Methylphenidate Extended-Release Orally Disintegrating Tablets

Name: Methylphenidate Extended-Release Orally Disintegrating Tablets

Indications

COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies].

Side effects

The following are discussed in more detail in other sections of the labeling:

  • Known hypersensitivity to methylphenidate or other ingredients of Cotempla XR-ODT [see CONTRAINDICATIONS]
  • Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Drug dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
  • Serious cardiovascular reactions [see WARNINGS AND PRECAUTIONS]
  • Blood pressure and heart rate increases [see WARNINGS AND PRECAUTIONS]
  • Psychiatric adverse reactions [see WARNINGS AND PRECAUTIONS]
  • Priapism [see WARNINGS AND PRECAUTIONS]
  • Peripheral vasculopathy, including Raynaud’s phenomenon [see WARNINGS AND PRECAUTIONS]
  • Long-term suppression of growth [see WARNINGS AND PRECAUTIONS]

Clinical Trial 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 the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience With Other Methylphenidate Products In Children, Adolescents, And Adults With ADHD

Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Clinical Trials Experience With COTEMPLA XR-ODT In Children With ADHD

There is limited experience with COTEMPLA XR-ODT in controlled trials. Based on this limited experience, the adverse reaction profile of COTEMPLA XR-ODT appears similar to other methylphenidate extended release-products.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows:

Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura

Cardiac Disorders: Angina pectoris, Bradycardia, Extrasystole, Supraventricular tachycardia, Ventricular extrasystole

Eye Disorders: Diplopia, Mydriasis, Visual impairment

General Disorders: Chest pain, Chest discomfort, Hyperpyrexia

Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritis NEC, Rashes, Eruptions, and Exanthemas NEC

Investigations: Alkaline phosphatase increased, 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

Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Libido changes, Mania

Urogenital System: Priapism Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema

Vascular Disorders: Raynaud’s phenomenon

Read the entire FDA prescribing information for Cotempla XR ODT (Methylphenidate Extended-Release Orally Disintegrating Tablets)

Read More »
(web3)