Composition, form of production and packaging
? Suspension for ingestion for children pink color with the smell of strawberry.
5 ml
paracetamol 120 mg
Excipients: sugar syrup, sorbitol solution 70%, glycerol, gum, methylparahydroxybenzoate, carmoizine (E122), flavor, purified water.
70 ml - bottles of dark glass (1) complete with measuring spoon for 2.5 and 5 ml - cardboard boxes.
100 ml - bottles of dark glass (1) complete with a measuring spoon for 2.5 and 5 ml - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Analgetic-antipyretic. Has analgesic, antipyretic. The mechanism of action is associated with inhibition of prostaglandin synthesis. Paracetamol affects the water-electrolyte metabolism (does not lead to sodium and water retention) and does not have a damaging effect on the gastrointestinal mucosa.
PHARMACOKINETICS
Suction and distribution
After taking the drug inside C max is reached in 30-90 minutes. The ratio of V d and bioavailability in adults, children and newborns is approximately the same.
Metabolism
Paracetamol is metabolized in the liver with the formation of several metabolites. In newborns of the first 2 days of life and in children aged 3 to 10 years, the main metabolite is paracetamol sulfate, and in children 12 years and older - conjugated glucuronide. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis.
Excretion
T 1/2 is 1.5-2.5 hours.
Within 24 hours with the kidneys, about 85-95% paracetamol is excreted, in unchanged form - less than 4%.
INDICATIONS
The drug is prescribed for children aged 3 months to 6 years as:
- antipyretic agents for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by fever;
- analgesic for pain syndrome of mild to moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain with injuries and burns.
The question of the possibility of using the drug Kalp on these indications in children aged 1 to 3 months is decided individually by the attending physician.
DOSING MODE
Suspension Kalpol taken inside 1-2 hours after eating, squeezed large amounts of liquid. Multiplicity of admission 3-4 times / day with an interval of at least 4 hours.
Suspension should not be diluted, for convenience and accuracy of dosing is recommended to use the attached measuring spoon (with a mark of 2.5 and 5 ml).
Recommended doses for children from 3 months to 6 years are presented in the table.
Age Single dose
3 months-1 year 60-120 mg of paracetamol (2.5-5 ml of suspension)
from 1 year to 6 years 120-240 mg of paracetamol (5-10 ml of suspension)
The duration of therapy is 3 days when used as an antipyretic agent; up to 5 days - as an analgesic.
SIDE EFFECT
Possible: nausea, vomiting, abdominal pain, allergic reactions in the form of skin rash, itching, urticaria, and Quincke's edema.
Rarely: anemia, leukopenia, agranulocytosis, thrombocytopenia.
With prolonged use in high doses , hepatotoxic and nephrotoxic effects are possible, as well as the occurrence of pancytopenia and methemoglobinemia.
When taken at recommended doses, paracetamol rarely causes serious side effects.
CONTRAINDICATIONS
severe hepatic impairment;
- severe renal dysfunction;
- Blood diseases;
- deficiency of glucose-6-phosphate dehydrogenase;
- Children's age up to 1 month;
- Hypersensitivity to the components of the drug.
With caution appoint a drug for light and moderate violations of the liver or kidney function, Gilbert syndrome, Dubin-Johnson and Rotor.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in severe violations of kidney function. With caution appoint a drug for mild and moderate violations of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in severe violations of liver function. With caution appoint the drug for light and moderate violations of the liver, Gilbert syndrome, Dubin-Johnson and Rotor.
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 1 month.
Age Single dose
3 months-1 year 60-120 mg of paracetamol (2.5-5 ml of suspension)
from 1 year to 6 years 120-240 mg of paracetamol (5-10 ml of suspension)
SPECIAL INSTRUCTIONS
It is necessary to avoid the use of Kalpol simultaneously with other paracetamolosoderzhaschimi drugs, tk. this can lead to an overdose of paracetamol.
When using the drug for more than 5-7 days, monitor the picture of peripheral blood and indicators of the functional state of the liver.
The suspension contains sugar, which should be taken into account when treating patients with diabetes mellitus.
Paracetamol distorts the results of laboratory tests to determine the content of glucose and uric acid in the blood plasma.
It is necessary to warn about the need to see a doctor if the temperature is high for more than 3 days and the pain syndrome is more than 5 days.
OVERDOSE
Symptoms: the most frequent and early include the pallor of the skin, increased sweating, stomach pain, nausea, vomiting. After 1-2 days, there may be signs of liver damage - soreness in the liver, increased activity of hepatic enzymes, an increase in prothrombin time. In severe cases, hepatic failure develops, hepatonecrosis, encephalopathy, coma.
Treatment: gastric lavage, intake of enterosorbents (activated charcoal, polyphepan), iv administration of the antidote of N-acetylcysteine ​​or methionine intake. The patient should be informed that when overdosing occurs, stop taking the drug and consult a doctor.
DRUG INTERACTION
When combined with barbiturates, tricyclic antidepressants, ethanol, anticonvulsants (phenytoin), phenylbutazone, rifampicin, the risk of hepatotoxic effect of paracetamol is significantly increased.
When taken together with salicylates, the nephrotoxic effect of paracetamol increases.
Combined use with chloramphenicol leads to an increase in the toxic properties of the latter.
Paracetamol increases the effect of anticoagulants of indirect action and weakens the effect of uricosuric drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
