Rizatriptan (Page 6 of 6)

14.2 Pediatric Patients 6 to 17 Years of Age

The efficacy of rizatriptan benzoate orally disintegrating tablets in pediatric patients 6 to 17 years was evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial (Study 7). Patients had to have at least a 6-month history of migraine attacks (with or without aura) usually lasting 3 hours or more (when untreated). The patient population was historically non-responsive to NSAIDs and acetaminophen therapy.
Patients were instructed to treat a single migraine attack with headache pain of moderate to severe intensity. The treatment phase of the study had two stages. Stage 1 was used to identify placebo non-responders, who then entered into Stage 2, in which patients were randomized to rizatriptan benzoate orally disintegrating tablets or placebo. Using a weight-based dosing strategy, patients 20 kg to <40 kg (44 lb to <88 lb) received rizatriptan benzoate orally disintegrating tablets 5 mg or placebo, and patients ≥40 kg (88 lb) received rizatriptan benzoate orally disintegrating tablets 10 mg or placebo.
The mean age for the studied patient population was 13 years. Sixty-one percent of the patients were Caucasian, and fifty-six percent of the patients were female. The percentage of patients achieving the primary efficacy endpoint of no headache pain at 2 hours after treatment was significantly greater in patients who received rizatriptan benzoate orally disintegrating tablets , compared with those who received placebo (33% vs. 24%). Study 7 results are summarized in Table 4. Table 4: Response Rates 2 Hours Following Treatment of Initial Headache in Pediatric Patients 6 to 17 Years of Age in Study 7

Endpoint Placebo Rizatriptan Orally Disintegrating Tablets p-value
No headache pain at 2 hours post-dose 24 %(n/m-94/388) 33 %(n/m-126/382) 0.01

n = Number of evaluable patients with no headache pain at 2 hours post-dose.
m = Number of evaluable patients in population.
The observed percentage of pediatric patients achieving no headache pain within 2 hours following initial treatment with rizatriptan benzoate orally disintegrating tablets is shown in Figure 5.
Figure 5: Observed Percentage of Patients Reporting No Headache Pain by 2 Hours Post-Dose in Study 7

fig-5
(click image for full-size original)

The prevalence of the exploratory endpoints of absence of migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose was not statistically significantly different between patients who received rizatriptan benzoate orally disintegrating tablets and those who received placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

Rizatriptan benzoate tablets, USP

The 10 mg tablets are pale pink, capsule-shaped, compressed tablets debossed “CL 34” on one side and plain on the other.

NDC: 71335-1352-1: 10 Tablets in a BLISTER PACK

NDC: 71335-1352-2: 6 Tablets in a BLISTER PACK

NDC: 71335-1352-3: 90 Tablets in a BLISTER PACK

NDC: 71335-1352-4: 9 Tablets in a BLISTER PACK

NDC: 71335-1352-5: 30 Tablets in a BLISTER PACK

NDC: 71335-1352-6: 18 Tablets in a BLISTER PACK

NDC: 71335-1352-7: 12 Tablets in a BLISTER PACK

Store between 68ºF to 77ºF (20ºC to 25ºC). [See USP Controlled Room Temperature.]

Preserve in well-closed, light-resistant containers.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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 breastfeeding 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)].
Manufactured for :
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by :
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, India.

Revised: 07/2022

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SPL PATIENT PACKAGE INSERT

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PATIENT INFORMATION

RIZATRIPTAN BENZOATE TABLETS

5 mg and 10 mg

Read this Patient Information before you start taking rizatriptan benzoate 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.

What is rizatriptan benzoate tablet?

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

Rizatriptan benzoate is available as a traditional 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 tablet is not to be used to prevent migraine attacks.

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

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

It is not known if rizatriptan benzoate tablet 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:
o high blood pressure
o high cholesterol
o smoking
o obesity
o diabetes
o family history of heart problems
o you are post menopausal
o 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, 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:
o 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 3 10-mg tablets in a 24-hour period).
o 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 a heart attack may include:
o chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
o chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
o pain or discomfort in your arms, back, neck, jaw or stomach
o shortness of breath with or without chest discomfort
o breaking out in a cold sweat
o nausea or vomiting
o feeling lightheaded
stroke. Symptoms of a stroke may include the following sudden symptoms:
o numbness or weakness in your face, arm or leg, especially on one side of your body
o confusion, problems speaking or understanding
o problems seeing in 1 or both of your eyes
o problems walking, dizziness, loss of balance or coordination
o severe headache with no known cause

blood vessel problems. Symptoms of blood vessel problems may include:
o stomach pain
o bloody diarrhea
o vision problems
o 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:
o agitation
o hallucinations
o coma
o fast heartbeat
o fast changes in your blood pressure
o increased body temperature
o muscle spasm
o loss of coordination
o 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 room temperature between 59°F to 86°F (15°C to 30°C).
• 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, call Macleods Pharma USA, Inc at1-888-943-3210 or 1-855-926-3384.

What are the ingredients in rizatriptan benzoate tablets?
Active ingredient: rizatriptan benzoate.

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


*The brand names mentioned are registered trademarks of their respective manufacturers.

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

Manufactured for:

Macleods Pharma USA, Inc.
Princeton, NJ 08540

Manufactured by:

Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

Revised: 07/2022

Rizatriptan Benzoate 10mg Tablet (Blister)

Label
(click image for full-size original)
RIZATRIPTAN rizatriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1352(NDC:33342-088)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIZATRIPTAN BENZOATE (RIZATRIPTAN) RIZATRIPTAN 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
FERRIC OXIDE RED
MAGNESIUM STEARATE
Product Characteristics
Color PINK (pale pink) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code CL34
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-1352-1 10 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:71335-1352-2 6 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:71335-1352-3 90 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:71335-1352-4 9 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:71335-1352-5 30 TABLET, FILM COATED in 1 BLISTER PACK None
6 NDC:71335-1352-6 18 TABLET, FILM COATED in 1 BLISTER PACK None
7 NDC:71335-1352-7 12 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203147 03/11/2014
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-1352), RELABEL (71335-1352)

Revised: 11/2023 Bryant Ranch Prepack

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