DESCRIPTION
id: A4E522C7-3C1B-BEF5-3C16-63A4E4F87062
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Tramadol hydrochloride tablet is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:The molecular formula of tramadol hydrochloride is C16H25NO2•HCl and its molecular weight is 299.8.Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride.In addition, it also contains the following inactive ingredients:
hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide.
INDICATIONS AND USAGE
id: B1ABA34C-2696-ECAB-4088-76CA9B64AED9
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.
CONTRAINDICATIONS
id: 509303F6-B8F3-EEE8-F7AC-EA46170779E5
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Tramadol hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride may worsen central nervous system and respiratory depression in these patients.
ADVERSE REACTIONS
id: B524DE45-2CC5-35FF-6CB7-4B136D6F2F14
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol hydrochloride administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for tramadol hydrochloride and the active control groups, acetaminophen 300 mg with codeine phosphate 30 mg, and aspirin 325 mg with codeine phosphate 30 mg however the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride groups.
Table 2 Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride in Chronic Trials of Nonmalignant Pain (N=427)
|
Up to
7 Days |
Up to
30 Days |
Up to
90 Days |
| Dizziness/Vertigo |
26% |
31% |
33% |
| Nausea |
24% |
34% |
40% |
| Constipation |
24% |
38% |
46% |
| Headache |
18% |
26% |
32% |
| Somnolence |
16% |
23% |
25% |
| Vomiting |
9% |
13% |
17% |
| Pruritus |
8% |
10% |
11% |
”CNS Stimulation”“CNS Stimulation” is a composite of nervousness, anxiety, agitation, tremor, spasticity,
euphoria, emotional lability and hallucinations. |
7% |
11% |
14% |
| Asthenia |
6% |
11% |
12% |
| Sweating |
6% |
7% |
9% |
| Dyspepsia |
5% |
9% |
13% |
| Dry Mouth |
5% |
9% |
10% |
| Diarreah |
5% |
6% |
10% |
DRUG ABUSE AND DEPENDENCE
id: 68BDB36C-0FF8-F84E-3E89-78F9371ADF5A
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
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
id: 877B80C0-5456-097E-0F03-24D0D37DFA72
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
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
id: 1A716586-EB3F-FF6E-8650-B7A1878EDC55
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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..
HOW SUPPLIED
id: 96FC1828-CCCC-642F-FA8B-A8CA34FCA19C
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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 08846Distributed by:
Akyma Pharmaceuticals LLC
Glasgow, KY 42141
June 2006
MF # 153-06
