Trade name of the drug: Romidon

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

Dosage form: powder for solution preparation with lemon, orange flavor

Composition:

Each packet contains:

Active substances:

Paracetamol 500 mg

Caffeine 30 mg

Phenylephrine hydrochloride 10 mg

Chlorpheniramine maleate 4 mg

Ascorbic acid 50 mg

Excipients: Orange flavoring, lemon flavoring, citric acid monohydrate, sucralose, sucrose, “Sunset Yellow” dye.

Description : dry powder, light yellow color, in hermetically sealed bags.

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

ATX code:  N02BE51

 

Pharmacological properties

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 vasculature, 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.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, increases the body’s resistance to infections, reduces vascular permeability. Improves the tolerance of paracetamol and lengthens its action.

 

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.

Vitamin C

Absorbed in the  gastrointestinal tract  (mainly in the small intestine). With an increase in the dose to 200 mg, up to 140 mg (70%) is absorbed; with a further increase in the dose, absorption decreases (50-20%). Communication with plasma proteins – 25%. Diseases of the gastrointestinal tract ( peptic ulcer  and  12 duodenal ulcer , constipation or diarrhea, helminthic invasion,  giardiasis ), the use of fresh fruit and vegetable juices, alkaline drinks reduce the absorption of ascorbate in the intestine. It is excreted by the kidneys, through the intestines, with sweat, breast milk in the form of unchanged ascorbate and 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

Dissolve the contents of one sachet in 1 glass of boiled hot water; use hot.

A repeated dose can be taken every 4 hours, but no more than 3 doses of the drug within 24 hours.

Duration of admission as an antipyretic agent – no more than 3 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,

– concomitant use of beta-blockers, tricyclic antidepressants and MAO inhibitors,

– the period of pregnancy and lactation,

– children under 12 years old,

– increased sensitivity to the components of the drug.

– diabetes

– peptic ulcer of the stomach and duodenum

– diseases of the pancreas

– difficulty urinating with prostate adenoma

 

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, and corticosteroids increase 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 enhance the sympathomimetic effects 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 intoxications 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 managing other potentially dangerous mechanisms that require speed of psychomotor reactions and concentration of attention.

The drug should not be used after the expiration date and should be kept out of the reach of children.

 

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 needed to control the condition. The antidotes of paracetamol are acetylcysteine ​​or methionine, which exhibit a hepatoprotective effect.

 

 

 

Release form

Powder for solution preparation 20g, 10 pcs in a pencil case with instructions for use.

 

Storage conditions

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

Keep out of the reach of children.

 

Shelf life

2 years.

 

Conditions of dispensing from pharmacies

Without recipe.