Description

Tapentadol oral solution and tablets are used to treat pain so severe that opioid treatment is required, and when other pain relievers are ineffective or cannot be tolerated. The extended-release tablet is used to treat severe pain, including pain caused by nerve damage in diabetes. It should not be used to treat pain that occurs only occasionally or is treated “as needed.” Tapentadol belongs to a group of medications called narcotic analgesics (pain relievers), which act on the central nervous system (CNS) to relieve pain.

Prolonged use of tapentadol can cause addiction (which can lead to psychological or physical dependence). However, people with chronic pain should not allow the fear of addiction to deter them from using pain relievers. Psychological dependence (addiction) is unlikely to occur with the use of narcotics for this purpose. Physical dependence can lead to withdrawal symptoms if treatment is suddenly discontinued. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before stopping treatment completely.

This medication is available only through a restricted distribution program called opioid analgesic REMS (Risk and Mitigation Strategy).

This product is available in the following  forms:

• Extended-release tablet
• tablet

Before use

When deciding to use a medication, the risks of taking it must be weighed against the benefits. This decision is made by you and your doctor. The following should be considered with this medication:

Allergies:
Tell your doctor if you have ever had an unusual or allergic reaction to this or any other medication. Also tell your healthcare provider if you have any other allergies, such as those to food, dyes, preservatives, or animals. For nonprescription products, read the label or package ingredients carefully.

Pediatric:
Appropriate studies have not been conducted to evaluate the relationship between age and the effects of tapentadol extended-release tablets, immediate-release tablets, and oral liquids in children, or for tablets in children under 6 years of age and weighing less than 40 kilograms (kg). Safety and effectiveness have not been established.

Geriatric:
Appropriate studies conducted to date have not revealed any geriatric-specific problems that would limit the usefulness of tapentadol in the elderly. However, elderly patients are more likely to experience constipation and age-related lung, liver, or kidney problems, which may require caution and dose adjustment in patients receiving tapentadol.

Breastfeeding:
There are no adequate studies in women to determine the risk to infants from using this drug while breastfeeding. Weigh the potential benefits against the potential risks before using this drug while breastfeeding.

Drug interactions

While certain medications should not be used together at all, in other cases two different medications can be used together even if an interaction could occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. It is especially important that your healthcare provider know if you are taking any of the following medications. The following interactions have been selected based on their potential significance and are not necessarily exhaustive.

Using this medication with any of the following drugs is not recommended. Your doctor may decide not to treat you with this drug or may change some of the other medications you are taking.

• Isocarboxazid
• Linezolid
• Methyl blue
• Naltrexone
• Phenelzin
• Procarbazine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• Tranylcypromine

Using this medication with any of the following drugs is not usually recommended, but may be necessary in some cases. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both drugs.

Further interactions

Some medications should not be taken at the same time as or near the intake of certain foods, as interactions may occur. The use of alcohol or tobacco with certain medications may also cause interactions. The following interactions were selected based on their potential significance and are not necessarily exhaustive.

Using this medication with any of the following is not usually recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medication, or give you special instructions regarding the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems

The presence of other medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

• Problems with the adrenal glands
• Alcohol abuse or history
• History of a brain tumor
• Breathing or other lung problems (e.g. COPD, sleep apnea)
• History of depression
• History of drug abuse or addiction
• Gallbladder problems
• History of head injuries
• Increased pressure in the head
• Kyphoscoliosis (severe curvature of the spine that can cause breathing problems)
• Weakened health – Caution advised. May increase the risk of more serious side effects.
• Asthma, acute or severe
• Severe breathing or lung problems
• Gastric or intestinal obstruction (including paralytic ileus) – Should not be used in patients with these conditions.
• diabetes

Correct application

Take this medication only as directed by your doctor. Do not take more of it, more often, or for a longer time than your doctor has prescribed. This is especially important for elderly patients, who may be more sensitive to the effects of painkillers. If too much of this medication is taken for a long time, it may cause addiction (psychological or physical dependence) or an overdose.

It’s very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of tapentadol. This medication should also come with a Medication Guide. Read and follow these instructions carefully. Read them again each time you refill your prescription in case there’s new information. Ask your doctor if you have any questions.

You can take this medicine with or without food.

Swallow the extended-release tablet whole, one at a time, with plenty of water. Do not crush, break, loosen, or chew it.

Measure the oral fluid using the marked dosing syringe provided with the package. Your dose must be measured and administered accurately to avoid overdose.

dosage

The dosage of this medication will vary for different patients. Follow your doctor’s instructions or the directions on the label. The following information contains only the average doses of this medication. If your dose is different, do not change it unless directed by your doctor.

 (extended-release tablets):

• For severe pain:
  • Patients switching from Nucynta® to Nucynta® ER:
    • Adults – The tablet is taken every 12 hours. The total amount in milligrams (mg) per day corresponds to the total amount of regular tapentadol taken per day. The total daily amount is divided into 2 doses. However, the dose is usually no more than 500 mg per day.
    • Children – Use and dosage must be determined by your doctor.
  • For patients not taking narcotic medications:
    • Adults – Initially, 50 milligrams (mg) twice daily (every 12 hours). Your doctor may adjust the dose as needed. However, the dose should usually not exceed 500 mg per day.
    • Children – Use and dosage must be determined by your doctor.

 (immediate release tablets):

• For moderate to severe pain:
  • Adults – Initially, 50 to 100 milligrams (mg) every 4 to 6 hours. Your doctor may adjust the dose as needed.
  • Children – Use and dosage must be determined by your doctor.

 form (solution):

• For moderate to severe pain:
  • Adults – Initially, 2.5 milliliters (mL) (50 milligrams [mg]), 3.75 mL (75 mg), or 5 mL (100 mg) every 4 to 6 hours. On the first day of treatment, 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 doctor may adjust the dose as needed.
  • Children – Use and dosage must be determined by your doctor.

For oral dosage form (tablets):

• For moderate to severe pain:
  • Adults – Initially, 50 to 100 milligrams (mg) every 4 to 6 hours. On the first day of treatment, 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 doctor may adjust the dose as needed and tolerable.
  • Children 6 years of age and older weighing 80 kilograms (kg) or more – 50 mg every 4 hours. Your doctor may adjust the dose as needed and tolerable. However, the dose should generally not exceed 100 mg per dose.
  • Children 6 years and older weighing 60 to 79 kg – 50 mg every 4 hours. Your doctor may adjust the dose as needed and tolerable. However, the dose should generally not exceed 75 mg per dose.
  • Children aged 6 years and older weighing 40 to 59 kg – 50 mg every 4 hours.
  • Children under 6 years of age and weighing less than 40 kg – use and dosage must be determined by your doctor.