Sodium valproate injection may be given by direct slow intravenous injection or by infusion using a separate intravenous line in normal saline, dextrose 5%, or dextrose saline. Infection* Recommended Dose/Duration of Therapy; 1 see dosing tables below for maximum doses evaluated by indication: DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]: Acute otitis media: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. Discontinue the medicine if Pancreatitis is detected and an alternate medicine should be considered.Use with caution in patients with the bleeding disorder as it may cause Thrombocytopenia. Salicylates should not be used concomitantly with sodium valproate since they employ the same metabolic pathway (see sections 4.4 and 4.8). Sodium valproate is eliminated mainly through the kidneys, partly in the form of ketone bodies; this may give false positives in the urine testing of possible diabetics.Patients with an underlying carnitine palmitoyltransferase (CPT) type II deficiency should be warned of the greater risk of rhabdomyolysis when taking sodium valproate.Alcohol intake is not recommended during treatment with valproate.Sodium valproate may potentiate the effect of other psychotropics such as antipsychotics, monoamine oxidase inhibitors, antidepressants and benzodiazepines; therefore, clinical monitoring is advised and the dosage of the other psychotropics should be adjusted when appropriate.
The decision was made to initiate intravenous valproate sodium 1 g in 250 mL of normal saline given over 1 hour.
88 0 obj <>/Filter/FlateDecode/ID[<24579C6B4ACCB15E50210C12B2CC0B6B><28DA6A1156932A47B10AFBDC493A03B7>]/Index[83 13]/Info 82 0 R/Length 49/Prev 83229/Root 84 0 R/Size 96/Type/XRef/W[1 2 1]>>stream When suggestions are available use up and down arrows to review and ENTER to select. Do not use for administration of doses other than 1 gram.
Sodium valproate IV is an option in the treatment of status epilepticus resistant to initial treatment with benzodiazepines in children and adults as a second-line agent. If switching is not possible, the woman should receive further counselling regarding the valproate risks for the unborn child to support her informed decision making regarding family planning.If a woman using valproate becomes pregnant, she must be immediately referred to a specialist to re-evaluate treatment with valproate and consider alternative options.
Afibrinogenemia has also been reported and may be fatal. • The parents/caregivers of female children who have experienced menarche are provided with comprehensive information about the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to valproate In patients who experienced menarche, the prescribing specialist must reassess the need for valproate therapy annually and consider alternative treatment options.
Although the pharmacokinetics of sodium valproate are modified in the elderly, they have limited clinical significance and dosage should be determined by seizure control. NICE has advised that switching between different manufacturer's valproate preparations is not normally recommended due to the clinical implications of possible variations in plasma concentrations. -I.V. Haematological disorders have been shown in breastfed newborns/infants of treated women (see section 4.8).A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from valproate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.Amenorrhoea, polycystic ovaries and increased testosterone levels have been reported in women using valproate (see section 4.8). More extensive biological investigations (including prothrombin rate) are recommended in these patients; a reduction in dosage may be considered when appropriate and tests should be repeated as necessary. POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3).Blood tests (blood cell count, including platelet count, bleeding time and coagulation tests) are recommended prior to initiation of therapy or before surgery, and in case of spontaneous bruising or bleeding (see section 4.8).
If it’s almost time for your next dose, skip the missed dose.
-IV dosing: Equivalent to oral dose and frequency-Administration: 60-minute IV infusion (no more than 20 mg/min)-Drug level monitoring and dosage adjustments may be necessary-Patients should be switched to the oral formulation as soon as clinically feasible, use of the IV formulation for periods longer than 14 days has not been studied Comments: Pancreatitis, which may be severe and result in fatalities, has been very rarely reported.
4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. Where adequate control is not achieved within this range, the dose may be increased to 40 mg/kg/day but only in patients in whom plasma valproic acid levels can be monitored. METHODS: Retrospective review was performed on 40 pediatric patients with intravenous valproate (VPA) loading. Folate supplementation before the pregnancy may decrease the risk of neural tube defects which may occur in all pregnancies. However, a method for measurement of plasma levels is available and may be helpful where there is poor control or side effects are suspected (see section 5.2). In patients with renal insufficiency, it may be necessary to decrease dosage. Toxnet.nlm.nih.gov. Valproate has a high teratogenic potential and children exposed Sodium Valproate 100mg/ml Solution for Injection or Infusion is contraindicated in the following situations: 7.2 Dose Sodium valproate: Loading dose – 20-30mg/kg IV over 5 min Maintenance dose – 10mg/kg twice daily oral 7.3 Duration Clinical monitoring is recommended especially at the beginning of combined therapy with dosage adjustment when appropriate.Sodium valproate decreases phenytoin total plasma concentration. A patient guide and patient card should be provided to all women of childbearing potential using valproate. A favourable outcome is usual, however some deaths have occurred following massive overdose. If a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options. In both studies a wash-out period of at least 1 week elapsed between the periods. Valproate administration may also impair fertility in men (see section 4.8).