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Metronidazole Tablets
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What is Metronidazole?
Active Ingredients: Metronidazole
Metronidazole Tablets are used to treat certain infections caused by anaerobic bacteria or protozoa. It is prescribed to treat infections in many parts of the body, such as the gastrointestinal tract, bones, joints, and nervous system. This drug is prescribed with other medications to treat ulcers caused by H. pylori.
Metronidazole is a broad-spectrum nitroimidazole with antimicrobial properties. It shows activity against gram-negative anaerobic bacteria, gram-positive anaerobic bacteria, and protozoa.
Metronidazole’s antimicrobial effects are thought to be the result of a reduced intermediate that is only made by anaerobic bacteria and protozoa. Due to the differing redox potentials of anaerobic and aerobic microorganisms, only anaerobic organisms reduce metronidazole’s nitro group into toxic metabolites, which gives metronidazole its selectivity. This intermediate may then bind to the DNA and electron-transport proteins of these organisms to inhibit nucleic acid synthesis.
AdvaCare Pharma is a trusted global supplier of Metronidazole Tablets, Capsules, Oral Suspensions, and Injections. We offer a wide range of high-quality and cost-effective medical products that are available for distribution. Our factories are GMP-certified and are regularly inspected to ensure they continue to meet the high standards necessary to comply with WHO guidelines and standards.
Why are we a top Metronidazole manufacturer?
AdvaCare Pharma is a trusted Metronidazole manufacturer committed to providing quality-assured, cost-effective pharmaceuticals for an ever-changing global market. Manufacturing a wide range of 200+ pharmaceutical products in tablet form, we ensure that all of our oral solid dosage forms adhere to stringent GMP standards.
We operate according to a unique "vested supplier-distributor relationship" business model, in which we tie our success in a market to that of our distributor. Such a model facilitates a closer relationship by working together to achieve pre-defined goals for market entry and expansion. As a Metronidazole manufacturer and global supplier, we implement unique strategies to ensure successful distribution.
Uses
What is Metronidazole used for?
It is used to treat certain anaerobic bacterial infections, such as:
- intra-abdominal infections (including peritonitis)
- skin and skin structure infections
- gynecologic infections (including endometritis)
- bacterial septicemia
- bone and joint infections, as adjuvant therapy
- central nervous system infections (including meningitis)
- lower respiratory tract infections (including pneumonia)
- endocarditis
Metronidazole is not effective against viral infections, such as colds and the flu.
How should Metronidazole Tablets be used?
This medication is intended to be taken orally. Tablets should be taken whole with a glass of water. Do not chew, break, or crush Metronidazole Tablets.
This medication should be taken for the full duration of treatment. Skipping doses or discontinuing treatment prematurely can result in bacterial infections that are resistant to current and future treatments.
What dose should be taken and for how long?
Recommended dosage may vary based on different medical conditions and age.
Adults Dosage may vary based on different medical indications:
- Trichomoniasis can be treated with either: a one-day regimen of 2g, taken once, or 1g, taken twice; OR a seven-day regimen of 250mg, taken three times each day. There is some evidence that the cure rate is higher for the seven-day regimen. If repeat treatments are needed, they should be separated by an interval of at least 4 to 6 weeks.
- For the treatment of amebiasis, the recommended dose is 750mg, taken three times a day for 5 to 10 days.
- For the treatment of amebic liver abscess, the recommended dose is 500-750mg, taken three times a day for 5 to 10 days.
- For the treatment of bacterial vaginosis, the recommended dose is 500mg, taken twice a day for 7 days.
- For surgical prophylaxis, the recommended dose is 1g, taken three times over the course of 10 hours. Treatment should begin the evening before surgery.
- For the treatment of other infections, the recommended dose is 500mg, taken four times a day for 7 to 10 days. Infections of the bone and joints, lower respiratory tract, and endocardium may require longer treatments. Dosages should not exceed a maximum of 4g/day.
Children Recommended dosage for children may vary based on different medical conditions:
- For the treatment of trichomoniasis in children weighing less than 45kg, the recommended dose is 45mg/kg/day, given in three doses for 7 days. Dosages should not exceed a maximum of 2g/day.
- For the treatment of trichomoniasis in children weighing 45kg or more, the recommended dose is a single dose of 2g.
- For the treatment of amebiasis, the recommended dose is between 35 and 50mg/kg/day, given in three doses for 10 days.
- For the treatment of bacterial vaginosis in children weighing < 45kg, the recommended dose is 15-25mg/kg/day, given in three doses for 7 days. Dosages should not exceed a maximum of 2g/day.
- For the treatment of bacterial vaginosis in children weighing ≥ 45kg, the adult dosage can be used.
- For surgical prophylaxis, the recommended dose is 15mg/kg, given three times over the course of 10 hours. Treatment should begin the evening before surgery. Dosages should not exceed a maximum of 1g/day.
- For the treatment of other infections, the recommended dose is between 7.5 and 10mg/kg, given two or three times a day. Infections of the bone and joints, lower respiratory tract, and endocardium may require longer treatments. Dosages should not exceed a maximum of 2.25g/day.
The dosage is based on medical condition, response to treatment, age, and weight. Refer to a doctor or pharmacist for guidelines on dosage. Do not exceed what they advise.
What happens if a dose is missed?
The missed dose should be taken as soon as possible. Skip the dose if it is almost time for the next dose. Do not take two doses at once.
Who can use Metronidazole?
Metronidazole can be administered to adults and children, but caution is advised for those who are:
Pregnant Animal studies have not revealed evidence of impaired fertility or fetal harm related to oral metronidazole administration. Current human studies are insufficient to rule out fetal risk. Metronidazole use during the first trimester should be avoided. If metronidazole is deemed medically necessary for the treatment of trichomoniasis during pregnancy, the one-day regimen should NOT be used, as it exposes the fetus to higher serum concentrations.
Nursing Metronidazole is excreted in human milk at concentrations lower than maternal serum levels. Studies have demonstrated metronidazole’s potential for carcinogenicity in animals and potential mutagenicity in humans.
Cases of Candida infections and diarrhea have been reported in some nursing infants. The benefits of breastfeeding, the potential patient benefit, and the potential infant risk should all be considered.
Pediatric Although the safety and efficacy of metronidazole use in children have only been established for the treatment of amebiasis, the American Academy of Pediatrics (AAP), Infectious Diseases Society of America (IDSA), Surgical Infection Society (SIS), Centers for Disease Control (CDC), American Society of Health-System Pharmacists (ASHP), and Society for Healthcare Epidemiology of America (SHEA) have published recommendations for dosing metronidazole to treat various bacterial infections in pediatric patients. For more accurate weight-based dosing, the use of Metronidazole Oral Suspension is recommended.
Geriatric There are insufficient studies to determine if adults aged ≥ 65 years respond differently to metronidazole compared to those aged < 65 years. Due to the likelihood of decreased hepatic function in older patients, the dose should be adjusted, and serum level monitoring is encouraged.
Other warnings
In patients with severe hepatic insufficiency, dosages should be reduced and administered with caution.
Metronidazole should not be used in the absence of a proven or strongly suspected bacterial infection or prophylactic need, as it increases the risk of drug-resistant bacteria.
Alcohol should be avoided during metronidazole treatment and for at least one day afterward, as abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
Convulsive seizures and peripheral neuropathy (numbness, paresthesia) have been reported in patients treated with metronidazole. Metronidazole should be discontinued immediately if adverse neurological events occur. Caution is advised when treating patients with central nervous system disease.
Medications that decrease hepatic enzyme activity, such as cimetidine, may result in decreased clearance and increased half-life of metronidazole. These effects should be considered when administering such medications concomitantly.
In patients receiving high doses of lithium, metronidazole therapy may elevate lithium serum levels and potentially result in lithium toxicity.
Metronidazole should be administered with caution to patients who are taking anticoagulants, as it can increase their effects and result in a prolonged prothrombin time.
Metronidazole may interfere with certain types of laboratory values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. These interferences are associated with assays that involve the oxidation-reduction of nicotinamide adenine dinucleotide.
Studies in mice and rats have found statistically significant evidence of metronidazole’s carcinogenic and tumorigenic potential. Two studies in hamsters have not found the same evidence of tumorigenicity with lifetime metronidazole administration. Animal studies have not revealed evidence of metronidazole’s potential for mutagenic activity or fertility impairment. The significance of these conclusions in relation to the use of metronidazole in humans is unknown.
Side Effects
As with all pharmaceuticals, some unwanted effects can occur from the use of Metronidazole Tablets.
Common side effects include, but may not be limited to:
- nausea
- headache
- abdominal pain
- vomiting
- diarrhea
- metallic taste
Seek medical attention if the following develop:
- sudden wheezing
- severe skin reactions
- itching all over the body
- loss of appetite or weight loss
For a comprehensive understanding of all potential side effects, consult a medical professional.
If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.
Precautions
Do NOT use Metronidazole Tablets if:
- You are allergic to any of the ingredients.
- You are pregnant.
- You are taking busulfan or have taken disulfiram within the past 2 weeks.
- You have alcohol use disorder.
Before treatment, consult your doctor regarding any medications you are taking to address potential drug interactions.
This medication may not be suitable for people with certain conditions, so it is important to consult with a doctor if you have any health conditions.
References
Double-blind randomised controlled trial of effect of metronidazole on pain after day-case haemorrhoidectomy
This study evaluates the effect of metronidazole on pain after day-case haemorrhoidectomy (DCH).
It included random assignment of 40 consecutive patients admitted for DCH metronidazole 400mg (n=20) or placebo (n=20) three times daily, both for 7 days.
All patients were administered lactulose starting from 2 days before surgery and continued for 2 weeks thereafter. Diathermy DCH was performed without pedicle ligature or anal-canal dressing, with a diclofenac suppository administered post-procedure. Patients were discharged on the same day with a prescription.
Patients receiving metronidazole reported significantly less pain than those receiving placebo on days 5, 6, and 7 (p=0.004, p=0.02, and p=0.006). The median time for a return to work or normal activity was 15 days (range 12–28) in the metronidazole group and 18 days (7–34) in the placebo group (p=0.009). Patient satisfaction scores were higher in the metronidazole group compared to the placebo group at 1 week (p=0.005).
In conclusion, prophylactic administration of metronidazole in diathermy DCH effectively reduced secondary pain between days 5 and 7 post-surgery, but it also enhanced patient satisfaction and facilitated earlier return to work.
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