Atomoxapex Syrup 100 ml

Atomoxapex Syrup 100 ml

Description:

Atomoxapex 4 mg/ml Syrup 100 ml is a prescription medicine containing atomoxetine, a selective norepinephrine reuptake inhibitor (SNRI) used for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. It is a non-stimulant ADHD medication that helps improve attention span, reduce impulsivity, and control hyperactive behavior. This oral syrup formulation from Multi-Apex is particularly suitable for patients who have difficulty swallowing capsules or tablets, allowing accurate weight-based dosing and easier administration. Atomoxapex is used as part of a comprehensive ADHD management plan that may include psychological, educational, and social interventions.

Indications:

• Treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.
• Helps improve attention, concentration, and focus in individuals diagnosed with ADHD.
• Reduces symptoms of hyperactivity and impulsive behavior.
• Supports better behavioral control, academic performance, and social functioning when used as part of a comprehensive treatment program.

Active Ingredients / Key Components:

• Atomoxetine hydrochloride – 4 mg/ml (each 1 ml of syrup contains 4 mg of atomoxetine). Total content per 100 ml bottle: 400 mg atomoxetine.
• Excipients: Other inactive ingredients (such as solvents, sweeteners, stabilizers, and preservatives) are present to form the syrup, but their exact names and concentrations are not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).

Dosage & Administration / How to Use:

• Route of administration: Oral use only.
• General dosing principle: Dose is individualized based on body weight and clinical response. Always follow your doctor’s prescription and the instructions on the package insert.
• Children and adolescents up to 70 kg body weight:
  • Initial dose: 0.5 mg/kg/day.
  • After a minimum of 3 days, the dose may be increased to a target total daily dose of approximately 1.2 mg/kg/day.
  • The total daily dose may be given as a single morning dose or divided into two doses (morning and late afternoon/early evening).
  • Maximum dose: Do not exceed 1.4 mg/kg/day or 100 mg/day, whichever is lower.
• Children and adolescents over 70 kg body weight, and adults:
  • Initial dose: 40 mg/day.
  • After a minimum of 3 days, the dose may be increased to a target total daily dose of approximately 80 mg/day.
  • Dose may be administered as a single morning dose or divided into two doses (morning and late afternoon/early evening).
  • Maximum dose: 100 mg/day.
• With or without food: Atomoxapex syrup may be taken with or without food. Taking it with food may help reduce gastrointestinal side effects such as nausea.
• Measuring the dose: Use a calibrated oral syringe or dosing cup for accurate measurement. Do not use household teaspoons.
• Missed dose: If a dose is missed, take it as soon as you remember unless it is close to the time of the next dose. Do not double the dose to make up for a missed dose.
• Duration of use: Long-term treatment should be regularly reviewed by the prescribing physician to assess effectiveness and the need for continuation.

Clinical Benefits:

• Non-stimulant ADHD management: Provides effective symptom control for ADHD without being a stimulant, making it suitable for patients who cannot tolerate or should avoid stimulant medications.
• Improves attention and focus: Enhances the ability to concentrate on tasks, sustain attention, and reduce distractibility.
• Reduces hyperactivity and impulsivity: Helps decrease restlessness, fidgeting, and impulsive actions, supporting better behavioral control.
• Once- or twice-daily dosing: Flexible dosing schedule (single morning dose or divided doses) supports adherence and can be tailored to individual needs.
• Suitable for patients with swallowing difficulties: Syrup form allows easier administration and precise weight-based dosing, especially in children.
• Supports academic and social performance: By controlling core ADHD symptoms, it may contribute to improved school performance, organization, and interpersonal relationships when combined with behavioral and educational interventions.

Warnings & Contraindications:

• Contraindications:
  • Hypersensitivity to atomoxetine or any component of the formulation.
  • Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI due to risk of serious interactions.
• Cardiovascular warnings: Atomoxetine may increase heart rate and blood pressure. Use with caution in patients with hypertension, tachycardia, cardiovascular or cerebrovascular disease. Baseline and periodic monitoring of blood pressure and heart rate are recommended.
• Psychiatric warnings: Monitor for new or worsening psychiatric symptoms, including anxiety, agitation, irritability, depression, or suicidal thoughts, especially at the beginning of treatment or during dose changes.
• Liver function: Rare cases of severe liver injury have been reported with atomoxetine. Discontinue and seek medical attention if signs of liver problems occur (e.g., dark urine, jaundice, persistent nausea, abdominal pain).
• Growth in children: Long-term use may affect growth (weight and height). Regular monitoring of growth parameters in children and adolescents is recommended.
• Driving and operating machinery: Atomoxetine may cause dizziness, fatigue, or drowsiness in some patients. Avoid driving or operating heavy machinery until you know how the medicine affects you.
• Pregnancy and breastfeeding: Use only if clearly needed and prescribed by a doctor. Discuss potential risks and benefits with your healthcare provider.
• Drug interactions: Inform your doctor about all medicines you are taking, especially MAOIs, certain antidepressants (e.g., SSRIs), asthma medications, and drugs affecting blood pressure or heart rhythm.
• Consult your doctor before use if you have liver disease, cardiovascular disease, hypertension, psychiatric disorders, glaucoma, or seizure disorders.
• Not intended to diagnose, treat, cure, or prevent any disease outside its approved indication for ADHD.
• Keep out of reach of children.
• Use only under medical supervision and strictly according to the prescribed dose.

Side Effects:

• Common side effects: Nausea, vomiting, decreased appetite, stomach pain, dry mouth, headache, dizziness, fatigue, sleep disturbances (insomnia or sleepiness), and mild increase in heart rate or blood pressure.
• Less common side effects: Mood changes, irritability, anxiety, constipation, urinary retention or difficulty urinating, sweating, and weight loss.
• Serious side effects (seek immediate medical attention): Signs of liver problems (yellowing of skin or eyes, dark urine, severe abdominal pain), chest pain, fainting, severe or persistent mood changes, suicidal thoughts, or allergic reactions such as rash, itching, swelling, or difficulty breathing.
• If any side effects are severe, persistent, or concerning, stop use and contact your doctor or pharmacist promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the package. Do not freeze. Store at the temperature conditions specified on the pack (exact temperature range is not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.)).

Specifications:

• Product type: Prescription medicine for ADHD.
• Form: Syrup for oral use.
• Strength: 4 mg/ml atomoxetine.
• Pack size: 100 ml bottle.
• Intended users: Children, adolescents, and adults diagnosed with ADHD, as prescribed by a physician.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.