Tramadol Hydrochloride Tablets, USP, 50 mg – Rx only

DESCRIPTION

id: ab5fdeea-fb8c-48df-9d2b-cd57d03ae6f5
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Tramadol hydrochloride tablet, USP is a centrally acting analgesic. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Molecular formula is C₁₆H₁₃NO₂•HCl The molecular weight of tramadol hydrochloride, USP is 299.8. Tramadol hydrochloride, USP 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 pH7. Tramadol hydrochloride tablets, USP for oral administration contain 50 mg of tramadol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide.

Clinical Studies

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displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

Tramadol hydrochloride tablets have been given in single oral doses of 50, 75, and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars). In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg tramadol hydrochloride tablets tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg. Tramadol hydrochloride tablets have been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving tramadol hydrochloride tablets. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of tramadol hydrochloride tablets in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL^® with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX^®) daily. [TYLENOL^® is the registered trademark of McNeil Consumer Healthcare and TYLOX^® is the registered trademark of RW Johnson].

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.

CONTRAINDICATIONS

id: b1550ab9-c09d-4b98-a752-29080d8101ad
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Tramadol hydrochloride tablets 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 may worsen central nervous system and respiratory depression in these patients.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Tramadol hydrochloride tablets were 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 tablets 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 tablets and the active control groups, TYLENOL^® with codeine #3 (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. [TYLENOL^® is the registered trademark of McNeil Consumer Healthcare and TYLOX^® is the registered trademark of RW Johnson].

OVERDOSAGE

id: 74571945-86e1-40bd-93d5-eb391db66200
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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 reestablishment 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 tramadol hydrochloride tablet 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

id: 78e247ed-80b0-4e02-9e6a-d38e75f239a6
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 tablets can be improved by initiating therapy with the following 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 tablets 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 tablets 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: df110b17-d4ad-481d-81f3-83cee3936ec1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Tramadol hydrochloride tablet, USP 50 mg are available as white capsule shaped film coated tablets, debossed with “377” on one side and plain on the other side. NDC 33261-377-30    Bottles of 30
NDC 33261-377-60    Bottles of 60
NDC 33261-377-90    Bottles of 90
NDC 33261-377-120  Bottles of 120 Dispense in tight container. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 -86°F). Manufactured by:
Sun pharmaceutical industries
Dadra 396 191,India Distributed by:
Caraco pharmaceutical Laboratories,Ltd
1150 Elijah McCoy Drive,Detroit,MI 48202
C.S.No:5243T65
Iss:11/10 Repackaged By:
Aidarex Pharmaceuticals, LLC
Corona, CA 92880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 50 mg 100 count

id: 6caf7055-81cf-41dd-a53e-9153bd978243
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4