A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Maxalt Indications, Dosage, Storage, Stability - Rizatriptan
Maxalt Indications, Dosage, Storage, Stability - Rizatriptan
INDICATIONS
MAXALT is indicated for the acute
treatment of migraine
attacks with or without aura
in adults. MAXALT is not intended for the prophylactic therapy of
migraine or for use
in the management of hemiplegic
or basilar migraine (see CONTRAINDICATIONS
).
Safety and effectiveness
of MAXALT has not been established for cluster headache, which is
present in an older,
predominantly male population.
DOSAGE AND ADMINISTRATION
In controlled clinical
trials, single doses of 5 and 10 mg
of MAXALT Tablets or MAXALT-MLT were effective for the acute
treatment of migraines
in adults. There is evidence
that the 10-mg dose may
provide a greater effect than the 5-mg dose
(see CLINICAL PHARMACOLOGY,
Clinical Studies). Individuals may vary in response to doses
of MAXALT Tablets. The choice of dose
should therefore be made on an individual basis, weighing the possible
benefit of the 10-mg
dose with the potential
risk for increased adverse
events.
Redosing: Doses should be separated by at least 2
hours; no more than 30 mg
should be taken in any 24-hour period. The safety of treating, on
average, more than four
headaches in a 30-day period
has not been established.
Patients receiving propranolol: In
patients receiving propranolol, the 5-mg dose
of MAXALT should be used, up to a maximum
of 3 doses in any 24-hour period. (See CLINICAL
PHARMACOLOGY, Drug Interactions)
For MAXALT-MLT Orally Disintegrating Tablets, administration
with liquid is not necessary. The orally disintegrating tablet
is packaged in a blister within an outer aluminum
pouch. Patients should be instructed not to remove the blister
from the outer pouch until
just prior to dosing. The blister pack should then be peeled open
with dry hands and the orally disintegrating tablet placed on the
tongue, where it will dissolve
and be swallowed with the saliva.
HOW SUPPLIED
No. 3732 - MAXALT Tablets, 5 mg, are pale pink, capsule-shaped,
compressed tablets coded MRK on one side
and 266 on the other. They are supplied as follows:
- NDC 0006-0266-74, bottles of 500
- NDC 0006-0266-06, unit
of use carrying case
of 6 tablets.
No. 3733 - MAXALT Tablets, 10 mg, are pale pink, capsule-shaped,
compressed tablets coded MAXALT on one side
and MRK 267 on the other. They are supplied as follows:
- NDC 0006-0267-74, bottles of 500
- NDC 0006-0267-06, unit
of use carrying case
of 6 tablets.
No. 3800 - MAXALT-MLT Orally Disintegrating Tablets, 5 mg, are
white to off-white, round
lyophilized orally disintegrating tablets debossed with a modified
triangle on one side,
and measuring 10.0-11.5 mm
(side-to-side) with a peppermint flavor. Each orally disintegrating
tablet is individually
packaged in a blister
inside an aluminum
pouch (sachet).They are
supplied as follows:
- NDC 0006-3800-06, 2 x unit
of use carrying case
of 3 orally disintegrating tablets (6 tablets total).
No. 3801 - MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are
white to off-white, round
lyophilized orally disintegrating tablets debossed with a modified
square on one side, and measuring 12.0-13.8 mm
(side-to-side) with a peppermint flavor. Each orally disintegrating
tablet is individually
packaged in a blister
inside an aluminum
pouch (sachet). They are
supplied as follows:
- NDC 0006-3801-06, 2 x unit
of use carrying case
of 3 orally disintegrating tablets (6 tablets total).
Storage
Store MAXALT Tablets at room
temperature, 15-30°C (59-86°F). Dispense in a tight container,
if product is subdivided.
Store MAXALT-MLT Orally Disintegrating Tablets at room
temperature, 15-30°C (59-86°F).
The patient should
be instructed not to remove the blister
from the outer aluminum
pouch until the patient
is ready to consume the orally disintegrating tablet inside.
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