Stiemycin 2.0% w / v

1. Name Of The Medicinal Product

Stiemycin 2.0% w/v.

2. Qualitative And Quantitative Composition

Erythromycin Base EP 2.46 w/w.

For a 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.

• Children

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.

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 life-threatening. 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 antibiotic-associated 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 Pregnancy And Lactation

Fertility

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

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.

Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

The following convention has been used for the classification of frequency:

Very common:
Common:
Uncommon:
Rare:
Very rare:	<1/10000
Not known:	Cannot be estimated from the available datam

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

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 away from heat and flame.

Replace cap firmly after use to prevent evaporation.

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 And Other Handling

There are no special instructions for use or handling of Stiemycin.

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 / 6 August 2004

10. Date Of Revision Of The Text

16 August 2011