INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
OTALGON (Ear Drops)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

OTALGON (Ear Drops)

COMPOSITION:

Phenazone	5%
Chlorbutol	1%
Benzocaine	1%

Glycerine base

PHARMACOLOGICAL CLASSIFICATION:
A 16.2 Aural Preparations, Ear Drops.

PHARMACOLOGICAL ACTION:
Otalgon combines the antibacterial and antifungal properties of Clorbutol and the anaesthetic properties of Phenazone and Benzocaine.

INDICATIONS:
Otitis media and inflammation of the inner ear.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients. The administration of Phenazone is contraindicated in patients where there is a family history of porphyria.

WARNINGS:
Should not be used in conditions with discharge or perforated tympanic membrane.

DOSAGE AND DIRECTIONS FOR USE:
5 - 10 drops warmed to body temperature to be instilled into the ear every 2 hours and the ear lightly plugged with cotton wool; or as directed by a physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Phenazone may give rise to skin eruptions in susceptible individuals. Benzocaine may cause methaemoglobinaemia. Allergic reactions may appear. The application of local anaesthetics to the skin for prolonged periods or to extensive areas should be avoided. Local anaesthetics should be given cautiously to patients with epilepsy, impaired cardiac conduction, shock, myasthenia gravis or with liver damage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Acute poisoning with Chlorbutol may produce central nervous system depression with weakness, loss of consciousness, and depressed respiration. The systemic toxicity of local anaesthetics mainly involves the central nervous system and the cardiovascular system. Excitation of the CNS may be manifested by restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions. Numbness of the tongue and perioral region may appear as an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure, and coma. Effects on the cardiovascular system may be myocardial depression and peripheral vasodilation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear odourless viscous solution.

PRESENTATION:
15 mL dropper bottle with a white screw cap.

STORAGE INSTRUCTIONS:
Store below 25ºC. Keep container tightly closed
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
H1545 (Act 101 of 1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Gulf Drug Company (PTY) Ltd.
22 Burnside Drive, Old Mill Industrial Park
Mount Edgecombe, 4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1974

New addition to this site: July 2010
Source: Pharmaceutical Industry
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