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KAOLIN & MORPHINE MIXTURE BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Kaolin and Morphine Mixture B.P.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Mixture containing light Kaolin 20% w/w
Sodium bicarbonate 5%
Chloroform and Morphine Tincture 4% w/w

3

PHARMACEUTICAL FORM
Liquid mixture.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For diarrhoea.

4.2

Posology and method of administration
Route of Administration
Oral
Adults:
Two 5ml spoonfuls in water. Repeat dose every six hours if necessary.
This product is not recommended for children under 12 years of age.

4.3

Contraindications
Patients with impaired renal function or cardiac disorders, moderate to severe
respiratory depression, acute alcoholism, head injuries and conditions in which
there is raised intracranial pressure.
Hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use
Avoid in phaeochromocytoma.
Although the daily dose of morphine is rather small, however, the product
should be used with caution in patients with inflammatory or obstructive
bowel disorders, as there is a risk of precipitating toxic megacolon.
The labelling shall state:
Consult a doctor if symptoms persist for 36 hours.
Do not exceed the stated dose.
Suitable for the symptomatic relief of diarrhoea only. No substitute for
Rehydration therapy. Drink plenty of fluids if you have diarrhoea.

4.5

Interaction with other medicinal products and other forms of interaction
The following interactions have been observed with other morphinecontaining medicinal products.
Clinically significant interactions may occur in patients taking MAOI’s
concurrently or within 14 days of such treatment and these reactions may be
serious. The depressant effects of morphine may enhance depressants of the
CNS such as alcohol, anaesthetics, hypnotics, sedatives and phenothiazines.
Kaolin
Kaolin reduces absorption of Chloroquine and Hydroxychloroquine, and
possibly reduces absorption of Aspirin, Phenothiazines, Quinidine and
Tetracyclines.

4.6

Pregnancy and lactation
Unlikely to cause any serious effects in pregnancy or lactation if taken at the
recommended dose.

4.7

Effects on ability to drive and use machines
Kaolin and morphine mixture may cause drowsiness in certain individuals and
may therefore interfere with the ability to drive or operate machinery.

4.8

Undesirable effects
The following adverse events have been observed with other morphinecontaining medicinal products.
Common side effects, which may occur, include nausea, vomiting,
constipation, drowsiness, dry mouth, sweating, facial flushing and miosis.
Other side effects include difficulty with micturation, vertigo, bradycardia,
postural hypotension, urticaria, pruritus, rashes, hypothermia, hallucination
and mood changes.

4.9

Overdose
Overdose of Kaolin is unlikely to lead to significant toxicity.
The amount of morphine in the product is low, but in the event of a substantial
overdose the following advice is given:
Symptoms of morphine overdose may include nausea, vomiting, drowsiness,
confusion, dry mouth, sweating, facial flushing, bradycardia, palpitations,
orthostatic hypotension and miosis. Respiratory depression, circulatory failure,
deepening coma and convulsions may also occur.
Treatment consists of supportive measures and naloxone as appropriate.
Activated charcoal (50g for adults, 10-15 g for children) may be given if a
substantial amount has been ingested within 1 hour, provided the airway can
be protected.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The chloroform and morphine tincture due to its morphine content acts as an
analgesic while the light kaolin is present to absorb toxic and other substances
and increase the bulk of the faeces.

5.2

Pharmacokinetic properties
Morphine is absorbed from the gastrointestinal tract and undergoes significant
first pass metabolism in the liver. It is metabolised in the liver, principally to
morphine 3- and 6- glucoronides, although smaller amounts of morphine
undergo n-demethylation and O-methylation. Morphine is widely distributed.
About 10% of morphine is secreted in the bile and eliminated in faeces, while
the remainder is excreted in the urine, namely as conjugates.
Morphine is bound to plasma proteins only to the extent of 25-35% and
therefore functions that change the extent of protein binding will have only a
minor impact on its pharmacodynamic effects.

5.3

Preclinical safety data
Kaolin and morphine mixture is well-established for its pharmacological and
toxicological properties. There are no pre-clinical data of clerical concern.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium methyl hydroxy benzoate
Sodium propyl hydroxy benzoate.
Potable water

6.2

Incompatibilities
None.

6.3

Shelf life
12 months.

6.4

Special precautions for storage
Store out of reach of children.

6.5

Nature and contents of container
Nature:
Amber glass bottle containing 200m1
Polyethylene bottle containing 2000m1

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0060

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/10/96

10

DATE OF REVISION OF THE TEXT
28/02/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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