Nurofen for Children (Oral suspension)

Active material: Ibuprofen
When ATH: M01AE01
CCF: NSAIDs
ICD-10 codes (testimony): G43, H92.0, J06.9, J10, K08.8, M79.2, R07, R50, R51, R52.0, R52.2, T14.3
When CSF: 05.01.01.06
Manufacturer: RECKITT BENCKISER HEALTHCARE INTERNATIONAL Ltd. (Great Britain)

Pharmaceutical form, composition and packaging

Oral suspension (orange) white or nearly white, syrupy consistency, with characteristic orange odor.

5 ml
Ibuprofen100 mg

Excipients: Maltitol syrup, water, glycerol, lemon acid, sodium citrate, sodium chloride, sodium saccharin, orange flavor 2M16014, xanthan gum, polysorbate 80, domiphen bromide.

100 ml – vials polyethylene with a protective cap (1) complete with a measured syringe 5 ml – packs cardboard.

Oral suspension (strawberry) white or nearly white, syrupy consistency, with a characteristic smell of strawberry.

5 ml
Ibuprofen100 mg

Excipients: Maltitol syrup, water, glycerol, lemon acid, sodium citrate, sodium chloride, sodium saccharin, xanthan gum, strawberry flavoring 500244E, polysorbate 80, domiphen bromide.

100 ml – vials polyethylene with a protective cap (1) complete with a measured syringe 5 ml – packs cardboard.

 

Pharmacological action

NSAIDs. It is a derivative of phenylpropionic acid. It has analgesic, antipyretic and anti-inflammatory action. The mechanism of action is due to inhibition of prostaglandin synthesis (mediators of pain and inflammation) by blocking the enzyme cyclooxygenase.

 

Pharmacokinetics

Data on the pharmacokinetics of the drug Nurofen® Children are not provided.

 

Testimony

As antipyretic diseases and conditions, accompanied by fever, incl. at:

- Acute respiratory diseases;

- Flu;

- Of children's infections;

- Postvaktsinalynыh reaktsiyah.

As an analgesic agent for pain syndrome weak or moderate intensity, incl. at:

- Headache;

- Toothache;

- Migraine;

- Nevralgiяh;

- Pain in the ears and throat;

- The pain of injuries of the musculoskeletal system (incl. sprains).

 

Dosage regimen

At fever and pain the drug is prescribed in a dose of 5-10 mg / kg of body weight of the child 3-4 times / day. The maximum daily dose should not exceed 30 mg / kg body weight.

Age of childDosage regimenThe maximum daily dose
3-6 Months50 mg (2.5 ml) 3 times / day150 mg
6-12 Months50 mg (2.5 ml) 3-4 times / day200 mg
1-3 years100 mg (5 ml) 3 times / day300 mg
4-6 years150 mg (7.5 ml) 3 times / day450 mg
7-9 years200 mg (10 ml) 3 times / day600 mg
10-12 years300 mg (15 ml) 3 times / day900 mg

As an antipyretic drug should not be taken more 3 days, as analgesic – no more 5 days.

At fever after immunization prescribed drug dose 50 mg (2.5 ml); if necessary, older children 1 years later 6 h possible re-taking the drug at the same dose. The maximum daily dose should not exceed 5 ml (100 mg).

The suspension before use must be thoroughly shaken.

For accurate dosing suspension is attached to the bottle-sided scoop (on 2.5 ml 5 ml) or measuring syringe.

 

Side effect

From the digestive system: nausea, vomiting, discomfort or pain in the epigastric, diarrhea, erosive and ulcerative mucosal lesions and bleeding from the gastrointestinal tract.

Allergic reactions: skin rash, itch, hives, bronchospasm, fever, erythema multiforme exudative (incl. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

CNS: headache, dizziness, psychomotor agitation, insomnia.

From the urinary system: impairment of renal function, cystitis.

From the hematopoietic system: anemia, thrombocytopenia, agranulocytosis, leukopenia.

 

Contraindications

- Bronchial asthma, hives, rhinitis, provoked by taking acetylsalicylic acid (salicylates) or other NSAIDs;

- Erosive and ulcerative lesions of the gastrointestinal tract, active gastrointestinal bleeding, inflammatory bowel disease;

- Blood disorders (lowering of blood clotting, leukopenia, hemophilia);

- Expressed human liver and / or kidney;

- Hearing loss;

- Confirmation of hypokalemia;

- Children up to age 3 Months;

- Hypersensitivity to ibuprofen, acetylsalicylic acid and other NSAIDs, as well as other components of the drug.

 

Cautions

With care use in patients with a history of peptic ulcer baby, gastritis, ulcerative colitis, bleeding from the gastrointestinal tract, for liver or kidney problems, bronchial asthma, krapivnice, while taking other analgesics, anticoagulants, antihypertensive drugs, diuretics, lithium preparations, methotrexate.

Nurofen® Children can be used for children with diabetes, tk. product does not contain sugar. Does not contain dyes.

The child's parents must be informed about the, that the appearance of side effects, stop taking the drug and seek medical advice.

 

Overdose

Symptoms: stomach ache, nausea, vomiting, headache, noise in ears, metabolic acidosis, coma, acute renal failure, decrease in blood pressure, bradycardia, tachycardia.

Treatment: gastric lavage (Only one hour after administration), administration of activated charcoal, alkaline water, diurez; if necessary, symptomatic therapy.

 

Drug Interactions

With simultaneous use of Nurofen® Children and anticoagulants may increase the action of the past.

With simultaneous use of Nurofen® for children with diuretics and antihypertensive drugs may weaken the effects of past.

In a joint application Nurofen® Children intensifies the side effects of mineralocorticoid and glucocorticoid.

In a joint application Nurofen® Children increases blood concentration of digoxin, phenytoin, methotrexate, lithium.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored in a dry place at temperatures no higher than 25 ° C. Shelf life – 3 year.

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