Adult Dosing

Treatment of lower extremity diabetic neuropathic ulcers

• Apply qd on affected area until healed

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Lower extremity diabetic neuropathic ulcers extending to subcutaneous tissue or beyond and having adequate blood supply

• Hypersensitivity to any ingredient of the product
• Neoplasm at the site of application

• An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of gel in a post-marketing retrospective cohort study
• Gel should be used with caution in patients with known malignancy
• Use recommended only when the benefits can be expected to outweigh the risks

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of gel in a post-marketing retrospective cohort study [US Black Box Warning]
• Use with caution in patients with known malignancy
• Should not be used in wounds that close by primary intention
• Carefully evaluate benefits and risks of treatment before prescribing
• For external use only

Cautions: Use cautiously in

• Known malignancy

Supplemental Patient Information

• Advise patient to apply gel using cotton swab, tongue depressor, or other application aid
• Advise patient to apply gel once a day in a carefully measured quantity

Pregnancy Category:C

Breastfeeding: Safety unknown; manufacturer advises caution.

• MISC: Infection, malignancy
• DERM: Cellulitis, osteomyelitis, erythematous rashes

• Platelet-derived growth factor; promotes the chemotactic recruitment and proliferation of cells involved in wound repair and enhance formation of granulation tissue
• Metabolism; Minimal systemic availability after topical application; CYP450: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Regranex

US Availability

Regranex

• GEL: 0.01%

Canadian Trade Name(s)

• Regranex

Canadian Availability

Regranex

• GEL: 0.01%

UK Trade Name(s)

• Regranex

UK Availability

Regranex

• GEL: 0.01%

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Dermatologic Topical Agents

Wound Healing Agent

Pricing data from www.DrugStore.com in U.S.A.

• Regranex 0.01 % GEL [Tube] (MCNEIL)
  15 % = $665.98
  45 % = $1883.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.