TRAMADOL HYDROCHLORIDE — tramadol hydrochloride tablet
Alivio Medical Products, LLC
Each capsule contains:
Tramadol Hydrochloride, USP ……….50 mg
Usual Dosage: For dosage and other prescribing
information, see accompanying insert.
Store at 20 to 25 C (68 to 77 F); excursions
permitted to 15 to 30 C (59 to 86 F)[See
USP Controlled Room Temperature]
Dispense in a tight container as defined in
Keep out of reach of children.
Tramadol hydrochloride tablets, USP are a centrally acting analgesic.
PHARMACODYNAMICS Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid
Tramadol hydrochloride has been given in single oral doses pf 50, 75 and 100 mg to patients with pain
following surgical procedures and pain following oral surgery (extraction if impacted molars).
INDICATIONS AND USAGE
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to
moderately severe pain in adults.
Tramadol hydrochloride tablets, USP should not be administered to patients who have previously
demonstrated hypersensitivity to tramadol, any other component of this product or opoids.
Seizure Risk Seizures have been reported in patients receiving Tramadol hydrochloride within the
recommended dosage range.
Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment
of patients with acute abdominal conditions
Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label
extension periods in U.S. clinical studies of chronic nonmalignant pain.
DRUG ABUSE AND DEPENDENCE.
Abuse Tramadol has mu-opoid agonist activity.
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.
DOSAGE AND ADMINISTRATION
Adults (17 years of age and older) For patients with moderate to moderately severe chronic pain not
requiringrapid onset of analgesic effect, the tolerability of tramadol hydrochloride, USP can be improved by
initiating therapy with a titration regimen:
|TRAMADOL HYDROCHLORIDE tramadol hydrochloride tablet|
|Labeler — Alivio Medical Products, LLC (079670828)|
Revised: 10/2015 Alivio Medical Products, LLC
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