Griseofulvin (Page 2 of 2)

ADVERSE REACTIONS

There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section).
When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesia of the hands and feet have been reported after extended therapy. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities. Proteinuria and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

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 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 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 infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.
Pediatric Use: Approximately 7.3 mg per kg 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:

16-27 kg: 125 mg to 187.5 mg daily.

over 27 kg: 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.

HOW SUPPLIED

Ultramicrosize Griseofulvin Tablets, USP 125 mg are white to off-white, round, standard concave, bisected tablets, debossed ‘Σ’ and ’13’ on either side of the bisection and plain on the other side. The 125 mg strength is available in bottles of 30’s (NDC 64980-184-03) and 100’s (NDC 64980-184-01).

Ultramicrosize Griseofulvin Tablets, USP 250 mg are white to off-white, round, standard concave, bisected tablets, debossed ‘Σ’ and ’14’ on either side of the bisection and plain on the other side. The 250 mg strength is available in bottles of 30’s (NDC 64980-185-03) and 100’s (NDC 64980-185-01).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.


Rx ONLY

Manufactured for:

image description

Rising Pharmaceuticals, Inc.
Allendale, NJ 07401


Manufactured by:
Sigmapharm Laboratories, LLC
Bensalem, PA 19020OS014-06 REV.0516

ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP 125 MG — 100 TABLET CONTAINER LABEL

125 mg Container label-100 fill
(click image for full-size original)

Ultramicrosize Griseofulvin Tablets, USP 125 mg Container Label

Rising Pharmaceuticals, Inc.

NDC 64980-184-01

Ultramicrosize Griseofulvin Tablets, USP

125 mg

100 Tablets

Rx Only

ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP 125 MG — 30 TABLET CONTAINER LABEL

125 mg Container label-30 fill
(click image for full-size original)

Ultramicrosize Griseofulvin Tablets, USP 125 mg Container Label

Rising Pharmaceuticals, Inc.

NDC 64980-184-03

Ultramicrosize Griseofulvin Tablets, USP

125 mg

30 Tablets

Rx Only

ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP 250 MG — 100 TABLET CONTAINER LABEL

250 mg Container label-100 fill
(click image for full-size original)

Ultramicrosize Griseofulvin Tablets, USP 250 mg Container Label

Rising Pharmaceuticals, Inc.

NDC 64980-185-01

Ultramicrosize Griseofulvin Tablets, USP

250 mg

100 Tablets

Rx Only

ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP 250 MG — 30 TABLET CONTAINER LABEL

image description
(click image for full-size original)

Ultramicrosize Griseofulvin Tablets, USP 250 mg Container Label

Rising Pharmaceuticals, Inc.

NDC 64980-185-03

Ultramicrosize Griseofulvin Tablets, USP

250 mg

30 Tablets

Rx Only

GRISEOFULVIN griseofulvin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-184
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (GRISEOFULVIN) GRISEOFULVIN 125 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POVIDONE
POLYETHYLENE GLYCOL 400
POLOXAMER 188
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (round, standard concave, bisected tablets) Size 10mm
Flavor Imprint Code ;13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-184-01 100 TABLET in 1 BOTTLE None
2 NDC:64980-184-03 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202545 11/15/2012
GRISEOFULVIN griseofulvin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (GRISEOFULVIN) GRISEOFULVIN 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POVIDONE
POLYETHYLENE GLYCOL 400
POLOXAMER 188
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (round, standard concave, bisected tablets) Size 13mm
Flavor Imprint Code ;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-185-01 100 TABLET in 1 BOTTLE None
2 NDC:64980-185-03 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202545 11/15/2012
Labeler — Rising Pharmaceuticals, Inc (041241766)
Registrant — Sigmapharm Laboratories, LLC (556234636)
Establishment
Name Address ID/FEI Operations
Sigmapharm Laboratories, LLC 556234636 manufacture (64980-185), analysis (64980-185), pack (64980-185), manufacture (64980-184), analysis (64980-184), pack (64980-184)

Revised: 05/2016 Rising Pharmaceuticals, Inc

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