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  • CLASSES

    All Other Wound Healing Agents

    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.

    COMMON BRAND NAMES

    Optase

    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

    DOSAGE & 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.

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed.

    Renal Impairment

    No dosage adjustment needed.

    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).

    STORAGE

    AllanDerm-T :
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Granul-derm:
    - Avoid exposure to heat
    - Store at room temperature (between 59 to 86 degrees F)
    Granulex:
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    Optase:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Revina :
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Trypsin:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Vasolex:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Xenaderm:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Castor oil; peru balsam; trypsin is for external use only; ingestion may lead to intestinal cramping or diarrhea due to the high concentration of castor oil.
    As trypsin is known to dissolve blood clots, do not use castor oil; peru balsam; trypsin on fresh arterial thrombosis.

    Ocular exposure

    As contact with Castor Oil; Peru Balsam; Trypsin in the eyes may cause severe irritation, avoid ocular exposure. If accidental exposure occurs, remove contact lens (when applicable) and flush affected eye(s) with water for 15 minutes; seek medical attention for persistent irritation.

    Eczema, psoriasis

    Avoid use in patients with known hypersensitivity to castor oil, peru balsam, trypsin, or any of the product excipients. Although, no cases of contact sensitization were reported in a study of 212 healthy adults exposed by repeated-insult patch test to castor oil; peru balsam; trypsin in an ointment base (Xenaderm), use with caution in patients with atopic dermatitis, eczema, or psoriasis.

    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.

    Breast-feeding

    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.

    DRUG INTERACTIONS

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

    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.

    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.