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TAPENTADOL ZENTIVA is a brand name for Tapentadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tapentadol Zentiva/Castenro is indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics.
Verbatim from this product's MHRA label. Tap a section to expand.
4). The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient. Tapentadol Zentiva/Castenro should be taken twice daily, approximately every 12 hours.
Treatment goals and discontinuation Before initiating treatment with Tapentadol Zentiva/Castenro a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with Tapentadol Zentiva/Castenro it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Initiation of therapy Initiation of therapy in patients currently not taking opioid analgesics Patients should start treatment with single doses of 50 mg Tapentadol Zentiva/Castenro administered twice daily. Initiation of therapy in patients currently taking opioid analgesics When switching from opioids to Tapentadol Zentiva/Castenro and choosing the initial dose, the nature of the previous medicinal product, administration and the mean daily dose should be taken into account.
This may require higher initial doses of Tapentadol Zentiva/Castenro for patients currently taking opioids compared to those not having taken opioids before initiating therapy with Tapentadol Zentiva/Castenro. Titration and maintenance After initiation of therapy the dose should be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician.
Experience from clinical trials has shown that a titration regimen in increments of 50 mg prolonged-release tapentadol twice daily every 3 days was appropriate to achieve adequate pain control in most of the patients. Total daily doses of more than 500 mg prolonged-release tapentadol have not yet been studied and are therefore not recommended.
Duration of treatment Tapentadol Zentiva/Castenro should not be used longer than necessary. 2). 2). 2). Tapentadol Zentiva/Castenro should be used with caution in patients with moderate hepatic impairment. e. Tapentadol Zentiva/Castenro 50 mg, and not be administered more frequently than once every 24 hours.
The adverse drug reactions that were experienced by patients in the placebo- controlled trials performed with tapentadol prolonged-release were predominantly of mild and moderate severity. The most frequent adverse drug reactions were in the gastrointestinal and central nervous system (nausea, dizziness, constipation, headache and somnolence).
The table below lists adverse drug reactions that were identified from clinical trials performed with tapentadol prolonged-release and from post-marketing environment. They are listed by class and frequency. Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
4) Nervous system disorders Dizziness, Somnolen ce, Headache Disturbance in attention, Tremor, Muscle contractions involuntary Depressed level of consciousness, Memory impairment, Mental impairment, Syncope, Sedation, Balance disorder, Dysarthria, Hypoaesthesia, Paraesthesia Convulsion, Presyncope, Coordinatio n abnormal Eye disorders Visual disturbance Cardiac disorders Heart rate increased, Heart rate decreased, Palpitations Vascular disorders Flushing Blood pressure decreased Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory depression Gastrointestinal disorders Nausea, Constipation Vomiting, Diarrhoea, Dyspepsia Abdominal discomfort Impaired gastric emptying Skin and subcutaneous tissue disorders Pruritus, Hyperhidrosis, Rash Urticaria Renal and urinary disorders Urinary hesitation, Pollakiuria Reproductive system and breast disorders Sexual dysfunction General disorders and administration Asthenia, Fatigue, Feeling of body temperature Drug withdrawal syndrome, Feeling Feeling drunk, Feeling of relaxation site conditions change, Mucosal dryness, Oedema abnormal, Irritability * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported.
Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Tapentadol Zentiva/Castenro. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD.
Abuse or intentional misuse of opioids may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.
g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with tapentadol. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.
When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
1. e. 5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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At initiation of therapy a daily dose greater than 50 mg prolonged-release tapentadol is not recommended. 2). 2). Elderly patients (≥65 years) In general, a dose adaptation in elderly patients is not required. 2). Paediatric population The safety and efficacy of Tapentadol Zentiva/Castenro in children and adolescents below 18 years of age has not yet been established.
Therefore Tapentadol Zentiva/Castenro is not recommended for use in this population. Method of administration Tapentadol Zentiva/Castenro is for oral use. Tapentadol Zentiva/Castenro has to be taken whole, not divided, crushed or chewed, to ensure that the prolonged-release mechanism is maintained.
The score line on the tablet is not intended for breaking the tablet. Tapentadol Zentiva/Castenro should be taken with sufficient liquid. Tapentadol Zentiva/Castenro can be taken with or without food. The shell (matrix) of the tablet may not be digested completely and therefore it can be eliminated and seen in the patient's stool.
However, this finding has no clinical relevance, since the active substance of the tablet will have already been absorbed.
** Post-marketing cases of delirium were observed in patients with additional risk factors such as cancer and advanced age. Drug dependence Repeated use of Tapentadol Zentiva/Castenro can lead to drug dependence, even at therapeutic doses.
4). Clinical trials performed with tapentadol prolonged-release with patient exposure up to 1 year have shown little evidence of withdrawal symptoms upon abrupt discontinuations and these were generally classified as mild, when they occurred.
2) and treat patients accordingly should they occur. The risk of suicidal ideation and suicides committed is known to be higher in patients suffering from chronic pain. In addition, substances with a pronounced influence on the monoaminergic system have been associated with an increased risk of suicidality in patients suffering from depression, especially at the beginning of treatment.
For tapentadol data from clinical trials and post-marketing reports do not provide evidence for an increased risk. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances Concomitant use of Tapentadol Zentiva/Castenro and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Tapentadol Zentiva/Castenro concomitantly with sedating medicinal products, the reduction of dose of one or both medicinal products should be considered and the duration of the concomitant treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Respiratory depression At high doses or in mu-opioid receptor agonist sensitive patients, Tapentadol Zentiva/ Castenro may produce dose-related respiratory depression.
Therefore, Tapentadol Zentiva/Castenro should be administered with caution to patients with impaired respiratory functions. Alternative non-mu-opioid receptor agonist analgesics should be considered and Tapentadol Zentiva/Castenro should be employed only under careful medical supervision at the lowest effective dose in such patients.
9). Head injury and increased intracranial pressure Tapentadol Zentiva/Castenro should not be used in patients who may be particularly susceptible to the intracranial effects of carbon dioxide retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
Analgesics with mu-opioid receptor agonist activity may obscure the clinical course of patients with head injury. Tapentadol Zentiva/Castenro should be used with caution in patients with head injury and brain tumours. Seizures Prolonged-release tapentadol has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical trials.
However, like other analgesics with mu-opioid receptor agonist activity Tapentadol Zentiva/Castenro is not recommended in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.
5). 2). 5-fold increase in systemic exposure, respectively, compared with subjects with normal hepatic function. Tapentadol […]