Medicinal Products

PEDIAZOLE 200 mg / 600 mg / 5 mL

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Erythromycin, Acetyl sulfafurazole
laboratory: Bioprojet Pharma

Granulated for syrup
Bottle of reconstituted syrup (+ scoop-graduated) of 200 ml
All forms

Indication

- Acute otitis media of the child with susceptible germs and in particular Haemophilus influenzae secretion of Betalactamases.
- Official recommendations regarding the proper use of antibacterials should be taken into account.

Dosage PEDIAZOLE 200 mg / 600 mg / 5 mL Granule for syrup Reconstituted syrup bottle (+ scoop-graduated) of 200 ml

Dosage:
- Do not administer in children under 2 months.
- In children: 50 mg / kg / day of erythromycin and 150 mg / kg / day of sulfisoxazole in divided doses for 10 days.
Administration mode :
- Reconstitute the syrup with the appropriate volume of water. Fit the adapter plug.
The administration is done with a measuring-graduated which is introduced in the adapter plug.
- The dose per dose is indicated, according to the weight of the child, on the body of the graduated measuring scale in kg.
It is therefore read directly on the graduations of the measuring-graduated. Thus, the indicated weight corresponds to the dose for a catch.
Three takes a day are needed.
For example, the graduation 12 corresponds to the dose to be administered per dose for a child of 12 kg and this, 3 times a day .

Against indications

CONTRAINDICATED:
This medicine MUST NEVER BE USED in the following situations:
- hypersensitivity to erythromycin,
- hypersensitivity to sulphonamides,
- in case of G6PD deficiency, including in the breastfed child: risk of triggering haemolysis,
- during breastfeeding if the newborn is less than one month old: this medication passes into breast milk. Breastfeeding is contraindicated if the mother or child has a G6PD deficiency, to prevent the occurrence of haemolysis. With sulfonamides with a long half-life, nuclear jaundices have been reported in neonates. As a result, breastfeeding is contraindicated when the newborn is less than one month old.
- in association with:
. Bepridil,
. cisapride,
. the alkaloids of the ergot of rye vasoconstrictors,
. methylergometrine,
. mizolastine,
. the pimozide,
. the sertindole,
. simvastatin (see interactions).
Due to the presence of sucrose, this drug is contraindicated in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Do not administer in children under 2 months.
NOT RECOMMENDED :
This medicine IS GENERALLY NOT RECOMMENDED:
- during pregnancy: studies in animals have shown a teratogenic effect of most sulfonamides. In the clinic, sulphonamides pass into the placenta. There are currently no data of sufficient relevance to evaluate a malformative or foetotoxic effect of this combination when administered during pregnancy. Cases of nuclear jaundice have been reported with sulfonamides with a long half-life due to the immaturity of bilirubin detoxification systems in neonates. In neonates exposed in utero and deficient in G6PD, haemolyses have been reported. As a result, the use of this combination is not recommended during pregnancy. This element does not constitute the systematic argument for counseling a termination of pregnancy, but leads to an attitude of caution and oriented antenatal surveillance. In the case of treatment at the end of pregnancy, a neonatal surveillance of a few days is necessary.
- and during breastfeeding.
- in association with:
. alfuzosin,
. alkaloids of ergot dopaminergic rye,
. the buspirone,
. carbamazepine,
. ciclosporin,
. colchicine,
. disopyramide,
. ebastine,
. halofantrine
. lumefantrine,
. tacrolimus,
. theophylline,
. tolterodine,
. triazolam,
. phenytoin (and by extrapolation fosphenytoin), due to the presence of the sulfonamide (see interactions).

Pediazole side effects

This medication is a fixed combination of a macrolide, erythromycin and a sulfonamide, sulfizoxazole, the side effects of which may be more attributable to one component than the other.
- Gastrointestinal manifestations: nausea, vomiting, gastralgia, anorexia, diarrhea, abdominal pain, pancreatitis, stomatitis. Exceptional cases of pseudomembranous colitis have been reported.
- Hepatic manifestations: rare cases of liver damage with elevated alkaline phosphatase and / or transaminases have been reported with sometimes clinical manifestations (jaundice, fever) possibly associated with acute abdominal pain. The appearance of clinical signs requires the immediate cessation of treatment.
- Cutaneous and allergic manifestations: generalized rash, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, fixed erythema pigmentosa, photosensitization, urticaria, pruritus, angioedema, anaphylactic reactions.
- Haematological manifestations: anemia, haemolytic anemia, neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, purpura, hypothrombinemia, methemoglobinemia.
- Neurological manifestations: headache, peripheral neuropathy, depression, convulsions, ataxia, hallucinations, vertigo, insomnia.
- Other manifestations: hyperthermia, nephrotic syndrome, lupus syndrome.
- Isolated cases of tinnitus have been reported.
- Isolated cases of reversible hypo-acoustics have been reported mainly in patients with renal impairment and in patients treated with high dose erythromycin.
- Cases of interstitial nephritis have been reported.

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