VYVANSE Capsule / Tablet chewable (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Shire LLC

Λέξεις κλειδιά

59417-101 59417-102 59417-103 59417-104 59417-105 59417-106 59417-107 59417-115 59417-116 59417-117 59417-118 59417-119 59417-120

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING: ABUSE AND DEPENDENCE CNS stimulants (amphetamines and methylphenidate-containing products), including VYVANSE, have a high potential for abuse and dependence. Assess the risk of abuse ...

1. Indications and Usage

VYVANSE is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)] Moderate to Severe Binge Eating Disorder (BED) in adults [see Clinical ...

2. Dosage and Administration

2.1 Pre-treatment Screening Prior to treating children, adolescents, and adults with CNS stimulants, including VYVANSE, assess for the presence of cardiac disease (e.g., a careful history, family history ...

3. Dosage Forms and Strengths

Information for VYVANSE capsules: Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg) Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg) Capsules 30 mg: white body/orange ...

4. Contraindications

VYVANSE is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria ...

5. Warnings and Precautions

5.1 Potential for Abuse and Dependence CNS stimulants (amphetamines and methylphenidate-containing products), including VYVANSE, have a high potential for abuse and dependence. Assess the risk of abuse ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see Contraindications ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of VYVANSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5. Drugs having clinically important interactions with amphetamines: MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants ...

8. Use in Specific Populations

8.7 Gender No dosage adjustment of VYVANSE is necessary on the basis of gender [see Clinical Pharmacology (12.3)].

8.1. Pregnancy

Risk Summary The limited available data from published literature and postmarketing reports on use of VYVANSE in pregnant women are not sufficient to inform a drug-associated risk for major birth defects ...

8.2. Lactation

Risk Summary Lisdexamfetamine is a pro-drug of dextroamphetamine. Based on limited case reports in published literature, amphetamine (d-or d, l-) is present in human milk, at relative infant doses of 2% ...

8.2. Labor and Delivery

ADHD Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)] ...

8.5. Geriatric Use

Clinical studies of VYVANSE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience and pharmacokinetic ...

8.6. Renal Impairment

Due to reduced clearance in patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m²), the maximum dose should not exceed 50 mg/day. The maximum recommended dose in ESRD (GFR <15 mL/min/1.73 ...

9.1. Controlled Substance

VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled substance.

9.2. Abuse

CNS stimulants, including VYVANSE, other amphetamines, and methylphenidate-containing products have a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, ...

9.3. Dependence

Tolerance Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drugs desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants ...

10. Overdosage

Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms ...

11. Description

VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] ...

12.1. Mechanism of Action

Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known. ...

12.2. Pharmacodynamics

Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The parent drug, lisdexamfetamine, ...

12.3. Pharmacokinetics

Pharmacokinetic studies after oral administration of lisdexamfetamine dimesylate have been conducted in healthy adult (capsule and chewable tablet formulations) and pediatric (6 to 12 years) patients with ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenicity studies of lisdexamfetamine dimesylate have not been performed. No evidence of carcinogenicity was found in studies in which d-, l-amphetamine (enantiomer ratio of 1:1) was ...

13.2. Animal Toxicology and/or Pharmacology

Acute administration of high doses of amphetamine (d- or d,l-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance of these ...

14. Clinical Studies

Efficacy of VYVANSE in the treatment of ADHD has been established in the following trials: Three short-term trials in children (6 to 12 years, Studies 1, 2, 3) One short-term trial in adolescents (13 to ...

16.1. How Supplied

Information for VYVANSE capsules: VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg), bottles of 100, NDC 59417-101-10 VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted ...

16.2. Storage and Handling

Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20ºC to 25º C (68ºF to 77º F). Excursions permitted between 15ºC and 30º C (59 to 86º F) [see USP Controlled ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/High Potential for Abuse and Dependence Advise patients that VYVANSE is a controlled substance ...