Prescription Drug Information: TRAMADOL HYDROCHLORIDE (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

Tramadol hydrochloride may induce psychic and physical dependence of the morphine-type (μ-opioid) (See WARNINGS). Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher. Tramadol hydrochloride is associated with craving and tolerance development. Withdrawal symptoms may occur if tramadol hydrochloride is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol hydrochloride discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.

OVERDOSAGE

Serious potential consequences of overdosage are respiratory depression, lethargy, coma, seizure, cardiac arrest and death (See WARNINGS). Fatalities have been reported in post marketing in association with both intentional and unintentional overdose with tramadol hydrochloride. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol hydrochloride the risk of seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic doses of tramadol 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 & 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 tramadol hydrochloride can be improved by initiating therapy with a titration regimen: 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, tramadol hydrochloride 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.

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, tramadol hydrochloride 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 upwards 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 tramadol hydrochloride 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

Tramadol hydrochloride tablets 50 mg are supplied as unscored, white, round film coated tablets debossed “cor” over “127”.

They are supplied as follows:

Bottles of 100 (NDC 65162-127-10)

Bottles of 500 (NDC 65162-127-50)

Bottles of 1000 (NDC 65162-127-11)

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

Dispense in a tight container as defined in the USP.

Manufactured by:
Corepharma LLC
Middlesex, NJ 08846

Distributed by:
Akyma Pharmaceuticals LLC
Glasgow, KY 42141
June 2006MF # 153-06

TRAMADOL HYDROCHLORIDE tramadol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-127
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE (Tramadol) Tramadol 50 mg
Inactive Ingredients
Ingredient Name Strength
hypromellose
lactose monohydrate
magnesium stearate
microcrystalline cellulose
polyethylene glycol
polysorbate 80
pregelatinized starch
sodium starch glycolate
titanium dioxide
Product Characteristics
Color WHITE (White) Score no score
Shape ROUND (round) Size 9mm
Flavor Imprint Code cor;127
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-127-10 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:65162-127-50 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:65162-127-11 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE, PLASTIC None
Labeler — COREPHARMA LLC.

Revised: 08/2006 COREPHARMA LLC.

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