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DRUG DESCRIPTION
Meterra is designed as a capsule for once-a-day oral
administration.Meterra capsules contain 20 mg, 30 mg, 40 mg, 50
mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the
following inactive ingredients: microcrystalline cellulose,
croscarmellose sodium, and magnesium stearate.
INDICATIONS
Attention Deficit Hyperactivity Disorder
Meterra™ is indicated for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
The efficacy of Meterra in the treatment of ADHD was established
on the basis of two controlled trials in children aged 6 to 12 and
one controlled trial in adults.
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD;
DSM-IV®) implies the presence of hyperactive-impulsive and/or
inattentive symptoms that cause impairment and were present before
the age of 7 years. The symptoms must cause clinically significant
impairment, e.g. in social, academic, or occupational functioning,
and be present in two or more settings, e.g. school (or work) and
at home. The symptoms must not be better accounted for by another
mental disorder. For the Inattentive Type, at least 6 of the
following symptoms must have persisted for at least 6 months: lack
of attention to details/careless mistakes; lack of sustained
attention; poor listener; failure to follow through on tasks; poor
organization; avoids tasks requiring sustained mental effort;
loses things; easily distracted; forgetful. For the
Hyperactive-Impulsive Type, at least 6 of the following symptoms
(or adult equivalent symptoms) must have persisted for at least 6
months: fidgeting/squirming; leaving seat; inappropriate
running/climbing; difficulty with quiet activities; “on the go”;
excessive talking; blurting answers; can't wait turn; intrusive.
The Combined Type requires both inattentive and
hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no
single diagnostic test. Adequate diagnosis requires the use not
only of medical but also of special psychological, educational,
and social resources. Learning may or may not be impaired. The
diagnosis must be based upon a complete history and evaluation of
the patient and not solely on the presence of the required number
of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Meterra is indicated as an integral part of a total treatment
program for ADHD that may include other measures (psychological,
educational, social) for patients with this syndrome. Drug
treatment may not be indicated for all patients with this
syndrome. Stimulants are not intended for use in patients who
exhibit symptoms secondary to environmental factors and/or other
primary psychiatric disorders, including psychosis. Appropriate
educational/vocational placement is essential and psychosocial
intervention is often helpful. When remedial measures alone are
insufficient, the decision to prescribe stimulant medication will
depend upon the physician's assessment of the chronicity and
severity of the patient's symptoms and on the level of functional
impairment.
Long-Term Use
The effectiveness of Meterra for long-term use, i.e., for more
than 4 weeks, has not been systematically evaluated in controlled
trials. Therefore, the physician who elects to use Meterra for
extended periods should periodically re-evaluate the long-term
usefulness of the drug for the individual patient.
DOSAGE AND ADMINISTRATION
Dosage should be individualized according to the therapeutic needs
and response of the patient. Meterra should be administered at the
lowest effective dosage.
In children 6 to12 years of age or adults who are either starting
treatment for the first time or switching from another medication,
30 mg once daily in the morning is the recommended dose. If the
decision is made in the judgment of the clinician to increase the
dose beyond 30 mg/day, daily dosage may be adjusted in increments
of 10 mg or 20 mg at approximately weekly intervals. The maximum
recommended dose is 70 mg/day; doses greater than 70 mg/day of
Meterra have not been studied. Amphetamines are not recommended
for children under 3 years of age. Meterra has not been studied in
children under 6 years of age or over 12 years of age.
Meterra should be taken in the morning. Afternoon doses should be
avoided because of the potential for insomnia.
Meterra may be taken with or without food.
Meterra capsules may be taken whole, or the capsule may be opened
and the entire contents dissolved in a glass of water. The
solution should be consumed immediately and should not be stored.
The dose of a single capsule should not be divided. The contents
of the entire capsule should be taken, and patients should not
take anything less than one capsule per day.
SIDE EFFECTS
Weight Loss – In the controlled adult trial, mean weight loss
after 4 weeks of therapy was 2.8 lbs, 3.1 lbs, and 4.3 lbs, for
patients receiving final doses of 30 mg, 50 mg, and 70 mg of
Meterra, respectively, compared to a mean weight gain of 0.5 lbs
for patients receiving placebo.
Cardiac Disorders – palpitation
Eye Disorders – vision blurred, mydriasis, diplopia
Immune System Disorders – hypersensitivity
Nervous System Disorders – seizure, dyskinesia
Psychiatric Disorder – psychotic episodes, mania,
hallucination, depression, aggression, dysphoria, euphoria,
logorrhea
Skin and Subcutaneous Tissue Disorder – angioedema,
urticaria Adverse Reactions Associated with the Use of Amphetamine
Cardiovascular
Palpitations, tachycardia, elevation of blood pressure, sudden
death, myocardial infarction. There have been isolated reports of
cardiomyopathy associated with chronic amphetamine use.
Central Nervous System - Psychotic episodes at recommended
doses, overstimulation, restlessness, dizziness, insomnia,
euphoria, dyskinesia, dysphoria, depression, tremor, headache,
exacerbation of motor and phonic tics and Tourette's syndrome,
seizures, stroke.
Gastrointestinal - Dryness of the mouth, unpleasant taste,
diarrhea, constipation, other gastrointestinal disturbances.
Allergic - Urticaria, rashes, and hypersensitivity
reactions, including angioedema and anaphylaxis. Serious skin
reactions, including Stevens-Johnson Syndrome and Toxic Epidermal
Necrolysis have been reported.
Endocrine - Impotence, changes in libido.
WARNINGS
Serious Cardiovascular Events
Sudden Death and Pre-existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
Children and Adolescents
Sudden death has been reported in association with CNS stimulant
treatment at usual doses in children and adolescents with
structural cardiac abnormalities or other serious heart problems.
Although some serious heart problems alone carry an increased risk
of sudden death, stimulant products generally should not be used
in children or adolescents with known serious structural cardiac
abnormalities, cardiomyopathy, serious heart rhythm abnormalities,
or other serious cardiac problems that may place them at increased
vulnerability to the sympathomimetic effects of a stimulant drug
[see CONTRAINDICATIONS].
Adults
Sudden death, stroke, and myocardial infarction have been reported
in adults taking stimulant drugs at usual doses for ADHD. Although
the role of stimulants in these adult cases is unknown, adults
have a greater likelihood than children of having serious
structural cardiac abnormalities, cardiomyopathy, serious heart
rhythm abnormalities, coronary artery disease, or other serious
cardiac problems. Adults with such abnormalities should also
generally not be treated with stimulant drugs [see
CONTRAINDICATIONS].
CONTRAINDICATIONS
* Advanced arteriosclerosis, symptomatic cardiovascular disease,
moderate to severe hypertension, hyperthyroidism, known
hypersensitivity or idiosyncratic reaction to sympathomimetic
amines, glaucoma
* Agitated states
* Patients with a history of drug abuse
* During or within 14 days following the administration of
monoamine oxidase inhibitors (hypertensive crises may result)
Presentation
Meterra Capsules
Blister of 10 Capsules
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