Prostudox oral solution powder lemon 5g sachets, 5pcs

Composition

Active ingredients:

paracetamol-750 mg,

phenylephrine hydrochloride-10 mg,

ascorbic acid-60 mg.

Auxiliary substances: sodium citrate pentahemihydrate (sodium citric acid 5.5-water), citric acid monohydrate, sodium saccharinate dihydrate, lemon flavor (food powder flavor “Lemon”), sucrose.

Pharmacological action

Pharmacotherapeutic group: a remedy for eliminating the symptoms of acute respiratory infections and “colds” (analgesic non-narcotic agent + alpha-adrenomimetic + vitamin).

ATX code: N02BE51

Pharmacological properties

A combined remedy, the action of which is determined by the components that make up its composition.

Pharmacodynamics

Paracetamol is an analgesic and antipyretic agent. The mechanism of its action presumably consists in suppressing the synthesis of prostaglandins, mainly in the central nervous system.

It practically does not affect the synthesis of prostaglandins in peripheral tissues, does not change water and electrolyte metabolism, and does not damage the mucous membrane of the gastrointestinal tract. This property of paracetamol makes the drug particularly suitable for patients with a history of gastrointestinal diseases (for example, patients with a history of gastrointestinal bleeding or elderly patients) or patients taking concomitant medication, in which suppression of peripheral prostaglandin synthesis may be undesirable.

Phenylephrine hydrochloride is a sympathomimetic agent whose action is aimed at stimulating adrenoreceptors (mainly alpha-adrenoreceptors), which leads to a decrease in swelling of the nasal mucosa and facilitates nasal breathing.

Ascorbic acid (vitamin C) makes up for the increased need for vitamin C in “colds” and flu, especially in the initial stages of the disease. The components included in the preparation do not cause drowsiness and do not interfere with concentration.

Pharmacokinetics

Suction and distribution

Absorption of paracetamol in the gastrointestinal tract is high. The time to reach the maximum concentration in plasma is 0.5-2 hours; the maximum concentration in plasma is 5-20 mcg / ml. Binding to plasma proteins is 15%. Penetrates the blood-brain barrier.

Phenylephrine hydrochloride is unevenly absorbed from the gastrointestinal tract. The maximum concentration in plasma is reached in the range from 45 min to 2 h. Distribution data are not available.

Ascorbic acid is rapidly absorbed from the gastrointestinal tract and distributed throughout the body. Binding to plasma proteins is 25%.

Metabolism

Paracetamol is primarily metabolized in the liver. 90-95% in three main ways: 80% enter into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergo hydroxylation to form 8 active metabolites, which conjugate with glutathione to form already inactive metabolites. When glutathione is deficient, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug.

Phenylephrine hydrochloride undergoes primary metabolism by monoamine oxidases in the intestine and liver. Thus, the bioavailability of phenylephrine decreases with oral use.

There are no data on ascorbic acid metabolism.

Deduction

Paracetamol is excreted by the kidneys in the form of metabolites, mainly glucuronide and sulfate conjugates, less than 5% is excreted unchanged. The elimination half-life is 1-4 hours. In elderly patients, the clearance of the drug decreases and the half-life increases, but no dose adjustment is required. Phenylephrine hydrochloride is excreted by the kidneys almost completely in the form of sulfate conjugates. The elimination period is 2-3 hours.

When used in doses exceeding the body’s needs for ascorbic acid, ascorbic acid is excreted by the kidneys in the form of metabolites.

Indications

The drug is used as a temporary remedy to eliminate the symptoms of “colds” and flu, including: :

– fever;

– headache;

– chills;

– joint and muscle pain;

– sinus pain and congestion;

– sore throat.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

Contraindications

– hypersensitivity to paracetamol, phenylephrine, ascorbic acid (vitamin C) or any other component of the drug;

– disorders of the liver and kidneys, severe;

– hyperthyroidism (including hyperthyroidism);

– diabetes and deficiency of sucrase/isomaltase, with rare hereditary disturbance in the form of fructose intolerance, glucose-galactose malabsorption, because the composition of the drug includes sucrose;

– deficiency of glucose-6-phosphate dehydrogenase;

– diseases of the heart (in severe stenosis of the mouth of the aorta, acute myocardial infarction, tachyarrhythmia);

– arterial hypertension;

– concomitant use of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors (MAOIS), including in the period up to 14 days after their cancellation;

– simultaneous reception of other parazitologiia remedies decongestants, non-narcotic analgesics, non-steroidal anti-inflammatory drugs, drugs for the relief of symptoms of cold, flu and nasal congestion, drugs that regulate appetite, amphetaminetype of stimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol (see section “Interaction with other medicines”);

– simultaneous reception of etanolsodergaszczye drink and drugs;

– alcoholism;

– hyperplasia of the prostate;

– closure glaucoma;

pregnancy and lactation;

– age up to 12 years.

With caution

If you have any of these diseases / conditions / risk factors, be sure to consult your doctor before taking this medicine. :

– benign hyperbilirubinemia;

– disorders of the liver and kidney of mild and moderate severity;

alcoholic liver disease;

– stenosing ulcer of the stomach and / or duodenum;

– diseases of the prostate or problems with urination;

– cardiovascular diseases, including high blood pressure, occlusive vascular disease (Raynaud’s syndrome);

– pheochromocytoma;

– the presence of severe infections, because the drug can increase the risk of metabolic acidosis;

– deficiency of glutathione (in particular, extremely malnourished patients with anorexia chronic alcoholism or patients with low body mass index);

– concomitant use of digoxin and cardiac glycosides, ergot alkaloids (eg, ergotamine or methysergide).

Side effects

At the recommended doses, the drug is usually well tolerated.

The following adverse reactions were detected spontaneously during post-marketing use of the drug.

Adverse reactions are classified according to body systems and frequency of development. The frequency of adverse reactions is determined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (

Paracetamol

Paracetamol rarely has a side effect.

Disorders of the blood and lymphatic system

Very rare: thrombocytopenia, leukopenia, agranulocytosis.

Immune system disorders

Very rare: anaphylactic shock, hypersensitivity skin reactions, including, but not limited to, skin rash, urticaria, angioedema (Quincke’s edema), Stevens-Johnson syndrome, toxic epidermal necrolysis.

Respiratory, thoracic and mediastinal disorders

Very rare: bronchospasm in patients with hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.

Liver and biliary tract disorders

Very rare: liver function disorders.

Kidney and urinary tract disorders

With prolonged use of the drug in doses exceeding the recommended one, the probability of nephrotoxic action increases.

Phenylephrine

Immune system disorders

Rare: hypersensitivity reactions, urticaria, allergic dermatitis.

Mental disorders

Often: nervousness

Nervous system disorders

are common: headache, dizziness, insomnia.

Visual disturbances

Rare: mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

Disorders of the cardiovascular system

are common: increased blood pressure.

Rare: tachycardia, palpitations that disappear immediately after discontinuation of the drug.

Disorders of the gastrointestinal tract

Often: nausea, vomiting.

Skin and subcutaneous tissue disorders

Very rare: rash.

Kidney and urinary tract disorders

Rare: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.

Ascorbic acid

Blood and lymphatic system disorders

Frequency unknown: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

Immune system disorders

Frequency unknown: allergic reactions (skin rash, skin hyperemia).

Gastrointestinal disorders

Frequency unknown: irritation of the gastrointestinal mucosa.

Moderate pollakiuria is possible if ascorbic acid is taken more than 600 mg / day. If you experience any of these adverse reactions, immediately stop taking the drug and consult a doctor as soon as possible.

If any of the adverse reactions listed in the instructions get worse, or you notice other adverse reactions that are not listed in the instructions, tell your doctor.

Interaction

Potentially clinically significant drug interactions are described below (see the sections “Contraindications” and “Special Instructions”).

Paracetamol, when taken regularly for a long time, increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic use of a single dose of the drug does not significantly affect their effect.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone, and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses and concomitant use with paracetamol.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects.

Halothane increases the risk of ventricular arrhythmia.

Paracetamol reduces the effectiveness of diuretic and uricosuric drugs. Metoclopramide and domperidone increase, and colestyramine reduces the rate of absorption of paracetamol.

Paracetamol enhances the effects of MAO inhibitors, sedatives, and ethanol. Concomitant use of paracetamol and alcoholic beverages increases the risk of developing liver damage and acute pancreatitis.

Phenylephrine, when taken with MAO inhibitors, can lead to an increase in blood pressure.

Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (including such drugs as debrisoquine, guanethidine, reserpine, methyldopa), may increase the risk of hypertension and cardiovascular disorders.

Tricyclic antidepressants (for example, amitriptyline) 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 ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, increases the alpha-adrenostimulating activity of phenylephrine.

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

Concomitant use of glucocorticosteroids with phenylephrine increases the risk of glaucoma.

Concomitant use of digoxin and other cardiac glycosides may increase the risk of cardiac arrhythmia and heart attack.

Concomitant use of phenylephrine with sympathomimetic amines may increase the risk of side effects from the cardiovascular system. Concomitant use of phenylephrine and ergot alkaloids (e. g. ergotamine and metisergide) may increase the risk of ergotism.

Ascorbic acid increases the risk of crystalluria in the treatment of short-acting salicylates and sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Ethanol contributes to the development of acute pancreatitis.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

How to take, course of use and dosage

For oral use.

Do not exceed the recommended dose!

Apply the lowest dose necessary to achieve the effect, for the shortest possible duration of treatment!

The minimum interval between doses of Prodrodox® should be at least 4 hours.

Pour the contents of 1 packet into a mug, pour about 250 ml of hot water and mix thoroughly. If necessary, add cold water and sugar.

Adults and children over 12 years of age

1 package every 4-6 hours, but no more than 4 packages per day. The maximum duration of use of the drug without consulting a doctor should be no more than 5 days.

It is not recommended to use the drug as an antipyretic for more than 3 days without consulting a doctor.

It is not recommended to use simultaneously with other paracetamol-containing products, decongestants and means to relieve the symptoms of “cold” and flu, as well as with ethanol-containing products and beverages.

If the symptoms of the disease persist while taking the drug, you should consult a doctor.

If you exceed the recommended dose, seek immediate medical attention, even if you feel well, as there is a risk of delayed serious liver damage. An overdose of paracetamol may cause hepatic and / or renal failure.

Special patient groups

Patients with impaired renal function

Patients with impaired renal function should first consult a doctor before using the drug Prodrodox®. Limitations associated with the use of drugs containing such a combination of active substances in patients with impaired renal function are mainly associated with the content of paracetamol in the drug.

Patients with impaired liver function

Patients with hepatic impairment should first consult a physician before using Prodrodox®. Limitations associated with the use of drugs containing such a combination of active substances in patients with impaired liver function are mainly associated with the content of paracetamol in the drug.

Overdose

The drug should be taken only in the recommended doses!

If an overdose is suspected, even if you feel well, you should stop using the drug and immediately consult a doctor, as 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 paracetamol can lead to liver failure, which can lead to the need for liver transplantation or death.

Within 24 hours, paleness of the skin, loss of appetite, nausea, vomiting, abdominal pain, sweating are possible. Clinical signs of liver damage develop, as a rule, in 24-48 hours and reach a maximum in 4-6 days. There may be signs of impaired glucose metabolism and metabolic acidosis. Toxic effect in adults is possible after taking more than 10 g of paracetamol: increased activity of “liver” transaminases. Acute pancreatitis was observed, usually with impaired liver function and toxic effects on the liver. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without severe liver dysfunction. There are reports of cardiac arrhythmias associated 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 alcohol consumption in excessive quantities;

– glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).

At the first sign of overdose, you should immediately consult a doctor, even if there are no clear symptoms of poisoning. In the early period, symptoms may be limited only to nausea and vomiting and may not reflect the severity of overdose or the risk of internal organ damage.

Treatment

During the first hours after a suspected overdose, it is advisable to prescribe activated carbon inside. After 4 or more hours after the suspected overdose, it is necessary to determine the concentration of paracetamol in the blood plasma (an earlier determination of the concentration of paracetamol may be unreliable). Treatment with acetylcysteine can be carried out up to 24 hours after taking paracetamol, but the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, 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 receive inpatient care) is to prescribe methionine orally. Treatment of patients with severe hepatic impairment 24 hours after taking paracetamol should be carried out in conjunction with specialists of the toxicology center or specialized department of liver diseases.

Phenylephrine

Symptoms

Symptoms of an overdose of phenylephrine are similar to the manifestations 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, seizures, 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, with 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 disorders of the gastrointestinal tract, such as nausea, stomach discomfort. It should be borne in mind that the appearance of clinically significant symptoms of ascorbic acid overdose when taking the drug is always associated with severe liver damage on the background of an overdose of paracetamol.

Treatment

Symptomatic, forced diuresis.

Description

Package Contents:

“Lemon-flavored” – powder from white or white with a yellowish tinge to light yellow or light brown in color with a lemon smell, prone to clumping. White, yellow, or brown inclusions are allowed.

Description of the reconstituted solution

“Lemon-flavored” -from colorless or light yellow to yellow or light brown opalescent solution with the smell of lemon.

Special instructions

If there is no improvement in the condition when taking the drug or the first signs of overdose appear, even if there are no clear symptoms of poisoning, you should immediately consult a doctor.

The drug contains paracetamol, it should not be taken simultaneously with other paracetamol-containing drugs, as well as non-narcotic analgesics, NSAIDs (metamizole sodium, acetylsalicylic acid, ibuprofen, etc. ), drugs to eliminate the symptoms of “cold” and flu, sympathomimetics (decongestants, appetite-regulating drugs, amphetamine-like psychostimulants), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

In order to avoid toxic liver damage, the drug should not be combined with ethanol-containing drugs and beverages, as well as taken by peoplewho are prone to chronic alcohol consumption.

Concomitant liver diseases increase the risk of further liver damage when taking the drug. When taking the drug in patients with non-alcoholic cirrhosis of the liver, there is a high risk of overdose.

When performing uric acid and blood glucose tests, inform your doctor about the use of Coldox®, as the drug may distort the results of laboratory tests that assess the concentration of glucose and uric acid.

Patients with glutathione deficiency due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion, are susceptible to overdose, so precautions should be taken and it is recommended to consult a doctor before taking the drug. Cases of hepatic insufficiency / impaired liver function have been reported with a small overdose of paracetamol (5 g or more) in patients with low glutathione levels, in particular, in extremely emaciated patients suffering from anorexia, chronic alcoholism, in patients with a low body mass index or sepsis.

The use of the drug in patients with low levels of glutathione, for example, in sepsis, may increase the risk of developing metabolic acidosis, accompanied by symptoms of rapid, shortness of breath (feeling of lack of air, shortness of breath), nausea, vomiting, loss of appetite. If these symptoms occur at the same time, you should immediately consult a doctor.

Before taking Coldox®, you should consult your doctor if::

– if you are taking warfarin or other indirect anticoagulants to thin the blood;

– if you are taking metoclopramide, domperidone (usually used to treat nausea and vomiting) or colestyramine, used to lower blood cholesterol;

– if you are following a low-sodium diet.

Influence on the ability to drive vehicles and mechanisms

The drug may cause dizziness. If dizziness occurs, it is not recommended to drive vehicles or work with mechanisms.

Form of production

Powder for the preparation of an oral solution [with the taste of black currant, with the taste of lemon].

5 g each in heat-sealable single-dose bags made of polyethylene, or a combined multi-layer material based on foil, or packaging paper with a polyethylene coating.

5 or 10 bags with instructions for use are placed in a pack of cardboard

Storage conditions

At a temperature not exceeding 25 °C in the original packaging (packages in a bundle). Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Paracetamol, Phenylephrine, Ascorbic acid

Dosage form

oral solution