COAL TAR AND SALICYLIC ACID OINTMENT BP

Active substance: SALICYLIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Coal Tar and Salicylic Acid Ointment BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Coal Tar BP 2.0% w/w
Salicylic Acid BP 2.0% w/w

3

PHARMACEUTICAL FORM
Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
The ointment can be used in the treatment of eczema, psoriasis, ichthyosis (dryness,
roughness and scaliness of the skin).
Used Externally.

4.2

Posology and method of administration
For External Use Only
Dose: Adults (including the elderly), and children over 12 years:
Apply sparingly to the affected area one to three times daily until an improvement
occurs.
Not recommended for children under 12 years.

4.3

Contraindications
Hypersensitivity to any of the ingredients.
Should not be applied on sore, acute, or pustular psoriasis, in the presence of
infection, or broken skin.

4.4

Special warnings and precautions for use
Do not apply to broken or inflammed skin, avoid contact with the eyes.
May stain skin and fabric.
For External Use Only.
Discontinue use if excessive dryness or irritation occurs. Avoid prolonged use. Use
with care on large areas of skin.

4.5

Interaction with other medicinal products and other forms of interaction
Salicylates interfere with the spectrophotometric assay of Theophylline (used to treat
asthma). The effectiveness of Dithranol (used to treat psoriasis, i.e. thickening and
scaling of the skin) may be impaired.

4.6

Fertility, pregnancy and lactation
This product should not be used during pregnancy and lactation without medical
advice.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Skin irritation and acne like eruptions may occur. Coal Tar has a photosensitising
effect.
Sensitivity, excessive drying and irritation may occur after use. Prolonged use may
result in systemic effects (i.e. in other areas of the body). When large areas are treated
salicylism (marked by nausea, vomiting and ringing in the ears) may occur.

4.9

Overdose
In acute Salicylate overdosage, the stomach should be emptied by inducing emesis or
by aspiration and lavage. Patients With mild intoxication should be encouraged to
drink plenty of fluids. In patients with more serious intoxication, forced alkaline
diuresis may be required and should be continued until the plasma salicylate
concentration is less than 35g/ml in adults, then intravenous fluids can be stopped and
the patient encouraged to take fluids by mouth. Plasma electrolytes, especially
Potassium, and the acid-base balance should be monitored regularly.
Acidaemia must be corrected by infusion of sodium bicarbonate before starting
forced diuresis. In the presence of cardiac or renal impairment or in very severe
intoxication, haemodialysis or peritoneal dialysis may be necessary.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code:
Coal Tar; D05AA
Salicylic Acid; D11AC
Salicylic Acid has keratolytic properties. Coal Tar is antipruritic, keratoplastic
arid a weak antiseptic.

5.2

Pharmacokinetic properties
The Salicylic Acid produces slow and painless destruction of the epithelium it is
absorbed by the skin, metabolised by the liver and kidneys to glucuronide conjugates,
Salicyluric and gentisic acids. It is excreted in the urine as unmetabolised Salicylic
Acid as well as the metabolites listed above. The Salicylic Acid also has keratolytic
properties and is removed unabsorbed with the hard skin when it is removed. The

Coal Tar is absorbed by the skin and the many hydrocarbons which it contains affect
the psoriasis, etc, by enzyme inhibition. The absorbed materials are metabolised in
the liver and kidneys and excreted in the urine.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Coconut Oil BP
White Soft Paraffin BP
Emulsifying Wax BP
Liquid Paraffin BP
Polysorbate SO BP

6.2

Incompatibilities
Salicylates are incompatible with iodine, iron salts and oxidising substances.

6.3

Shelf life
3 Years.

6.4

Special precautions for storage
The product must be stored at a temperature below 25°C.

6.5

Nature and contents of container
Opaque containers and lids 500

6.6

Special precautions for disposal
None Stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0050

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27.04.84 / 05.03.2004

10

DATE OF REVISION OF THE TEXT
06/01/2012

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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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