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PANITAZ is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Panitaz is not suitable for the treatment of acute pain. Panitaz is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Panitaz should be administered every 7th day.
Patients aged 18 years and over:
The lowest Panitaz dose (Panitaz 5 micrograms/h transdermal patch) should be used as the initial dose. 5) as well as to the current general condition and medical status of the patient. 5) as needed until analgesic efficacy with Panitaz is attained.
During the titration process, the dose of Panitaz may be adjusted every 3 days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient’s analgesic response to the patch.
To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 micrograms/hour.
2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. 4). A Panitaz dose reduction or discontinuation of Panitaz treatment or treatment review may be indicated.
Conversion from opioids:
Panitaz can be used as an alternative to treatment with other opioids. 5) during titration, as required.
Paediatric population:
The safety and efficacy of Panitaz in children below 18 years of age has not been established. No data are available.
Elderly:
No dosage adjustment of Panitaz is required in elderly patients.
Renal impairment:
No special dose adjustment of Panitaz is necessary in patients with renal impairment.
Hepatic impairment:
There is no need for dosage adjustment of Panitaz in patients with mild to moderate hepatic impairment. Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function.
4).
The following undesirable effects have occurred:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). 4) Depersonalisation Nervous system disorders Headache Dizziness Somnolence Tremor Sedation Dysgeusia Dysarthria Balance disorder Speech disorder Involuntary muscle contractions Seizures, Sleep apnoea syndrome, Hyperalgesia Hypoaesthesia Memory impairment Migraine Syncope Abnormal coordination Disturbance in attention Paraesthesia Eye disorders Dry eye Blurred vision Visual disturbance Eyelid oedema Miosis Ear and labyrinth disorders Tinnitus Vertigo Ear pain Cardiac disorders Palpitations Tachycardia Angina pectoris Vascular disorders Hypotension Circulatory collapse Hypertension Flushing Vasodilatation Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Cough Wheezing Hiccups Respiratory depression Respiratory failure Asthma aggravated Hyperventilation Rhinitis Gastrointestinal disorders Constipation Nausea Vomiting Abdominal pain Diarrhoea Dyspepsia Dry mouth Flatulence Dysphagia Ileus Diverticulitis Hepatobiliary disorders Biliary colic Skin and subcutaneous tissue disorders Pruritus Erythema Rash Sweating Exanthema Dry skin Urticaria Face oedema Pustules Vesicles Dermatitis contact, Application skin discolouration Musculoskeletal and connective tissue disorders Muscular weakness Myalgia Muscle spasms Renal and urinary disorders Urinary incontinence Urinary retention Urinary hesitation Reproductive system and breast disorders Erectile dysfunction Sexual dysfunction General disorders and administration site conditions Application site reactions1 Tiredness Asthenic conditions Peripheral oedema Fatigue Pyrexia Rigors Oedema Drug withdrawal syndrome Chest pain Influenza like illness Drug withdrawal syndrome neonatal Drug Tolerance Investigations Alanine aminotransferase increased Weight decreased Injury, poisoning and procedural complications Accidental injury Fall 1 Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritus, rash, vesicles, painful/burning sensation at the application site.
Do not use for acute post-operative pain owing to the increased risk of persistent post- operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). 2). • constipation Respiratory depression Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route.
A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine, usually with benzodiazepines concomitantly. 9). Caution should be exercised when prescribing Panitaz to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness.
Concomitant use of opioids such as buprenorphine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe buprenorphine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. 1). 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 Panitaz.
5) • patients suffering from myasthenia gravis • patients suffering from delirium tremens.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Therefore patients with hepatic insufficiency should be carefully monitored during treatment with Panitaz. Patients with severe hepatic impairment may accumulate buprenorphine during treatment. Consideration of alternate therapy should be considered, and Panitaz should be used with caution, if at all, in such patients.
Method of administration Treatment goals and discontinuation Before initiating treatment with Panitaz, 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 Panitaz, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces. 4), the following directions of use should be followed: Panitaz should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars.
Panitaz should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven. If the application site must be cleaned, it should be done with clean water only.
Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the patch is applied. Panitaz should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges.
If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape to ensure a 7 day period of wear. The patch should be worn continuously for 7 days. Bathing, showering, or swimming should not affect the patch.
If a patch falls off, a new one should be applied and worn for 7 days.
Duration of administration:
Panitaz should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Panitaz is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
Discontinuation:
After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Panitaz is to be followed by other opioids.
As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the patch. At present, only limited information is available on the starting dose of other opioids administered after discontinuation of the transdermal […]
* In some cases delayed local allergic reactions occurred with marked signs of inflammation. g. laceration) are also possible in patients with fragile skin. Chronic inflammation may lead to long-lasting sequelae, such as post inflammatory hyper- and hypopigmentation, as well as dry and thick scaly skin lesions, which may closely resemble scars.
In such cases treatment with buprenorphine should be terminated. Drug dependence Repeated use of Panitaz can lead to drug dependence, even at therapeutic doses. 4). After discontinuation of buprenorphine, withdrawal symptoms are uncommon.
This may be due to the very slow dissociation of buprenorphine from the opioid receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30 hours after removal of the last patch). 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.
Repeated use of Panitaz can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Panitaz 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. The clinical need for analgesic treatment should be reviewed regularly. 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 Panitaz.
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 minimize symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterized 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.
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 […]