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STIEMYCIN 2.0% W/V

Active substance(s): ERYTHROMYCIN / ERYTHROMYCIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Stiemycin 2.0% w/v.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin Base EP 2.46 w/w.
Excipient with known effect:
Propylene Glycol
For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Cutaneous solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Stiemycin is indicated for use in the treatment of acne vulgaris.

4.2

Posology and method of administration


Adults and adolescents

To be applied in a thin film to the affected area twice daily after washing and
drying the skin.
Hands should be washed after application.
Patients should be advised that a therapeutic effect may not be seen until after
6-8 weeks of treatment. Treatment may be continued for up to a maximum of
6 months. If there has been no improvement after 6 to 8 weeks, or if the
condition becomes worse, treatment should be discontinued.
Owing to the flammable nature of the product, Stiemycin solution should be
kept away from open fire and flames and all sources of ignition, including
smoking, during and immediately after use.



Paediatric population

Safety and effectiveness of topical erythromycin in children under the age of
12 have not been established.
• Elderly
There are no specific recommendations for use in the elderly.
• Renal impairment
No dosage adjustment is necessary.
• Hepatic impairment
No dosage adjustment is necessary.

4.3.

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.

4.4

Special warnings and precautions for use
Stiemycin should be used with caution in patients with a known sensitivity or
allergy to any ingredients. Stiemycin contains propylene glycol which may
cause skin irritation.
Concomitant topical acne therapy should be used with caution because a
cumulative irritancy effect may occur, especially with the use of peeling,
desquamating or abrasive agents. If irritancy or dermatitis occurs,
erythromycin should be discontinued.
Contact with the mouth, eyes, lips, other mucous membranes or areas of
broken skin should be avoided.
Resistance to erythromycin
Cross-resistance and cross-sensitivity with other antibiotics of the macrolide
group and with clindamycin may occur.
The use of antibiotic agents may be associated with the overgrowth of
antibiotic-resistant organisms. If this occurs, discontinue use.
Pseudomembranous colitis
Stiemycin should be used with caution in patients with a history of regional
enteritis, ulcerative colitis, or antibiotic-associated colitis (including
pseudomembranous colitis).
Pseudomembranous colitis has been reported with nearly all antibacterial
agents, including erythromycin, and may range in severity from mild to lifethreatening. Although this is unlikely to occur with topically applied
erythromycin, if prolonged or significant diarrhoea occurs or the patient
suffers from abdominal cramps, treatment should be discontinued immediately

and the patient investigated further, as the symptoms may indicate antibioticassociated colitis.

4.5

Interaction with other medicinal products and other forms of interaction
Clindamycin and erythromycin have been shown to be antagonistic in vitro.
No clinical data is available.

4.6

Fertility, pregnancy and lactation
Pregnancy
There are limited data on the use of topical erythromycin in pregnant women. No
effects during pregnancy are anticipated since systemic exposure to erythromycin is
very limited. However, topical erythromycin should be used during pregnancy only if
the expected benefit justifies the potential risk to the foetus.

Breast-feeding
Percutaneous absorption of erythromycin is very limited, however, it is not known
whether erythromycin is excreted in human milk after topical application.
Erythromycin is excreted in human milk following oral and parenteral administration.
Topical erythromycin should be used during lactation only if the expected benefit
justifies the potential risk to the infant. If used during lactation, erythromycin should
not be applied to the breast area to avoid accidental ingestion by the infant.

Fertility
There are no data on the effect of topical erythromycin on fertility in humans.

4.7

Effects on ability to drive and use machines
Stiemycin solution has no or negligible influence on the ability to drive and use
machines.

4.8

Undesirable effects
The following convention has been used for the classification of frequency:
Very common:

≥1/10

Common:

≥1/100 to <1/10

Uncommon:

≥1/1000 to <1/100

Rare:

≥1/10000 to <1/1000

Very rare:

<1/10000

Not known:

Cannot be estimated from the available data

Clinical trial data
Skin and subcutaneous tissue disorders
Very common: Skin burning sensation, skin irritation, dry skin, especially on
initiation of treatment, application site stinging, application site erythema, especially
on initiation of treatment.

Post-marketing data
The following adverse drug reactions are based on post-marketing reports. Since
these reports are from a population of uncertain size and are subject to confounding
factors, it is not possible to reliably estimate their frequency, however in reality
systemic reactions are rarely seen.

Immune system disorders
Not known:

Allergic reaction

Gastrointestinal disorders
Not known:

Diarrhoea, abdominal discomfort, upper abdominal pain

Skin and subcutaneous disorders
Not known:

Rash, urticaria, pruritus.

General disorders and administration site conditions
Not known:

Facial oedema

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms and signs
In the event of accidental ingestion, the same gastrointestinal adverse reactions
as those seen with orally administered erythromycin may be seen.

The formulation contains a significant quantity of ethanol. Systemic
absorption of this should be considered a possibility in the event of
overdosage.
Treatment
Further management should be as clinically indicated or as recommended by
the National Poisons Centre, where available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Erythromycin, ATC code: D10AF02
Erythromycin suppresses propionibacterium acnes, a resident bacterial of
sebaceous follicles, and as a result of this organism's role in the hydrolysis of
triglycerides to free fatty acids, administration decreases fatty acid formation.
This is thought to be responsible for its effectiveness in reducing acne lesion
counts and the fatty acid to fatty ester ratios in acne patients.

5.2

Pharmacokinetic properties
Percutaneous absorption of erythromycin from Stiemycin solution is
negligible.

5.3

Preclinical safety data
The preclinical and clinical safety of erythromycin is well established.
Erythromycin has been in widespread use for many years.

6

PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Propylene Glycol
Ethanol Absolute
Polyoxyethylene-4-lauryl ether
6.2

Incompatibilities
None.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25°C.
Keep container tightly closed when not in use.
Contents are flammable. Keep away from fire, flame or heat.
Do not leave Stiemycin solution in direct sunlight.

6.5

Nature and contents of container
Amber glass screw capped bottle of 25ml and 50ml.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

8

MARKETING AUTHORISATION NUMBER(S)
PL 19494/0055

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21 June 1988 / 05 August 2004

10

DATE OF REVISION OF THE TEXT
22/07/2014

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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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