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NUCYNTA ER (TAPENTADOL HCL)
- Chronic pain
- Diabetic peripheral neuropathy
- Severe pain
100 mg tablet,extended release
- 1 tablet (100 mg) by oral route every 12 hours
150 mg tablet,extended release
- 1 tablet (150 mg) by oral route every 12 hours
200 mg tablet,extended release
- 1 tablet (200 mg) by oral route every 12 hours
250 mg tablet,extended release
- 1 tablet (250 mg) by oral route every 12 hours
50 mg tablet,extended release
- 1 tablet (50 mg) by oral route every 12 hours
Chronic pain
- 1 tablet (50 mg) by oral route every 12 hours
- 2 tablets (100 mg) by oral route every 12 hours
- 1 tablet (100 mg) by oral route every 12 hours
- 1 tablet (150 mg) by oral route every 12 hours
- 2 tablets (200 mg) by oral route every 12 hours
- 1 tablet (200 mg) by oral route every 12 hours
- 1 tablet (250 mg) by oral route every 12 hours
Diabetic peripheral neuropathy
- 1 tablet (50 mg) by oral route every 12 hours
- 2 tablets (100 mg) by oral route every 12 hours
- 1 tablet (100 mg) by oral route every 12 hours
- 1 tablet (150 mg) by oral route every 12 hours
- 2 tablets (200 mg) by oral route every 12 hours
- 1 tablet (200 mg) by oral route every 12 hours
- 1 tablet (250 mg) by oral route every 12 hours
Severe pain
- 1 tablet (50 mg) by oral route every 12 hours
- 2 tablets (100 mg) by oral route every 12 hours
- 1 tablet (100 mg) by oral route every 12 hours
- 1 tablet (150 mg) by oral route every 12 hours
- 2 tablets (200 mg) by oral route every 12 hours
- 1 tablet (200 mg) by oral route every 12 hours
- 1 tablet (250 mg) by oral route every 12 hours
- Azilect
- Depade
- Eldepryl
- ethyl alcohol-herbal drugs
- isocarboxazid
- linezolid
- Lydia Pinkham Herbal
- Marplan
- Matulane
- methylene blue (antidote)
- naltrexone
- naltrexone microspheres
- Nardil
- Parnate
- phenelzine
- procarbazine
- rasagiline
- Revia
- selegiline HCl
- tranylcypromine
- Vivitrol
- Zelapar
- Zyvox
Contraindicated
- almotriptan malate
- Alsuma
- Amerge
- amitriptyline
- amitriptyline-chlordiazepoxide
- amoxapine
- Amrix
- Anafranil
- Axert
- Buprenex
- buprenorphine
- buprenorphine-naloxone
- butorphanol tartrate
- Butrans
- carbamazepine
- Carbatrol
- clomipramine
- cyclobenzaprine
- cyclobenzaprine with msm
- desipramine
- doxepin
- eletriptan HBr
- Epitol
- Equetro
- Frova
- frovatriptan
- imipramine HCl
- imipramine pamoate
- Imitrex
- Imitrex Statdose Kit Refill
- Imitrex Statdose Pen
- maprotiline
- Maxalt
- Maxalt-mlt
- nalbuphine
- naratriptan
- Norpramin
- nortriptyline
- Pamelor
- perphenazine-amitriptyline
- protriptyline
- Relpax
- rizatriptan
- Silenor
- sodium oxybate
- Suboxone
- sumatriptan
- sumatriptan succinate
- Sumavel Dosepro
- Surmontil
- Tabradol
- Tegretol
- Tegretol Xr
- Tofranil
- Tofranil-pm
- trimipramine
- Vivactil
- Xyrem
- zolmitriptan
- Zomig
- Zomig Zmt
- Zubsolv
Severe
Moderate
- Brintellix
- Brisdelle
- Celexa
- citalopram
- Cymbalta
- desvenlafaxine
- desvenlafaxine fumarate
- desvenlafaxine succinate
- duloxetine
- Effexor Xr
- escitalopram oxalate
- Fanatrex
- Fetzima
- fluoxetine
- fluvoxamine
- gabapentin
- gabapentin enacarbil
- Gralise
- Gralise 30-day Starter Pack
- Horizant
- Khedezla
- levomilnacipran
- Lexapro
- Luvox Cr
- milnacipran
- Neurontin
- olanzapine-fluoxetine
- paroxetine HCl
- paroxetine mesylate
- Paxil
- Paxil Cr
- Pexeva
- Pristiq
- Prozac
- Prozac Weekly
- Sarafem
- Savella
- sertraline
- Symbyax
- venlafaxine
- Viibryd
- vilazodone
- vortioxetine
- Zoloft
- Acute asthma attack
- Child-pugh class C hepatic impairment
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Paralytic ileus
Contraindicated
- Acute pancreatitis
- Alcohol intoxication
- Child-pugh class B hepatic impairment
- Coma
- Drug abuse
- Gastrointestinal obstruction
- History of opioid overdose
- Hypotension
- Intracranial hypertension
- Respiratory depression
- Shock
- Sleep apnea
Severe
Moderate
- Adrenal cortical insufficiency
- Biliary tract disorder
- Cachexia
- Chronic obstructive pulmonary disease
- Constipation
- Cor pulmonale
- Debilitation
- Seizure disorder
- Untreated hypothyroidism
- Urinary retention
NUCYNTA ER (TAPENTADOL HCL)
- Chronic pain
- Diabetic peripheral neuropathy
- Severe pain
- Hypotension
- Constipation
- Dizziness
- Drowsy
- Headache disorder
- Nausea
- Vomiting
More Frequent
Severe
Less Severe
- Pruritus of skin
- Anorexia
- Blurred vision
- Chills
- Depression
- Disturbance of attention
- Dream disorder
- Dyspepsia
- Erectile dysfunction
- Fatigue
- Flushing
- Hyperhidrosis
- Insomnia
- Lethargy
- Symptoms of anxiety
- Tremor
- Vertigo
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute confusion
- Adrenal cortical insufficiency
- Anaphylaxis
- Androgen deficiency
- Angioedema
- Biliary spasm
- CNS depression
- Dyspnea
- Gastrointestinal hypomotility
- Intracranial hypertension
- Panic disorder
- Respiratory depression
- Seizure disorder
- Serotonin syndrome
- Severe hypotension
- Skin rash
- Sleep apnea
- Suicidal ideation
- Urticaria
Less Severe
- Acute abdominal pain
- Agitation
- Ataxia
- Diarrhea
- Dysarthria
- Euphoria
- Hallucinations
- Hypesthesia
- Increased urinary frequency
- Infertility
- Irritability
- Libido changes
- Memory impairment
- Palpitations
- Paresthesia
- Sedation
- Syncope
- Urinary hesitancy
- Visual changes
- Weight loss
Contraindicated
None
Severe Precaution
Tapentadol
Risk of respiratory depression. Safety and efficacy not established.
- 1 Day – 18 Years
- Risk of respiratory depression. Safety and efficacy not established.
Management or Monitoring Precaution
None
Tapentadol
- Severity Level:
C
- Additional Notes: Neonatal withdrawal/resp.depress. w/chronic or high dose
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Tapentadol
Low mw, may be excreted; monitor for infant withdrawal symptoms
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Low mw, may be excreted; monitor for infant withdrawal symptoms |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Tapentadol
Pulmonary-DO NOT USE in opioid intolerance. Life-threatening respiratory depression due to reduced clearance. Use cautiously with respiratory disease, when initiating, titrating and giving with other respiratory depressants. Consider naloxone Rx. Neuro/Psych-Risk for confusion, delirium and falls. Avoid treatment with 3 or more CNS active agents. Gastrointestinal-Increased rate of constipation in the elderly. Cardiovascular-Vasodilation may predispose to orthostatic hypotension.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | Y | Y | Y | Y | N |
BEERS: Y HEDIS: N STOPP: Y
No Known Risk
None
- Tapentadol has a risk for abuse and addiction, which can lead to overdose and death. Tapentadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tapentadol that works, and take it for the shortest possible time.<br /><br />See also How to Use section for more information about addiction. The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death.<br /><br />Be sure you know how to take tapentadol and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.<br /><br /> Do not crush, break, chew, or dissolve this medication. Also, do not drink alcohol or use any product that contains alcohol while taking this medication. Drinking alcohol with this medication or taking crushed, broken, chewed, or dissolved forms of extended-release tapentadol could cause serious (possibly fatal) overdose.<br /><br /> Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits.<br /><br />Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy.<br /><br />Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
| Chronic pain | |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.21 | Chronic pain due to trauma |
| G89.22 | Chronic post-thoracotomy pain |
| G89.28 | Other chronic postprocedural pain |
| G89.29 | Other chronic pain |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| Diabetic peripheral neuropathy | |
| E08.40 | Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified |
| E08.42 | Diabetes mellitus due to underlying condition with diabetic polyneuropathy |
| E09.40 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy, unspecified |
| E09.42 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy |
| E10.40 | Type 1 diabetes mellitus with diabetic neuropathy, unspecified |
| E10.42 | Type 1 diabetes mellitus with diabetic polyneuropathy |
| E11.40 | Type 2 diabetes mellitus with diabetic neuropathy, unspecified |
| E11.42 | Type 2 diabetes mellitus with diabetic polyneuropathy |
| E13.40 | Other specified diabetes mellitus with diabetic neuropathy, unspecified |
| E13.42 | Other specified diabetes mellitus with diabetic polyneuropathy |
| Severe pain | |
| G89 | Pain, not elsewhere classified |
| G89.1 | Acute pain, not elsewhere classified |
| G89.11 | Acute pain due to trauma |
| G89.12 | Acute post-thoracotomy pain |
| G89.18 | Other acute postprocedural pain |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.21 | Chronic pain due to trauma |
| G89.22 | Chronic post-thoracotomy pain |
| G89.28 | Other chronic postprocedural pain |
| G89.29 | Other chronic pain |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| M25.5 | Pain in joint |
| M25.50 | Pain in unspecified joint |
| M25.51 | Pain in shoulder |
| M25.511 | Pain in right shoulder |
| M25.512 | Pain in left shoulder |
| M25.519 | Pain in unspecified shoulder |
| M25.52 | Pain in elbow |
| M25.521 | Pain in right elbow |
| M25.522 | Pain in left elbow |
| M25.529 | Pain in unspecified elbow |
| M25.53 | Pain in wrist |
| M25.531 | Pain in right wrist |
| M25.532 | Pain in left wrist |
| M25.539 | Pain in unspecified wrist |
| M25.54 | Pain in joints of hand |
| M25.541 | Pain in joints of right hand |
| M25.542 | Pain in joints of left hand |
| M25.549 | Pain in joints of unspecified hand |
| M25.55 | Pain in hip |
| M25.551 | Pain in right hip |
| M25.552 | Pain in left hip |
| M25.559 | Pain in unspecified hip |
| M25.56 | Pain in knee |
| M25.561 | Pain in right knee |
| M25.562 | Pain in left knee |
| M25.569 | Pain in unspecified knee |
| M25.57 | Pain in ankle and joints of foot |
| M25.571 | Pain in right ankle and joints of right foot |
| M25.572 | Pain in left ankle and joints of left foot |
| M25.579 | Pain in unspecified ankle and joints of unspecified foot |
| M26.62 | Arthralgia of temporomandibular joint |
| M54.5 | Low back pain |
| M54.6 | Pain in thoracic spine |
| M79.6 | Pain in limb, hand, foot, fingers and toes |
| M79.60 | Pain in limb, unspecified |
| M79.601 | Pain in right arm |
| M79.602 | Pain in left arm |
| M79.603 | Pain in arm, unspecified |
| M79.604 | Pain in right leg |
| M79.605 | Pain in left leg |
| M79.606 | Pain in leg, unspecified |
| M79.609 | Pain in unspecified limb |
| M79.62 | Pain in upper arm |
| M79.621 | Pain in right upper arm |
| M79.622 | Pain in left upper arm |
| M79.629 | Pain in unspecified upper arm |
| M79.63 | Pain in forearm |
| M79.631 | Pain in right forearm |
| M79.632 | Pain in left forearm |
| M79.639 | Pain in unspecified forearm |
| M79.64 | Pain in hand and fingers |
| M79.641 | Pain in right hand |
| M79.642 | Pain in left hand |
| M79.643 | Pain in unspecified hand |
| M79.644 | Pain in right finger(s) |
| M79.645 | Pain in left finger(s) |
| M79.646 | Pain in unspecified finger(s) |
| M79.65 | Pain in thigh |
| M79.651 | Pain in right thigh |
| M79.652 | Pain in left thigh |
| M79.659 | Pain in unspecified thigh |
| M79.66 | Pain in lower leg |
| M79.661 | Pain in right lower leg |
| M79.662 | Pain in left lower leg |
| M79.669 | Pain in unspecified lower leg |
| M79.67 | Pain in foot and toes |
| M79.671 | Pain in right foot |
| M79.672 | Pain in left foot |
| M79.673 | Pain in unspecified foot |
| M79.674 | Pain in right toe(s) |
| M79.675 | Pain in left toe(s) |
| M79.676 | Pain in unspecified toe(s) |
| R07.82 | Intercostal pain |
| R10.0 | Acute abdomen |
| R10.1 | Pain localized to upper abdomen |
| R10.10 | Upper abdominal pain, unspecified |
| R10.11 | Right upper quadrant pain |
| R10.12 | Left upper quadrant pain |
| R10.2 | Pelvic and perineal pain |
| R10.3 | Pain localized to other parts of lower abdomen |
| R10.30 | Lower abdominal pain, unspecified |
| R10.31 | Right lower quadrant pain |
| R10.32 | Left lower quadrant pain |
| R10.33 | Periumbilical pain |
| R10.8 | Other abdominal pain |
| R10.84 | Generalized abdominal pain |
| R10.9 | Unspecified abdominal pain |
| R52 | Pain, unspecified |
| R68.84 | Jaw pain |
| 0-9 | A-Z |
|---|---|
| E08.40 | Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified |
| E08.42 | Diabetes mellitus due to underlying condition with diabetic polyneuropathy |
| E09.40 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy, unspecified |
| E09.42 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy |
| E10.40 | Type 1 diabetes mellitus with diabetic neuropathy, unspecified |
| E10.42 | Type 1 diabetes mellitus with diabetic polyneuropathy |
| E11.40 | Type 2 diabetes mellitus with diabetic neuropathy, unspecified |
| E11.42 | Type 2 diabetes mellitus with diabetic polyneuropathy |
| E13.40 | Other specified diabetes mellitus with diabetic neuropathy, unspecified |
| E13.42 | Other specified diabetes mellitus with diabetic polyneuropathy |
| G89 | Pain, not elsewhere classified |
| G89.1 | Acute pain, not elsewhere classified |
| G89.11 | Acute pain due to trauma |
| G89.12 | Acute post-thoracotomy pain |
| G89.18 | Other acute postprocedural pain |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.21 | Chronic pain due to trauma |
| G89.21 | Chronic pain due to trauma |
| G89.22 | Chronic post-thoracotomy pain |
| G89.22 | Chronic post-thoracotomy pain |
| G89.28 | Other chronic postprocedural pain |
| G89.28 | Other chronic postprocedural pain |
| G89.29 | Other chronic pain |
| G89.29 | Other chronic pain |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| M25.5 | Pain in joint |
| M25.50 | Pain in unspecified joint |
| M25.51 | Pain in shoulder |
| M25.511 | Pain in right shoulder |
| M25.512 | Pain in left shoulder |
| M25.519 | Pain in unspecified shoulder |
| M25.52 | Pain in elbow |
| M25.521 | Pain in right elbow |
| M25.522 | Pain in left elbow |
| M25.529 | Pain in unspecified elbow |
| M25.53 | Pain in wrist |
| M25.531 | Pain in right wrist |
| M25.532 | Pain in left wrist |
| M25.539 | Pain in unspecified wrist |
| M25.54 | Pain in joints of hand |
| M25.541 | Pain in joints of right hand |
| M25.542 | Pain in joints of left hand |
| M25.549 | Pain in joints of unspecified hand |
| M25.55 | Pain in hip |
| M25.551 | Pain in right hip |
| M25.552 | Pain in left hip |
| M25.559 | Pain in unspecified hip |
| M25.56 | Pain in knee |
| M25.561 | Pain in right knee |
| M25.562 | Pain in left knee |
| M25.569 | Pain in unspecified knee |
| M25.57 | Pain in ankle and joints of foot |
| M25.571 | Pain in right ankle and joints of right foot |
| M25.572 | Pain in left ankle and joints of left foot |
| M25.579 | Pain in unspecified ankle and joints of unspecified foot |
| M26.62 | Arthralgia of temporomandibular joint |
| M54.5 | Low back pain |
| M54.6 | Pain in thoracic spine |
| M79.6 | Pain in limb, hand, foot, fingers and toes |
| M79.60 | Pain in limb, unspecified |
| M79.601 | Pain in right arm |
| M79.602 | Pain in left arm |
| M79.603 | Pain in arm, unspecified |
| M79.604 | Pain in right leg |
| M79.605 | Pain in left leg |
| M79.606 | Pain in leg, unspecified |
| M79.609 | Pain in unspecified limb |
| M79.62 | Pain in upper arm |
| M79.621 | Pain in right upper arm |
| M79.622 | Pain in left upper arm |
| M79.629 | Pain in unspecified upper arm |
| M79.63 | Pain in forearm |
| M79.631 | Pain in right forearm |
| M79.632 | Pain in left forearm |
| M79.639 | Pain in unspecified forearm |
| M79.64 | Pain in hand and fingers |
| M79.641 | Pain in right hand |
| M79.642 | Pain in left hand |
| M79.643 | Pain in unspecified hand |
| M79.644 | Pain in right finger(s) |
| M79.645 | Pain in left finger(s) |
| M79.646 | Pain in unspecified finger(s) |
| M79.65 | Pain in thigh |
| M79.651 | Pain in right thigh |
| M79.652 | Pain in left thigh |
| M79.659 | Pain in unspecified thigh |
| M79.66 | Pain in lower leg |
| M79.661 | Pain in right lower leg |
| M79.662 | Pain in left lower leg |
| M79.669 | Pain in unspecified lower leg |
| M79.67 | Pain in foot and toes |
| M79.671 | Pain in right foot |
| M79.672 | Pain in left foot |
| M79.673 | Pain in unspecified foot |
| M79.674 | Pain in right toe(s) |
| M79.675 | Pain in left toe(s) |
| M79.676 | Pain in unspecified toe(s) |
| R07.82 | Intercostal pain |
| R10.0 | Acute abdomen |
| R10.1 | Pain localized to upper abdomen |
| R10.10 | Upper abdominal pain, unspecified |
| R10.11 | Right upper quadrant pain |
| R10.12 | Left upper quadrant pain |
| R10.2 | Pelvic and perineal pain |
| R10.3 | Pain localized to other parts of lower abdomen |
| R10.30 | Lower abdominal pain, unspecified |
| R10.31 | Right lower quadrant pain |
| R10.32 | Left lower quadrant pain |
| R10.33 | Periumbilical pain |
| R10.8 | Other abdominal pain |
| R10.84 | Generalized abdominal pain |
| R10.9 | Unspecified abdominal pain |
| R52 | Pain, unspecified |
| R68.84 | Jaw pain |
Formulary Reference Tool