- Approval Id
- 0a349491b0e0da36
- Drug Name
- VYVANSE CAPSULES 20 mg
- Product Name
- VYVANSE CAPSULES 20 mg
- Approval Number
- SIN15840P
- Approval Date
- 2019-11-01
- Registrant
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Licence Holder
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Pre-treatment Screening</strong><br>
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 of sudden death or ventricular arrhythmia, and physical exam) <em>[see Warnings and Precautions (5.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for VYVANSE use <em>[see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1, 9.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.2 General Instructions for Use</strong><br>
Take VYVANSE by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. VYVANSE may be administered in the following way:</p>
<ul>
<li>Swallow VYVANSE capsules whole, or</li>
<li>Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture <strong>immediately</strong>. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.</li>
</ul>
<p>Do not take anything less than one capsule per day. A single dose should not be divided.</p>
<p><strong>2.3 Dosage for Treatment of ADHD</strong><br>
The recommended starting dose is 30 mg once daily in the morning in patients aged 6 and above. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with the 20 mg once daily in the morning. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day <em>[see Clinical Studies (14)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.4 Dosage in Patients with Renal Impairment</strong><br>
In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m<sup>2</sup>), the maximum dose should not exceed 50 mg/day. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m<sup>2</sup>), the maximum recommended dose is 30 mg/day <em>[see Use in Specific Populations (8.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.5 Dosage Modifications due to Drug Interactions</strong><br>
Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly <em>[see Drug Interactions (7.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>VYVANSE® is indicated for the treatment of:</p>
<ul>
<li> Attention Deficit Hyperactivity Disorder (ADHD) <em>[see Clinical Studies (14)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em></li>
</ul>
<p>Limitation of Use:<br>
VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established <em>[see Warnings and Precautions (5.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>VYVANSE is contraindicated in patients with:</p>
<ul>
<li>Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in post-marketing reports <em>[see Adverse Reactions (6.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
<li>Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis <em>[see Warnings and Precautions (5.7) and Drug Interactions (7.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
<li>Pheochromocytoma</li>
</ul>
- Atc Code
- N06BA12
- Atc Item Name
- lisdexamfetamine
- Pharma Manufacturer Name
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
