Medicinal Products

DOLSTIC 100 mg / mL

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Ionfarma

Drinkable solution
60 ml bottle (+ syringe for oral administration)
All forms

Indication

Symptomatic treatment of fever less than three days and mild to moderate pain.

Dosage DOLSTIC 100 mg / mL oral solution Bottle (+ syringe for oral administration) 60 ml

Dosage

DOLSTIC 100 mg / ml, oral solution is reserved for children between 13 and 32 kg (approximately between 3 and 10 years). It is imperative to respect the posology determined from the body weight of the child and thus to select the appropriate dose in ml of the oral solution. Approximate ages from body weight are for information only.

The recommended daily dose of paracetamol is approximately 60 mg / kg / day, divided into 4 to 6 doses, ie 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.

To administer 15 mg / kg every 6 hours, the instructions are as follows:

From 13 kg (about 3 years):

2.0 ml (200 mg)

Up to 18.5 kg (4 to 5 years):

2.8 ml (280 mg)

Up to 24 kg (from 6 to 8 years old):

3.6 ml (360 mg)

Up to 32 kg (from 9 to 10 years old):

4.8 ml (480 mg)

This dose can be repeated every 6 hours.

If the desired effects are not achieved within 3 to 4 hours after dosing, then 10 mg / kg (the dose can be given every 4 hours).

In children less than 3 years old, paracetamol should only be used on the recommendation of a doctor.

Maximum recommended dose

The total dose of paracetamol should not exceed 80 mg / kg in children weighing less than 40 kg.

See section Warnings and precautions for use

Frequency of administrations

Systematic administration avoids the oscillations of pain and fever.

In children, administrations should be regularly spaced, including overnight, preferably at 6-hour intervals, but maintaining intervals of at least 4 hours.

Renal failure

In severe renal impairment (creatinine clearance less than 10 ml / min), the minimum interval between 2 administrations should be increased to 8 hours.

Administration mode

Oral way.

In children under 3 years of age, it is recommended to administer the oral solution with the dropper provided in the 30 ml pack (DOLSTIC 100 mg / ml oral drops solution).

In children aged 3 years or older, it is recommended to administer the oral solution using the oral syringe supplied in the 60 ml pack (DOLSTIC 100 mg / ml, oral solution).

Against indications

Hypersensitivity to paracetamol or any of the excipients.

Severe hepatocellular insufficiency.

Viral hepatitis.

Severe hemolytic anemia.

Dolstic side effects

Like all medicines containing paracetamol, side effects are rare or very rare. They are described below:

Estimated frequency: very common (≥ 1/10); frequent (≥ 1/100 and <1/10); infrequent (≥ 1/1000 and <1/100); rare (≥ 1/10 000 and <1/1000); very rare (<1 / 10, 000).

Hematological and lymphatic system disorders:

Very rare: thrombocytopenia, agranulocytosis, leukopenia, neutropenia, hemolytic anemia.

Metabolism disorders:

Very rare: hypoglycemia.

Heart conditions:

Rare: hypotension.

Gastrointestinal disorders:

Rare: elevation of hepatic transaminases.

Very rare: hepatotoxicity (jaundice).

Renal and urinary disorders:

Very rare: sterile pyuria (cloudy urine), renal adverse effects (see Warnings and precautions for use ).

General disorders and administration site defects:

Rare: malaise.

Very rare: hypersensitivity reactions ranging from a simple rash or hives to anaphylactic shock. Their occurrence requires the discontinuation of this drug.

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