This application is not a substitute for seizure safety. Please talk to your doctor for more information on seizure first aid. The Track It! AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. Health insurance that you or a family member obtained through an employer or purchased privately. The DEPAKOTE Savings Card is not available to individuals who are paying cash for their prescription or who are receiving prescription reimbursement under a state or federally funded insurance program.
This rebate form is not available to individuals who are paying cash for their prescription or who are receiving prescription reimbursement under a state or federally funded insurance program. Important Safety Information Prescribing Information. Home Depakote Formulations. Depakote formulations. Tablets and capsule shown are not actual size. When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part D , Medicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE.
The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. In some cases, liver damage may continue despite stopping the drug. Call your healthcare provider right away if you get any of the following symptoms: nausea or vomiting that does not go away, loss of appetite, pain on the right side of your stomach abdomen , dark urine, swelling of your face, or yellowing of your skin or the whites of your eyes.
If you take DEPAKOTE during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every babies born to mothers who use this medicine during pregnancy. 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.
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.
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. All women of childbearing age including girls from the start of puberty should talk to their healthcare provider about using other possible treatments instead of DEPAKOTE. You can enroll in this registry by calling toll-free or by visiting the website, www.
The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Inflammation of your pancreas that can cause death. Call your healthcare provider right away if you have any of these symptoms: severe stomach pain that you may also feel in your back, nausea or vomiting that does not go away. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping insomnia ; new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking mania ; other unusual changes in behavior or mood.
Thus, when a patient was admitted taking Depakote ER mg twice a day for seizure control, the pharmacy incorrectly dispensed Depakote delayed-release tablets. Thus, an equivalent dose of either dosage form does not provide an equivalent pharmacokinetic profile.
Product confusion may therefore result in significant clinical effects in patients. Asked what contributed to the product confusion, almost all reporters said they never knew there was a difference between delayed-release and extended-release dosage formulations and did not know of the introduction of the new extended-release formulation. Other contributing factors included the sound-alike names Depakote ER extended-release and Depakote DR delayed-release , visual similarities in the unit-dose packaging, and computer entry errors due to the overlapping portion of established names divalproex sodium , and overlapping product strengths mg and mg.
It is important for practitioners to understand the pharmacokinetic differences for each formulation of Depakote, and to implement strategies to minimize the potential unwanted outcomes and errors.
Divalproex sodium extended-release dosage form divalproex-ER has been promoted as innovative formulation for the treatment of epilepsy and manic disorders, and for migraine headache prevention, with the advantage of being dosing once a day. Due to a significant decreasing in the peak-trough fluctuation of plasma valproic acid levels, in comparison with the twice-daily dosing of conventional delayed-release formulations divalproex-DR , concentration-dependent side effects would be prevented.
However the main constraint for divalproex-ER usage is the need to be administered in a higher daily dose, because of its lower bioavailability, in order to prevent eventual breakthrough seizures when patients are switched from the twice-daily divalproex DR regimen. In order to overcome the need of increase divalproex-ER daily dose, maintenance of the twice-daily regimen is suggested.
Divalproex-ER administered every 12 hours not only increases steady state trough concentration to a higher value in comparison with divalproex-DR, avoiding inefficacy of the treatment, but also achieves the safest manner to treat patients with valproic acid because of reaching practically a plateau profile of drug levels.
Actual bioavailability of divalproex sodium extended-release tablets and its clinical implications. Valproic acid and its derivatives are indicated for the treatment of different types of epilepsy, for the treatment of acute manic or mixed episodes associated with bipolar disorder, and for prophylaxis of migraine headaches. Particularly, a complex constituted by a molar relationship of valproic acid and sodium valproate divalproex sodium has recently reached some preference in the market.
Divalproex sodium is marketed by Abbott Laboratories as conventional delayed-release DR , enteric-coated, dosage forms Depakote tablets, and Depakote sprinkle capsules , and as innovative extended-release ER tablets Depakote ER. Both tablets divalproex-DR and divalproex-ER are supplied in dosage strengths containing divalproex sodium equivalent to and mg of valproic acid, and the DR form is supplied containing divalproex sodium equivalent to of valproic acid as well.
Divalproex-ER has the advantage of diminishing the peak-trough fluctuation PTF of plasma valproic acid concentrations at the steady state after multiple dose administration, and hence its concentration-dependent side effects may be substantially reduced. Furthermore, technological properties of the dosage form allow it to be administered once a day, making more comfortable its use by the patients.
However, the main constraint of divalproex-ER is its lower bioavailability in comparison with divalproex-DR. This fact is highlighted by the manufacturer, which gives guidance for changing the total daily dose when the treatment of patients is converted from DR to ER regimen. We will return on this point in next sections. Before going deeper inside the bioavailability it should be remembered that valproic acid has a saturable plasma protein binding, which produces a nonlinear relationship between the total valproate concentration in plasma and the dose administered.
However, these studies compared average total drug levels in plasma assuming constant clearance, but, as it was already said, the clearance for total drug is not constant due to the variable plasma protein binding of valproic acid. For this reason we have recalculated the ratio of steady state average valproic acid concentrations taking into account free plasma drug levels and hence we have arrived to a more confident relative bioavailability factor.
Equation 1 relates steady state average plasma drug concentrations Cssav , reached after equal multiple daily dosing of both formulations DR and ER , with the fraction of dose absorbed F and with the actual drug clearance CL. Being the unbound drug clearance a constant, the ratio of average free plasma concentrations C free ssav becomes a reliable estimator of drug-product relative bioavailability Equation 2.
In order to calculate free plasma valproic acid concentration Equation 3 was used. Feeding the equation with valproic acid binding data a close to the real molar concentration for the total plasma protein is obtained, which validates the assumption of a molar relationship for drug-protein binding.
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