Indications
Concerta is primarily indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and older, adolescents, and adults. It is designed to help increase attention and decrease impulsiveness and hyperactivity in patients diagnosed with ADHD.
Mechanism of Action
Methylphenidate, the active ingredient in Concerta, is a central nervous system stimulant. It works by affecting chemicals in the brain and nerves that contribute to hyperactivity and impulse control. The extended-release formulation of Concerta allows for once-daily dosing, providing a controlled release of the medication throughout the day.
Administration and Dosage
- Administration Route: Oral
- Dosage:
- The typical starting dose is 18 mg once daily in the morning.
- The dosage may be adjusted in increments of 18 mg at weekly intervals, with a maximum recommended dose of 54 mg per day for children and 72 mg per day for adolescents and adults.
- Concerta should be taken with a glass of water, and the tablets should not be chewed or crushed.
Key Features
- Extended-release formulation: Provides a steady release of medication over 12 hours.
- Once-daily dosing: Simplifies medication regimen and improves adherence.
- Tablet design: Specially designed osmotic-controlled release oral delivery system (OROS) that ensures a consistent release rate.
Contraindications
- Hypersensitivity to methylphenidate or any other components of the product.
- Patients with marked anxiety, tension, or agitation.
- Glaucoma.
- Family history or diagnosis of Tourette’s syndrome.
- During or within 14 days following the administration of monoamine oxidase inhibitors (MAOIs).
Precautions and Warnings
- Cardiovascular Risks: Use with caution in patients with a history of cardiovascular conditions. Monitoring of heart rate and blood pressure is recommended.
- Psychiatric Risks: Monitor for worsening of psychiatric symptoms such as aggression, hostility, or suicidal thoughts.
- Growth Suppression: Long-term use may affect growth in pediatric patients; growth should be monitored during treatment.
- Potential for Abuse: Methylphenidate has a high potential for abuse and dependence.
Side Effects
Common side effects may include:
- Insomnia
- Decreased appetite
- Abdominal pain
- Headache
- Dry mouth
- Increased heart rate and blood pressure
Less common but serious side effects:
- Hallucinations
- Seizures
- Severe allergic reactions (rash, itching, swelling)
Storage
Store Concerta at room temperature, between 20°C to 25°C (68°F to 77°F). Protect from moisture and keep out of reach of children.
Additional Information
- Packaging: Concerta 54 mg is available in blister packs containing 30 tablets.
- Manufacturer Contact: Janssen-Cilag AG, a reputable pharmaceutical company known for producing high-quality medications and adhering to stringent safety and efficacy standards.
Patient Counseling Information
- Inform patients and caregivers about the potential for serious cardiovascular and psychiatric effects.
- Advise patients to take the medication exactly as prescribed and not to share it with others.
- Encourage patients to maintain regular follow-up visits for dose adjustments and monitoring of side effects.
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