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| IMPORTANT SAFETY INFORMATION Rybix® ODT (tramadol HCl) belongs to a class of medicines called opioids, which are used for the treatment of pain. Do not take Rybix®ODT if you have had an allergic reaction to tramadol or other opioids in the past, as serious and rarely fatal allergic reactions can occur. |
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| IMPORTANT SAFETY INFORMATION CONTINUED BELOW | ||||||||||
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| Click here for Important Eligibility Information |
Rybix®ODT: | |
 | Pain relief that disolves on the tongue |
| Indication |
| Rybix® ODT is indicated for the management of moderate to moderately severe pain in adults (17 years of age and older). The safety and efficacy of Rybix® ODT in patients under 16 years of age have not been established. |
| Important Safety Information |
| Rybix® ODT (tramadol HCl) belongs to a class of medicines called opioids, which are used for the treatment of pain. Do not take Rybix® ODT if you have had an allergic reaction to tramadol or other opioids in the past, as serious and rarely fatal allergic reactions can occur. Do not take Rybix® ODT in any situation where opioids should not be used. Taking Rybix® ODT alone or in combination with alcohol, tranquilizers, hypnotics (sleep aids), or other opioids can cause breathing difficulty, seizures, overdose, and possibly death. Seizures have been reported in people taking tramadol, the active ingredient in Rybix® ODT, at recommended doses and the risk is increased when doses exceed the recommended range or when taking antidepressants, other opioids, or other drugs that can cause seizures. Risk of convulsions may also increase in people with epilepsy; a history of seizures; or other risk factors for seizures, such as head trauma, metabolic disorders, alcohol and drug withdrawal, and central nervous system infections. Do not take Rybix® ODT if you are suicidal or have a history of addiction. Use of alcohol should be avoided when taking Rybix® ODT. Rybix® ODT may be associated with a potentially life-threatening condition when taken together with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) (classes of drugs for depression or other disorders), triptans, lithium, or St. John's wort. Some common SSRIs are Paxil® (paroxetine), Prozac®/Sarafem® (fluoxetine), Celexa® (citalopram), Lexapro® (escitalopram), and Zoloft® (sertraline). Some common SNRIs are Cymbalta® (duloxetine), Pristiq® (desvenlafaxine), and Effexor® (venlafaxine). Some common triptans are Axert® (almotriptan), Imitrex® (sumatriptan), Zomig® (zolmitriptan), Maxalt® (rizatriptan benzoate), and Relpax® (eletriptan). Symptoms of Serotonin Syndrome can include mental-state changes such as agitation, hallucinations, and coma. Symptoms can also include autonomic instability (eg, fast heartbeat, fluctuating blood pressure, increased body temperature), neuromuscular aberrations (eg, overactive reflexes, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). Rybix® ODT can be abused or cause dependence. Do not change your dose or stop taking Rybix® ODT without talking with your health care professional first, as you may experience withdrawal symptoms. Before beginning Rybix® ODT, talk with your health care professional about all medications you are taking. Also, tell your health care professional about all your medical conditions and if you are pregnant, think you might be pregnant, or are trying to become pregnant. Before taking Rybix® ODT, you should inform your health care professional if you have been diagnosed with increased intracranial pressure, head injury, or kidney or liver disease. Rybix® ODT may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery. Rybix® ODT should be taken only as prescribed by your health care professional. Do not take Rybix® ODT if you are sensitive to phenylketone. You should not break, chew, or split Rybix® ODT. The most common side effects reported with Rybix® ODT were dizziness, nausea, constipation, headache, drowsiness, and vomiting. If you experience symptoms such as restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, or diarrhea, contact your health care professional immediately. Please talk to your health care professional for more information or if you have further questions about Rybix® ODT. For further information on Rybix® ODT, please see the full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. |
| Click here for full Prescribing Information |
| Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac and Cymbalta are registered trademarks of Eli Lilly and Company. Sarafem is a registered trademark of Warner Chilcott (US), LLC. Celexa is a registered trademark of Forest Laboratories, Inc. Lexapro is a registered trademark of Forest Pharmaceuticals, Inc. Zoloft, Pristiq, and Relpax are registered trademarks of Pfizer Inc. Effexor is a registered trademark of Wyeth Pharmaceuticals Inc. Axert is a registered trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Zomig is a registered trademark of the AstraZeneca group of companies. Maxalt is a registered trademark of Merck & Co., Inc. |
| Reference: 1. US Food and Drug Administration. Overview. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction=Search.Overview&DrugName=TRAMADOL%20HYDROCHLORIDE. Accessed October 7, 2011. |
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