclopromide – an increase in the absorption of paracetamol concentration and an increase in its concentration in blood plasma.

Phenylephrine reduces the hypotensive effect of guanethidine. Guanethidine enhances the alpha-adrenostimulating effect, and tricyclic antidepressants – the sympathomimetic effect of phenylephrine.

Caffeine reduces the effect of hypnotics and anesthetics, increases the effect of non-narcotic analgesics.

 

special instructions

With prolonged use, it is necessary to monitor the functions of the liver, kidneys, the state of the hematopoietic system (due to the presence of paracetamol in the composition of the drug).

Prescribed with caution to the elderly.

Blood pressure and ECG should be monitored during treatment.

Stimulants of microsomal oxidation in the liver ( phenytoin , ethanol , barbiturates, rifampicin, phenylbutazone , tricyclic antidepressants ) increase the production of hydroxylated active metabolites of paracetamol, which makes it possible to develop severe intoxication with small overdoses.

Influence on the ability to drive a car and complex mechanisms

While taking the drug, you should refrain from driving vehicles and controlling other potentially dangerous mechanisms that require the speed of the speed of psychomotor reactions and concentration of attention.

 

Overdose

Symptoms: The condition of a patient who has taken an excessively high dose of paracetamol may be satisfactory during the first 3 days, and only after that there are signs of liver damage. Overdose changes in liver cells cause damage and accumulation of toxic metabolic intermediates.

Treatment: gastric lavage, the use of saline laxatives. If the central nervous system is severely damaged, mechanical ventilation and oxygen supply, as well as the administration of naloxone, may be necessary to control the condition. The antidotes of paracetamol are acetylcysteine ​​or methionine, which exhibit a hepatoprotective effect.

 

Release form

10 tablets in a blister strip packaging.

1 or 10 blister packs in a cardboard box along with instructions for medical prescription.

 

Storage conditions

Store in a dry and dark place at a temperature not exceeding 25˚С.

Keep out of the reach of children.

 

Shelf life

3 years.

Do not use after the expiration date.

 

Conditions of dispensing from pharmacies

Without recipe.