Discontinuation of ULTRAM
When a patient who has been taking ULTRAM regularly and may be physically dependent no longer requires therapy with ULTRAM, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue ULTRAM in a physically-dependent patient. (see
Drug Abuse and Dependence).
ULTRAM (tramadol hydrochloride) Tablets — 50 mg are white, capsule-shaped, coated tablet imprinted “ULTRAM” on one side and “06 59″ on the scored side.
Bottles of 15 tablets: NDC 55289-650-15
Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to30°C (59°F to 86°F). [see USP Controlled Room Temperature].
|This Medication Guide has been approved by the U.S. Food and Drug Administration. || Issued: 08/2017 |
|Medication Guide ULTRAM [UHL-tram] (tramadol hydrochloride)
Tablets, CIV |
| ULTRAM is: |
- A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
| Important information about ULTRAM: |
- Get emergency help right away if you take too much ULTRAM (overdose). When you first start taking ULTRAM, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Taking ULTRAM with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- Never give anyone else your ULTRAM. They could die from taking it. Store ULTRAM away from children and in a safe place to prevent stealing or abuse. Selling or giving away ULTRAM is against the law.
| Important Information Guiding Use in Pediatric Patients: |
Do not take ULTRAM if you have:
- Do not give ULTRAM to a child younger than 12 years of age.
- Do not give ULTRAM to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
- Avoid giving ULTRAM to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
- Severe asthma, trouble breathing, or other lung problems.
- A bowel blockage or have narrowing of the stomach or intestines.
- An allergy to tramadol.
- Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.
| Before taking ULTRAM, tell your healthcare provider if you have a history of: |
| || |
- head injury, seizures
- problems urinating
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
| || |
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of ULTRAM during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. Not recommended; it may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking ULTRAM with certain other medicines can cause serious side effects that could lead to death.
| When taking ULTRAM: |
- Do not change your dose. Take ULTRAM exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 8 tablets per day. If you miss a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking ULTRAM regularly, do not stop taking ULTRAM without talking to your healthcare provider.
- After you stop taking ULTRAM, ask your pharmacist how to dispose of any unused tablets.
| While taking ULTRAM DO NOT: |
- Drive or operate heavy machinery, until you know how ULTRAM affects you. ULTRAM can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ULTRAM may cause you to overdose and die.
| The possible side effects of ULTRAM: |
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of ULTRAM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information go to dailymed.nlm.nih.gov
Manufactured by: Janssen Ortho, LLC, Gurabo, Puerto Rico 00778. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560, 1-800-526-7736
PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label
(tramadol HCl tablets)
Keep out of reach of children.
| ULTRAM tramadol hydrochloride tablet, coated |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:55289-650(NDC:50458-659) |
|Route of Administration ||ORAL ||DEA Schedule ||CIV
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|TRAMADOL HYDROCHLORIDE (TRAMADOL) ||TRAMADOL HYDROCHLORIDE ||50 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| STARCH, CORN || |
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) || |
| HYPROMELLOSE, UNSPECIFIED || |
| LACTOSE, UNSPECIFIED FORM || |
| MAGNESIUM STEARATE || |
| MICROCRYSTALLINE CELLULOSE || |
| POLYETHYLENE GLYCOL, UNSPECIFIED || |
| POLYSORBATE 80 || |
| SODIUM STARCH GLYCOLATE TYPE A POTATO || |
| TITANIUM DIOXIDE || |
| CARNAUBA WAX || |
|Product Characteristics |
|Color ||white ||Score ||2 pieces |
|Shape ||OVAL (capsule-shaped) ||Size ||13mm |
|Flavor || ||Imprint Code ||ULTRAM;06;59 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:55289-650-15 ||15 TABLET, COATED in 1 BOTTLE, PLASTIC ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|NDA ||NDA020281 ||03/03/1995 || |
|Labeler — PD-Rx Pharmaceuticals, Inc.
|Registrant — PD-Rx Pharmaceuticals, Inc. (156893695) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|PD-Rx Pharmaceuticals, Inc. || ||156893695 ||repack (55289-650) |
Revised: 03/2018 PD-Rx Pharmaceuticals, Inc.
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