Griseofulvin label

Griseofulvin

Griseofulvin Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

For external use only

Ask a doctor before use if you have

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

When using this product

•
do not exceed the recommended daily dosage unless directed by a doctor
•
do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

•
bleeding occurs
•
condition worsens or does not improve within 7 days
•
an allergic reaction develops
•
the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if you have

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

•
bleeding occurs
•
condition worsens or does not improve within 7 days
•
an allergic reaction develops
•
the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

•
for temporary relief of pain, soreness and burning
•
helps relieve the local itching and discomfort associated with hemorrhoids
•
temporarily shrinks hemorrhoidal tissue
•
temporarily provides a coating for relief of anorectal discomforts
•
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Griseofulvin Manufacturers

  • Bimeda Inc, Division Of Cross Vetpharm Group
    Griseofulvin | Wal-mart Stores Inc
    No Recall

    Griseofulvin | Wal-mart Stores Inc

    Griseofulvin | Wal-mart Stores Inc
    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. • when first opening the tube, puncture foil seal with top end of cap • apply externally or in the lower portion of the anal canal only • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus. • thoroughly cleanse dispensing cap after each use and replace cover • children under 12 years of age: ask a doctor
  • Rising Pharmaceuticals, Inc
    Griseofulvin | Rising Pharmaceuticals, Inc
    No Recall

    Griseofulvin | Rising Pharmaceuticals, Inc

    Griseofulvin | Rising Pharmaceuticals, Inc

    Accurate diagnosis of infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Medication should be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium-depending on rate of growth-fingernails, at least 4 months; toenails, at least 6 months.

    General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of athlete's foot, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or monilial infection.

    Ultramicrosize Griseofulvin Tablets, USP may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

    Adults: Daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungal injections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.

    Pediatric Use: Approximately 3.3 mg per pound of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested. Children weighing 35-60 pounds -125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds - 187.5 mg to 375 mg daily. Children and infants 2 years of age and younger - dosage has not been established.

    Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

  • Rising Pharmaceuticals Inc.
    Griseofulvin | Rising Pharmaceuticals Inc.
    No Recall

    Griseofulvin | Rising Pharmaceuticals Inc.

    Griseofulvin | Rising Pharmaceuticals Inc.

    Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

    Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium – depending on rate of growth – fingernails, at least 4 months; toenails, at least 6 months.

    General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin will not eradicate these associated bacterial or yeast infections.

    ADULTS: 0.5 g daily (125 mg q.i.d., 250 mg b.i.d., or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

    PEDIATRIC PATIENTS (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lb, 125 mg to 250 mg daily; pediatric patients over 50 lb, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

    Safety is not established at higher doses than recommended.

  • Oceanside Pharmaceuticals
    Griseofulvin | L&r Distributors, Inc.
    No Recall

    Griseofulvin | L&r Distributors, Inc.

    Griseofulvin | L&r Distributors, Inc.

    do not take more than directed
    (see overdose warning)

    adults and children 12 years and over

    take 2 caplets every 4 hours

    swallow whole - do not crush, chew, or dissolve

    do not take more than 10 caplets in 24 hours

    children under 12 years: ask a doctor

  • Sandoz Inc
    Griseofulvin | Sandoz Inc
    No Recall

    Griseofulvin | Sandoz Inc

    Griseofulvin | Sandoz Inc

    Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

    Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium – depending on rate of growth – fingernails, at least 4 months; toenails, at least 6 months.

    General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin tablets, USP will not eradicate these associated bacterial or yeast infections.

    ADULTS: 0.5 g daily (125 mg q.i.d., 250 mg b.i.d., or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

    PEDIATRIC PATIENTS (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lb, 125 mg to 250 mg daily; pediatric patients over 50 lb, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

    Safety is not established at higher doses than recommended.