Tramadal Hydrochloride And Acetaminophen
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Questions & Answers
Side Effects & Adverse Reactions
Seizure Risk
Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking:
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- Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),
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- Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
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- Other opioids.
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- MAO inhibitors (see alsoWARNINGS: Use with MAO Inhibitors),
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- Neuroleptics, or
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- Other drugs that reduce the seizure threshold.
Anaphylactoid Reactions
Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson Syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride and acetaminophen tablets (see CONTRAINDICATIONS).
Respiratory Depression
Administer tramadol hydrochloride and acetaminophen tablets cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see WARNINGS: Seizure Riskand OVERDOSAGE).
Interaction With Central Nervous System (CNS) Depressants
Tramadol hydrochloride and acetaminophen tablets should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol increases the risk of CNS and respiratory depression in these patients.
Increased Intracranial Pressure or Head Trauma
Tramadol hydrochloride and acetaminophen tablets should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving tramadol hydrochloride and acetaminophen tablets (see Respiratory Depression).
Use in Ambulatory Patients
Tramadol may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.
Use With MAO Inhibitors and Serotonin Reuptake Inhibitors
Use tramadol hydrochloride and acetaminophen tablets with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. Concomitant use of tramadol with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome.
Use With Alcohol
Tramadol hydrochloride and acetaminophen tablets should not be used concomitantly with alcohol consumption. The use of tramadol hydrochloride and acetaminophen tablets in patients with liver disease is not recommended.
Use With Other Acetaminophen-containing Products
Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, tramadol hydrochloride and acetaminophen tablets should not be used concomitantly with other acetaminophen-containing products.
Withdrawal
Withdrawal symptoms may occur if tramadol hydrochloride and acetaminophen tablets are discontinued abruptly. (See DRUG ABUSE AND DEPENDENCE.) 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 avoided by tapering tramadol hydrochloride and acetaminophen tablets at the time of discontinuation.
Physical Dependence and Abuse
Tramadol may induce psychic and physical dependence of the morphine-type ((See DRUG ABUSE AND DEPENDENCE.) Tramadol should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence.
Risk of Overdosage
Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. (See OVERDOSAGE.)
Serious potential consequences of overdosage with acetaminophen are hepatic (centrilobular) necrosis, leading to hepatic failure and death. Emergency help should be sought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (5 days or less) management of acute pain.
History
There is currently no drug history available for this drug.
Other Information
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, combines two analgesics, tramadol and acetaminophen.
The chemical name for tramadol hydrochloride is (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 151.16. 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 yellow in color. Inactive ingredients in the tablet are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, povidone, stearic acid, titanium dioxide, triacetin and yellow iron oxide.
Sources
Tramadal Hydrochloride And Acetaminophen Manufacturers
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Remedyrepack Inc.
![Tramadal Hydrochloride And Acetaminophen Tablet [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tramadal Hydrochloride And Acetaminophen | Remedyrepack Inc.
For the short-term (5 days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, is two tablets every 4 to 6 hours as needed for pain relief up to a maximum of eight tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, be increased not to exceed two tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.
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