Flamyd IV Infusion 500 mg/100 ml
Flamyd IV Infusion 500 mg/100 ml Uses, Dosage, Side Effects, Food Interaction and all others data.
Flamyd IV Infusion 500 mg/100 ml, a nitroimidazole has an extremely broad spectrum antiprotozoal and antimicrobial activities, with high activity against anaerobic bacteria and protozoa. Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml penetrates well into body tissues and fluids. The liver is the main site of metabolism. Both unchanged Flamyd IV Infusion 500 mg/100 ml and metabolites are excreted in various proportions in the urine after oral administration.
Flamyd IV Infusion 500 mg/100 ml treats amebiasis, trichomoniasis, and giardiasis, exerting both antibacterial and antiprotozoal activities. Flamyd IV Infusion 500 mg/100 ml is an effective treatment for some anaerobic bacterial infections. Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml |
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/100 ml |
Type | IV Infusion |
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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml GEL (approximately 5 grams containing approximately 37.5 mg of Flamyd IV Infusion 500 mg/100 ml) intravaginally once or twice a day for 5 days. For once a day dosing, Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml may provoke a disulphiram like effect.
Interaction
Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml Disease Interaction
Major: colitis, blood dyscrasias, neurologic toxicityModerate: dialysis, liver disease, sodium, alcoholism
Volume of Distribution
Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml is contraindicated in patients with prior history of hypersensitivity to Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml
Flamyd IV Infusion 500 mg/100 ml contains Metronidazole see full prescribing information from innovator Flamyd IV Infusion 500 mg/100 ml Monograph, Flamyd IV Infusion 500 mg/100 ml MSDS, Flamyd IV Infusion 500 mg/100 ml FDA label
FAQ
What are the side effects of Flamyd IV Infusion 500 mg/100 ml?
Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml kill?
Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml is prescribed?
Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml can also be given intravenously (by the veins). The recommended dose of Flamyd IV Infusion 500 mg/100 ml will vary depending on the type of infection that is being treated. Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml?
If you miss a dose of Flamyd IV Infusion 500 mg/100 ml, 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 IV Infusion 500 mg/100 ml?
If you miss doses of Flamyd IV Infusion 500 mg/100 ml, the infection will continue and possibly worsen. Therefore, it is extremely important that you take Flamyd IV Infusion 500 mg/100 ml for the entire duration of the treatment.
Does Flamyd IV Infusion 500 mg/100 ml make you sleepy?
Flamyd IV Infusion 500 mg/100 ml oral tablet doesn't cause drowsiness, but it can cause other side effects.
Can Flamyd IV Infusion 500 mg/100 ml treat yeast infection?
Flamyd IV Infusion 500 mg/100 ml 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 IV Infusion 500 mg/100 ml vaginal.