KAOLIN & MORPHINE MIXTURE B.P.
NAME OF THE MEDICINAL PRODUCT
Kaolin and Morphine Mixture B.P.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kaolin Light Sterilised 1.0g / 5ml
Sodium Bicarbonate 250mg / 5ml
Morphine Hydrochloride 0.45mg / 5ml
For excipients, see 6.1.
For the relief of diarrhoea.
Posology and Method of Administration
For oral use.
Adults, the elderly and children over 12 years of age
Two 5ml spoonfuls three times a day or as directed.
Children under 12 years of age
Hypersensitivity to any of the ingredients. As for other morphine-containing
preparations: respiratory depression, obstructive airways disease, acute hepatic
disease, acute alcoholism, head injuries, coma, convulsive disorders, raised
intracranial pressure, concurrent administration of monamine oxidase
inhibitors or within two weeks of discontinuation of their use. Intestinal
obstruction in view of the kaolin content.
Special Warnings and Special Precautions for Use
As with other morphine preparations, Kaolin and Morphine Mixture should be
used with caution in the elderly, in hypothyroidism, in renal and hepatic
disease, adrenocortical insufficiency, prostatic hypertrophy, shock or reduced
respiratory reserve and should not be given if paralytic ileus is likely to occur.
In view of the sodium bicarbonate content, Kaolin and Morphine Mixture
should be administered with caution in patients with congestive heart failure,
hypertension and receiving corticosteroids. It is also not recommended in
metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.
Do not exceed the stated dose. If symptoms persist, consult your doctor.
Shake the bottle.
Interactions with other Medicinal Products and other Forms of
The adsorbent effects of kaolin, the reduction in intestinal motility produced
by morphine, and the antacid effect of sodium bicarbonate may reduce or
delay the absorption of other drugs from the gastrointestinal tract when given
The depressant effects of morphine may potentiate the effects of tranquillisers,
anaesthetics, hypnotics, sedatives and alcohol.
Pregnancy and Lactation
Kaolin and Morphine Mixture should not be used during pregnancy or
lactation unless the physician considers it necessary.
Morphine is known to cross the placenta, and is excreted in the breast milk
although therapeutic doses are unlikely to affect the infant.
Effects on Ability to Drive and Use Machines
Morphine may cause drowsiness and patients should not drive or operate
machinery if so affected.
Prolonged use of morphine may produce tolerance and psychological and
physical dependence. Morphine may cause nausea and vomiting, constipation,
drowsiness and confusion. Large doses may produce respiratory depression
Sodium bicarbonate may cause flatulence and prolonged use may lead to
Signs of morphine toxicity and overdosage include pin-point pupils,
respiratory depression and hypotension, circulatory failure and deepening
coma may occur in more severe cases.
Excessive administartion of sodium bicarbonate may lead to metabolic
Emergency procedures and antidotes
Administration of naloxone. Aspiration and gastric lavage with supportive
therapy such as replacement of fluids and electrolytes and assisted respiration
The possibility of intestinal obstruction should be investigated because of the
Kaolin adsorbs toxic and other substances from the gastrointestinal tract and
increases stool bulk.
Morphine reduces intestinal motility.
Sodium bicarbonate is an alkalising agent and antacid.
Kaolin is not absorbed and remains unchanged throughout transit of the
Morphine is rapidly, but variably, absorbed from the gastrointestinal tract with
peak levels occurring in 30 - 120 minutes. Bioavailability by the oral route is
only about 30% due to significant first-pass metabolism in the liver. The
mean plasma half-life is 3 hours (range 1 - 5 hours). It is distributed
throughout the body but mainly in the kidneys, liver, lungs and spleen with
lower concentrations in the brain and muscles. Morphine diffuses across the
placenta and traces also appear in milk (less than 1%) and sweat. About 35%
is protein bound.
Conjugation to morphine 3- and 6-glucuronides occurs in the liver. About
10% of a dose of morphine is excreted through the bile into the faeces and the
remainder is excreted in the urine. About 90% of total morphine is excreted in
24 hours with traces up to 48 hours.
Sodium bicarbonate, not used in neutralising gastric acid with the production
of carbon dioxide, is absorbed and in the absence of a deficit of bicarbonate in
the plasma, bicarbonate ions are excreted in the urine together with sodium
Preclinical Safety Data
No relevant data.
List of Excipients
Treacle, commercial grade
Liquorice liquid extract
Morphine salts are sensitive to changes in pH and morphine is liable to be
precipitated out of solution in an alkaline environment.
Sodium bicarbonate is incompatible with acids, acidic salts and many
Special Precautions for Storage
Store in a well-filled, well closed glass container below 25°C.
Nature and Contents of Container
2 litre and 500ml amber glass bottles with a white plastic screw cap with an
EPE aluminium foil faced liner.
100 and 200ml amber glass bottles with a white low density polyethylene Jay
Not all pack sizes may be marketed.
Instruction for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF
9th March 2005
DATE OF REVISION OF THE TEXT
9th March 2005