TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Manufacturer: NuCare Pharmaceuticals,Inc.

Score: 144.0

Quick Summary

Tramadol Hydrochloride and Acetaminophen is a combination medication used for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is indicated for short-term use of five days or less. The medication has several key clinical findings and indications, including the management of acute pain, and has important safety information and contraindications, such as the risk of addiction, abuse, and misuse, and life-threatening respiratory depression. The main dosing recommendations include an initial dose of 2 tablets every 4 to 6 hours as needed for pain relief, with a maximum of 8 tablets per day. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Management of acute pain severe enough to require an opioid analgesic
Short-term use of five days or less
Acute pain management

Important Safety Information

Warning

Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Accidental Ingestion, and Interactions with Other CNS Depressants

Contraindications

Children younger than 12 years of age
Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
Significant respiratory depression
Acute or severe bronchial asthma
Known or suspected gastrointestinal obstruction
Previous hypersensitivity to tramadol or acetaminophen
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days

Adverse Reactions

Constipation
Diarrhea
Nausea
Somnolence
Anorexia
Dizziness
Sweating increased
Serotonin syndrome
Adrenal insufficiency
Androgen deficiency
Hyperalgesia and allodynia

Dosing Recommendations

General Guidance

Do not exceed the recommended dose. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals.

Acute pain

Adult Dose

2 tablets every 4 to 6 hours as needed for pain relief, with a maximum of 8 tablets per day

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
Available data with tramadol hydrochloride and acetaminophen in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

Tramadol hydrochloride and acetaminophen is not recommended for use in nursing mothers

Pediatric Use

The safety and effectiveness of tramadol hydrochloride and acetaminophen in pediatric patients have not been established
Life-threatening respiratory depression and death have occurred in children who received tramadol

Geriatric Use

Elderly patients (65 years of age or older) may have increased sensitivity to tramadol
Use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range

Similar Drugs

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