Sevredol tablets 10mg, 20mg and 50mg
Drug Class Description
Morphine Sulphate 10 mg, 20 mg, 50 mg
Film-coated tablet. 10 mg Blue, film-coated, capsule-shaped, biconvex tablet with a score line on one side. "IR" is marked on the left side and "10" on the right. 20 mg Pink, film-coated, capsule-shaped, biconvex tablet with a score line on one side. "IR" is marked on the left side and "20" on the right. 50 mg Pale, green film-coated, capsule-shaped, biconvex tablet with a score line on one side. "IR" is marked on the left side and "50" on the right.
Sevredol tablets are indicated for the relief of severe pain.
Route of administration
Adults and children over 12 years.
The dosage of Sevredol tablets is dependent on the severity of pain and the patient's previous history of analgesic requirements. One tablet to be taken every four hours or as directed by a physician. Increasing severity of pain or tolerance to morphine will require increased dosage of Sevredol tablets using 10 mg, 20 mg or 50 mg alone or in combination to achieve the desired relief.
Patients receiving Sevredol tablets in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration. Usually such increased requirement is of the order of 100%. In such patients individual dose adjustments are required.
A reduction in adult dosage may be advisable.
Children 3 -12 years of age:
Only Sevredol 10 mg and 20 mg tablets are suitable for children:-
|3 - 5 years 6 -12 years||5 mg, 4-hourly 5 -10 mg, 4-hourly|
Sevredol tablets 50 mg are not recommended for children.
Under 3 years, not recommended; 3 - 5 years, 5 mg four hourly; 6 - 12 years, 5 - 10 mg four hourly.
Hypersensitivity to any of the constituents, respiratory depression, head injury, obstructive airways disease, paralytic ileus, acute abdomen, delayed gastric emptying, known morphine sensitivity, acute hepatic disease, concurrent administration of mono-amine oxidase inhibitors or within two weeks of discontinuation of their use. Not recommended during pregnancy.
Not recommended for children below 3 years of age.
The major risk of opioid excess is respiratory depression.
As with all narcotics a reduction in dosage may be advisable in the elderly, in hypothyroidism, in renal and chronic hepatic disease. Use with caution in patients with impaired respiratory function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, severe cor pulmonale, opioid dependent patients, patients with a history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency. Sevredol tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Sevredol tablets should be discontinued immediately.
Morphine may lower the seizure threshold in patients with a history of epilepsy.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receiveSevredol tablets for 4 hours prior to the intervention . If further treatment with Sevredol tablets is indicated then the dosage should be adjusted to new post-operative requirements. Sevredol tablets should be used with caution pre-operatively and within the first 24 hours post-operatively. Sevredol tablets should also be used with caution following abdominal surgery as morphine impairs intestinal motility and should not be used until the physician is assured of normal bowel function.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with morphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal
Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur in particular in high doses. A morphine sulphate dose reduction or change in opioid may be required.
Morphine has an abuse profile similar to other strong agonist opioids. Morphine may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addition) to opioid analgesics, including morphine. The product should be used with particular care in patients with a history of alcohol and drug abuse.
Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
Morphine should be used with caution in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anaesthetics, phenothiazines, other tranquilisers, muscle relaxants, antihypertensives and alcohol. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual doses of morphine.
In a study involving healthy volunteers (N = 12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.
Mixed agonist/antagonist opioid analgesics (e.g. buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.
Medicinal products that block the action of acetylcholine, for example antihistamines, anti-parkinsons and anti-emetics, may interact with morphine to potentiate the anticholinergic adverse effects.
Cimetidine inhibits the metabolism of morphine.
Monoamine oxidase inhibitors are known to interact with narcotic analgesics producing CNS excitation or depression with hyper- or hypotensive crisis. Morphine should not be co-administered with monoamine oxidase inhibitors or within two weeks of such therapy.
Plasma concentrations of morphine may be reduced by rifampicin.
Although there are no pharmacokinetic data available for concomitant use of ritonavir with morphine, ritonavir induces the hepatic enzymes responsible for the glucuronidation of morphine, and may possibly decrease plasma concentrations of morphine.
In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with Sevredol tablets but should they occur the tablets can be readily combined with an anti-emetic if required. Constipation may be treated with appropriate laxatives.
The following frequencies are the basis for assessing undesirable effects:
Very common (1/10); Common ( 1/100 to < 1/10); Uncommon ( 1/1,000 to < 1/100); Rare ( 1/10,000 to < 1/1,000); Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
Immune system disorders
Not known: Allergic reaction, anaphylactic reaction, anaphylactic reaction
Common: Confusion, insomnia
Uncommon: Agitation, euphoria, hallucinations, mood altered
Not known: Drug dependence, dysphoria, thinking disturbances
Nervous system disorders
Common: Dizziness, headache, involuntary muscle contractions, somnolence
Uncommon: Convulsions, hypertonia, paraesthesia, syncope, myoclonus
Not known: Hyperalgesia
Uncommon: Visual disturbance
Not known: Miosis
Ear and labyrinth disorders
Not known: Bradycardia, tachycardia
Uncommon: Facial flushing, hypotension
Not known: Hypertension
Respiratory, thoracic and mediastinal disorders
Uncommon: Bronchospasm, pulmonary oedema, respiratory depression
Not known: Cough decreased
Very common: Nausea
Common: Abdominal pain, anorexia, constipation, dry mouth, vomiting
Uncommon: Dyspepsia, ileus, taste perversion
Uncommon: Increased hepatic enzymes
Not known: Biliary pain, exacerbation of pancreatitis
Skin and subcutaneous tissue disorders
Common: Hyperhidrosis, rash
Renal and urinary disorders
Uncommon: Urinary retention
Not known: Ureteric spasm
Reproductive system and breast disorders
Not known: Amenorrhoea, decreased libido, erectile dysfunction
General disorders and administration site conditions
Common: Asthenic conditions, pruritus
Uncommon: Malaise, peripheral oedema
Not known: Drug tolerance, drug withdrawal syndrome
Napp Pharmaceuticals Limited