Please wait while the formulary information is being retrieved.
Drug overview for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
Generic name: HYDROCORTISONE/PRAMOXINE HCL/CHLOROXYLENOL (HYE-droe-KOR-ti-sone/pram-OX-een/klor-oh-ZIGH-len-ol)
Drug class: Topical Corticosteroids
Therapeutic class: Otic (Ear)
Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Pramoxine is a local anesthetic.
Pramoxine preparations are used for self-medication for the temporary relief of pain and itching associated with minor lip or skin irritations (e.g., dermatoses, insect bites, minor burns or sunburns, minor cuts or scrapes, cold sores, rashes due to poison ivy, poison oak, or poison sumac). Pramoxine preparations also are used for self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort associated with hemorrhoids or other anorectal/anogenital disorders (e.g., inflammation, irritation, fissures, anogenital pruritus).
Generic name: HYDROCORTISONE/PRAMOXINE HCL/CHLOROXYLENOL (HYE-droe-KOR-ti-sone/pram-OX-een/klor-oh-ZIGH-len-ol)
Drug class: Topical Corticosteroids
Therapeutic class: Otic (Ear)
Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Pramoxine is a local anesthetic.
Pramoxine preparations are used for self-medication for the temporary relief of pain and itching associated with minor lip or skin irritations (e.g., dermatoses, insect bites, minor burns or sunburns, minor cuts or scrapes, cold sores, rashes due to poison ivy, poison oak, or poison sumac). Pramoxine preparations also are used for self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort associated with hemorrhoids or other anorectal/anogenital disorders (e.g., inflammation, irritation, fissures, anogenital pruritus).
DRUG IMAGES
CORTANE-B LOTION
The following indications for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol) have been approved by the FDA:
Indications:
Otitis externa
Professional Synonyms:
Inflammation of the outer ear and ear canal
Swimmer's ear
Indications:
Otitis externa
Professional Synonyms:
Inflammation of the outer ear and ear canal
Swimmer's ear
The following dosing information is available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
Hydrocortisone or its acetate ester is applied topically to the eye or ear. For ophthalmic or otic use, hydrocortisone and hydrocortisone acetate currently are commercially available only in fixed-combination preparations.
Care should be taken to avoid contamination of the tip of the ointment tube or dropper of the solution or suspension when the drug is used ophthalmically.
For self-medication for the temporary relief of pain and itching associated with lip or skin irritations in adults and children 2 years of age and older, pramoxine hydrochloride 1% gel, lotion, ointment, or solution is applied topically to the affected area up to 3 or 4 times daily. For use in children younger than 2 years of age, a pediatrician should be consulted.
For self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort caused by hemorrhoids or other anorectal disorders in adults and children 12 years of age and older, pramoxine hydrochloride 1% aerosol foam, cream, ointment, or pledget is applied topically to the affected area up to 4 or 5 times daily or after each bowel movement. The manufacturers state that this dosage should not be exceeded unless directed by a clinician. For use in children younger than 12 years of age, a clinician should be consulted.
For self-medication for the management of anogenital pruritus, pramoxine hydrochloride 1% pledget is applied to the external vaginal area up to 3-4 times daily. For use in children younger than 12 years of age, a clinician should be consulted.
Care should be taken to avoid contamination of the tip of the ointment tube or dropper of the solution or suspension when the drug is used ophthalmically.
For self-medication for the temporary relief of pain and itching associated with lip or skin irritations in adults and children 2 years of age and older, pramoxine hydrochloride 1% gel, lotion, ointment, or solution is applied topically to the affected area up to 3 or 4 times daily. For use in children younger than 2 years of age, a pediatrician should be consulted.
For self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort caused by hemorrhoids or other anorectal disorders in adults and children 12 years of age and older, pramoxine hydrochloride 1% aerosol foam, cream, ointment, or pledget is applied topically to the affected area up to 4 or 5 times daily or after each bowel movement. The manufacturers state that this dosage should not be exceeded unless directed by a clinician. For use in children younger than 12 years of age, a clinician should be consulted.
For self-medication for the management of anogenital pruritus, pramoxine hydrochloride 1% pledget is applied to the external vaginal area up to 3-4 times daily. For use in children younger than 12 years of age, a clinician should be consulted.
Preparations containing pramoxine hydrochloride are applied topically. These preparations may be applied to the lip in the form of an ointment (''lip balm''); to the skin in the form of a gel, lotion, ointment, or solution; to the external vaginal area in the form of pledgets (pads); or to the external anorectal area in the form of an aerosol foam, cream, ointment, or pledgets. The lotion containing pramoxine hydrochloride should be shaken well prior to use.
The aerosol foam should be shaken well and dispersed onto a clean tissue before applying to the affected area. Pledgets should be applied gently by patting or wiping the affected area; pledgets should be used only once and then discarded. Patients receiving pramoxine-containing preparations for the management of hemorrhoids or other anorectal disorders should be advised to cleanse the affected perianal area with mild soap and warm water and rinsing thoroughly whenever practical; the area then should be dried by patting or blotting with toilet tissue or a soft cloth before application of the drug.
The aerosol foam should be shaken well and dispersed onto a clean tissue before applying to the affected area. Pledgets should be applied gently by patting or wiping the affected area; pledgets should be used only once and then discarded. Patients receiving pramoxine-containing preparations for the management of hemorrhoids or other anorectal disorders should be advised to cleanse the affected perianal area with mild soap and warm water and rinsing thoroughly whenever practical; the area then should be dried by patting or blotting with toilet tissue or a soft cloth before application of the drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CORTANE-B LOTION | Maintenance | Adults apply to the affected area(s) by topical route 3 times per day |
No generic dosing information available.
The following drug interaction information is available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Long-acting Bupivacaine/Local Anesthetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1) PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) |
BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF |
There are 0 moderate interactions.
The following contraindication information is available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Large open wound |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypothalamic-pituitary insufficiency |
The following adverse reaction information is available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 31 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dermatitis due to topical drug Folliculitis Purpura Skin and skin structure infection Skin atrophy |
| Rare/Very Rare |
|---|
|
Acute respiratory failure Adrenocortical insufficiency Anaphylaxis Angioedema Bradycardia Bronchospastic pulmonary disease Bullous dermatitis Cardiac arrhythmia Cataracts Central serous chorioretinopathy CNS toxicity Cyanosis Eyelid edema Glaucoma Headache disorder Hypotension Hypothalamic-pituitary insufficiency Methemoglobinemia Ocular hypertension Respiratory depression Seizure disorder Skin hypopigmentation Skin striae Skin ulcer Unconsciousness Urticaria |
There are 42 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Erythema Stinging of skin |
Acute pain at drug application site Blanching of skin Blurred vision Edema Erythema Headache disorder Paresthesia Pruritus of skin Skin rash Stinging of skin Telangiectasia Treatment site sequelae Urticaria |
| Rare/Very Rare |
|---|
|
Acneiform eruption Acute cognitive impairment Alopecia Apprehension Blistering skin Blurred vision Contact dermatitis Dizziness Drowsy Dry skin Dyschromia Euphoria Glycosuria Hirsutism Hypercortisolism Hyperesthesia Hyperglycemia Miliaria Muscle fasciculation Nervousness Perioral dermatitis Sensation of cold Sensation of warmth Skin irritation Tinnitus Tremor Vomiting |
The following precautions are available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Women who are pregnant should consult a clinician before initiating therapy with pramoxine-containing preparations.
Women who are breast-feeding should consult a clinician before initiating therapy with pramoxine-containing preparations.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CORTANE-B (hydrocortisone/pramoxine hcl/chloroxylenol)'s list of indications:
| Otitis externa | |
| H60.33 | Swimmer's ear |
| H60.331 | Swimmer's ear, right ear |
| H60.332 | Swimmer's ear, left ear |
| H60.333 | Swimmer's ear, bilateral |
| H60.339 | Swimmer's ear, unspecified ear |
| H60.9 | Unspecified otitis externa |
| H60.90 | Unspecified otitis externa, unspecified ear |
| H60.91 | Unspecified otitis externa, right ear |
| H60.92 | Unspecified otitis externa, left ear |
| H60.93 | Unspecified otitis externa, bilateral |
Formulary Reference Tool