Pfizer – Neo-Medrol 25ml

NEO-MEDROL* ACNE LOTION
(Methylprednisolone Acetate, Neomycin Sulfate,
Aluminum Chlorhydroxide Complex and Colloidal Sulfur)

INDICATIONS
For control of acne vulgaris in the adolescent and young adult. Also in some cases of acne
rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
In tuberculosis of the skin, herpes simplex, vaccinia, varicella and in other cutaneous infections
which do not respond to neomycin. Known hypersensitivity to any of the components.
PRECAUTIONS
Avoid contact with eyes. If signs of irritation or sensitivity develop, application should be
discontinued. As with any antibiotic containing product, overgrowth by resistant organisms may
occur, particularly monilia. If this occurs, discontinue treatment and institute appropriate
measures. Articles in current medical literature indicate an increase in the incidence of patients
allergic to neomycin. The possibility of such a reaction should be borne in mind.
If extensive areas are treated or if the occlusion technique is used, the possibility exists of increased absorption of the corticosteroid and suitable precautions should be taken. The
prolonged use of antibiotic-containing preparations may result in overgrowth of nonsusceptible
organisms, particularly fungi. If new infections appear during treatment, appropriate therapy
should be instituted.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine.
Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with the individual use of either
drug may be more apt to occur.
Ototoxicity and nephrotoxicity have been reported following absorption of topically applied
neomycin.
Pregnancy: Although topical steroids have not been reported to have an adverse effect on
pregnancy, the safety of their use has not absolutely been established. Therefore, use with care
during pregnancy.
Children: When topical corticosteroids are applied for a prolonged period of time, sufficient
systemic absorption can suppress the hypothalamic-pituitary-adrenal axis. Growth suppression
may also occur.
ADVERSE EFFECTS
The following local adverse reactions have been reported with topical corticosteroids, either with
or without occlusive dressings: burning sensation, itching, irritation, dryness, folliculitis,
secondary infection, skin atrophy, striae, hypertrichosis, acneiform, eruptions, allergic contact dermatitis, laceration of the skin and hypopigmentation.
DOSAGE
After careful cleansing of the affected skin to minimize the possibility of introducing infection,
Neo-Medrol Acne Lotion should be applied sparingly to the affected areas once or twice a day
initially. Care should be taken 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 to every other day in some patients.

SUPPLIED
Each mL contains: methylprednisolone acetate 2.5 mg, neomycin sulfate 2.5 mg, aluminum
chlorhydroxide complex 100 mg and colloidal sulfur 50 mg. Nonmedicinal ingredients:
butylparaben, cetyl palmitate, lexemul ar, methylcellulose, methylparaben, perfume oil,
polyethylene glycol, polysorbate 80, polysorbate 85 and propylene glycol. Plastic squeeze
bottles of 25