Methotrexate Sodium (Page 4 of 4)

HANDLING AND DISPOSAL

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-5 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

Methotrexate Tablets USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate.

2.5 mg: Yellow, oval-shaped, scored tablet. Debossed with stylized b/572 on one side.

Bottles of 02 NDC 54868-3826-9
Bottles of 12 NDC 54868-3826-1
Bottles of 16 NDC 54868-3826-0
Bottles of 20 NDC 54868-3826-3
Bottles of 28 NDC 54868-3826-4
Bottles of 30 NDC 54868-3826-7
Bottles of 40 NDC 54868-3826-8
Bottles of 50 NDC 54868-3826-6
Bottles of 100 NDC 54868-3826-5

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light.

REFERENCES

1. Controlling occupational exposure to hazardous drugs (OSHA Work-Practice Guidelines). Am J Health Syst Pharm 1996; 53:1669-1685.

2. National Study Commission on Cytotoxic Exposure — Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc D, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

3. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1983; 1:426-428.

4. Jones RB, et al. Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. CA — A Cancer Journal for Clinicians Sept/Oct 1983; 258-263.

5. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 1990; 47:1033-1049.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 2/2010

Relabeling and Repackaging by;

Physicians Total Care, Inc.

Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

METHOTREXATE

Tablets USP

2.5 mg

Warning: Discontinue or reduce dosage

immediately at first sign of ulceration or

bleeding in mouth, gastrointestinal

ulceration or bleeding, diarrhea or marked

depression of bone marrow.

Rx only

image of package label
(click image for full-size original)
METHOTREXATE SODIUM methotrexate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3826(NDC:0555-0572)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE SODIUM (METHOTREXATE) METHOTREXATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
STARCH, CORN
PROPYLENE GLYCOL
SODIUM CARBONATE MONOHYDRATE
TALC
Product Characteristics
Color yellow (yellow) Score 2 pieces
Shape OVAL (oval) Size 8mm
Flavor Imprint Code 572
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3826-1 12 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-3826-3 20 TABLET (TABLET) in 1 BOTTLE None
3 NDC:54868-3826-4 28 TABLET (TABLET) in 1 BOTTLE None
4 NDC:54868-3826-5 100 TABLET (TABLET) in 1 BOTTLE None
5 NDC:54868-3826-6 50 TABLET (TABLET) in 1 BOTTLE None
6 NDC:54868-3826-7 30 TABLET (TABLET) in 1 BOTTLE None
7 NDC:54868-3826-8 40 TABLET (TABLET) in 1 BOTTLE None
8 NDC:54868-3826-9 2 TABLET (TABLET) in 1 BOTTLE None
9 NDC:54868-3826-0 16 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081099 12/05/2007
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 06/2010 Physicians Total Care, Inc.

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