Report on Vyvanse (lisdexamfetamine dimesylate)
According to Pubmed, (2011), the use of the drug Vyvanse is used to treat ADHD (Attention Deficit Hyperactivity Disorder). ADHD is a condition in which the patient is hyperactive, impulsive, or inattentive. This drug works to release amphetamines which are stimulants that have a soothing and calming effect on the patient (Pubmed 2011).
ADHD is a common childhood behavioral disorder that affects approximately 3-5% of school going children. While the cause of ADHD is unclear, it is sometimes noted in family members indicating a possible genetic origin (Pubmed 2011).
Review of Package Insert
The package insert of this drug is very detailed and gives comprehensive information on the safe use of the drug. The insert begins by giving a warning on the susceptibility of the amphetamines in the drug to abuse. Vyvanse contains lisdexamfetamine which is converted into dextroamphetamine which is a stimulant with a calming effect (Vyvanse 2011). It warns of a possibility of dependence in case of prolonged use or cardiovascular distress and death in case of the misuse of the drugs.
The insert then highlights the dates when recent changes were made in the following factors affecting the drug: indications and usage; dosage administration; and precautions and warnings. After highlighting the dates when changes were made, the insert then gives specific information on the ‘Indications and Usage’ of the drug. These indications inform the reader that the drug acts as a central nervous system stimulant used in the treatment of ADHD. This section also confirms that the drug is active in children, adolescents, and adults (Vyvanse, 2011). This section gives very specific information on the diagnosis of ADHD and the duration for which these symptoms must have persisted which is at least six months. It then details special considerations during diagnosis and recommends that diagnosis be based not only on symptoms; but also on social, psychological, and educational evaluations. It also explains the importance of the drug being part of a wholesome treatment program that includes social, psychological, and educational measures. It finally recommends that long term treatment be marked by periods of evaluation of the drug’s efficacy.
The next section outlines the ‘Dosage and Administration’ recommended for the drug (Vyvanse 2011). It states the recommended dose for adults and children and also gives the maximum dose allowed for the drug. The insert advises the administration of the drug be done in the morning so as to avoid insomnia, and clarifies that the drug may be taken with or without food. The form of the drug (capsules) is then described and the various strengths in which it is available are provided.
The next section is titled ‘Contraindications’ and this gives the disease conditions where it is advisable not to administer the drug. The drug is contraindicated in certain conditions like inpatients who have abused drugs before, patients who are in a state of agitation. Patients who have glaucoma, hypertension, hypersensitivity to amines, and advanced arteriosclerosis.
The next section is titled ‘Warnings and Precautions’. This sections details dangerous reactions which could possibly occur as a result of using the drug. These include detailing cases where using the drug has resulted in: grave cardiovascular and psychiatric events; seizures; visual disturbances; tics; or growth suppression. The next section is titled ‘Adverse Reactions’ which details the undesirable side effects which occurred among various age groups during clinical trials. Detailed tables of these reactions are given and the age groups are classified into pediatric, adolescent, and adult (Vyvanse 2011). It also outlines the adverse reactions which can occur on various systems like the cardiovascular, psychiatric, central nervous system, gastrointestinal, and endocrine system in addition to allergic reactions.
The next section is titled ‘Drug Interactions’ which outlines the potential drug interactions that could alter the effects of amphetamines. These include agents which may increase, potentiate, or reduce the effects of amphetamines in the blood. The final section is titled ‘Use in Specific Populations’. This section describes guidelines which should be followed when administering the drug to special groups like pregnant and lactating women, and its use in children and the elderly (Vyvanse 2011). The insert warns that the drug has not been well tested in pregnant women and advises caution during its administration in pregnancy. It is also not recommended for administration in lactating women because it is excreted into human milk. The long term effects of Vyvanse in pediatric use is not known, neither is its use in the elderly.
The following section is titled ‘Drug Abuse and Dependence’ which explains the susceptibility of amphetamines to abuse. Vyvanse is a controlled substance and induces dependence in patients who take higher doses than that recommended by the physician. It also outlines the effects of dependence on the drug in both animal and human studies. After this is the segment titled ‘Over dosage’ which explains the classic symptoms of an amphetamine overdose and the treatment and management of such an event. The next section is ‘Description’ which describes the drug and gives its chemical name and structure. This section generally describes the physical and chemical properties of the drug .The chemical properties include molecular weight, contents of the capsule shells, solubility in water, and inactive ingredients.
‘Clinical Pharmacology’ is the next stage which describes the mechanism through which the drug Vyvanse acts when it is in the blood stream. It also describes its pharmacokinetics which describes how it reacts from the time it is swallowed and the effect of food, weight, and dose on its absorption into the bloodstream. The following part is titled ‘Nonclinical Toxicology’ which explains the carcinogenic effects of the drug and its toxicity to animals. The final sections are: ‘Clinical Studies’ which gives a report on the results of clinical trials carried out; ‘References’; ‘Storage and Handling’ guidelines; and ‘Patient Counseling Information’ which answers commonly asked questions by patients or caregivers. Patient information basically summarized the information in the insert in terms which are not technical and that can be understood by the patient who is not part of the medical fraternity. Storage and handling information prescribes storage of the drug at temperatures of 25 degrees Celsius with an allowed range of 15-30 degrees Celsius.
Treatment Trends of the Drug Vyvanse
Studies to examine the effect of Vyvanse on adults who exhibit negative symptom predominant schizophrenia reported positive results after a fourteen week study (PR Newsire 2011). Scientists speculate that if these results are confirmed in later trials, a significant step would have been made towards the treatment of schizophrenia’s negative symptoms (PR Newswire 2011).
Staton (2011, suggests that Shire, the company that produces Vyvanse is in the process of developing the drug to treat binge eating in addition to ADHD. This development is being attempted on the basis that binge-eaters indulge in food because the food acts as a drug which directly stimulates the reward center. They hope that Vyvanse will be able to affect the neurotransmitters involved and thus control binge eating. This will in turn reduce the occurrence of obesity. However, they are careful not to classify Vyvanse as an obesity drug in the control of binge-eating but as psychiatric drug (Staton, 2011).
References
Pubmed Health (2011). Attention Deficit Hyperactivity Disorder (ADHD). Available at http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002518/
PR Newswire (2011).Shire announces positive results from signal-finding study of Vyvanse. (2011). PharmaWatch: CNS, 10(6), 21-22.
Staton T. (2011). As rumors swirl, Shire eyes Vyvanse for binge eating. http://www.fiercepharma.com/story/rumors-swirl-shire-eyes-vyvanse-binge-eating/2011-07-13
Vyvanse Insert (2011). Vyvanse insert information. Available at http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf
