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Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral
administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-
diamino-N-[(1S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate. The molecular
formula is C15H25N3O•(CH4O3S)2, which corresponds to a molecular weight of 455.60.
Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792
mg/mL). Vyvanse capsules contain 30 mg, 50 mg and 70 mg of lisdexamfetamine dimesylate
and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and
magnesium stearate. The capsule shells contain gelatin, titanium dioxide, and one or more of
the following: D&C Red #28, D&C Yellow #10, FC&C Blue #1 and FD&C Red #40.
Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of Vyvanse in the treatment of ADHD was established on the basis of two
controlled trials in children aged 6 to 12, who met DSM-IV® criteria for ADHD
A diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD; DSM-IV®) implies the
presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were
present before age 7 years. The symptoms must cause clinically significant impairment, in
social, academic, or occupational functioning, and be present in two or more settings, e.g., at
school (or work) and at home. The symptoms must not be better accounted for by another
mental disorder. For the Inattentive Type, at least six 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 six of the following 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
How to take
How should I take VYVANSE?
? Take VYVANSE exactly as your doctor tells you to take it.
? Your doctor may change your dose until it is right for you.
? Take VYVANSE 1 time each day in the morning.
? VYVANSE can be taken with or without food.
? VYVANSE capsules may be swallowed whole.
? If you have trouble swallowing capsules, open your VYVANSE capsule and pour all the powder
into yogurt, water, or orange juice.
o Use all of the VYVANSE powder from the capsule so you get all of the medicine.
o Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE powder and
yogurt, water or orange juice until they are completely mixed together.
o Eat all the yogurt or drink all the water or orange juice right away after it has been mixed with
VYVANSE. Do not store the yogurt, water, or orange juice after it has been mixed with
VYVANSE. It is normal to see a filmy coating on the inside of your glass or container after you
eat or drink all the VYVANSE.
? Your doctor may sometimes stop VYVANSE treatment for a while to check your ADHD or your
? Your doctor may do regular checks of your heart, and blood pressure while taking VYVANSE.
? Children should have their height and weight checked often while taking VYVANSE. VYVANSE
treatment may be stopped if a problem is found during these check-ups.
If you take too much VYVANSE, call your doctor or poison control center (1-800-222-1222) right away, or
get to the nearest hospital emergency room.
The premarketing development program for Vyvanse included exposures in a total of 404
participants in clinical trials (348 pediatric patients and 56 healthy adult subjects). Of these,
348 pediatric patients (ages 6 to 12) were evaluated in two controlled clinical studies (one
parallel-group and one crossover), one open-label extension study, and one single-dose
clinical pharmacology study. The information included in this section is based on data from
the 4-week parallel-group controlled clinical trial in pediatric patients with ADHD. Adverse
reactions were assessed by collecting adverse events, results of physical examinations, vital
signs, weights, laboratory analyses, and ECGs.
Adverse events during exposure were obtained primarily by general inquiry and recorded by
clinical investigators using terminology of their own choosing. Consequently, it is not
possible to provide a meaningful estimate of the proportion of individuals experiencing
adverse events without first grouping similar types of events into a smaller number of
standardized event categories. In the tables and listings that follow, MedRA terminology has
been used to classify reported adverse events.
The stated frequencies of adverse events represent the proportion of individuals who
experienced, at least once, a treatment-emergent adverse event of the type listed.
Adverse events associated with discontinuation of treatment: Ten percent (21/218) of
Vyvanse-treated patients discontinued due to adverse events compared to 1% (1/ 72) who
received placebo. The most frequent adverse events leading to discontinuation and
considered to be drug-related (i.e., leading to discontinuation in at least 1% of Vyvansetreated
patients and at a rate at least twice that of placebo) were ECG voltage criteria for
ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash (2/218
Adverse events occurring in a controlled trial: Adverse events reported in a 4-week
clinical trial in pediatric patients treated with Vyvanse or placebo are presented in the table
The prescriber should be aware that these figures cannot be used to predict the incidence of
adverse events in the course of usual medical practice where patient characteristics and other
factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies
cannot be compared with figures obtained from other clinical investigations involving
different treatments, uses, and investigators. The cited figures, however, do provide the
prescribing physician with some basis for estimating the relative contribution of drug and
non-drug factors to the adverse event incidence rate in the population studied.
The following adverse events that occurred in at least 5% of the Vyvanse patients and at a rate
twice that of the placebo group (Table 1): Upper abdominal pain, decreased appetite,
dizziness, dry mouth, irritability, insomnia, nausea, vomiting, and decreased weight.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe
hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the
sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase
inhibitors (hypertensive crises may result).
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