Rizatriptan SmeltTab Mylan

Uses

Rizatriptan SmeltTab Mylan Benzoate is used for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.

Rizatriptan SmeltTab Mylan is also used to associated treatment for these conditions: Migraine with acute onset aura, Acute Migraine without aura

How Rizatriptan SmeltTab Mylan works

Three distinct pharmacological actions have been implicated in the antimigraine effect of the triptans: (1) stimulation of presynaptic 5-HT1D receptors, which serves to inhibit both dural vasodilation and inflammation; (2) direct inhibition of trigeminal nuclei cell excitability via 5-HT1B/1D receptor agonism in the brainstem and (3) vasoconstriction of meningeal, dural, cerebral or pial vessels as a result of vascular 5-HT1B receptor agonism.

Dosage

Rizatriptan SmeltTab Mylan dosage

Dosing Information In Adults: The recommended starting dose of Rizatriptan SmeltTab Mylan Benzoate 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.

Redosing In Adults: Although the effectiveness of a second dose or subsequent doses has not been established in placebocontrolled 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.

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 SmeltTab Mylan Benzoate is 5 mg in patients weighing less than 40 kg, and 10 mg in patients weighing 40 kg or more.

The efficacy and safety of treatment with more than one dose of Rizatriptan SmeltTab Mylan Benzoate within 24 hours in pediatric patients 6 to 17 years of age have not been established.

Dosage Adjustment For Patients On Propranolol: Sections or subsections omitted from the full prescribing information are not listed.

• Adult Patients: In adult patients taking propranolol, only the 5-mg dose of Rizatriptan SmeltTab Mylan Benzoate is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg)
• Pediatric Patients: For pediatric patients weighing 40 kg or more, taking propranolol, only a single 5-mg dose of Rizatriptan SmeltTab Mylan Benzoate is recommended (maximum dose of 5 mg in a 24-hour period). Rizatriptan SmeltTab Mylan Benzoate should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg

Administration of Rizatriptan SmeltTab Mylan Benzoate Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not 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.

Side Effects

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina
• Arrhythmias
• Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure
• Cerebrovascular Events
• Other Vasospasm Reactions
• Medication Overuse Headache
• Serotonin Syndrome
• Increase in Blood Pressure

Toxicity

Symptoms of overdose include dizziness, fainting, heart and blood vessel problems, high blood pressure, loss of bowel and bladder control, slow heartbeat, and vomiting.

Precaution

Elderly; mild to moderate hepatic or renal impairment; coronary artery disease; pregnancy, lactation. May cause drowsiness. History of seizures. Ensure an interval of at least 24 hr after stopping an ergotamine compound and starting a serotonin (5-HT1) agonist.

Interaction

Propranolol: The dose of Rizatriptan SmeltTab Mylan should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70%

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 SmeltTab Mylan within 24 hours is contraindicated

Other 5-HT1 Agonists: Because their vasospastic effects may be additive, co-administration of Rizatriptan SmeltTab Mylan and other 5-HT1 agonists within 24 hours of each other is contraindicated

SSRIs /SNRIs And Serotonin Syndrome: Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

Monoamine Oxidase Inhibitors: Rizatriptan SmeltTab Mylan is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite

Food Interaction

• Take with or without food. However, the onset of action may be delayed by approximately 1 hour when taken with food.

Rizatriptan SmeltTab Mylan Cholesterol interaction

[Major] The group of drugs known as 5-hydroxytryptamine1 receptor (5-HT1) agonists can cause vasospastic reactions, including coronary vasospasm, peripheral vascular ischemia, and colonic ischemia.

Rarely, serious adverse cardiac events including acute myocardial infarction, arrhythmia, cardiac arrest, and death have been reported within a few hours following the administration of 5-HT1 agonists, in some cases even in patients with no prior history or findings of coronary artery disease (CAD).

Significant elevation in blood pressure, including hypertensive crisis, has also been reported on rare occasions in patients with and without a history of hypertension, as have transient increases in blood pressure and peripheral vascular resistance.

In general, patients with potentially unrecognized CAD as predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, tobacco use, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) should not be administered 5-HT1 agonists unless a cardiovascular evaluation provides satisfactory clinical evidence indicating the lack of CAD, ischemic heart disease, or other significant underlying cardiovascular disease.

As a precaution, the manufacturers recommend that the first dose be administered under medical surveillance in such patients, and that electrocardiographic monitoring be considered during the interval immediately following administration to help detect any asymptomatic cardiac ischemia that may occur.

Periodic cardiovascular evaluations should be performed during intermittent, long-term use.

Rizatriptan SmeltTab Mylan Drug Interaction

Major: duloxetine, ondansetronModerate: acetaminophen / hydrocodoneUnknown: amphetamine / dextroamphetamine, erenumab, diphenhydramine, galcanezumab, omega-3 polyunsaturated fatty acids, fluticasone nasal, pregabalin, albuterol, montelukast, topiramate, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol, lisdexamfetamine, alprazolam, cetirizine

Rizatriptan SmeltTab Mylan Disease Interaction

Major: CAD risk factors, cardiovascular disease, liver disease, migrainesModerate: PKU, renal dysfunction

Volume of Distribution

• 140 L [male]
• 110 L [female]

Elimination Route

Rapid following oral administration. Bioavailability is 45%. Food has no effect on the bioavailability of rizatriptan. However, administering rizatriptan with food will delay by 1 hour the time to reach peak plasma concentration. The rate of absorption is not affected by the presence of a migraine attack.

Half Life

2-3 hours

Elimination Route

Approximately 14% of an oral dose is excreted in urine as unchanged rizatriptan while 51% is excreted as indole acetic acid metabolite, indicating substantial first pass metabolism.

Pregnancy & Breastfeeding use

Pregnancy: Inform patients that Rizatriptan SmeltTab Mylan Benzoate should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

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 SmeltTab Mylan Benzoate is administered to a nursing woman. Rizatriptan SmeltTab Mylan is extensively excreted in rat milk, with levels in milk at least 5-fold higher than levels in maternal plasma.

Contraindication

Rizatriptan SmeltTab Mylan Benzoate is contraindicated in patients with:

• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease
• Coronary artery vasospasm including Prinzmetal's angina
• History of stroke or transient ischemic attack (TIA)
• Peripheral vascular disease (PVD)
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide)
• Hemiplegic or basilar migraine
• Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor
• Hypersensitivity to Rizatriptan SmeltTab Mylan Benzoate (angioedema and anaphylaxisseen)

Special Warning

Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established. The efficacy and safety of Rizatriptan SmeltTab Mylan in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received Rizatriptan SmeltTab Mylan to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.

Geriatric Use: Clinical studies of Rizatriptan SmeltTab Mylan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Although the pharmacokinetics of rizatriptan were similar in elderly (aged ≥65 years) and in younger adults (n=17), in general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range. 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.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation prior to receiving Rizatriptan SmeltTab Mylan

Renal Impairment: For mild-moderate impairment, initate with 5 mg. Further dose of 5 mg may be taken after an interval of at least 2 hr. Max: 10 mg/24 hr. Avoid in severe impairment.

Hepatic Impairment: For mild-moderate impairment, initate with 5 mg. Further dose of 5 mg may be taken after an interval of at least 2 hr. Max: 10 mg/24 hr. Avoid in severe impairment.

Acute Overdose

May cause hypertension and CV symptoms. Gastric lavage using activated charcoal may be considered. Monitor ECG and clinical status of the patient.

Storage Condition

Store at 15-30° C.

Innovators Monograph

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