Valproate Sodium (Valproate Sodium)

Trade Name : Valproate Sodium

West-Ward Pharmaceuticals Corp

INJECTION

Strength 500 mg/5mL

Storage and handling for Valproate Sodium

VALPROATE SODIUM Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Valproate Sodium (Valproate Sodium) which is also known as Valproate Sodium and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 500 mg/5mL per ml. Read more

Valproate Sodium (Valproate Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Hepatotoxicityn n- Arrayn- Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see WARNINGS AND PRECAUTIONS ()].
Arrayn- Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Valproate Sodium Injection is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
Arrayn- There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase n- u03b3n- (POLG) gene (e.g. Alpers Huttenlocher Syndrome). Valproate Sodium Injection is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see CONTRAINDICATIONS ()].
In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Valproate Sodium Injection should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Valproate Sodium Injection for the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice [see WARNINGS AND PRECAUTIONS ()].
Fetal Risk
Arrayn- Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores and neuro development disorders following exposure.
Arrayn- Array
Arrayn- Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate [see WARNINGS AND PRECAUTIONS (, , ) n- andn- PATIENT COUNSELING INFORMATION ()n- ].
Pancreatitis
Arrayn- Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated [see WARNINGS AND PRECAUTIONS ()].
WARNING: LIFE THREATENING ADVERSE REACTIONSn
See full prescribing information for complete boxed warning

Hepatotoxicity, including fatalities, usually during first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter ()
Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ (, , )
Pancreatitis, including fatal hemorrhagic cases ()

Boxed Warning Fetal Risku00a0
Indications and Usage, Important Limitations ()u00a0u00a0u00a0 03/2019
Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 03/2019
Warnings and Precautions, Use in Women of Childbearing Potential ()u00a0u00a0u00a0u00a0 03/2019

Valproate Sodium Injection, USP isu00a0indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions:

Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ()

Valproate Sodium Injection is intended for intravenous use only.

Epilepsy nn

Valproate Sodium Injection, equivalent to 100 mg of valproic acid per mL, is a clear, colorless solution in 5 mL single dose vials, available in trays of 10 vials.
Recommended storage: Store vials at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP Controlled Room Temperature].
No preservatives have been added. Unused portion of container should be discarded.
Injection: 100 mg per mL in a 5 mL single dose vial ()

No data

Hepatic disease or significant hepatic dysfunction (, ) nn
Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase u03b3 (POLG) (, ) nn
Suspected POLG-related disorder in children under two years of age (, ) nn
Known hypersensitivity to the drug (, ) nn
Urea cycle disorders (, )
Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception (, )

No data

Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ()
Birth defects, decreased IQ, and neurodevelopmental disorders following exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable (, , )
Pancreatitis; Valproate Sodium Injection should ordinarily be discontinued ()
Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests ()
Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapyu00a0(, , )
Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate ()
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-organ hypersensitivity reaction; discontinue Valproate Sodium Injection ()
Somnolence in the elderly can occur. Valproate Sodium Injection dosage should be increased slowly and with regular monitoring for fluid and nutritional intake ()

The following serious adverse reactions are described below and elsewhere in the labeling:
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The adverse reactions that can result from Valproate Sodium Injection use include all of those associated with oral forms of valproate. The following describes experience specifically with Valproate Sodium Injection. Valproate Sodium Injection has been generally well tolerated in clinical trials involving 111u00a0healthy adult male volunteers and 352 patients with epilepsy, given at doses of 125 to 6,000u00a0mg (total daily dose). A total of 2% of patients discontinued treatment with Valproate Sodium Injection due to adverse reactions. The most common adverse reactions leading to discontinuation were 2 cases each of nausea/vomiting and elevated amylase. Other adverse reactions leading to discontinuation were hallucinations, pneumonia, headache, injection site reaction, and abnormal gait. Dizziness and injection site pain were observed more frequently at a 100 mg/min infusion rate than at rates up to 33 mg/min. At a 200 mg/min rate, dizziness and taste perversion occurred more frequently than at a 100 mg/min rate. The maximum rate of infusion studied was 200u00a0mg/min.
Adverse reactions reported by at least 0.5% of all subjects/patients in clinical trials of Valproate Sodium Injection are summarized in Table 1.
In a separate clinical safety trial, 112 patients with epilepsy were given infusions of Valproate Sodium Injection (up to 15 mg/kg) over 5 to 10 minutes (1.5u00a0-u00a03.0 mg/kg/min). The common adverse reactions (> 2%) were somnolence (10.7%), dizziness (7.1%), paresthesia (7.1%), asthenia (7.1%), nausea (6.3%), and headache (2.7%). While the incidence of these adverse reactions was generally higher than in Table 1 (experience encompassing the standard, much slower infusion rates), e.g., somnolence (1.7%), dizziness (5.2%), paresthesia (0.9%), asthenia (0%), nausea (3.2%), and headache (4.3%), a direct comparison between the incidence of adverse reactions in the 2u00a0cohorts cannot be made because of differences in patient populations and study designs.
Ammonia levels have not been systematically studied after IV valproate, so that an estimate of the incidence of hyperammonemia after IV Valproate Sodium Injection cannot be provided. Hyperammonemia with encephalopathy has been reported in 2 patients after infusions of Valproate Sodium Injection.
Adverse reactions occurring in at least 5% of patients treated with divalproex sodium in Monotherapy or Adjunctive Complex Partial Seizures Trials:
Additional adverse reactions not included above that occurred in > 0.5% of patients treated with Valproate Sodium Injection:
Additional adverse reactions not included above that occurred in other clinical trials with divalproex sodium:
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or .

No data

Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn ()
Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended ()
Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g. diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement ()
Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose ()
Dosage adjustment of amitryptyline/nortryptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Valproate Sodium Injection ()
Topiramate: Hyperammonemia and encephalopathy (, )

No data

Pregnancy: Valproate Sodium Injection can cause congenital malformations including neural tube defects,u00a0decreased IQ, and neurodevelopmental disordersu00a0(, , )
Pediatric: Children under the age of two years are at considerably higher risk of fatalu00a0hepatotoxicity (, )
Geriatric: Reduce starting dose, increase dosage more slowly; monitor fluid and nutritional intake, and somnolence (, )

Overdosage with valproate may result in somnolence, heart block, deep coma and hypernatremia. Fatalities have been reported; however patients have recovered from valproate serum concentrations as high as 2120 mcg/mL.
In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output.
Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage. Because naloxone could theoretically also reverse the antiepilepticu00a0effects of valproate, it should be used with caution in patients with epilepsy.

Valproate sodium is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:
Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, crystalline, deliquescent powder.
Valproate Sodium Injection, USPu00a0is available in 5 mL single dose vials for intravenous injection. Each mL contains valproate sodium equivalent to 100 mg valproic acid, edetate disodium 0.40u00a0mg, and water for injection to volume. The pH is adjusted to 7.6 with sodium hydroxide and/u200cor hydrochloric acid. The solution is clear and colorless.

No data

Carcinogenesisn
Mutagenesisn
Valproate was not mutagenic in an bacterial assay (Ames test), did not produce dominant lethal effects in mice, and did not increase chromosome aberration frequency in an cytogenetic study in rats. Increased frequencies of sister chromatid exchange (SCE) have been reported in a study of epileptic children taking valproate; this association was not observed in another study conducted in adults.
Impairment of Fertilityn

The studies described in the following section were conducted with oral divalproex sodium tablets.
The efficacy of valproate in reducing the incidence of complex partial seizures (CPS) that occur in isolation or in association with other seizure types was established in two controlled trials.
In one, multi-clinic, placebo controlled study employing an add-on design (adjunctive therapy), 144 patients who continued to suffer eight or more CPS per 8 weeks during an 8 week period of monotherapy with doses of either carbamazepine or phenytoin sufficient to assure plasma concentrations within the u201ctherapeutic rangeu201d were randomized to receive, in addition to their original antiepilepsy drug (AED), either divalproex sodium or placebo. Randomized patients were to be followed for a total of 16 weeks. The following table presents the findings.
Figure 1 presents the proportion of patients (X axis) whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study. A positive percent reduction indicates an improvement (i.e., a decrease in seizure frequency), while a negative percent reduction indicates worsening. Thus, in a display of this type, the curve for an effective treatment is shifted to the left of the curve for placebo. This figure shows that the proportion of patients achieving any particular level of improvement was consistently higher for valproate than for placebo. For example, 45% of patients treated with valproate had a u2265 50% reduction in complex partial seizure rate compared to 23% of patients treated with placebo.
The second study assessed the capacity of valproate to reduce the incidence of CPS when administered as the sole AED. The study compared the incidence of CPS among patients randomized to either a high or low dose treatment arm. Patients qualified for entry into the randomized comparison phase of this study only if 1) they continued to experience 2 or more CPS per 4 weeks during an 8 to 12 week long period of monotherapy with adequate doses of an AED (i.e., phenytoin, carbamazepine, phenobarbital, or primidone) and 2) they made a successful transition over a two week interval to valproate. Patients entering the randomized phase were then brought to their assigned target dose, gradually tapered off their concomitant AED and followed for an interval as long as 22 weeks. Less than 50% of the patients randomized, however, completed the study. In patients converted to divalproex sodium monotherapy, the mean total valproate concentrations during monotherapy were 71 and 123 mcg/mL in the low dose and high dose groups, respectively.
The following table presents the findings for all patients randomized who had at least one postu2011randomization assessment.
Figure 2 presents the proportion of patients (X axis) whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study. A positive percent reduction indicates an improvement (i.e., a decrease in seizure frequency), while a negative percent reduction indicates worsening. Thus, in a display of this type, the curve for a more effective treatment is shifted to the left of the curve for a less effective treatment. This figure shows that the proportion of patients achieving any particular level of reduction was consistently higher for high dose valproate than for low dose valproate. For example, when switching from carbamazepine, phenytoin, phenobarbital or primidone monotherapy to high dose valproate monotherapy, 63% of patients experienced no change or a reduction in complex partial seizure rates compared to 54% of patients receiving low dose valproate.
Information on pediatric studies is presented in section 8.

No data

Valproate Sodium Injection, USP, equivalent to 100 mg of valproic acid per mL, is a clear, colorless solution in 5 mL single dose vials, available in trays of 10 vials (NDC 0143-9785-10).
Recommended storage: Store vials at 20u00ba to 25u00baC (68u00ba to 77u00baF) with excursions between 15u00ba and 30u00baC (59u00ba and 86u00baF) [See USP Controlled Room Temperature].
No preservatives have been added. Unused portion of container should be discarded.

Hepatotoxicityn n- WARNINGS AND PRECAUTIONS ()
Pancreatitisn n- WARNINGS AND PRECAUTIONS ()
Birth Defects and Decreased IQn n- in utero
Advise women to use effective contraception while using valproate. When appropriate, counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headache [see (), and ].
Pregnancy Registry
Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.
Encourage women who are taking valproate to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 or visit the website, http://www.aedpregnancyregistry.org/ [see ()].
Hyperammonemian n- WARNINGS AND PRECAUTIONS (, )
CNS Depressionn
Multiorgan Hypersensitivity Reactionsn n- WARNINGS AND PRECAUTIONS ()
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Revised: March 2019
PIN237-WES/11

NDC 0143-9785-01VALPROATEn- 500 mg/5 mL(100 mg/mL)FOR IV INFUSION ONLYRx ONLYn- USUAL DOSAGE:n- CONTAINS NO PRESERVATIVES

NDCu00a00143-9785-10n n 10 x 5 mL Single Dose VialsEach mL contains: valproic acid100 mg, edetate disodium 0.4 mg,and water for injection. pHadjusted with sodium hydroxideand/or hydrochloric acid.n See packageinsert.n n
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