Amotrex

Amotrex Iv Infusion, Tablet, Syrup

Amotrex, a nitroimidazole has an extremely broad spectrum antiprotozoal and antimicrobial activities, with high activity against anaerobic bacteria and protozoa. Amotrex is usually completely and rapidly absorbed after oral administration. The half-life in plasma is about 8 hours. About 10% of the drug is bound to plasma proteins. Amotrex penetrates well into body tissues and fluids. The liver is the main site of metabolism. Both unchanged Amotrex and metabolites are excreted in various proportions in the urine after oral administration.

Uses

Amotrex is used for:

  • All forms of amoebiasis (intestinal and extra-intestinal disease including liver abscess and that of symptomless cyst passers)
  • Trichomoniasis
  • Giardiasis
  • Bacterial vaginosis
  • Acute ulcerative gingivitis
  • Anaerobic infections including septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis etc.
  • Anaerobically-infected leg ulcers and pressure sores
  • Acute dental infections (e.g. acute pericoronitis and acute apical infections)
  • Surgical prophylaxis (prevention of postoperative infections due to anaerobic bacteria, particularly species of bacteroides and anaerobic streptococci
  • Chronic symptomatic peptic ulcer disease (as an agent of triple therapy to eradicate H. pylori-the most important aetiological factor of peptic ulcer)

Amotrex is also used to associated treatment for these conditions: Abscess, Intra-Abdominal, Acne Rosacea, Amebiasis, Anaerobic Infection, Bacteremia, Bacterial Endocarditis, Bacterial Peritonitis, Bacterial Vaginosis (BV), Balantidiasis, Bloodstream Infections, Bone and Joint Infections, Brain abscess, CNS Infection, Candidal Vulvovaginitis, Clostridium Difficile Infection (CDI), Empyema, Endometritis, Endomyometritis, Facial Rosacea, Giardiasis, Gynaecological infection, Helicobacter Pylori Infection, Infection, Bacteroides, Intraabdominal Infections, Lower Respiratory Infection, Lower respiratory tract infection bacterial, Lung Abscess, Meningitis, Mixed Vaginal Infections, Parasitic infection NOS, Periodontitis, Pneumonia, Postoperative Infections, Pouchitis, Septicemia bacterial anaerobic, Skin and Subcutaneous Tissue Bacterial Infections, Tetanus, Trichomonal Vaginitis, Trichomonas Vaginitis, Tubo-ovarian abscess, Urethritis, Vulvovaginitis, Asymptomatic Trichomoniasis, Entamoeba histolytica, Hepatic abscess, Refractory Sinusitis, Skin and skin-structure infections, Symptomatic Trichomoniasis, Asymptomatic Infections

Amotrex

Trade Name Amotrex
Generic Metronidazole
Metronidazole Other Names Metronidazol, Métronidazole, Metronidazole, Metronidazolum
Weight 500mg/100ml, 200mg, 400mg, 200mg/5ml
Type Iv Infusion, Tablet, Syrup
Formula C6H9N3O3
Weight Average: 171.154
Monoisotopic: 171.064391169
Protein binding

Metronidazole is less than 20% bound to plasma proteins.

Therapeutic Class Amoebicides, Anti-diarrhoeal Antiprotozoal
Manufacturer ACI Limited
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:23 am

Structure

Amotrex
Metronidazole Structure

Dosage

Amotrex dosage

Tablet and Suspension:

Amoebic dysentery: Duration 5-10 Days; 

  • For Tablet: Adults- 750 mg t.i.d. Children- (7-10 years) 500 mg t.i.d. (3-7 years) 250 mg q.i.d. (1-3 years) 250 mg t.i.d.
  • For Suspension: Adults- 800 mg t.i.d. Children- (7-10 years) 500 mg t.i.d. (3-7 years) 200 mg q.i.d. (1-3 years) 200 mg t.i.d.

Asymptomatic amoebiasis: Duration 5-10 Days;

  • For Tablet: Adults- 500-750 mg t.i.d. Children- (7-10 years) 250-500 mg t.i.d. (3-7 years) 250 mg q.i.d. (1-3 years) 250 mg t.i.d.
  • For Suspension: Adults- 500-800 mg t.i.d. Children- (7-10 years) 200-500 mg t.i.d.; (3-7 years) 200 mg q.i.d.; (1-3 years) 200 mg t.i.d.

Hepatic extraintestinal amoebiasis : Duration 5-10 Days (or 2days); 

  • For Tablet: Adults- 500-750 mg t.i.d.; Children- (7-10 years) 250-500 mg t.i.d.; (3-7 years) 250 mg q.i.d.; (1-3 years) 250 mg t.i.d.
  • For Suspension: Adults- 500-800 mg t.i.d.; Children- (7-10 years) 200-500 mg t.i.d.; (3-7 years) 200 mg q.i.d.; (1-3 years) 200 mg t.i.d.

Giardiasis: Duration 3 Days;

  • For Tablet: Adults- 2 g once daily; Children-(7-10 years) 1g once daily; (3-7 years) 750 mg once daily; (1-3 years) 500 mg once daily.
  • For suspension: Adults- 2 g once daily; Children-(7-10 years) 1g once daily; (3-7 years) 800 mg once daily; (1-3 years) 500 mg once daily.

Trichomoniasis: Duration 7 Days;

  • For Tablet: Adults- 250 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.
  • For Suspension: Adults- 200 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Trichomoniasis: Duration 1 Day;

  • For Tablet: Adults- 2 g single dose;
  • For Suspension: Adults- 2 g single dose;

Vincent's infection (Ulceration of mucous membrane of respiratory tract & mouth): Duration 3 Days;

  • For Tablet: Adults- 250 mg t.i.d. or 500 mg b.i.d; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.
  • For Suspension: Adults- 200 mg t.i.d. or 500 mg b.i.d; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Periodontal infection: Duration 3 Days;

  • For Tablet: Adults- 250 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.
  • For Suspension: Adults- 200 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Severe dental infection: Duration 3 Days;

  • For Tablet: Adults- 500 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.
  • For Suspension: Adults- 500 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Anaerobic infection: Duration 7 Days;

  • For Tablet: Adults- 500 mg t.i.d.; Children- 7.5 mg/kg body weight t.i.d.
  • For Suspension: Adults- 500 mg t.i.d.; Children- 7.5 mg/kg body weight t.i.d.

Postoperative anaerobic infection (specially in operation abdominal or gynecological surgery): Duration 7 Days;

  • For Tablet: Adults- 500 mg t.i.d. before and after operation; Children- 7.5 mg/kg body weight t.i.d.
  • For Suspension: Adults- 500 mg t.i.d. before and after operation; Children- 7.5 mg/kg body weight t.i.d.

Bacterial vaginitis: Duration 7 Days;

  • For Tablet: Adults- 500 mg b.i.d.
  • For Suspension: Adults- 500 mg b.i.d.

Leg ulcers: Duration 1 Day;

  • For Tablet: Adults- 2 g as a single dose
  • For Suspension: Adults- 2 g as a single dose

Pressure sores: Duration 7 Days;

  • For Tablet: Adults- 500 mg t.i.d.
  • For Suspension: Adults- 500 mg t.i.d.

H. pylori infection: Duration 7 Days;

  • For Tablet: Adults- 500 mg b.i.d
  • For Suspension: Adults-500 mg b.i.d

Antibiotic Associated Pseudomembranus colitis: Duration 7 Days;

  • For Tablet: Adults- 500 mg b.i.d
  • For Suspension: Adults- 500 mg b.i.d

Vaginal Gel:

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

Suppository:

Anaerobic infections:

  • Adult: 1 g 8 hrly for 3 days, then 12 hrly thereafter until oral medication is possible.
  • Child: 5-10 yr 500 mg. All doses to be given 8 hrly for 3 days, then 12 hrly thereafter until oral medication is possible.

Prophylaxis of postoperative anaerobic bacterial infections:

  • Adult: 1 g 2 hr before surgery, repeated 8 hrly for 3 days, then 12 hrly thereafter until oral medication is possible.
  • Child: 5-10 yr 500 mg 2 hr before surgery, repeated 8 hrly for 3 days, then 12 hrly thereafter until oral medication is possible.

IV Infusion:

Amotrex injection should be infused intravenously at an approximate rate of 5 ml/min. Oral medication should be substituted as soon as feasible. Treatment for 7 days should be satisfactory for most patients, but the physician might decide to prolong treatment.

  • For bacterial infections: Adults: 500 mg (100 ml) 8 hourly. Children: 7.5 mg/kg (1.5 ml/kg) 8 hourly.
  • For treatment before and during surgery: Adults: 500 mg (100 ml) shortly before operation, repeated 8 hourly. Children: 7.5 mg/kg (1.5 ml/kg) 8 hourly

Side Effects

Side effects of Amotrex include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.

Precaution

Amotrex should not be used in patients with blood dyscrasia. It is suggested that it should not be given in the first three months of pregnancy. When given in conjunction with alcohol, Amotrex may provoke a disulphiram like effect.

Interaction

Amotrex interacts with warfarin, nicoumalone, phenytoin, phenobarbitone, fluorouracil, disulfiram, lithium, cimetidine etc.

Food Interaction

  • Avoid alcohol. Unpleasant symptoms such as nausea, vomiting, and abdominal distress may occur with alcohol.
  • Take with or without food. The extended release formulation should, however, be taken without food.

Volume of Distribution

Amotrex is widely distributed throughout the body and various body fluids. They include the bile, saliva, breastmilk, cerebrospinal fluid, and the placenta. Steady-state volume distribution of metronidazole in adults ranges from 0.51 to 1.1 L/kg. It attains 60 to 100% of plasma concentrations in various tissues, such as the central nervous system, however, is not measured in high concentrations in the placental tissue.

Half Life

The elimination half-life of metronidazole is 7.3 ± 1.0 after a single 500mg IV dose in healthy subjects. Another resource indicates that the elimination half-life for metronidazole ranges from 6 to 10 hours.

Clearance

Dose adjustments may be required in patients with hepatic impairment, as clearance is impaired in these patients. The clearance of metronidazole in the kidneys is estimated at 10 mL/min/1.73 m2. The total clearance from serum is about 2.1 to 6.4 L/h/kg.

Pregnancy & Breastfeeding use

Not recommended during first & later trimesters. Breast feeding should be delayed until 48 hours after discontinuing metronidazole in the mother.

Contraindication

Amotrex is contraindicated in patients with prior history of hypersensitivity to Amotrex or other Nitroimidazole derivatives.

Storage Condition

Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of children

Innovators Monograph

Amotrex contains Metronidazole see full prescribing information from innovator // generic/metronidazole/metronidazole-intravenous-infusion-prescribing-information" Monograph

FAQ

What are the side effects of Amotrex?

Amotrex side effects are notorious for causing an upset stomach and killing your appetite. For many people, the nausea and even vomiting can occur just from the bad taste. Heartburn, constipation, and diarrhea can occur, too.

Side effects of Amotrex include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.

What bacteria does Amotrex kill?

Amotrex has activity against protozoans like Entamoeba histolytica, Giardia lamblia and Trichomonas vaginalis, for which the drug was first approved as an effective treatment. Anaerobic bacteria which are typically sensitive are primarily Gram-negative anaerobes belonging to the Bacteroides and Fusobacterium spp.

When Amotrex is prescribed?

Amotrex is a drug used to treat infections caused by parasites (amoeba) and anaerobe bacteria. It can be given to treat diarrhea caused by Entamoeba histolytica, Giardia lamblia, or Clostridium difficile. It can also be used to treat vaginal infections or various types of bacterial infections.

How should this drug be taken?

Amotrex is available as 250 mg tablets and 500 mg capsules. It is also available as vaginal creams and inserts as well as a cream to apply on the skin. If needed, Amotrex can also be given intravenously (by the veins). The recommended dose of Amotrex will vary depending on the type of infection that is being treated. Amotrex can be taken with or without food. You should NOT take any alcohol during your treatment and for at least 24 hours following the end of the treatment.

What should I do if I forget to take Amotrex?

If you miss a dose of Amotrex, take it as soon as possible. However, if it is time for your next dose, do not double the dose, just carry on with your regular schedule.

Why should I do not forget to take Amotrex?

If you miss doses of Amotrex, the infection will continue and possibly worsen. Therefore, it is extremely important that you take Amotrex for the entire duration of the treatment.

Does Amotrex make you sleepy?

Amotrex oral tablet doesn't cause drowsiness, but it can cause other side effects.

Can Amotrex treat yeast infection?

Amotrex vaginal will not treat a vaginal yeast infection. You may even develop a new vaginal yeast infection after using this medicine. Watch for symptoms such as itching or discharge during or after treatment with Amotrex vaginal.