CONTRAINDICATIONS
CARDAMYST is contraindicated in patients with:
- Hypersensitivity to CARDAMYST or any of its components.
- Heart failure - New York Heart Association (NYHA) Class II to IV.
- Wolff-Parkinson-White (WPW), Lown-Ganong-Levine (LGL) syndromes, or manifest pre-excitation (delta wave) on a 12-lead electrocardiogram (ECG).
- Sick sinus syndrome without a permanent pacemaker.
- Second degree atrioventricular (AV) Mobitz 2 block or higher degree of AV block.
WARNINGS AND PRECAUTIONS
Syncope Related to Hemodynamic Effects
- Because of effects on blood pressure, heart rate, and cardiac conduction, CARDAMYST may cause dizziness and/or syncope, especially in patients with a history of syncope and high-grade AV block or sinus node dysfunction, or those with a history of syncope during an episode of PSVT.
- In clinical trials, a small percentage of patients (0.4%) experienced clinically significant hypotension during test dosing prior to randomization, which precluded further participation in the study. Patients with a history of hypotensive episodes or those at increased risk for hemodynamic instability should be monitored appropriately when initiating CARDAMYST.
- If syncope occurs, patients should be placed in the recumbent position and treated supportively.
- Patients should be cautioned about these possible adverse effects and advised to administer CARDAMYST in a sitting position, and in a location where the risk of fall is minimal.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 5%) observed in randomized controlled studies are nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis.
Lactation: A lactating woman should pump and discard breastmilk for 12 hours after CARDAMYST administration in order to minimize exposure to a breastfed infant.