Tapentadol Hydrochloride 20 mg/mL Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Opioid Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Tapentadol is a prescription opioid used for severe pain — the kind that other treatments can't adequately manage. The immediate-release tablets are for short-term acute pain, whil...
- What exactly is tapentadol used for, and is it the same as regular opioids?
- The most important rule: swallow the extended-release tablet whole with water — never crush, cut, chew, or dissolve it. Breaking it down releases the full dose all at once, which c...
- How do I take the extended-release tablet correctly?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tapentadol Hydrochloride 20 mg/mLthis 70954-0801-20 | ANI | 1 bottle | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70954-0801-10 | 1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLE | 2026-07-13 | Active |
| 70954-0801-20 You're viewing this | 1 BOTTLE in 1 CARTON (70954-801-20) / 200 mL in 1 BOTTLE | 2026-07-13 | Active |
Pack size FAQ
What quantity is in NDC 70954-0801-20?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TAPENTADOL HYDROCHLORIDE ORAL SOLUTION Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering tapentadol hydrochloride oral solution. Dosing errors due to confusion between mg and mL and other tapentadol oral solutions can result in accidental overdose and death [see Dosage and Administration (2.1), Warnings and Precautions (5.1)] . Addiction, Abuse, and Misuse Because the use of tapentadol hydrochloride oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing tapentadol hydrochloride oral solution, and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.2)] .
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of tapentadol hydrochloride oral solution, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol hydrochloride oral solution are essential [see Warnings and Precautions (5.3)] . Accidental Ingestion Accidental ingestion of even one dose of tapentadol hydrochloride oral solution, especially by children, can result in a fatal overdose of tapentadol [see Warnings and Precautions (5.3)] .
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of tapentadol hydrochloride oral solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.4), Drug Interactions (7)] . Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated.
Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.5)] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.6)] WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TAPENTADOL HYDROCHLORIDE ORAL SOLUTION See full prescribing information for complete boxed warning .
Ensure accuracy when prescribing, dispensing, and administering tapentadol hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other tapentadol oral solutions of different concentrations can result in accidental overdose and death. (2.1, 5.1) Tapentadol hydrochloride oral solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.
Assess patient’s risk before prescribing and reassess regularly for these behaviors and conditions. (5.2) Serious, life-threatening, or fatal respiratory depression may occur, especially when initiation and following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol hydrochloride oral solution are essential.
(5.3) Accidental ingestion of tapentadol hydrochloride oral solution, especially by children, can result in a fatal overdose of tapentadol. (5.3) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternati…
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Tapentadol hydrochloride oral solution is 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 dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.2)] , reserve opioid analgesics, including tapentadol hydrochloride oral solution 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 oral solution. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Tapentadol hydrochloride oral solution is 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 over the course of therapy, reserve opioid analgesics, including tapentadol hydrochloride oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1, 5.2)
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Tapentadol hydrochloride oral solution 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 tapentadol hydrochloride oral solution 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, 5.2) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with tapentadol hydrochloride oral solution. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.3) Tapentadol hydrochloride oral solution can be taken with or without food (2.1).
Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with tapentadol hydrochloride oral solution, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. (2.2, 5.2, 5.3, 5.4) Dosing in Adults: See full prescribing information for detailed dosing instructions. (2.3) Moderate Hepatic Impairment in Adult Patients : Initiate treatment with 50 mg no more than once every 8 hours (maximum of three doses in 24 hours).
Regularly evaluate patients for respiratory and central nervous system depression. (2.5) Periodically reassess patients receiving tapentadol hydrochloride oral solution to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. (2.6) Do not rapidly reduce or abruptly discontinue tapentadol hydrochloride oral solution in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
(2.6)
2.1Important Dosage and Administration Instructions Tapentadol hydrochloride oral solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)] . Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of tapentadol hydrochloride oral solution 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.
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. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
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 [se…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Oral solution: 20 mg/mL in 100 mL and 200 mL fill bottles with child-resistant closure [see Description (11) and How Supplied/Storage and Handling (16)] . Oral Solution: 20 mg/mL (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Tapentadol hydrochloride oral solution is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.9)] Known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see Warnings and Precautions (5.13)] 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 gastrointestinal obstruction, including suspected paralytic ileus. (4) Hypersensitivity to tapentadol.
(4) Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. (5.7) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate patients, particularly during initiation and titration.
(5.9) Serotonin Syndrome : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue tapentadol hydrochloride oral solution if serotonin syndrome is suspected. (5.8) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
(5.10) Severe Hypotension : Regularly evaluate patients during dosage initiation and titration. Avoid use of tapentadol hydrochloride oral solution in patients with circulatory shock. (5.11) Risks of Use in Patients with Increased Intracranial Pressure , Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression.
Avoid use of tapentadol hydrochloride oral solution in patients with impaired consciousness or coma. (5.12)
5.1Risk of Accidental Overdose and Death due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL when prescribing, dispensing, and administering tapentadol hydrochloride oral solution. Ensure that the dose is communicated clearly and dispensed accurately.
Instruct patients and caregivers on how to measure and take or administer the correct dose of tapentadol hydrochloride oral solution and to use extreme caution when measuring the dose. Instruct patients and caregivers to always use the enclosed graduated syringe when administering tapentadol hydrochloride oral solution to adult patients to ensure the dose is measured and administered accurately.. Instruct patients and caregivers to never use a household teaspoon or tablespoon to measure a dose because these are not adequate measuring devices.
Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA oral solution. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
5.2Addiction, Abuse, and Misuse Tapentadol hydrochloride oral solution contains tapentadol, a Schedule II controlled substance. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tapentadol hydrochloride oral solution. Addiction can occur at recommended dosages and if the drug is misused or abused.
The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6.2)] . Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing tapentadol hydrochloride oral solution and reassess all patients receiving tapentadol hydrochloride oral solution for the development of these behaviors and conditions.
Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as tapentadol hydrochloride oral solution but use in such patients necessitates intensive counseling about the risks and proper use of tapentadol hydrochloride oral solution along with frequent r…
🤒 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 (5.2)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)] Interactions with CNS Benzodiazepine or Other Depressants [see Warnings and Precautions (5.4)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)] Serotonin Syndrome [see Warnings and Precautions (5.8)] Adrenal Insufficiency [see Warnings and Precautions (5.10)] Severe Hypotension [see Warnings and Precautions (5.11)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13)] Seizures [see Warnings and Precautions (5.14)] Withdrawal [see Warnings and Precautions (5.15)] The most common adverse reactions were Adults (incidence ≥10%): nausea, dizziness, vomiting and somnolence.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact. ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Adults Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Based on data from nine Phase 2/3 studies that administered multiple doses (seven placebo-and/or active-controlled, one noncontrolled and one Phase 3 active-controlled safety study) the most common adverse reactions (reported by ≥10% in any tapentadol hydrochloride dose group) were: nausea, dizziness, vomiting and somnolence.
The most common reasons for discontinuation due to adverse reactions in the studies described above (reported by ≥1% in any tapentadol hydrochloride dose group) were dizziness (2.6% vs. 0.5%), nausea (2.3% vs. 0.6%), vomiting (1.4% vs.
0.2%), somnolence (1.3% vs. 0.2%) and headache (0.9% vs. 0.2%) for tapentadol hydrochloride -and placebo-treated patients, respectively.
Seventy-six percent of tapentadol hydrochloride -treated patients from the nine studies experienced adverse events. Tapentadol hydrochloride was studied in multiple-dose, active-or placebo-controlled studies, or noncontrolled studies (n = 2178), in single-dose studies (n = 870), in open-label study extension (n = 483) and in Phase 1 studies (n = 597). Of these, 2034 patients were treated with doses of 50 mg to 100 mg of tapentadol hydrochloride dosed every 4 to 6 hours.
The data described below reflect exposure to tapentadol hydrochloride in 3161 patients, including 449 exposed for 45 days. Tapentadol hydrochloride was studied primarily in placebo-and active-controlled studies (n = 2266, and n = 2944, respectively). The population was 18 to 85 years old (mean age 46 years), 68% were female, 75% white and 67% were postoperative.
Most patients received tapentadol hydrochloride doses of 50 mg, 75 mg, or 100 mg every 4 to 6 hours. Table 1 Adverse Reactions Reported by ≥1% of Tapentadol Hydrochloride-Treated Patients In Seven Phase 2/3 Placebo- and/or Oxycodone-Controlled, One Non-controlled, and One Phase 3 Oxycodone-Controlled Safety, Multiple-Dose Clinical Studies System/Organ Class MedDRA Preferred Term Tapentadol Hydrochloride 21 mg – 120 mg (n = 2178) % Placebo (n = 619) % Gastrointestinal disorders Nausea 30 13 Vomiting 18 4 Constipation 8 3 Dry mouth 4 <1 Dyspepsia 2 <1 General disorders and administration site conditions Fatigue 3 <1 Feeling hot 1 <1 Infections and infestations Nasopharyngitis 1 <1 Upper respiratory tract infection 1 <1 Urinary tract infection 1 <1 Metabolism and nutrition Decreased appetite 2 0 Nervous system disorders Dizziness 24 8 Somnolence 15 3 Tremor 1 <1 Lethargy 1 <1 Psychiatric disorders Insomnia 2 <1 Confusional state 1 0 Abnormal dreams 1 <1 Anxiety 1 <1 Skin and subcutaneous tissue disorders Pruritus 5 1 Hyperhidrosis 3 <1 Pru…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 2 includes clinically significant drug interactions with tapentadol hydrochloride oral solution. Table 2 Clinically Significant Drug Interactions with tapentadol hydrochloride oral solution 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 [Warnings and Precautions (5.4)] .
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 [see Dosage and Administration (2.2), Warnings and Precautions (5.2, 5.3, 5.4)] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Warnings and Precautions (5.8)].
Intervention: If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue tapentadol hydrochloride oral solution if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.3)] Intervention: Do not use tapentadol hydrochloride oral solution in patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of tapentadol hydrochloride oral solution and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Tapentadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Intervention: Because respiratory depression may be greater than otherwise expected, decrease the dosage of tapentadol hydrochloride oral solution and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2), Warnings and Precautions (5.3, 5.4)]. Examples: cyclobenzaprine, metaxalone Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Intervention: Evaluate patients for si…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm (8.1) Lactation: Closely monitor infants of nursing women receiving tapentadol hydrochloride oral solution. (8.2) Moderate Hepatic Impairment : Follow closely for respiratory and central nervous system depression. (2.5, 8.6, 12.3) Severe Hepatic or Renal Impairment: Use not recommended. (8.6, 8.7) Pediatric Patients with Hepatic or Renal Impairment: Use not recommended. (8.4)
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . Available data with tapentadol hydrochloride oral solution in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are risks to the mother and infant associated with use of tapentadol hydrochloride oral solution for an extended period of time during pregnancy (see Clinical Considerations).
In animal reproduction studies, embryofetal mortality and structural malformations were observed with subcutaneous administration of tapentadol during organogenesis to rabbits and delays in skeletal maturation were observed in rats at exposures equivalent to and less than the maximum recommended human dose (MRHD), respectively. When administered to pregnant rats during organogenesis and through lactation, increased pup mortality was noted following oral tapentadol exposures to doses equivalent to the MRHD [see Data] .
Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.
The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.5)] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Tapentadol hydrochloride oral solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including tapentadol hydrochloride oral solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.
However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Tapentadol hydrochloride was evaluated for teratogenic effects in pregnant rats and rabbits following subcutaneous exposure during organogenesis.
When tapentadol was administered twice daily by the subcutaneous route in rats at dose levels of 10, 20, or 40 mg/kg/day [producing up to 1 times the plasma exposu…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . Available data with tapentadol hydrochloride oral solution in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are risks to the mother and infant associated with use of tapentadol hydrochloride oral solution for an extended period of time during pregnancy (see Clinical Considerations).
In animal reproduction studies, embryofetal mortality and structural malformations were observed with subcutaneous administration of tapentadol during organogenesis to rabbits and delays in skeletal maturation were observed in rats at exposures equivalent to and less than the maximum recommended human dose (MRHD), respectively. When administered to pregnant rats during organogenesis and through lactation, increased pup mortality was noted following oral tapentadol exposures to doses equivalent to the MRHD [see Data] .
Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.
The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.5)] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Tapentadol hydrochloride oral solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including tapentadol hydrochloride oral solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.
However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Tapentadol hydrochloride was evaluated for teratogenic effects in pregnant rats and rabbits following subcutaneous exposure during organogenesis.
When tapentadol was administered twice daily by the subcutaneous route in rats at dose levels of 10, 20, or 40 mg/kg/day [producing up to 1 times the plasma exposure at the maximum recommended human dose (MRHD) of 700 mg/day based on an area under the time-curve (AUC) comparison], no teratogenic effects were observed. Evidence of embryo fetal toxicity included transient delays in skeletal maturation (i.e. reduced ossification) at the 40 mg/kg/day dose which was associated with significant maternal toxicity. Administration of tapentadol hydrochloride in rabbits at doses of 4, 10, or 24 mg/kg/day by…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of tapentadol hydrochloride oral solution in pediatric patients less than 6 years of age or who weigh less than 16 kg have not been established. Tapentadol hydrochloride oral solution has not been studied in pediatric patients with hepatic or renal impairment; therefore, use in these populations is not recommended [see Dosage and Administration (2.4)] . Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA oral solution.
However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients in Phase 2/3 double-blind, multiple-dose clinical studies of tapentadol hydrochloride, 19% were 65 and over, while 5% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The rate of constipation was higher in subjects greater than or equal to 65 years than those less than 65 years (12% vs.
7%). Elderly patients (aged 65 years or older) may have increased sensitivity to tapentadol. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of tapentadol hydrochloride oral solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.9)] . Tapentadol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Presentation Acute overdosage with tapentadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations [see Clinical Pharmacology (12.2)] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.
Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures.
For clinically significant respiratory or circulatory depression secondary to tapentadol overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of tapentadol in tapentadol hydrochloride oral solution, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed in the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.
12.2Pharmacodynamics Effects on the Central Nervous System (CNS) Tapentadol produces respiratory depression by direct action on the brainstem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Tapentadol causes miosis, even in total darkness.
Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Effects on the Gastrointestinal Tract and on Other Smooth Muscle Tapentadol causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED).
Effects on the Cardiovascular System There was no effect of therapeutic and supratherapeutic doses of tapentadol on the QT interval. In a randomized, double-blind, placebo- and positive-controlled crossover study, healthy subjects were administered five consecutive doses of tapentadol hydrochloride 100 mg every 6 hours, tapentadol hydrochloride 150 mg every 6 hours, placebo and a single oral dose of moxifloxacin. Similarly, tapentadol hydrochloride had no relevant effect on other ECG parameters (heart rate, PR interval, QRS duration, T-wave or U-wave morphology).
Tapentadol produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6.2)] .
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon [see Adverse Reactions (6.2)] . Use of opioids for an extended period of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6.2)] .
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration-Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with opioid agonists. The minimum effective analgesic concentration of tapentadol for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the de…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Tapentadol Hydrochloride Oral Solution, 20 mg/mL, is available as a clear, colorless solution free from visible particulate matter. Supplied with calibrated syringes for adult dosing. Tapentadol Hydrochloride Oral Solution, 20 mg/mL, is available as: Bottles of 100 mL (NDC 70954-801-10) Bottles of 200 mL (NDC 70954-801-20) Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Store the oral solution bottle upright after opening. Store Tapentadol Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information (17)] .
📋 Description ▾
11 DESCRIPTION Tapentadol hydrochloride oral solution is a mu-opioid receptor agonist, available in a liquid solution for oral administration. The chemical name is 3-[(1 R ,2 R )-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride and it has the following chemical structure: The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C 14 H 23 NO·HCl. The n-octanol:water partition coefficient log P value is 2.87.
The pKa values are 9.34 and 10.45. Tapentadol Hydrochloride Oral Solution is supplied as a clear, colorless solution free from visible particulate matter and contains 20 mg/mL of tapentadol (corresponding to 23 mg/mL of tapentadol hydrochloride). The inactive ingredients in tapentadol hydrochloride oral solution include: citric acid anhydrous, purified water, artificial raspberry flavor (flavoring ingredients, propylene glycol), sodium hydroxide, and sucralose. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal : Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store tapentadol hydrochloride oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving tapentadol hydrochloride oral solution unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.2, 5.3), Drug Abuse and Dependence (9.2)] .
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused tapentadol hydrochloride oral solution should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Medication Errors Instruct patients and caregivers how to measure and take or administer the correct dose of tapentadol hydrochloride oral solution, and to always use the enclosed syringe when administering tapentadol hydrochloride oral solution to correctly measure the prescribed amount of medication for adult patients.. Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure tapentadol hydrochloride oral solution [see Dosage and Administration (2), Warnings and Precautions (5.1)] .
If the prescribed concentration is changed, instruct patients and caregivers on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death. Addiction, Abuse, and Misuse Inform patients that the use of tapentadol hydrochloride oral solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions ( 5.2 )]. Instruct patients not to share tapentadol hydrochloride oral solution with others and to take steps to protect tapentadol hydrochloride oral solution from theft or misuse.
Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting tapentadol hydrochloride oral solution or when the dosage is increased, and that it can occur even at recommended dosages . Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.3)] .
Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3)] . Interactions with Benzodiazepines and Other CNS Depressants Inform patients that potentially fatal serious additive effects may occur if tapentadol hydrochloride oral solution is used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.4), Drug Interactions (7)].
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid…
💬 Medication Guide ▾
MEDICATION GUIDE Medication Guide Tapentadol Hydrochloride (ta-PEN-ta-dol hai·drow·klaw·ride) Oral Solution, CII Tapentadol hydrochloride oral solution is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about tapentadol hydrochloride oral solution: Get emergency help or call 911 right away if you take too much tapentadol hydrochloride oral solution (overdose) . When you first start taking tapentadol hydrochloride oral solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
Taking tapentadol hydrochloride oral solution with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your tapentadol hydrochloride oral solution. They could die from taking it.
Selling or giving away tapentadol hydrochloride oral solution is against the law. Store tapentadol hydrochloride oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take tapentadol hydrochloride oral solution if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines.
Before taking tapentadol hydrochloride oral solution, tell your healthcare provider if you have a history of: head injury, seizures liver, kidney, thyroid problems problems urinating pancreas or gallbladder problems abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems. Tell your healthcare provider if you are: noticing your pain getting worse. If your pain gets worse after you take tapentadol hydrochloride oral solution, do not take more of tapentadol hydrochloride oral solution without first talking to your healthcare provider.
Tell your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking tapentadol hydrochloride oral solution. pregnant or planning to become pregnant. Use of tapentadol hydrochloride oral solution for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding. Tapentadol hydrochloride oral solution passes into breast milk and may harm your baby.
Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs. living in a household where there are small children or someone who has abused street or prescription drugs. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tapentadol hydrochloride oral solution with certain other medicines can cause serious side effects that could lead to death.
When taking tapentadol hydrochloride oral solution: Do not change your dose. Take tapentadol hydrochloride oral solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
For acute (short-term) pain, you may only need to take tapentadol hydrochloride oral solution for a few days. You may have some tapentadol hydrochloride oral solution left over that you did…