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Divalproex Sodium Delayed-Release Tablets, USP Rx only | DIVALPROEX SODIUM [WOCKHARDT LIMITED] | BioPortfolio

12:01 EST 27th January 2019 | BioPortfolio

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Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients Divalproex sodium delayed-release tablets: silicon dioxide, silicified microcrystalline cellulose, pregelatinized starch, povidone, croscarmellose sodium, glyceryl behenate, talc, hypromellose, polysorbate, simethicone emulsion, methacrylic acid copolymer, polyvinyl alcohol, titanium dioxide, polyethylene glycol, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate.

Study 1
YMRS Total Score
1.   Mean score at baseline 2.   Change from baseline to Week 3 (LOCF) 3.   Difference in change from baseline to Week 3 endpoint (LOCF) between divalproex sodium delayed-release tablets and placebo
Group Baseline1 BL to Wk 32 Difference3
Placebo 28.8 + 0.2
Divalproex Sodium Delayed-Release Tablets 28.5 - 9.5 9.7
BPRS-A Total Score
Group Baseline1 BL to Wk 32 Difference3
Placebo 76.2 + 1.8
Divalproex Sodium Delayed-Release Tablets 76.4 -17.0 18.8
GAS Score
Group Baseline1 BL to Wk 32 Difference3
Placebo 31.8 0.0
Divalproex Sodium Delayed-Release Tablets 30.3 + 18.1 18.1
Study 2
MRS Total Score
1.   Mean score at baseline 2.   Change from baseline to Day 21 (LOCF) 3.   Difference in change from baseline to Day 21 endpoint (LOCF) between divalproex sodium delayed-release tablets and placebo and lithium and placebo
Group Baseline1 BL to Day 212 Difference3
Placebo 38.9 - 4.4
Lithium 37.9 -10.5 6.1
Divalproex Sodium Delayed-Release Tablets 38.1 - 9.5 5.1
MSS Total Score
Group Baseline1 BL to Day 212 Difference3
Placebo 18.9 - 2.5
Lithium 18.5 - 6.2 3.7
Divalproex Sodium Delayed-Release Tablets 18.9 - 6.0 3.5
BIS Total Score
Group Baseline1 BL to Day 212 Difference3
Placebo 16.4 - 1.4
Lithium 16.0 - 3.8 2.4
Divalproex Sodium Delayed-Release Tablets 15.7 - 3.2 1.8
Adjunctive Therapy Study Median Incidence of CPS per 8 Weeks
Add-on
Treatment
Number
of Patients
Baseline
Incidence
Experimental
Incidence
*Reduction from baseline statistically significantly greater for divalproex sodium delayed-release tablets than placebo at p ≤ 0.05 level.
Divalproex Sodium Delayed-Release Tablets 75 16.0 8.9*
Placebo 69 14.5 11.5
Monotherapy Study Median Incidence of CPS per 8 Weeks
Treatment Number of
Patients
Baseline
Incidence
Randomized
Phase Incidence
*Reduction from baseline statistically significantly greater for high dose than low dose at p ≤ 0.05 level.
High dose Divalproex Sodium Delayed-Release Tablets 131 13.2 10.7*
Low dose Divalproex Sodium Delayed-Release Tablets 134 14.2 13.8

VALPROATE CAN PRODUCE TERATOGENIC EFFECTS. DATA SUGGEST THAT THERE IS AN INCREASED INCIDENCE OF CONGENITAL MALFORMATIONS ASSOCIATED WITH THE USE OF VALPROATE BY WOMEN WITH SEIZURE DISORDERS DURING PREGNANCY WHEN COMPARED TO THE INCIDENCE IN WOMEN WITH SEIZURE DISORDERS WHO DO NOT USE ANTIEPILEPTIC DRUGS DURING PREGNANCY, THE INCIDENCE IN WOMEN WITH SEIZURE DISORDERS WHO USE OTHER ANTIEPILEPTIC DRUGS, AND THE BACKGROUND INCIDENCE FOR THE GENERAL POPULATION. THEREFORE, VALPROATE SHOULD BE CONSIDERED FOR WOMEN OF CHILDBEARING POTENTIAL ONLY AFTER THE RISKS HAVE BEEN THOROUGHLY DISCUSSED WITH THE PATIENT AND WEIGHED AGAINST THE POTENTIAL BENEFITS OF TREATMENT. THERE ARE MULTIPLE REPORTS IN THE CLINICAL LITERATURE THAT INDICATE THE USE OF ANTIEPILEPTIC DRUGS DURING PREGNANCY RESULTS IN AN INCREASED INCIDENCE OF CONGENITAL MALFORMATIONS IN OFFSPRING. ANTIEPILEPTIC DRUGS, INCLUDING VALPROATE, SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING POTENTIAL ONLY IF THEY ARE CLEARLY SHOWN TO BE ESSENTIAL IN THE MANAGEMENT OF THEIR MEDICAL CONDITION. Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus. Human Data Congenital Malformations The North American Antiepileptic Drug Pregnancy Registry reported 16 cases of congenital malformations among the offspring of 149 women with epilepsy who were exposed to valproic acid monotherapy during the first trimester of pregnancy at doses of approximately 1,000 mg per day, for a prevalence rate of 10.7% (95% CI 6.3% to 16.9%). Three of the 149 offspring (2%) had neural tube defects and 6 of the 149 (4%) had less severe malformations. Among epileptic women who were exposed to other antiepileptic drug monotherapies during pregnancy (1,048 patients) the malformation rate was 2.9% (95% CI 2.0% to 4.1%). There was a 4-fold increase in congenital malformations among infants with valproic acid-exposed mothers compared with those treated with other antiepileptic monotherapies as a group (Odds Ratio 4.0; 95% CI 2.1 to 7.4). This increased risk does not reflect a comparison versus any specific antiepileptic drug, but the risk versus the heterogeneous group of all other antiepileptic drug monotherapies combined. The increased teratogenic risk from valproic acid in women with epilepsy is expected to be reflected in an increased risk in other indications (e.g., migraine or bipolar disorder). THE STRONGEST ASSOCIATION OF MATERNAL VALPROATE USAGE WITH CONGENITAL MALFORMATIONS IS WITH NEURAL TUBE DEFECTS (AS DISCUSSED UNDER THE NEXT SUBHEADING). HOWEVER, OTHER CONGENITAL ANOMALIES (E.G. CRANIOFACIAL DEFECTS, CARDIOVASCULAR MALFORMATIONS AND ANOMALIES INVOLVING VARIOUS BODY SYSTEMS), COMPATIBLE AND INCOMPATIBLE WITH LIFE, HAVE BEEN REPORTED. SUFFICIENT DATA TO DETERMINE THE INCIDENCE OF THESE CONGENITAL ANOMALIES IS NOT AVAILABLE. Neural Tube Defects THE INCIDENCE OF NEURAL TUBE DEFECTS IN THE FETUS IS INCREASED IN MOTHERS RECEIVING VALPROATE DURING THE FIRST TRIMESTER OF PREGNANCY. THE CENTERS FOR DISEASE CONTROL (CDC) HAS ESTIMATED THE RISK OF VALPROIC ACID EXPOSED WOMEN HAVING CHILDREN WITH SPINA BIFIDA TO BE APPROXIMATELY 1 TO 2%. THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS (ACOG) ESTIMATES THE GENERAL POPULATION RISK FOR CONGENITAL NEURAL TUBE DEFECTS AS 0.14% TO 0.2%. Tests to detect neural tube and other defects using current accepted procedures should be considered a part of routine prenatal care in pregnant women receiving valproate. Evidence suggests that pregnant women who receive folic acid supplementation may be at decreased risk for congenital neural tube defects in their offspring compared to pregnant women not receiving folic acid. Whether the risk of neural tube defects in the offspring of women receiving valproate specifically is reduced by folic acid supplementation is unknown. DIETARY FOLIC ACID SUPPLEMENTATION BOTH PRIOR TO AND DURING PREGNANCY SHOULD BE ROUTINELY RECOMMENDED TO PATIENTS CONTEMPLATING PREGNANCY. Other Adverse Pregnancy Effects PATIENTS TAKING VALPROATE MAY DEVELOP CLOTTING ABNORMALITIES (SEE PRECAUTIONS - GENERAL AND WARNINGS). A PATIENT WHO HAD LOW FIBRINOGEN WHEN TAKING MULTIPLE ANTICONVULSANTS INCLUDING VALPROATE GAVE BIRTH TO AN INFANT WITH AFIBRINOGENEMIA WHO SUBSEQUENTLY DIED OF HEMORRHAGE. IF VALPROATE IS USED IN PREGNANCY, THE CLOTTING PARAMETERS SHOULD BE MONITORED CAREFULLY. PATIENTS TAKING VALPROATE MAY DEVELOP HEPATIC FAILURE (SEE WARNINGS - HEPATOTOXICITY AND BOX WARNING). FATAL HEPATIC FAILURES, IN A NEWBORN AND IN AN INFANT, HAVE BEEN REPORTED FOLLOWING THE MATERNAL USE OF VALPROATE DURING PREGNANCY. Animal DataAnimal studies have demonstrated valproate-induced teratogenicity. Increased frequencies of malformations, as well as intrauterine growth retardation and death, have been observed in mice, rats, rabbits, and monkeys following prenatal exposure to valproate. Malformations of the skeletal system are the most common structural abnormalities produced in experimental animals, but neural tube closure defects have been seen in mice exposed to maternal plasma valproate concentrations exceeding approximately 230 mcg/mL (2.3 times the upper limit of the human therapeutic range) during susceptible periods of embryonic development. Administration of an oral dose of 200 mg/kg/day or greater (50% of the maximum human daily dose or greater on a mg/ m basis) to pregnant rats during organogenesis produced malformations (skeletal, cardiac, and urogenital) and growth retardation in the offspring. These doses resulted in peak maternal plasma valproate levels of approximately 340 mcg/mL or greater (3.4 times the upper limit of the human therapeutic range or greater). Behavioral deficits have been reported in the offspring of rats given a dose of 200 mg/kg/day throughout most of pregnancy. An oral dose of 350 mg/kg/day (approximately 2 times the maximum human daily dose on a mg/ m basis) produced skeletal and visceral malformations in rabbits exposed during organogenesis. Skeletal malformations, growth retardation, and death were observed in rhesus monkeys following administration of an oral dose of 200 mg/kg/day (equal to the maximum human daily dose on a mg/ m basis) during organogenesis. This dose resulted in peak maternal plasma valproate levels of approximately 280 mcg/mL (2.8 times the upper limit of the human therapeutic range). Suicidal Behavior and Ideation Antiepileptic drugs, (AEDs), including divalproex sodium delayed-release tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Anyone considering prescribing divalproex sodium delayed-release tablets or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Interaction with Carbapenem Antibiotics Carbapenem antibiotics (ertapenem, imipenem, meropenem) may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates (see Drug Interactions). Somnolence in the Elderly In a double-blind, multicenter trial of valproate in elderly patients with dementia (mean age = 83 years), doses were increased by 125 mg/day to a target dose of 20 mg/kg/day. A significantly higher proportion of valproate patients had somnolence compared to placebo, and although not statistically significant, there was a higher proportion of patients with dehydration. Discontinuations for somnolence were also significantly higher than with placebo. In some patients with somnolence (approximately one-half), there was associated reduced nutritional intake and weight loss. There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and a higher BUN. In elderly patients, dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse events. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence (see DOSAGE AND ADMINISTRATION). Thrombocytopenia The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia (see PRECAUTIONS) may be dose-related. In a clinical trial of divalproex sodium delayed-release tablets as monotherapy in patients with epilepsy, 34/126 patients (27%) receiving approximately 50 mg/kg/day on average, had at least one value of platelets ≤ 75 x 10/L. Approximately half of these patients had treatment discontinued, with return of platelet counts to normal. In the remaining patients, platelet counts normalized with continued treatment. In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males). The therapeutic benefit which may accompany the higher doses should therefore be weighed against the possibility of a greater incidence of adverse effects.

Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional  Drug Patients with Events Per 1000 Patients
Epilepsy 1.0 3.4 3.5 2.4
Psychiatric 5.7 8.5 1.5 2.9
Other 1.0 1.8 1.9 0.9
Total 2.4 4.3 1.8 1.9
Table 2. Adverse Events Reported by > 5% of Divalproex Sodium Delayed-Release Tablets - Treated Patients During Placebo-Controlled Trials of Acute Mania1
Adverse Event Divalproex Sodium Delayed-Release Tablets
(n = 89)
Placebo
(n = 97)
1.  The following adverse events occurred at an equal or greater incidence for placebo than for divalproex sodium delayed-release tablets: back pain, headache, constipation, diarrhea, tremor, and pharyngitis.
Nausea 22% 15%
Somnolence 19% 12%
Dizziness 12% 4%
Vomiting 12% 3%
Asthenia 10% 7%
Abdominal pain 9% 8%
Dyspepsia 9% 8%
Rash 6% 3%
Table 3. Adverse Events Reported by > 5% of Divalproex Sodium Delayed-Release Tablets-Treated Patients During Migraine Placebo-Controlled Trials with a Greater Incidence Than Patients Taking Placebo1
Body System Event Divalproex Sodium Delayed-Release Tablets
(N = 202)
Placebo
(N = 81)
1.   The following adverse events occurred in at least 5% of divalproex sodium delayed-release tablets - treated patients and at an equal or greater incidence for placebo than for divalproex sodium delayed-release tablets: flu syndrome and pharyngitis.
Gastrointestinal System
     Nausea 31% 10%
     Dyspepsia 13% 9%
     Diarrhea 12% 7%
     Vomiting 11% 1%
     Abdominal pain 9% 4%
     Increased appetite 6% 4%
Nervous System
     Asthenia 20% 9%
     Somnolence 17% 5%
     Dizziness 12% 6%
     Tremor 9% 0%
Other
     Weight gain 8% 2%
     Back pain 8% 6%
     Alopecia 7% 1%
Table 4. Adverse Events Reported by ≥ 5% of Patients Treated with Divalproex Sodium Delayed-Release Tablets During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures
Body System/Event Divalproex Sodium Delayed-Release Tablets (%)
(n = 77)
Placebo (%)
(n = 70)
Body as a Whole
     Headache 31 21
     Asthenia 27 7
     Fever 6 4
Gastrointestinal System
     Nausea 48 14
     Vomiting 27 7
     Abdominal Pain 23 6
     Diarrhea 13 6
     Anorexia 12 0
     Dyspepsia 8 4
     Constipation 5 1
Nervous System
     Somnolence 27 11
     Tremor 25 6
     Dizziness 25 13
     Diplopia 16 9
     Amblyopia/Blurred Vision 12 9
     Ataxia 8 1
     Nystagmus 8 1
     Emotional Lability 6 4
     Thinking Abnormal 6 0
     Amnesia 5 1
Respiratory System
     Flu Syndrome 12 9
     Infection 12 6
     Bronchitis 5 1
     Rhinitis 5 4
Other
     Alopecia 6 1
     Weight Loss 6 0
Table 5. Adverse Events Reported by ≥ 5% of Patients in the High Dose Group in the Controlled Trial of Divalproex Sodium Delayed-Release Tablets Monotherapy for Complex Partial Seizures1
Body System/Event High Dose (%)
(n = 131)
Low Dose (%)
(n = 134)
1.   Headache was the only adverse event that occurred in ≥ 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.
Body as a Whole
     Asthenia 21 10
Digestive System
     Nausea 34 26
     Diarrhea 23 19
     Vomiting 23 15
     Abdominal Pain 12 9
     Anorexia 11 4
     Dyspepsia 11 10
Hemic/Lymphatic System
     Thrombocytopenia 24 1
     Ecchymosis 5 4
Metabolic/Nutritional
     Weight Gain 9 4
     Peripheral Edema 8 3
Nervous System
     Tremor 57 19
     Somnolence 30 18
     Dizziness 18 13
     Insomnia 15 9
     Nervousness 11 7
     Amnesia 7 4
     Nystagmus 7 1
     Depression 5 4
Respiratory System
     Infection 20 13
     Pharyngitis 8 2
     Dyspnea 5 1
Skin and Appendages
     Alopecia 24 13
Special Senses
     Amblyopia/Blurred Vision 8 4
     Tinnitus 7 1

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

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