FOCALIN XR PACKAGE INSERT PDF

Specifically, pharmacists have access to drug information from a variety of resources, including print publications, subscription-based electronic databases e. Thus, when searching for drug information, many times the problem facing a pharmacist is not a lack of resources, but rather too many resources from which to choose. Its availability, ease of use, contents, and legal weight make the PI the resource that should often be the starting point when initiating a search for drug information. Evolution of the PI The Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing these provisions on foods, drugs, cosmetics, and medical devices.

Author:Garr Kagara
Country:South Sudan
Language:English (Spanish)
Genre:Video
Published (Last):1 January 2017
Pages:481
PDF File Size:1.26 Mb
ePub File Size:18.92 Mb
ISBN:664-8-38617-162-4
Downloads:7786
Price:Free* [*Free Regsitration Required]
Uploader:Moogusar



Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions 6.

Concomitant treatment with monoamine oxidase inhibitors MAOIs , or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions 7.

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence 9. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD.

Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems.

Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Focalin treatment.

Individuals may have larger increases. Monitor all patients for hypertension and tachycardia. Prior to initiating treatment, screen patients for risk factors for developing a manic episode e. If such symptoms occur, consider discontinuing Focalin. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose.

Priapism has also appeared during a period of drug withdrawal drug holidays or during discontinuation. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

Further clinical evaluation e. Careful follow-up of weight and height in patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months to the ages of 10 to 13 years , suggests that consistently medicated pediatric patients i.

Closely monitor growth weight and height in pediatric patients treated with CNS stimulants, including Focalin, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions 5.

Clinical Trials Experience with Focalin in Pediatric Patients with ADHD The safety data in this section is based on data related to Focalin exposure during the premarketing development program in a total of participants in clinical trials patients, 12 healthy adult subjects.

The ADHD patients ages 6 to 17 years were evaluated in 2 controlled clinical studies, 2 clinical pharmacology studies, and 2 open-label long-term safety studies. System Organ Class.

HP F2410 PDF

Focalin XR

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Focalin XR use [see Boxed Warning, Warnings and Precautions 5. Adult patients: Start with 10 mg orally once daily in the morning with or without food. Patients currently using Focalin dexmethylphenidate immediate-release tablets may be given the same daily dose of Focalin XR. Titration Schedule The dose may be titrated weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients. The dose should be individualized according to the needs and response of the patient.

AMLIE NOTHOMB LE SABOTAGE AMOUREUX PDF

The Package Insert

Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions 6. Concomitant treatment with monoamine oxidase inhibitors MAOIs , or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions 7. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence 9. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Focalin treatment. Individuals may have larger increases.

Related Articles