Granulex

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Granulex

Classes

All Other Wound Healing Agents

Administration
Topical Administration

Use only as directed. Avoid contact with eyes.
Do not apply to fresh arterial clots.
Wash hands before and after application.
Apply a minimum of twice daily or as often as necessary.
After use, wound may be left unbandaged or appropriate dressing applied.

Cream/Ointment/Lotion Formulations

Gel and Ointment: Apply as a thin film. To remove, wash gently with appropriate cleanser. Store between 15—30 degrees C (59—86 degrees F). Avoid freezing.

Other Topical Formulations

Aerosol: Shake well prior to use. Hold the canister upright, approximately 12 inches from the area to be treated. Press the aerosol valve and coat the wound rapidly but not excessively. Product is flammable; do not expose to fire or open flame. Contents are under pressure; do not puncture or incinerate. Do not store at temperature above 48 degrees C (120 degrees F).

Common Brand Names

Optase

Dea Class

Rx

Description

Prescription only topicals used in wound care; stimulates local circulation, reduce pain/odor, debride necrotic tissue, improve epithelization, and acts as barrier; approved for sunburn, varicose ulcers, dehiscent wounds, decubital ulcers, and debriding of eschar.

Dosage And Indications
For wound management.
NOTE: Wounds heal poorly in the presence of hemoglobin or zinc deficiency; nutritional status assessment is prudent in wound management and prevention.

NOTE: Following application, wounds may be left open or appropriate dressing applied.
For debridement of eschar (necrotic tissue as associated with burns or cauterization). Topical dosage (aerosol, gel†, or ointment†) Adults, Geriatric, Adolescents, and Children

Apply twice daily as directed or as often as necessary.

For treatment of decubitus ulcer, varicose ulcer, and dehiscent wounds. Topical dosage (aerosol, gel, or ointment) Adults, Geriatric, Adolescents, and Children

Apply twice daily as directed or as often as necessary.

For treatment of sunburn. Topical dosage (aerosol) Adults, Geriatric, Adolescents, and Children

Apply twice daily as directed or as often as necessary.

Dosing Considerations
Hepatic Impairment

No dosage adjustment needed.

Renal Impairment

No dosage adjustment needed.

Drug Interactions

There are no drug interactions associated with Castor Oil; Peru Balsam; Trypsin products.

How Supplied

Balsam Peru, Castor Oil, Trypsin/Granul-derm/TBC Topical Aer: 72.5-650-0.1mg
Balsam Peru, Castor Oil, Trypsin/Revina/Vasolex Topical Ointment: 1g, 87-788-90USPu
Optase Topical Gel: 1g, 87-788-0.12mg

Maximum Dosage
Adults

Maximum dosage information is not available.

Elderly

Maximum dosage information is not available.

Children

Maximum dosage information is not available.

Infants

Safety and efficacy have not been established.

Mechanism Of Action

Castor oil; peru balsam; trypsin is a combination product with mild debridement, antibacterial, blood flow stimulant, and protective barrier activities. Peru balsam is an effective capillary bed stimulant used to increase circulation in the wound site area; a mean increase in local blood flow was measured to be 45 percent three hours post-treatment with castor oil; peru balsam; trypsin ointment (Xenaderm™) in 10 healthy adults. Also, Peru balsam has a mildly bactericidal action. Castor oil is used to improve epithelialization by reducing premature epithelial desiccation and cornification. Also, it can act as a protective covering and aids in the reduction of pain and odor. Trypsin, a selective enzymatic protease, is intended for debridement of eschar and other necrotic tissue. It appears that in many instances removal of wound debris strengthens humoral defense mechanisms sufficiently to retard proliferation of local pathogens.

Pharmacokinetics

Castor oil; peru balsam; trypsin is applied topically and acts locally in the epidermis and dermis. Pharmacokinetic studies have not been undertaken by the manufacturers; significant systemic absorption and effects are not expected with appropriate use.

Pregnancy And Lactation
Pregnancy

The use of castor oil; peru balsam; trypsin in pregnancy has not been formally evaluated; the product is not formally assigned an FDA pregnancy risk category. Castor oil; peru balsam; trypsin should be used during pregnancy only when clearly needed. However, the published medical literature contains reports of its use for wound care in pregnancy when clinically indicated.

It is unknown whether castor oil; peru balsam; trypsin is distributed into breast milk; however, minimal systemic absorption would be expected with topical use, given the local intent of action. In general, it would be advisable to avoid breast-feeding if use on the breast was medically necessary to avoid infant contact with the product. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.