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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 ® (LISDEXAMFETAMINE DIMESYLATE) IS A PRESCRIPTION
MEDICINE USED FOR THE TREATMENT OF
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) IN PATIENTS 6
YEARS AND ABOVE, AND FOR THE TREATMENT OF MODERATE TO SEVERE
BINGE EATING DISORDER (B.E.D.) IN ADULTS. METERRA IS NOT FOR
WEIGHT LOSS. IT IS NOT KNOWN IF METERRA IS SAFE AND EFFECTIVE
FOR THE TREATMENT OF OBESITY.
IMPORTANT SAFETY INFORMATION
Meterra® is a federally controlled substance (CII) because it
can be abused or lead to dependence. Keep Meterra in a safe
place to prevent misuse and abuse. Selling or giving away
Meterra may harm others and is against the law.
Meterra is a stimulant medicine. Tell the doctor if you or your
child have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
Who should not take Meterra?
Do not take Meterra if you or your child are:
• taking or has taken an anti-depression medicine called a
monoamine oxidase inhibitor (MAOI) within the past 14 days.
• sensitive or allergic to, or had a reaction to other stimulant
medicines.
Problems that can occur while taking Meterra. Tell the doctor:
• if you or your child have heart problems or heart defects,
high blood pressure, or a family history of these problems. This
is important because sudden death has occurred in people with
heart problems or defects taking stimulant medicines, and sudden
death, stroke and heart attack have happened in adults taking
stimulant medicines. Since increases in blood pressure and heart
rate may occur, the doctor should regularly check these during
treatment. Call the doctor right away if you or your child have
any signs of heart problems such as chest pain, shortness of
breath, or fainting while taking Meterra.
• if you or your child have mental problems, or a family history
of suicide, bipolar illness, or depression. This is important
because new or worsening behavior and thought problems or
bipolar illness may occur. New symptoms such as seeing or
hearing things that are not real, believing things that are not
true, being suspicious, or having new manic symptoms may occur.
Call the doctor right away if there are any new or worsening
mental symptoms during treatment.
• if you or your child have circulation problems in fingers and
toes (peripheral vasculopathy, including Raynaud’s phenomenon).
Fingers or toes may feel numb, cool, painful, sensitive to
temperature and/or change color from pale, to blue, to red. Call
the doctor right away if any signs of unexplained wounds appear
on fingers or toes while taking Meterra.
• if your child is having slowing of growth (height and weight);
Meterra may cause this serious side effect. Your child should
have his or her height and weight checked often while taking
Meterra. The doctor may stop treatment if a problem is found
during these check-ups.
• if you or your child are pregnant or plan to become pregnant.
It is not known if Meterra may harm your unborn baby.
• if you or your child are breastfeeding or plan to breastfeed.
Do not breastfeed while taking Meterra. Talk to your doctor
about the best way to feed your baby if you take Meterra.
What are possible side effects of Meterra?
The most common side effects of Meterra reported in ADHD studies
include:
o anxiety
o decreased appetite
o diarrhea
o dizziness
o dry mouth
o irritability
o loss of appetite
o nausea
o trouble sleeping
o upper stomach pain
o vomiting
o weight loss
The most common side effects of Meterra reported in adults with
moderate to severe BED include:
o dry mouth
o trouble sleeping
o decreased appetite
o increased heart rate
o constipation
o feeling jittery
o anxiety
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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