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Flazol is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
Flazol is active against a wide range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.
It is also active against Trichomonas, Entamoeba histolytica, Giardia lamblia and Balantidium coli.
Flazol is indicated in adults and children for the following indications:
1. The prevention of post-operative infections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic streptococci.
2. The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, and post-operative wound infections from which pathogenic anaerobes have been isolated.
3. Urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male.
4. Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).
5. All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers).
6. Giardiasis.
7. Acute ulcerative gingivitis.
8. Anaerobically-infected leg ulcers and pressure sores.
9. Acute dental infections (e.g. acute pericoronitis and acute apical infections).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
1. 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, Eubacteria, Clostridia and anaerobic cocci.
Flazol has been used successfully in: septicaemia, bacteraemia, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, peritonitis and post-operative wound infection from which one or more of these anaerobes have been isolated.
2. Prevention of post-operative infections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic Streptococci.
VANDAZOLE (metronidazole vaginal gel) is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.
Flazol is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.
For oral administration.
Flazol tablets should be swallowed, without chewing, with half a glassful of water during or after meals.
Prophylaxis against anaerobic infection:
Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.
Adults: 400 mg 8 hourly during 24 hours immediately preceding operation followed by postoperative intravenous or rectal administration until the patient is able to take tablets.
Children < 12 years: 20-30mg/kg as a single dose given 1-2 hours before surgery
Newborns with a gestation age < 40 weeks: 10mg/kg body weight as a single dose before operation
Anaerobic infections:
The duration of a course of Flazol treatment is about 7 days but it will depend upon the seriousness of the patient's condition as assessed clinically and bacteriologically.
Treatment of established anaerobic infection:
Adults: 800 mg followed by 400 mg 8 hourly.
Children > 8 weeks to 12 years of age: The usual daily dose is 20-30 mg/kg/day as a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.
Children < 8 weeks of age: 15 mg/kg as a single dose daily or divided into 7.5 mg/kg every 12 hours.
In newborns with a gestation age <40 weeks, accumulation of Flazol can occur during the first week of life, therefore the concentrations of Flazol in serum should preferable be monitored after a few days therapy.
Prophylaxis against postoperative infections caused by anaerobic bacteria: Children < 12 years: 20-30 mg/kg as a single dose given 1-2 hours before surgery Newborns with a gestation age <40 weeks: 10 mg/kg body weight as a single dose before operation
Protozoal and other infections:
Urogenital trichomoniasis:
Where re-infection is likely, in adults the consort should receive a similar course of treatment concurrently
Adults and adolescents: 2000 mg as a single dose or 200 mg 3 times daily for 7 days or 400 mg twice daily for 5-7 days
Children 1-10 years: 40 mg/kg orally as a single dose or 15 - 30 mg/kg/day divided in 2-3 doses for 7 days; not to exceed 2000 mg/dose
Bacterial vaginosis:
Adults and children over 10 years: 400mg twice daily for 5-7 days or 2000mg as a single dose for 1 day
Amoebiasis:
a) Invasive intestinal disease in susceptible subject:
Adults, elderly and children over 10 years: 800mg three times daily for 5 days.
Children (7-10 years): 400 mg three times daily for 5 days.
Children (3-7 years): 200 mg four times daily for 5 days.
Children (1-3 years): 200 mg three times daily for 5 days.
b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis:
Adults, elderly and children over 10 years: 400mg three times daily for 5-10 days.
Children (7-10 years): 200 mg three times daily for 5-10 days.
Children (3-7 years): 100 mg four times daily for 5-10 days.
Children (1-3 years): 100 mg three times daily for 5-10 days.
c) Amoebic liver abscess, also forms of extra-intestinal amoebiasis:
Adults, elderly and children over 10 years: 400mg three times daily for 5 days.
Children (7-10 years): 200 mg three times daily for 5 days.
Children (3-7 years): 100 mg four times daily for 5 days.
Children (1-3 years): 100 mg three times daily for 5 days.
d) Symptomless cyst passers:
Adults, elderly and children over 10 years: 400-800mg three times daily for 5-10 days.
Children (7-10 years): 200-400 mg three times daily for 5-10 days.
Children (3-7 years): 100-200 mg four times daily for 5-10 days.
Children (1-3 years): 100-200 mg three times daily for 5-10 days.
Alternatively, 35 to 50 mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400 mg/day
Giardiasis:
Adults, elderly and children over > 10 years: 2000 mg once daily for 3 days, or 400 mg three times daily for 5 days, or 500 mg twice daily for 7 to 10 days
Children 7 to 10 years: 1000 mg once daily for 3 days
Children 3 to 7 years: 600 to 800 mg once daily for 3 days
Children 1 to 3 years: 500 mg once daily for 3 days
Alternatively, as expressed in mg per kg of body weight:
15-40 mg/kg/day divided in 2-3 doses.
Eradication of Helicobacter pylori in paediatric patients:
As a part of a combination therapy, 20 mg/kg/day not to exceed 500 mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy
Acute ulcerative gingivitis:
Adults, elderly and children over 10 years: 200 mg three times daily for 3 days.
Children (7-10 years): 100 mg three times daily for 3 days.
Children (3-7 years): 100 mg twice daily for 3 days.
Children (1-3 years): 50 mg three times daily for 3 days.
Acute dental infections:
Adults, elderly and children over 10 years: 200 mg three times daily for 3-7 days.
Leg ulcers and pressure sores:
Adults, elderly and children over 10 years: 400 mg three times daily for 7 days
Children and infants weighing less than 10 kg should receive proportionally smaller dosages.
Elderly: Flazol is well tolerated by the elderly but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group.
Route of administration: Rectal
1. Treatment of Anaerobic Infections:
Adults and children over 10 years: 1 gram suppository inserted into the rectum eight hourly for three days. Oral medication with 400 mg three times daily should be substituted as soon as this becomes feasible. If rectal medication must be continued for more than three days, the suppositories should be inserted at 12 hourly intervals.
Children (5 -10 years): As for adults but with 500 mg suppositories and oral medication with 7.5 mg/kg bodyweight three times daily.
Infants and children under 5 years: As for children of 5-10 years but with appropriate reduction in dosage of suppositories (one half of a 500 mg suppository for 1 to 5 years and one quarter of a 500 mg suppository for under 1 year).
2. Prevention of Anaerobic Infections:
In appendectomy and post-operative medication for elective colonic surgery.
Adults and children over 10 years: 1 gram suppository inserted into the rectum two hours before surgery and repeated at eight hourly intervals until oral medication (200 to 400 mg three times daily) can be given to complete a seven day course.
If rectal medication is necessary after the third post-operative day, the frequency of administration should be reduced to 12 hourly.
Children (5-10 years): 500 mg suppositories administered as for adults until oral medication (3.7 to 7.5 mg/kg bodyweight three times daily) becomes possible.
The recommended dose is one applicator full of VANDAZOLE (metronidazole vaginal gel) , (approximately 5 grams of gel containing approximately 37.5 mg of metronidazole) administered intravaginally once a day for 5 days. For once a day dosing, VANDAZOLE should be administered at bedtime.
Not for ophthalmic, dermal, or oral use.
A single-dose, pre-filled disposable applicator (which delivers approximately 5 g of gel containing 65 mg of metronidazole) administered once intravaginally. Flazol should be administered at bedtime.
Flazol is not for ophthalmic, dermal or oral use.
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