What is Flazol?
Flazol is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis).
Flazol belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, Flazol will not work for colds, flu, or other virus infections.
Flazol is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Flazol is used in certain patients with the following medical conditions:
- Clostridium difficile diarrhea or colitis (antibiotic-associated colitis).
- Crohn's disease (inflammatory bowel disease).
- Gastritis or stomach ulcers due to Helicobacter pylori.
- Giardiasis (parasite infection in the intestines).
Flazol is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of thetrichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).
Flazol is indicated in the treatment of asymptomatic females when the organism is associated with endocervi-citis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.
Treatment of Asymptomatic Consorts.
T. vagi-nalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with Flazol in cases of reinfection.
Flazol is indicated in the treatment of acute intestinal amebiasis (amebic dysen-tery)and amebic liver abscess.
In amebic liver abscess, Flazol therapy does not obviate the need for aspiration or drainage of pus.
Anaerobic Bacterial Infections
Flazol is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Flazol therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Flazol.
In the treatment of most serious anaerobic infections, Flazol I.V. (Flazol hydrochloride) or Flazol I.V. RTU® (Flazol) is usually administered initially. This may be followed by oral ther-apy with Flazol at the discretion of the physician.
INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostrid-ium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species.
SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger,Peptostreptococcus species, and Fusobacte-rium species.
GYNECOLOGIC INFECTIONS, including endo-metritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcusniger, and Pepto-streptococcus species.
BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clos-tridium species.
BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group.
CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B.fragilis group.
LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.
ENDOCARDITIS caused by Bacteroides species including the B.fragilis group.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flazol and other antibacterial drugs, Flazol should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How should I use Flazol?
Use Flazol gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Flazol gel. Talk to your pharmacist if you have questions about this information.
- If you are using Flazol gel once daily, use it at bedtime.
- Remove the cap from the tube and break the metal seal on the tube with the pointed tip of the cap. Screw the end of the applicator onto the tube. Slowly squeeze gel out of the tube and into the applicator. The plunger will stop when the applicator is full. Unscrew applicator and replace the cap on the tube.
- You may insert Flazol gel lying on your back with your knees bent or in any comfortable position. Hold the filled applicator by the barrel, and gently insert into the vagina as far as it will comfortably go. Slowly press the plunger until it stops, and then remove the applicator.
- If you will be using Flazol gel twice daily, you will need to clean the applicator after your first dose of the day and use it again for your second dose. To clean the applicator, pull the plunger out of the barrel. Wash both the plunger and barrel in warm, soapy water and rinse well. To put the applicator back together, gently push the plunger back into the barrel.
- Wash your hands immediately after using Flazol gel.
- When you throw the applicator away, be sure that it is out of the reach of children and pets.
- Using Flazol gel at the same time each day will help you remember to use it.
- To clear up your infection completely, use Flazol gel for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Flazol gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Flazol gel.
Uses of Flazol in details
Flazol is an antibiotic that is used to treat a wide variety of infections. It works by stopping the growth of certain bacteria and parasites.
This antibiotic treats only certain bacterial and parasitic infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
Flazol may also be used with other medications to treat certain stomach/intestinal ulcers caused by a bacteria (H. pylori).
How to use Flazol
Take this medication by mouth as directed by your doctor. To prevent stomach upset, take this medication with food or a full glass of water or milk. The dosage is based on your medical condition and response to treatment.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals.
Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.
Tell your doctor if your condition lasts or gets worse.
Each 100 mL contains Metronidazole USP 500 mg, sodium chloride USP 0.72% w/v, water for injection USP as needed.
Flazol injection, USP is a parenteral dosage form of the synthetic antibacterial agent 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The empirical formula is C6H9N3O3 and the molecular weight is 171.15.
Flazol injection, USP in 100 mL is a sterile, nonpyrogenic, iso-osmotic, buffered solution of 500 mg Flazol, USP, 790 mg sodium chloride, USP, 47.6 mg dried dibasic sodium phosphate, USP and 22.9 mg anhydrous citric acid, USP. Flazol injection, USP has an osmolarity of 310 mOsmol/L (calc) and a pH of 5.5 (4.5 to 7).
Usual Adult Dose for Acne Rosacea
Flazol topical 1% gel or cream: Apply a thin film to the affected area once a day.
Flazol topical 0.75% gel, cream, or lotion: Apply a thin film to the affected area twice a day.
Usual Adult Dose for Bacterial Vaginosis
Insert one applicatorful of Flazol topical 0.75% vaginal gel intravaginally once (at bedtime) or twice a day for 5 consecutive days.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Gel, cream, lotion: Data not available
Vaginal gel: The manufacturer recommends caution when administering this drug to patients with severe hepatic disease.
The duration of topical therapy is 4 to 10 weeks depending on the nature and severity of the condition.
Patients should be advised to use Flazol topical less frequently or discontinue use if a reaction suggesting local irritation occurs.
Convulsive seizures and peripheral neuropathy have been reported in patients receiving oral or IV Flazol. If abnormal neurologic signs appear, Flazol topical vaginal gel should be discontinued at once. The use of Flazol topical 1% gel should be reevaluated at once if abnormal neurologic signs appear. Flazol topical should be used with caution in patients with central nervous system diseases.
Flazol topical should be used with caution in patients with evidence of, or history of blood dyscrasia.
Although disulfiram-like reactions have not been reported in patients receiving vaginal Flazol, the manufacturer recommends that alcohol be avoided. Flazol topical vaginal gel should not be used in patients who have taken disulfiram within the last 2 weeks.
Safety and efficacy have not been established in pediatric patients (less than 18 years of age).
Data not available
Flazol topical may cause eye irritation if applied too close to the eyes. Contact with the eyes should be avoided.
Topical areas to be treated should be washed with a mild cleanser prior to application.
The manufacturer recommends avoidance of vaginal intercourse during treatment with Flazol topical vaginal gel.
What other drugs will affect Flazol?
The intravaginal administration of a single 5 gram dose of Flazol results in relatively lower mean systemic exposure to Flazol that is approximately 2% to 5% of that achieved following a 500 mg oral dose of Flazol. The following drug interactions were reported for oral Flazol.
Use of oral Flazol has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. Flazol (Flazol vaginal gel) should not be used by patients who have taken disulfiram within the last two weeks.
Use of oral Flazol has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least three days after Flazol therapy.
Coumarin and Other
Use of oral Flazol has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Flazol (Flazol vaginal gel) is prescribed for patients on this type of anticoagulant therapy. In patients on oral anticoagulants, consider monitoring prothrombin time, international normalized ratio (INR), and other coagulation parameters while on Flazol.
Short-term use of oral Flazol has been associated with elevation of serum lithium concentrations and, in a few cases signs of lithium toxicity, in patients stabilized on relatively high doses of lithium. Use Flazol (Flazol vaginal gel) with caution in patients treated with lithium and consider monitoring lithium serum concentrations while on Flazol.
Use of oral Flazol with cimetidine may prolong the half-life and decrease plasma clearance of Flazol. No dose adjustment of Flazol (Flazol vaginal gel) is necessary.
Flazol side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Flazol compared to another formulation of vaginal Flazol in 220 women in a single trial. The population was non-pregnant females (age range 18 to 72 years, the mean was 33 years +/- 11 years) with bacterial vaginosis. The racial demographic of those enrolled was 71 (32%) of White, 143 (65%) of Black, 3 (1%) of Hispanic, 2 (1%) of Asian, and 1 (0%) of other. Patients administered an applicator full of Flazol (Flazol vaginal gel) intravaginally once daily at bedtime for 5 days.
There were no deaths or serious adverse reactions related to drug therapy in the clinical trial. Flazol (Flazol vaginal gel) was discontinued in 5 patients (2.3%) due to adverse reactions.
The incidence of all adverse reactions in Flazol (Flazol vaginal gel) -treated patients was 42% (92/220). Adverse reactions occurring in ≥ 1% of patients were: fungal infection* (12%), headache (7%), pruritus (6%), abdominal pain (5%), nausea (3%), dysmenorrhea (3%), pharyngitis (2%), rash (1%), infection (1%), diarrhea (1%), breast pain (1%), and metrorrhagia (1%).
* Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with Flazol (Flazol vaginal gel). Approximately 10% of patients treated with Flazol (Flazol vaginal gel) developed Candida vaginitis during or immediately after therapy.
Additional uncommon events, reported by < 1% of those women treated with Flazol (Flazol vaginal gel) included:
General: allergic reaction, back pain, flu syndrome, mucous membrane disorder, pain
Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, gingivitis, vomiting
Nervous System: depression, dizziness, insomnia
Respiratory System: asthma, rhinitis
Skin and Appendages: acne, sweating, urticaria
Urogenital System: breast enlargement, dysuria, female lactation, labial edema, leucorrhea, menorrhagia, pyleonephritis, salpingitis, urinary frequency, urinary tract infection, vaginitis, vulvovaginal disorder
Other Flazol Formulations
Other Vaginal Formulations
Other reactions that have been reported in association with the use of other formulations of Flazol vaginal gel include: unusual taste and decreased appetite.
Topical (Dermal) Formulations
Other reactions that have been reported in association with the use of topical (dermal) formulations of Flazol include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse reactions exceeded an incidence of 2% of patients.
The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of Flazol:
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.
Nervous System: The most serious adverse reactions reported in patients treated with Flazol have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia.
Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, “furry” tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.
Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis.
Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.
Hypersensitivity Reactions: Urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.
Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.
The use of Flazol (Flazol vaginal gel) is contraindicated in patients with a history of hypersensitivity to Flazol, other nitroimidazole derivatives, or parabens. Reported reactions include urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.
Psychotic Reaction with Disulfiram
Use of oral Flazol is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer Flazol (Flazol vaginal gel) to patients who have taken disulfiram within the last two weeks.
Interaction with Alcohol
Use of oral Flazol is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue alcohol consumption during and for at least three days after therapy with Flazol (Flazol vaginal gel).
Active ingredient matches for Flazol:
Metronidazole in Oman, Yemen.
List of Flazol substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Injectable; Injection; Metronidazole 5 mg / ml (Tecnofarma)|
|Flazole (Bahrain, Latvia, Oman)|
|Flazole 400 x 2 Blister x 10 Tablet|
|Flazole 500 x 2 Blister x 10 Tablet|
|Flazole 400 mg x 2 Blister x 10 Tablet|
|Flazole 500 mg x 2 Blister x 10 Tablet|
|Suspension; Otic; Metronidazole Benzoate 200 mg / 5 ml (Sanofi-aventis)|
|Suspension; Otic; Metronidazole Benzoate 200 mg / 5 ml|
|Emulsion, Concentrated; Topical; Trifloxystrobin 250 g / l (Togal)|
|Granules, Water Dispersible; Topical; Trifloxystrobin 500 g / kg (Togal)|
|Flodal MT 30 ml Suspension (Dallas Pharmaceuticals)||$ 0.08|
|Tablet, Extended Release; Oral; Metronidazole 750 mg|
|Tablets, Extended Release; Oral; Metronidazole 750 mg|
|Florazole ER tablet / extended-release 750 mg (Ferring Inc (Canada))|
|Floxagyl 30 ml Suspension (Vasphar (India))||$ 0.07|
|Floxagyl 500 mg/200 mg Tablet (Vasphar (India))||$ 0.10|
|Floxagyl Suspension (Vasphar (India))||$ 0.55|
|Floxwin M 30 ml Syrup (Biocare Remedies)||$ 0.08|
|Fogyl 200 mg x 100 mL (Fourrts)|
|Fogyl oral susp 200 mg 100 mL x 1's (Fourrts)|
|Foramebex 125 mg/5 mL x 60 mL|
|Formenin 0.75 % x 10 g|
|Formenin 0.75 % x 25 g|
|Formenin 0.75 % x 35 g|
|Fortagyl 5 mg/1 mL x 100 mL x 1's (Prafa)||$ 7.81|
|FRESOGYL infusion 0.5 g x 100ml (Fresenius Kabi)||$ 0.25|
|Frotin (Hong Kong, Malaysia, Taiwan)|
|Frotin 250 mg x 10's x 10 (Ysp)|
|Frotin 200 mg x 100 x 10's (Ysp)|
|Frotin 250 mg x 1000's (Ysp)|
|Frotin 250 mg x 10 x 10's (Ysp)|
|Pessaries; Vaginal; Metronidazole 250 mg (Ysp)|
|Tablets; Oral; Metronidazole 200 mg (Ysp)|
|Tablets, Sugar-Coated; Oral; Metronidazole 250 mg (Ysp)|
|Frotin F.C. (Malaysia)|
|Frotin F.C. 200 mg x 10's x 100|
- DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "metronidazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "metronidazole". http://www.drugbank.ca/drugs/DB00916 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Flazol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Flazol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
2 consumers reported usefulWas the Flazol drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
2 consumers reported price estimatesWas the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Flazol drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
13 consumers reported time for resultsTo what extent do I have to use Flazol before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 5 days and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Flazol. To get the time effectiveness of using Flazol drug by other patients, please click here.
|> 3 month||1||7.7%|
38 consumers reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology