Please see 3. SERIOUS WARNINGS AND PRECAUTIONS BOX. NAPO-TAPENTADOL (tapentadol) Page 12 of 58 General Patients should be instructed not to give APO-TAPENTADOL (tapentadol) tablets to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
APO-TAPENTADOL should be stored securely to avoid theft or misuse. APO-TAPENTADOL should only be prescribed by persons knowledgeable in the administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
Patients should be cautioned not to consume alcohol while taking APO-TAPENTADOL as it may increase the chance of experiencing serious adverse events, including death. Hyperalgesia that will not respond to a further dose increase of opioids can occur at particularly high doses.
A tapentadol dose reduction or change in opioid may be required. Abuse and Misuse Like all opioids, tapentadol is a potential drug of abuse and misuse, which can lead to overdose and death. Therefore, APO-TAPENTADOL should be prescribed and handled with caution.
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids, such as tapentadol, should be used with particular care in patients with a history of alcohol and illicit/prescription drug abuse.
However, concerns about abuse, addiction, and diversion should not prevent the proper management of pain. APO-TAPENTADOL is intended for oral use only. The tablets should be swallowed whole with sufficient liquid and not chewed or crushed.
Abuse of oral dosage forms can be expected to result in serious adverse events, including death. Carcinogenesis and Mutagenesis See 16. NON-CLINICAL TOXICOLOGY section. Cardiovascular Hypotension NAPO-TAPENTADOL (tapentadol) Page 13 of 58 Tapentadol administration may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of drugs such as phenothiazines and other tranquilizers, sedative/hypnotics, tricyclic antidepressants or general anesthetics.
These patients should be monitored for signs of hypotension after initiating or titrating the dose of tapentadol tablets. The use of APO-TAPENTADOL in patients with circulatory shock should be avoided as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Dependence/Tolerance As with other opioids, tolerance and physical dependence may develop upon repeated administration of APO-TAPENTADOL and there is a potential for development of psychological dependence. Physical dependence and tolerance reflect the neuroadaptation of the opioid receptors to chronic exposure to an opioid, and are separate and distinct from abuse and addiction.
Tolerance, as well as physical dependence, may develop upon repeated administration of opioids, and are not by themselves evidence of an addictive disorder or abuse. Patients on prolonged therapy should be tapered gradually from the drug if it is no longer required for pain control.
Withdrawal symptoms may occur following abrupt discontinuation of therapy or upon administration of an opioid antagonist. Some of the symptoms that may be associated with abrupt withdrawal of an opioid analgesic include body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, anxiety, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, palpitations, unexplained fever, weakness and yawning (see 8.
ADVERSE REACTIONS and 4. DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment). Interactions with Alcohol and Drugs of Abuse Due to its mu-opioid agonist activity, tapentadol may be expected to have additive effects when used in conjunction with alcohol, opioids, or illicit drugs that cause central nervous system depression, respiratory depression, hypotension, and profound sedation, coma, or death.
If such combined therapy is necessary, a dose reduction of one or both agents should be considered. Use of APO-TAPENTADOL with alcoholic beverages or prescription or non- prescription products containing alcohol should be avoided (see 9.
DRUG INTERACTIONS). Use in Drug and Alcohol Addiction Tapentadol is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission is for the management of pain requiring opioid analgesia.
Patients with a history of addiction to drugs or alcohol may be at higher risk of becoming addicted to APO-TAPENTADOL; extreme caution and awareness is warranted to mitigate the risk. NAPO-TAPENTADOL (tapentadol) Page 14 of 58 Driving and Operating Machinery Patients should be cautioned that APO-TAPENTADOL may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
This is to be expected especially at the beginning of treatment, at any change of dosage, as well as in combination with other CNS depressants, including other opioids, phenothiazine, sedative/hypnotics and alcohol (see 9. DRUG INTERACTIONS).
Endocrine and Metabolism Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic […]