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Sevredol tablets 10mg, 20mg and 50mg

23-11-2011

Generic Name

Morphine sulphate

Drug Class Description

Morphine Sulphate 10 mg, 20 mg, 50 mg

Presentation

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.

Indications

Sevredol tablets are indicated for the relief of severe pain.

Adult Dosage

Route of administration

Oral.

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.

Elderly:

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.

Child Dosage

Under 3 years, not recommended; 3 - 5 years, 5 mg four hourly; 6 - 12 years, 5 - 10 mg four hourly.

Contra Indications

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.

Special Precautions

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.

Interactions

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.

Adverse Reactions

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 (GREATER-THAN OR EQUAL TO (8805)1/10); Common (GREATER-THAN OR EQUAL TO (8805) 1/100 to < 1/10); Uncommon (GREATER-THAN OR EQUAL TO (8805) 1/1,000 to < 1/100); Rare (GREATER-THAN OR EQUAL TO (8805) 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

 

Psychiatric disorders

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

 

Eye disorders

Uncommon: Visual disturbance

Not known: Miosis

 

Ear and labyrinth disorders

Uncommon: Vertigo

 

Cardiac disorders

Uncommon: Palpitations

Not known: Bradycardia, tachycardia

 

Vascular disorders

Uncommon: Facial flushing, hypotension

Not known: Hypertension

 

Respiratory, thoracic and mediastinal disorders

Uncommon: Bronchospasm, pulmonary oedema, respiratory depression

Not known: Cough decreased

 

Gastrointestinal disorders

Very common: Nausea

Common: Abdominal pain, anorexia, constipation, dry mouth, vomiting

Uncommon: Dyspepsia, ileus, taste perversion

Hepatobiliary disorders

Uncommon: Increased hepatic enzymes

Not known: Biliary pain, exacerbation of pancreatitis

 

Skin and subcutaneous tissue disorders

Common: Hyperhidrosis, rash

Uncommon: Urticaria

 

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

Manufacturer

Napp Pharmaceuticals Limited

Drug Availability

(CD)