TRAMADOL HYDROCHLORIDE – Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION

/TRAMADOL HYDROCHLORIDE – Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION
TRAMADOL HYDROCHLORIDE – Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRAMADOL HYDROCHLORIDE – Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION

ID:

1b439a3a-319a-43fd-e054-00144ff88e88

Code:

34391-3

DESCRIPTION


id: 1b439a3a-3158-43fd-e054-00144ff88e88
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Tramadol hydrochloride tablets, USP, 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 weight of tramadol hydrochloride 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. Tramadol hydrochloride
tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide.

CLINICAL STUDIES


id: 1b439a3a-3166-43fd-e054-00144ff88e88
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

Tramadol hydrochloride has 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 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 has been studied in three longterm controlled trials involving a total of 820 patients, with 530 patients receiving tramadol hydrochloride. 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 in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg 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 daily.

INDICATIONS AND USAGE


id: 1b439a3a-3168-43fd-e054-00144ff88e88
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: 1b439a3a-3169-43fd-e054-00144ff88e88
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: 1b439a3a-318f-43fd-e054-00144ff88e88
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%
Diarrhea 5% 6% 10%
Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with tramadol hydrochloride exists. Body as a Whole: Malaise. Cardiovascular: Vasodilation. Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder. Gastrointestinal: Abdominal pain, Anorexia, Flatulence. Musculoskeletal: Hypertonia. Skin: Rash. Special Senses: Visual disturbance. Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention. Incidence less than 1%, possibly causally related: the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience. Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma). Cardiovascular : Orthostatic hypotension, Syncope, Tachycardia. Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure (see
WARNINGS ), Tremor.
Respiratory: Dyspnea. Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles. Special Senses: Dysgeusia. Urogenital: Dysuria, Menstrual disorder. Other adverse experiences, causal relationship unknown: A variety of other adverse events were reported infrequently in patients taking tramadol hydrochloride during clinical trials and/or reported in post-marketing experience. A causal relationship between tramadol hydrochloride and these events has not been determined. However, the most significant events are listed below as alerting information to the physician. Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism. Central Nervous System: Migraine, Speech disorders. Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure. Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria. Sensory: Cataracts, Deafness, Tinnitus.

OVERDOSAGE


id: 1b439a3a-3193-43fd-e054-00144ff88e88
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 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 tramadol hydrochloride 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.

HOW SUPPLIED


id: 1b439a3a-319b-43fd-e054-00144ff88e88
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Tramadol hydrochloride tablets, USP, 50 mg, are available as white, oval, film-coated tablets debossed with “
101” on one side and “
OUYI” on the other side.
Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F) [see USP Controlled Room Temperature]. Repackaged By: Medsource Pharmaceuticals Lake Forest, CA 92630

PRINCIPAL DISPLAY PANEL – 50 mg 90s Label Text


id: 1b51ced0-1767-0679-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

TRAMADOL HCL TABLETS 50MG #90 NDC: 45865-0357-90