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CELASTYMIS is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe pain, which can be adequately managed only with opioid analgesics. Celastymis is indicated in adults and adolescents aged 12 years and older.
Verbatim from this product's MHRA label. Tap a section to expand.
The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment.
The following general dosage recommendations apply:
Adults and adolescents 12 years of age and older Dose titration and adjustment In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg oxycodone hydrochloride to minimize the incidence of adverse reactions.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. For doses not realisable/practicable with this strength other strengths of this medicinal product are available.
Generally, the lowest effective dose for analgesia should be selected. Increasing severity of pain will require an increased dosage of Celastymis tablets, using the different tablet strengths, either alone or in combination, to achieve pain relief.
The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary, increases should be made in 25% - 50% increments.
The need for escape medication more than twice a day indicates that the dosage of Celastymis tablets should be increased. Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Celastymis after conversion from other opioids, with 50-75% of the calculated oxycodone dose.
Celastymis is not intended for use as a prn analgesic. Some patients who take Celastymis following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Celastymis is not indicated for the treatment of acute pain and/or breakthrough pain.
The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Celastymis. Use of the rescue medication more than twice daily indicates that the dose of Celastymis needs to be increased. The dose should not be adjusted more often than once every 1-2 days until a stable twice daily administration has been achieved.
Summary of the safety profile Due to its pharmacological properties oxycodone may cause respiratory depression, miosis, bronchial spasm and spasm of unstriated muscles and may suppress the cough reflex. The most frequently reported undesirable effects are nausea (especially at the beginning of treatment) and constipation.
Respiratory depression is the chief hazard of an opioid overdose and occurs most commonly in elderly or debilitated patients. g. 4) Not known: Aggression, drug dependence Nervous system disorders Very common: Somnolence, sedation, dizziness, headache Common: Tremor, lethargy Uncommon: Amnesia, convulsion (especially in persons with epileptic disorder or predisposition to convulsions), concentration impaired, migraine, hypertonia, involuntary muscle contractions, hypoaesthesia, abnormal coordination, speech disorder, syncope, paraesthesia, dysgeusia Not known: Hyperalgesia Eye disorders Uncommon: Visual impairment, miosis, Ear and labyrinth disorders Uncommon: Hearing impaired, vertigo Cardiac disorders Uncommon: Tachycardia, Palpitations (in the context of withdrawal syndrome), supraventricular tachycardia.
Vascular disorders Uncommon:
Vasodilatation, facial flushing.
Rare:
Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Common: Dyspnoea, bronchospasm, cough decreased. g. g. 8). ‘Not known’ should not be interpreted as an indication of the rarity of the occurrence of opioid tolerance and opioid withdrawal syndrome, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency.
Drug dependence The frequency above regarding drug dependence reflects the current evidence, including cumulative data from clinical trials and additional post marketing sources, and indicates that the risk of drug dependence with opioids is highly variable depending upon: definition of drug dependence; duration of treatment; dose; individual patient risk factors; and clinical settings.
“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)”. 5). Respiratory and cardiac depression Respiratory depression is the most significant risk induced by opioids and is most likely to occur in elderly or debilitated patients.
The respiratory depressant effect of oxycodone can lead to increased carbon dioxide concentrations in blood and hence in cerebrospinal fluid. In predisposed patients opioids can cause severe decrease in blood pressure. Oxycodone 60mg, 80mg and 120mg tablets should not be used in patients not previously exposed to opioids.
These tablet strengths may cause fatal respiratory depression when administered to opioid naïve patients. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone.
Repeated use of Celastymis may lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Celastymis 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.
A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained online, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.
1. • Severe respiratory depression with hypoxia and/or elevated carbon dioxide levels in the blood (hypercapnia). • Severe chronic obstructive pulmonary disease. • Cor pulmonale. • Severe bronchial asthma. • Paralytic ileus. • Acute abdomen, • Delayed gastric emptying.
• Head injury. • Moderate to severe hepatic impairment. • Severe renal impairment (creatinine clearance <10 ml/min). • Chronic constipation. • Concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Following a dose increase from 10 mg to 20 mg taken every 12 hours dose adjustments should be made in steps of approximately one third of the daily dose. The aim is a patient- specific dosage which, with twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little rescue medication as possible as long as pain therapy is needed.
Even distribution (the same dose mornings and evenings) following a fixed schedule (every 12 hours) is appropriate for the majority of the patients. For some patients it may be advantageous to distribute the doses unevenly. In general, the lowest effective analgesic dose should be chosen.
For the treatment of non-malignant pain a daily dose of 40 mg is generally sufficient; but higher dosages may be necessary. Patients with cancer-related pain may require dosages of 80 to 120 mg, which in individual cases can be increased to up to 400 mg.
If even higher doses are required, the dose should be decided individually balancing efficacy with the tolerance and risk of undesirable effects. Doses in excess of 1000mg have been recorded. Conversion from oral morphine According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation.
It must be emphasised that this is a guide to the dose of Celastymis tablets required. Inter- patient variability requires that each patient is carefully titrated to the appropriate dose.
Transferring patients between oral and parenteral oxycodone:
The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Elderly patients Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments. Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that, compared with younger adults, the clearance of oxycodone is only slightly reduced.
No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate. Patients with low body weight or slow metabolism Risk patients, for example patients with low body weight or slow metabolism of medicinal products, should initially half the recommended adult dose if they are opioid naïve.
e. 10 mg, may not be suitable as a starting dose. Dose titration should be performed in accordance with the individual clinical situation. Patients with renal or hepatic impairment The dose initiation should follow a conservative approach as the plasma concentration may be increased in these patients.
The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.
Use in non-malignant pain:
Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease.
Children under 12 years of age Oxycodone has not been studied in children younger than 12 years of age. The safety and efficacy of Celastymis have not been demonstrated and the use in children younger than 12 years of age is therefore not recommended.
Method of administration For oral use. Celastymis should be taken twice […]
‘Not known’ should not be interpreted as an indication of the rarity of the occurrence of drug dependence, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency. Repeated use of Celastymis can lead to drug dependence, even at therapeutic doses.
4). 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.
Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.
It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse or addiction The clinical need for analgesic treatment should be reviewed regularly.
Tolerance and dependence 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 oxycodone. 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. For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities.
A crucial part of the assessment of a patient with chronic non-malignant pain is the patient's addiction and substance abuse history. If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a minimum of side effects.
Long-term use of Celastymis can cause the development of tolerance which leads to the use of higher doses in order to achieve the desired analgesic effect. There is a cross-tolerance to other opioids. Chronic use of Celastymis can cause physical dependence.
Withdrawal symptoms may occur following abrupt discontinuation of therapy. If therapy with oxycodone is no longer required it may be advisable to reduce the daily dose gradually in order to avoid the occurrence of a withdrawal syndrome.
Withdrawal symptoms may include restlessness, perspiration, chills, myalgia, palpitations, yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions and insomnia. Other symptoms also may develop, including: irritability, backache, joint pain, weakness, abdominal cramps, nausea, anorexia, vomiting, diarrhoea, or increased blood pressure, 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 that will not respond to a further dose increase of oxycodone may occur, […]