INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
NEO-MEDROL™ Acne Lotion

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NEO-MEDROL™ Acne Lotion

COMPOSITION:
Each mL contains:

	Methylprednisolone acetate	2,5 mg
	Neomycin sulphate (equivalent to 1,75 mg neomycin base)	2,5 mg
	Aluminium chlorhydroxide complex	100 mg
	Sulphur	50 mg

Preservatives:

	Methylparaben	0,2% m/v
	Butylparaben	0,3% m/v

PHARMACOLOGICAL CLASSIFICATION:
Catogory A.13.4.1 (Corticosteroids with or without anti-infective agents)

PHARMACOLOGICAL ACTION:
Topical steroids are primary effective because of their anti-inflammatory, antipyretic and vasoconstrictive actions.
Methylprednisolone applied locally has been found to be rapidly effective in acute uncomplicated allergic dermatitis. In many instances objective signs of improvement, subsidence of erythema and oedema as well as symptomatic relief occur within a few hours of the first application. With symptomatic relief, further damage to the skin, with subsequent possible infection, is prevented. Following discontinuance of applications no "rebound" activation of lesion has been observed.
Neomycin is an antibacterial substance derived from cultures of the soil organism, Streptomyces fradiae. It exhibits a wider spectrum of antibacterial activity than does bacitracin, streptomycin, or penicillin and its active against a variety of gram-positive and gram-negative organisms including staphylococci, Escherichia coli, and Hemophilus influenzae. It is not active against fungi. Neomycin rarely causes resistant strains of micro organisms to develop. In addition, it is unusually nontoxic for human epithelial cells in tissue culture and is nonirritating topically in therapeutic concentrations.

INDICATIONS:
NEO-MEDROL Acne Lotion is recommended for the topical therapy of acne vulgaris, particularly as encountered in the adolescent or young adult. It has been shown to produce improvement in 80-90% of such patients, and to be definitely superior to a placebo in this respect. It is less useful in the treatment of cystic acne. Additional forms of therapy may be required in resistant cases.

CONTRA-INDICATIONS
Because of the corticosteroid content, local application of NEO-MEDROL Acne Lotion is contraindicated in tuberculosis of the skin, herpes simplex, vaccinia, varicella, and in other cutaneous infections for which an effective antibiotic or chemotherapeutic agent is not available for simultaneous application.
Patients with known hypersensitivity to neomycin should not be treated with this preparation.

DOSAGE AND DIRECTION FOR USE:
NEO-MEDROL Acne Lotion should be applied thinly to the affected areas once or twice a day initially, taking care to avoid contact with the eyes. The frequency of application will vary from patient to patient, depending on their susceptibility to the drying effect of the lotion and may have to be reduced in some patients to applications every other day. A 30 ml vial will treat the average acne case during one to four weeks, depending upon the extension of the lesions.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
This preparation is usually well tolerated. However, neomycin may occasionally induce hypersensitivity reactions. If signs of irritation or hypersensitivity should develop, application should be discontinued. Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use on pregnant patients has not been established. Therefore, they should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
Care should be taken to avoid contact with the eyes.
Prolonged and intensive treatment may cause:

1	Atrophic changes in the skin, such as loss of elasticity, thinning, dilation of superficial blood vessels and purpura particularly when occlusive dressings are used:
2.	The possibility of systemic absorption of steroid and complications of steroid therapy, especially growth retardation in children, suppression of pituitary-adrenal function, increase susceptibility of infection, hypoglycaemia, cushingoid state and benign intracranial hypertension.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should by symptomatic and supportive.

IDENTIFICATION:
Yellow emulsion.

PRESENTATION:
NEO-MEDROL Acne Lotion is available in a plastic squeeze bottle containing 30 mL or 75 mL.

STORAGE INSTRUCTIONS:
Store at room temperature (15° - 30°C).
Protect from light.
Keep out of reach of children.

REFERENCE NUMBER:
G 1327 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
MIDRAND 1685
R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30.8.76

^TM = Trademark

New addition to this site: January 2005
Source: Pharmaceutical Industry
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