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CAM MIXTURE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Cam Mixture.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituent:
Ephedrine hydrochloride Ph.Eur.

3.

quantity per 5ml
4.0mg

PHARMACEUTICAL FORM
Oral liquid.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
Cam Mixture is indicated in the symptomatic treatment of bronchospasm in
children and adults with bronchitis.

4.2

Posology and method of administration
Cam Mixture is for oral administration.
Adults and the elderly

: 20ml, 3-4 times daily.

Children (over 4 years)

: 10ml, 3 times daily.

Children (2-4 years)

: 5ml, 3 times daily.

Children (6 months- 2 years)

: 2.5ml, 3 times daily.

The duration of use should not exceed 5 days.
4.3

Contraindications

Should be avoided in patients with most types of cardiovascular disorders,
hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, and
closed-angle glaucoma. In patients with prostatic enlargement it may increase
difficulty with micturition. It should not be given to patients taking MAGI or
within 14 days of stopping such treatment.

4.4

Special warnings and precautions for use
Care should be taken in patients with any of the following conditions; diabetes
mellitus, ischaemic heart disease and renal impairment.

4.5

Interactions with other medicinal products and other forms of interaction
When possible ‘Cam’ Mixture should be discontinued prior to giving
chloroform, cyclopropane, halothane or other halogenated anaesthetics. The
effects of ephedrine are diminished by guanethidine, reserpine and probably
methyldopa and may be diminished or enhanced by tricyclic antidepressants. It
may also diminish the effects of guanethidine and B blockers and may
increase the possibility of arrhythmias in digitalised patients.

4.6

Pregnancy and lactation
While no evidence of ill-consequences have been reported, as with most drugs,
administration should be avoided especially during the first and third
trimesters.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Although not reported for ‘Cam’ Mixture the following effects are possible,
based on experience with other ephedrine-containing products; tachycardia,
anxiety, restlessness, insomnia, tremor, arrhythmias, dry mouth and cold
extremities

4.9

Overdose

The effects of overdosage include CNS stimulation, hallucinations and
hypertension. Management involves supportive and symptomatic treatment. In
severe overdosage the stomach should be emptied by aspiration and lavage if
within 4 hours of ingestion. Diazepam may be given to control CNS
stimulation and convulsions. For marked excitement or hallucinations
chlorpromazine may be necessary.
Severe hypertension may call for administration of an alpha-receptor blocking
agent such as phentolamine.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Ephedrine stimulates both alpha and beta adrenergic receptors, which as a rule
are excitatory and inhibitory, respectively, in their effect. Ephedrine is more
stable than epinephrine and is effective when given by mouth; its action is less
intense, but more prolonged than that of epinephrine.
Ephedrine causes contraction of arterioles with consequent rise in blood
pressure; there is no secondary arteriole dilation as with epinephrine. It causes
dilation of the pupil, relaxation of intestinal and bronchial muscles; in some
animals it produces hyperglycaemia but ordinary doses have no such effect in
man. Unlike epinephrine, it has powerful stimulating effects on the CNS. At
least part of the peripheral action of ephedrine is attributed to the release of
norepinephrine, depletion of which is assumed to be the reason for the
diminishing peripheral response when administration of ephedrine is repeated
at short intervals.

5.2

Pharmacokinetic properties
Ephedrine is readily and completely absorbed from the gastrointestinal tract. It
is resistant to metabolism by monoamine oxidase and is largely excreted
unchanged in the urine, together with small amounts of metabolites produced
by hepatic metabolism. Ephedrine has been reported to have a plasma half-life
ranging from 3 to 6 hours depending on urinary PH; elimination is enhanced
and half-life accordingly shorter in acid urine.

5.3

Preclinical safety data
No remarks.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

6.2

Saccharin Sodium (E954)
Potassium Sorbate (E202)
Nipasept Sodium
Glycerol (E422)
Sorbitol Solution 70%
Amyl Acetate
Chloroform
Citric Acid Monohydrate
Purified Water
Incompatibilities
None known.

6.3

Shelf life
Three years from date of manufacture. Once opened, use within 4 weeks.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Amber glass bottles with ROPP closures containing 50 ml, 100 ml, 150 ml or
200 ml ‘CAM’ Mixture.

6.6

Instruction for use, handling and disposal
No special instructions are necessary

7

MARKETING AUTHORISATION HOLDER
Cambridge Healthcare Supplies Ltd
Unit 1 Chestnut Drive
Wymondham
Norfolk
NR18 9SB

8.

MARKETING AUTHORISATION NUMBER
PL 16794/0005

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/09/2005

10

DATE OF REVISION OF THE TEXT
07/01/2014

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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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