KAOLIN & MORPHINE MIXTURE B.P.

Active substance: SODIUM BICARBONATE

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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
Kaolin Light Sterilised 1.0g / 5ml
Sodium Bicarbonate 250mg / 5ml
Morphine Hydrochloride 0.45mg / 5ml
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Oral solution

4

CLINICAL PARTICULARS

4.1

Therapeutic Indications
For the relief of diarrhoea.

4.2

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
Not recommended.

4.3

Contra-indications

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.

4.4

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.

4.5
Interactions with other Medicinal Products and other Forms of
Interaction
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
concomitantly.
The depressant effects of morphine may potentiate the effects of tranquillisers,
anaesthetics, hypnotics, sedatives and alcohol.

4.6

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.

4.7

Effects on Ability to Drive and Use Machines

Morphine may cause drowsiness and patients should not drive or operate
machinery if so affected.

4.8

Undesirable Effects
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
and hypotension.
Sodium bicarbonate may cause flatulence and prolonged use may lead to
metabolic alkalosis.

4.9

Overdose
Symptoms
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
alkalosis.
Emergency procedures and antidotes
Administration of naloxone. Aspiration and gastric lavage with supportive
therapy such as replacement of fluids and electrolytes and assisted respiration
if necessary.
The possibility of intestinal obstruction should be investigated because of the
kaolin content.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
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.

5.2

Pharmacokinetic Properties
Kaolin is not absorbed and remains unchanged throughout transit of the
gastrointestinal tract.
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
ions.

5.3

Preclinical Safety Data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Treacle, commercial grade
Nipastat sodium
Chloroform
Peppermint oil
Anaesthetic ether
Liquorice liquid extract
Syrup
Ethanol 96%
Water potable

6.2

Incompatibilities
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
alkaloidal salts.

6.3

Shelf Life
24 months.

6.4

Special Precautions for Storage
Store in a well-filled, well closed glass container below 25°C.

6.5

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
cap.
Not all pack sizes may be marketed.

6.6

Instruction for Use, Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street

Manchester
M19 2RB
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0012

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
9th March 2005

10

DATE OF REVISION OF THE TEXT
9th March 2005

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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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