DIAZOXIDE CHOLINE

Other

Brand names: VYKAT XR

Oral

Mechanism of Action

12.1 Mechanism of Action The exact mechanism of action of diazoxide choline in the treatment of hyperphagia in patients 4 years of age and older with Prader-Willi syndrome (PWS) is unknown.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS VYKAT XR is contraindicated in patients with known hypersensitivity to diazoxide
• other components of VYKAT XR
• or to thiazides. Erythema multiforme has been reported with VYKAT XR [see Adverse Reactions (6) ] . Known hypersensitivity to diazoxide
• other components of VYKAT XR
• or to thiazides. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hyperglycemia : Hyperglycemia, including diabetic ketoacidosis, has been reported
Monitor fasting glucose more frequently during first few weeks of treatment in patients with risk factors for hyperglycemia
1 ) Risk of Fluid Overload : Edema, including severe reactions associated with fluid overload, has been reported
Monitor fasting glucose more frequently for the first few weeks of treatment with VYKAT XR in patients with risk factors for hyperglycemia, such as obesity, elevated FPG, HbA1c at the upper limit of normal or above, concomitant use of growth hormone, or concomitant use of systemic corticosteroids

Known Side Effects

4 documented side effects by frequency

Drug Not Working

>10%

Peripheral Edema

1-10%

Weight Gain

0.1-1%

Shortness of Breath

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral