Medicinal Products

APAROXAL 100 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Phenobarbital
laboratory: Pierre Fabre Medicament

Tablet breackable
Case of 20
All forms

Indication

· In adults :

o either as monotherapy,

o in combination with another antiepileptic treatment:

§ treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures,

§ treatment of partial epilepsies: partial seizures with or without secondary generalization.

· In children :

o either as monotherapy,

o in combination with another antiepileptic treatment:

§ treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures,

§ treatment of partial epilepsies: partial seizures with or without secondary generalization.

Dosage APAROXAL 100 mg scored tablet Case of 20

The efficacy of the drug can only be judged after 15 days of treatment.

It will be the same for any change in dosage.

When the clinic warrants it, check the barbititus by taking the sample preferably in the morning (usually 65 to 130 μmol / l in the adult or 15 to 30 mg / l in the adult and 85 μmol / l or 20 mg / l in children).

Children by weight:

· Less than 20 kg: 5 mg / kg per day,

· Between 20 and 30 kg: 3 to 4 mg / kg per day,

· Above 30 kg: 2 to 3 mg / kg daily.

In children under 6 years, the tablet will be crushed and mixed with food before administration because of the risk of miscarriage.

adults:

2-3 mg / kg daily,

One dose per day at bedtime (see section Pharmacokinetic properties ).

Against indications

This medicine should never be used in the following situations:

· Porphyries.

· History of hypersensitivity to barbiturates.

· Severe respiratory failure.

· Treatment with voriconazole and telaprevir.

· In patients with wheat allergy (other than celiac disease).

· In combination with St. John's wort.

This drug is generally not recommended in the following situations:

· In combination with alcohol, aprepitant, boceprevir, bosentan, dabigatran, dronedarone, fentanyl, ifosfamide, tyrosine kinase inhibitors, ivacaftor, mianserine, nimodipine, praziquantel, ranolazine, sertraline, telithromycin, ulipristal, vemurafenib, and estrogens and progestins used as contraceptives. See section Interactions with other drugs and other forms of interaction .

· Breastfeeding

Aparoxal side effects

Skin and subcutaneous tissue disorders

- Skin reactions most often in the form of morbilliform or scarlatiniform maculopapular rashes

- Very rare cases of severe skin reactions such as Lyell's syndrome, Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported (see Warnings and Precautions section ).

Affection of the ear and labyrinth

- rarely vertigo with headache

Immune system disorders

- Multisystemic hypersensitivity reactions with fever, rash, eosinophilia and liver damage have been reported.

The rare occurrence of cross reactions between phenobarbital, phenytoin and carbamazepine should make it prudent to replace phenobarbital with either molecule.

Nervous system disorders

- sleepiness early in the day

- Difficult awakening with sometimes difficulties to articulate

- disorders of coordination and balance

Blood and lymphatic system disorders

- Megaloblastic anemia due to folic acid deficiency

Hepatobiliary disorders

- Very rare cases of hepatitis

Musculoskeletal and systemic disorders

- Arthralgia (shoulder-hand syndrome or "rheumatism gardénalique"),

- Cases of decreased bone mineral density, osteopenia, osteoporosis, and fractures have been reported in phenobarbital long-term treated patients. The mechanism by which phenobarbital affects bone metabolism has not been identified.

Psychiatric disorders

- Mood disorders

- Prolonged intake of phenobarbital (100 mg daily for 3 months) may lead to the development of a dependence syndrome.

investigations

- An isolated increase of gamma-glutamyltranspeptidase, related to the hepatic enzymatic inducing factor of phenobarbital, can be observed. As a rule, this increase is of no clinical significance.

- An isolated and moderate elevation of a transaminase and / or alkaline phosphatase is very occasionally observed.

Serious effects affecting the hepatic and / or dermatological systems as well as hypersensitivity reactions require discontinuation of treatment.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.

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