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DRUG IMAGES
PRAMOSONE 1% LOTION
PRAMOSONE 1%-1% CREAM
PRAMOSONE 2.5%-1% LOTION
The following indications for PRAMOSONE (hydrocortisone acetate/pramoxine hcl) have been approved by the FDA:
Indications:
Pruritus ani
Skin inflammation
Professional Synonyms:
Dermatitis
Indications:
Pruritus ani
Skin inflammation
Professional Synonyms:
Dermatitis
The following dosing information is available for PRAMOSONE (hydrocortisone acetate/pramoxine hcl):
Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters are applied topically. Dermatologic preparations of the drugs are applied sparingly in thin films and are rubbed gently into the affected area 1-4 times daily. Rectal creams and ointments of the drugs are applied externally to the anal area.
Some commercially available creams may be applied externally to the anogenital areas. Nonprescription preparations of the drugs should not be used for self-medication for longer than 7 days; if the condition worsens or symptoms persist, the drug should be discontinued and a physician consulted. Nonprescription preparations of the drugs should not be used in children younger than 2 years of age unless directed and supervised by a physician.
For dermatoses of the scalp, the hair may be parted and a small amount of lotion applied directly to the affected area and rubbed gently into the scalp. Usual hair care should be maintained, but the lotion should not be washed out immediately after application. Alternatively, for dermatoses of the scalp, hydrocortisone aerosol is applied to the dry scalp after shampooing.
When the aerosol is used for other dermatoses, each 10-cm2 of affected area is sprayed for 1-2 seconds from a distance of about 15 cm 2 or 3 times daily.
Occlusive dressings may be used for severe or resistant dermatoses.
For use in the mouth, a small amount of 0.5% hydrocortisone acetate paste is pressed to the lesion without rubbing until a thin film develops. The paste is applied 2 or 3 times daily after meals and at bedtime.
If substantial regeneration or repair of the oral tissues does not occur after 7 days of treatment, further investigation of the etiology of the oral lesions should be undertaken.
Hydrocortisone is administered rectally as a retention enema, and hydrocortisone acetate is given rectally as a suppository or an aerosol foam suspension according to the manufacturers' instructions. Patients should be advised that hydrocortisone acetate suppositories may stain fabric so that they can take appropriate precautionary measures. For the adjunctive treatment of ulcerative colitis, 100 mg of hydrocortisone is administered nightly as a retention enema.
The patient should lie on his left side during and for 30 minutes after administration of the retention enema so that the drug will distribute throughout the left colon; the enema should be retained for at least 1 hour and preferably all night. Some clinicians administer 100 mg as a retention enema twice daily followed by 100 mg nightly when improvement occurs. The drug is usually given for 21 days or until clinical and proctologic remissions are achieved.
Clinical symptoms may improve in 3-5 days, followed by proctologic improvement; in some cases, 2-3 months of therapy may be required to attain a proctologic remission. Therapy with hydrocortisone retention enema should be discontinued if clinical or proctologic improvement does not occur within 2-3 weeks. Following treatment for longer than 21 days, therapy with hydrocortisone enema should be withdrawn gradually by giving the drug every other night for 2-3 weeks and then discontinuing it.
In patients with ulcerative proctitis of the distal rectum who cannot retain corticosteroid enemas, 90 mg of hydrocortisone acetate (1 applicatorful of a 10% aerosol foam suspension) may be given rectally 1 or 2 times daily for 2-3 weeks and then, if necessary, every other day until clinical and proctologic improvements occur; symptoms may improve within 5-7 days. For the adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum, 25 mg of hydrocortisone acetate as a suppository may be administered rectally in the morning and at night for 2 weeks; in severe proctitis, 25 mg may be given 3 times daily or 50 mg may be given twice daily. For the adjunctive treatment of postirradiation or factitial proctitis, therapy is generally continued for 6-8 weeks or less if an adequate response is attained.
Alternatively, for the symptomatic treatment of internal hemorrhoids and the adjunctive treatment of other inflammatory conditions of the anorectum, 10 mg of hydrocortisone acetate as a suppository may be administered rectally in the morning and at night for 2-6 days.
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.
Some commercially available creams may be applied externally to the anogenital areas. Nonprescription preparations of the drugs should not be used for self-medication for longer than 7 days; if the condition worsens or symptoms persist, the drug should be discontinued and a physician consulted. Nonprescription preparations of the drugs should not be used in children younger than 2 years of age unless directed and supervised by a physician.
For dermatoses of the scalp, the hair may be parted and a small amount of lotion applied directly to the affected area and rubbed gently into the scalp. Usual hair care should be maintained, but the lotion should not be washed out immediately after application. Alternatively, for dermatoses of the scalp, hydrocortisone aerosol is applied to the dry scalp after shampooing.
When the aerosol is used for other dermatoses, each 10-cm2 of affected area is sprayed for 1-2 seconds from a distance of about 15 cm 2 or 3 times daily.
Occlusive dressings may be used for severe or resistant dermatoses.
For use in the mouth, a small amount of 0.5% hydrocortisone acetate paste is pressed to the lesion without rubbing until a thin film develops. The paste is applied 2 or 3 times daily after meals and at bedtime.
If substantial regeneration or repair of the oral tissues does not occur after 7 days of treatment, further investigation of the etiology of the oral lesions should be undertaken.
Hydrocortisone is administered rectally as a retention enema, and hydrocortisone acetate is given rectally as a suppository or an aerosol foam suspension according to the manufacturers' instructions. Patients should be advised that hydrocortisone acetate suppositories may stain fabric so that they can take appropriate precautionary measures. For the adjunctive treatment of ulcerative colitis, 100 mg of hydrocortisone is administered nightly as a retention enema.
The patient should lie on his left side during and for 30 minutes after administration of the retention enema so that the drug will distribute throughout the left colon; the enema should be retained for at least 1 hour and preferably all night. Some clinicians administer 100 mg as a retention enema twice daily followed by 100 mg nightly when improvement occurs. The drug is usually given for 21 days or until clinical and proctologic remissions are achieved.
Clinical symptoms may improve in 3-5 days, followed by proctologic improvement; in some cases, 2-3 months of therapy may be required to attain a proctologic remission. Therapy with hydrocortisone retention enema should be discontinued if clinical or proctologic improvement does not occur within 2-3 weeks. Following treatment for longer than 21 days, therapy with hydrocortisone enema should be withdrawn gradually by giving the drug every other night for 2-3 weeks and then discontinuing it.
In patients with ulcerative proctitis of the distal rectum who cannot retain corticosteroid enemas, 90 mg of hydrocortisone acetate (1 applicatorful of a 10% aerosol foam suspension) may be given rectally 1 or 2 times daily for 2-3 weeks and then, if necessary, every other day until clinical and proctologic improvements occur; symptoms may improve within 5-7 days. For the adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum, 25 mg of hydrocortisone acetate as a suppository may be administered rectally in the morning and at night for 2 weeks; in severe proctitis, 25 mg may be given 3 times daily or 50 mg may be given twice daily. For the adjunctive treatment of postirradiation or factitial proctitis, therapy is generally continued for 6-8 weeks or less if an adequate response is attained.
Alternatively, for the symptomatic treatment of internal hemorrhoids and the adjunctive treatment of other inflammatory conditions of the anorectum, 10 mg of hydrocortisone acetate as a suppository may be administered rectally in the morning and at night for 2-6 days.
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 |
|---|---|---|
| PRAMOSONE 1%-1% CREAM | Maintenance | Adults apply to the affected area(s) by topical route 3 times per day |
| PRAMOSONE 2.5%-1% LOTION | Maintenance | Adults apply to the affected area(s) by topical route 3 times per day |
| PRAMOSONE 1% LOTION | Maintenance | Adults apply to the affected area(s) by topical route 3 times per day |
| PRAMOSONE 1%-1% OINTMENT | Maintenance | Adults apply to the affected area(s) by topical route 3 times per day |
| PRAMOSONE 2.5%-1% OINTMENT | 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 PRAMOSONE (hydrocortisone acetate/pramoxine hcl):
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 PRAMOSONE (hydrocortisone acetate/pramoxine hcl):
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 PRAMOSONE (hydrocortisone acetate/pramoxine hcl):
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 PRAMOSONE (hydrocortisone acetate/pramoxine hcl):
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 PRAMOSONE (hydrocortisone acetate/pramoxine hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PRAMOSONE (hydrocortisone acetate/pramoxine hcl)'s list of indications:
| Pruritus ani | |
| L29.0 | Pruritus ani |
| L29.3 | Anogenital pruritus, unspecified |
| Skin inflammation | |
| L20 | Atopic dermatitis |
| L20.8 | Other atopic dermatitis |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
| L21 | Seborrheic dermatitis |
| L21.8 | Other seborrheic dermatitis |
| L21.9 | Seborrheic dermatitis, unspecified |
| L25 | Unspecified contact dermatitis |
| L30.8 | Other specified dermatitis |
| L30.9 | Dermatitis, unspecified |
| L40 | Psoriasis |
| L40.1 | Generalized pustular psoriasis |
| L40.8 | Other psoriasis |
| L40.9 | Psoriasis, unspecified |
| R21 | Rash and other nonspecific skin eruption |
Formulary Reference Tool