Description
Each capsule contains:
Tramadol Hydrochloride, USP ..........50 mg
Usual Dosage: For dosage and other prescribing
information, see accompanying insert.
DESCRIPTION
Tramadol hydrochloride tablets, USP are a centrally acting analgesic.
Tramadol Hydrochloride
FDA Label NDC 69512-627
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alivio Medical Products, Llc for the product Tramadol Hydrochloride (NDC 69512-627). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, storage and handling, clinical pharmacology, clinical studies, indications & usage, contraindications, warnings, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Storage And Handling
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
the USP.
Keep out of reach of children.
Clinical Pharmacology
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid
analgesic.
Clinical Studies
CLINICAL STUDIES
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 & Usage
INDICATIONS AND USAGE
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to
moderately severe pain in adults.
Contraindications
CONTRAINDICATIONS
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.
Warnings
WARNINGS
Seizure Risk Seizures have been reported in patients receiving Tramadol hydrochloride within the
recommended dosage range.
Precautions
PRECAUTIONS
Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment
of patients with acute abdominal conditions
Adverse Reactions
ADVERSE REACTIONS
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
DRUG ABUSE AND DEPENDENCE.
Abuse Tramadol has mu-opoid agonist activity.
Overdosage
OVERDOSAGE
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 & Administration
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:
Package Label.Principal Display Panel
Copy Of Label (Tramadol Label)
* Please review the disclaimer below.
