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What is Nucynta (Tapentadol)?

Tapentadol (brand names: Nucynta, Palexia and Tapal) is a centrally acting opioid analgesic of the benzenoid class with a dual mode of action as an agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor (NRI). Analgesia occurs within 32 minutes of oral administration, and lasts for 4–6 hours. An opioid is sometimes called a narcotic.

It is similar to Tramadol in its dual mechanism of action; namely, its ability to activate the mu opioid receptor and inhibit the reuptake of norepinephrine. Unlike tramadol, it has only weak effects on the reuptake of serotonin and is a significantly more potent opioid with no known active metabolites. Tapentadol (Nucynta) is not a pro-drug and therefor does not rely on metabolism to produce its therapeutic effects; this makes it a useful moderate-potency analgesic option for patients who do not respond adequately to more commonly used opioids due to genetic disposition, as well as providing a more consistent dosage-response range among the patient population.

Nucynta Tapentadol general potency is somewhere between that of Tramadol and Morphine, with an analgesic efficacy comparable to that of Oxycodone despite a lower incidence of side effects. It is generally regarded as a weak-moderate strength opioid.
Tapentadol was approved by the US FDA in November, 2008, by the TGA of Australia in December 2010 and by the MHRA of the UK in February 2011.

Tapentadol is 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. Nucynta ER is not for use on an as-needed basis for pain.

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

Medical use

Nucynta and generic Tapentadol is used for the treatment of moderate to severe pain for both acute (following injury, surgery, etc.) and chronic musculoskeletal pain. It is also specifically indicated for controlling the pain of diabetic neuropathy when around-the-clock opioid medication is required.

Its general potency is somewhere between that of tramadol and morphine,with an analgesic efficacy comparable to that of oxycodone despite a lower incidence of side effects.

Nucynta and generic Tapentadol is Pregnancy Category C. There are no adequate and well-controlled studies of Tapentadol in pregnant women, and Tapentadol is not recommended for use in women during and immediately prior to labor and delivery.
There are no adequate and well-controlled studies of Nucynta and generic Tapentadol in children.

 

Important information about Nucynta and generic Tapentadol

Do not use Tapentadol if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
You should not use this medicine if you have severe breathing problems, or a bowel obstruction called paralytic ileus.

Nucynta and generic Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

Nucynta and generic Tapentadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.


Tell your doctor if you are pregnant. Tapentadol may cause life-threatening withdrawal symptoms in a newborn.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Tapentadol.

Before buying Nucynta and generic Tapentadol without prescription online

You should not use this medication if you are allergic to Tapentadol, or if you have: 

•    severe asthma or breathing problems; or
•    a bowel obstruction called paralytic ileus.

Do not use Tapentadol if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
Tapentadol may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Tapentadol to any other person is against the law.

To make sure Nucynta and generic Tapentadol is safe for you, tell your doctor if you have:

•    any type of breathing problem or lung disease;
•    a history of head injury, brain tumor, or seizures;
•    a history of drug abuse, alcohol addiction, or mental illness;
•    urination problems;
•    liver or kidney disease; or
•    problems with your gallbladder, pancreas, or thyroid.

Tapentadol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

It is not known whether this medicine will harm an unborn baby. If you use Tapentadol while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Tapentadol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. Do not give this medicine to a child.

How should I take Nucynta and generic Tapentadol?

Take Tapentadol exactly as prescribed. Follow all directions on your prescription label. Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Nucynta and generic Tapentadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Take this medicine with a full glass of water. Tapentadol can be taken with or without food.
Stop taking all other around-the-clock narcotic pain medications when you start taking Tapentadol extended-release tablets.
Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.
Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

While using this medicine, you may need frequent blood tests.
Do not stop using Nucynta and generic Tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Never crush or break a Nucynta or generic Tapentadol pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Tapentadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

What happens if I miss a dose of Nucynta or generic Tapentadol?

Since Tapentadol is used for pain, you are not likely to miss a dose. If you do miss a dose, take the medicine as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.
Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid when taking Nucynta or generic Tapentadol?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Tapentadol. Check your food and medicine labels to be sure these products do not contain alcohol.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Possible Nucynta and generic Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tapentadol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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;
•    seizure (convulsions);
•    severe drowsiness or dizziness, confusion, problems with speech or balance; or
•    signs of too much serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Common Tapentadol 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.

Tapentadol use dosage information

Usual Adult Dose for Pain:
Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Comments:


-Adjust the dosing regimen for each patient individually, taking into account the patient´s prior analgesic experience, general condition, other medications, and risk factors for abuse.


-On the first day of dosing, the second dose may be administered as soon as one hour later if adequate pain relief is not attained.
-May be taken with or without food.


-Consider starting elderly patients at the lower end of the recommended dose range.
-When the patient no longer requires therapy with this drug, gradually taper to prevent withdrawal symptoms in the physically dependent patient.




Extended release:
 Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day).

Note: No adequate data on converting patients from other opioids to Tapentadol extended release. 

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

Comments:


-Adjust the dosing regimen for each patient individually, taking into account the patient´s prior analgesic experience, general condition, other medications, and risk factors for abuse.


-Convert from immediate release to extended release using the equivalent total daily dose of the immediate release and divide it into 2 equal doses of the extended release separated by approximately 12 hour intervals.


-When converting from other opioids begin with half of the estimated daily Tapentadol requirement as the initial dose and manage inadequate analgesia with immediate release rescue medication.


-Consider starting elderly patients at the lower end of the recommended dose range.


-Monitor for respiratory depression, especially within the first 24-72 hours of initiating therapy.


-Titrate with dose increases of 50 mg no more than twice a day every three days.


-Efficacy was demonstrated relative to placebo between 100 and 250 mg twice a day.


-Tablets must be swallowed whole. Cutting, crushing, chewing, or dissolving this drug will result in uncontrolled delivery and could result in death.


-Discontinue all other Tapentadolapentadol, tramadol, and around-the-clock opioid products when taking this drug.
-When the patient no longer requires therapy with this drug, gradually taper to prevent withdrawal symptoms in the physically dependent patient.



Tapentadol Uses:

Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate; neuropathic pain associated with diabetic peripheral neuropathy in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

What other drugs will affect Nucynta and generic Tapentadol?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Nucynta and generic Tapentadol with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with Tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

History of Tapentadol.

Tapentadol was discovered by scientists at the German pharmaceutical company Grünenthal in the late 1980s led by Helmut Buschmann; the team started by analyzing the chemistry and activity of Tramadol, which had been discovered at the same company in 1962. Tramadol has several enantiomers, and each forms metabolites after processing in the liver. These Tramadol variants have varying activities at the μ-opioid receptor, the norepinephrine transporter, and the serotonin transporter, and differing half-lives, with the metabolites having the best activity. Using Tramadol as a starting point, the team aimed to discover a single molecule that minimized the serotonin activity, had strong μ-opioid receptor agonism and strong norepinephrine reuptake inhibition, and would not require metabolism to be active; the result was Tapentadol.

In 2003 Grünenthal partnered with two Johnson & Johnson subsidiaries, Johnson & Johnson Pharmaceutical Research and Development and Ortho-McNeil Pharmaceutical to develop and market Tapentadol; Johnson & Johnson had exclusive rights to sell the drug in the US, Canada, and Japan while Grünenthal retained rights elsewhere. In 2008 Tapentadol received FDA approval; in 2009 it was classified by DEA as a Schedule II drug, and entered the US market. Tapentadol was reported to be the "first new molecular entity of oral centrally acting analgesics" class approved in the United States in more than 25 years.

In 2010 Grünenthal granted Johnson & Johnson the right to market Tapentadol in about 80 additional countries. Later that year, Tapentadol was approved in Europe. In 2011, Nucynta ER, an extended release formulation of Tapentadol, was released in the United States for management of moderate to severe chronic pain and received FDA approval the following year for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.

After annual sales of $166 million, in January 2015, Johnson & Johnson sold its rights to market Tapentadol in the US to Depomed for $1 billion.

Nucynta and generic Tapentadol is only marketed in countries where appropriate controls exist. Since 2009 the drug has been categorized in the US as a Schedule II narcotic with ACSCN 9780; in 2014 it was allocated a 17,500 kilogram aggregate manufacturing quota. In 2010, Australia made Tapentadol an S8 controlled drug. The following year, Tapentadol was classified as a Class A controlled drug in the United Kingdom, and was also placed under national control in Cyprus, Estonia, Finland, Greece, Latvia and Spain. More recently, Canada made the opioid a Schedule I controlled drug. After performing a critical review, the United Nations Expert Committee on Drug Dependence in 2014 advised that Tapentadol not be placed under international control but remain under surveillance.



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