Flagentyl 500mg is an antibiotic that fights bacteria.
Flagentyl 500mg is used in women to treat bacterial vaginal infections.
This medicine will not treat a fungal (yeast) infection.
Flagentyl 500mg may also be used for purposes not listed in this medication guide.
Flagentyl 500mg indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Bacterial Vaginosis
Flagentyl 500mg is indicated for the treatment of bacterial vaginosis in adult women.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flagentyl 500mg and other antibacterial drugs, Flagentyl 500mg 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.
Uses of Flagentyl 500mg in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Flagentyl 500mg is used to treat intestinal amoebiasis (infection of the intestinal), hepatic amoebiasis (infection of the liver), urethritis (infection of the urethra) and vaginitis (infection of the vagina) caused by Trichomonas vaginalis and giardiasis (parasitic infections).
Flagentyl 500mg description
Flagentyl 500mg (brand name Flagentyl 500mg,Sindose) is a nitroimidazole anti-infective. Effectiveness in the treatment of dientamoebiasis has been reported. It has also been tested against Atopobium vaginae.
Flagentyl 500mg dosage
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Flagentyl 500mg Dosage
Generic name: Flagentyl 500mg 2g in 4.8g
Dosage form: oral granules
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The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosage
The recommended dosage of Flagentyl 500mg is a single 2-gram packet of granules taken once orally, without regard to the timing of meals.
Instructions for the Preparation and Administration of Flagentyl 500mg
Open the Flagentyl 500mg packet by folding over the corner (marked by an arrow) and tearing across the top.
Sprinkle the entire contents of the Flagentyl 500mg packet onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the mixture within 30 minutes without chewing or crunching the granules. A glass of water may be taken after the administration of Flagentyl 500mg to aid in swallowing.
The granules are not intended to be dissolved in any liquid.
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
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 safety data described below reflect exposure to 589 patients, of whom 518 received a 2 g dose of Flagentyl 500mg. Flagentyl 500mg was evaluated in three clinical trials of patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and one uncontrolled safety trial (Trial 3 n=321).
All patients received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of Flagentyl 500mg. Trial 2 evaluated a 2 g dose (n=125). The population was female, aged 15 to 54 years. Patients in the placebo- controlled trials were primarily Black or African American (54%) or Caucasian (41%).
There were no deaths in the trials. Two patients in Trial 3 discontinued due to vulvovaginal candidiasis in the Flagentyl 500mg-treated arm.
Most Common Adverse Reactions
Among 197 patients treated with a single 2 g dose of Flagentyl 500mg in the two placebo-controlled trials, Trial 1 and 2, adverse reactions were reported by approximately 29% of patients. Table 1 displays the most common adverse reactions (≥ 2 % in Flagentyl 500mg-treated patients) in these two trials.
Table 1: Adverse Reactions Occurring (≥ 2 % Flagentyl 500mg-Treated Patients) in the Pooled Placebo-Controlled Trials 1 and 2 in Adult Women with Bacterial Vaginosis
Adverse Reaction
Flagentyl 500mg
N=197
n (%)
Placebo
N=136
n (%)
Vulvo-vaginal candidiasis
19 (9.6)
4 (2.9)
Headache
7 (3.6)
2 (1.5)
Nausea
7 (3.6)
1 (0.7)
Diarrhea
5 (2.5)
1 (0.7)
Abdominal pain
4 (2.0)
2 (1.5)
Vulvovaginal pruritus
4 (2.0)
2 (1.5)
Among the 321 patients in an uncontrolled trial, Trial 3, adverse reactions were reported in 30% of patients. Vulvovaginal candidiasis (8.4%), nausea (5.3%), vomiting (2.5%) and dysgeusia (3.4%) were the most common adverse reactions reported in this trial.
Postmarketing Experience
The following adverse reactions have been reported during use of other formulations of Flagentyl 500mg 2 g outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Reported adverse reactions were nausea, dysgeusia, abdominal pain, headache, and vomiting.
Flagentyl 500mg is contraindicated in patients who have shown hypersensitivity to Flagentyl 500mg, other ingredients of the formulation, or other nitroimidazole derivatives.
DailyMed. "SECNIDAZOLE: 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).
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