Arofen (ibuprofen) suppositories for children 60 mg. №10

Description

Ingredients:

active substance: ibuprofen;
1 suppository contains 60 mg of ibuprofen;
excipient: solid fat.

Medicinal form. Rectal suppositories.

Main physico-chemical properties: white or almost white torpedo-shaped suppositories.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of propionic acid. ATX code M01A E01.

Pharmacological properties 

Pharmacodynamics.

The mechanism of action consists in inhibiting the synthesis of prostaglandins – mediators of pain, inflammation and temperature reaction. The drug has an analgesic, anti-inflammatory and antipyretic effect. In addition, ibuprofen inhibits the aggregation of platelets.

Pharmacokinetics.

After rectal administration, ibuprofen is quickly and almost completely absorbed, reaching the maximum concentration in the blood plasma after 45 minutes. Ibuprofen binds to blood plasma proteins and penetrates into the synovial fluid. Ibuprofen is metabolized in the liver to two inactive metabolites, which are quickly and almost completely excreted by the kidneys. Some amount is excreted unchanged. The half-life is 2 hours.

Indications.

• For the symptomatic treatment of pain of mild to moderate intensity.
• For symptomatic treatment of fever.
• Arofen for children, rectal suppositories, is recommended for use when oral ibuprofen is impossible, for example, in case of vomiting.
  

Contraindications.

• Hypersensitivity to ibuprofen or any of the components of Arofen (ibuprofen).
• Hypersensitivity reactions (such as asthma, rhinitis, angioedema or urticaria) after the use of ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in the anamnesis.
• Active gastric and duodenal ulcer disease/bleeding or history of recurrences (two or more severe episodes of confirmed ulcer disease or bleeding).
• Gastrointestinal bleeding or perforation of the wall of the digestive tract in the anamnesis associated with the use of NSAIDs.
  Severe heart failure, severe hepatic impairment or severe renal impairment.

Dosage and Administration.

Arofen (ibuprofen) is intended for rectal use.
For short-term use only.
Do not use this medicine in children under 3 months of age without a doctor’s recommendation. Do not use this medicine for children weighing less than 6 kg. The maximum single dose should not exceed 10 mg/kg. The dosing interval should not be less than 6 hours. The maximum total daily dose of ibuprofen is 20-30 mg/kg of the child’s body weight in 3-4 doses.

Dosage scheme

Age
 Body weight (kg)
 Recommended dosage

Infants aged 3 to 9 months with a body weight of more than 6 kg
 6-8
 60 mg up to 3 times a day

Children aged 9 months – 2 years
 8-12
 60 mg up to 4 times a day

If in children aged 3-5 months the symptoms worsen or persist after 24 hours from the start of treatment, you should immediately consult a doctor.

If symptoms persist for more than 3 days from the start of treatment or worsen in children aged 6 months or older, a doctor should be consulted.

Children.
The drug is used for children aged 3 months to 2 years with a body weight of at least 6 kg.