DESCRIPTION
id: a63a2340-cfb6-4f97-9ba4-12e95d1c3980
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, combines two analgesics, tramadol and acetaminophen.
The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder.
The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is:
The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are orange in color. Tramadol hydrochloride and acetaminophen tablets are intended for oral administration. Inactive ingredients in the tablet are crospovidone, magnesium stearate, microcrystalline cellulose, OPADRY® II Orange, povidone, pregelatinized starch, purified water, and stearic acid. OPADRY® II Orange contains: FD&C red #40; FD&C yellow #6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose; polyethylene glycol; titanium dioxide; triacetate; and triacetin.
CLINICAL PHARMACOLOGY
id: 943b9043-0422-49f3-aad9-66f51733f276
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
The following information is based on studies of tramadol alone or acetaminophen alone, except where otherwise noted:
INDICATIONS AND USAGE
id: 0adc43e1-6267-4a87-b34d-0e0684c48815
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain.
CONTRAINDICATIONS
id: 4d4e6735-e49b-4669-9dc7-b67a450de852
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Tramadol hydrochloride and acetaminophen tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. Tramadol hydrochloride and acetaminophen 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 and acetaminophen tablets may worsen central nervous system and respiratory depression in these patients.
ADVERSE REACTIONS
id: a0f91f2a-670d-4cc0-9d28-9ec3dcce7518
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Table 2 reports the incidence rate of treatment-emergent adverse events over five days of tramadol hydrochloride and acetaminophen tablet use in clinical trials (subjects took an average of at least 6 tablets per day).
Table 2: Incidence of Treatment-Emergent Adverse Events (≥2.0%)
|
* Number of males = 62
|
|
Body System
|
Tramadol Hydrochloride and Acetaminophen Tablets (N=142) % |
| Preferred Term |
|
Gastrointestinal System Disorders
|
|
| Constipation |
6 |
| Diarrhea |
3 |
| Nausea |
3 |
| Dry Mouth |
2 |
|
Psychiatric Disorders
|
|
| Somnolence |
6 |
| Anorexia |
3 |
| Insomnia |
2 |
|
Central & Peripheral Nervous System
|
|
| Dizziness |
3 |
|
Skin and Appendages
|
|
| Sweating Increased |
4 |
| Pruritus |
2 |
| Reproductive Disorders, Male[1] |
|
| Prostatic Disorder |
2 |
Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of tramadol hydrochloride and acetaminophen tablets.
Body as a Whole – Asthenia, fatigue, hot flushes.
Central and Peripheral Nervous System – Dizziness, headache, tremor.
Gastrointestinal System – Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting.
Psychiatric Disorders – Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence.
Skin and Appendages – Pruritus, rash, increased sweating.
Selected Adverse events occurring at less than 1%:
The following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in tramadol hydrochloride and acetaminophen tablets clinical trials.
Body as a Whole – Chest pain, rigors, syncope, withdrawal syndrome.
Cardiovascular Disorders – Hypertension, aggravated hypertension, hypotension.
Central and Peripheral Nervous System – Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paraesthesia, stupor, vertigo.
Gastrointestinal System – Dysphagia, melena, tongue edema.
Hearing and Vestibular Disorders – Tinnitus.
Heart Rate and Rhythm Disorders – Arrhythmia, palpitation, tachycardia.
Liver and BiIiary System – Hepatic function abnormal.
Metabolic and Nutritional Disorders – Weight decrease.
Psychiatric Disorders – Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking.
Red Blood Cell Disorders – Anemia.
Respiratory System – Dyspnea.
Urinary System – Albuminuria, micturition disorder, oliguria, urinary retention.
Vision Disorders – Abnormal vision.
Other clinically significant adverse experiences previously reported with tramadol hydrochloride.
Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis liver failure and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs.
Other clinically significant adverse experiences previously reported with acetaminophen.
Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary to acetaminophen are rare and generally controlled by discontinuation of the drug and, when necessary, symptomatic treatment.
DRUG ABUSE AND DEPENDENCE
id: 27f2818d-b3d1-4cb5-b3f0-c54045a2c482
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
Tramadol may induce psychic and physical dependence of the morphine-type (µ-opioid). (See WARNINGS.) Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with a prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher. Tramadol is associated with craving and tolerance development. Withdrawal symptoms may occur if tramadol is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol hydrochloride and acetaminophen tablet discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.
OVERDOSAGE
id: ab760499-c823-491c-9c94-e029011c9506
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Tramadol hydrochloride and acetaminophen tablet is a combination product. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, acetaminophen toxicity or both. The initial symptoms of tramadol overdosage may include respiratory depression and or seizures. The initial symptoms seen within the first 24 hours following an acetaminophen overdose are: anorexia, nausea, vomiting, malaise, pallor and diaphoresis.
DOSAGE AND ADMINISTRATION
id: 2a5f0be0-4e9e-4351-aa58-5b01ba841201
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
HOW SUPPLIED
id: fae83b38-ae4a-4477-9436-196b8273e72b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed “083” on one side and “KALI” on the other .
They are supplied by Keltman Pharmaceuticals Inc. as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 68387-497-20 |
37.5 mg / 325 mg |
20 Tablets in a Plastic Bottle |
ORANGE |
49884-946 |
| 68387-497-30 |
37.5 mg / 325 mg |
30 Tablets in a Plastic Bottle |
ORANGE |
49884-946 |
| 68387-497-60 |
37.5 mg / 325 mg |
60 Tablets in a Plastic Bottle |
ORANGE |
49884-946 |
| 68387-497-90 |
37.5 mg / 325 mg |
90 Tablets in a Plastic Bottle |
ORANGE |
49884-946 |
| 68387-497-12 |
37.5 mg / 325 mg |
120 Tablets in a Plastic Bottle |
ORANGE |
49884-946 |
Dispense in a tight container. Store at 25oC (77oF); excursions permitted to 15º to 30oC (59º to 86oF).
Manufactured by:
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, NY 10977
This Product was Repackaged By Sandhills Repackaging For:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States
37.5 MG/325 MG Label
id: e058ba3a-7fdb-498e-a347-b4bf9cd00ec7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
