Metronidazole 500 mg Tablet

Metronidazole 500 mg Tablet

Therapeutic Class: Anti-Infectives

Dosage Forms: Tablets

Brand Name: Metronidazole 500 mg Tablet™

Best Metronidazole 500 mg Tablet Manufacturer, Supplier & Exporter In India.
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WHO
WHO
PPB KENYA
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NAFDAC NIGERIA
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MOH COMBODIA
MOH COMBODIA
FDA JORDAN
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Uses of Metronidazole 500 mg Tablet

What are the Uses of Metronidazole 500 mg tablet?

  • Anaerobic infections (caused by bacteria that thrive without oxygen), such as:
    • Dental infections.
    • Skin and soft tissue infections.
    • Bone and joint infections.
    • Abdominal infections (e.g., peritonitis)

Parasitic Infections

  • Amebiasis—an intestinal infection caused by Entamoeba histolytica.
  • Giardiasis—a diarrheal illness caused by Giardia lamblia.

Sexually Transmitted Infections (STIs)

  • Trichomoniasis—caused by Trichomonas vaginalis, often treated in both partners.

Gynecological Conditions

  • Bacterial vaginosis—imbalance of vaginal bacteria.
  • Pelvic inflammatory disease (PID)—often used in combination with other antibiotics.

Gastrointestinal Conditions

  • Helicobacter pylori infections—part of combination therapy for stomach ulcers.
  • Clostridium difficile colitis—sometimes used when other treatments aren’t suitable.

Surgical Prophylaxis

  • Given before surgery to prevent infection, especially in colorectal procedures.

Precautions of Metronidazole 500 mg Tablet

Precautions When Using Metronidazole 500 mg Tablet

Alcohol

  • Do not drink alcohol during treatment and for 48 hours after stopping metronidazole. It can cause serious reactions like flushing and low blood pressure.

Health Conditions

  • Porphyria: Use with caution.
  • Blood disorders or brain conditions (not caused by infection): Avoid using metronidazole.
  • Epilepsy or history of seizures: High doses may trigger seizures—use carefully.
  • Syphilis: High doses may hide signs of syphilis—testing is important.

Pregnancy & Breastfeeding

  • Pregnancy:
    • Not safe in the first trimester.
    • Use with caution in the second and third trimesters for vaginal infections.
    • For other uses, only take if absolutely necessary and no safer option is available.
  • Breastfeeding:
    • Stop breastfeeding during treatment and for 12–24 hours after stopping the medicine.

Monitoring

  • If treatment lasts more than 10 days, regular check-ups and lab tests are recommended.
  • Long-term use may cause nerve damage—weigh the benefits and risks carefully.

Infections

  • Even after treating Trichomonas vaginalis, other infections like gonorrhea may still be present—follow-up testing may be needed.

Kidney Function

  • Kidney failure: No dose change needed, but the body may hold onto drug by-products. The effect of this is unclear.
  • Hemodialysis: The drug is removed during dialysis—take a dose right after dialysis.
  • Peritoneal dialysis (IPD or CAPD): No dose adjustment needed.

Liver Function

  • Liver disease or encephalopathy: Use with caution. Reduce the dose to one-third and take once daily.
  • Cockayne syndrome:
    • Serious liver damage has occurred, sometimes fatal.
    • Only use if absolutely necessary and no other treatment is available.
    • Liver tests must be done before, during, and after treatment.
    • Stop treatment if liver tests worsen.
    • Report any signs of liver problems (like yellowing of skin or eyes) immediately.

Skin Reactions

  • Rare but serious skin conditions like SJS, TEN, or AGEP have been reported.
  • Stop the medicine immediately if you notice a rash, blisters, or peeling skin.

Other Notes

  • Metronidazole may darken urine—this is harmless.
  • Long-term use should be avoided unless absolutely necessary due to unclear risks related to genetic changes.

Dosages administration of Metronidazole 500 mg Tablet

Dosage & Administration Guide of Metronidazole 500 mg Tablet

General Administration Instructions

  • Route: Oral use only
  • Timing: Take during or after meals
  • Method: Swallow whole with water; do not chew

Special Populations

Elderly

  • Use with caution, especially at high doses
  • Limited data on dosage modification

Hepatic Impairment

  • In hepatic encephalopathy: → Administer ⅓ of the daily dose once daily.

Anaerobic Infections

Age Group Dosage Frequency Duration
Children >8 weeks to 12 years 20–30 mg/kg/day Single dose or 7.5 mg/kg every 8 hrs Usually 7 days
Severe cases Up to 40 mg/kg/day — —
Children <8 weeks 15 mg/kg/day Single dose or 7.5 mg/kg every 12 hrs —
Preterm newborns (<40 weeks gestation) Monitor serum levels — —

Children under 10 years: Use a more suitable dosage form.

Prophylaxis (Anaerobic Infection – Surgical Context)

Adults

  • 1 g stat dose 24 hrs pre-op
  • Then 400 mg every 8 hrs for 24 hrs pre-op
  • Continue post-op via IV or rectal route until oral intake is possible

Children <12 years

  • 20–30 mg/kg as a single dose 1–2 hrs before surgery

Newborns (<40 weeks gestation)

  • 10 mg/kg as a single dose before surgery

Children under 10 years: Use a more suitable dosage form.

Treatment of Established Infections.

Age Group Dosage Frequency
Adults & Children >10 years 800 mg initially Then 400 mg every 8 hrs
Children <10 years — Use a more suitable dosage form

Urogenital Trichomoniasis

Group Dosage Options
Adults & Adolescents 2000 mg single dose OR 200 mg 3× daily for 7 days OR 400 mg 2× daily for 5–7 days
Children <10 years 40 mg/kg single dose OR 15–30 mg/kg/day in 2–3 doses for 7 days (Max 2000 mg/day)

Treat sexual partners simultaneously to prevent reinfection.

Bacterial Vaginosis

Group Dosage Options
Adults 400 mg 2× daily for 7 days OR 2000 mg single dose
Adolescents 400 mg 2× daily for 5–7 days OR 2000 mg single dose

Amoebiasis

Age Group Dosage Frequency Duration
Adults over 10 years 400–800 mg 3× daily 5–10 days
Children 7–10 years 200–400 mg 3× daily 5–10 days
Children 3–7 years 100–200 mg 4× daily 5–10 days
Children 1–3 years 100–200 mg 3× daily 5–10 days
Alternative (All ages) 35–50 mg/kg/day 3 divided doses Max 2400 mg/day

Children under 7 years: Use a more suitable dosage form.

Giardiasis

Age Group Dosage Options
Adults >10 years 2000 mg once daily for 3 days OR 400 mg 3× daily for 5 days OR 500 mg 2× daily for 7–10 days
Children 7–10 years 1000 mg once daily for 3 days
Children 3–7 years 600–800 mg once daily for 3 days
Children 1–3 years 500 mg once daily for 3 days
Alternative 15–40 mg/kg/day Divided in 2–3 doses

Children under 7 years: Use a more suitable dosage form.

Dental & Skin Infections

Condition Age Group Dosage Duration
Acute Ulcerative Gingivitis Adults & Children >10 years 200 mg 3× daily 3 days
Acute Dental Infections Adults & Children >10 years 200 mg 3× daily 3–7 days
Leg Ulcers/Pressure Sores Adults & Children >10 years 400 mg 3× daily 7 days

Children under 10 years: Use a more suitable dosage form.

Helicobacter pylori (Combination Therapy)

  • 20 mg/kg/day.
  • Max dose: 500 mg twice daily.
  • Duration: 7–14 days.
  • Follow official guidelines before initiating therapy.

Side effects of Metronidazole 500 mg Tablet

Side Effects of Metronidazole 500 mg Tablet

  • Alcohol: Avoid alcohol during treatment and for 48 hours after stopping metronidazole. It may cause flushing, low blood pressure, and other serious reactions.
  • Porphyria: Use with caution.
  • Blood & CNS Conditions: Do not use in patients with blood disorders or active non-infectious brain diseases.
  • Syphilis: High doses may mask symptoms—ensure proper testing.
  • Seizure Risk: Use cautiously in patients with epilepsy or seizure history.
  • Pregnancy: Use with caution in the 2nd and 3rd trimesters for vaginal infections.
  • Long-Term Use: If treatment exceeds 10 days, regular clinical and lab monitoring is advised.
  • Peripheral Neuropathy: Weigh benefits vs. risks in chronic use.
  • Trichomoniasis: Gonorrhea may persist even after Trichomonas is treated—follow-up testing may be needed.
  • Renal Impairment:
    • No dose adjustment is needed, but metabolites may accumulate.
    • Hemodialysis: Re-administer metronidazole immediately after dialysis.
    • Peritoneal Dialysis (IPD/CAPD): No dose adjustment required.
  • Liver Impairment:
    • In hepatic encephalopathy, reduce the dose to one-third, given once daily.
    • In Cockayne syndrome, metronidazole should only be used if no alternatives exist. Liver function tests are mandatory before, during, and after treatment. Discontinue if liver values worsen.
  • Skin Reactions: Discontinue immediately if signs of SJS, TEN, or AGEP appear.
  • Urine Discoloration: May darken urine—this is harmless.
  • Mutagenicity Risk: Long-term use should be avoided unless absolutely necessary.

Storage instruction of Metronidazole 500 mg Tablet

Store below 30°C.

Keep out of reach of children.

Packing details of Metronidazole 500 mg Tablet

6×3 Alu/PVC Blister

Metronidazole 500 mg tablets are available in an Alu/PVC blister of 6 tablets. Such 3 blisters in a unit carton with a package insert.

 

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A pharma CMO is a special kind of an organization, offering contract manufacturing services to pharmaceutical companies for various kinds of drug formulations.

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Contract manufacturers already have the needed infrastructure and technical staff, so working with a CMO or CDMO can decrease the cost of manufacturing your pharmaceutical products.

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We have 7+ manufacturing sites with a minimum of WHO GMP certification and other country-specific approvals like NAFDAC approved, PPK Kenya Approved, TFDA Tanzania Approved, EU-GMP Approved.

We have below manufacturing capacity:
For Tablet, Capsule, and soft gel: up to 1 million units per shift
For Syrup: up to 0.05 Million per shift
For Ampoule and Vial: up to 0.1 million units per shift
For Ointment and Cream: up to 0.1 million units per shift
For Suppository: 0.1 Million units per shift

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