Flagyl Comp

Metronidazole:

• Pharmacological action
• Pharmacokinetics
• Why is Flagyl Comp prescribed?
• Dosage and administration
• Flagyl Comp (Metronidazole) side effects, adverse reactions
• Flagyl Comp contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Flagyl Comp drug interactions
• Flagyl Comp in case of emergency / overdose
• Flagyl Comp (Metronidazole) reviews

Pharmacological action

Flagyl Comp is an anti protozoal agent. It is believed that the mechanism of action is associated with DNA damage-sensitive microorganisms. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, and obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).

Aerobic bacteria are resistant to Flagyl Comp (Metronidazole).

In combination with amoxicillin Flagyl Comp (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Flagyl Comp (Metronidazole).

Pharmacokinetics

Flagyl Comp (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Flagyl Comp (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Flagyl Comp (Metronidazole) is metabolized in the liver by oxidation and binding to glucuronic acid. T_1/2 is 8 hours. This drug is excreted in the urine (60-80%) and feces (6-15%).

Why is Flagyl Comp prescribed?

Trichomonazice vaginitis and urethritis in women, trichomonazice urethritis in men, giardiasis, amoebic dysentery, anaerobic infections caused by metronidazole-sensitive organisms, combination therapy of severe mixed aerobic-anaerobic infections. Preventing anaerobic infection in surgery (particularly abdominal, urinary tract). Chronic alcoholism.

Flagyl Comp (Metronidazole) in combination with amoxicillin: chronic gastritis in acute phase, gastric ulcer and duodenal ulcer in acute phase, associated with Helicobacter pylori.

For external and topical use: treatment of acne vulgaris and pink, bacterial vaginosis, treatment of long-term healing of wounds and trophic ulcers.

Dosage and administration

Flagyl Comp is administered for oral use for adults and children over 12 years in 7.5 mg / kg every 6 h or 250-750 mg 3-4 times / day. For children up to 12 years the dose is 5-16.7 mg / kg 3 times / day. For IV injections for adults and children over 12 years starting dose is 15 mg / kg, followed by 7.5 mg / kg every 6 hours or depending on the etiology of the disease - by 500-750 mg every 8 hours. The duration of treatment and frequency of tests is determined individually.

Intravaginally - 500 mg 1 time a night.

In combination with amoxicillin (2.25 g / day) daily dose of Flagyl Comp (Metronidazole) is 1.5 g; multiplicity of admission - 3 times / day. For patients with severe renal impairment (creatinine clearance less than 30 ml / min) and / or liver daily dose of Flagyl Comp (Metronidazole) is 1 g (amoxicillin - 1.5 g / day), the multiplicity of the reception is 2 times / day. This medication takes for external and local use 2 times / day, doses are determined individually.

The maximum daily dose for adults when taken orally and IV is 4 g.

Flagyl Comp (Metronidazole) side effects, adverse reactions

Digestive system: nausea, vomiting, anorexia, metallic taste in the mouth.

CNS and peripheral nervous system: headache, nervousness, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, seizures, hallucinations.

Allergic reactions: skin rash, itching, hives.

Hemopoietic system: leucopenia.

Local reactions: irritation.

Other: arthralgia, burning sensation in the urethra.

Flagyl Comp contraindications

Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Flagyl Comp (Metronidazole).

Using during pregnancy and breastfeeding

Flagyl Comp is rapidly crosses the placental barrier. In II and III trimester of pregnancy Flagyl Comp (Metronidazole) is used only for health reasons.

Flagyl Comp (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.

Special instructions

Patients should with careful use of Flagyl Comp (Metronidazole) in liver diseases.

In combination with amoxicillin this medication is not recommended for patients younger than 18 years. During the treatment period it is necessary the regular control of pattern of peripheral blood.

During the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men patients should refrain from sexual activity, simultaneous treatment of both partners is mandatory.

During the taking of Flagyl Comp (Metronidazole) there is a more dark staining of urine.

During treatment with Flagyl Comp (Metronidazole) should avoid alcohol because to violations of the oxidation of alcohol can accumulate acetaldehyde. As a result may develop reactions similar to those characteristic of disulfiram (abdominal cramps, nausea, vomiting, headache, a sudden rush of blood to the face).

Flagyl Comp drug interactions

Simultaneous administration of Flagyl Comp (Metronidazole) with:

Nystatin:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Flagyl Comp (Nystatin) reviews

DESCRIPTION

Flagyl Comp (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

• C₄₇H₇₅NO₁₇ M.W. 926.13

Flagyl Comp (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

Structural formula for Flagyl Comp (Nystatin)

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of Flagyl Comp is insignificant. Most orally administered Flagyl Comp (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Flagyl Comp (Nystatin) may occasionally occur.

Microbiology

Flagyl Comp (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Flagyl Comp (Nystatin) in vitro on repeated subculture in increasing levels of Flagyl Comp (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Flagyl Comp (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Flagyl Comp (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Flagyl Comp (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

Flagyl Comp (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Flagyl Comp. It is also not known whether Flagyl Comp (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Flagyl Comp (Nystatin) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Flagyl Comp (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flagyl Comp (Nystatin) is administered to a nursing woman.

ADVERSE REACTIONS

Flagyl Comp is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

OVERDOSAGE

Oral doses of Flagyl Comp (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Flagyl Comp (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Flagyl Comp (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. N 2/2016

NDC 0093-0983-01

Flagyl Comp (Nystatin)

Tablets USP

500,000 units (oral)

Rx only

100 TABLETS

TEVA