Sumansetron: Package Insert and Label Information (Page 5 of 8)

PATIENT PACKAGE INSERT

Patient Information

Sumatriptan Tablets USP

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

What is the most important information I should know about sumatriptan tablets?

Sumatriptan tablets can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death.

Stop taking sumatriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • chest pain or chest discomfort that feels like uncomfortable heavy pressure, squeezing, or 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

Sumatriptan tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
  • are a female who has gone through menopause
  • are a male over age 40

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking sumatriptan tablets, especially if sumatriptan tablets are used with antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).

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

Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • nausea, vomiting, or diarrhea

What are sumatriptan tablets?

Sumatriptan tablets are a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Sumatriptan tablets are not used to prevent or decrease the number of migraine headaches you have.

Sumatriptan tablets are not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura).

It is not known if sumatriptan tablets are safe and effective to treat cluster headaches.

It is not known if sumatriptan tablets are safe and effective in children under 18 years of age.

Who should not take sumatriptan tablets?

Do not take sumatriptan tablets if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours:
  • almotriptan (AXERT ®)
  • eletriptan (RELPAX ®)
  • frovatriptan (FROVA ®)
  • naratriptan (AMERGE ®)
  • rizatriptan (MAXALT ® , MAXALT-MLT ®)
  • sumatriptan and naproxen (TREXIMET ®)
  • ergotamines (CAFERGOT ® , ERGOMAR ® , MIGERGOT ®)
  • dihydroergotamine (D.H.E. 45 ® , MIGRANAL ®)

Ask your doctor if you are not sure if your medicine is listed above.

  • an allergy to sumatriptan or any of the ingredients in sumatriptan tablets. See the end of this leaflet for a complete list of ingredients in sumatriptan tablets.

What should I tell my healthcare provider before taking sumatriptan tablets?

Before you take sumatriptan tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • are a female who has gone through menopause
  • have heart disease or a family history of heart disease or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • are pregnant or plan to become pregnant. It is not known if sumatriptan tablets will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Sumatriptan tablets passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take sumatriptan tablets.

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

Sumatriptan tablets and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider 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 healthcare provider or pharmacist when you get a new medicine.

How should I take sumatriptan tablets?

  • Certain people should take their first dose of sumatriptan tablets in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
  • Take sumatriptan tablets exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.
  • Take sumatriptan tablets with water or other liquids.
  • If you do not get any relief after your first sumatriptan tablet, do not take a second tablet without first talking with your healthcare provider.
  • If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet
  • Do not take more than a total of 200 mg of sumatriptan tablets in a 24-hour period.
  • Some people who take too many sumatriptan tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan tablets.
  • If you take too much sumatriptan tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take sumatriptan tablets so you can talk with your healthcare provider about how sumatriptan tablets are working for you.

What should I avoid while taking sumatriptan tablets?

Sumatriptan tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of sumatriptan tablets? Sumatriptan tablets may cause serious side effects. See “What is the most important information I should know about sumatriptan tablets?”

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
  • shortness of breath or wheezing
  • hives (itchy bumps); swelling of your tongue, mouth, or throat

The most common side effects of sumatriptan tablets include:

  • tingling or numbness in your fingers or toes
  • dizziness
  • warm, hot, burning feeling to your face (flushing)
  • feeling weak, drowsy, or tired

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

These are not all the possible side effects of sumatriptan tablets. For more information, ask your healthcare provider 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 Sumatriptan Tablets?

Store at 20 to 25°C (68 – 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep sumatriptan tablets and all medicines out of the reach of children.

General information about the safe and effective use of sumatriptan tablets.

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

This Patient Information leaflet summarizes the most important information about sumatriptan tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan tablets that is written for healthcare professionals.

For more information, call 1-888-375-3784.

What are the ingredients in Sumatriptan Tablets?

Active ingredients : Sumatriptan succinate

Inactive ingredients: croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.

To reorder additional Patient Information Leaflets, please contact Dr. Reddy’s Customer Service at 1-866-733-3952.

IMITREX, AMERGE, and TREXIMET are registered trademarks of GlaxoSmithKline. The other brands listed are trademarks of their respective owners.

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

RX Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA

Revised : 0312

1 INDICATIONS AND USAGE

Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
• highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2.
• initial and repeat courses of moderately emetogenic cancer chemotherapy.
• radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and Vomiting

Indication Dosage Regimen
Highly Emetogenic Cancer Chemotherapy A single 24 mg dose administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin greater than or equal to 50 mg/m 2
Moderately Emetogenic Cancer Chemotherapy 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose. Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy
Radiotherapy For total body irradiation: 8 mg administered 1 to 2 hours before each fraction of radiotherapy each day. For single high-dose fraction radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy, with subsequent 8 mg doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy, with subsequent 8 mg doses every 8 hours after the first dose for each day radiotherapy is given.
Postoperative 16 mg administered 1 hour before induction of anesthesia

Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting

Indication Dosage Regimen
Moderately Emetogenic Cancer Chemotherapy 12 to 17 years of age: 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 4 and 8 hours after the first dose. Then administer 8 mg three times a day for 1 to 2 days after completion of chemotherapy. 4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4 mg dose 4 and 8 hours after the first dose. Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy.

2.2 Dosage in Hepatic Impairment

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Ondansetron Tablets USP, are available in the following strengths:
• 4 mg – white, oval, film-coated tablets engraved with “4” on one side and “NO” on other side.
• 8 mg – yellow, oval, film-coated tablets engraved with “8” on one side and “NO” on the other side.

4 CONTRAINDICATIONS

Ondansetron tablets are contraindicated in patients:
• known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2)].
• receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. If hypersensitivity reactions occur, discontinue use of ondansetron tablets; treat promptly per standard of care and monitor until signs and symptoms resolve [see Contraindications (4)].

5.2 QT Prolongation

Electrocardiogram (ECG) changes including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron tablets. Avoid ondansetron tablets in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation [see Clinical Pharmacology (12.2)].

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.