Flamyd Tablet 500 mg
Flamyd Tablet 500 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Flamyd Tablet 500 mg, a nitroimidazole has an extremely broad spectrum antiprotozoal and antimicrobial activities, with high activity against anaerobic bacteria and protozoa. Flamyd Tablet 500 mg 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. Flamyd Tablet 500 mg penetrates well into body tissues and fluids. The liver is the main site of metabolism. Both unchanged Flamyd Tablet 500 mg and metabolites are excreted in various proportions in the urine after oral administration.
Flamyd Tablet 500 mg treats amebiasis, trichomoniasis, and giardiasis, exerting both antibacterial and antiprotozoal activities. Flamyd Tablet 500 mg is an effective treatment for some anaerobic bacterial infections. Flamyd Tablet 500 mg has shown antibacterial activity against the majority of obligate anaerobes, however, during in vitro studies, it does not demonstrate significant action against facultative anaerobes or obligate aerobes. The nitro group reduction of metronidazole by anaerobic organisms is likely responsible for the drug's antimicrobial cytotoxic effects, causing DNA strand damage to microbes.
A note on convulsions and neuropathy and carcinogenesis
It is important to be aware of the risk of peripheral neuropathy and convulsions associated with metronidazole, especially at higher doses. If convulsions or numbness of an extremity occur, discontinue the drug immediately. Flamyd Tablet 500 mg has been found to be carcinogenic in mice and rats. The relevance to this effect in humans is unknown. It is advisable to only administer metronidazole when clinically necessary and only for its approved indications.
Trade Name | Flamyd Tablet 500 mg |
Availability | Prescription only |
Generic | Metronidazole |
Metronidazole Other Names | Metronidazol, Métronidazole, Metronidazole, Metronidazolum |
Related Drugs | amoxicillin, prednisone, omeprazole, pantoprazole, doxycycline, ciprofloxacin, cephalexin, azithromycin, clindamycin, ceftriaxone |
Weight | 500 mg |
Type | Tablet |
Formula | C6H9N3O3 |
Weight | Average: 171.154 Monoisotopic: 171.064391169 |
Protein binding | Metronidazole is less than 20% bound to plasma proteins. |
Groups | Approved |
Therapeutic Class | Amoebicides, Anti-diarrhoeal Antiprotozoal |
Manufacturer | Incepta Pharmaceuticals Ltd. |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
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Uses
Flamyd Tablet 500 mg 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)
Flamyd Tablet 500 mg 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
How Flamyd Tablet 500 mg works
The exact mechanism of action of metronidazole has not been fully established, however, it is possible that an intermediate in the reduction of metronidazole which is only made by anaerobic bacteria and protozoa, binds deoxyribonucleic acid and electron-transport proteins of organisms, blocking nucleic acid synthesis. After administration, metronidazole enters cells by passive diffusion. Following this, ferredoxin or flavodoxin reduce its nitro group to nitro radicals. The redox potential of the electron transport portions of anaerobic or microaerophilic microorganisms renders metronidazole selective to these organisms, which cause nitro group reduction, leading to the production of toxic metabolites. These include N-(2-hydroxyethyl) oxamic acid and acetamide, which may damage DNA of replicating organisms.
Dosage
Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg GEL (approximately 5 grams containing approximately 37.5 mg of Flamyd Tablet 500 mg) intravaginally once or twice a day for 5 days. For once a day dosing, Flamyd Tablet 500 mg 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:
Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg 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.
Toxicity
LD50 information
The oral LD50 of metronidazole in rats is 5000 mg/kg
Overdose information
Adverse effects that may be exaggerated with an overdose include peripheral neuropathy, central nervous system toxicity, seizures, disulfiram-like effect (if combined with alcohol) dark urine, a metallic taste in the mouth, nausea, epigastric discomfort, and vertigo, in addition to neutropenia. There is no specific antidote for metronidazole overdose. Symptomatic and supportive treatment should be employed in addition to the administration of activated charcoal to remove the unabsorbed drug from the gastrointestinal tract. In addition to the above measures, contact the local poison control center for updated information on the management of a metronidazole overdose.
Precaution
Flamyd Tablet 500 mg 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, Flamyd Tablet 500 mg may provoke a disulphiram like effect.
Interaction
Flamyd Tablet 500 mg 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.
[Major] CONTRAINDICATED: Use of alcohol or products containing alcohol during nitroimidazole therapy may result in a disulfiram-like reaction in some patients.
There have been a few case reports involving metronidazole, although data overall are not convincing.
The presumed mechanism is inhibition of aldehyde dehydrogenase (ALDH) by metronidazole in a manner similar to disulfiram.
Following ingestion of alcohol, inhibition of ALDH results in increased concentrations of acetaldehyde, the accumulation of which can produce an unpleasant physiologic response referred to as the 'disulfiram reaction'.
Symptoms include flushing, throbbing in head and neck, throbbing headache, respiratory difficulty, nausea, vomiting, sweating, thirst, chest pain, palpitation, dyspnea, hyperventilation, tachycardia, hypotension, syncope, weakness, vertigo, blurred vision, and confusion.
Severe reactions may result in respiratory depression, cardiovascular collapse, arrhythmia, myocardial infarction, acute congestive heart failure, unconsciousness, convulsions, and death.
However, some investigators have questioned the disulfiram-like properties of metronidazole.
One study found neither elevations in blood acetaldehyde nor objective or subjective signs of a disulfiram-like reaction to ethanol in six subjects treated with metronidazole (200 mg three times a day for 5 days) compared to six subjects who received placebo.
MANAGEMENT: Because clear evidence is lacking concerning the safety of ethanol use during nitroimidazole therapy, patients should be apprised of the potential for interaction.
Consumption of alcoholic beverages and products containing propylene glycol is specifically contraindicated during and for at least 3 days after completion of metronidazole and benznidazole therapy according to their product labeling.
Flamyd Tablet 500 mg Hypertension interaction
[Moderate] Flagyl I.V. RTU (brand of metronidazole ready-to-use injection) contains 14 mEq of sodium per each 500 mg dose of metronidazole.
The sodium content should be considered when this product is used in patients with conditions that may require sodium restriction, such as congestive heart failure, hypertension, and fluid retention.
Flamyd Tablet 500 mg Drug Interaction
Moderate: ciprofloxacin, bifidobacterium infantis / lactobacillus acidophilus, ondansetronUnknown: aspirin, amoxicillin / clavulanate, diphenhydramine, duloxetine, omega-3 polyunsaturated fatty acids, pregabalin, esomeprazole, acetaminophen / hydrocodone, acetaminophen, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, ergocalciferol, cholecalciferol, alprazolam, cetirizine
Flamyd Tablet 500 mg Disease Interaction
Major: colitis, blood dyscrasias, neurologic toxicityModerate: dialysis, liver disease, sodium, alcoholism
Volume of Distribution
Flamyd Tablet 500 mg 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.
Elimination Route
After the intravenous infusion of a 1.5g dose, peak concentration was reached within 1 hour and was peak level of 30-40 mg/L. When a multiple-dose regimen of 500mg three times a day administered intravenously, steady-state concentrations were achieved within about 3 days and peak concentration was measured at 26 mg/L. When administered orally in the tablet form, metronidazole is absorbed entirely absorbed, showing a bioavailability of greater than 90%. One resource indicates that Cmax after a single oral dose of 500mg metronidazole ranges from 8 to 13 mg/L, with a Tmax of 25 minutes to 4 hours. The AUC following a single 500mg oral dose of metronidazole was 122 ± 10.3 mg/L • h.
A note on the absorption of topical preparations
Insignificant percutaneous absorption of metronidazole occurs after the application of 1% metronidazole cream topically. Healthy volunteers applied one 100 mg dose of 14C-labelled metronidazole 2% cream to unbroken skin. After 12 hours, metronidazole was not detected in the plasma. Approximately 0.1% to 1% of the administered metronidazole was measured in the urine and feces.
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.
Elimination Route
Flamyd Tablet 500 mg and metabolites are 60 to 80% eliminated in the urine, and 6-15% excreted in the feces.
Pregnancy & Breastfeeding use
Not recommended during first & later trimesters. Breast feeding should be delayed until 48 hours after discontinuing metronidazole in the mother.
Contraindication
Flamyd Tablet 500 mg is contraindicated in patients with prior history of hypersensitivity to Flamyd Tablet 500 mg 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
You find simplified version here Flamyd Tablet 500 mg
Flamyd Tablet 500 mg contains Metronidazole see full prescribing information from innovator Flamyd Tablet 500 mg Monograph, Flamyd Tablet 500 mg MSDS, Flamyd Tablet 500 mg FDA label
FAQ
What are the side effects of Flamyd Tablet 500 mg?
Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg kill?
Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg is prescribed?
Flamyd Tablet 500 mg 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?
Flamyd Tablet 500 mg 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, Flamyd Tablet 500 mg can also be given intravenously (by the veins). The recommended dose of Flamyd Tablet 500 mg will vary depending on the type of infection that is being treated. Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg?
If you miss a dose of Flamyd Tablet 500 mg, 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 Flamyd Tablet 500 mg?
If you miss doses of Flamyd Tablet 500 mg, the infection will continue and possibly worsen. Therefore, it is extremely important that you take Flamyd Tablet 500 mg for the entire duration of the treatment.
Does Flamyd Tablet 500 mg make you sleepy?
Flamyd Tablet 500 mg oral tablet doesn't cause drowsiness, but it can cause other side effects.
Can Flamyd Tablet 500 mg treat yeast infection?
Flamyd Tablet 500 mg 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 Flamyd Tablet 500 mg vaginal.