Valprola Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Valproic acid

Indications/Uses

As monotherapy or adjunct therapy in the treatment of partial seizures (elementary or complex) & absence seizures (petit mal seizures).

Click to view Valprola detailed prescribing information

Dosage/Direction for Use

Recommended initial dose: 15 mg/kg/day, may be increased by 5-10 mg/kg/day at wkly interval until seizure control or occurrence of any side effect that prevent further treatment. Max: 60 mg/kg/day. Give in divided doses if total daily dose is >250 mg.

Click to view Valprola detailed prescribing information

Administration

Should be taken with food.

Contraindications

Hypersensitivity. Patients w/ known mitochondrial disorders due to mitochondrial DNA polymerase γ (POLG) gene (eg, Alpers Huttenlocher syndrome) mutation; systemic primary carnitine deficiency w/ uncorrected hypocarnitinemia. Liver disease or patients showing significant liver dysfunction. Childn <2 yr w/ suspected POLG-related disorders.

Click to view Valprola detailed prescribing information

Special Precautions

Patients w/ hereditary neurometabolic syndrome caused by mutations in the gene for mitochondrial POLG. Increased risk of suicidal behavior or thought. May cause fatal hepatotoxicity or liver disfunction. May impair ability to drive vehicle or operate machinery. Women of childbearing potential. Pregnancy. Childn <2 yr. Elderly >65 yr.

Click to view Valprola detailed prescribing information

Adverse Reactions

Headache, asthenia, fever, nausea, vomiting, abdominal pain, diarrhea, anorexia, dyspepsia, constipation, somnolence, tremor, dizziness, diplopia, amblyopia, ataxia, nystagmus, unstable emotion, abnormal thinking, amnesia, flu-like syndrome, resp tract infection, bronchitis, rhinitis, alopecia, wt loss.

Click to view Valprola detailed prescribing information

Drug Interactions

Concomitant use w/ ritonavir, phenytoin, carbamazepine, phenobarb, primidone, aspirin, carbapenem antibiotics, colestyramine, oestrogen-containing hormonal contraceptive, felbamate, metamizole, MTX, lopinavir, rifampicin, amitriptyline/nortriptyline, carbamazepine-10,11-epoxide, clonazepam, diazepam, ethosuximide, lamotrigine, cefditoren pivoxil, adefovir dipivoxil, pivmecillinam, pivampicillin, primidone, propofol, nimodipine, tolbutamide, cannabidiol, topiramate, acetazolamide, warfarin, zidovudine, quetiapine, lorazepam, olanzapine, rufinamide, steroid-containing OC.

Click to view Valprola detailed prescribing information

Description

View Valprola description for details of the chemical structure and excipients (inactive components).

MIMS Class

Anticonvulsants

ATC Classification

N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.

Regulatory Classification

Presentation/Packing

Form

Valprola syr 250 mg/5 mL

Packing/Price

120 mL x 1's

Valprola

valproic acid

Manufacturer:

Gracia Pharmindo