M72 PI
This is the FDA approved age range for M72
What is 13-65 years old?
This is the contraindication for Osmolex ER
What is patients with End Stage Renal Disease? (Creatinine clearance below 15 mL/min/1.73 m2)
M72 has a black box warning for this
What is Drug Dependence?
These are all of the dosing strengths available for Methylphenidate ER
What is 18, 27, 36, 54, 72?
This is the maximum savings benefit the Methlyphenidate ER 72 Co pay savings card may provide?
What is $40
This is the delivery mechanism that M72 utilizes
What is Osmotic or Osmodex?
This is the full indication for Osmolex ER
What is indicated to treat Parkinson's disease and Drug Induced Extra Pyramidal Reactions in adult patients?
This was the most common adverse event in clinical trials seen in pediatric patients on Methylphenidate
What is Abdominal Pain Upper (PI Section 6)
This is the suggested interval time for titrating doses of Methylphenidate ER
What are 1 week intervals? (PI section 2.4)
Name 2 delivery systems besides the one utilized by M72, that are utilized by other generic manufacturers producing Methylphenidate.
What are Bead, Diffusion, or Matrix delivery mechanisms.
This is the substance class that M72 falls within for the Controlled Substances Act
What is Schedule 2?
This should be done if a patient misses a dose of Osmolex
What is skip the dose and take the next scheduled dose? (PI 2.4)
Name at least 4 of the most common adverse events in clinical trials seen in adult patients on Methylphenidate
What is decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis? (PI Section 6)
Should M72 be dosed with or without food?
What is either or? It does not matter because there were no differences in either the pharmacokinetics or the pharmacodynamic performance either way
In what year did the FDA change the bioequivalence guideline metrics from 2 points, to 5 points for generic Methylphenidate?
What is the year 2014
The reuptake of of these two neurotransmitters are believed to be impacted by the use of Methylphenidate
What are Dopamine and Norepinephrine? (PI 12.1)
Name 3 warnings and precautions of Osmolex ER
What are falling asleep during activities of daily living & somnolence, suicidality and depression, hallucinations/psychotic behavior, dizziness and Orthostatic hypotension, withdrawal emergent hyperpyrexia and confusion, impulse control/ compulsive behaviors?
Name 2 of the most common adverse events associated with the discontinuation of M72
What are anxiety, irritability, insomnia, and blood pressure increase (PI 6.3)?
These are the dosing strengths available for Osmolex ER
What are 129, 193, 258, and 352 (129 + 193)?
This is the cost of Osmolex ER for 4 out of 5 prescriptions filled by utilizing the Access Osmolex program?
What is between $30-40
These are the two Isomers that make up the pharmacodynamics for Methylphenidate. Name which isomer is more active
What are D- and I- Isomers? What is the D- Isomer? (PI 12.2)
Name 3 things that a patient should avoid doing when they are first starting Osmolex ER
What is do not drive, operate heavy machinery, do other dangerous activities, and do not drink alcohol since it can increase chances of serious side effects?
These are the three most common adverse reactions that occurred more than 5% of the time in clinical trials for Osmolex
What are Nausea, Dizziness/ Lightheadedness, and Insomnia? (PI 6.1)
In study 5 for Methylphenidate ER, which was the 7 week Dose-Titration Study, this was the dosing range that was used
What is 36 mg- 108mg? (PI 14.3)
In this month and year the USP Salt Policy required the name and strength of the active ingredient in a drug product to be expressed in terms of the active moiety rather than the salt strength treatment
What is May 2013