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Drug overview for SARNA CALM-COOL (pramoxine hcl/menthol):
Generic name: pramoxine HCl/menthol
Drug class: Topical Local Anesthetics
Therapeutic class: Dermatological
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: pramoxine HCl/menthol
Drug class: Topical Local Anesthetics
Therapeutic class: Dermatological
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
SARNA CALM-COOL 1%-0.5% LOTION
The following indications for SARNA CALM-COOL (pramoxine hcl/menthol) have been approved by the FDA:
Indications:
Minor skin wound pain
Pruritus of skin
Skin irritation
Professional Synonyms:
Itchy skin eruption
Pruritic dermatitis
Indications:
Minor skin wound pain
Pruritus of skin
Skin irritation
Professional Synonyms:
Itchy skin eruption
Pruritic dermatitis
The following dosing information is available for SARNA CALM-COOL (pramoxine hcl/menthol):
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.
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.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for SARNA CALM-COOL (pramoxine hcl/menthol):
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 SARNA CALM-COOL (pramoxine hcl/menthol):
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 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Burns |
| Large open wound |
There are 0 moderate contraindications.
The following adverse reaction information is available for SARNA CALM-COOL (pramoxine hcl/menthol):
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 17 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dermatitis due to topical drug |
| Rare/Very Rare |
|---|
|
Acute respiratory failure Anaphylaxis Angioedema Bradycardia Bronchospastic pulmonary disease Burns Cardiac arrhythmia CNS toxicity Cyanosis Eyelid edema Headache disorder Hypotension Methemoglobinemia Respiratory depression Seizure disorder Unconsciousness |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Blanching of skin Edema Erythema Pruritus of skin Skin rash Stinging of skin Urticaria |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Apprehension Blurred vision Dizziness Drowsy Euphoria Muscle fasciculation Nervousness Sensation of cold Sensation of warmth Tinnitus Tremor Vomiting |
The following precautions are available for SARNA CALM-COOL (pramoxine hcl/menthol):
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 SARNA CALM-COOL (pramoxine hcl/menthol):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for SARNA CALM-COOL (pramoxine hcl/menthol)'s list of indications:
| Pruritus of skin | |
| L29.8 | Other pruritus |
| L29.81 | Cholestatic pruritus |
| L29.89 | Other pruritus |
| L29.9 | Pruritus, unspecified |
| Skin irritation | |
| L24 | Irritant contact dermatitis |
| L24.0 | Irritant contact dermatitis due to detergents |
| L24.1 | Irritant contact dermatitis due to oils and greases |
| L24.2 | Irritant contact dermatitis due to solvents |
| L24.3 | Irritant contact dermatitis due to cosmetics |
| L24.4 | Irritant contact dermatitis due to drugs in contact with skin |
| L24.5 | Irritant contact dermatitis due to other chemical products |
| L24.6 | Irritant contact dermatitis due to food in contact with skin |
| L24.7 | Irritant contact dermatitis due to plants, except food |
| L24.8 | Irritant contact dermatitis due to other agents |
| L24.81 | Irritant contact dermatitis due to metals |
| L24.89 | Irritant contact dermatitis due to other agents |
| L24.9 | Irritant contact dermatitis, unspecified cause |
| L24.A | Irritant contact dermatitis due to friction or contact with body fluids |
| L24.A0 | Irritant contact dermatitis due to friction or contact with body fluids, unspecified |
| L24.A1 | Irritant contact dermatitis due to saliva |
| L24.A2 | Irritant contact dermatitis due to fecal, urinary or dual incontinence |
| L24.A9 | Irritant contact dermatitis due friction or contact with other specified body fluids |
| L24.B | Irritant contact dermatitis related to stoma or fistula |
| L24.B0 | Irritant contact dermatitis related to unspecified stoma or fistula |
| L24.B1 | Irritant contact dermatitis related to digestive stoma or fistula |
| L24.B2 | Irritant contact dermatitis related to respiratory stoma or fistula |
| L24.B3 | Irritant contact dermatitis related to fecal or urinary stoma or fistula |
| L25 | Unspecified contact dermatitis |
| L25.0 | Unspecified contact dermatitis due to cosmetics |
| L25.1 | Unspecified contact dermatitis due to drugs in contact with skin |
| L25.2 | Unspecified contact dermatitis due to dyes |
| L25.3 | Unspecified contact dermatitis due to other chemical products |
| L25.4 | Unspecified contact dermatitis due to food in contact with skin |
| L25.5 | Unspecified contact dermatitis due to plants, except food |
| L25.8 | Unspecified contact dermatitis due to other agents |
| L25.9 | Unspecified contact dermatitis, unspecified cause |
| L30.9 | Dermatitis, unspecified |
| R21 | Rash and other nonspecific skin eruption |
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