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1. Name of the medicinal product;
OxyNorm 5 mg, 10 mg and 20 mg
2. Qualitative and quantitative composition:
Each 5 mg capsule contains 4.5 mg of oxycodone as 5 mg of oxycodone hydrochloride.
Each 10 mg capsule contains 9 mg of oxycodone as 10 mg of oxycodone hydrochloride.
Each 20 mg capsule contains 18 mg of oxycodone as 20 mg of oxycodone hydrochloride.
Excipient with known effect:
The 5 mg capsule contains sunset yellow (E 110). May cause allergic reactions.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form:
OxyNorm capsules 5 mg are orange/beige, printed ONR 5.
OxyNorm capsules 10 mg are white/beige, printed ONR 10.
OxyNorm capsules 20 mg are pink/beige, printed ONR 20.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.
4.2 Posology and method of administration:
Adults over 18 years
OxyNorm capsules should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements.
Generally, the lowest effective dose for analgesia should be selected. Increasing severity of pain will require an increased dosage of OxyNorm capsules. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this.
The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief.
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with oxycodone in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).
Conversion from oral morphine
Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of OxyNorm capsules 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.
A dose adjustment is not usually necessary in elderly patients. 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 renal or hepatic impairment
The plasma concentration in this patient population may be increased. The dose initiation should follow a conservative approach 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.
OxyNorm capsules should not be used in patients under 18 years.
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. The need for continued treatment in non-malignant pain should be assessed at regular intervals.
Method of administration:
OxyNorm capsules are for oral use.
Duration of treatment:
Oxycodone should not be used for longer than necessary. In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.
Discontinuation of treatment:
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1.
Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, elevated carbon dioxide levels in the blood, moderate to severe hepatic impairment, chronic constipation.
4.4 Special warnings and precautions for use:
Caution must be exercised when administering oxycodone to the debilitated elderly, opioid-dependent patients, patients with severely impaired pulmonary function, patients with impaired hepatic or renal function, patients with myxoedema, hypothyroidism, Addison's disease, toxic psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, hypotension, hypovolaemia, raised intracranial pressure, intracranial lesions or head injury (due to risk of increased intracranial pressure), reduced level of consciousness of uncertain origin, sleep apnoea, or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors (see section 4.5).
The primary risk of opioid excess is respiratory depression.
Opioids may cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent manner in some patients. Opioids may also cause worsening of pre-existing sleep apnoea (see section 4.8). In patients who present with CSA, consider decreasing the total opioid dosage.
Concomitant use of oxycodone 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 oxycodone concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
OxyNorm capsules must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks.
OxyNorm capsules should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, OxyNorm capsules should be discontinued immediately.
OxyNorm capsules should be used with caution pre-operatively and within the first 12-24 hours post-operatively.
As with all opioid preparations, oxycodone products should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.
4.5 Fertility, pregnancy and lactation:
OxyNorm capsules are not recommended for use in pregnancy nor during labour. There are limited data from the use of oxycodone in pregnant women. Regular use in pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in pregnant women, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.
Administration to nursing women is not recommended as oxycodone may be secreted in breast milk and may cause respiratory depression in the infant.
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