Side effects of nucynta

Nucynta IR

How does this medication work? What will it do for me?

Tapentadol belongs to a class of pain relievers known as opioid analgesics (also known as narcotic analgesics) that act on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

It is used to treat moderate to moderately severe pain in adults.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

50 mg
Each yellow, round, biconvex, film-coated tablet debossed with “O-M” on one side and “50” on the other side contains tapentadol 50 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K29 to K32). Film coating: D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

75 mg
Each yellow-orange, round, biconvex, film-coated tablet debossed with “O-M” on one side and “75” on the other side contains tapentadol 75 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K29 to K32). Film coating: D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

100 mg

Each orange, round, biconvex, film-coated tablet debossed with “O-M” on one side and “100” on the other side contains tapentadol 100 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K29 to K32). Film coating: FD&C Yellow No. 6 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

How should I use this medication?

The recommended starting dose (for people who are not currently taking opioid pain relievers) is 50 mg to 100 mg every 4 to 6 hours depending on the level of your pain. The dose may be increased depending on how the medication is tolerated and how well it works for your pain. The maximum total daily dose on the first day is 700 mg. On the second and subsequent days of treatment, the maximum total daily dose is 600 mg.

If you have been taking another opioid medication, the starting dose of tapentadol may be higher, depending on the dose of the other medication. Your doctor will determine the most appropriate starting dose.

Always swallow the tablet whole with sufficient liquid. You may take the tablets on an empty stomach or with meals.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Stopping the medication suddenly may cause withdrawal symptoms (such as restlessness, irritability, nausea and vomiting, diarrhea, sweating, chills, muscle aches, or watery eyes and nose). Do not stop taking this medication without checking with your doctor first. Your doctor will advise you on how to stop the medication safely.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children and pets. Accidental use by a child is a medical emergency and may result in death.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take tapentadol if you:

  • are allergic to tapentadol, or any ingredients of the medication
  • are allergic to opioids
  • are also taking MAO inhibitors (certain medications used for treatment of depression) or have taken them in the last 14 days before treatment with tapentadol
  • are pregnant, in labour, or breast-feeding
  • have a head injury, increased intracranial pressure (pressure inside the head), or severe central nervous system depression (a slowing of the central nervous system leading to decreased heart rate, decreased breathing rate, or loss of consciousness)
  • have asthma or dangerously slow or shallow breathing (respiratory depression, hypercapnia)
  • have convulsions or a seizure disorder
  • have pain that can be controlled by occasional use of painkillers or by painkillers available without a prescription
  • have paralysis of the gut or a bowel obstruction
  • have severe kidney or liver dysfunction
  • are addicted to alcohol

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • dizziness
  • drowsiness
  • headache
  • nausea
  • tiredness
  • vomiting

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • opioid withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety, and shivering (these may occur after converting from your previous opioid analgesic to tapentadol or converting from tapentadol to another opioid)
  • severe dizziness when getting up from a sitting or lying position

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
  • symptoms of too much medication (e.g., extreme sleepiness, a slow heartbeat, cold, clammy skin, feeling faint, confused, or being unable walk or talk normally)
  • trouble breathing or slow or shallow breathing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal (stomach) conditions: As with other narcotic medications, tapentadol may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Addiction: Tapentadol may lead to physical and psychological addiction. Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medications, or street drugs.

Alcohol use: People taking this medication should not consume alcohol since doing so can reduce the effectiveness of this medication and increase the risk of side effects. It is not recommended for people with alcohol abuse problems.

Breathing: Tapentadol can suppress breathing. This effect on breathing may be more pronounced for people with breathing problems, brain damage, or who are taking other medications that suppress breathing (e.g., codeine, morphine). If you have breathing problems, such as COPD, asthma or respiratory depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with this medication. Severe withdrawal symptoms may be experienced (e.g., seizures) if the dose is significantly reduced or suddenly stopped. Withdrawal symptoms include irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.

Drowsiness/reduced alertness: This medication may cause drowsiness or reduced alertness. Avoid driving or engaging in other activities requiring alertness unless and until you know how the medication affects you. Alcohol and antianxiety medications can increase the drowsiness caused by this medication.

Head injury: Tapentadol can cause increased pressure inside the head. If you have acute head injuries or other conditions which increase their intracranial pressure (pressure inside the head) discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The safety and effectiveness of tapentadol has not been established for people with reduced kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Overdose: If you experience the following symptoms after taking very high doses, seek medical help immediately:

  • breathing that is stopped or dangerously slow or shallow
  • collapse
  • disturbed consciousness or coma (deep unconsciousness)
  • drop in blood pressure
  • fast heart beat
  • pin-point pupils
  • vomiting
  • seizures

Pancreatitis: If you have a history of pancreatitis (inflammation of the pancreas), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Seizures: There have been reports of seizures occurring with tapentadol. Seizures are more likely to occur when higher doses of this medication are taken. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed..

Serotonin Syndrome: Severe reactions are possible when tapentadol is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

Pregnancy: This medication should not be used during pregnancy, prior to or during labour. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if tapentadol passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Tapentadol is not recommended for use by people under 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between tapentadol and any of the following:

  • alcohol
  • amphetamines (e.g., dexamphetamine, lisdexamphetamine)
  • anesthetics
  • anti-emetic medications (serotonin antagonists; e.g., granisetron, ondansetron)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aripiprazole
  • azelastine
  • baclofen
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • bromocriptine
  • buprenorphine
  • buspirone
  • butorphanolcabergoline
  • carbamazepine chloral hydrate
  • cyclobenzaprine
  • desmopressin
  • desvenlafaxine
  • dextromethorphan
  • efavirenz
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • gabapentin
  • guanfacine
  • lamotrigine
  • levetiracetam
  • linezolid
  • lithium
  • magnesium sulfate
  • MAO inhibitors (certain medications for the treatment of depression, e.g., moclobemide, phenelzine, selegiline, tranylcypromine)
  • methylene blue
  • metoclopramide
  • mirtazapine
  • muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • olopatadine
  • paraldehyde
  • peginterferon alfa-2b
  • pentazocine
  • phenytoin
  • phenobarbital
  • pramipexole
  • procarbazine
  • rasagiline
  • ropinirole
  • scopolamine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • topiramate
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
  • “triptan” migraine medications (e.g., eletriptan, sumatriptan)
  • tryptophan
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Nucynta-IR

tapentadol (Nucynta, Nucynta ER)

Brand Names: Nucynta, Nucynta ER

Generic Name: tapentadol

  • What is tapentadol (Nucynta, Nucynta ER)?
  • What are the possible side effects of tapentadol (Nucynta, Nucynta ER)?
  • What is the most important information I should know about tapentadol (Nucynta, Nucynta ER)?
  • What should I discuss with my healthcare provider before taking tapentadol (Nucynta, Nucynta ER)?
  • How should I take tapentadol (Nucynta, Nucynta ER)?
  • What happens if I miss a dose (Nucynta, Nucynta ER)?
  • What happens if I overdose (Nucynta, Nucynta ER)?
  • What should I avoid while taking tapentadol (Nucynta, Nucynta ER)?
  • What other drugs will affect tapentadol (Nucynta, Nucynta ER)?
  • Where can I get more information (Nucynta, Nucynta ER)?

What is tapentadol (Nucynta, Nucynta ER)?

Tapentadol is an opioid medication used to treat moderate to severe pain.

The extended-release form of this medicine (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Tapentadol may also be used for purposes not listed in this medication guide.

Nucynta 100 mg

round, orange, imprinted with O-M, 100

Nucynta 50 mg

round, yellow, imprinted with O-M, 50

Nucynta 75 mg

round, orange, imprinted with O-M, 75

What are the possible side effects of tapentadol (Nucynta, Nucynta ER)?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • weak or shallow breathing, weak pulse, slow heartbeat;
  • a light-headed feeling, like you might pass out;
  • agitation, feeling hot;
  • seizure (convulsions);
  • severe drowsiness or dizziness, confusion, problems with speech or balance;
  • infertility, missed menstrual periods;
  • impotence, sexual problems, loss of interest in sex; or
  • low cortisol levels– nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • constipation, mild nausea, stomach pain;
  • headache, tired feeling; or
  • mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tapentadol (Nucynta, Nucynta ER)?

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

SIDE EFFECTS

The following adverse reactions are discussed, or described in greater detail in other sections:

  • Addiction, Abuse, and Misuse
  • Life-Threatening Respiratory Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Interactions with CNS Benzodiazepine or Other Depressants
  • Serotonin Syndrome
  • Adrenal Insufficiency
  • Severe Hypotension
  • Gastrointestinal Adverse Reactions
  • Seizures
  • Withdrawal

Clinical Trials Experience

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 NUCYNTA dose group) were: nausea, dizziness, vomiting and somnolence.

NUCYNTAwas 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 NUCYNTA dosed every 4 to 6 hours.

The data described below reflect exposure to NUCYNTA in 3161 patients, including 449 exposed for 45 days. NUCYNTA 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 NUCYNTA doses of 50 mg, 75 mg, or 100 mg every 4 to 6 hours.

Table 1 Adverse Reactions Reported by ≥1% of NUCYNTA-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 NUCYNTA
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
Pruritus generalized 3 <1
Rash 1 <1
Vascular disorders
Hot flush 1 <1

The following adverse drug reactions occurred in less than 1% of NUCYNTA-treated patients in the pooled safety data from nine Phase 2/3 clinical studies:

Cardiac disorders: heart rate increased, heart rate decreased

Eye disorders: visual disturbance

Gastrointestinal disorders: abdominal discomfort, impaired gastric emptying

General disorders and administration site conditions: irritability, edema, drug withdrawal syndrome, feeling drunk

Immune system disorders: hypersensitivity

Investigations: gamma-glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased

Musculoskeletal and connective tissue disorders: involuntary muscle contractions, sensation of heaviness

Nervous system disorders: hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, depressed level of consciousness, memory impairment, ataxia, presyncope, syncope, coordination abnormal, seizure

Psychiatric disorders: euphoric mood, disorientation, restlessness, agitation, nervousness, thinking abnormal

Renal and urinary disorders: urinary hesitation, pollakiuria

Respiratory, thoracic and mediastinal disorders: oxygen saturation decreased, cough, dyspnea, respiratory depression

Skin and subcutaneous tissue disorders: urticarial

Vascular disorders: blood pressure decreased

In the pooled safety data, the overall incidence of adverse reactions increased with increased dose of NUCYNTA, as did the percentage of patients with adverse reactions of nausea, dizziness, vomiting, somnolence, and pruritus.

Post-Marketing Experience

The following additional adverse reactions have been identified during post-approval use of tapentadol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: diarrhea

Nervous system disorders: headache

Psychiatric disorders: hallucination, suicidal ideation, panic attack

Cardiac disorders: palpitations

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in NUCYNTA oral solution.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids .

Read the entire FDA prescribing information for Nucynta (Tapentadol Immediate-Release Oral Tablets)

Tapentadol

Tapentadol may be habit forming, especially with prolonged use. Take tapentadol exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking tapentadol, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse tapentadol if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Tapentadol may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will adjust your dose to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take tapentadol. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), a head injury, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weakened or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications during your treatment with tapentadol may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor if you are taking or plan to take any of the following medications: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); other narcotic pain medications; medications for mental illness or nausea; muscle relaxants; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take tapentadol with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with tapentadol increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment with tapentadol.

Do not allow anyone else to take your medication. Tapentadol may harm or cause death to other people who take your medication, especially children. Keep tapentadol in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep tapentadol out of the reach of children. Keep track of how many tablets or extended-release tablets are left so you will know if any medication is missing. Flush any tablets or extended-release tablets that are outdated or no longer needed down the toilet so that others will not take them.

If you are taking the extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.

Tell your doctor if you are pregnant or plan to become pregnant. If you take tapentadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Talk to your doctor about the risks of taking tapentadol.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin your treatment with tapentadol and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

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