Rizatriptan benzoate tablet

1 indications and usage

Rizatriptan benzoate is a serotonin (5-HT) 1B/1Dreceptor 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)

Spl unclassified section

Rizatriptan benzoate 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 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 tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
  • Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications ( 4)].
  • Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache.

2 dosage and administration

  • Adults: 5 mg 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 <40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) ( 2.2)
  • Adjust dose if co administered with propranolol ( 2.4)

3 dosage forms and strengths

  • Rizatriptan Benzoate Tablets, USP 5 mg and 10 mg ( 3)

Spl unclassified section

Rizatriptan benzoate tablets, USP:

  • 5 mg tablets are pink, oval-shaped tablets debossed with '462'on one side and "IG"on the other side.
  • 10 mg tablets are pink, oval-shaped tablets, debossed with '463'on one side and "IG"on the other side.

4 contraindications

  • History of ischemic heart disease or coronary artery vasospasm ( 4)
  • History of stroke or transient ischemic attack ( 4)
  • Peripheral vascular disease ( 4)
  • Ischemic bowel disease ( 4)
  • Uncontrolled hypertension ( 4)
  • Recent (within 24 hours) use of another 5-HT 1agonist (e.g., another triptan), or of an ergotamine-containing medication ( 4)
  • Hemiplegic or basilar migraine ( 4)
  • MAO-A inhibitor used in the past 2 weeks ( 4)
  • Hypersensitivity to rizatriptan benzoate ( 4)

Spl unclassified section

Rizatriptan benzoate tablets are contraindicated in patients with:

  • Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions ( 5.1)].
  • Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions ( 5.1)].
  • History of stroke or transient ischemic attack (TIA) [see Warnings and Precautions ( 5.4)].
  • Peripheral vascular disease (PVD) [see Warnings and Precautions ( 5.5)].
  • Ischemic bowel disease [see Warnings and Precautions ( 5.5)].
  • Uncontrolled hypertension [see Warnings and Precautions ( 5.8)].
  • Recent use (i.e., within 24 hours) of another 5-HT 1agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions ( 7.2and 7.3)].
  • Hemiplegic or basilar migraine.
  • Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)].
  • Hypersensitivity to rizatriptan benzoate tablets or rizatriptan benzoate orally disintegrating tablets (angioedema and anaphylaxis seen) [see Adverse Reactions ( 6.2)].

5 warnings and precautions

6 adverse reactions

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 Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Spl unclassified section

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)].

7 drug interactions

8 use in specific populations

  • Pregnancy: Based on animal data, may cause fetal harm ( 8.1)

8.1 pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Rizatriptan benzoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a general reproductive study in rats, birth weights and pre- and post-weaning weight gain were reduced in the offspring of females treated prior to and during mating and throughout gestation and lactation with doses of 10 mg/kg/day and 100 mg/kg/day. In a pre- and postnatal developmental toxicity study in rats, an increase in mortality of the offspring at birth and for the first three days after birth, a decrease in pre- and post-weaning weight gain, and decreased performance in a passive avoidance test (which indicates a decrease in learning capacity of the offspring) were observed at doses of 100 mg/kg/day and 250 mg/kg/day. The no-effect dose for all of these effects was 5 mg/kg/day, associated with a maternal plasma exposure (AUC) approximately 7.5 times that in humans receiving the MRDD. With doses of 100 mg/kg/day and 250 mg/kg/day, the decreases in average weight of both the male and female offspring persisted into adulthood. All effects on the offspring in both studies occurred in the absence of any apparent maternal toxicity.

In embryofetal development studies, no teratogenic effects were observed when pregnant rats and rabbits were administered doses of 100 mg/kg/day and 50 mg/kg/day, respectively, during organogenesis. Fetal weights were decreased in conjunction with decreased maternal weight gain at the highest doses tested. The developmental no-effect dose in these studies was 10 mg/kg/day in both rats and rabbits (maternal exposures approximately 15 times human exposure at the MRDD). Toxicokinetic studies demonstrated placental transfer of drug in both species.

8.3 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.

8.4 pediatric use

Safety and effectiveness in pediatric patients under 6 years of age have not been established.

The efficacy and safety of rizatriptan benzoate in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study [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.

8.5 geriatric use

Clinical studies of rizatriptan benzoate 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 benzoate [see Warnings and Precautions ( 5.1)].

10 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.

In a clinical pharmacology study in which 12 adult subjects received rizatriptan benzoate, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.

In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10 mg doses of rizatriptan benzoate orally disintegrating tablets within a 24 hour period. 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. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with rizatriptan benzoate. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.

The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

11 description

Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist.

Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:

Rizatriptan benzoate

Its molecular formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25C.

Rizatriptan benzoate 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 compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.

12 clinical pharmacology

12.1 mechanism of action

Rizatriptan binds with high affinity to human cloned 5-HT 1B/1Dreceptors. Rizatriptan presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1Dreceptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

12.3 pharmacokinetics

Absorption

Rizatriptan is completely absorbed following oral administration. The mean oral absolute bioavailability of the rizatriptan benzoate is about 45%, and mean peak plasma concentrations (C max) are reached in approximately 1 to 1.5 hours (T max). The presence of a migraine headache did not appear to affect the absorption or pharmacokinetics of rizatriptan. Food has no 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 C maxof rizatriptan benzoate were similar following administration of rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets, but the rate of absorption is somewhat slower with rizatriptan benzoate orally disintegrating tablets, with T maxdelayed by up to 0.7 hour. AUC of rizatriptan benzoate is approximately 30% higher in females than in males. No accumulation occurred on multiple dosing.

Distribution

The mean volume of distribution is approximately 140 liters in male subjects and 110 liters in female subjects. Rizatriptan benzoate is minimally bound (14%) to plasma proteins.

Metabolism

The primary route of rizatriptan benzoate metabolism is via oxidative deamination by monoamine oxidase-A (MAO-A) to the indole acetic acid metabolite, which is not active at the 5-HT 1B/1Dreceptor. N-monodesmethyl-rizatriptan, a metabolite with activity similar to that of parent compound at the 5-HT 1B/1Dreceptor, is formed to a minor degree. Plasma concentrations of N-monodesmethyl-rizatriptan are approximately 14% of those of parent compound, and it is eliminated at a similar rate. Other minor metabolites, the N-oxide, the 6- hydroxy compound, and the sulfate conjugate of the 6-hydroxy metabolite are not active at the 5-HT 1B/1Dreceptor.

Elimination

The total radioactivity of the administered dose recovered over 120 hours in urine and feces was 82% and 12%, respectively, following a single 10 mg oral administration of 14C-rizatriptan. Following oral administration of 14C-rizatriptan, rizatriptan accounted for about 17% of circulating plasma radioactivity. 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.

The plasma half-life of rizatriptan in males and females averages 2 to 3 hours.

Cytochrome P450 Isoforms

Rizatriptan benzoate is not an inhibitor of the activities of human liver cytochrome P450 isoforms 3A4/5, 1A2, 2C9, 2C19, or 2E1; rizatriptan is a competitive inhibitor (K i=1400 nM) of cytochrome P450 2D6, but only at high, clinically irrelevant concentrations.

Special Populations

Geriatric:Rizatriptan pharmacokinetics in healthy elderly non-migraineur volunteers (age 65 to 77 years) were similar to those in younger non-migraineur volunteers (age 18 to 45 years).

Pediatric:The pharmacokinetics of rizatriptan was determined in pediatric migraineurs 6 to 17 years of age. Exposures following single dose administration of 5 mg rizatriptan benzoate orally disintegrating tablets to pediatric patients weighing 20 to 39 kg (44 to 87 lb) or 10 mg rizatripan benzoate orally disintegrating tablets to pediatric patients weighing 40 kg (88 lb) were similar to those observed following single dose administration of 10 mg rizatriptan benzoate orally disintegrating tablets to adults

Gender:The mean AUC 0-and C maxof rizatriptan (10 mg orally) were about 30% and 11% higher in females as compared to males, respectively, while T maxoccurred at approximately the same time.

Hepatic impairment:Following oral administration in patients with hepatic impairment caused by mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of rizatriptan were similar in patients with mild hepatic insufficiency compared to a control group of subjects with normal hepatic function; plasma concentrations of rizatriptan were approximately 30% greater in patients with moderate hepatic insufficiency.

Renal impairment:In patients with renal impairment (creatinine clearance 10 to 60 mL/min/1.73 m 2), the AUC 0-of rizatriptan was not significantly different from that in subjects with normal renal function. In hemodialysis patients, (creatinine clearance <2 mL/min/1.73 m 2), however, the AUC for rizatriptan was approximately 44% greater than that in patients with normal renal function.

Race:Pharmacokinetic data revealed no significant differences between African American and Caucasian subjects.

Drug Interactions

[See also Drug Interactions ( 7).]

Monoamine oxidase inhibitors:Rizatriptan is principally metabolized via monoamine oxidase, 'A' subtype (MAO-A). Plasma concentrations of rizatriptan may be increased by drugs that are selective MAO-A inhibitors (e.g., moclobemide) or nonselective MAO inhibitors [type A and B] (e.g., isocarboxazid, phenelzine, tranylcypromine, and pargyline). In a drug interaction study, when rizatriptan 10 mg was administered to subjects (n=12) receiving concomitant therapy with the selective, reversible MAO-A inhibitor, moclobemide 150 mg t.i.d., there were mean increases in rizatriptan AUC and C maxof 119% and 41% respectively; and the AUC of the active N-monodesmethyl metabolite of rizatriptan was increased more than 400%. 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 ( 7.5)].

Propranolol:In a study of concurrent administration of propranolol 240 mg/day and a single dose of rizatriptan 10 mg in healthy adult subjects (n=11), mean plasma AUC for rizatriptan was increased by 70% during propranolol administration, and a four-fold increase was observed in one subject. The AUC of the active N-monodesmethyl metabolite of rizatriptan was not affected by propranolol [see Dosage and Administration ( 2.4) and Drug Interactions ( 7.1)].

Nadolol/Metoprolol:In a drug interactions study, effects of multiple doses of nadolol 80 mg or metoprolol 100 mg every 12 hours on the pharmacokinetics of a single dose of 10 mg rizatriptan were evaluated in healthy subjects (n=12). No pharmacokinetic interactions were observed.

Paroxetine:In a study of the interaction between the selective serotonin reuptake inhibitor (SSRI) paroxetine 20 mg/day for two weeks and a single dose of rizatriptan 10 mg in healthy subjects (n=12), neither the plasma concentrations of rizatriptan nor its safety profile were affected by paroxetine [see Warnings and Precautions ( 5.7), Drug Interactions ( 7.4), and Patient Counseling Information ( 17)].

Oral contraceptives:In a study of concurrent administration of an oral contraceptive during 6 days of administration of rizatriptan benzoate (10 to 30 mg/day) in healthy female volunteers (n=18), rizatriptan did not affect plasma concentrations of ethinyl estradiol or norethindrone.

13 nonclinical toxicology

14 clinical studies

16 how supplied/storage and handling

Product: 63629-7433

NDC: 63629-7433-1 10 TABLET in a BOTTLE

NDC: 63629-7433-2 6 TABLET in a BOTTLE

NDC: 63629-7433-3 90 TABLET in a BOTTLE

NDC: 63629-7433-4 9 TABLET in a BOTTLE

NDC: 63629-7433-5 30 TABLET in a BOTTLE

Patient counseling information

See 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 tablets 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 tablets 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 tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations ( 8.1)].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.3)].

Ability To Perform Complex Tasks

Since migraines or treatment with rizatriptan benzoate tablets may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of rizatriptan benzoate tablets.

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)].

Revised: 07/2016

17 patient counseling information

RIZATRIPTAN BENZOATE TABLETS, USP

(rye'' za trip' tan ben' zoe ate).

5 mg and 10 mg

Read this Patient Information before you start taking rizatriptan benzoate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Unless otherwise stated, the information in this Patient Information leaflet applies to both rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets.

What is rizatriptan benzoate?

Rizatriptan benzoate is a prescription medicine that belongs to a class of medicines called Triptans.

Rizatriptan benzoate is available as a traditional tablet and as an orally disintegrating tablet.

Rizatriptan benzoate tablets are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age.

Rizatriptan benzoate is not to be used to prevent migraine attacks.

Rizatriptan benzoate is not for the treatment of hemiplegic or basilar migraines.

It is not known if rizatriptan benzoate is safe and effective for the treatment of cluster headaches.

It is not known if taking more than 1 dose of rizatriptan benzoate in 24 hours is safe and effective in children 6 to 17 years of age.

It is not known if rizatriptan benzoate is safe and effective in children under 6 years of age

Who should not take rizatriptan benzoate tablets?

Do not take rizatriptan benzoate tablets if you:

  • have or have had heart problems
  • have or have had a stroke or a transient ischemic attack (TIA)
  • have or have had blood vessel problems including ischemic bowel disease
  • have uncontrolled high blood pressure
  • have taken other Triptan medicines in the last 24 hours
  • have taken ergot-containing medicines in the last 24 hours
  • have hemiplegic or basilar migraines
  • take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks
  • are allergic to rizatriptan benzoate or any of the ingredients in rizatriptan benzoate tablets. See the end of this leaflet for a complete list of ingredients in rizatriptan benzoate tablets.

Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines.

What should I tell my doctor before taking rizatriptan benzoate tablets?

Before you take rizatriptan benzoate tablets,tell your doctor if you:

  • have or have had heart problems, high blood pressure, chest pain, or shortness of breath
  • have any risk factors for heart problems or blood vessel problems such as:
    • high blood pressure
    • high cholesterol
    • smoking
    • obesity
    • diabetes
    • family history of heart problems
    • you are post-menopausal
    • you are a male over 40
  • have kidney or liver problems
  • have any other medical condition
  • are pregnant or plan to become pregnant. It is not known if rizatriptan benzoate will harm your unborn baby. If you become pregnant while taking rizatriptan benzoate tablets, talk to your healthcare provider.
  • are breastfeeding or plan to breastfeed. It is not known if rizatriptan benzoate passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take rizatriptan benzoate tablets.

Tell your doctor about all the medicines you take,including prescription and nonprescription medicines, vitamins, and herbal supplements.

Rizatriptan benzoate tablets and other medicines may affect each other causing side effects. Rizatriptan benzoate tablets may affect the way other medicines work, and other medicines may affect how rizatriptan benzoate tablets work.

Especially tell your doctor if you take:

  • propranolol containing medicines such as Inderal ®, Inderal ®LA, or Innopran ®XL
  • medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take rizatriptan benzoate tablets?

  • Take rizatriptan benzoate tablets exactly as your doctor tells you to take it.
  • Your doctor will tell you how much rizatriptan benzoate to take and when to take it.
  • If your headache comes back after your first rizatriptan benzoate tablets dose.

For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 30 mg of rizatriptan benzoate tablets in a 24-hour period (for example, do not take more than three 10 mg tablets in a 24-hour period)

For children 6 to 17 years of age: It is not known if taking more than 1 dose of rizatriptan benzoate tablets in 24 hours is safe and effective. Talk to your doctor about what to do if your headache does not go away or comes back.

  • If you take too much rizatriptan benzoate, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking rizatriptan benzoate tablets?

Rizatriptan benzoate tablets may cause dizziness, weakness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.

What are the possible side effects of rizatriptan benzoate tablets?

Rizatriptan benzoate tablets may cause serious side effects.Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects of rizatriptan benzoate tablets including:

  • Heart attack. Symptoms of heart attack may include:
    • chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
    • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
    • pain or discomfort in your arms, back, neck, jaw or stomach
    • shortness of breath with or without chest discomfort
    • breaking out in a cold sweat
    • nausea or vomiting
    • feeling lightheaded
  • Stroke.Symptoms of a stroke may include the following sudden symptoms:
    • numbness or weakness in your face, arm or leg, especially on one side of your body
    • confusion, problems speaking or understanding
    • problems seeing in one or both of your eyes
    • problems walking, dizziness, loss of balance or coordination
    • severe headache with no known cause
  • Blood vessel problems.Symptoms of blood vessel problems may include:
    • stomach pain
    • blood diarrhea
    • vision problems
    • coldness and numbness of hands and feet
  • serotonin syndrome.A condition called serotonin syndrome can happen when Triptan medicines such as rizatriptan benzoate tablets are taken with certain other medicines. Symptoms of serotonin syndrome may include:
    • agitation
    • hallucinations
    • coma
    • fast heartbeat
    • fast changes in your blood pressure
    • increased body temperature
    • muscle spasm
    • loss of coordination
    • nausea, vomiting or diarrhea
  • increased blood pressure

The most common side effects of rizatriptan benzoate tablets in adults include:

  • Feeling sleepy or tired
  • pain or pressure in your chest or throat
  • dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away.

If you take rizatriptan benzoate tablets too often, this may result in you getting chronic headaches. In such cases, you should contact your doctor, as you may have to stop taking rizatriptan benzoate tablets.

These are not all the possible side effects of rizatriptan benzoate tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store rizatriptan benzoate tablets?

  • Store rizatriptan benzoate tablets at 68F to 77F (20C to 25C). [See USP Controlled Room Temperature]
  • Safely throw away medicine that is out of date or no longer needed.

Keep rizatriptan benzoate tablets and all medicines out of the reach of children.

General Information about the safe and effective use of rizatriptan benzoate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use rizatriptan benzoate for a condition for which it was not prescribed. Do not give rizatriptan benzoate tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about rizatriptan benzoate tablets. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about rizatriptan benzoate tablets that is written for health professionals.

For more information about rizatriptan benzoate call Cipla Ltd. at 1-866-604-3268.

What are the ingredients in rizatriptan benzoate tablets?

Active ingredient in rizatriptan benzoate tablets:

Rizatriptan benzoate, USP.

Inactive ingredients in rizatriptan benzoate tablets:lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch (maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.

*All brand names mentioned are registered trademarks of their respective owners and are not of Cipla Limited.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Cipla USA Inc.,

9100 S. Dadeland Blvd., Suite 1500

Miami, FL 33156

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788

Revised: 07/2016

Spl patient package insert section

Ingredients and appearance - Product information

Rizatriptan benzoate tablet- Rizatriptan benzoate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63629-7433
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Rizatriptan benzoate ( UNII: WR978S7QHH)( Rizatriptan - UNII: 51086HBW8G ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Ferric oxide red ( UNII: 1K09F3G675)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color PINK Shape OVAL
Size 12 mm Score 1
Imprint Code IG;463

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 63629-7433-1 10 in 1 BOTTLE 2017/11/07
2 NDC: 63629-7433-2 6 in 1 BOTTLE 2017/11/07
3 NDC: 63629-7433-3 90 in 1 BOTTLE 2017/11/07
4 NDC: 63629-7433-4 9 in 1 BOTTLE 2017/11/07
5 NDC: 63629-7433-5 30 in 1 BOTTLE 2017/11/07

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA204339 USA 2017/11/07

Labeler - Bryant Ranch Prepack( 171714327)

Establishment

Name ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK( 63629-7433), RELABEL( 63629-7433)

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