Lidocaine-Hydrocortisone

Drug overview for LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate):

Generic name: LIDOCAINE HCL/HYDROCORTISONE ACETATE (HYE-droe-KOR-ti-sone/LIE-doh-cane)
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological

Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Lidocaine, a nonselective voltage-gated sodium channel inhibitor, is an amide-type local anesthetic.

Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters Lidocaine is used topically for the treatment of pain. Various topical lidocaine products are commercially available. Lidocaine 1.8%

and 5% share the actions of other topical corticosteroids and are used for the relief of inflammatory manifestations of corticosteroid-responsive topical systems (i.e., patches) are FDA-labeled for the treatment of pain associated with postherpetic neuralgia (PHN). Lidocaine is also available dermatoses, including dermatoses of the anogenital areas. Nonprescription in various over-the-counter (OTC) topical preparations for the temporary preparations containing 0.5%

hydrocortisone or hydrocortisone acetate are treatment of pain. used for the temporary relief of minor skin irritations, itching, and rashes caused by eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, or jewelry; for temporary relief of itchy anal and/or genital areas; and for temporary relief of itching and minor scalp irritation caused by scalp dermatitis. Hydrocortisone acetate also is used as a paste for adjunctive treatment to provide temporary relief of symptoms associated with oral inflammatory or ulcerative lesions resulting from trauma.

Hydrocortisone also is administered rectally as a retention enema for the adjunctive treatment of mild or moderate acute ulcerative colitis limited to the rectosigmoid or left colon and, to a lesser extent, in some patients with mild ulcerative colitis of the transverse or descending colon. Hydrocortisone acetate is administered rectally as a suppository or an aerosol foam suspension for the adjunctive treatment of ulcerative colitis of the rectum. As rectal suppositories, hydrocortisone acetate is used in the treatment of other inflammatory conditions of the anorectum (e.g., inflamed hemorrhoids, postirradiation or factitial proctitis, cryptitis, pruritus ani).

DRUG IMAGES

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The following indications for LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate):

Dosing
Administration
LIDOCAINE-HYDROCORTISONE
LIDOCAINE-HYDROCORTISONE

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.

Lidocaine patches are applied topically to intact skin. Applyimmediately after removal from the protective envelope. Patches may be cut into smaller sizes with scissors prior to removal of therelease liner.

Up to 3 patches may be applied at one time as prescribed; application of more than the recommended number of patches or for longer durations than recommended can result in increased blood concentrations of lidocaine, resulting in adverse reactions. Advise patients on proper application of the patches. Clothing may be worn over the area ofapplication.

If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides. Lidocaine 5% (Lidoderm(R)) patches may not stick if they get wet. The manufacturer states to avoid contact with water, such as bathing,swimming or showering.

The manufacturer of Ztlido(R) states that the patches may be used during moderate exercise, such as biking for 30 minutes and may be exposed to water, such as showering, for 10 minutes or immersion for 15 minutes. To dry the topical system after water exposure, gently pat the skin; do not rub the skin or topical system. Do not apply external heat sources, such as heating pads or electric blankets,directly to lidocaine patches, since this may increase plasma lidocaine levels.

The manufacturer of Ztlido(R) states that the patches can beapplied to an administration site after moderate heat exposure, such as15 minutes of heating pad exposure on a medium setting. Topical lidocaine (Lidoderm(R)and generics; Ztildo(R)) patches should be stored at 20-25degreesC with excursions permitted to 15-30degreesC.

Dosing information for LIDOCAINE-HYDROCORTISONE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
LIDOCAINE-HC 3-0.5% CREAM	Maintenance	Adults apply a thin layer to the affected area(s) by topical route 3 times per day

Generic dosing information for LIDOCAINE-HYDROCORTISONE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
LIDOCAINE-HC 3-0.5% CREAM	Maintenance	Adults apply a thin layer to the affected area(s) by topical route 3 times per day

The following drug interaction information is available for LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate):

Contraindicated
Severe
Moderate

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

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 LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

*Known history of sensitivity to local anesthetic of the amide type, or to any other component of the product.

There are 2 contraindications. Absolute contraindication.

Contraindication List
Large open wound
Methemoglobinemia

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Heart block
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Sepsis
Shock

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Hypothalamic-pituitary insufficiency
Respiratory depression
Seizure disorder

The following adverse reaction information is available for LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate):

Overview
Severe
Less Severe

Adverse reaction overview.

Common adverse effects of lidocaine 1.8 and 5% patches include mild and transient application site reactions (e.g., blisters, bruising, burning sensation, depigmentation,dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia,pruritus, vesicles). Systemic adverse reactions following topical use of lidoderm patch are unlikely due to minimal drug absorption.

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

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 LIDOCAINE-HYDROCORTISONE (lidocaine hcl/hydrocortisone acetate):

Pediatric
Pregnant
Lactation
Geriatric

Safety and effectiveness in pediatric patients have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Lidocaine 5% patch has not been studied in pregnancy. The limited human data with the 1.8% patch are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Animal reproductionstudies found that subcutaneous administration of the drug at doses higher than recommended human doses during the period of organogenesis resulted in lower fetal weights. Some manufacturers recommend that lidocaine patches should be used during pregnancy only if clearly needed. Lidoderm patches have not been studied and are contraindicated in labor and delivery. If lidocaine patches are used concomitantly with other productscontaining lidocaine, total doses contributed by all formulations must be considered.

Lidocaine is excreted into humanmilk in low concentrations following topical application. Caution should be exercised whenlidocaine is administered to a nursing woman, especially when administered with other local anesthetics.

Clinical studies of lidocaine 1.8% patch did not include sufficient number of patients >=65 years of age to determine whether they respond differently from younger patients. No differences in response have been identified in other clinical experience.