Drug Interaction:
MAOIs, fluoxetine,paroxetine other CYP2D6 inhibitors,
sabutamol, other beta agonists, pressor agents
Antidepressants, decongestants
Quinidine
,Drugs that prolong QT intervals, cause electrolyte imbalance or reduce threshold
Desipramine, diazepam, phenytoin, aspirin Albuterol,terbinafine
Indication:
STRATTERA® (atomoxetine hydrochloride) capsule for oral use
Initial U.S. Approval: 2002
WARNING: SUICIDAL IDEATION
IN CHILDREN AND ADOLESCENTS
See full prescribing information for complete boxed warning.
Increased risk of suicidal ideation in children or adolescents (5.1)
No suicides occurred in clinical trials (5.1)
Patients started on therapy should be monitored closely (5.1)
RECENT MAJOR CHANGES
Warning and Precautions, Severe Liver Injury (5.2) 06/2009
Warnings and Precautions, Effects on Blood Pressure
and Heart Rate (5.4) 09/2008
Boxed Warning 07/2008
Warnings and Precautions, Suicidal Ideation (5.1),
Effects on Blood Pressure and Heart Rate (5.4),
Effects on Urine Outflow from the Bladder (5.9) 07/2008
LIST OF DRUGS DURING 2004
Sr.No- 255
Name of the Drug- Atomoxetine HCL (10/18/25/40mg) capsule Pharmacological Classification- For ADHD
Date of Approval- 09-11-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2006
Sr.No- 22
Name of the Drug- Atomoxetine 60mg capsule (Addl.stgth) Pharmacological Classification- For ADHD
Date of Approval- 27-02-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1. Atomoxetine 60mg capsule ( Addl.stgh.) 27-02-2006
For AHD
2. Atomoxetine 10/18//25/40mg ) capsule 09-11-2004
For AHD
Hyperacidity
Adverse Reaction:
Abdominal pain, decreased appetite, weight loss,anorexia, dry mouth
Early waking, somnolence, dizziness, mood swings, irritability,
Aggressive behavour or hostility, suicidal ideation Mydriasis, drmatitis, fatigue GI upset, skin reactions, upper resipratory infections
Palpitations, hypertension, urinary retension and or hesitation
Sweating, Dysmenorhea Headache. Discontinue if signs of liver injury
Emergence of new psychotic or maina symptoms
Sudden deaths in patients with existing heart problems, and report of stroke and cardiac arrest in aduts with certain risk factors
Male and female sexual dysfunction
Priapism, pelvis pain in males
Hypoaesthesia, paresthesia
Contra-Indications:
Glaucoma, Concurrent use of MAOIs before or after 14 days
Special precautions
Hepatic or renal insufficiency Suicidal ideaton, clinical worsening, behavoural change. monior intially at dose change. Hypertension, hypotension, tachycardia.
cardiovascular or cerbro-vascular disease
Monitor pulse and BP periodically, pre-exiting structural cardiac abnormalities
History of hypothyroidism
Seizure history - discontinue if occur Congenital , acquired or family history of QT prongation
Monitor growth development, cognition and sexual maturation during long term treatment
Risk of urinary retension
Pregnancy and lactation
Dosages/ Overdosage Etc:
Indication-
Hyperacidity
Dosage-
Children under 6 years not recommended Over 6 years and under 70kg Initially 0.5mg/kg daily for minumum 7 days before increasing to maintenance 1- 2 mg/kg daily
Over 70 years- Intially 40mg daily for minmum 7 days before increasing to maintenance 80mg daily
Maximum daily- 100mg daily
Adminster as a single dose in the morning or as two evenly divided dose morning and late afternoon or early evening
INDICATIONS AND USAGE
STRATTERA® is a selective norepinephrine reuptake inhibitor indicated
for the treatment of Attention–Deficit/Hyperactivity Disorder (ADHD).
DOSAGE AND ADMINISTRATION
Dosing adjustment
Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be
CYP2D6 poor metabolizers (PMs).
Target Total Daily Dose Maximum Total Daily Dose
Children and 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg
and adolescents
up to 70kg
Children and 40 mg 80 mg 100 mg
adolescents
over 70 kg
and adults
DOSAGE FORMS AND STRENGTHS
Each capsule contains atomoxetine HCl equivalent
to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine.
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide.
1. General Information
Physicians should instruct their patients to read the Medication Guide before starting
therapy with STRATTERA and to reread it each time the prescription is renewed.
Prescribers or other health professionals should inform patients, their families,
and their caregivers about the benefits and risks associated with treatment
with STRATTERA and should counsel them in its appropriate use.
The prescriber or health professional should instruct patients, their families, and their
caregivers to read the Medication Guide and should assist them in understanding
its contents.
Patients should be given the opportunity to discuss the contents of the Medication
Guide and to obtain answers to any questions they may have.
Patients should be advised of the following issues and asked to alert their
prescriber if these occur while taking STRATTERA.
2. Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the
emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania,
mania, other unusual changes in behavior, depression, and suicidal ideation,
especially early during STRATTERA treatment and when the dose is adjusted.
Families and caregivers of patients should be advised to observe for the
emergence of such symptoms on a day–to–day basis, since changes may be
abrupt.
Such symptoms should be reported to the patient’s prescriber or health
professional, especially if they are severe, abrupt in onset, or were not part
of the patient’s presenting symptoms.
Symptoms such as these may be associated with an increased risk for suicidal
thinking and behavior and indicate a need for very close monitoring and possibly
changes in the medication.
3. Severe Liver Injury
Patients initiating STRATTERA should be cautioned that severe liver injury may
develop. Patients should be instructed to contact their physician immediately
should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness,
or unexplained “flu– like” symptoms
4. Aggression or Hostility
Patients should be instructed to call their doctor as soon as possible should they
notice an increase in aggression or hostility.
5. Priapism
Rare postmarketing cases of priapism, defined as painful and nonpainful penile
erection lasting more than 4 hours, have been reported for pediatric and adult
patients treated with STRATTERA.
The parents or guardians of pediatric patients taking STRATTERA and adult
patients taking STRATTERA should be instructed that priapism requires
prompt medical attention.
6. Ocular Irritant
STRATTERA is an ocular irritant. STRATTERA capsules are not intended to be
opened. In the event of capsule content coming in contact with the eye, the
affected eye should be flushed immediately with water, and medical advice
obtained.
Hands and any potentially contaminated surfaces should be washed as
soon as possible.
7. Drug-Drug Interaction
Patients should be instructed to consult a physician if they are taking or plan to
take any prescription or over-the-counter medicines, dietary supplements,
or herbal remedies.
8. Pregnancy
Patients should be instructed to consult a physician if they are nursing, pregnant,
or thinking of becoming pregnant while taking STRATTERA.
9. Food
Patients may take STRATTERA with or without food.
10. Missed Dose
If patients miss a dose, they should be instructed to take it as soon as possible,
but should not take more than the prescribed total daily amount of STRATTERA
in any 24 hour period.
11. Interference with Psychomotor Performance
Patients should be instructed to use caution when driving a car or operating
hazardous machinery until they are reasonably certain that their performance is
not affected by atomoxetine.
Literature revised June 3, 2009 Eli Lilly and Company Indianapolis,
IN 46285, USA Copyright © 2002, 2009,
Pharmacology/ Pharmacokinetics:
Pharmacology
Atomoxetine is a selective norephinephrine reuptake inhibitor. The precise mechanism by which atomextine produces its therapeutic effects is unknown, but is thought to be related to selective inhibition of the presynaptic norephinephrine transporter as determined in ex vivo uptake and neurotransmitter depletion studies.
Pharmacokinetics
Atomexine is rapidly absorbed after oral admin. and minimally affected by food, with an absolute bioavailability of about 63 % Maximum plasma concentraton is reached in approximately 1 to 2 hours
Interaction with Food:
Swallow whole. Do not open cap
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C
No adequate and well-controlled studies have been conducted in pregnant women.
STRATTERA should not be used during pregnancy unless the potential benefit
justifies the potential risk to the fetus.
2. Nursing Mothers
It is not known if atomoxetine is excreted in human milk.
Caution should be exercised if STRATTERA is administered to a nursing woman.
3. Pediatric Use
Anyone considering the use of STRATTERA in a child or adolescent must balance
the potential risks with the clinical need [see
4. Geriatric Use
The safety, efficacy and pharmacokinetics of STRATTERA in geriatric patients
have not been evaluated.
Manufacturer Details