Release form, packaging and composition of the drug Clinical-pharmacological group Pharmaco-therapeutic group Pharmacological action Indications for use Method of administration and doses Side effects Contraindications for use Use in children Special instructions Drug interactions
Registration Certificate Holder:
GLAXO WELLCOME, GmbH & Co (Germany)
ATX Code:
N02BE01
Active substance:
paracetamol
Dosage form:
Calpol
| The drug is approved for use as an over-the-counter product | Calpol | Susp. for oral administration for children 120 mg/5 ml: vial. 70 ml or 100 ml reg. No.: P N015380/01 dated 03/20/09 - Cancellation of State. registration |
Pharmacokinetics
Cmax in plasma is achieved 30–90 minutes after oral administration. The ratio of volume of distribution to bioavailability in children and neonates is similar to that in adults. T1/2 - 1.5–2.5 hours. Metabolized in the liver. In newborns and children under 10 years of age, the main metabolite is paracetamol sulfate, in children 12 years of age and older - conjugated glucuronide. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. Approximately 85–95% of the dose is excreted in the urine within 24 hours (less than 4% of the drug is unchanged).
Release form, packaging and composition of the drug Calpol
Oral suspension for children
pink color with strawberry scent.
| 5 ml | |
| paracetamol | 120 mg |
Excipients
: sugar syrup, sorbitol 70%, glycerol, gum, methyl parahydroxybenzoate, carmoisin (E122), flavoring, purified water.
70 ml - dark glass bottles (1) complete with a 2.5 and 5 ml measuring spoon - cardboard boxes. 100 ml - dark glass bottles (1) complete with a 2.5 and 5 ml measuring spoon - cardboard boxes.
Directions for use and doses
Orally, with plenty of liquid, 1–2 hours after meals, 3–4 times a day with an interval of at least 4 hours.
Calpol suspension for children should not be diluted. For convenience and accuracy of dosing, use a measuring spoon that measures 2.5 and 5 ml of suspension.
Recommended doses for children from 3 months to 6 years
| Age | Single doses |
| 3 months - 1 year | 60–120 mg paracetamol (2.5–5 ml) |
| From 1 year to 6 years | 120–240 mg paracetamol (5–10 ml) |
Duration of treatment: 3 days as an antipyretic and up to 5 days as an analgesic. If it is necessary to continue taking the drug, consult a doctor.
Calpol (susp. for oral administration for children 120 mg/5 ml 100 ml)
Active substance
Paracetamol + Ascorbic acid
Compound
Bottle 100 ml Paracetamol 120 mg per 5 ml. Excipients: sugar syrup, sorbitol 70%, glycerol, gum, methyl parahydroxybenzoate, carmoisin (E122), flavoring, purified water. Oral suspension for children, pink in color with strawberry scent.
pharmachologic effect
Analgesic-antipyretic. It has analgesic and antipyretic properties. The mechanism of action is associated with inhibition of prostaglandin synthesis. Paracetamol does not affect water-electrolyte metabolism (does not lead to sodium and water retention) and does not have a damaging effect on the gastrointestinal mucosa.
Indications for use
The drug is prescribed to children aged 3 months to 6 years as: - an antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in temperature; - an analgesic for pain of mild to moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain from injuries and burns. The question of the possibility of using the drug Calpol for these indications in children aged 1 to 3 months is decided individually by the attending physician.
Side effects
Possible: nausea, vomiting, abdominal pain, allergic reactions in the form of skin rash, itching, urticaria, Quincke's edema. Rarely: anemia, leukopenia, agranulocytosis, thrombocytopenia. With long-term use in high doses, hepatotoxic and nephrotoxic effects are possible, as well as the occurrence of pancytopenia and methemoglobinemia. When taken in recommended doses, paracetamol rarely causes serious side effects.
Contraindications
- severe liver dysfunction;
- severe renal dysfunction; - blood diseases; - deficiency of glucose-6-phosphate dehydrogenase; - children up to 1 month; - hypersensitivity to the components of the drug. The drug is prescribed with caution for mild to moderate impairment of liver or kidney function, Gilbert, Dubin-Johnson and Rotor syndrome. Use in children The drug is contraindicated in children under 1 month of age. Age Single doses 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)
Mode of application
Calpol suspension is taken orally 1-2 hours after meals with plenty of liquid. The frequency of administration is 3-4 times a day with an interval of at least 4 hours. The suspension should not be diluted; for convenience and accuracy of dosing, it is recommended to use the included measuring spoon (marked for 2.5 and 5 ml). Recommended doses for children from 3 months to 6 years are presented in the table. Age | Single doses 3 months-1 year | 60-120 mg paracetamol (2.5-5 ml suspension) from 1 year to 6 years | 120-240 mg paracetamol (5-10 ml suspension) Duration of therapy is 3 days when used as an antipyretic; up to 5 days - as an analgesic.
special instructions
You should avoid using Calpol simultaneously with other paracetamol-containing drugs, because this may lead to an overdose of paracetamol. When using the drug for more than 5-7 days, the peripheral blood picture and indicators of the functional state of the liver should be monitored. The suspension contains sugar, which should be taken into account when treating patients with diabetes. Paracetamol distorts the results of laboratory tests to determine the content of glucose and uric acid in blood plasma. You should be warned about the need to consult a doctor if a high temperature persists for more than 3 days and pain persists for more than 5 days.
Overdose
Symptoms: the most common and early symptoms include pale skin, increased sweating, stomach pain, nausea, and vomiting. After 1-2 days, signs of liver damage may appear - pain in the liver area, increased activity of liver enzymes, increased prothrombin time. In severe cases, liver failure, hepatonecrosis, encephalopathy, and coma develop. Treatment: gastric lavage, taking enterosorbents (activated carbon, polyphepan), intravenous administration of the antidote N-acetylcysteine or taking methionine orally. The patient should be informed that if overdose symptoms occur, stop taking the drug and consult a doctor.
Interaction with other drugs
When used together with barbiturates, tricyclic antidepressants, ethanol, anticonvulsants (phenytoin), phenylbutazone, rifampicin, the risk of developing the hepatotoxic effect of paracetamol significantly increases. 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 enhances the effect of indirect anticoagulants and weakens the effect of uricosuric drugs.
Overdose
Symptoms: pallor, sweating, stomach pain, nausea and vomiting, after 1–2 days - signs of liver damage (pain in the liver, increased activity of liver enzymes in the blood, increased prothrombin time). In severe cases - liver failure, hepatonecrosis, encephalopathy, coma.
Treatment: discontinuation of the drug, gastric lavage, administration of enterosorbents (activated carbon, polyphepan), intravenous administration of the antidote - N-acetylcysteine or oral administration of methionine.
Calpol
From the skin: itching, rash on the skin and mucous membranes (usually erythematous, urticaria), angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
From the side of the central nervous system (usually develops when taking high doses): dizziness, psychomotor agitation and disorientation.
From the digestive system: nausea, epigastric pain, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
From the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the hematopoietic organs: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency). With long-term use in large doses - aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.
From the urinary system: (when taking large doses) - nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis). Overdose. Symptoms (acute overdose develops 6-14 hours after taking the drug, chronic - 2-4 days after exceeding the dose) of acute overdose: dysfunction of the gastrointestinal tract (diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or pain in stomach), increased sweating.
Symptoms of chronic overdose: a hepatotoxic effect develops, characterized by general symptoms (pain, weakness, adynamia, increased sweating) and specific ones characterizing liver damage. As a result, hepatonecrosis may develop. The hepatotoxic effect of the drug may be complicated by the development of hepatic encephalopathy (thought disturbances, central nervous system depression, stupor), convulsions, respiratory depression, coma, cerebral edema, hypocoagulation, development of disseminated intravascular coagulation syndrome, hypoglycemia, metabolic acidosis, arrhythmia, collapse. Rarely, liver dysfunction develops suddenly and can be complicated by renal failure (renal tubular necrosis).
Treatment: 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 in depending on the concentration of the drug in the blood, as well as on the time elapsed after its administration.
Drug interactions
When used together with barbiturates, tricyclic antidepressants, ethanol, anticonvulsants (phenytoin), phenylbutazone, rifampicin, the risk of developing the hepatotoxic effect of paracetamol significantly increases. 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 enhances the effect of indirect anticoagulants and weakens the effect of uricosuric drugs.
special instructions
You should avoid using Calpol simultaneously with other paracetamol-containing drugs, because this can lead to an overdose of paracetamol. When using the drug for more than 5-7 days, the peripheral blood picture and indicators of the functional state of the liver should be monitored. The suspension contains sugar, which should be taken into account when treating patients with diabetes. Paracetamol distorts the results of laboratory tests for determining glucose and uric acid in the blood plasma. You should be warned about the need to consult a doctor if a high temperature persists for more than 3 days and pain persists for more than 5 days.
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Indications for use
The drug is prescribed to children aged 3 months to 6 years as:
- antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by fever;
- analgesic for pain of mild to moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain from injuries and burns.
The question of the possibility of using the drug Calpol for these indications in children aged 1 to 3 months is decided individually by the attending physician.
Instructions for use DICLOPOL
NSAIDs. It has anti-inflammatory, analgesic and antipyretic effects. The mechanisms of these actions are not fully understood, but appear to be associated with inhibition of prostaglandin synthesis.
Anti-inflammatory effect
Diclofenac inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase, an enzyme that catalyzes the formation of prostaglandin precursor from arachidonic acid. Diclofenac in high concentrations also inhibits the formation of other arachidonic acid metabolites, including leukotrienes and 5-HETE (5-hydroxy-6-(E)-8,11,14-(Z)-eicosatetraenoic acid).
Diclofenac may inhibit the migration of leukocytes, including multinucleated leukocytes in inflammatory tissues.
This action is not a direct consequence of the inhibition of lipoxygenase; diclofenac also inhibits liposomal enzymes released from multinucleated leukocytes and can inhibit the production of peroxides and the chemotaxis of these leukocytes.
The strength of the anti-inflammatory effect of diclofenac is less than piroxicam and 2.5 times more than indomethacin, 10 times more than naproxen, 24 times more than phenylbutazone, 80 times more than ibuprofen and 430 times more than acetylsalicylic acid (the criterion in the studies was a decrease swelling of the paw in rats).
In experimental joint inflammation in rats, the anti-inflammatory effect of diclofenac is similar to indomethacin, and is also approximately 30 times stronger than naproxen, 95 times stronger than phenylbutazone and 380 times stronger than ibuprofen.
Analgesic effect
Also associated with inhibition of prostaglandin synthesis. Prostaglandins increase the sensitivity of pain receptors to mechanical stimulation and to the action of chemical mediators (bradykinin, histamine). Diclofenac may have an analgesic effect by inhibiting the synthesis of prostaglandins in the peripheral nervous system and central nervous system. Some researchers believe that diclofenac increases the release of endorphins from the pituitary gland.
The analgesic potency of diclofenac (in mouse studies) is similar to that of indomethacin and approximately 5 times that of naproxen, 10 times that of ibuprofen, 22 times that of phenylbutazone, and 38 times that of acetylsalicylic acid. .
In clinical studies, the analgesic effect of diclofenac was similar in strength to that of codeine, was 3-8 times stronger than that of naproxen, 8-16 times stronger than that of ibuprofen, and also 12-18 times stronger than that of acetylsalicylic acid.
The development of tolerance to diclofenac was not observed during long-term therapy.
Antipyretic effect.
Diclofenac reduced body temperature in animals with experimental fever.
The mechanism of antipyretic action is plausibly associated with inhibition of prostaglandin synthesis in the central nervous system. In tests on rats, it was found that the antipyretic effect of diclofenac at a dose of 0.5 mg/kg was similar to the effect of indomethacin at a dose of 1.2 mg/kg, ibuprofen at a dose of 24 mg/kg, phenylbutazone at a dose of 35 mg/kg, naproxen at a dose of 55 mg/kg and acetylsalicylic acid - at a dose of 185 mg/kg.
Effect on the digestive system.
Diclofenac may damage the gastric mucosa (causes ulceration or bleeding). It is assumed that the mechanism of this action is the result of inhibition of the synthesis of prostaglandins, which have a protective effect on the gastric mucosa, as well as the formation of oxide radicals and leukotrienes.
Effect on the hematopoietic system
.
Diclofenac may inhibit blood platelet aggregation and increase the duration of bleeding. The mechanism of this action is associated with inhibition of the synthesis of arachidonic acid products. In studies conducted on healthy volunteers, it was found that diclofenac does not significantly affect blood platelet aggregation, platelet count, prothrombin time, or bleeding duration, although in isolated cases an increase in prothrombin time was observed.
Diclofenac may increase the concentration of free fatty acids and lipoprotein lipase activity. In healthy people, diclofenac does not significantly affect the concentration of luteinizing and thyroid-stimulating hormones in plasma, while at the same time it reduces the concentration of prolactin in plasma.
