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Atomoxetine (Atomoxetine)

Trade Name : Atomoxetine

Major Pharmaceuticals

CAPSULE

Strength 40 mg/1

ATOMOXETINE HYDROCHLORIDE Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atomoxetine (Atomoxetine) which is also known as Atomoxetine and Manufactured by Major Pharmaceuticals. It is available in strength of 40 mg/1 per ml. Read more

Atomoxetine (Atomoxetine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine hydrochloride in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine hydrochloride is approved for ADHD in pediatric and adult patients. Atomoxetine hydrochloride is not approved for major depressive disorder.
  • Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine hydrochloride in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine hydrochloride compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine hydrochloride was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see n n- .
  • WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTSu00a0u00a0
  • See full prescribing information for complete boxed warning
  • Increased risk of suicidal ideation in children or adolescents n n
  • No suicides occurred in clinical trials n n
  • Patients started on therapy should be monitored closely n
  • Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). n
  • Initial, Target and Maximum Daily Dose n
  • (Acute and Maintenance/Extended Treatment)
  • u00a0Dosing adjustment u2013 Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). (, )
  • Each capsule contains atomoxetine HCL equivalent to 10 mg (Opaque white, opaque white), 18 mg (Opaque dark gold, opaque white), 25 mg (Opaque dark blue, opaque white), 40 mg (Opaque dark blue, opaque dark blue), 60 mg (Opaque dark blue, opaque dark gold) 80 mg (Opaque dark brown, opaque white) and 100 mg (Opaque dark brown, opaque dark brown)u00a0u00a0of atomoxetine.
  • Each capsule contains atomoxetine HCL equivalent to 10, 18, 25, 40, 60, 80 or 100 mg mg of atomoxetine. (, , )
  • No data
  • (n- 4.2n- 7.1n- )
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  • (5.4)n- .
  • (5.6)n- u00a0
  • (5.7)n- u00a0
  • (5.8)n- u00a0
  • (n- 5.10n- 17.5n- )u00a0
  • Most common adverse reactions (u2265 5% and at least twice the incidence of placebo patients)
  • To report SUSPECTED ADVERSE REACTIONS, contact u00a0Dr. Reddyu2019s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 to www.fda.gov/medwatch.
  • Child and Adolescent Clinical Trials- Nausea, vomiting, fatigue, decreased appetite.
  • Adult Clinical Trials - Constipation, dry mouth, nausea, fatigue, decreased appetite, dizziness, erectile dysfunction and urinary hesitation.
  • No data
  • 4.2n- ,n- 7.1
  • No data
  • 8.1n- 8.3
  • No data
  • No data
  • Atomoxetine HCL is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the (-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(-tolyloxy)-propylamine hydrochloride. The molecular formula is CHNOu2022HCL, which corresponds to a molecular weight of 291.82. The chemical structure is:
  • Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are intended for oral administration only.
  • Each capsule contains atomoxetine Hydrochloride equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate and strong ammonia solution.
  • No data
  • No data
  • No data
  • No data
  • See n
  • ATOMOXETINE CAPSULES, USP
  • (A-toe-MOX-e-teen)
  • Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your childu2019s treatment with atomoxetine hydrochloride.
  • Atomoxetine Capsules, USP
  • 40 mg
  • 30 Capsules

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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