Source: Medicines Authority (MT) Revision Year: 2022 Publisher: LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. – FARDI, Grassot, 16 – 08025-Barcelona (Spain) <u>Local representative:</u> Europharma Ltd, Catalunya Buildings, Psaila Street, Birkirkara. BKR 9076. ...
Algidrin pediatric is indicated in children aged over 3 months of age and adolescents for the:
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
The dose of ibuprofen depends on the age and weight of the child. For children aged between 3 months and 12 years, the daily recommended dose of ibuprofen is 20 to 30 mg/kg of body weight, divided into three or four individual doses (see table below).
The use of this medicinal product is not recommended in children under 3 months of age or under 5 kg of body weight.
The interval between doses will depend on the course of the symptoms, but should never be less than 4 hours.
By way of guidance, follow the recommended doses in the table below. Doses may be repeated every 6-8 hours, without exceeding the daily amounts in the last column:
| POSOLOGY FOR CHILDREN | |||
|---|---|---|---|
| Age/weight | Frequency | Dosage | Maximum daily dose |
| 3 to 6 months 5 to 7.6 kg approx. | 3 times a day | 50 mg (2.5 ml)/dose | 150 mg (7.5 ml) |
| 6 at 12 months 7.7 to 9 kg approx. | 3 to 4 times a day | 50 mg (2.5 ml)/dose | 150-200 mg (7.5-10 ml) |
| 1 to 3 years 10 to 15 kg approx. | 3 to 4 times a day | 100 mg (5 ml)/dose | 300-400 mg (15-20 ml) |
| 4 to 6 years 16 to 20 kg approx. | 3 to 4 times a day | 150 mg (7.5 ml)/dose | 450-600 mg (22.5-30 ml) |
| 7 to 9 years 21 to 29 kg approx. | 3 to 4 times a day | 200 mg (10 ml)/dose | 600-800 mg (30-40 ml) |
| 10 to 12 years 30 to 40 kg approx. | 3 to 4 times a day | 300 mg (15 ml)/dose | 900-1200 mg (45-60 ml) |
The recommended dose is 10-20 ml (equivalent to 200-400 mg of ibuprofen) every 4 to 6 hours, if necessary, without exceeding the dose of 1200 mg of ibuprofen in a 24-hour period. Due to the amount of ibuprofen in this medicinal product, the use of other presentations with more suitable doses is recommended for the treatment of adults and adolescents over 12 years of age.
Precautions should be adopted when non-steroidal anti-inflammatory drugs (NSAIDs) are used in patients with kidney failure, as ibuprofen is usually eliminated renally. Lower doses are used for patients with mild to moderate kidney dysfunction. Ibuprofen should not be used in patients with severe kidney failure (see section 4.3).
Although no differences in the pharmacokinetic profile of ibuprofen have been observed in patients with liver failure, it is advisable to adopt precautions with the use of NSAIDs in this type of patients. Patients with mild to moderate liver failure should start treatment at lower doses and be carefully monitored. Ibuprofen should not be used in patients with severe liver failure (see section 4.3).
This medicinal product is administered by oral route. It can be administered directly or diluted with water.
Shake the bottle before use.
The packages contain a 5-ml graduated syringe for oral use, for accurate dosage.
The syringe should be removed from the bottle, dismantled, cleaned and dried after each use.
Patients with gastric problems should take the medicinal product during meals.
Most cases of overdose are asymptomatic. Generally no signs and of toxicity have been observed at doses below 100 mg/kg in children and adults. However, in some cases supplementary care may be required. Children have been observed to show signs and symptoms of toxicity after ingesting quantities at or above 400 mg/kg.
Most patients who have taken significant quantities of ibuprofen have shown symptoms within the following 4 to 6 hours.
The most frequently reported symptoms in case of overdose include abdominal pain, nausea, vomiting, lethargy, drowsiness.
The effects on the central nervous system (CNS) include headache, tinnitus, dizziness, convulsions, loss of consciousness and ataxia. There are also reports on rare occasions of nystagmus, metabolic acidosis, hypothermia, alterations to kidney function, gastrointestinal haemorrhage, coma, apnoea and CNS and respiratory system depression. Cases of cardiovascular, including hypotension, bradycardia and tachycardia have been reported.
In severe poisoning, metabolic acidosis may occur.
In the case of major overdose, kidney impairment and liver damage may occur.
Treatment is symptomatic and no specific antidote is available. For amounts in which symptoms are unlikely to occur (less than 50 mg/kg of ibuprofen) water can be administered to reduce gastrointestinal discomfort as much as possible. If large amounts have been ingested, activated carbon should be administered. Emptying the stomach by vomiting should only be considered within 60 minutes of ingestion. Thus, gastric lavage should not be considered unless the patient has ingested a life-threatening amount of the drug and less than 60 minutes have passed since ingestion. The benefit of measures such as forced diuresis, haemodialysis or haemoperfusion is questionable, as ibuprofen binds strongly to plasma proteins.
3 years.
Once opened for the first time, the suspension is stable for 12 months.
Do not store at a temperature above 30ºC.
Topaz-coloured 100 ml, 120 ml or 200 ml PET bottle, with white polyethylene cap, fitted with a safety mechanism for children and a translucent polyethylene stopper. It contains a 5 ml graduated syringe for oral dosage.
Not all pack sizes may be marketed.
Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
