Nucynta

1 What is Nucynta?

Brand: Nucynta, Nucynta ER

Generic: Tapentadol

Nucynta is a narcotic analgesic that acts in the central nervous system for the relief of severe pain including pain caused by nerve damage from diabetes.

Prolonged use of this drug can cause mental or physical dependence. Physical dependence may lead to side effects when you stop taking the drug. This drug requires a prescription.

2 What to Know Before Using

Before using Nucynta, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of tapentadol have not been performed while safety and efficacy have not been established. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of tapentadol.

Adjustments in the dose of the elderly may be required since they are more likely to have age-related kidney, liver, or heart problems. Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding.

Discuss with your healthcare professional about potential risks and benefits of taking this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • CNS Depressants
  • Monoamine Oxidase Inhibitors
  • Serotonergic drugs
  • Mixed Agonist/Antagonist Opioid Analgesics
  • Anticholinergics
  • Alcohol
  • Opioids
  • Drugs of abuse

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

  • Alcohol abuse
  • Brain tumor
  • Breathing or other lung problems
  • Depression
  • Drug abuse or dependence
  • Gallbladder problems
  • Head injuries
  • Kyphoscoliosis
  • Weakened physical condition
  • Paralytic ileus
  • Respiratory depression
  • Hypotension
  • Pancreatitis
  • Seizures or Epilepsy
  • Kidney disease
  • Liver disease

3 Proper Usage

To use Nucynta properly, you must follow all instructions given by your doctor. To prevent any side effects, take this drug exactly as directed on the label. You can take this drug with or without food.

The extended-release tablet must be swallowed whole, one tablet at a time, with enough water. Crushing, breaking, dissolving, or chewing the drug is not recommended. The oral liquid must be measured accurately with the marked dosing syringe that comes with the package to avoid any chance of overdose.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with severe pain are given a tablet every 12 hours. The total amount of milligrams per day is the same as the total amount of regular tapentadol that is taken per day. The total amount per day will be divided and given as 2 doses during the day. The dose must not exceed 500 mg per day.

Use and dose in children must be determined by your healthcare professional. Adults who are not taking narcotic drugs are initially given 50 milligrams two times a day. Your healthcare professional may adjust your dose if necessary.

The dose must not exceed 500 mg per day. Use and dose in children must be determined by your healthcare professional. Adults switching from other narcotic drugs are given a tablet every 12 hours.

The total amount of milligrams per day will be determined by your healthcare professional and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day.

The dose must not exceed 500 mg per day. Use and dose in children must be determined by your healthcare professional. Adults with nerve pain caused by diabetes are initially given 50 milligrams two times a day. Your healthcare professional may adjust your dose if necessary.

The dose must not exceed 500 mg per day. Use and dose in children must be determined by your healthcare professional. Adults with moderate to severe pain are initially given 2.5 milliliters, 3.75 mL, or 5 mL every 4 to 6 hours.

On the first day of dosing, the second dose may be given as soon as 1 hour after the first dose, if pain is not relieved with the first dose. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

Adults with moderate to severe pain are initially given 50 to 100 milligrams every 4 to 6 hours. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose. Store the drug in a closed container at room temperature, away from heat, moisture, and direct light.

Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Nucynta, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Seek immediate medical attention if you experience symptoms of anaphylaxis such as rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this drug.

It is not recommended to use this drug with a MAO inhibitor such as isocarboxazid, phenelzine, selegiline, tranylcypromine, EldeprylВ®, MarplanВ®, NardilВ®, or ParnateВ® within 14 days.

Contact emergency medical services if you experience symptoms of overdose such as difficult, fast or slow, irregular, shallow, or trouble breathing, pale or blue lips, fingernails, or skin, or shortness of breath.

This drug will potentiate the effects of alcohol and other CNS depressants such as:

  • Antihistamines or Drug for allergies or colds
  • Sedatives, Tranquilizers, or Sleeping drug
  • Other prescription pain drug or narcotics
  • Drug for seizures or barbiturates
  • Muscle relaxants
  • Anesthetics, including some dental anesthetics

This drug may cause dizziness, lightheadedness, fainting, drowsiness, or reduced alertness. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous.

Getting up slowly from a lying or sitting position may also help. Check with your healthcare professional first before you take any other drugs to prevent a serious condition called serotonin syndrome.

Call your healthcare professional immediately if you have a fever, confusion, restlessness, loss of coordination, or diarrhea. Check with your healthcare professional before changing your dose or suddenly stop taking this drug if you have been using this drug regularly for several weeks or longer.

Your healthcare professional may slowly taper the amount you are using before stopping it completely to reduce the possibility of withdrawal symptoms, such as:

  • Abdominal or Stomach cramps
  • Anxiety
  • Fever
  • Nausea
  • Runny nose
  • Sweating
  • Tremors
  • Trouble with sleeping

Using narcotics for a long time can cause severe constipation. To prevent this, your healthcare professional may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.

Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems. Using this drug while you are pregnant may cause serious unwanted effects in your newborn baby.

Tell your healthcare professional right away if you think you are pregnant or if you plan to become pregnant while using this drug. Consult with your healthcare professional before you take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Nucynta. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Bladder pain
  • Bloody or Cloudy urine
  • Body aches or pain
  • Chills
  • Cough
  • Difficult, Burning, or Painful urination
  • Difficulty with breathing
  • Fever
  • Headache
  • Loss of voice
  • Lower back or side pain
  • Muscle aches
  • Unusual tiredness or weakness
  • Anxiety
  • Being forgetful or Confused
  • Clumsiness or Unsteadiness
  • Convulsions
  • Drowsiness
  • Fast or Irregular heartbeat
  • Feeling drunk
  • Irritability or restlessness
  • Joint pain, stiffness, or swelling
  • Pale or Blue lips, fingernails, or skin
  • Rash, Hives, or Itching
  • Sensation of heaviness
  • Shakiness or trembling
  • Slurred speech
  • Swelling of the eyelids, face, lips, hands, or feet
  • Tightness in the chest
  • Trouble with speaking or hoarseness
  • Troubled breathing or swallowing
  • Changes in behavior
  • Dizziness
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Seeing, hearing, or feeling things that are not there
  • Thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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