Prostudox®
The drug should be taken only in recommended doses!
If you suspect an overdose, even if you feel well, you should stop using the drug and consult a doctor immediately, as there is a risk of delayed serious liver damage.
Overdose is usually caused by paracetamol.
Symptoms (due to paracetamol)
An overdose of paracetamol may cause liver failure, which may lead to the need for liver transplantation or death.
Within 24 hours it is possible: pale skin, anorexia, nausea, vomiting, abdominal pain. Signs of liver dysfunction may appear within 12-48 hours. Signs of impaired glucose metabolism and metabolic acidosis (including lactic acidosis) may appear. Toxic effects in adults are possible after taking more than 10 g of paracetamol. In cases of severe poisoning, severe liver failure may develop, including hepatic encephalopathy, the need for a liver transplant, coma and death. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without severe impairment of liver function. There have been reports of cases of cardiac arrhythmia, hypokalemia and pancreatitis following 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 consumption of alcohol in excess quantities; glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).
At the first signs of an overdose, you should immediately consult a doctor, even in the absence of clear symptoms of poisoning.
In the early period, symptoms may be limited only to nausea and vomiting and may not reflect the severity of the overdose or the risk of damage to internal organs.
Treatment
: within the first hour after the expected overdose, it is advisable to administer activated carbon orally. Four or more hours after the expected overdose, it is necessary to determine the concentration of paracetamol in the blood plasma (earlier determination of the concentration of paracetamol may be unreliable).
Treatment with acetylcyssine 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 this, 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 obtain hospital care) is to prescribe methionine orally.
Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department.
Symptoms (due to phenylephrine)
Symptoms of a phenylephrine overdose are similar to those of side effects. In addition, the following may occur: irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, convulsions, 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, for severe arterial hypertension, the use of alpha-blockers such as phentolamine.
Symptoms (due to ascorbic acid)
When using 1000 mg or more ascorbic acid, headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the gastrointestinal mucosa, inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).
High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea and stomach discomfort. It should be borne in mind that the appearance of clinically significant symptoms of an overdose of ascorbic acid when taking the drug is always associated with severe liver damage due to an overdose of paracetamol.
Treatment
: symptomatic therapy, forced diuresis.
Prostudox® Powder, bags, 10 pcs., 5 g, for solution preparation
Overdose
The drug should be taken only in recommended doses! If you suspect an overdose, even if you feel well, you should stop using the drug and consult a doctor immediately, as there is a risk of delayed serious liver damage. Overdose is usually caused by paracetamol. Symptoms (due to paracetamol) An overdose of paracetamol may cause liver failure, which may lead to the need for a liver transplant or death. Within 24 hours it is possible: pale skin, anorexia, nausea, vomiting, abdominal pain. Signs of liver dysfunction may appear within 12-48 hours. Signs of impaired glucose metabolism and metabolic acidosis (including lactic acidosis) may appear. Toxic effects in adults are possible after taking more than 10 g of paracetamol. In cases of severe poisoning, severe liver failure may develop, including hepatic encephalopathy, the need for a liver transplant, coma and death. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without severe impairment of liver function. There have been reports of cases of cardiac arrhythmia, hypokalemia and pancreatitis following an overdose of paracetamol. Taking 5 g or more of paracetamol can lead to liver damage in patients with the following risk factors: - long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other drugs that stimulate liver enzymes; – regular consumption of alcohol in excess quantities; glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion). At the first signs of an overdose, you should immediately consult a doctor, even in the absence of clear symptoms of poisoning. In the early period, symptoms may be limited only to nausea and vomiting and may not reflect the severity of the overdose or the risk of damage to internal organs. Treatment: within the first hour after the expected overdose, it is advisable to administer activated carbon orally. Four or more hours after the suspected overdose, it is necessary to determine the concentration of paracetamol in the blood plasma (earlier determination of the concentration of paracetamol may be unreliable). Treatment with acetylcysteine can be carried out up to 24 hours after taking paracetamol, however, the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After this, 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 obtain hospital care) is to prescribe methionine orally. Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department. Symptoms (due to phenylephrine) Symptoms of phenylephrine overdose are similar to those of side effects. In addition, the following may occur: irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, convulsions, 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, for severe arterial hypertension, the use of alpha-blockers such as phentolamine. Symptoms (due to ascorbic acid) When using 1000 mg or more ascorbic acid, headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the gastrointestinal mucosa, inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glycosuria) may appear. , hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies). High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea and stomach discomfort. It should be borne in mind that the appearance of clinically significant symptoms of an overdose of ascorbic acid when taking the drug is always associated with severe liver damage due to an overdose of paracetamol. Treatment: symptomatic therapy, forced diuresis.
Use with other drugs
Stimulators 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. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxicity of the drug. Paracetamol enhances the effects of monoamine oxidase inhibitors, sedatives, ethanol. Ethanol contributes to the development of acute pancreatitis. Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives - risk of urinary retention, dry mouth, constipation. Glucocorticosteroids - risk of developing glaucoma. Phenylephrine reduces the hypotensive effect of guanethidine. Guanethidine enhances the alpha-adrenergic stimulating effect, and tricyclic antidepressants enhance the sympathomimetic effects of phenylephrine. Reduces the effectiveness of uricosuric drugs. If gastric emptying is delayed (propantheline), the onset of the drug's effect may be delayed. By accelerating gastric emptying (metoclopramide), the drug begins to work faster. May enhance the effect of indirect anticoagulants.
Colds por d/prig solution with black currant flavor 5g N10
Registration Certificate Holder
SYNTHESIS (Russia)
Dosage form
Medicine - Prostudox®
Description
Powder for solution for oral administration
White to almost white in color with a blackcurrant scent.
1 pack
paracetamol 750 mg phenylephrine hydrochloride 10 mg ascorbic acid 60 mg
Excipients
: sodium citrate pentahemihydrate, citric acid, sodium saccharinate, currant flavoring (food powder “blackcurrant” flavoring), sugar.
5 g - disposable bags (5) - cardboard packs. 5 g - disposable bags (10) - cardboard packs.
Indications
- cold and flu symptoms (fever, headache, chills, nasal congestion, sore throat when swallowing).
Contraindications for use
- diseases of the cardiovascular system (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia);
- arterial hypertension;
- diabetes;
- prostatic hyperplasia;
- angle-closure glaucoma;
- thyrotoxicosis;
- pheochromocytoma;
- pregnancy;
- lactation period;
- children's age (up to 14 years);
- simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors (including within 14 days after their discontinuation);
- simultaneous use with other paracetamol-containing drugs;
- hypersensitivity to the components of the drug.
Should be done with caution
use the drug for renal/liver failure, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), COPD, glucose-6-phosphate dehydrogenase deficiency, blood diseases, and in elderly patients.
pharmachologic effect
A combined drug, the effect of which is determined by its constituent components (NSAID paracetamol, alpha-adrenergic agonist phenylephrine and vitamin C). It has an antipyretic, analgesic (pain reliever), vasoconstrictor effect, and eliminates cold symptoms. Constricts nasal vessels, eliminates swelling of the mucous membrane of the nasal cavity and nasopharynx, and replenishes vitamin C deficiency during colds.
The onset of action is 20-30 minutes after administration, duration is 4-4.5 hours.
Drug interactions
Stimulators 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.
Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxicity of the drug.
Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol.
Ethanol contributes to the development of acute pancreatitis.
Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation.
GCS increase the risk of developing glaucoma.
Phenylephrine reduces the hypotensive effect of guanethidine.
Guanethidine enhances the alpha-adrenergic stimulating effect, and tricyclic antidepressants enhance the sympathomimetic effects of phenylephrine.
The drug reduces the effectiveness of uricosuric drugs.
If gastric emptying is delayed (propantheline), the onset of the drug's effect may be delayed.
By accelerating gastric emptying (metoclopramide), the drug begins to work faster.
The drug may enhance the effect of indirect anticoagulants.
Dosage regimen
For adults
and
children over 14 years of age
should take 1 sachet every 4-6 hours, but no more than 4 sachets within 24 hours.
The drug is not recommended to be taken for more than 5 days without consulting a doctor.
If symptoms persist, you should consult a doctor. Pour the contents of 1 sachet into a glass and fill it with hot water, stir until completely dissolved and add sugar or honey to taste.
Overdose
An overdose of paracetamol appears after taking 10-15 g (15-20 sachets of Prostudox).
Symptoms:
discomfort in the epigastric region, nausea, vomiting, pallor of the skin, loss of appetite, nausea, vomiting, hepatonecrosis (the severity of necrosis directly depends on the degree of overdose), increased activity of liver transaminases, increased prothrombin time (12-48 hours after administration) , a detailed clinical picture of liver damage appears after 1-6 days. Rarely, liver dysfunction develops suddenly and can be complicated by renal failure (renal tubular necrosis).
Treatment:
symptomatic, gastric lavage, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.
Side effect
Allergic reactions:
sometimes - skin rash, itching, urticaria, angioedema.
From the hematopoietic system:
rarely - thrombocytopenia, leukopenia, agranulocytosis.
From the digestive system:
rarely - nausea, vomiting, epigastric pain.
Other:
rarely - increased intraocular pressure, urinary retention.
With long-term use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur.
Phenylephrine hydrochloride may cause nausea, headache, and increased blood pressure; rarely - palpitations. These symptoms disappear after discontinuation of the drug.
special instructions
You should not simultaneously use other drugs containing paracetamol, as well as other non-opioid analgesics, NSAIDs (including metamizole, acetylsalicylic acid, ibuprofen), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.
The simultaneous use of other drugs should be agreed with a doctor.
The drug may interfere with the results of laboratory tests assessing the concentration of glucose and uric acid in plasma.
Storage conditions
The drug should be stored out of the reach of children, in a dry place, protected from light, at a temperature not exceeding 25°C.
Best before date
Shelf life: 3 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
The use of the drug Prostudox® is contraindicated during pregnancy and breastfeeding.
Use for renal impairment
Restrictions for impaired renal function - With caution.
Should be done with caution
use the drug for renal failure.
Use for liver dysfunction
Restrictions for liver dysfunction - With caution.
Should be done with caution
use the drug for liver failure, congenital hyperbilirubinemia (including Gilbert, Dubin-Johnson and Rotor syndrome).
Use in children
Restrictions for children - Contraindicated. Contraindicated in children under 14 years of age.
Terms of sale
The drug is approved for use as a means of OTC.
Contacts for inquiries
SYNTHEZ OJSC Kurgan Joint-Stock Company of Medical Preparations and Products (Russia)
SYNTHEZ JSC
640008 Kurgan, Constitution Ave. 7 Tel.; Fax
Overdose
An overdose of paracetamol appears after taking 10-15 g: symptoms - discomfort in the epigastric region, nausea, vomiting, pale skin, loss of appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis directly depends on the degree of overdose); increased activity of “liver” transaminases, increased prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage appears after 1-6 days. Rarely, liver dysfunction develops suddenly and can be complicated by renal failure (renal tubular necrosis). Treatment: symptomatic, gastric lavage, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine after 12 hours. The need for additional therapeutic measures (further administration of methionine, i.v. N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.
Side effect
Sometimes allergic reactions are possible: skin rash, itching, urticaria, angioedema. Rarely - blood disorders (thrombocytopenia, leukopenia, agranulocytosis); increased intraocular pressure, nausea, vomiting, epigastric pain, urinary retention. With long-term use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur. Phenylephrine hydrochloride may cause nausea, headache, increased blood pressure and, in rare cases, palpitations, which resolve after discontinuation of the drug.
special instructions
You should not simultaneously use other drugs containing paracetamol, as well as other non-narcotic analgesics, non-steroidal anti-inflammatory drugs (metamizole, acetylsalicylic acid, ibuprofen, etc.), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol. The simultaneous use of other drugs should be agreed with a doctor. Distorts the results of laboratory tests assessing the concentration of glucose and uric acid in plasma.
Composition and release form
| Powder for solution for oral administration | 1 pack |
| paracetamol | 750 mg |
| phenylephrine hydrochloride | 10 mg |
| ascorbic acid | 60 mg |
| excipients: sodium citrate pentahemihydrate (sodium citrate 5.5-aqueous), citric acid, sodium saccharinate, currant flavor (food powder “blackcurrant” flavor), sugar |
in disposable bags made of combined material, 5 g each; There are 5 or 10 sachets in a cardboard pack.
Storage conditions
In a place protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
over the counter
Colds are a good choice. The quality of goods, including Colds, undergo quality control by our suppliers. You can buy Prostudox on our website by clicking on the “Add to cart” button. We will be happy to deliver Prostudox to you at any address within our delivery zone indicated in the “Delivery” section, or you can order Prostudox for pickup.
Contraindications
The drug should not be taken simultaneously with other paracetamol-containing drugs, in case of hypersensitivity to the ingredients included in the drug. Hypersensitivity, hyperthyroidism, diseases of the cardiovascular system (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia), arterial hypertension, diabetes mellitus, pheochromocytoma, prostatic hyperplasia, angle-closure glaucoma, concomitant use of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors (including .h. within 14 days after their cancellation), children's age (up to 14 years), pregnancy, lactation period.
