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CONC. FOR IPECACUANHA & MORPHINE MIXTURE BP 1980

Active substance(s): IPECACUANHA TINCTURE / MORPHINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Concentrate for Ipecacuanha and Morphine Mixture BP 1980 Double Strength

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Hydrochloride 0.915 mg/5 ml
Ipecacuanha Tincture 0.2 ml/5 ml
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Concentrated mixture

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Symptomatic relief of cough

4.2.

Posology and Method of Administration
For the reconstituted mixture
Adults
10 ml three to four times daily.
The elderly
Dosage should be reduced in elderly or debilitated patients.
Children
Not recommended for children under 12 years.

Route of administration
Oral use.

4.3.

Contraindications
Hypersensitivity to any of the ingredients. Preparations containing morphine
are generally contraindicated in respiratory depression especially in the
presence of cyanosis and excessive bronchial secretion. They are also
contraindicated in head injury, coma, convulsive disorders, raised intracranial
pressure and acute alcoholism. They should not be given during an attack of
bronchial asthma.

4.4.

Special Warnings and Precautions for Use
As for other morphine products, this product should be used with caution in
the elderly, patients with hypothyroidism, impaired kidney or liver function,
adrenocortical insufficiency, prostatic hypertrophy, hypotension, shock,
reduced respiratory reserve and inflammatory or obstructive bowel disorders.
Avoid alcoholic drinks.

4.5.

Interactions with other Medicaments and other forms of Interaction
Products containing morphine should not be given concurrently with
a) other CNS depressants or
b) monoamine oxidase inhibitors nor within two weeks of treatment with
them.
The gastrointestinal effects of opioids may delay absorption of other
compounds such as mexiletine or be counteractive as with metoclopramide or
domperidone.

4.6.

Pregnancy and Lactation
It is not recommended during pregnancy and lactation.

4.7.

Effects on Ability to Drive and Use Machines

The morphine content of this product may cause drowsiness and impair the
ability to drive and operate machines.

4.8.

Undesirable Effects
Ipecacuanha has an irritant effect on the gastrointestinal tract and large doses
may give rise to persistent vomiting and bloody diarrhoea.
Morphine may cause nausea, vomiting, constipation, drowsiness and
confusion. Prolonged use of morphine may cause dependence and tolerance.

4.9.

Overdose
Signs of overdosage due to morphine include pin-point pupils, depressed
respiration and coma. In severe poisoning, there may be dilatation of the
pupils, shock, severe respiratory depression and pulmonary oedema.
Overdosage due to ipecacuanha is unlikely as large doses are emetic but it
should be noted that if this does not occur then there have been cases of
cardiotoxicity. Treatment consists of general supportive therapy and may
include gastric lavage. In cases of respiratory depression, naloxone
hydrochloride, given intravenously, can be used as an antidote.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Morphine directly suppresses cough by an effect on the cough centre in the
medulla.
Ipecacuanha has been used traditionally as an expectorant. The reflex
expectorant action is thought to occur as a result of an irritant action, which
provides a stimulus for the reflex production of sputum by the glands in the
bronchial mucous membrane.

5.2.

Pharmacokinetic Properties
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.
No detailed information is available for ipecacuanha. The principal alkaloid,
emetine is rapidly absorbed after oral administration and is concentrated in
liver, kidneys, lungs and spleen. It is excreted very slowly with up to 35%
being retained at 35 days. Its metabolic fate is unknown.

5.3.

Preclinical Safety Data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Treacle of commerce
Chloroform
Peppermint Oil
Anaesthetic ether
Syrup
Ethanol 96% v/v
Liquorice Liquid Extract
Potable Water

6.2.

Incompatibilities
None.

6.3.

Shelf Life
24 months.

6.4.

Special Precautions for Storage

Store below 25°C.

6.5.

Nature and Contents of Container
2 litre amber glass bottle with a white plastic screw cap with an EPE liner
faced with aluminium.

6.6.

Instruction for Use/Handling
Dilute one part of the concentrated mixture with one part of potable water to
prepare Ipecacuanha and Morphine Mixture B.P. 1980.

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 18374/0043

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14th April 2005

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Source: Medicines and Healthcare Products Regulatory Agency

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