Each 5 mg tablet computer contains 4.5 mg of oxycodone together 5 mg the oxycodone hydrochloride.
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Each 10 mg tablet computer contains 9.0 mg that oxycodone together 10 mg that oxycodone hydrochloride.
Each 15 mg tablet computer contains 13.5 mg of oxycodone together 15 mg of oxycodone hydrochloride.
Each 20 mg tablet computer contains 18.0 mg that oxycodone together 20 mg the oxycodone hydrochloride.
Each 30 mg tablet computer contains 27 mg the oxycodone together 30 mg of oxycodone hydrochloride.
Each 40 mg tablet contains 36.0 mg of oxycodone together 40 mg of oxycodone hydrochloride.
Each 60 mg tablet computer contains 54 mg that oxycodone as 60 mg of oxycodone hydrochloride.
Each 80 mg tablet computer contains 72.0 mg of oxycodone together 80 mg the oxycodone hydrochloride.
Each 120 mg tablet computer contains108 mg that oxycodone as 120 mg that oxycodone hydrochloride.
Excipient with well-known effect:
Contains lactose monohydrate.
For the complete list the excipients, see ar 6.1.
3. Pharmaceutical form
Prolonged relax tablet.
The 5 mg tablets space light blue, round, convex tablets significant OC ~ above one side and also 5 ~ above the other.
The 10 mg tablets space white, round, convex tablets marked OC on one side and also 10 top top the other.
The 15 mg tablets space grey, round, convex tablets marked OC on one side and also 15 on the other.
The 20 mg tablets are pink, round, convex tablets significant OC on one side and also 20 top top the other.
The 30 mg tablets room brown, round, convex tablets marked OC top top one side and also 30 on the other.
The 40 mg tablets room yellow, round, convex tablets marked OC on one side and also 40 on the other.
The 60 mg tablets room red, round, convex tablets marked OC top top one side and also 60 top top the other.
The 80 mg tablets space green, round, convex tablets significant OC top top one side and 80 ~ above the other.
The 120 mg tablets space purple, round, convex tablets significant OC on one side and 120 on the other.
4. Clinical particulars
4.1 Therapeutic indications
For the therapy of center to significant pain in patients through cancer and also post-operative pain. Because that the treatment of major pain requiring the usage of a strong opioid.
4.2 Posology and method of administration
Adults over 18 years:
OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependence on the severity of the pain, and also the patient"s previous background of analgesic requirements.
Prior to beginning treatment through opioids, a discussion should be hosted with patients to placed in place a strategy for ending treatment v oxycodone in order to minimise the danger of addiction and drug withdrawal syndrome (see section 4.4).
OxyContin is not intended for usage as a prn analgesic.
Generally, the lowest effective dose for analgesia need to be selected. Raising severity of pain will call for an boosted dosage that OxyContin tablets, making use of the different tablet computer strengths, one of two people alone or in combination, to accomplish pain relief. The correct dosage for any type of individual patient is that which controls the pain and also is well tolerated for a complete 12 hours. Patients need to be titrated come pain relief unless unmanageable adverse drug reactions prevent this. If greater doses are necessary, boosts should it is in made in 25% - 50% increments. The need for to escape medication an ext than double a day shows that the dosage of OxyContin tablets have to be increased.
The usual starting dose because that opioid naïve patient or patients presenting with severe pain untreated by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a beginning dose that 5 mg come minimise the incidence of next effects. The dose have to then be closely titrated, as generally as once a job if necessary, to accomplish pain relief.
Conversion from oral morphine:
Patients receiving oral morphine prior to OxyContin therapy should have actually their everyday dose based upon the complying with ratio: 10 mg of dental oxycodone is equivalent to 20 mg of dental morphine. It need to be emphasised the this is a guide to the sheep of OxyContin tablets required. Inter-patient variability needs that every patient is closely titrated to the proper dose.
Transferring patients between oral and also parenteral oxycodone:
The dose have to be based upon the complying with ratio: 2 mg of dental oxycodone is tantamount to 1 mg the parenteral oxycodone. It need to be emphasised that this is a overview to the sheep required. Inter-patient variability calls for that every patient is very closely titrated come the proper dose.
A dose adjustment is no usually necessary in elderly patients.
Controlled pharmacokinetic researches in elderly patients (aged end 65 years) have presented that, contrasted with younger adults, the clearance that oxycodone is just slightly reduced. No untoward adverse medicine reactions were seen based on age, thus adult doses and also dosage intervals space appropriate.
OxyContin must not be provided in patient under 18 year of age.
Patients with renal or hepatic impairment:
The plasma concentration in this populace may be increased. The sheep initiation have to follow a conservative strategy in this patients. The recommended adult beginning dose need to be diminished by 50% (for example a complete daily sheep of 10 mg orally in opioid naïve patients), and each patient must be titrated to enough pain control according to their clinical situation.
Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain, nor space they recommended as the just treatment. Species of chronic pain which have actually been presented to be alleviated by solid opioids incorporate chronic osteoarthritic pain and intervertebral key disease. The need for continued treatment in non-malignant pain have to be assessed at constant intervals.
Method that administration
OxyContin tablets space for oral use.
OxyContin tablets need to be swallowed whole and also not broken, chewed or crushed.
Duration the treatment
Oxycodone must not be used for longer than necessary.
Discontinuation the treatment
When a patient no much longer requires therapy with oxycodone, it might be recipient to taper the dose progressively to prevent symptoms the withdrawal.
Hypersensitivity to oxycodone or to any of the excipients provided in ar 6.1.
Oxycodone need to not be offered in any kind of situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delay gastric emptying, serious chronic obstructive lung disease, cor pulmonale, major bronchial asthma, elevated carbon dioxide level in the blood, moderate to major hepatic impairment, chronic constipation.
Patients with rare hereditary difficulties of galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption have to not take it this medicine.
Caution need to be exercised when administering oxycodone to the debilitated elderly, patients v severely impaired pulmonary function, patients through impaired hepatic or renal function, patients with myxoedema, hypothyroidism, Addison"s disease, toxicity psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammation bowel disorders, hypotension, hypovolaemia increased intracranial pressure, intracranial lesions, head injury (due to risk of boosted intracranial pressure), reduced level of awareness of unsure origin, sleep apnoea or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors (see section 4.5).
The main risk the opioid overabundance is respiratory tract depression.
Opioids may reason sleep-related breathing disorders including central sleep apnoea (CSA) and also sleep-related hypoxemia. Opioid usage may boost the danger of CSA in a dose-dependent path in part patients. Opioids may additionally cause worsening that pre-existing sleep apnoea (see ar 4.8). In patients who present with CSA, take into consideration decreasing the full opioid dosage.
Concomitant usage of oxycodone and also sedative lifwynnfoundation.lifwynnfoundation.org such as benzodiazepines or connected drugs may an outcome in sedation, respiratory depression, coma and also death. Since of this risks, concomitant prescribing v these sedative medications should be scheduled for patients for whom alternate treatment options are no possible.
If a decision is made to prescribe oxycodone concomitantly v sedative lifwynnfoundation.lifwynnfoundation.org, the lowest effective dose must be used, and also the expression of treatment have to be as quick as feasible (see also general dose recommendation in section 4.2).
The patient need to be followed carefully for signs and also symptoms of respiratory depression and also sedation. In this respect, it is strongly recommended to educate patients and their caregivers come be conscious of these symptoms (see ar 4.5).
OxyContin tablets should be administered through caution in patients taking MAOIs or who have actually received MAOIs in ~ the previous 2 weeks.
OxyContin tablets must not be offered where over there is a opportunity of paralytic ileus occurring. Need to paralytic ileus be suspected or occur throughout use, OxyContin tablets should be discontinued immediately.
OxyContin tablets space not recommended because that pre-operative usage or in ~ the first 12-24 hrs post-operatively.
As with all opioid preparations, oxycodone assets should be supplied with fist following ab surgery as opioids are well-known to impair intestinal motility and should no be provided until the doctor is assured of typical bowel function.
Patients around to undergo additional pain relieving procedures (e.g. Surgery, plexus blockade) need to not obtain OxyContin tablets for 12 hrs prior to the intervention. If more treatment v OxyContin tablet computers is shown then the dosage should be adjusted to the brand-new post-operative requirement.
OxyContin 60 mg, 80 mg and also 120 mg tablets must not be offered in patients not formerly exposed come opioids. These tablet computer strengths may cause fatal respiratory depression once administered come opioid naïve patients.
For appropriate patients who endure with chronic non-malignant pain, opioids have to be used as part of a an extensive treatment programme involving other medications and also treatment modalities. A critical part that the evaluate of a patient through chronic non-malignant pains is the patient"s addiction and also substance abuse history.
If opioid therapy is considered ideal for the patient, climate the main aim of treatment is no to minimise the sheep of opioid yet rather to accomplish a dose which gives adequate ache relief v a minimum of next effects. There must be frequent contact between physician and patient so that dosage adjustments have the right to be made. The is strongly recommended the the physician defines treatment outcomes in accordance with pain monitoring guidelines. The physician and patient have the right to then agree to discontinue treatment if these missions are no met.
Drug dependence, tolerance and also potential for abuse
For all patients, lengthy use the this product may bring about drug dependence (addiction), even at therapeutic doses. The threats are enhanced in individuals with existing or past history of substance misuse disorder (including alcohol misuse) or mental health and wellness disorder (e.g. Major depression).
Additional support and monitoring might be essential when prescribing for patients at danger of opioid misuse.
A an extensive patient history should it is in taken to record concomitant medications, consisting of over-the-counter lifwynnfoundation.lifwynnfoundation.org and lifwynnfoundation.lifwynnfoundation.org obtained on-line, and past and present medical and psychiatric conditions.
Patients may discover that therapy is less reliable with chronic use and express a require to increase the dose to achieve the exact same level the pain regulate as initially experienced. Patient may additionally supplement their therapy with additional pain relievers. These could be indicators that the patient is developing tolerance. The threats of developing tolerance must be described to the patient.
Overuse or misuse may an outcome in overdose and/or death. It is vital that patients just use medications that space prescribed for them at the sheep they have been prescribed and also do not offer this medicine to everyone else.
Patients must be carefully monitored for signs of misuse, abuse or addiction.
The clinical need for analgesic treatment should be reviewed regularly.
Drug tap the money syndrome
Prior to beginning treatment with any kind of opioids, a discussion should be held with patients to placed in ar a withdrawal strategy for finishing treatment with oxycodone.
Drug withdrawal syndrome may happen upon abrupt cessation of therapy or dose reduction. Once a patience no longer requires therapy, that is advisable to taper the dose progressively to minimise symptoms of withdrawal. Tapering native a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by part or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Various other symptoms may additionally develop consisting of irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, ab cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory price or love rate.
If women take this drug during pregnancy over there is a hazard that their newborn babies will suffer neonatal tap the money syndrome.
Hyperalgesia may be diagnosed if the patience on permanent opioid therapy presents with boosted pain. This might be qualitatively and anatomically distinctive from pain related to disease progression or to breakthrough pain resulting from advancement of opioid tolerance. Pain associated with hyperalgesia often tends to be an ext diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve through a palliation of opioid dose.
OxyContin tablets have to be swallowed whole, and not broken, chewed or crushed. The management of broken, chewed, or crushed OxyContin tablet computers leads come a quick release and absorption of a perhaps fatal sheep of oxycodone (see ar 4.9).
Concomitant use of alcohol and also OxyContin may boost the undesirable effects of OxyContin; concomitant use need to be avoided.
Abuse of dental dosage forms by parenteral administration can be meant to result in significant adverse events, together as neighborhood tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, which may be fatal.
Empty matrix (tablets) may be watched in the stools.
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Opioids such as oxycodone hydrochloride may influence the hypothalamic-pituitary-adrenal or – gonadal axes. Some changes that have the right to be watched include an increase in serum prolactin, and decreases in plasma cortisol and also testosterone. Clinical symptoms may manifest indigenous these hormonal changes.