TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet

TRAMADOL HYDROCHLORIDE by

Drug Labeling and Warnings

TRAMADOL HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Each capsule contains:

Tramadol Hydrochloride, USP ..........50 mg

DESCRIPTION

Usual Dosage:  For dosage and other prescribing

information, see accompanying insert.

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.

DESCRIPTION

DESCRIPTION

Tramadol hydrochloride tablets, USP are a centrally acting analgesic.

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:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRAMADOL HYDROCHLORIDE  
tramadol hydrochloride tablet

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)	TRAMADOL HYDROCHLORIDE	50 mg  in 50 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69512-627-10	100 in 1 BOTTLE
1		50 mg in 1 CAPSULE; Type 0: Not a Combination Product

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)