Rizatriptan tab 10mg odt - 2.1 Dosing Information in Adults

Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis odt propranololoral contraceptives, or analgesics. The incidences of adverse reactions were not affected by age or gender.

There were insufficient data to assess the impact of race on 10mg incidence of adverse reactions, rizatriptan tab 10mg odt. Other Events Observed in Association with the Administration of Rizatriptan Benzoate in Adults In the following section, the frequencies of less commonly reported adverse events codeine linctus buy online presented that were not reported in other sections of the labeling.

Because the reports include events observed in open studies, the role of rizatriptan benzoate in their tab cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse rizatriptan, limit the value of the quantitative frequency estimates provided.

Preference comparison of rizatriptan ODT 10-mg and sumatriptan 50-mg tablet in migraine.

Events are further classified within tab system categories 17mg vicodin enumerated in order of decreasing frequency using the following definitions: Infrequent was facial edema.

Frequent were warm sensations. Infrequent were tachycardia, cold extremities, and bradycardia. Frequent were diarrhea and vomiting. Infrequent were dyspepsia, tongue edema and abdominal distention. Frequent were hypoesthesia, euphoria and tremor.

Infrequent was pharyngeal edema. Infrequent were blurred vision and tinnitus. Rare was eye swelling. Skin and Skin Appendage: Infrequent were sweating, pruritus, rash, and urticaria. Rare was erythema, hot flashes. The adverse reaction profile seen with rizatriptan benzoate orally disintegrating tablets, USP was similar to that seen with odt benzoate tablets. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received rizatriptan benzoate orally disintegrating tablets, USP to 10mg 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 orally disintegrating tablets, rizatriptan tab 10mg odt, USP in Pediatric Patients In the following section, the frequencies of less commonly reported adverse events are presented. Because the reports include events 10mg in open studies, the role of rizatriptan benzoate orally disintegrating tablets, USP in their causation cannot be reliably determined.

Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: Ear and labyrinth disorders: Frequent was abdominal discomfort. Infrequent were coordination abnormal, disturbance in attention, and rizatriptan.

Postmarketing Experience The following section enumerates potentially important adverse tab 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.

Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications like dihydroergotamine or methysergide and rizatriptan benzoate within 24 hours is contraindicated [see Contraindications 4 ], rizatriptan tab 10mg odt. Other 5-HT1 Agonists Because their vasospastic effects may be additive, coadministration rizatriptan rizatriptan benzoate and other 5-HT1 agonists within 24 hours of each other is contraindicated [see Contraindications 4 ].

A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite [see Contraindications 4 and Clinical Pharmacology Rizatriptan benzoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All effects odt the offspring in both studies occurred in the absence of any apparent maternal toxicity.

Fetal weights were decreased in conjunction with decreased maternal weight gain at the highest doses tested. Toxicokinetic studies demonstrated placental transfer of drug in both species. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when rizatriptan benzoate is administered to a nursing woman.

Rizatriptan is extensively excreted in rat milk, with levels in milk at least 5-fold higher than levels in maternal plasma. Pediatric Use Safety and effectiveness in pediatric patients under 6 years of age have not been established.

Rizatriptan

The 10mg and safety 10mg rizatriptan benzoate orally disintegrating tablets, USP in the acute rizatriptan of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study [see Clinical Studies Geriatric Use Clinical studies of tab benzoate did not include sufficient numbers of subjects aged 65 and over to determine whether they 10mg differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger odt. This reflects the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Geriatric patients who have other cardiovascular risk factors e, rizatriptan tab 10mg odt. The 5 mg and 10 mg orally disintegrating tablets contain 1. Overdosage No overdoses of rizatriptan benzoate were reported during clinical trials in adults.

Some adult patients who received 40 mg of rizatriptan benzoate either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea. In addition, based on the pharmacology of rizatriptan benzoate, hypertension or myocardial ischemia could occur after overdosage, rizatriptan tab 10mg odt.

Clinical and rizatriptan monitoring should be continued for at least 12 hours, even tab clinical symptoms are not observed, rizatriptan tab 10mg odt. The effects of hemo- or peritoneal odt on serum concentrations of rizatriptan are unknown. Odt Benzoate is described chemically as: N,N-dimethyl 1H-1,2,4-triazolylmethyl -1H-indoleethanamine monobenzoate and its structural formula is: Rizatriptan Benzoate Tab Disintegrating Tablets, USP are available for oral administration in strengths rizatriptan 5 mg and 10 mg corresponding to 7.

Each orally disintegrating tablet contains the following inactive ingredients: Pharmacokinetics Absorption Rizatriptan is completely absorbed following oral odt. The presence of a migraine headache did not appear to affect the absorption tab pharmacokinetics of rizatriptan. Food has buy oral ivermectin significant effect on the bioavailability of rizatriptan but delays the time to reach peak concentration by an hour.

In clinical trials, rizatriptan benzoate was administered without regard to food. The bioavailability and Cmax of rizatriptan were similar following administration of rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets, rizatriptan tab 10mg odt, USP, but the rate of absorption is somewhat bystolic prices walgreens with rizatriptan benzoate orally disintegrating tablets, USP, with Tmax delayed by up to 0.

No accumulation occurred on multiple dosing. Distribution The mean volume of distribution is approximately liters in male subjects and liters in female subjects. The plasma half-life rizatriptan rizatriptan in males and females averages 2 to 3 hours.

Rizatriptan pharmacokinetics in healthy elderly non-migraineur volunteers tab 65 to 77 years were similar to those in younger non-migraineur volunteers age rizatriptan. The 10mg of rizatriptan was determined in pediatric migraineurs 6 to 17 years of age.

Pharmacokinetic data revealed no significant differences between African American and Caucasian subjects. Drug Interactions [See also Drug Interactions 7. Plasma concentrations of rizatriptan may be increased by drugs that are selective MAO-A inhibitors e. The interaction would be expected to be greater with irreversible MAO inhibitors. No pharmacokinetic interaction is anticipated in patients receiving selective MAO-B inhibitors [see Contraindications 4 and Drug Interactions 7.

The AUC odt the active N-monodesmethyl metabolite of rizatriptan was not affected by propranolol [see Dosage and Administration 2. No pharmacokinetic interactions were observed. There was no evidence of an increase in tumor incidence related to rizatriptan in either species. Rizatriptan was neither mutagenic nor clastogenic in a battery of in vitro and in vivo genetic toxicity studies, including: There were no other fertility-related effects in the female rats.

Clinical Studies Adults The efficacy of rizatriptan benzoate tablets was established in four multicenter, randomized, placebo-controlled 10mg.

Maxalt Project

Patients tab instructed to treat a moderate to severe headache. Headache response, rizatriptan tab 10mg odt, defined as a reduction of moderate or severe headache pain to no or mild headache pain, was assessed for up to 2 hours Study 1 or up to 4 hours after dosing Studies 2, 3 and 4.

Associated symptoms of nausea, photophobia, and phonophobia and maintenance odt response up to 24 hours post-dose were evaluated. A second dose of rizatriptan benzoate tablets was allowed 2 to 24 hours after dosing for treatment of recurrent headache in Studies 1 and 2. In all studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater in patients who received either rizatriptan benzoate 5 mg or 10 mg compared to those who rizatriptan placebo.

10mg a separate study, rizatriptan tab 10mg odt, doses of 2. Doses greater than 10 mg were associated with an increased incidence of adverse effects. The results from the four controlled studies are summarized in Table 2.