Metsina 400

Generic

Metronidazole

 

Indications

Metronidazole is indicated in the treatment of following diseases:

• The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
• The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
• In the treatment of urogenital trichomoniasis.
• Bacterial vaginosis (also known as non-specific vaginitis).
• All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
• Giardiasis.
• Acute ulcerative gingivitis.
• Anaerobically infected leg ulcers and pressure sores.
• Acute dental infections due to anaerobic organisms.
• Antibiotic associated pseudomembranus colitis.

 

Pharmacology

Metronidazole could be a part of the imidazole lesson of antibacterial medicate and is classified restoratively as an antiprotozoal operator. The 5-nitro gather of Metronidazole is decreased by anaerobes metabolically. Thinks about have illustrated that the decreased frame of this medicate interatomic with DNA and gives bactericidal activity of Metronidazole.

 

Dosage & Administration

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

• 200 mg tid or 400 mg bid for 7 days
• 800 mg in the morning and 1-2 gm at night for 2 days
• 2 gm as a single dose for 1 days

Trichomoniasis (Children)-

• Children 7-10 yrs: 100 mg tid
• Children 3-7 yrs: 100 mg bid
• Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)- 

• 800 mg tid for 5 days

Intestinal amoebiasis (Children)-

• Children 7-10 yrs: 400 mg tid
• Children 3-7 yrs: 200 mg qid
• Children 1-3 yrs: 200 mg tidExtra-intestinal & Asymptomatic amoebiasis (Children)-
  
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
  Giardiasis (Adults & Children over 10 yrs)-
  
  • 2 gm once daily for 3 days
  Giardiasis (Children)-
  
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
  Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  
  • 200 mg tid for 3 days
  Acute ulcerative  gingivitis (Children)-
  
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tidAcute dental infections (Adults & Children over 10 yrs)-
    
    • 200 mg tid for 3-7 days
    Bacterial Vaginosis (Adults & Children over 10 yrs)-
    
    • 400 mg bid for 7 days
    • 2 gm as a single dose for 1 days
    Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
    
    • 400 mg tid for 7 days
    Anaerobic infections (Adults & Children over 10 yrs)-
    
    • 800 mg initially and then 400 mg tid for 7 days
    Anaerobic infections (Children)-
    
    • Children 1-10 yrs: 7.5 mg/kg tid
    Surgical prophylaxis (Adults & Children over 10 yrs)-
    
    • 400 mg tid started 24  hours before  surgery for 1 days
    Surgical prophylaxis (Children)-
    
    • Children 1-10 yrs: 7.5 mg/kg tid

      Vaginal Gel:

      The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

      
      Suppository:

      Anaerobic Infections-
      
      • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
      • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
      Surgical Prophylaxis-
      
      • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
      • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

        IV Infusion:

        Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
        
        • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
        • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

 

Interaction

• Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
• Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
• Lithium: Plasma levels of lithium may be increased by metronidazole.
• Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
• Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
• 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
• Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

 

Contraindications

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

 

Side Effect

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

 

Pregnancy & Lactation

US FDA Pregnancy Category of Metronidazole is B. There are, in any case, no satisfactory and well-controlled considers in pregnant ladies. Since creature generation ponders are not continuously prescient of human reaction, this sedate ought to be utilized amid pregnancy as it were in the event that clearly required. Metronidazole have been appeared to be excreted in human drain. So, caution ought to be worked out when Metronidazole is managed to a nursing lady.

 

Precautions & Warnings

In the event that for compelling reasons, metronidazole must be managed longer than the ordinarily suggested length, it is prescribed that hematological tests, particularly leucocyte check ought to be carried out frequently which patients ought to be observed for antagonistic responses such as fringe or central neuropathy (such as paresthesia, ataxia, discombobulation, convulsive seizures). Metronidazole ought to be managed with caution to patients with hepatic encephalopathy. Patients ought to be cautioned that metronidazole may obscure pee.

 

Therapeutic Class

Amoebicides, Anti-diarrhoeal Antiprotozoal

 

Storage Conditions

Store below 30° C in a cold, dry, and light-protected location. Keep out of children's reach. Because touching the dropper tip to surfaces can contaminate the solution, avoid doing so. After 30 days from the date of initial opening, do not use.

 

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.