INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MST CONTINUS® TABLETS

SCHEDULING STATUS:
S6

PROPRIETARY NAME:
(and dosage form)

MST CONTINUS® TABLETS

MST CONTINUS* 10 mg TABLETS
MST CONTINUS* 30 mg TABLETS
MST CONTINUS* 60 mg TABLETS
MST CONTINUS* 100 mg TABLETS

COMPOSITION:
Each MST CONTINUS* 10 mg tablet contains
Morphine Sulphate 10 mg in a controlled release matrix. Sugar free.
Each MST CONTINUS* 30 mg tablet contains Morphine Sulphate 30 mg in a controlled release matrix. Sugar free.
Each MST CONTINUS* 60 mg tablet contains Morphine Sulphate 60 mg in a controlled release matrix. Sugar free.
Each MST CONTINUS* 100 mg tablet contains Morphine Sulphate 100 mg in a controlled release matrix. Sugar free.

PHARMACOLOGICAL CLASSIFICATION:
A. 2.9 Other Analgesics

PHARMACOLOGICAL ACTION:
Morphine Sulphate is a narcotic analgesic.

INDICATIONS:
For the relief of severe and intractable pain not controlled with non-narcotic analgesics.

CONTRA-INDICATIONS:
Respiratory depression, obstructive airways disease, acute alcoholism, head injuries and conditions in which intracranial pressure is raised.
Contra-indicated after operation of the biliary tract.
MST CONTINUS* tablets are not recommended for paediatric use.

INTERACTIONS:
Concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of treatment with them.

PREGNANCY AND LACTATION:
MST CONTINUS* tablets are not recommended for use in pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
MST CONTINUS* tablets should be taken twice daily. The dosage is dependent upon the severity of pain and the patients previous history of analgesic therapy.
A patient with intractable pain due to cancer will normally be started on a dosage of one or two MST CONTINUS* 10 mg tablets twice daily. Increases in pain or tolerance to the drug will require increases in dosage using MST CONTINUS* 10 mg, 30 mg, 60 mg and 100 mg tablets alone or in combination.
When substituting MST CONTINUS* for parenteral morphine, patients should be given a sufficiently increased dosage to compensate for the reduction in analgesic effects associated with orally administered morphine. MST CONTINUS* tablets should be swallowed whole and not chewed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, constipation, difficulty in micturition, ureteric or biliary spasm, hypothermia, miosis, facial flushing, sweating, restlessness, drowsiness, changes of mood, confusion, mental cloudiness, dry mouth, vertigo, bradycardia, palpitations and orthostatic hypotension may occur. Tolerance and dependence may occur. Morphine Sulphate must be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy, shock or in patients with inflammatory or obstructive bowel disorders. Should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
The dosage should be reduced in the elderly and debilitated patient. The depressant effects of morphine are enhanced by depressants of the effects of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives and phenothiazines.
Allergic reactions, including urticaria and pruritus may occur.
Ambulant patients should be warned against driving or handling dangerous machinery.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Respiratory depression and hypotension with circulatory failure and coma.
Treatment:
400 ug Naloxone given intravenously, repeated at intervals of 2 to 3 minutes if necessary. Empty stomach using a 0,02% aqueous solution of potassium permanganate to lavage. Supportive therapy if necessary. Toxic effects may last for several hours.

IDENTIFICATION:
MST CONTINUS* 10 mg tablets: Golden brown, film coated, bi-convex tablets marked 10 mg on one side and NAPP on the other.
MST CONTINUS* 30 mg tablets: Purple, film coated, bi-convex tablets marked 30 mg on one side and NAPP on the other.
MST CONTINUS* 60 mg tablets: Orange, film coated, bi-convex tablets marked 60 mg on one side and NAPP on the other.
MST CONTINUS* 100 mg tablets: Grey, film coated, bi-convex tablets marked 100 mg on one side and NAPP on the other.

PRESENTATION:
Polypropylene securitainers of 60 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from moisture. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
MST CONTINUS* 10 mg TABLETS: R/2.9/294
MST CONTINUS* 30 mg TABLETS: R/2.9/295
MST CONTINUS* 60 mg TABLETS: S/2.9/278
MST CONTINUS* 100 mg TABLETS: S/2.9/279

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 November 1989

Licensed by Mundipharma AG, Switzerland.
®: MST CONTINUS and CONTINUS are Registered Trademarks.
The Trademark CONTINUS ® distinguishes the controlled release preparations of Mundipharma AG and its associates.

New addition to this site: April 2004
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004