Achrostatin

Nystatin:

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

DESCRIPTION

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

• C₄₇H₇₅NO₁₇ M.W. 926.13

Achrostatin (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 Achrostatin (Nystatin)

CLINICAL PHARMACOLOGY

Pharmacokinetics

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

Microbiology

Achrostatin (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 Achrostatin (Nystatin) in vitro on repeated subculture in increasing levels of Achrostatin (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Achrostatin (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. Achrostatin (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Achrostatin (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 Achrostatin. It is also not known whether Achrostatin (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Achrostatin (Nystatin) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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

ADVERSE REACTIONS

Achrostatin 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 Achrostatin (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 Achrostatin (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Achrostatin (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

Achrostatin (Nystatin)

Tablets USP

500,000 units (oral)

Rx only

100 TABLETS

TEVA

Tetracycline Hydrochloride:

• Activer ingredient (in each gram)
• Purpose
• Use
• Warnings
• Directions
• Other information
• Inactive ingredients
• Package label: 71491-100-00 viabeclicne 5 ml package label: 71491-100-01 viabecline 15ml
• Achrostatin (Tetracycline Hydrochloride) reviews

Activer Ingredient

Achrostatin (Tetracycline Hydrochloride) 30 mg

Purpose

First Aid Antibiotic

Use

First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert: Do not use if allergic to any ingredient listed on this label.

Do not use

• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor

Ask doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if the condition persists or gets worse.

Keep out of reach of children. ​If swallowed, get medical help or contact a poison Control Center right away.

Directions

• Clean the affected area
• Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
• May be covered with a sterile bandage.

Other information

• Keep product refrigerated to preserve its effectiveness and color
• Stop use if the product is misused: If the bottle is left open and or not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
• This product is an OTC antibiotic for human use.
• Contains no alcohol, no animal ingredients.
• Blended for typical skin color.
• May stain cloth.
• No claims regarding stem cell healing are implied for this product.

Inactive Ingredients

ACETIC ACID, ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL, DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA LACTONE, GLYCERIN, HISTIDINE, HYDROXETHYL-CELLULOSE, MAGNESIUM STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

Package Label: 71491-100-00 VIABECLICNE 5 ML

Package Label: 71491-100-01 Achrostatin 15ML

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