INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DERMADINE ANTISEPTIC OINTMENT

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

DERMADINE ANTISEPTIC OINTMENT
(Ointment)

COMPOSITION:
Each 25 g contains 2.5 g
povidone-iodine, which is equivalent to 1% available iodine, in a water miscible base.

PHARMACOLOGICAL CLASSIFICATION:
A 14.1 Wound disinfectants.

PHARMACOLOGICAL ACTION:
Povidone-iodine is a multivalent broad spectrum local disinfectant with bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Several viruses, protozoa, yeasts, cysts and spores are also susceptible.

INDICATIONS:
DERMADINE ANTISEPTIC OINTMENT
is used as a general antiseptic in the treatment of skin infections, wounds, cuts, abrasions, burns if not extensive, bedsores and postoperative wounds.

CONTRA-INDICATIONS:
DERMADINE ANTISEPTIC OINTMENT
is contra-indicated in patients:
With hypersensitivity to povidone-iodine.
With non-toxic nodular colloid goiter.
Who are pregnant or breast feeding.
Application to large areas of broken skin (e.g., severe and extensive burns) should be avoided as excessive absorption of iodine may occur.

WARNINGS:
Not to be used by persons allergic to iodine.

PREGNANCY AND LACTATION:
The use of DERMADINE ANTISEPTIC OINTMENT is contraindicated during pregnancy and lactation (see “CONTRAINDICATIONS”).

DOSAGE AND DIRECTIONS FOR USE:
The affected area should be cleaned and dried. Apply to affected areas twice daily or as directed. An occlusive dressing may be used if necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
:
Immune system disorders:
The following side-effects have been reported and frequencies are unknown: Hypersensitivity and local irritation may occur. However, if irritation, swelling or redness occur, discontinue treatment and consult your physician.
Endocrine system disorders:
The following side-effects have been reported and frequencies are unknown: Hypothyroidism may occur after topical application to neonates. Absorption of povidone-iodine may interfere with thyroid function tests. NOTE: Stains on synthetic fabrics may be removed by washing and rinsing in dilute ammonia.

Special Precautions:
Regular or prolonged use of DERMADINE ANTISEPTIC OINTMENT should be avoided in patients with thyroid disorders or those receiving lithium therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic effects including metabolic acidosis, hypernatraemia and renal impairment may follow the application of povidone-iodine to severe burns or large areas otherwise denuded of skin. Treatment is symptomatic and supportive.

IDENTIFICATION:
A smooth, amber coloured ointment with a characteristic iodine odour.

PRESENTATION:
25 g and 50 g tubes and 500 g jar.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.1049 (Act 101 /1965)

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:
MEDPRO PHARMACEUTICA (PTY) LTD.
Rosen Heights, Pasita Street
Rosen Park, Bellville, 7530, RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 2009

© MEDPRO PHARMACEUTICA (PTY) LTD.

DX88 A

Updated on this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2013/10/otc_dermadine-antiseptic-ointment-25g.pdf

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