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Uses
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use:
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- Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks.
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- Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
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- Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
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- Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
History
There is currently no drug history available for this drug.
Other Information
Rizatriptan benzoate orally disintegrating tablets contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
Rizatriptan benzoate is described chemically as: N,N-Dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine benzoate and its structural formula is:
Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to cream color powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
Rizatriptan benzoate orally disintegrating tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: aspartame, crospovidone, mannitol, magnesium stearate, peppermint flavor, silicon dioxide and sorbitol.
Sources
Gent-l-tip Manufacturers
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Chester Packaging
Gent-l-tip | Mylan Pharmaceuticals Inc.
2.1 Dosing Information in AdultsThe recommended starting dose of rizatriptan benzoate orally disintegrating tablets is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10 mg dose may provide a greater effect than the 5 mg dose, but may have a greater risk of adverse reactions [see Clinical Studies (14.1)].
Redosing in AdultsAlthough the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.
2.2 Dosing Information in Pediatric Patients (Age 6 to 17 Years)Dosing in pediatric patients is based on the patient's body weight. The recommended dose of rizatriptan benzoate orally disintegrating tablets is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more.
The efficacy and safety of treatment with more than one dose of rizatriptan benzoate orally disintegrating tablets within 24 hours in pediatric patients 6 to 17 years of age have not been established.
2.3 Administration of Rizatriptan Benzoate Orally Disintegrating TabletsFor rizatriptan benzoate orally disintegrating tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a bottle and patients should not remove the tablet from the bottle until just prior to dosing. The bottle should then be opened with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.
2.4 Dosage Adjustment for Patients on Propranolol Adult PatientsIn adult patients taking propranolol, only the 5 mg dose of rizatriptan benzoate orally disintegrating tablets is recommended, up to a maximum of three doses in any 24-hour period (15 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Pediatric PatientsFor pediatric patients weighing ≥ 40 kg (88 lb) taking propranolol, only a single 5 mg dose of rizatriptan benzoate orally disintegrating tablets is recommended (maximum dose of 5 mg in a 24-hour period). Rizatriptan benzoate orally disintegrating tablets should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 lb) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
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Chester Packaging
Gent-l-tip | Chester Packaging
Single daily dose
adults & children
12 years and over
1 bottlechildren 2 to under
12 years
one-half bottlechildren under
2 years
DO NOT USEHow to use this enema:
REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.
Positioning:
Left-side position: Lie on left side with knee bent and arms at rest.
Knee-chest position:
Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
Administering enema:
With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus. Do not force the enema tip into rectum as this can cause injury. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. Remove enema tip from rectum. Retain enema in accordance with doctor's instructions.
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