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RELEXXII is a brand name for Methylphenidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see Clinical Studies ( 14 )] . Limitations of Use The use of RELEXXII is not recommended in pediatric patients…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Administer once daily in the morning with or without food. 2 ) Swallow whole with liquid. Do not chew, divide, or crush. 3 ): Pediatric patients 6 to 17 years Starting dosage is 18 mg once daily. Dosage may be increased by 18 mg once per day at weekly intervals.
Maximum dosage for pediatric patients 6 to 12 years: 54 mg once daily. Maximum dosage for pediatric patients 13 to 17 years: 72 mg once daily. Adults (up to 65 years) Starting dosage is 18 mg or 36 mg once daily. Dosage may be increased by 18 mg once daily at weekly intervals.
Maximum dosage: 72 mg once daily. 2 )] . 11 )]. 2 General Administration Information Administer RELEXXII orally once daily in the morning with or without food. Swallow RELEXXII whole with liquid. 8 )] . 3 Dosage Recommendations for Patients New to Methylphenidate Table 1 includes the starting dosage and dosage recommendations for RELEXXII in pediatric patients 6 to 17 years and adults who are not currently taking methylphenidate or other stimulants.
4 Dosage Recommendations for Patients Currently Using Methylphenidate The recommended starting dosage of RELEXXII for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 mg to 60 mg daily is provided in Table 2.
5 Dose Titration Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved clinical response at a lower dose. Daily dosages above 54 mg in pediatric patients 6 to 12 years and above 72 mg in pediatric patients 13 to 17 years have not been studied and are not recommended.
Daily dosages above 72 mg are not recommended in adults. Dosage strengths of 27 mg, 45 mg, and 63 mg are available for additional titration options based on clinical response. 6 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reaction occur, reduce the dosage, or, if necessary, discontinue RELEXXII.
If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue RELEXXII.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of RELEXXII for the treatment of ADHD is based on adequate and well-controlled studies of another formulation of methylphenidate hydrochloride extended-release tablets. Below is a display of adverse reactions from those adequate and well-controlled studies in ADHD.
Adults and pediatric patients 6 to 17 years with ADHD were evaluated in six controlled clinical studies and eleven open-label clinical studies (see Table 3). Safety was assessed by collecting adverse reactions, vital signs, weights, and electrocardiograms (ECGs), and by performing physical examinations and laboratory analyses.
A total of 3,906 patients participated in the clinical trials. 5 times the maximum recommended dosage of RELEXXII. The most common adverse reactions in double-blind clinical trials (>5%) were: Pediatric patients 6 to 17 years: abdominal pain upper (see Table 4).
Adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis (see Table 5). The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased .
Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations. Pediatric Patients 6 to 17 Years Table 4 lists the adverse reactions reported in 1% or more of another formulation of methylphenidate hydrochloride extended-release tablet-treated pediatric patients (6 to 17 years) in four placebo-controlled, double-blind clinical trials.
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or serious cardiac disease.
2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. 3 ) Psychiatric Adverse Reactions: Prior to initiating RELEXXII, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing RELEXXII.
4 ) Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. 5 ) Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during RELEXXII treatment.
, rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. 6 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients.
Pediatric patients not growing or gaining weight as expected may need to have their treatment interrupted. 7 ) Gastrointestinal Obstruction: Avoid use with preexisting GI narrowing. , patients with significant hyperopia) should be evaluated by an ophthalmologist.
9 ) Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe RELEXXII to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma.
10 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating RELEXXII, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome.
4 CONTRAINDICATIONS RELEXXII is contraindicated in patients: with a known hypersensitivity to methylphenidate or other components of RELEXXII. 2 )] . 1 )] . Known hypersensitivity to methylphenidate or other components of RELEXXII ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2%) are combined into Insomnia. Adults Table 5 lists the adverse reactions reported in 1% or more of adults treated with another formulation of methylphenidate hydrochloride extended-release tablets in two placebo-controlled, double-blind clinical trials.
5 times the maximum recommended dosage of RELEXXII). Adverse Reactions Observed in Clinical Trials with Another Formulation of Methylphenidate Hydrochloride Extended-release Tablets This section includes adverse reactions reported with use of another formulation of methylphenidate hydrochloride extended-release tablets in double-blind trials that do not meet the criteria specified for Table 4 or Table 5 and all adverse reactions reported by the other formulation of methylphenidate hydrochloride extended-release tablets-treated patients who participated in open-label and postmarketing clinical trials.
3%). 8%) discontinued due to an adverse reaction. 7%). 9%). 0%) treated with another formulation of methylphenidate hydrochloride extended-release tablets discontinued due to an adverse reaction. 6%). Tics In a long-term uncontrolled study (n=432 pediatric patients 6 to 12 years), the cumulative incidence of new onset of tics was 9% after 27 months of treatment with another formulation of methylphenidate hydrochloride extended-release tablets.
In a second uncontrolled study (n=682 pediatric patients 6 to 12 years) the cumulative incidence of new-onset tics was 1% (9/682). 2 months. Blood Pressure and Heart Rate Increases In the laboratory classroom clinical trials in pediatric patients 6 to 12 years (Studies 1 and 2), both another formulation of methylphenidate hydrochloride extended-release tablets once daily and methylphenidate three times daily increased resting pulse by an average of 2 to 6 bpm and produced average increases of systolic and diastolic blood pressure of roughly 1 to 4 mm Hg during the day, relative to placebo.
In the placebo-controlled trial in pediatric patients 13 to 17 years (Study 4), mean increases from baseline in resting pulse rate were observed with another formulation of methylphenidate hydrochloride extended-release tablets and placebo at the end of the double-blind phase (5 and 3 beats/minute, respectively).
4 mm Hg (diastolic), respectively. 8 bpm from baseline in standing pulse rate were observed with another formulation of methylphenidate hydrochloride extended-release tablets at the end of the double-blind treatment vs. 7 beats/minute with placebo.
8 mm Hg (diastolic) for placebo. 6 beats/minute, respectively). 3 )] . 2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of another formulation of methylphenidate hydrochloride extended-release tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders:
Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura Cardiac Disorders: Angina pectoris, Bradycardia, Extrasystoles, Supraventricular tachycardia, Ventricular extrasystoles Eye Disorders: Diplopia, Increased intraocular pressure, Mydriasis, Visual impairment General Disorders: Chest pain, Chest discomfort, Drug effect decreased, Hyperpyrexia, Therapeutic response decreased Hepatobiliary Disorders: Hepatocellular injury, Acute hepatic failure Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus NEC, Rashes, Eruptions, and Exanthemas NEC Investigations: Blood alkaline phosphatase increased, Blood bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs, Motor and Verbal Tics Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Mania, Logorrhea, Libido changes Reproductive System and Breast Disorders: Priapism Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema Vascular Disorders: Raynaud's phenomenon
Discontinue treatment if clinically appropriate. 1 Abuse, Misuse, and Addiction RELEXXII has a high potential for abuse and misuse. The use of RELEXXII exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
3 )]. Misuse and abuse of CNS stimulants, including RELEXXII, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing RELEXXII, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store RELEXXII in a safe place, preferably locked, and instruct patients to not give RELEXXII to anyone else.
Throughout RELEXXII treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were taking CNS stimulants at the recommended ADHD dosage.
Avoid RELEXXII use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 1 )]. Some patients may have larger increases. Monitor all RELEXXII-treated patients for hypertension and tachycardia.
4 Psychiatric Adverse Reactions Exacerbation of Pre-existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients.
, comorbid or history of depressive symptoms, a family history of suicide, bipolar disorder, and depression). , hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients compared to 0% of placebo-treated patients.
If such symptoms occur, consider discontinuing RELEXXII. 2 )] . Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during a methylphenidate withdrawal (drug holidays or during discontinuation).
RELEXXII-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. 6 Peripheral Vasculopathy, including Raynaud’s Phenomenon CNS stimulants, such as RELEXXII, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.
Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at the therapeutic dosage in all age groups throughout the course of treatment.
Signs and symptoms generally improved after reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during RELEXXII treatment. , rheumatology referral) may be appropriate for RELEXXII-treated patients who develop signs or symptoms of peripheral vasculopathy.
4 )] . CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. 7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period. Closely monitor growth (weight and height) in RELEXXII-treated pediatric patients.
Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 8 Potential for Gastrointestinal Obstruction Because the RELEXXII tablet is nondeformable and does not appreciably change in shape in the GI tract, RELEXXII should not ordinarily be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: esophageal motility disorders, small bowel inflammatory disease, "short gut" syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel's diverticulum).
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of drugs in nondeformable controlled-release formulations. Due to the extended-release design of the tablet, RELEXXII should be used only in patients who are able to swallow the tablet whole [see Patient Counseling Information ( 17 )] .
9 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment. , patients with significant hyperopia) should be evaluated by an ophthalmologist. 2 )] . Prescribe RELEXXII to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor RELEXXII-treated patients with a history of abnormally increased IOP or open angle glaucoma. 11 Motor and Verbal Tics, and Worsening of Tourette's Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics.
2 )] . Before initiating RELEXXII, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor RELEXXII-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.