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  • CLASSES

    Other Corticosteroid Combinations
    Topical Anti-hemorrhoidals
    Topical Anti-hemorrhoidals with Corticosteroids

    DEA CLASS

    Rx

    DESCRIPTION

    Topical combination products used for inflamed and pruritic skin, typically for perianal and rectal skin disorders (e.g. hemorrhoids, post-episiotomy healing, anal fissures).

    COMMON BRAND NAMES

    Analpram HC, EndaRoid, Enzone, Epifoam, HC Pram, Mezparox-HC, Mezparox-HC Forte, Novacort, Paramox-HC, PRAM-HCA, PramCort, Pramosone, Pramosone E, ProCort, Proctocream-HC, ProctoFoam HC, Z-Pram, Zone A, ZyPram

    HOW SUPPLIED

    Analpram HC/EndaRoid/Enzone/HC Pram/Hydrocortisone Acetate, Pramoxine Hydrochloride/Hydrocortisone, Pramoxine/Mezparox-HC/PramCort/PRAM-HCA/Pramosone/Pramosone E/ProCort/Proctocream-HC/Zone A/Z-Pram/ZyPram Topical Cream: 1-1%, 1.85-1.15%, 2.35-1%, 2.5-1%
    Analpram HC/Pramosone Topical Lotion: 1-1%, 2.5-1%
    Epifoam Topical Foam: 1-1%
    Hydrocortisone Acetate, Pramoxine Hydrochloride/Hydrocortisone, Pramoxine/PRAM-HCA/Z-Pram/ZyPram Rectal Cream: 2.35-1%
    Novacort/Paramox-HC Topical Gel: 2-1%
    Pramosone Topical Ointment: 1-1%, 2.5-1%
    ProctoFoam HC Topical Aer Foam: 1-1%

    DOSAGE & INDICATIONS

    For the temporary relief of skin inflammation, pain, and pruritus associated with corticosteroid-responsive dermatitis, including psoriasis, anorectal inflammation, pain, pruritus, and swelling associated with hemorrhoids, proctitis, cryptitis, anal fissures, postoperative pain, and pruritus ani.
    For the adjunctive treatment of chronic ulcerative colitis† when disease is limited to the distal portion of the rectum (e.g., proctosigmoiditis).
    Rectal dosage (aerosol foam)
    Adults

    One applicatorful rectally twice per day, in the morning and at night, as directed. Use sparingly in geriatric persons since they may be more sensitive to the medications effects when used in larger volumes. The rectal foam may also be applied topically to the associated area.

    Topical dosage (cream, ointment, gel)
    Adults, Adolescents, and Children

    Apply a small amount to the cleansed affected area and rub in gently 3—4 times per day. Use sparingly on children and geriatric persons since they may be more sensitive to the medications effects when used in larger volumes. Use of occlusive dressings may be used for the management of psoriasis or recalcitrant conditions; however, if an infection develops, remove occlusive dressing.

    Topical dosage (aerosol foam; i.e., Epifoam)
    Adults, Adolescents, and Children

    Using a cleansing tissue or pad, apply a small amount of the aerosol foam to the cleansed affected area 3—4 times per day. Use sparingly on children and geriatric persons since they may be more sensitive to the medications effects when used in larger volumes. Use of occlusive dressings may be used for the management of psoriasis or recalcitrant conditions; however, if an infection develops, remove occlusive dressing.

    Topical dosage (lotion)
    Adults, Adolescents, and Children

    Shake well before use and apply a small amount to the cleansed affected area and rub in gently 3—4 times per day. Use sparingly on children and geriatric persons since they may be more sensitive to the medications effects when used in larger volumes. Use of occlusive dressings may be used for the management of psoriasis or recalcitrant conditions; however, if an infection develops, remove occlusive dressing.

    Rectal dosage (aerosol foam; i.e., Proctofoam HC)
    Adults, Adolescents, and Children

     Shake the aerosol container before using. Insert 1 applicatorful into anus 3 or 4 times daily. The foam may also be placed on a perianal pad and applied externally as required to relieve pain and itching.

    Rectal dosage (creams, gels, ointments, and medicated pledgets)
    Adults, Adolescents, and Children

     Apply a small amount to the cleansed affected area and rub in gently 3—4 times per day. Use sparingly on children and geriatric persons since they may be more sensitive to the medications effects when used in larger volumes.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information is available.

    Elderly

    No maximum dosage information is available.

    Adolescents

    No maximum dosage information is available.

    Children

    >= 2 years: No maximum dosage information is available.
    < 2 years: Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed for topical or rectal products.

    Renal Impairment

    No dosage adjustment needed for topical or rectal products.

    ADMINISTRATION

    Topical Administration

    Nonprescription preparations should not be used for self-medication for longer than 7 days; if condition worsens or symptoms persist, the drug should be discontinued and a physician consulted.
    Wash hands before and after application.

    Cream/Ointment/Lotion Formulations

    Cream, ointment, gel: Apply sparingly in a thin film and rub gently into the cleansed affected area. Occlusive dressings may be necessary for severe conditions. 
    Lotion: For cleansing, apply to cotton or cleansing tissue and gently wipe the affected area.

    Other Topical Formulations

    Aerosol foam: Shake the container vigorously for 5—10 seconds before each use. Prior to first use, while holding the container upright, prime the pump by pressing down several times (usually 1—2 pumps) on container cap until foam appears. Dispense foam onto a cleansing tissue or pad and gently rub into the cleansed affected area. Fingers or any other mechanical device should not be used to administer the aerosol foam. The container and cap should be disassembled and rinsed with warm water after each use.

    Rectal Administration

    Aerosol foam administration
    NOTE: The aerosol foam can also be used for topical administration to the perianal area.
    Wash hands before and after application.
    Place cap on top of container and shake the container vigorously for 5—10 seconds before each use; cap should not be removed during use.
    Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. Container must be held upright to obtain proper flow of medication.
    Pull applicator plunger past the fill line on the applicator barrel.
    Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath container; support the applicator with the other hand. Prime the container by pressing down firmly on the flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1—2 pumps for foam to appear.
    To fill the applicator barrel, press down firmly on cap flanges, hold for 1—2 seconds, and release. Allow 5—10 seconds for foam to expand in the applicator barrel. Repeat until the foam reaches the fill line. It usually requires 3—4 pumps for foam to reach fill line. Remove applicator from container cap. If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap.
    Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. Apply to anus only with the applicator provided with the foam. Do not insert any part of the applicator past the anus into the rectum. Fingers or any other mechanical device should not be used to administer the aerosol foam. Do not insert any part of the aerosol container directly into the anus.
    The rectal foam can also be applied topically to the perianal area. For topical application prime the container as described above. Dispense foam onto a cleansing tissue or pad and gently rub into the cleansed affected area. Fingers or any other mechanical device should not be used to administer the aerosol foam.
    The container and cap should be disassembled and rinsed with warm water after each use. The applicator parts should be pulled apart for thorough cleaning with warm water after each use.
    Cream administration
    NOTE: The cream can also be used for topical administration to the perianal area.
    Wash hands before and after application.
    Use provided cleansing wipe to gently clean the affected area.
    Remove cap from tube and puncture foil. Attach the provided applicator and squeeze tube until the applicator is full.
    Gently insert the tip of the filled applicator approximately 1/2 inch into the anus and squeeze the tube to dispense cream to the anus and the perianal area. Do not insert the applicator further into the anus or into the rectum. Cream can be applied topically to the perianal area with the fingertip.
    Remove the applicator and tube and thoroughly clean the applicator.

    STORAGE

    Generic:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Analpram E:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Analpram HC:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    EndaRoid:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Enzone :
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Epifoam:
    - Do not refrigerate
    - Store at controlled room temperature (between 68 and 77 degrees F)
    - Store upright
    HC Pram :
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Mezparox-HC:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Mezparox-HC Forte:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Novacort:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Paramox-HC:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    PramCort:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    PRAM-HCA:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Pramosone:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Pramosone E :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    ProCort:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Proctocream-HC:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    ProctoFoam HC:
    - Do not refrigerate
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Zone A:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Z-Pram:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    ZyPram:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Fungal infection, herpes infection, infection, peripheral vascular disease, tuberculosis, viral infection

    Use hydrocortisone; pramoxine with caution in patients with known sensitivity to corticosteroids or local anesthetics. If irritation or rash occur, discontinue treatment and institute appropriate therapy. Also use with caution in patients with severely traumatized mucosa and infection in the region of the application. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, varicella), should be initiated or continued only if the appropriate anti-infective treatment is instituted. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Use hydrocortisone; pramoxine with caution in patients with markedly impaired circulation or peripheral vascular disease; skin ulceration has been reported in these patients following topical corticosteroid use.

    Hypothalamic-pituitary-adrenal (HPA) suppression, occlusive dressing, skin abrasion

    Patients applying hydrocortisone; pramoxine with an occlusive dressing, in large doses applied to extensive areas, and/or to areas where the epidermal barrier is disrupted (i.e., skin abrasion) should be evaluated periodically for evidence of reversible hypothalamic-pituitary-adrenal (HPA) suppression. Hydrocortisone; pramoxine is typically not used over large surface areas or for extended periods of time and HPA-axis suppression is not typically seen with its use. However, if HPA-axis suppression is evident an attempt to withdraw the drug or reduce frequency of application should be made.

    Children, infants, neonates

    Hydrocortisone; pramoxine should not be used in neonates, infants and children < 2 years old. If hydrocortisone; pramoxine is used in children >= 2 years, they should be evaluated periodically for evidence of reversible hypothalamic-pituitary-adrenal (HPA) suppression. If HPA-axis suppression is evident an attempt to withdraw the drug or reduce frequency of application should be made.

    Geriatric, skin atrophy

    Hydrocortisone; pramoxine should only be used for brief periods and under close medical supervision in patients with evidence of pre-existing skin atrophy. Geriatric patients may be more likely to have pre-existing skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients.

    Diabetes mellitus

    Hydrocortisone; pramoxine should be used with caution in patients with diabetes mellitus. Although there is a low likelihood of occurrence with recommended use of hydrocortisone; pramoxine, exacerbation of diabetes may occur if there is systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.

    Cataracts, glaucoma, ocular exposure, ophthalmic administration

    Hydrocortisone; pramoxine is for external use only; it should not be applied via ophthalmic administration. Visual impairment, ocular hypertension and worsened cataracts have been reported with ocular exposure to other high potency topical corticosteroids. Preexisting glaucoma may be aggravated if hydrocortisone is applied in the periorbital area.

    Pregnancy

    Hydrocortisone; pramoxine is classified FDA pregnancy risk category C; pregnant women should consult a qualified health care professional prior to the use of these drug products. There have been reports of complications associated with systemic corticosteroids (e.g. cleft palate, still birth, and premature abortion), however, systemic absorption of hydrocortisone; pramoxine should not be significant and adverse fetal and infant effects are not typically reported with topical corticosteroid use in the mother during pregnancy. Hydrocortisone; pramoxine should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.

    Breast-feeding

    According to the manufacturer, caution should be exercised when topical corticosteroids are administered to a breast-feeding woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Additionally, the American Academy of Pediatrics (AAP) considers systemically administered prednisone to be usually compatible with lactation. 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 ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Hepatic disease

    Although not known to be pertinent to patients using pramoxine-containing products (e.g., hydrocortisone; pramoxine), patients with severe hepatic disease should generally use products containing local anesthetics with caution. Because of their inability to metabolize local anesthetics properly, these patients may be at greater risk for developing toxic pramoxine plasma concentrations.

    Fistula, GI obstruction, GI perforation, peritonitis, ulcerative colitis

    Rectal hydrocortisone; pramoxine should be used cautiously in patients with severe ulcerative disease or ulcerative colitis, and only after adequate proctologic examination, because of the risk of intestinal perforation. Rectal corticosteroid therapy is not recommended in patients with GI obstruction, abscess, impending GI perforation, peritonitis, an extensive fistula, and fresh intestinal anastomoses.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known
    bronchospasm / Rapid / Incidence not known
    skin atrophy / Delayed / Incidence not known

    Moderate

    contact dermatitis / Delayed / Incidence not known
    bleeding / Early / Incidence not known
    edema / Delayed / Incidence not known
    erythema / Early / Incidence not known
    hyperesthesia / Delayed / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known
    hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
    glycosuria / Early / Incidence not known
    hyperglycemia / Delayed / Incidence not known

    Mild

    urticaria / Rapid / Incidence not known
    skin irritation / Early / Incidence not known
    pruritus / Rapid / Incidence not known
    infection / Delayed / Incidence not known
    acneiform rash / Delayed / Incidence not known
    miliaria / Delayed / Incidence not known
    hypertrichosis / Delayed / Incidence not known
    xerosis / Delayed / Incidence not known
    purpura / Delayed / Incidence not known
    skin hypopigmentation / Delayed / Incidence not known
    striae / Delayed / Incidence not known

    DRUG INTERACTIONS

    Adapalene; Benzoyl Peroxide: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Benzocaine: (Moderate) Caution is advised if combining topical local anesthetics. The toxic effects of local anesthetics are additive. In addition, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed.
    Benzocaine; Butamben; Tetracaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia. (Moderate) Caution is advised if combining topical local anesthetics. The toxic effects of local anesthetics are additive. In addition, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed.
    Benzoyl Peroxide: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Benzoyl Peroxide; Clindamycin: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Benzoyl Peroxide; Erythromycin: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Benzoyl Peroxide; Sulfur: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Dibucaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
    Ethyl Chloride: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
    Hydrocortisone; Lidocaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
    Lidocaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
    Lidocaine; Prilocaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
    Lidocaine; Tetracaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
    Tetracaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.

    PREGNANCY AND LACTATION

    Pregnancy

    Hydrocortisone; pramoxine is classified FDA pregnancy risk category C; pregnant women should consult a qualified health care professional prior to the use of these drug products. There have been reports of complications associated with systemic corticosteroids (e.g. cleft palate, still birth, and premature abortion), however, systemic absorption of hydrocortisone; pramoxine should not be significant and adverse fetal and infant effects are not typically reported with topical corticosteroid use in the mother during pregnancy. Hydrocortisone; pramoxine should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.

    According to the manufacturer, caution should be exercised when topical corticosteroids are administered to a breast-feeding woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Additionally, the American Academy of Pediatrics (AAP) considers systemically administered prednisone to be usually compatible with lactation. 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 ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    •Hydrocortisone: Topical application of hydrocortisone produces anti-inflammatory, antipruritic, and vasoconstrictor actions to decrease local inflammation, itching, and swelling. The activity is thought to result at least in part from binding with a steroid receptor. Hydrocortisone reduces inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly other mechanisms as yet unknown.
     
    Tachyphylaxis to the anti-inflammatory effects of hydrocortisone may occur with repeated application although the clinical importance of this effect is unknown. Following 3-times daily application to normal skin at the same site, diminished vasoconstrictor response may occur within 45 days. Withdrawal of the drug for 24 days restores response, although maximum vasoconstrictor response may be diminished; when application of the drug is reinstated, tachyphylaxis recurs.
     
    •Pramoxine: Pramoxine hydrochloride is a local anesthetic that interferes with the transmission of impulses along sensory nerve fibers to relieve pain, itching, and irritation. Local anesthetics block both the initiation and conduction of nerve impulses from sensory nerves by decreasing the permeability of the neuronal membrane to sodium ions. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade.

    PHARMACOKINETICS

    Hydrocortisone and pramoxine combinations are given through topical or rectal administration.

    Topical Route

    Hydrocortisone: Percutaneous penetration of hydrocortisone varies among individual patients and can be increased by the use of occlusive dressings, by increasing the concentration of the hydrocortisone, and by using different formulation vehicles. Following topical application of hydrocortisone to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation; however, the absorption is markedly increased when the skin has lost its keratin layer and absorption can also be increased by the presence of inflammation and/or diseases of the epidermal barrier. Even after washing the area being treated, prolonged absorption of hydrocortisone occurs, possibly because it is retained in the stratum corneum. Topical preparations of hydrocortisone are metabolized in the skin.
    Pramoxine: Pramoxine is applied topically to the skin and its anesthetic effects are typically apparent within 3—5 minutes. Although poorly absorbed through the intact epidermis, pramoxine is readily absorbed from mucous membranes. When skin permeability has been increased by abrasions or ulcers, the absorption and efficacy of pramoxine improves. No other pharmacokinetic information is available.