Administrative Issues and Closeout, Sponsor Interactions, IRB Communication, Document Retention Essay

Administrative Issues and Closeout, Sponsor Interactions, IRB Communication, Document Retention, Close-out

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            Stavzor is an anticonvulsant drug used to treat bipolar mania, seizures and migraine headaches. It comes in the form of soft gel, enteric coated capsule that is time-released or delayed-released capsule which means that the medication is absorbed only when it reaches the small intestine. Its main component is valproic acid and was approved by FDA, July of 2008. This drug is available in capsule format in concentration of 125, 250, and 500 mg.

            The administration of Stavzor differs according to the condition of the body system of the patient and the disorder to be treated. For bipolar disorder, the initial dose is 750 mg daily in portioned concentrations then increasing the dose to the lowest concentration that reaches the most favorable plasma concentration. For those suffering from complex seizure, the initial dose is 10 to 15 mg/kg daily, to be increased by 5 to 10 mg/kg daily after one week of intake until most favorable response is observed in the patient. For cases of absence seizures, the initial dose is 15mg/kg a day, also increasing by 5 to 10 mg until the seizures stopped. For migraine headaches, the initial dose is 250 mg to be administered twice a day.

            When taking this drug, it is usually normal for patients experience any of the following adverse effects or reactions namely nausea, dizziness, vomiting, abdominal pain, rashes, diarrhea, increased appetite, tremors and weight gain.

            As a special precautionary measure, physicians are advised to conduct frequent checks on the patient to find out whether any complications appeared after the administration of the drug for several weeks. In cases of epileptic patients, physicians should measure the serum valproate levels of the patient so that specific doses can be administered in order to prevent seizures.

            Warning is strictly given to cases of patients who has liver problems, pancreatitis and birth defects when taken during pregnancy.

            Depakene is another anticonvulsant drug that can serve as an alternative to Stavzor. It has a molecular weight of 144, occurs as a colorless liquid with a characteristic odor, slightly soluble in water but very soluble in organic solvents. It comes in 250 mg soft gel form and 250 mg per 5 ml syrup form. It is used to treat epileptic orders with simple and/or complex seizures.

             Initial dose in administering Depakene is 10–15mg/kg daily, to be increased by 5-10 mg /kg after one week of usage. For maintenance cases, patients are given a dosage of 20 to 30 mg/kg for adults and 30mg/kg daily for children.

            Adverse effects include hemorrhage, bruising, nausea, vomiting, increased appetite, thrombocytopenia, anemia, bone marrow suppression, pancreatitis, and G.I. irritation. There are also cases of confusion, convulsion, transient effect of hair loss and fine postural tremor, nausea/dizziness, amenorrhea and irregular periods.

            Warning is also given that administration of Depakene to children less than two years of age increased the children to risk of developing hepatic failure due to fatal hepatotoxicity. Extreme precaution should be taken in prescribing this drug to patients with congenital metabolic disorder, those with severe seizure disorder accompanied by mental retardation, and those with organic brain disease.

            Other substitute drugs for Stavzor aside from Depakene are Epikor, Epilantin, Keppra, Lamictal, and Tegretol. All these drugs possess the same adverse effects and warning as that of Stavzor and Depakene.

            Based on the given information and component summaries of Stavzor and the other alternative drugs, this student concludes that the administration of Stavzor is more effective and safer to patients than the other alternative drugs. This is due to the fact that it is capable to address a wider range of disorders such as bipolar problems, epileptic seizures and even migraine headaches. Aside from these, adverse effects that patients suffer while taking this drug are lesser, more tolerable and less dangerous compared to the other substitute drugs. This student also finds that whatever kind of drugs one is taking, one has to consult physician first and willing to undergo monitoring, and most of all, heed precautionary warnings indicated in the labeling and summary of the drug to be taken.


Depakene. (2008). RXList. Retrieved November 27, 2008, from the RxList database.

Drugs approved by the FDA. (2008). Center Watch. Retrieved October 18, 2008, from Center


FDA issues approvable letter for Stavzor Delayed Release Valproic Acid Capsules. (2008).

Medical News. Retrieved October 18, 2008, from Medical News Today:

Stavzor. (2008). Stavzor. Retrieved October 18, 2008, from Stavzor:

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