Tramadol Hydrochloride And Acetaminophen

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Side Effects & Adverse Reactions

Hepatotoxicity

Tramadol hydrochloride and acetaminophen tablets contain tramadol hydrochloride and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products (see Boxed Warning).

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Seizure Risk

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous postmarketing 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:

Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),
Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
Other opioids.

Administration of tramadol may enhance the seizure risk in patients taking:

MAO inhibitors (see also WARNINGS, Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors),
Neuroleptics, or
Other drugs that reduce the seizure threshold.

Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, or CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizure.

Suicide Risk

Do not prescribe tramadol hydrochloride and acetaminophen tablets for patients who are suicidal or addiction-prone.
Prescribe tramadol hydrochloride and acetaminophen tablets with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess and who suffer from emotional disturbance or depression.

The judicious prescribing of tramadol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics.

Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs (see WARNINGS, Risk of Overdosage).

Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products, including tramadol hydrochloride and acetaminophen tablets, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Hypersensitivity/Anaphylaxis

Serious and rarely fatal anaphylactic 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).

There have been postmarketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue tramadol hydrochloride and acetaminophen tablets immediately and seek medical care if they experience these symptoms. Do not prescribe tramadol hydrochloride and acetaminophen tablets for patients with acetaminophen allergy.

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 Risk and 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.

Interactions With Alcohol and Drugs of Abuse

Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

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 reactions when evaluating altered mental status in these patients if they are receiving tramadol hydrochloride and acetaminophen tablets (see WARNINGS, 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 Re-uptake 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 SSRIs 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 tabletsin 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.

Misuse, Abuse and Diversion

Tramadol has mu-opioid agonist activity. Tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be sought by drug abusers and people with addiction disorders and may be subject to criminal diversion. The possibility of illegal or illicit use should be considered when prescribing or dispensing tramadol hydrochloride and acetaminophen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Misuse or abuse poses a significant risk to the abuser that could result in overdose and death (see DRUG ABUSE AND DEPENDENCE and OVERDOSAGE).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.

Risk of Overdosage

Patients taking tramadol should be warned not to exceed the dose recommended by their physician. Tramadol products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a cause of drug-related deaths. Patients should be cautioned about the concomitant use of tramadol products and alcohol because of potentially serious CNS additive effects of these agents. Because of its added depressant effects, tramadol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, tricyclic antidepressants, or other CNS depressant drugs. Patients should be advised of the additive depressant effects of these combinations.

Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression, and death. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (see OVERDOSAGE).

A serious potential consequence of overdosage with acetaminophen is 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.

Withdrawal

Withdrawal symptoms may occur if tramadol hydrochloride and acetaminophen tablets are discontinued abruptly (see also DRUG ABUSE AND DEPENDENCE). Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been reported less frequently with tramadol hydrochloride and acetaminophen tabletdiscontinuation 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.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.

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History

There is currently no drug history available for this drug.

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Other Information

Tramadol hydrochloride and acetaminophen tablets, USP combine two analgesics, tramadol, USP 37.5 mg and acetaminophen, USP 325 mg.

The chemical name for tramadol hydrochloride, USP is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder.

The chemical name for acetaminophen, USP is N-acetyl- p-aminophenol. Its structural formula is:

The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.

Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablets are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide.

Dissolution Method: Test 2

Sources

Tramadol Hydrochloride And Acetaminophen Manufacturers

Medsource Pharmaceuticals

Tramadol Hydrochloride And Acetaminophen | Medsource Pharmaceuticals

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Remedyrepack Inc.

Tramadol Hydrochloride And Acetaminophen | Remedyrepack Inc.

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.

In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets be increased not to exceed 2 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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Avkare, Inc.

Tramadol Hydrochloride And Acetaminophen | Avkare, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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, USP be increased not to exceed 2 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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Direct Rx

Tramadol Hydrochloride And Acetaminophen | Direct Rx

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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A-s Medication Solutions Llc

Tramadol Hydrochloride And Acetaminophen | A-s Medication Solutions Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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A-s Medication Solutions Llc

Tramadol Hydrochloride And Acetaminophen | A-s Medication Solutions Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Avpak

Tramadol Hydrochloride And Acetaminophen | Avpak

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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, USP be increased not to exceed 2 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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Preferred Pharmaceuticals, Inc.

Tramadol Hydrochloride And Acetaminophen | Preferred Pharmaceuticals, Inc.

For the short-term (5 days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets 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 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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Direct Rx

Tramadol Hydrochloride And Acetaminophen | Geritrex Corp

For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

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Preferred Pharmaceuticals, Inc.

Tramadol Hydrochloride And Acetaminophen | Preferred Pharmaceuticals, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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 be increased not to exceed 2 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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Rxchange Co.

Tramadol Hydrochloride And Acetaminophen | Rxchange Co.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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St. Mary’s Medical Park Pharmacy

Tramadol Hydrochloride And Acetaminophen | St. Mary's Medical Park Pharmacy

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Par Pharmaceutical Inc.

Tramadol Hydrochloride And Acetaminophen | Par Pharmaceutical Inc.

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.
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, be increased not to exceed 2 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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Alphapharm Pty Ltd

Tramadol Hydrochloride And Acetaminophen | Alphapharm Pty Ltd

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.
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 2 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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Physicians Total Care, Inc.

Tramadol Hydrochloride And Acetaminophen | Physicians Total Care, Inc.

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.
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 2 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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Keltman Pharmaceuticals Inc.

Tramadol Hydrochloride And Acetaminophen | Keltman Pharmaceuticals Inc.

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.
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 2 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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Rebel Distributors Corp

Tramadol Hydrochloride And Acetaminophen | Rebel Distributors Corp

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.
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 2 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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Remedyrepack Inc.

Tramadol Hydrochloride And Acetaminophen | Remedyrepack Inc.

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.
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 be increased not to exceed 2 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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Stat Rx Usa Llc

Tramadol Hydrochloride And Acetaminophen | Stat Rx Usa Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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 be increased not to exceed 2 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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Rebel Distributors Corp

Tramadol Hydrochloride And Acetaminophen | Rebel Distributors Corp

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.

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 be increased not to exceed 2 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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H.j. Harkins Company, Inc.

Tramadol Hydrochloride And Acetaminophen | H.j. Harkins Company, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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 be increased not to exceed 2 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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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Tramadol Hydrochloride And Acetaminophen | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

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.

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 be increased not to exceed 2 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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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Tramadol Hydrochloride And Acetaminophen | Apotex Corp.

Administer olopatadine hydrochloride nasal solution (nasal spray) by the intranasal route only.
2.1 Adults and Adolescents 12 years of age and older
The recommended dosage is two sprays per nostril twice daily.
2.2 Children 6 to 11 years of age
The recommended dosage is one spray per nostril twice daily.
2.3 Administration Information
Priming: Before initial use, prime olopatadine hydrochloride nasal solution (nasal spray) by releasing 5 sprays or until a fine mist appears. When olopatadine hydrochloride nasal solution (nasal spray) has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying olopatadine hydrochloride nasal solution (nasal spray) into the eyes.

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Stat Rx Usa Llc

Tramadol Hydrochloride And Acetaminophen | Stat Rx Usa Llc

For the short-term (five days or less) management of acute pain, the recommended dose of Tramadol HCl 37.5 mg/Acetaminophen 325 mg is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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 HCl 37.5 mg/Acetaminophen 325 mg be increased not to exceed 2 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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Aidarex Pharmaceuticals Llc

Tramadol Hydrochloride And Acetaminophen | Aidarex Pharmaceuticals Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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, USP be increased not to exceed 2 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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Cadila Healthcare Limited

Tramadol Hydrochloride And Acetaminophen | Cadila Healthcare Limited

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.
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 be increased not to exceed 2 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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Unit Dose Services

Tramadol Hydrochloride And Acetaminophen | Unit Dose Services

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Proficient Rx Lp

Tramadol Hydrochloride And Acetaminophen | Proficient Rx Lp

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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, USP be increased not to exceed 2 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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Zydus Pharmaceuticals (Usa) Inc.

Tramadol Hydrochloride And Acetaminophen | Zydus Pharmaceuticals (usa) Inc.

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.
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 be increased not to exceed 2 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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Mylan Pharmaceuticals Inc.

Tramadol Hydrochloride And Acetaminophen | Mylan Pharmaceuticals Inc.

For the short-term (5 days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets 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 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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Ivax Pharmaceuticals, Inc.

Tramadol Hydrochloride And Acetaminophen | Ivax Pharmaceuticals, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of Tramadol HCl 37.5 mg/Acetaminophen 325 mg is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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 HCl 37.5 mg/Acetaminophen 325 mg be increased not to exceed 2 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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Pd-rx Pharmaceuticals, Inc.

Tramadol Hydrochloride And Acetaminophen | Pd-rx Pharmaceuticals, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Micro Labs Limited

Tramadol Hydrochloride And Acetaminophen | Micro Labs Limited

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.

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 be increased not to exceed 2 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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Sun Pharmaceutical Industries, Inc.

Tramadol Hydrochloride And Acetaminophen | Sun Pharmaceutical Industries, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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 be increased not to exceed 2 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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Apotex Corp.

Tramadol Hydrochloride And Acetaminophen | Apotex Corp.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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 be increased not to exceed 2 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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American Health Packaging

Tramadol Hydrochloride And Acetaminophen | American Health Packaging

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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 be increased not to exceed 2 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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Bryant Ranch Prepack

Tramadol Hydrochloride And Acetaminophen | Bryant Ranch Prepack

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 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, USP be increased not to exceed 2 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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Preferred Pharmaceuticals, Inc.

Tramadol Hydrochloride And Acetaminophen | Preferred Pharmaceuticals, Inc.

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Tramadol Hydrochloride And Acetaminophen | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

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.
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, be increased not to exceed 2 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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Amneal Pharmaceuticals Of New York, Llc

Tramadol Hydrochloride And Acetaminophen | Amneal Pharmaceuticals Of New York, Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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A-s Medication Solutions Llc

Tramadol Hydrochloride And Acetaminophen | A-s Medication Solutions Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Amneal Pharmaceuticals Of New York, Llc

Tramadol Hydrochloride And Acetaminophen | Amneal Pharmaceuticals Of New York, Llc

For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 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, USP be increased not to exceed 2 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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Preferred Pharmaceuticals Inc.

Tramadol Hydrochloride And Acetaminophen | Preferred Pharmaceuticals Inc.

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.
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 be increased not to exceed 2 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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