DESCRIPTION
id: 29eef565-b0af-4007-92aa-490037c764e2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Tramadol hydrochloride and acetaminophen tablet, USP combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg.
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, USP is a white, crystalline powder.
The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is:
The molecular weight of acetaminophen is 151.16. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
Each tramadol hydrochloride and acetaminophen tablets, USP intended for oral administration contains tramadol hydrochloride, 37.5 mg and acetaminophen, 325 mg. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
id: 791d1a16-4007-4f86-9917-78b6c155debe
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: d7c417ac-24c6-4ab5-9c3e-13e1712ced49
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.
CONTRAINDICATIONS
id: a44ba1dc-4ace-4b7b-81d0-f52778b4c0e1
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: c74fb296-b270-41ef-8b3f-926c58d243ff
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 tablets use in clinical trials (subjects took an average of at least 6 tablets per day).
Table 2 Incidence of Treatment-Emergent Adverse Events (≥ 2%)
|
Tramadol Hydrochloride and Acetaminophen Tablets (N=142)
|
|
Body System
|
|
|
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
Number of males = 62
|
|
|
Prostatic Disorder
|
2
|
DRUG ABUSE AND DEPENDENCE
id: d6ac7f0c-6769-424b-96ee-1eb4a2cd76c8
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
Abuse:
Tramadol has mu-opioid agonist activity. Tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, continued use despite harm or risk of harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of tramadol hydrochloride and acetaminophen tablets can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.
Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product.
Tramadol hydrochloride and acetaminophen tablets are intended for oral use only.
Dependence:
Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist (see also
WARNINGS, Withdrawal).
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with tramadol hydrochloride and acetaminophen tablets.
OVERDOSAGE
id: 1a59c292-4148-4a18-8188-2415b0b2e8c4
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Tramadol hydrochloride and acetaminophen tablets 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. An overdosage of tramadol hydrochloride and acetaminophen tablets may be a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.
Tramadol:
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.
Deaths due to overdose have been reported with abuse and misuse of tramadol (see
WARNINGS, Misuse, Abuse, and Diversion
). 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 hydrochloride and acetaminophen tablets 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 AND ADMINISTRATION
id: fa4af4ba-465c-450a-912b-8da48c9e57e9
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 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: af56f463-c62a-4ce8-8aa8-e2ebe6d3732d
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg are white, capsule-shaped, beveled-edge, biconvex, film-coated tablets, debossed “334” on one side and plain on other side and are supplied as follows:
NDC 63187-585-30in bottle of 30 tablets
NDC 63187-585-60in bottle of 60 tablets
NDC 63187-585-90in bottle of 90 tablets
STORAGE AND HANDLING
id: 22d2539b-98e7-4a77-ade4-ae2444c38065
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: 7f4eaa22-b323-4bf1-89c8-d58cbfafb291
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 63187-585-60 in bottle of 60 tablets
Tramadol Hydrochloride and Acetaminophne Tablets USP, 37.5/325 mg
Rx only
60 tablets
ZYDUS
