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Logo KENACOMB CREAM
KENACOMB OINTMENT

SCHEDULING STATUS:
S4

PP Zimbabwe only
Reg No:E4/13.4.1/273

PROPRIETARY NAME
(and dosage form)

KENACOMB CREAM
KENACOMB OINTMENT

COMPOSITION
Each gram contains 100 000 units
nystatin, 2,5 mg neomycin base (as sulphate), 0,25 mg gramicidin, and 1,0 mg triamcinolone acetonide.

KENACOMB CREAM is preserved with methylparaben 0,2% and propylparaben 0,02%

PHARMACOLOGICAL CLASSIFICATION
Category A 13.4.1 Corticosteroids with or without anti-infective agents.

PHARMACOLOGICAL ACTION
KENACOMB combines the potent corticosteroid triamcinolone acetonide with the antifungal antibiotic nystatin and the wide spectrum antibacterial activity of neomycin and gramicidin.
KENACOMB reduces inflammation, relieves pruritis and combats or prevents monilial and bacterial infections.
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin, inflammation and/or other disease processes in the skin increase percutaneous absorption.
Nystatin and gramicidin are not absorbed from intact skin or mucous membranes.
Neomycin can be absorbed through inflamed skin. Once absorbed, it is rapidly excreted unchanged through the kidneys. The half-life is approximately 2 to 3 hours.
Microbiology
Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.
Nystatin exhibits no activity against bacteria, protozoa, or viruses.
Neomycin exerts its bacterial activity against a number of gram-negative organisms by inhibiting protein synthesis. It is not active against Pseudomonas aeruginosa, and resistant strains of gram-negative bacteria may develop.
Gramicidin exerts its antibacterial activity against many gram-positive organisms by altering cell membrane permeability.

INDICATIONS
KENACOMB is indicated for use in corticosteroid responsive dermatoses complicated or threatened by secondary monilial and/or bacterial infections, such as:
  Atopic dermatitis
  Seborrhoeic dermatitis
  Lichen simplex chronicus
  Psoriasis (particularly of the face and body folds)
  Allergic contact dermatitis
KENACOMB CREAM permits use in moist intertrigenous areas.

CONTRA-INDICATIONS
Sensitivity to any of the components of the preparation. Not indicated in those patients with tuberculous lesions, topical or systemic viral infections.
KENACOMB is not intended for ophthalmic use, nor should it be applied in the external auditory canal of patients with perforated eardrums.
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore KENACOMB Cream/Ointment should not be used during pregnancy.

DOSAGE AND DIRECTIONS FOR USE
KENACOMB CREAM:        Rub into affected areas 2 or 3 times daily.
KENACOMB OINTMENT: Apply a thin film to the affected areas 2 or 3 times daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The following adverse reactions have been reported with topical corticosteroids:
  Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Nystatin is well tolerated even with prolonged therapy. Irritation and cases of contact dermatitis have been reported.
Delayed type hypersensitivity reactions have been reported during use of neomycin; sensitization has been reported following prolonged use. Ototoxicity and nephrotoxicity have been reported when applied to large surfaces or damaged skin.
Sensitivity reactions to gramicidin have been reported.
In acute weeping skin conditions, transient stinging may be experienced when KENACOMB is applied.
Precautions
Prolonged use may result in overgrowth if non-susceptible organisms, including fungi other than candida. Should super-infection occur, suitable antimicrobial therapy must be administered. Application of KENACOMB should be discontinued until the infection is adequately controlled.
Patients undergoing stress, such as major surgery or severe infection, septicaemia, or extensive trauma, who have received extensive previous application of potent corticosteroids should receive replacement therapy to prevent possible adrenal crisis.
Use with particular caution in facial dermatoses, and only for short periods. A rosacea-like facies may be produced. Use with caution near the eyes.
Potent topical corticosteroids should be used for short courses only, and should not be applied to skin creases.
KENACOMB should not be used in nappy areas in infants for flexural eruptions and should be used with caution in infants and young children.
The treatment of psoriasis with potent topical corticosteroids may provoke the pustular form of the disease.
If sensitivity or irritation develops, topical use of this medication should be discontinued and appropriate therapy instituted. Hypersensitivity reactions to the anti-infective components may be masked by the presence of a corticosteroid.
Because of the potential hazard of nephrotoxicity and ototoxicity, this medication should not be used in patients with extensive skin damage or other conditions where absorption of neomycin is possible.
Prolonged and intensive treatment may cause atrophic changes in the skin, such as loss of elasticity, thinning, dilation of superficial bloodvessels, telangiectasiae, ecchymoses and purpura particularly when occlusive dressings are used, and the possibility of systemic absorption of steroid and complications of steroid therapy.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, and prolonged use. Therefore, patients receiving a large dose of any potent topical steroid under any condition(s) which may enhance systemic absorption, should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, for impairment of thermal homeostasis.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Nursing Mothers
It is not known whether topical administration of this medication could result in sufficient systemic absorption of the components to produce detectable quantities in breast milk. Nevertheless, caution should be executed when this medication is administered to a nursing woman.
Paediatric Use
Use of this medication over large surface areas or for prolonged periods in paediatric patients could result in sufficient systemic absorption to produce systemic effects. Paediatric patients may demonstrate greater susceptibility to HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Manifestations of adrenal suppression in paediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilloedema.
When applied to paediatric patients, this medication should be limited to the least amount for the shortest duration compatible with an effective therapeutic regimen. These patients should be closely monitored for signs and symptoms of systemic effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Topically applied corticosteroids and neomycin can be absorbed in sufficient amounts to produce systemic effects (see Precautions).
Treatment
No specific antidote is available, and treatment should be symptomatic and supportive.

IDENTIFICATION
KENACOMB CREAM: A smooth, soft, light buff-coloured, vanishing-type cream, with floral odour.
KENACOMB OINTMENT: A smooth, shiny yellow to amber-coloured ointment.

PRESENTATION
15g tube

STORAGE INSTRUCTIONS
Store at room temperature not exceeding 25°C. Avoid excessive heat.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER
KENACOMB CREAM:         G1591 (Act 101 of 1965)
KENACOMB OINTMENT:         G1592 (Act 101 of 1965)

NAME AND ADDRESS OF APPLICANT
Bristol-Myers Squibb (Pty) Ltd*
47 Van Buuren Road
BEDFORDVIEW 2008

DATE OF PUBLICATION OF THIS PACKAGE INSERT
August 1993

* Authorised user of the TM KENACOMB        29 00721

Updated on this site: June 2005
Source: Pharmaceutical Industry

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