Description
Release form
Powder for solution for oral administration, 0.280 g + 0.010 g + 0.100 g
3 g of powder in a bag of paper / A1 / polyethylene. 8 sachets together with instructions for use in a cardboard box.
Pharmacological action
Fervex ® for children is a combined preparation that contains paracetamol, pheniramine maleate and ascorbic acid.
Paracetamol is a non-steroidal anti-inflammatory drug that blocks cyclooxygenase, mainly in the central nervous system, acting on pain and thermoregulation centers and has an analgesic and antipyretic effect. Paracetamol has an analgesic and antipyretic effect.
Pheniramine maleate is a histamine H1 receptor blocker. Narrows the vessels of the nose, eliminates puffiness and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses.
Ascorbic acid is involved in the regulation of redox processes, reduces vascular permeability and increases the body’s resistance.
PHARMACOKINETICS
Paracetamol
Absorption of paracetamol is complete and fast. The peak concentration in plasma is reached 30-60 minutes after administration. The distribution of paracetamol in the tissues occurs quickly. Comparable concentrations of the drug in blood, saliva and plasma are achieved. Plasma protein binding is low, 10-25%. Penetrates through the blood-brain barrier.
Metabolism occurs in the liver, 80% undergoes a conjugation reaction with glucuronic acid and sulfates to form inactive metabolites 17% undergoes hydroxylation with the formation of 8 active metabolites, which conjugate with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the hepatocyte enzyme systems and cause their necrosis. The isoenzyme of CYP2E1 is also involved in the metabolism of the drug. T1 / 2 – 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates. Less than 5% is excreted unchanged. T1 / 2 for about 2 hours.
Pheniramine maleate
Well absorbed in the digestive tract. T1 / 2 from blood plasma is from 1 to 1.5 hours. It is excreted mainly by the kidneys.
Ascorbic acid
Well absorbed in the digestive tract. TCmax after oral administration – 4 hours. Metabolized mainly in the liver. It is excreted by the kidneys, through the intestines, with sweat in an unchanged form and in the form of metabolites.
Indications
For children aged 6 to 15 years for short-term treatment of conditions associated with:
– an increase in body temperature, a runny nose for colds – rhinitis and rhinitis inflammatory and allergic in nature.
Contraindications
– Hypersensitivity to one of the components of the
preparation – severe impaired liver function
– severe impaired renal function
– blood disease
– deficiency of the glucose-6-phosphate dehydrogenase
enzyme – I and III triceps age up to 6 years
– phenylketonuria
– sucrose / isomaltase deficiency
– fructose intolerance, glucose-galactose malabsorption.
Precautions: benign hyperbilirubinemia (including Gilbert syndrome), with impaired liver or kidney function, with diabetes mellitus, II trimester of pregnancy.
Use during pregnancy and lactation
The use of the drug in the I and III trimesters of pregnancy is contraindicated. With caution, the drug should be used in the second trimester of pregnancy.
The use of the drug during lactation is contraindicated.
Special instructions
Fervex ® for children should not be used simultaneously with other preparations containing paracetamol.
When using the drug for more than a week, monitoring of the functional state of the liver and peripheral blood picture is necessary.
Paracetamol distorts the results of laboratory studies of glucose and uric acid in blood plasma.
In the absence of a therapeutic effect (fever persists for more than 3 days and pain for more than 5 days), a doctor’s consultation is required.
Impact on the ability to drive vehicles and mechanisms
Given the possibility of adverse reactions such as drowsiness, disturbance of accommodation, one should refrain from driving vehicles and working with mechanisms.
Composition
Powder for solution for oral administration, light pink with a touch of white and dark pink.
1 pack
paracetamol
280 mg
pheniramine maleate
10 mg
ascorbic acid
100 mg
Excipients:
mannitol – 2.26 g,
citric acid – 0.03 g,
povidone K30 – 0.006 g,
magnesium citrate – 0.242 g,
potassium acesulfame – 0.036 g,
flavor raspberry * – 0.036 g.
* composition of raspberry flavor: srdlkram ,
E129 dye red charming,
E133 dye brilliant blue,
E110 dye sunny sunset yellow,
permastabil 505528 RI,
raspberry 054428 A (ethyl acetate, isoamyl acetate, acetic acid, benzyl p-hydroxytan, three , sodium chloride and / or sodium sulfate.
Dosage and administration
The drug is used orally. Before use, the contents of the bag must be dissolved in a glass (200 ml) of warm water.
Depending on the age of the child, the drug is used in the following doses:
– children from 6 to 10 years old – 1 sachet 2 times / day
– children from 10 to 12 years old – 1 sachet 3 times / day
– children from 12 to 15 years – 1 sachet 4 times / day.
The interval between doses of the drug is at least 4 hours. The duration of treatment is no more than 3 days.
Side effects
The drug is well tolerated in recommended doses.
Possible: dry mouth, nausea, vomiting, abdominal pain, impaired urination, constipation, allergic reactions (skin rash, itching, urticaria, Quincke edema), drowsiness, accommodation disturbance, anemia, leukopenia, agranulocytosis, thrombocytopenia.
With prolonged use in doses, exceeding the recommended, possibly hepatotoxic and nephrotoxic effects, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.
If adverse reactions occur, the patient must stop taking the drug and consult a doctor.
Drug interaction
Fervex ® for children, due to pheniramine maleate, enhances the effect of sedatives, and when used together with antipsychotics (phenothiazine derivatives), the risk of side effects of the drug (urinary retention, dry mouth, constipation) increases.
Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, imipramine group antidepressants, phenothiazine antipsychotics, anticholinergic antiparkinsonian drugs, atropine-like antispasmodics, disopyramid).
When using the drug together with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxicity is significantly increased (due to paracetamol).
With simultaneous use with salicylates, the risk of nephrotoxicity increases.
With simultaneous use with chloramphenicol (chloramphenicol), the toxicity of the latter increases.
Paracetamol contained in the drug enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.
Caution should be exercised with the simultaneous use of paracetamol and inducers of liver microsomal enzymes (e.g. ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, zidovudine, anticoagulants, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants because of the increased risk).
Myelotoxic drugs enhance the hematotoxicity of paracetamol, metoclopramide enhances its absorption.
Overdose of
Symptoms:
signs of acute paracetamol poisoning are anorexia, nausea, vomiting, epigastric pain, sweating, pale skin, drowsiness. After 1-2 days, signs of liver damage appear. In severe cases, liver failure develops, hepatonecrosis, encephalopathy and coma.
Treatment:
, if symptoms of poisoning appear, stop using the drug and consult a doctor immediately. Gastric lavage, administration of enterosorbents (activated charcoal, hydrolysis lignin), iv administration of an acetylcysteine antidote, and methionine administration are recommended.
Storage conditions
The product should be stored out of the reach of children at temperatures between 15 ° and 25 ° C.
Expiration
3 years.
Active ingredient srdl kp Paracetamol, Ascorbic acid, Rimantadine, Rutoside, Loratadine, Ascorbic acid
Terms leave through pharmacies
without prescription
lekarstvennaja form
Solution for pryema inside
