Administration Instructions: How to Use MIGRANAL Nasal Spray1
Important: Do not assemble the nasal spray pump until the time of use. Once it has been opened, it must be discarded after 8 hours.
Lift tab to bend back blue cover (Figure 1). In one piece, completely remove the blue cover and metal seal in a circular motion (Figure 2). Keeping the vial upright, remove the rubber stopper (Figure 3). Set vial aside.
Remove plastic cover from bottom of pump unit (Figure 4). Insert spray pump into vial and turn clockwise until securely fastened (Figure 5).
Remove cap from spray unit (Figure 6). Holding the vial as shown in Figure 7, point the nasal sprayer away from face and pump 4 times before using (Figure 7). DO NOT PUMP MORE THAN 4 TIMES. (Although some medication will spray out, there is enough medication in each vial to allow you to prepare your nasal spray pump properly and still receive a full treatment of MIGRANAL.)
Spray once into each nostril (Figure 8). Do not tilt head back or sniff through your nose while spraying or immediately after. Wait 15 minutes. Spray once again into each nostril.
After completing these instructions, carefully dispose of the nasal spray pump with vial.
Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Migranal Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.