Paracetamol -pediatric suspension- 24mg/ml 100ml
Non-narcotic analgesic, temperature lowering
means.
Description: Homogeneous, sweet,
strawberries aroma, reddish suspension.
Form: Suspension 120mg/5ml – 100
ml for peroral use.
Pharmacotherapeutic
group: Non-narcotic analgesic, temperature lowering
means.
ATC Code: NO2BEO1;
Composition: (on 100 ml) active
substance: Paracetamol – 2,4 gram;
Aiding substances: sucrose, carboxymethyloxyethy,
strawberry aromatizer, pigment, glycerol, propylene glycol, methylparaben,
distilled water.
Pharmacological
operation: Paracetamol
is non-narcotic analgesic mean. It has painkiller, temperature lowering and
slightly expressed anti- inflammatory
activity; preparation doesn’t cause irritation of stomach mucous tunic. Its
operating mechanism is related to suppression of prostaglandin synthesis,
advantageously – with the effort on heat
regulation center localized in hypothalamus. The preparation is effective at
time of pain, which isn’t caused by inflammation.
Paracetamol is quickly absorbed from gastrointestinal
tract. Its maximal concentration in plasma is indicated after 30-60 minutes
from taking; Paracetamol half-excretion period make up 1-3 hours. It connects
to blood plasma protein with less quality, metabolized in the liver. The formed conjugants are discharged by
uterine. Paracetamol’s pharmacokinetics is analogous to children, new-born and
adults.
Indication: It is used for children
above 3 months age. It is used as a:
- Temperature falling mean – in case of acute respiratory diseases,
influenza, pediatric infections, post-vaccine reactions and other states
that are followed temperature rise.
- Tranquilizer – in case of weak and moderate intensity pain
syndrome, among them: head and tooth ache, myalgia, arthralgia, neuralgia,
traumatic and scorch ache.
(Usage is permitted from 1 to 3 months age babies
according to the doctor-pediatrician prescription)
Contra-indication:
- Individual additional
sensitivity toward the any component of the preparation.
- Liver and kidney
hard functional disorder.
- Blood system
diseases.
- Gluco-6 –
phosphatedehydrogenase genetic deficiency.
- Till one month
age.
- Diabetes
mellitus.
- Carefully is given in case of liver and kidney
functional disorder, constitutional hyperbilirubinemia.
Using rule and
dosage: The
suspension it taken perorally, before eating together with great amount of
water 3-4 times in a day 4-6 hours interval.
5 ml suspension (1 teaspoon) contains 120mg
paracetamol.
Dosage for children is depend on age and weight.
Preparation’s one-time dose makes up 10-15mg/kg of
child’s body weight;
Maximal daily dose is not more than 60 mg/kg;
Paracetamol pediatric suspension is prescribed
according to the age with the following dose: babies from1 to 3 months 2,5-5 ml
(1/2-1 teaspoon) or 60-120 mg paracetamol; from 1 to 6 age – 5-10 ml (1-2
teaspoon) or 120-240 mg paracetamol;
from 6 to 14 age – 10-20 ml (2-4) teaspoon or 240-480 mg paracetamol.
Duration of treatment should be not more than three
days, when the preparation is used as a temperature falling, but if it is used
as a painkiller- it should be used not more than five days. Treatment may be
proceed after doctor’s consultation.
Side effects: nausea, vomit, anorexia, pain
in stomach area, allergic reactions (rash on the skin, itch, hives, angioedema swell);
leukocytopenia, agranulocytosis, thrombopenia. In case of prolonged use, big
dose - hepatotoxic and nephrotoxic action.
Surplus dose: Skin paleness, anorexia,
nausea, vomit. After two days there may be revealed liver damaging marks, that
is related to the accumulation of toxic metabolite, which becomes inactive with
glutathione on conjugation consumption at time of taking paracetamol in
therapeutic doses. In a hardest occasion there may be developed liver cell,
kidney insufficiency and compositional state. It case of surplus dose is
necessary gastric lavage, adsorbent prescription acetyl-cysteine and methionine
introduce.
Interaction with
other drugs: Enhances the effect of
indirect anticoagulants (coumarin derivatives) and liver damage by hepatotoxic
drugs. Metoclopramide increases and Сholestyramine
reduces the absorption intensity of the drug. Barbiturates reduce antipyretic
effect. Alcohol accelerates the absorption of paracetamol.
Production form: 100 ml in orange glass or
polymeric material vial tightened lid.
Etiquettes are stuck on each vial and put in a carton
box together with prescription.
Validity: 2 years.
In case of validity
term expiration or visual survey of defects detection – the preparation using
is inadmissible.
Storage
conditions: Store
not more than 25º C, in a dry, dark place and keep away from children
Issue: Pharmaceutical product group
III - without a
prescription.
