Tapentadol Hydrochloride 100 mg/1
Tapentadol Hydrochloride · TABLET, FILM COATED · EPIC PHARMA LLC
Tapentadol Hydrochloride is a tablet, film coated containing tapentadol hydrochloride at 100 mg/1, taken oral. Manufactured by EPIC PHARMA LLC.
Key Facts
- Brand Name
- Tapentadol Hydrochloride
- Generic Name
- Tapentadol Hydrochloride
- NDC Code (Product)
42806-628- Manufacturer
- EPIC PHARMA LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA214378
- Marketing Start
- 12/31/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1 )], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Tapentadol tablets are an opioid analgesic indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Tapentadol 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 consistent with individual patient treatment goals. Reserve titration to higher doses of tapentadol 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 guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with ta…
Contraindications
4 CONTRAINDICATIONS Tapentadol tablets are 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 (5.8) ] • Known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see Warnings and Precautions (5.12) ] • Hypersensitivity to tapentadol (e.g. anaphylaxis, angioedema) or to any other ingredients of the product [see Adverse Reactions (6.2) ]. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Drug Interactions (7) ]. • Significant respiratory depression ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) • Hypersensitivity to tapentadol ( 4 ) • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 2 includes clinically significant drug interactions with tapentadol tablets. Table 2: Clinically Significant Drug Interactions with Tapentadol Tablets Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3) ]. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.1 , 5.2, 5.3)]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or …
Adverse Reactions
6 ADVERSE REACTIONS The following 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) ] • Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3) ] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6)]. • Serotonin Syndrome [see Warnings and Precautions (5.7) ] • Adrenal Insufficiency [see Warnings and Precautions (5.9) ] • Severe Hypotension [see Warnings and Precautions (5.10) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] • Seizures [see Warnings and Precautions (5.13) ] • Withdrawal [see Warnings and Precautions (5.14) ] The most common adverse reactions were Adults (incidence ≥10%) were nausea, dizziness, vomiting and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adults Because clinical trials are …
Frequently Asked Questions
What is Tapentadol Hydrochloride used for?
Tapentadol Hydrochloride contains Tapentadol Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Tapentadol Hydrochloride a controlled substance?
Yes, Tapentadol Hydrochloride is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Tapentadol Hydrochloride?
The generic name for Tapentadol Hydrochloride is Tapentadol Hydrochloride. There are 9 other brand versions of Tapentadol Hydrochloride.
What is the NDC code for Tapentadol Hydrochloride 100 mg/1?
The NDC (National Drug Code) for Tapentadol Hydrochloride 100 mg/1 is 42806-628, listed by EPIC PHARMA LLC.