Medicinal Products

DILATRANE LP 100 mg

Generic drug of the therapeutic class: Pneumology
active ingredients: Theophylline
laboratory: Serp

Sustained-Release Capsule
Box of 30
All forms

Indication

Continuous symptomatic treatment of persistent asthma and other chronic obstructive pulmonary disease.

Dosage DILATRANE LP 100 mg Prolonged-release capsule Box of 30

Dosage:
This assay does not allow the delivery of a dosage suitable for children under 20 kg (approximately 6 years). The dosage will be adapted to the individual susceptibility according to the therapeutic effect and adverse effects.
Treatment will be started with a moderate initial dose to test individual tolerance, which will then be gradually adjusted by increasing or decreasing the dose in stages until a therapeutic effect is achieved without adverse effects.
As plasma levels reach at least a steady state after 3 consecutive days of well-conducted therapy, this minimum time should be respected to judge the therapeutic effect before each dose increase.
In case of therapeutic insufficiency and in the absence of any sign of intolerance, the dose will be gradually increased under control of theophyllinaemia, in steps of 2 mg / kg / day.
In children older than 30 months, below a daily dose of 16 mg / kg / day (adapted for obesity at the ideal weight) and not exceeding, in any case, 400 mg / day, and in the absence of risk factors for decreasing plasma clearance, control of theophylline is not necessary for the safety of the product.
Effective theophylline plasma concentrations are between 8 and 20 μg / ml.
The toxicity threshold of theophyllinemia is 20 μg / ml.
For information :
- Child from 6 to 8 years (20 to 25 kg) :
. recommended starting dose : 10 to 14 mg / kg / day.
. usually effective dosage : 13 to 20 mg / kg / day.
The daily dosage will be divided into 2 doses.
- Child from 9 to 16 years old (over 25 kg):
. recommended starting dose : 10 to 12 mg / kg / day.
. usually effective dosage : 10 to 16 mg / kg / day.
The daily dosage will be divided into 2 doses.
- Adult :
. recommended starting dose : 5 to 8 mg / kg / day.
. usually effective dosage : 7 to 12 mg / kg / day without exceeding 800 mg per day.
The daily dosage will be divided into 2 doses.
In case of obesity, the dosage will be adapted to the ideal weight (average weight compared to the size measured on standard growth and weight growth curves).
Administration mode :
Oral way.
The capsule will be swallowed with a glass of water.
The capsule should not be opened.

Against indications

CONTRAINDICATED: - intolerance to theophylline,
- child under 30 months,
- acute intermittent porphyria, - combination with enoxacin.
NOT RECOMMENDED :
- Breastfeeding: Theophylline passes into breast milk, which may cause hyperexcitability in the newborn. Therefore, breastfeeding is not recommended during treatment with theophylline.
- Not recommended combination with erythromycin and viloxazine.

Dilatrane LP side effects

Essentially:
- nausea, vomiting, epigastric pain,
- headache, excitement, insomnia,
- tachycardia.
These side effects may be the first signs of an overdose. The appearance of convulsion is the sign of confirmed intoxication, but may be the first sign, especially in children.
In children with gastroesophageal reflux, theophylline may increase reflux.
Rarely: possibility of gastrointestinal ulceration with haemorrhage and occlusive syndrome.

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