RIZATRIPTAN ODT 10MG 18 TAB
Generic: rizatriptan benzoate
RIZATRIPTAN ODT 10MG 18 TAB
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Identification
rizatriptan benzoate
RIZATRIPTAN BENZOATE
Bionpharma Inc.,
HUMAN PRESCRIPTION DRUG
Administration
TABLET, ORALLY DISINTEGRATING
ORAL
ANDA204722
Active Ingredients
| Ingredient | Strength |
|---|---|
| RIZATRIPTAN BENZOATE | 10 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE 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 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, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ] . Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of Rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache. Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use : Use only after clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults: 5 or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg ( 2.1 ) Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more ( 2.2 ) Adjust dose if coadministered with propranolol ( 2.4 ) 2.1 Dosing Information in Adults The 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 Adults Although 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 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, USP within 24 hours in pediatric patients 6 to 17 years of age have not been established. 2.3 Administration of Rizatriptan Benzoate Orally Disintegrating Tablets USP For rizatriptan benzoate orally disintegrating tablets, USP, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer carton and patients should not remove the blister from the outer carton 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. 2.4 Dosage Adjustment for Patients on Propranolol Adult Patients In adult patients taking propranolol, only the 5 mg dose of Rizatriptan benzoate orally disintegrating tablets, USP are recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Pediatric Patients For pediatric patients weighing ≥40 kg (88 lb), taking propranolol, only a single 5 mg dose of rizatriptan benzoate tablets, USP 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) ].
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions (5.1) ] . Arrhythmias [see Warnings and Precautions (5.2) ] . Chest and or Throat, Neck and/or Jaw Pain/ Tightness/ Pressure [see Warnings and Precautions (5.3) ] . Cerebrovascular Events [see Warnings and Precautions (5.4) ] . Other Vasospasm Reactions [see Warnings and Precautions (5.5) ] . Medication Overuse Headache [see Warnings and Precautions (5.6) ] . Serotonin Syndrome [see Warnings and Precautions (5.7) ] . Increase in Blood Pressure [see Warnings and Precautions (5.8) ] . The most common adverse reactions in adults were (incidence ≥ 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma, Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adults Incidence in Controlled Clinical Trials Adverse reactions to Rizatriptan benzoate were assessed in controlled clinical trials that included over 3,700 adult patients who received single or multiple doses ofRizatriptan benzoate. The most common adverse reactions during treatment with Rizatriptan benzoate (≥ 5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. These adverse reactions appeared to be dose relatedTable 1 lists the adverse reactions (incidence ≥ 2% and greater than placebo) after a single dose of Rizatriptan benzoate in adults. Table 1 lists the adverse reactions (incidence ≥ 2% and greater than placebo) after a single dose of Rizatriptan benzoate in adults Table 1: Incidence (≥2% and Greater than Placebo) of Adverse Reactions After a Single Dose of Rizatriptan Benzoate or Placebo in Adults % of Patients Rizatriptan Rizatriptan Benzoate Benzoate Placebo Adverse Reactions 5 mg 10 mg (N = 627) (N = 977) (N = 1167) Atypical Sensations 4 5 4 Paresthesia 3 4 ) 1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients General: Infrequent was facial edema. Rare were syncope and edema/swelling Atypical Sensations: Frequent were warm sensations Cardiovascular: Frequent was palpitation. Infrequent were tachycardia, cold extremities, and bradycardia Digestive: Frequent were diarrhea and vomiting. Infrequent were dyspepsia, tongue edema and abdominal distention Musculoskeletal: Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor. Infrequent were vertigo, insomnia, confusion/disorientation, gait abnormality, memory impairment, and agitation Respiratory: Frequent was dyspnea. Infrequent was pharyngeal edema Special Senses: Infrequent were blurred vision and tinnitus. Rare was eye swelling Skin and Skin Appendage: Frequent was flushing. Infrequent were sweating, pruritus, rash, and urticaria. Rare was erythema, hot flashes. The adverse reaction profile seen with Rizatriptan benzoate orally disintegrating tablets was similar to that seen with Rizatriptan benzoate tablets. Pediatric Patients 6 to 17 Years of Age Incidence in Controlled Clinical Trials in Pediatric Patients Adverse reactions to Rizatriptan benzoate were assessed in a controlled clinical trial in the acute treatment of migraines (Study 7) that included a total of 1382 pediatric patients 6-17 years of age, of which 977 (72%) administered at least one dose of study treatment (Rizatriptan benzoate and/or placebo) [see Clinical Studies (14.2) ] . The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received Rizatriptan benzoate to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults. Other Events Observed in Association with the Administration of Rizatriptan benzoate in Pediatric Patients In the following section, the frequencies of less commonly reported adverse events are presented. Because the reports include events observed in open studies, the role of Rizatriptan benzoate in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of pediatric patients 6 to 17 years of age who used Rizatriptan benzoate and reported an event divided by the total number of patients exposed to rizatriptan benzoate orally disintegrating tablets, USP (N=1068). All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in (>)1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients General: Frequent was fatigue. Ear and labyrinth disorders: Infrequent was hypoacusis. Gastrointestinal disorders: Frequent was abdominal discomfort. Nervous system disorders: Infrequent were coordination abnormal, disturbance in attention, and presyncope. Psychiatric disorders: Infrequent was hallucination. 6.2 Postmarketing Experience The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated include all except those already listed in other sections of the labeling or those too general to be informative. Because the reports cite events reported spontaneously from worldwide post-marketing experience, frequency of events and the role of Rizatriptan benzoate in their causation cannot be reliably determined. Neurological/Psychiatric: Seizure. General: Allergic conditions including anaphylaxis/ anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis [see Contraindications (4) ] . Special Senses: Dysgeusia.
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-related Events, and Cerebrovascular Events Inform patients that rizatriptan benzoate may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 )] . Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the use of rizatriptan benzoate or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs )[see Warnings and Precautions (5.7) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3) ] . Pregnancy Inform patients that rizatriptan benzoate should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1) ] . Lactation Advise patients to notify their healthcare provider if they are breast-feeding or plan to breastfeed [see Use in Specific Populations (8.2) ]. Ability to Perform Complex Tasks Since migraines or treatment with rizatriptan benzoate may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of rizatriptan benzoate. Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ] . Handling of Orally Disintegrating Tablets Packages Instruct patients not to remove the blister from a carton until ready to use the orally disintegrating tablet inside [see Dosage and Administration (2.3) ] . Patients with Phenylketonuria Inform phenylketonuric patients that rizatriptan benzoate orally disintegrating tablets contain phenylalanine (a component of aspartame). Each 5-mg orally disintegrating tablet contains 1.1 mg phenylalanine, and each 10-mg orally disintegrating tablet contains 2.1 mg phenylalanine [see Use in Specific Populations (8.6) ] . Rizatriptan Benzoate Orally Disintegrating Tablets are manufactured by: Panacea Biotec Pharma Limited Malpur, Baddi, Dist. Solan (H.P.) – 173205, India Distributed by: Bionpharma Inc., 600 Alexander Road, Suite 2-4B, Princeton, NJ 08540, USA. Artwork No.: PPIR017A Mfg.Lic.No: MNB/05/202 Revised: 10/2020
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.