TRAMADOL HYDROCHLORIDE

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

the USP.

Keep out of reach of children.

DESCRIPTION

Tramadol hydrochloride tablets, USP are a centrally acting analgesic.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid

analgesic.

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 AND USAGE

Tramadol hydrochloride tablets, USP are indicated for the management of moderate to

moderately severe pain in adults.

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

Seizure Risk Seizures have been reported in patients receiving Tramadol hydrochloride within the

recommended dosage range.

PRECAUTIONS

Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment

of patients with acute abdominal conditions

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.

Abuse Tramadol has mu-opoid agonist activity.

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 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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-627 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 50 mg in 50 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 TITANIUM DIOXIDE HYPROMELLOSES STARCH, CORN

Product Characteristics Color white (White) Score no score Shape ROUND Size 9mm Flavor Imprint Code AN;627 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69512-627-10 100 CAPSULE in 1 BOTTLE contains a CAPSULE 1 50 mg in 1 CAPSULE This package is contained within the BOTTLE (69512-627-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076003 10/01/2015

Labeler — Alivio Medical Products, LLC (079670828)

Revised: 10/2015 Alivio Medical Products, LLC