Drugplain

Tramadol Hydrochloride and Acetaminophen 325 mg/1

Tramadol Hydrochloride and Acetaminophen · TABLET · Amneal Pharmaceuticals of New York LLC

No Recall History
Plain English

Tramadol Hydrochloride and Acetaminophen is a tablet containing tramadol hydrochloride and acetaminophen at 325 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.

Key Facts

Brand Name
Tramadol Hydrochloride and Acetaminophen
Generic Name
Tramadol Hydrochloride and Acetaminophen
NDC Code (Product)
53746-617
Manufacturer
Amneal Pharmaceuticals of New York LLC
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule IV (Controlled)
Application #
ANDA090485
Marketing Start
12/17/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea80 reports
drug ineffective70 reports
off label use70 reports
malaise56 reports
dizziness55 reports
pain53 reports
vomiting52 reports
headache51 reports
dyspnoea42 reports
arthralgia40 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Tramadol hydrochlorideandacetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Have not been tolerated orare not expected to be tolerated, Have not provided adequate analgesia orare not expected to provide adequate analgesia. Tramadol hydrochloride and acetaminophen tablets should notbeused for an extended period of time. Tramadol hydrochloride and acetaminophen tablets are a combination of tramadol hydrochloride, an opioid agonist, and acetaminophen, and are indicated for the management of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use: ( 1 ) Trama…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride and acetaminophen. Consider prescribing naloxone based on the patient’s risk factors for overdose ( 2.2 , 5.1 , 5.2 , 5.3 ). Do not use with other acetaminophen- or tramadol-containing products. ( 2 , 5.20 ) Tramadol hydrochloride and acetaminophen tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of tramadol hydrochloride and acetaminophen tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical…

Contraindications

4 CONTRAINDICATIONS Tramadol hydrochloride and acetaminophen tablets are contraindicated for: all children younger than 12 years of age [see Warnings and Precautions (5.6) ] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.6) ] . Tramadol hydrochloride and acetaminophen tablets are also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] . Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.13) ] . Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.18) ] . Previous hypersensitivity to tramadol, acetaminophen, any other component of this product, or opioids [see Warnings and Precautions (5.19) ] . Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see Drug Interactions (7) ] . Children younger than 12 years of age ( 4 ) Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. ( 4 ) Significan…

Drug Interactions

7 DRUG INTERACTIONS Table 2 includes clinically significant interactions with tramadol hydrochloride and acetaminophen. Table 2: Clinically Significant Drug Interactions with Tramadol Hydrochloride and Acetaminophen Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride and acetaminophen and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride and acetaminophen is achieved. Since M1 is a more potent µ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol. Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome. After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase which could increase or prolong therapeutic effec…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see Warnings and Precautions (5.6) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.9) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Opioid-Induced Hyperalgesia and Allodynia [See Warnings and Precautions (5.8) ] Serotonin Syndrome [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Suicide [see Warnings and Precautions (5.12) ] Adrenal Insufficiency [see Warnings and Precautions (5.14) ] Severe Hypotension [see Warnings and Precautions (5.15) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.18) ] Hypersensitivity Reactions [see Warnings and Precautions (5.19) ] Withdrawal [see Warnings and Precautions (5.21) ] The most co…

Frequently Asked Questions

What is Tramadol Hydrochloride and Acetaminophen used for?

Tramadol Hydrochloride and Acetaminophen contains Tramadol Hydrochloride and Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Tramadol Hydrochloride and Acetaminophen a controlled substance?

Yes, Tramadol Hydrochloride and Acetaminophen is classified as CIV under the DEA Controlled Substances Act.

What is the generic name for Tramadol Hydrochloride and Acetaminophen?

The generic name for Tramadol Hydrochloride and Acetaminophen is Tramadol Hydrochloride and Acetaminophen. There are 2 other brand versions of Tramadol Hydrochloride and Acetaminophen.

What is the NDC code for Tramadol Hydrochloride and Acetaminophen 325 mg/1?

The NDC (National Drug Code) for Tramadol Hydrochloride and Acetaminophen 325 mg/1 is 53746-617, listed by Amneal Pharmaceuticals of New York LLC.

Product NDC

53746-617

Package NDC

53746-617-01

Other Tramadol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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