Leflunomide (Page 7 of 7)

DRUG ABUSE AND DEPENDENCE

Leflunomide has no known potential for abuse or dependence.

OVERDOSAGE

In mouse and rat acute toxicology studies, the minimally toxic dose for oral leflunomide was 200 — 500 mg/kg and 100 mg/kg, respectively (approximately >350 times the maximum recommended human dose, respectively).

There have been reports of chronic overdose in patients taking leflunomide at daily dose up to five times the recommended daily dose and reports of acute overdose in adults or children. There were no adverse events reported in the majority of case reports of overdose. Adverse events were consistent with the safety profile for leflunomide (see ADVERSE REACTIONS). The most frequent adverse events observed were diarrhea, abdominal pain, leukopenia, anemia and elevated liver function tests.

In the event of a significant overdose or toxicity, cholestyramine or charcoal administration is recommended to accelerate elimination (see PRECAUTIONS — General — Need for Drug Elimination).

Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that M1, the primary metabolite of leflunomide, is not dialyzable. (See CLINICAL PHARMACOLOGY – Elimination).

DOSAGE AND ADMINISTRATION

Loading Dose

Due to the long half-life in patients with RA and recommended dosing interval (24 hours), a loading dose is needed to provide steady-state concentrations more rapidly. It is recommended that leflunomide therapy be initiated with a loading dose of one 100 mg tablet per day for 3 days.

Elimination of the loading dose regimen may decrease the risk of adverse events. This could be especially important for patients at increased risk of hematologic or hepatic toxicity, such as those receiving concomitant treatment with methotrexate or other immunosuppressive agents or on such medications in the recent past. (See WARNINGS — Hepatotoxicity).

Maintenance Therapy

Daily dosing of 20 mg is recommended for treatment of patients with RA. A small cohort of patients (n=104), treated with 25 mg/day, experienced a greater incidence of side effects; alopecia, weight loss, liver enzyme elevations. Doses higher than 20 mg/day are not recommended. If dosing at 20 mg/day is not well tolerated clinically, the dose may be decreased to 10 mg daily. Liver enzymes should be monitored and dose adjustments may be necessary (see WARNINGS – Hepatotoxicity). Due to the prolonged half-life of the active metabolite of leflunomide, patients should be carefully observed after dose reduction, since it may take several weeks for metabolite levels to decline.

Monitoring

Hematology parameters and liver enzymes should be monitored (see PRECAUTIONS – Laboratory Tests; WARNINGS – Hepatotoxicity; WARNINGS – Immunosuppression Potential/Bone Marrow Suppression).

HOW SUPPLIED

Leflunomide Tablets, USP in 10 and 20 mg strengths are packaged in bottles.

Strength Quantity NDC Number Description
10 mg 30 count bottle 23155-043-03 White, round bi-convex tablets debossed with “HP 43” on one side and plain on the other.
500 count bottle 23155-043-05
20 mg 30 count bottle 23155-044-03 White, triangular bi-convex tablets debossed with “HP 44” on one side and plain on the other.
500 count bottle 23155-044-05

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Rx only

Manufactured for:

Heritage Pharmaceuticals Inc.

Edison, NJ 08837

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68258-2992-03
(click image for full-size original)

NDC 68258-2992-03

LEFLUNOMIDE
leflunomide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-2992(NDC:23155-044)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEFLUNOMIDE (LEFLUNOMIDE) LEFLUNOMIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TALC
Product Characteristics
Color WHITE (WHITE) Score no score
Shape TRIANGLE (TRIANGLE) Size 8mm
Flavor Imprint Code HP;44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-2992-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077086 10/29/2009
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (68258-2992), repack (68258-2992)

Revised: 10/2013 Dispensing Solutions, Inc.

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