Flagentyl

Flagentyl Uses, Dosage, Side Effects, Food Interaction and all others data.

Flagentyl is the first nitroimidazole to offer a 3 day antiprotozoal activity from one single dose. With its prolonged half life, Flagentyl offers an effective treatment and thus ensures improved patient compliance because of the short duration of treatment with excellent therapeutic efficacy.

Flagentyl exhibits activity against anaerobic protozoa Entamoeba histolytica, Giardia lamblia and Trichomonas vaginalis. Flagentyl is rapidly absorbed following oral administration. The maximum serum level is obtained after 3 hours following oral administration of 2 gm secnidazole.

The plasma elimination half life is about 20 hours. The majority of Flagentyl is eliminated via urine (50% of the ingested dose is excreted within 120 hours). The pharmacokinetic profile of Flagentyl gives it the longest half-life of all the second generation nitroimidazoles, ensuring 72-hour therapeutic blood levels from a 2 gm single dose.

Flagentyl is a nitroimidazole antimicrobial drug that displays selectivity against many anaerobic Gram-positive and Gram-negative bacteria and protozoa . In vitro studies demonstrates the effectiveness of the drug against Bacteroides fragilis, Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia . There is no significant bacterial or protozoal resistance reported from secnidazole treatment .

Trade Name Flagentyl
Availability Prescription only
Generic Secnidazole
Secnidazole Other Names Secnidazole
Related Drugs metronidazole, clindamycin, Flagyl, Cleocin, tinidazole, Solosec, Flagyl IV
Type Tablet
Formula C7H11N3O3
Weight Average: 185.183
Monoisotopic: 185.080041226
Protein binding

The plasma protein binding of secnidazole is < 5-15% .

Groups Approved
Therapeutic Class Amoebicides, Anti-diarrhoeal Antiprotozoal
Manufacturer Sanofi
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Flagentyl
Flagentyl

Uses

Flagentyl is used for Intestinal Amoebiasis, Hepatic Amoebiasis, Urethritis and Vaginitis due to Trichomonas vaginalis, Giardiasis

Flagentyl is also used to associated treatment for these conditions: Bacterial Vaginosis (BV), Candidiasis, Trichomonas Vaginitis, Trichomoniasis

How Flagentyl works

Flagentyl enters the bacterial cell as a prodrug without an antimicrobial activity. The drug is converted to an active form via reduction of nitro groups to radical anions by bacterial enzymes. The radical anions are thought to interfere with bacterial DNA synthesis of susceptible isolates .

Dosage

Flagentyl dosage

Flagentyl tablet should be administered orally. The dosage schedule of Flagentyl tablet is mentioned below:

Flagentyl Tablet:

Amoebiasis:Acute intestinal amoebiasis:

  • Adults: 2 gm single dose (2x1000 mg tablet), taken preferably just before meal.
  • Children: 30 mg/kg single dose, taken preferably just before meal.

Asymptomatic amoebiasis (minute & cystic form):

  • Adults: 2 gm once daily (2x1000 mg tablet) for only 3 days, taken preferably just before meal.
  • Children: 30 mg/kg once daily for only 3 days, taken preferably just before meal.

Hepatic amoebiasis :

  • Adults: 1.50 gm/day, in a single or divided dose, just before meal for 5 days.
  • Children: 30 mg/kg/day, in a single or divided dose, just before meal for 5 days.

N.B.: Evacuation of pus must be performed simultaneously with Flagentyl treatment at the suppurative stage of hepatic amoebiasis.Giardiasis :

  • Adults: 2 gm single dose (2x1000 mg tablet), taken preferably just before meal.
  • Children: 35-50 mg/kg single dose, taken preferably just before meal.

Trichomoniasis :

  • Adults: 2 gm single dose (2x1000 mg tablet), taken preferably just before meal.
  • Children: 30 mg/kg single dose, taken preferably just before meal. The partner should also receive the same treatment concomitantly.

Flagentyl Suspension:

Suspension should be administered orally. The dosage schedule of Flagentyl suspension is mentioned below:

  • Children of 10 to 15 kg body weight: 1 bottle of Flagentyl 500 mg suspension.
  • Children of 16 to 25 kg body weight: 1½ bottle of Flagentyl 500 mg suspension.
  • Children of 26 kg or more body weight: 2 bottles of Flagentyl 500 mg suspension.

Side Effects

The clinical studies have shown that secnidazole is characterized by very good tolerance and no serious adverse reactions have been reported to date. The following side-effects may be observed with secnidazole as with all nitroimidazole derivatives & are rarely serious

Most frequent side-effects: Gastrointestinal disturbances, nausea, epigastric pain, metallic taste, glossitis, and stomatitis.

Occasional side-effects: Urticaria, moderate leukopenia which is reversible on treatment discontinuation.

Rare side-effects: Vertigo, ataxia and motor incoordination, paresthesia, and peripheral neuropathy. With secnidazole, gastrointestinal disorders e.g. nausea, vomiting, epigastric pain, etc. have been reported in very rare cases.

Toxicity

Oral LD50 in mouse, rabbit and rat is 300 mg/kg, 3200 mg/kg and 980 mg/kg, in a respective order . Flagentyl was positive in the Bacterial Reverse Mutation Assay, but was negative for the rat micronucleus test and mouse lymphoma test. No parental toxicity or signs of reproductive toxicity were observed in female rat fertility studies at doses of up to the maximum tolerated dose of 300 mg/kg/day .

Precaution

Patients should be advised not to take alcohol during treatment with secnidazole (because of possibility of antabuse effect). Administration of secnidazole should be avoided to patients with a history of blood dyscrasia.

Interaction

Administration of secnidazole with disulfiram is not recommended: confusional state & paranoid reaction may occur.

Use of secnidazole simultaneously with warfarin requires close monitoring: increased effect of oral anticoagulants and of the hemorrhagic risk is likely.

Food Interaction

  • Take with or without food. Sprinkle onto applesauce, yogurt, or pudding and ingest without crushing the granules.

Flagentyl Disease Interaction

Moderate: alcoholism

Volume of Distribution

The apparent volume of distribution of secnidazole is approximately 42-49 L .

Elimination Route

Flagentyl is rapidly and completely absorbed after oral administration . Following a single oral dose of 2 g in healthy adult female subjects, the mean (SD) secnidazole peak plasma concentration (Cmax) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC0-inf) of 1331.6 (230.16) mcg x hr/mL was reached. Median (range) time to peak concentration (Tmax) was 4.0 (3.0-4.0) hours .

Half Life

The plasma elimination half-life for secnidazole is approximately 17 hours .

Clearance

The total body clearance of secnidazole is approximately 25 mL/min. The renal clearance of secnidazole is approximately 3.9 mL/min .

Elimination Route

The predominant route of elimination is renal elimination. Following a single oral dose of 2g secnidazole, approximately 15% of the drug is excreted as unchanged compoung in the urine .

Pregnancy & Breastfeeding use

Flagentyl may be prescribed in pregnancy after the first trimester. As with other similar drugs, secnidazole should not be administered during the first trimester of pregnancy or during lactation because secnidazole is found in placenta and breast milk.

Contraindication

Flagentyl is contraindicated for those patients who are hypersensitive to imidazole derivatives.

Storage Condition

Store in a cool dry place, protected from heat.

Innovators Monograph

You find simplified version here Flagentyl

Flagentyl contains Secnidazole see full prescribing information from innovator Flagentyl Monograph, Flagentyl MSDS, Flagentyl FDA label

FAQ

What is Flagentyl used for?

Flagentyl is used in women to treat bacterial vaginal infections.Flagentyl will not treat a fungal (yeast) infection.Flagentyl may also be used for purposes not listed in this medication guide.

How should I take Flagentyl?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Flagentyl is taken in a single dose of one packet of oral granules.You may take this medicine with or without food.

How does Flagentyl work?

Flagentyl works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

What are the common side effects of Flagentyl?

Common side effects may include:nausea, vomiting, diarrhea, stomach pain; headache.

Is Flagentyl safe during pregnancy?

The manufacturer makes no recommendation regarding use during pregnancy.Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Is Flagentyl safe during breastfeeding?

Breastfeeding is not recommended during use of this drug and for 96 hours after dose administration.

Can I drink alcohol with Flagentyl?

Intake of alcohol while on Flagentyl treatment is to be strictly restricted as it may cause severe reactions.Do not drink alcohol during treatment and for at least 2 days after the last dose.

Can I drive after taking Flagentyl?

You should not drive if you experience any discomfort after taking this medicine.

How long Flagentyl take to work ?

Flagentyl is rapidly and completely absorbed after oral administration and has a longer terminal elimination half-life (approximately 17 to 29 hours) than commonly used drugs in this class.

How should I take Flagentyl?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Flagentyl is taken in a single dose of one packet of oral granules.You may take this medicine with or without food.

What happens if I miss a dose?

Since Flagentyl is used as a single dose, it does not have a daily dosing schedule.

Can I overdose of Flagentyl?

It's unlikely that taking an extra dose of Flagentyl can harm you. You can, however, experience side effects such as stomach cramps, being sick, nausea, vomiting and diarrhea.

Is Flagentyl an antibiaotic?

Flagentyl is an antibiotic that works by preventing bacteria from growing. This antibiotic is only used to treat bacterial infections.

Who should not take Flagentyl?

Flagentyl is not approved for use by anyone younger than 18 years old.

Can Flagentyl used for stomach infection?

Flagentyl is used for the treatment of various infections such as stomach, intestine, urinary tract and genital area.

How should Flagentyl be taken?

Flagentyl is taken in a single dose of one packet of oral granules. You may take this medicine with or without food.

How many tablets of Flagentyl should an adult take?

Adults 2 grams (1 packet) one time. Children use and dose must be determined by your doctor.

*** Taking medicines without doctor's advice can cause long-term problems.
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