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The following indications for ITCH RELIEF (diphenhydramine hcl/zinc acetate) have been approved by the FDA:
Indications:
Cutaneous candidiasis
Diaper rash
Pruritus of skin
Skin irritation
Tinea corporis
Tinea cruris
Tinea pedis
Tinea versicolor
Professional Synonyms:
Corporeal ringworm
Cutaneous candidosis
Cutaneous moniliasis
Dermatomycosis pedis
Dhobie itch
Diaper dermatitis
Eczema marginatum
Itchy skin eruption
Jock itch
Pityriasis versicolor
Pruritic dermatitis
Tinea circinata
Tinea furfuracea
Tinea glabrosa
Tinea inguinalis
Tinea of the foot
Indications:
Cutaneous candidiasis
Diaper rash
Pruritus of skin
Skin irritation
Tinea corporis
Tinea cruris
Tinea pedis
Tinea versicolor
Professional Synonyms:
Corporeal ringworm
Cutaneous candidosis
Cutaneous moniliasis
Dermatomycosis pedis
Dhobie itch
Diaper dermatitis
Eczema marginatum
Itchy skin eruption
Jock itch
Pityriasis versicolor
Pruritic dermatitis
Tinea circinata
Tinea furfuracea
Tinea glabrosa
Tinea inguinalis
Tinea of the foot
The following dosing information is available for ITCH RELIEF (diphenhydramine hcl/zinc acetate):
Dosage should be individualized according to the patient's response and tolerance.
The usual adult oral dosage of diphenhydramine hydrochloride is 25-50 mg 3 or 4 times daily at 4- to 6-hour intervals, not to exceed 300 mg in 24 hours.
The usual adult IM or IV dose of diphenhydramine hydrochloride is 10-50 mg; in a few patients, up to 100 mg may be required. Some experts recommend a dose of 25-50 mg. The rate of IV administration should not exceed 25 mg/minute.
The maximum adult IM or IV dosage of diphenhydramine hydrochloride is 400 mg daily.
When diphenhydramine was available only by prescription, the prescribing information for the drug indicated a usual oral diphenhydramine hydrochloride dosage for children weighing more than 9.1 kg of 12.5-25 mg 3 or 4 times daily at 4- to 6-hour intervals and for children weighing 9.1
kg or less an oral diphenhydramine hydrochloride dosage of 6.25-12.5 mg 3 or 4 times daily at 4- to 6-hour intervals.
However, these dosage recommendations are not included in the current labeling of nonprescription oral diphenhydramine preparations, and clinicians should use caution when considering use of nonprescription oral diphenhydramine in children younger than 4 years of age. (See Cautions: Pediatric Precautions.)
Alternatively, for oral, deep IM, or IV therapy, children (other than premature or full-term neonates) may be given 5 mg/kg daily or 150 mg/m2 daily divided in 4 doses; some experts recommend a dosage of 1-2 mg/kg daily. The rate of IV administration should not exceed 25 mg/minute.
The maximum oral, IM, or IV dosage of diphenhydramine hydrochloride in children older than 1 month of age is 300 mg daily.
For temporary relief of pruritus and pain associated with various skin conditions in adults and children 2 years of age or older, creams, lotions, or solutions containing 1-2% diphenhydramine hydrochloride are applied to the affected areas 3 or 4 times daily or as directed by a clinician; topical diphenhydramine should not be used more often than directed.
If the condition worsens, or if symptoms persist for longer than 7 days or resolve and then recur within a few days, topical therapy with diphenhydramine hydrochloride should be discontinued and a clinician consulted; the possibility of sensitization by, or hypersensitivity to, the drug should be considered.
Topical preparations containing diphenhydramine hydrochloride should not be used on large areas of the body or concomitantly with other preparations containing the antihistamine, including those used orally, since increased serum concentrations of diphenhydramine may occur that can result in systemic toxicity. (See Acute Toxicity: Manifestations, in the Antihistamines General Statement 4:00.) The drug also should not be used for topical self-medication in the management of varicella (chickenpox) or measles without first consulting a clinician.
The usual adult oral dosage of diphenhydramine hydrochloride is 25-50 mg 3 or 4 times daily at 4- to 6-hour intervals, not to exceed 300 mg in 24 hours.
The usual adult IM or IV dose of diphenhydramine hydrochloride is 10-50 mg; in a few patients, up to 100 mg may be required. Some experts recommend a dose of 25-50 mg. The rate of IV administration should not exceed 25 mg/minute.
The maximum adult IM or IV dosage of diphenhydramine hydrochloride is 400 mg daily.
When diphenhydramine was available only by prescription, the prescribing information for the drug indicated a usual oral diphenhydramine hydrochloride dosage for children weighing more than 9.1 kg of 12.5-25 mg 3 or 4 times daily at 4- to 6-hour intervals and for children weighing 9.1
kg or less an oral diphenhydramine hydrochloride dosage of 6.25-12.5 mg 3 or 4 times daily at 4- to 6-hour intervals.
However, these dosage recommendations are not included in the current labeling of nonprescription oral diphenhydramine preparations, and clinicians should use caution when considering use of nonprescription oral diphenhydramine in children younger than 4 years of age. (See Cautions: Pediatric Precautions.)
Alternatively, for oral, deep IM, or IV therapy, children (other than premature or full-term neonates) may be given 5 mg/kg daily or 150 mg/m2 daily divided in 4 doses; some experts recommend a dosage of 1-2 mg/kg daily. The rate of IV administration should not exceed 25 mg/minute.
The maximum oral, IM, or IV dosage of diphenhydramine hydrochloride in children older than 1 month of age is 300 mg daily.
For temporary relief of pruritus and pain associated with various skin conditions in adults and children 2 years of age or older, creams, lotions, or solutions containing 1-2% diphenhydramine hydrochloride are applied to the affected areas 3 or 4 times daily or as directed by a clinician; topical diphenhydramine should not be used more often than directed.
If the condition worsens, or if symptoms persist for longer than 7 days or resolve and then recur within a few days, topical therapy with diphenhydramine hydrochloride should be discontinued and a clinician consulted; the possibility of sensitization by, or hypersensitivity to, the drug should be considered.
Topical preparations containing diphenhydramine hydrochloride should not be used on large areas of the body or concomitantly with other preparations containing the antihistamine, including those used orally, since increased serum concentrations of diphenhydramine may occur that can result in systemic toxicity. (See Acute Toxicity: Manifestations, in the Antihistamines General Statement 4:00.) The drug also should not be used for topical self-medication in the management of varicella (chickenpox) or measles without first consulting a clinician.
Diphenhydramine hydrochloride usually is administered orally. Diphenhydramine citrate usually is administered orally. When oral therapy is not feasible, diphenhydramine hydrochloride may be given by deep IM or, preferably, IV injection.
The drug should not be given subcutaneously, intradermally, or perivascularly because of its irritating effects; local necrosis has been reported following subcutaneous or intradermal administration of parenteral diphenhydramine. IV use of the drug in a home-care setting should be employed under careful supervision. Use of diphenhydramine for local anesthesia via local infiltration is discouraged because of the risk of local tissue necrosis.
Diphenhydramine hydrochloride should not be given to premature or full-term neonates. (See Cautions: Pediatric Precautions.) For the temporary relief of pruritus associated with various skin conditions and disorders, diphenhydramine hydrochloride-containing preparations are applied topically in the form of a cream, lotion, or topical solution. The possibility of clinically important percutaneous absorption of the drug following topical application should be considered.
(See Cautions.) Clotrimazole is administered topically to the oropharyngeal area as an oral lozenge, to the skin as a cream or solution, or intravaginally as a vaginal cream. The topical cream and solution are not intended for ophthalmic use. Clotrimazole also is available in fixed combination with betamethasone dipropionate as a cream or lotion; see prescribing information for the combination product for additional details.
Store clotrimazole oral lozenges, topical cream, and topical solution at 20--25degreesC. Avoid freezing oral lozenges.
The drug should not be given subcutaneously, intradermally, or perivascularly because of its irritating effects; local necrosis has been reported following subcutaneous or intradermal administration of parenteral diphenhydramine. IV use of the drug in a home-care setting should be employed under careful supervision. Use of diphenhydramine for local anesthesia via local infiltration is discouraged because of the risk of local tissue necrosis.
Diphenhydramine hydrochloride should not be given to premature or full-term neonates. (See Cautions: Pediatric Precautions.) For the temporary relief of pruritus associated with various skin conditions and disorders, diphenhydramine hydrochloride-containing preparations are applied topically in the form of a cream, lotion, or topical solution. The possibility of clinically important percutaneous absorption of the drug following topical application should be considered.
(See Cautions.) Clotrimazole is administered topically to the oropharyngeal area as an oral lozenge, to the skin as a cream or solution, or intravaginally as a vaginal cream. The topical cream and solution are not intended for ophthalmic use. Clotrimazole also is available in fixed combination with betamethasone dipropionate as a cream or lotion; see prescribing information for the combination product for additional details.
Store clotrimazole oral lozenges, topical cream, and topical solution at 20--25degreesC. Avoid freezing oral lozenges.
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
CVS ITCH RELIEF 1% TOP CREAM | Maintenance | Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening |
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
CLOTRIMAZOLE 1% TOPICAL CREAM | Maintenance | Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening |
CVS CLOTRIMAZOLE 1% TOP CREAM | Maintenance | Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening |
TM-CLOTRIMAZOLE 1% TOP CREAM | Maintenance | Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening |
QC CLOTRIMAZOLE 1% TOP CREAM | Maintenance | Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening |
The following drug interaction information is available for ITCH RELIEF (diphenhydramine hcl/zinc acetate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ITCH RELIEF (diphenhydramine hcl/zinc acetate):
Drug contraindication overview.
*Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.
*Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
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 |
---|
No disease contraindications |
The following adverse reaction information is available for ITCH RELIEF (diphenhydramine hcl/zinc acetate):
Adverse reaction overview.
Lozenge: nausea, vomiting, unpleasant mouth sensations, and pruritus. Topical cream or solution: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, and general irritation of skin.
Lozenge: nausea, vomiting, unpleasant mouth sensations, and pruritus. Topical cream or solution: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, and general irritation of skin.
There are 16 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
None. | None. |
Rare/Very Rare |
---|
Abnormal desquamation Anaphylaxis Angioedema Blistering skin Dermatitis due to topical drug Dyspnea Edema Erythema Hypersensitivity drug reaction Hypotension Pruritus of skin Skin irritation Skin rash Stinging of skin Syncope Urticaria |
There are 1 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
None. | None. |
Rare/Very Rare |
---|
Contact dermatitis |
The following precautions are available for ITCH RELIEF (diphenhydramine hcl/zinc acetate):
Safety and efficacy of clotrimazole lozenges have not been established in children <3 years of age. Safety and efficacy of prophylactic therapy with clotrimazole lozenges have not been established in children. Clotrimazole topical cream or solution is not recommended for self-medication in children <3 years of age.
Clotrimazole vaginal cream is not recommended for self-medication in children <12 years of age. Preparations containing clotrimazole in fixed combination with betamethasone dipropionate are not recommended for use in children <17 years of age or for diaper dermatitis.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Clotrimazole vaginal cream is not recommended for self-medication in children <12 years of age. Preparations containing clotrimazole in fixed combination with betamethasone dipropionate are not recommended for use in children <17 years of age or for diaper dermatitis.
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
None |
Reproduction studies in rats and rabbits receiving diphenhydramine hydrochloride dosages up to 5 times the recommended human dosage have not revealed evidence of harm to the fetus. However, diphenhydramine has been shown to cross the placenta. In one epidemiologic study, use of bromodiphenhydramine (no longer commercially available) but not diphenhydramine was associated with an increased risk of teratogenic effects.
In another epidemiologic study, there also was no evidence of increased risk of teratogenicity associated with diphenhydramine use during the first trimester, although a modest association could not be ruled out. Use of diphenhydramine during the first trimester of pregnancy has been associated with an increased risk of cleft palate alone or combined with other fetal abnormalities, and the drug has been reported to potentiate the teratogenic effect of morphine in mice. The manufacturers state that there are no adequate and controlled studies to date using diphenhydramine in pregnant women, and the drugs should be used during pregnancy only when clearly needed.
There are no adequate and controlled studies of clotrimazole lozenges in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. In clinical trials, use of intravaginal clotrimazole in pregnant women in the second and third trimester was not associated with adverse effects; there are no adequate and well-controlled studies in pregnant women in the first trimester. . In animal reproductive studies, clotrimazole demonstrated embryotoxic effects, but was not teratogenic when given in doses significantly higher than the recommended human dose.
In another epidemiologic study, there also was no evidence of increased risk of teratogenicity associated with diphenhydramine use during the first trimester, although a modest association could not be ruled out. Use of diphenhydramine during the first trimester of pregnancy has been associated with an increased risk of cleft palate alone or combined with other fetal abnormalities, and the drug has been reported to potentiate the teratogenic effect of morphine in mice. The manufacturers state that there are no adequate and controlled studies to date using diphenhydramine in pregnant women, and the drugs should be used during pregnancy only when clearly needed.
There are no adequate and controlled studies of clotrimazole lozenges in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. In clinical trials, use of intravaginal clotrimazole in pregnant women in the second and third trimester was not associated with adverse effects; there are no adequate and well-controlled studies in pregnant women in the first trimester. . In animal reproductive studies, clotrimazole demonstrated embryotoxic effects, but was not teratogenic when given in doses significantly higher than the recommended human dose.
Diphenhydramine has been detected in milk. Because of the potential for serious adverse reactions to antihistamines in nursing infants, a decision should be made whether to discontinue nursing or diphenhydramine, taking into account the importance of the drug to the woman. It is not known whether clotrimazole is excreted in human milk, caution should be exercised when the drug is used in nursing woman.
There were an insufficient number of patients >=65 years of age in clinical studies of clotrimazole lozenges to determine whether geriatric patients respond differently from younger patients; other reported experience did not find any differences in response between these patients.
The following prioritized warning is available for ITCH RELIEF (diphenhydramine hcl/zinc acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ITCH RELIEF (diphenhydramine hcl/zinc acetate)'s list of indications:
Cutaneous candidiasis | |
B37.2 | Candidiasis of skin and nail |
Diaper rash | |
L22 | Diaper dermatitis |
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 |
Tinea corporis | |
B35.4 | Tinea corporis |
Tinea cruris | |
B35.6 | Tinea cruris |
Tinea pedis | |
B35.3 | Tinea pedis |
Tinea versicolor | |
B36.0 | Pityriasis versicolor |
Formulary Reference Tool