ULTRAM (Page 6 of 6)

OVERDOSAGE

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death.

Deaths due to overdose have been reported with abuse and misuse of tramadol (see WARNINGS, Misuse, Abuse, and Diversion).Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.

In the treatment of tramadol overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of ULTRAM® could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

DOSAGE AND ADMINISTRATION

Adults (17 years of age and over)

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of ULTRAM® can be improved by initiating therapy with the following titration regimen: ULTRAM® should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, ULTRAM® 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.

For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, ULTRAM® 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.

Individualization of Dose

Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

  • In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of ULTRAM® be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
  • The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.
  • In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.

HOW SUPPLIED

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 100 tablets: NDC 54868-3605-4

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F).

Manufactured by:

Janssen Ortho, LLC
Gurabo, Puerto, Rico 00778

Manufactured for:

PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, New Jersey 08869

© OMPJI 2003
Revised September 2009

Relabeling and Repackaging by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL — 50 mg Bottle Label

NDC 54868-3605-4

Ultram ®
(tramadol HCl tablets)

50 mg

SCOREDTABLET

100 tablets

Rx only.

PRINCIPAL DISPLAY PANEL -- 50 mg Bottle Label
(click image for full-size original)
ULTRAM tramadol hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3605(NDC:50458-659)
Route of Administration ORAL DEA Schedule
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)
hypromelloses
lactose
magnesium stearate
cellulose, microcrystalline
polyethylene glycol
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3605-4 100 TABLET, COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020281 02/10/1999
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 05/2012 Physicians Total Care, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.