BIOGYL Oral suspension Ref.[115632] Active ingredients: Methronidazole

Source: Registered Drug Product Database (NG)  Publisher: BIOMEDICAL LTD, 1, Ohimege Road, Industrial Estate, Ilorin Kwara State, PMB 1449

4.1. Therapeutic indications

Metronidazole is indicated in adults and children for the following indications:

  • In the treatment of urogenital trichomonaisis.
  • In the treatment of acute ulcerative gingivitis.
  • In the treatment of infections due to E. histolytica (including carrier states).
  • In the treatment of infections due to G. Lamblia (including carrier states).
  • In the prevention and treatment of infections due to anaerobic bacteria, particularly species of Bacteroides, anaerobic Streptococci, fusobacteria, clostridia, etc.
  • In the treatment of acute dental infections.
  • In the treatment of non-specific vaginitis.

Metronidazole is indicated in adults only for the following indications:

  • In the treatment of chronic pressure sores and ulcers with possible infection due to anaerobes.

4.2. Posology and method of administration

Posology

The safety and efficacy of promethazine hydrochloride used in the formulation of Biothazine syrup has been established in adults and paediatric populations when taken at the prescribed doses.

Method of Administration

Indications 1 to 3 years 3 to 7 years 7 to 10 years Duration of
Dosage in Days
Acute Ulcerative
Gingivitis
2.5 ml (100 mg)
once daily
2.5 ml (100 mg)
twice daily
2.5 ml (100 mg)
thrice daily
3
Amoebiasis (a)
Invasive intestinal
disease in susceptible
subjects
5 ml three
times
5 ml four times
daily
10 ml three times
daily
5
(b) Intestinal disease in
susceptible subjects
2.5 ml three
times daily
2.5 ml four
times daily
5 ml three times
daily
5-10
© Symptomless cyst
passers
2.5 ml three
times daily
2.5-5 ml four
times daily
5-10 ml three
times daily
5
Urogenital
Trichomoniasis where
re-infection is likely. The
consort should receive a
similar course of
treatment concurrently
1.2 ml three
times daily
2.5 ml two
times daily
2.5 ml three times
daily
7 or 2
Giardiasis 10 ml once
daily
15 ml once
daily
25 ml once daily 3

Or as directed by the physician.

4.9. Overdose

Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdosage, a symptomatic and supportive treatment should be instituted.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Biogyl suspension should be stored in a cool dry place at temperatures not more than 30°C.

6.5. Nature and contents of container

Plain Amber-coloured Polyethylene terephthalates (PET) bottle with ROPP cap placed inside a paperboard carton.

6.6. Special precautions for disposal and other handling

Container and/or any unused product should be disposed in accordance with the local requirement.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.