Mafenide Acetate (Page 2 of 2)

OVERDOSAGE

Single oral doses of 2000 mg/kg of Mafenide Acetate as a 5% Topical Solution did not cause mortality or clinical symptoms of toxicity in rats.

DOSAGE AND ADMINISTRATION

Mafenide Acetate 5% Topical Solution

Directions for Preparation of the Solution

Mafenide Acetate 5% Topical Solution is supplied as a sterile powder and is to be reconstituted with Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. Aseptic techniques should be observed during preparation of the solution. Premeasured quantities of 50 g of Mafenide Acetate powder are provided in sterile packets. The entire quantity of Mafenide Acetate pouch should be emptied into a suitable container which contains 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP and mixed until completely dissolved. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable. Not for Injection-For Topical Use Only.

Directions for Use of the Solution

The grafted area should be covered with one layer of fine mesh gauze. An eight-ply burn dressing should be cut to the size of the graft and wetted with Mafenide Acetate 5% Topical Solution using an irrigation syringe and/or irrigation tubing until leaking is noticeable. If irrigation tubing is used, the tubing should be placed over the burn dressing in contact with the wound and covered with a second piece of eight-ply dressing. The irrigation dressing should be secured with a bolster dressing and wrapped as appropriate. The gauze dressing should be kept wet. In clinical studies, this has been accomplished by irrigating with a syringe or injecting the solution into the irrigation tubing every 4 hours or as necessary. If irrigation tubing is not used, the gauze dressing may be moistened every 6-8 hours or as necessary to keep wet.

Wound dressings may be left undisturbed, except for the irrigations, for up to five days. Additional soaks may be initiated until graft take is complete. Maceration of skin may result from wet dressings applied for intervals as short as 24 hours. Treatment is usually continued until autograft vascularization occurs and healing is progressing (typically occurring in about 5 days). Safety and effectiveness have not been established for longer than 5 days for an individual grafting procedure.

If allergic manifestations occur during treatment with Mafenide Acetate 5% Topical Solution, discontinuation of treatment should be considered. If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing the soaks with the Mafenide Acetate solution for 24 to 48 hours may aid in restoring acid-base balance (see PRECAUTIONS section). Dressing changes and monitoring the site for bacterial growth during this interruption should be adjusted accordingly.

HOW SUPPLIED

Mafenide Acetate for Topical Solution USP, 5% is available in packets (NDC 50742-310-50) containing 50 g of sterile Mafenide Acetate to be prepared using 1000 mL Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. (See DOSAGE AND ADMINISTRATION: Mafenide Acetate for Topical Solution USP, 5%: Directions for Preparation of the Solution.) The packets are supplied as follows:

Carton of five 50 g packets
NDC 50742-310-25

Recommended Storage:

Packets — Store PACKETS in a dry place at room temperature 15° to 30°C (59° to 86°F).

Prepared Solution — Store SOLUTION at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

The solution may be held for up to 28 days if stored in unopened containers.

ONCE A CONTAINER IS OPENED, ANY UNUSED SOLUTION MUST BE DISCARDED WITHIN 48 HOURS.

Keep this and all medications out of the reach of children.

Manufactured for:
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
Rev. 08/17

Package Label — Principal Display Panel – 50g Packet

NDC 50742-310-50

STERILE

Mafenide Acetate for Topical Solution USP, 5%

Not for Injection. Solution for Topical Use Only.

Rx Only

Net Wt. 50 grams sterile powder per packet

Package Label — Principal Display Panel – 5 Packets Carton

NDC 50742-310-25

STERILE

Mafenide Acetate for Topical Solution USP, 5%

Not for Injection. Solution for Topical Use Only.

Rx Only

5 Packets

Net Wt. 50 grams sterile powder per packet

MAFENIDE ACETATE mafenide acetate powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-310 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAFENIDE ACETATE (MAFENIDE) MAFENIDE ACETATE 50 g

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50742-310-25 5 PACKET in 1 CARTON contains a PACKET (50742-310-50) 1 NDC:50742-310-50 1 POWDER, FOR SOLUTION in 1 PACKET This package is contained within the CARTON (50742-310-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206716 10/22/2018

Labeler — Ingenus Pharmaceuticals, LLC (833250017)

Registrant — Novast Laboratories Ltd. (527695995)

Establishment
Name	Address	ID/FEI	Operations
Sharp Corporation		143696495	MANUFACTURE (50742-310)

Revised: 12/2018 Ingenus Pharmaceuticals, LLC