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DRUGS & SUPPLEMENTS
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Flagistatin B, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
Flagistatin B 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 Flagistatin B
Gastrointestinal absorption of Flagistatin B is insignificant. Most orally administered Flagistatin B is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Flagistatin B may occasionally occur.
Flagistatin B is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Flagistatin B in vitro on repeated subculture in increasing levels of Flagistatin B; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Flagistatin B 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. Flagistatin B exhibits no appreciable activity against bacteria, protozoa, or viruses.
Flagistatin B tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Flagistatin B tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
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.
Animal reproduction studies have not been conducted with Flagistatin B. It is also not known whether Flagistatin B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Flagistatin B should be given to a pregnant woman only if clearly needed.
It is not known whether Flagistatin B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flagistatin B is administered to a nursing woman.
Flagistatin B is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported .
Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.
Oral doses of Flagistatin B 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).
The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Flagistatin B) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.
Flagistatin B 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
Flagistatin B
Tablets USP
500,000 units (oral)
Rx only
100 TABLETS
TEVA
Depending on the reaction of the Flagistatin B after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Flagistatin B not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Flagistatin B addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology