Product image of Focalin XR 10 mg/1 (Dexmethylphenidate Hydrochloride) 10 mg/1 CAPSULE, EXTENDED RELEASE supplied by GNH India

Focalin XR 10 mg/1

Active Ingredient:
Dexmethylphenidate Hydrochloride
Form:
CAPSULE, EXTENDED RELEASE
Brand:
Focalin XR
Origin:
USA

Focalin XR 10 mg/1 (Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE) 10 mg/1

Dexmethylphenidate hydrochloride, the active ingredient in Focalin XR, is a central nervous system stimulant presented as a 10 mg extended-release capsule for oral use. It is used to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 and older and in adults. GNH India supplies Focalin XR as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Focalin XR is designed to provide extended coverage, helping to manage ADHD symptoms throughout the day. It is part of a comprehensive treatment program that may include counseling or other therapies.

Strength

10 mg/1

Pack Size

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)

Manufacturer / TM Owner

Novartis Pharmaceuticals Corporation

1
Pack/s
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Indications & Clinical Uses

Focalin XR is a central nervous system stimulant used to manage symptoms of attention deficit hyperactivity disorder (ADHD).

  • ADHD in children 6 years and older: Helps improve attention and reduce impulsiveness and hyperactivity.
  • ADHD in adults: Aids in managing symptoms of inattention, hyperactivity, and impulsivity.
  • Part of a total treatment program: Often used alongside counseling or other therapies to address ADHD comprehensively.

How It Works

  • Dexmethylphenidate hydrochloride works by inhibiting the reuptake of norepinephrine and dopamine in the brain. This action increases the levels of these neurotransmitters in the synaptic gap, enhancing focus and reducing symptoms of ADHD. The extended-release formulation of Focalin XR provides a sustained release of the medication, ensuring prolonged therapeutic effects.

Side Effects

Focalin XR, like other stimulants, can cause a range of side effects, from mild to serious.

Common Side Effects

  • Decreased appetite: May lead to weight loss or reduced growth in children.
  • Insomnia: Difficulty falling or staying asleep.
  • Headache: Mild to moderate headaches.
  • Stomach pain: Discomfort or pain in the abdominal area.
  • Nervousness: Feelings of restlessness or anxiety.
  • Increased heart rate: Elevated pulse or heart palpitations.
  • Dry mouth: Reduced saliva production.
  • Dizziness: Lightheadedness or vertigo.

Serious or Rare Side Effects

  • Cardiovascular issues: Increased risk of heart problems, including sudden death, stroke, and heart attack in individuals with pre-existing heart conditions.
  • Psychiatric symptoms: Worsening of psychosis or bipolar illness, or new psychotic or manic symptoms.
  • Priapism: Prolonged and painful erection requiring immediate medical attention.
  • Peripheral vasculopathy: Conditions like Raynaud’s phenomenon affecting fingers and toes.
  • Growth suppression: Long-term use may suppress growth in children, necessitating regular monitoring.
  • Allergic reactions: Symptoms such as itching, hives, swelling, and difficulty breathing.

Precautions & Warnings

Focalin XR should be used with caution and under the supervision of a healthcare provider. It is important to follow the prescribed dosage and monitor for any adverse effects.

  • Prescription only: Available only with a valid prescription from a healthcare provider.
  • Heart conditions: Use with caution in individuals with pre-existing heart conditions or a family history of heart problems.
  • Mental health: Monitor for worsening of psychiatric conditions such as psychosis or bipolar disorder.
  • Substance abuse: Has a high potential for abuse and misuse, which can lead to addiction.
  • Pregnancy: Should be used during pregnancy only if clearly needed, as it may affect fetal development.
  • Breastfeeding: It is not known whether dexmethylphenidate is excreted in human milk, so caution is advised.
  • Storage: Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Focalin XR can interact with other medications, potentially altering its effectiveness or increasing the risk of side effects.

Major Interactions (Avoid)

  • MAO inhibitors: Concurrent use with MAO inhibitors or within 14 days of stopping one can cause dangerous interactions.
  • Serotonergic drugs: Increased risk of serotonin syndrome when combined with other serotonergic medications.
  • Alcohol: Avoid alcohol as it can intensify the side effects of Focalin XR.

Moderate Interactions (Monitor Closely)

  • Antidepressants: May require dose adjustments or close monitoring when used together.
  • Blood pressure medications: Focalin XR can affect blood pressure, necessitating careful monitoring.
  • Seizure medications: May require dose adjustments or close monitoring when used together.

Frequently Asked Questions

Focalin XR is used to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 and older and in adults. It helps improve attention and reduce symptoms of impulsiveness and hyperactivity. The medication is part of a comprehensive treatment program that may include counseling or other therapies.

Dexmethylphenidate works by inhibiting the reuptake of norepinephrine and dopamine in the brain. This action increases the levels of these neurotransmitters in the synaptic gap, enhancing focus and reducing symptoms of ADHD. The extended-release formulation of Focalin XR provides a sustained release of the medication, ensuring prolonged therapeutic effects.

The usual starting dose of Focalin XR for children new to stimulants is 5 mg once daily in the morning, with weekly increases of 5 mg as needed, up to a maximum of 30 mg daily. Adults typically start at 10 mg once daily, with weekly increases of 10 mg up to a maximum of 40 mg daily. The prescriber sets the dose based on individual needs and response to the medication.

Focalin XR should be used during pregnancy only if clearly needed, as it may affect fetal development. It is not known whether dexmethylphenidate is excreted in human milk, so caution is advised for breastfeeding mothers. Always consult a healthcare provider before using Focalin XR during pregnancy or breastfeeding.

To order Focalin XR from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will reply with pricing, availability, shipping, and the import paperwork.

Focalin XR is a central nervous system stimulant that contains dexmethylphenidate, the active d-enantiomer of methylphenidate. It is similar to other stimulants like Adderall and Ritalin but is specifically designed to provide extended coverage with a single morning dose. The choice of medication depends on individual response and the prescriber's recommendation.

Focalin XR should be stored below 25°C, kept in the original pack, and protected from moisture. It is important to follow the storage instructions to maintain the medication's effectiveness and safety. Always keep the medication out of reach of children and pets.

Focalin XR is taken once daily in the morning, either with or without food. The capsule should be swallowed whole; do not crush, chew, or break it. If swallowing capsules is difficult, the contents of the capsule can be sprinkled onto a small amount of applesauce and consumed immediately without chewing. Avoid taking the medication in the afternoon or evening, as it may disrupt sleep.

The most serious risks associated with Focalin XR include cardiovascular issues such as sudden death, stroke, and heart attack in individuals with pre-existing heart conditions. It can also worsen psychosis or bipolar illness, or cause new psychotic or manic symptoms. Priapism, a prolonged and painful erection, requires immediate medical attention. Regular monitoring and follow-up with a healthcare provider are essential.

Focalin XR should not be used by individuals with known hypersensitivity to methylphenidate or any of the inactive ingredients in the formulation. It is also contraindicated in individuals with certain heart conditions, severe anxiety, agitation, or a history of drug abuse. Always consult a healthcare provider before starting Focalin XR to ensure it is safe and appropriate for you.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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