ZAGYL Tablets

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

ZAGYL Tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ZAGYL Tablets

COMPOSITION:
Each tablet contains 400 mg metronidazole.

PHARMACOLOGICAL CLASSIFICATION:
A. 20.2.6 Medicines against protozoa.

PHARMACOLOGICAL ACTION:
Metronidazole has anti-protozoal activity and is effective against Trichomonas vaginalis and other protozoa including Entamoeba histolytica and Giardia intestinalis. Metronidazole has bactericidal activity against anaerobic bacteria, including Bacteroides species. Metronidazole is well absorbed from the gastro-intestinal tract and widely distributed in body tissues.

INDICATIONS:

1.	In the oral treatment of:
	-	urogenital trichomoniasis
	-	all forms of amoebiasis except asymptomatic carrier state
	-	acute ulcerative gingivitis (Vincent's)
	-	giardiasis
2.	Treatment of infections, in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of Bacteroides and including other species for which metronidazole is bactericidal such as fusobacteria clostridia, eubacteria and anaerobic streptococci.
3.	Prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroides and anaerobic streptococci:
	i.	given alone before or after gynaecological surgery;
	ii.	given alone before or after appendectomy;
	iii.	given in association with bacteriologically appropriate antibacterial agents (e.g. kanamycin) before or after colonic surgery.

CONTRA INDICATIONS:
Hypersensitivity to metronidazole. Patients with blood dyscrasias or with active disease of the central nervous system. Its use should be avoided during pregnancy.

WARNINGS:
Alcohol should be avoided during treatment with metronidazole. Metronidazole enhances the effect of warfarin.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Administration: Tablets should be swallowed (without chewing) with a half glassful of water. It is recommended that tablets be taken during or after a meal. Immature children and babies weighing less than 12 kg should receive proportionally smaller dosage, as advised by the doctor. Children over 10 years may be given a suitable proportion of the adult dosage according to bodymass.

Indications	Duration of dosage in days	Number of tablets to be taken
UROGENITAL TRICHOMONIASIS: Where reinfection is likely, the consort should receive a similar course of treatment concurrently	7 or	1 morning and night
	1	5 as a single dose
AMOEBIASIS: a) Intestinal disease in susceptible subjects	5 or	2 three times a day
	3	5 once daily
b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis	5 –10 or	1 three times a day
	2	5 once daily
c) Amoebic liver abscess also other forms of extra intestinal amoebiasis	5 or	1 three times a day
	2	5 once daily
ACUTE ULCERATIVE GINGIVITIS	3	1 night and morning
GIARDIASIS: A second course of treatment may be necessary for some patients two weeks after the end of the first course	3	5 once daily

ANAEROBIC INFECTIONS:

a)	Treatment:
	Metronidazole tablets may be given alone or concurrently with other bacteriologically appropriate anti-bacterial agents. They should be given for 7 days or longer depending on clinical and bacteriological assessment of the patients condition.
	Adults:	400 mg by mouth three times daily during or after meals.
	Children and infants:	7 mg/kg bodymass by mouth three times daily during or after meals.
b)	Prevention:
	Adults:	Administered in doses similar to those used for the treatment of established infection. 400 mg may be given every 8 hours for 3–4 days, followed post operatively if oral therapy is possible. Shorter pre-operative courses of oral doses of up to 1 g have been used.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
There have been reports of peculiar taste in the mouth, furred tongue, nausea, vomiting and gastro-intestinal upset.
Drowsiness, headache, vertigo, ataxia, disorientation, skin rashes and pruritus have been reported.
Alcohol should be avoided during treatment with metronidazole.
Slight and transient falls in blood pressure have been reported with the parent substance; it may, therefore be advisable to lower the dosage of any antihypertensive drug which may be given concurrently with the tablets.
During intensive and prolonged treatment bone marrow depression and peripheral neuropathy have been reported. Side effects are more prominent with larger doses. ZAGYL enhances the effect of warfarin and if metronidazole is to be given to patients receiving this or other oral anticoagulants, the dosage of the latter should be recalibrated.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side Effects.
In recent overdosage gastric lavage is recommended. Further treatment is symptomatic and supportive.

IDENTIFICATION:
Biconvex white tablets with score on one side.

PRESENTATION:
Tablets in containers of:
10 x 400 mg tablets
100 x 400 mg tablets
250 x 400 mg tablets

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C) out of direct sunlight.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/20.2.6/0421

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
Sandton
P.O. Box 2080, Gallo Manor, 2052

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22 March 1993

93E0693

P1352

06/93