|
|
|
|
|
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
|
Adverse Reaction | Divalproex Sodium Delayed-Release Tablets
(n=89) % |
Placebo
(n=97) % |
---|---|---|
Nausea
|
22
|
15
|
Somnolence
|
19
|
12
|
Dizziness
|
12
|
4
|
Vomiting
|
12
|
3
|
Accidental Injury
|
11
|
5
|
Asthenia
|
10
|
7
|
Abdominal Pain
|
9
|
8
|
Dyspepsia
|
9
|
8
|
Rash
|
6
|
3
|
|
% |
% |
|
||
Headache | 31 | 21 |
Asthenia | 27 | 7 |
Fever | 6 | 4 |
|
||
Nausea | 48 | 14 |
Vomiting | 27 | 7 |
Abdominal Pain | 23 | 6 |
Diarrhea | 13 | 6 |
Anorexia | 12 | 0 |
Dyspepsia | 8 | 4 |
Constipation | 5 | 1 |
|
||
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 |
|
||
Flu Syndrome | 12 | 9 |
Infection | 12 | 6 |
Bronchitis | 5 | 1 |
Rhinitis | 5 | 4 |
|
||
Alopecia | 6 | 1 |
Weight Loss | 6 | 0 |
Body System/Reaction | High Dose
(n=131) % |
Low Dose
(n=134) % |
---|---|---|
|
||
Asthenia | 21 | 10 |
|
||
Nausea | 34 | 26 |
Diarrhea | 23 | 19 |
Vomiting | 23 | 15 |
Abdominal Pain | 12 | 9 |
Anorexia | 11 | 4 |
Dyspepsia | 11 | 10 |
|
||
Thrombocytopenia | 24 | 1 |
Ecchymosis | 5 | 4 |
|
||
Weight Gain | 9 | 4 |
Peripheral Edema | 8 | 3 |
|
||
Tremor | 57 | 19 |
Somnolence | 30 | 18 |
Dizziness | 18 | 13 |
Insomnia | 15 | 9 |
Nervousness | 11 | 7 |
Amnesia | 7 | 4 |
Nystagmus | 7 | 1 |
Depression | 5 | 4 |
|
||
Infection | 20 | 13 |
Pharyngitis | 8 | 2 |
Dyspnea | 5 | 1 |
|
||
Alopecia | 24 | 13 |
|
||
Amblyopia/Blurred Vision | 8 | 4 |
Tinnitus | 7 | 1 |
Body System Reaction | Divalproex Sodium Delayed-Release Tablets
(n=202) % |
Placebo
(n=81) % |
---|---|---|
|
||
Nausea | 31 | 10 |
Dyspepsia | 13 | 9 |
Diarrhea | 12 | 7 |
Vomiting | 11 | 1 |
Abdominal Pain | 9 | 4 |
Increased Appetite | 6 | 4 |
|
||
Asthenia | 20 | 9 |
Somnolence | 17 | 5 |
Dizziness | 12 | 6 |
Tremor | 9 | 0 |
|
||
Weight Gain | 8 | 2 |
Back Pain | 8 | 6 |
Alopecia | 7 | 1 |
|
|||
|
|
|
|
Placebo | 28.8 | + 0.2 | |
Divalproex sodium delayed-release tablets | 28.5 | - 9.5 | 9.7 |
|
|||
|
|
|
|
Placebo | 76.2 | + 1.8 | |
Divalproex sodium delayed-release tablets | 76.4 | -17 | 18.8 |
|
|||
|
|
|
|
Placebo | 31.8 | 0 | |
Divalproex sodium delayed-release tablets | 30.3 | + 18.1 | 18.1 |
|
|||
|
|
|
|
Placebo | 38.9 | - 4.4 | |
Lithium | 37.9 | -10.5 | 6.1 |
Divalproex sodium delayed-release tablets | 38.1 | - 9.5 | 5.1 |
|
|||
|
|
|
|
Placebo | 18.9 | - 2.5 | |
Lithium | 18.5 | - 6.2 | 3.7 |
Divalproex sodium delayed-release tablets | 18.9 | - 6.0 | 3.5 |
|
|||
|
|
|
|
Placebo | 16.4 | - 1.4 | |
Lithium | 16.0 | - 3.8 | 2.4 |
Divalproex sodium delayed-release tablets | 15.7 | - 3.2 | 1.8 |
Add-on
Treatment |
Number of
Patients |
Baseline
Incidence |
Experimental Incidence |
---|---|---|---|
Divalproex Sodium Delayed-Release Tablets | 75 | 16 | 8.9
|
Placebo | 69 | 14.5 | 11.5 |
Treatment | Number of
Patients |
Baseline
Incidence |
Randomized Phase Incidence |
---|---|---|---|
High Dose Divalproex Sodium Delayed-Release Tablets | 131 | 13.2 | 10.7
|
Low Dose Divalproex Sodium Delayed-Release Tablets | 134 | 14.2 | 13.8 |
|
• feeling very weak, tired or uncomfortable (malaise) • swelling of your face • not feeling hungry • nausea or vomiting that does not go away • diarrhea • pain on the right side of your stomach (abdomen) • dark urine • yellowing of your skin or the whites of your eyes • loss of seizure control in people with epilepsy • If you take divalproex sodium delayed-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord (such as spina bifida or neural tube defects). These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen. • Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. • Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. • If you take divalproex sodium delayed-release tablets during pregnancy for any medical condition, your child is at risk for having lower IQ and may be at risk for developing autism or attention deficit/hyperactivity disorder. • There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child. • Women who are pregnant must not take divalproex sodium delayed-release tablets to prevent migraine headaches. • • Tell your healthcare provider right away if you become pregnant while taking divalproex sodium delayed-release tablets. You and your healthcare provider should decide if you will continue to take divalproex sodium delayed-release tablets while you are pregnant. • o severe stomach pain that you may also feel in your back o nausea or vomiting that does not go away o not feeling hungry o attempts to commit suicide o new or worse depression o new or worse anxiety o feeling agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worse irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity and talking (mania) o other unusual changes in behavior or mood o Keep all follow-up visits with your healthcare provider as scheduled. |
Divalproex sodium delayed-release tablets are prescription medicines used: o complex partial seizures in adults and children 10 years of age and older o simple and complex absence seizures • with other medications to treat: o patients with multiple seizure types that include absence seizures |
• have or think you have a genetic liver problem caused by a mitochondrial disorder such as Alpers-Huttenlocher syndrome. • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium delayed-release tablets. See the end of this Medication Guide for a complete list of ingredients in divalproex sodium delayed-release tablets. • have a genetic problem called urea cycle disorder • are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception) |
• have or think you have a genetic liver problem caused by a mitochondrial disorder such as Alpers Huttenlocher syndrome. • drink alcohol. • have or have had depression, suicidal thoughts or behavior, unusual changes in mood, or thoughts about self-harm • are male and plan to father a child. Divalproex sodium delayed-release tablets may cause fertility problems, which may affect your ability to father a child. Talk to your healthcare provider if this is a problem for you. • are pregnant or may become pregnant. Divalproex sodium delayed-release tablets may harm your unborn baby. See " • are breastfeeding. Divalproex sodium can pass into breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take divalproex sodium delayed-release tablets. • medicines that can affect how the liver breaks down other medicines (such as phenytoin, carbamazepine, felbamate, phenobarbital, primidone, rifampin) • aspirin, carbapenem antibiotics, or estrogen-containing hormonal contraceptives • methotrexate • topiramate • cannabidiol |
• Divalproex sodium comes in different dosage forms. • Take divalproex sodium delayed-release tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how many divalproex sodium delayed-release tablets to take and when to take it. • Your healthcare provider may change your dose, if needed. • Do not change your dose of divalproex sodium delayed-release tablets without talking to your healthcare provider. • • Swallow divalproex sodium delayed-release tablets whole. Do not crush or chew divalproex sodium delayed-release tablets. Tell your healthcare provider if you cannot swallow divalproex sodium delayed-release tablets whole. You may need a different medicine. • If you miss a dose of divalproex sodium delayed-release tablets, take it as soon as you remember unless it's almost time for your next dose. Take the next dose at your regular time. Do not take 2 doses at the same time. • If you take too many divalproex sodium delayed-release tablets, call your healthcare provider or poison control center right away. |
• Do not drive a car, operate dangerous machinery, or do dangerous activities until you know how divalproex sodium delayed-release tablets affect you. Divalproex sodium delayed-release tablets can slow your thinking and motor skills and may affect your vision. |
• See " • o bleeding from your mouth or nose o cough up blood or blood clots o pain and swelling in your joints • o confusion o memory loss o skin rash o hives o sores in your mouth, • • weakness • sleepiness • dizziness • tremors • difficulty walking or problems with coordination • ringing in your ears • blurred vision • double vision • unusual eye movement • hair loss (alopecia) • swelling of your arms or legs |
•Store divalproex sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F). |
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use divalproex sodium delayed-release tablets for a condition for which it was not prescribed. Do not give divalproex sodium delayed-release tablets to other people, even if they have the same symptoms that you have. It may harm them. |
Active ingredient: divalproex sodium Inactive ingredients: 250 mg tablets: FD&C Yellow #6, and iron oxide yellow 500 mg tablets: D&C Red #30, FD&C Blue #2, and iron oxide red |