TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, film coated 
TRAMADOL HYDROCHLORIDE ER- tramadol hydrochloride tablet, extended release 
DirectRX

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TRAMADOL HYDROCHLORIDE

DESCRIPTION SECTION

Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (±)cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

Figure 1

tramadol-structure

The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol.

Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol.

CLINICAL PHARMACOLOGY SECTION

CLINICAL STUDIES SECTION

INDICATIONS & USAGE SECTION

Tramadol hydrochloride extended-release tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

CONTRAINDICATIONS SECTION

Tramadol hydrochloride extended-release tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride extended-release tablets are 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 extended-release tablets may worsen central nervous system and respiratory depression in these patients.

WARNINGS SECTION

DRUG ABUSE AND DEPENDENCE SECTION

PRECAUTIONS SECTION

INFORMATION FOR PATIENTS SECTION

ADVERSE REACTIONS SECTION

OVERDOSAGE SECTION

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, bradycardia, hypotension, and death.

Deaths due to overdose have been reported with abuse and misuse of tramadol, by ingesting, inhaling, or injecting the crushed tablets. 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 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.

DOSAGE & ADMINISTRATION SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60597675787772747371

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45

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TRAMADOL HYDROCHLORIDE 
tramadol hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-597(NDC:68382-319)
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 319
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-597-82180 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
2NDC:61919-597-2020 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
3NDC:61919-597-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
4NDC:61919-597-4040 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
5NDC:61919-597-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
6NDC:61919-597-9090 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
7NDC:61919-597-72120 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
8NDC:61919-597-84240 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09040407/23/2020
TRAMADOL HYDROCHLORIDE  ER
tramadol hydrochloride tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-892(NDC:47335-859)
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MANNITOL (UNII: 3OWL53L36A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SHELLAC (UNII: 46N107B71O)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 531
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-892-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20138401/01/2014
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-892, 61919-597)

Revised: 7/2020
Document Id: ab1fe522-aebd-59a2-e053-2995a90af01b
Set id: c34a95e3-d508-428f-9022-19cc5a90b4ec
Version: 4
Effective Time: 20200723
 
DirectRX