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Dosage and Administration
Adults, elderly and children over 18 Years . Prior to initiation and titration of doses, refer to the Section 4.4for information on special risk groups such as females and the elderly.
OXYNORM capsules or liquid 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.
Increasing severity of pain will require an increased dosage of OXYNORM capsules or liquid. 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-naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 5mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses.
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Side and Effects
Very common side effects
(May affect more than 1 in 10 people)
Constipation (your doctor can prescribe a laxative to overcome this problem).Feeling or being sick (this should normally wear off after a few days,
however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).
Drowsiness (this is most likely when you start taking your capsules or when your dose is increased, but it should wear off after a few days).
Common side effects
May affect up to 1 in 10 people
Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.
Confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams.
Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.
Hypersensitivity to opioids or any of the constituents of OXYNORM solution for injection or infusion listed in section 6.1, acute respiratory depression, cor pulmonale, cardiac arrhythmias, acute asthma or other obstructive airways disease, paralytic ileus, suspected surgical abdomen, severe renal impairment (creatinine clearance <10 mL/min), moderate to severe hepatic impairment, chronic constipation, acute abdominal pain, delayed gastric emptying, acute alcoholism, coma, brain tumour, increased cerebrospinal or intracranial pressure, head injury (due to risk of raised intracranial pressure), severe CNS depression, convulsive disorders, delirium tremens, hypercarbia, concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use, anxiety states under the influence of alcohol or hypnotics, and pregnancy.
– have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;
– have myxoedema (a thyroid disorder with dryness, coldness and swelling [‘puffiness’] of the skin affecting the face and limbs;
– have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull is increased;
– have low blood pressure (hypotension);
– have low blood volume (hypovolaemia); this can happen with severe external or internal bleeding, severe burns, excessive sweating, severe
diarrhoea or vomiting;
– have a mental disorder as a result of an infection (toxic psychosis);
– have inflammation of the pancreas (which causes severe pain in the abdomen and back);
– have problems with your gall bladder or bile duct;
– have inflammatory bowel disease;
– have an enlarged prostate gland, which causes difficulty in passing urine(in men);
– have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), e.g. Addison’s disease;
– have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;
– have kidney or liver problems;
– have previously suffered from withdrawal symptoms such as agitation,anxiety, shaking or sweating upon stopping taking alcohol or drugs;
– are or have ever been addicted to alcohol or drugs or have a known
– have an increased sensitivity to pain;
– need to take increasingly higher doses of OxyNorm to gain the same level of pain relief (tolerance) More info : WIKI