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Drug overview for MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone):
Generic name: HYDROQUINONE/TRETINOIN/HYDROCORTISONE
Drug class: Acne Products
Therapeutic class: Dermatological
Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Hydroquinone, which is structurally related to monobenzone, is a Tretinoin, all trans-retinoic acid, is a retinoid. depigmenting agent.
Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters share the actions of other topical corticosteroids and are used for the relief of inflammatory manifestations of corticosteroid-responsive dermatoses, including dermatoses of the anogenital areas. Nonprescription preparations containing 0.5% hydrocortisone or hydrocortisone acetate are 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).
Generic name: HYDROQUINONE/TRETINOIN/HYDROCORTISONE
Drug class: Acne Products
Therapeutic class: Dermatological
Hydrocortisone is a corticosteroid secreted by the adrenal cortex. Hydroquinone, which is structurally related to monobenzone, is a Tretinoin, all trans-retinoic acid, is a retinoid. depigmenting agent.
Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters share the actions of other topical corticosteroids and are used for the relief of inflammatory manifestations of corticosteroid-responsive dermatoses, including dermatoses of the anogenital areas. Nonprescription preparations containing 0.5% hydrocortisone or hydrocortisone acetate are 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 MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for MELONDIS PLUS (hydroquinone/tretinoin/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.
To depigment hyperpigmented skin, a thin layer of hydroquinone cream or solution should be applied uniformly and rubbed into the pigmented area twice daily, in the morning and evening. Application of the drug should be limited to an area equal to that of the face and neck or hands and arms. Exposure to sunlight should be minimized during treatment (See Cautions: Precautions and Contraindications); the opaque base in some hydroquinone preparations (Eldopaque(R), Eldopaque Forte(R)) may provide sufficient protection from sunlight.
If no depigmentation is evident after 2 months of hydroquinone treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, hydroquinone should be applied only as often as needed to maintain depigmentation.
Excessive application of tretinoin does not increase the therapeutic effects of the drug and may produce marked inflammatory reactions, including peeling and discomfort.
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.
To depigment hyperpigmented skin, a thin layer of hydroquinone cream or solution should be applied uniformly and rubbed into the pigmented area twice daily, in the morning and evening. Application of the drug should be limited to an area equal to that of the face and neck or hands and arms. Exposure to sunlight should be minimized during treatment (See Cautions: Precautions and Contraindications); the opaque base in some hydroquinone preparations (Eldopaque(R), Eldopaque Forte(R)) may provide sufficient protection from sunlight.
If no depigmentation is evident after 2 months of hydroquinone treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, hydroquinone should be applied only as often as needed to maintain depigmentation.
Excessive application of tretinoin does not increase the therapeutic effects of the drug and may produce marked inflammatory reactions, including peeling and discomfort.
Preparations containing 2-4% hydroquinone are applied topically. Hydroquinone should not be administered orally. Tretinoin is applied topically to the skin as a cream, gel, or solution.
Patients should be instructed carefully in proper use of the drug, including associated precautions. (See Cautions: Precautions and Contraindications and also Drug Interactions.)
Patients should be instructed carefully in proper use of the drug, including associated precautions. (See Cautions: Precautions and Contraindications and also Drug Interactions.)
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone):
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 |
|---|---|
| Topical Tretinoin/Tetracyclines SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use of topical tretinoin with tetracyclines may increase the risk of phototoxicity(1) in some patients.(2) PREDISPOSING FACTORS: Patients using topical tretinoin for the treatment of photodamage may be predisposed to photosensitivity.(2) PATIENT MANAGEMENT: Concurrent use of topical tretinoin and tetracycline is standard practice in the treatment of acne.(3) However, patients taking tetracyclines should not use topical tretinoin (e.g Renova) for the treatment of photodamage.(1,2) DISCUSSION: The concurrent use of topical tretinoin and tetracyclines may result in an increased risk of phototoxicity.(1,2) |
AVIDOXY, AVIDOXY DK, BENZODOX 30, BENZODOX 60, BISMUTH-METRONIDAZOLE-TETRACYC, DEMECLOCYCLINE HCL, DORYX, DORYX MPC, DOXY 100, DOXYCYCLINE HYCLATE, DOXYCYCLINE IR-DR, DOXYCYCLINE MONOHYDRATE, EMROSI, MINOCIN, MINOCYCLINE ER, MINOCYCLINE HCL, MINOCYCLINE HCL ER, MONDOXYNE NL, MORGIDOX, NUZYRA, ORACEA, OXYTETRACYCLINE HCL, PYLERA, SEYSARA, TARGADOX, TETRACYCLINE HCL, XERAVA, XIMINO |
There are 0 moderate interactions.
The following contraindication information is available for MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone):
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 |
|---|
| Eczema |
| Sunburn |
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 MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone):
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 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Contact dermatitis Folliculitis Hypersensitivity drug reaction Purpura Skin and skin structure infection Skin atrophy |
| Rare/Very Rare |
|---|
|
Adrenocortical insufficiency Blistering skin Bullous dermatitis Cataracts Central serous chorioretinopathy Dyschromia Glaucoma Hypothalamic-pituitary insufficiency Ocular hypertension Skin crusting Skin hypopigmentation Skin inflammation Skin striae Skin ulcer Urticaria |
There are 27 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Erythema Skin photosensitivity Stinging of skin |
Acute pain at drug application site Blurred vision Headache disorder Paresthesia Pruritus of skin Skin rash Telangiectasia Treatment site sequelae |
| Rare/Very Rare |
|---|
|
Acneiform eruption Alopecia Blistering skin Contact dermatitis Dry skin Dyschromia Edema Glycosuria Hirsutism Hypercortisolism Hyperesthesia Hyperglycemia Miliaria Perioral dermatitis Skin irritation |
The following precautions are available for MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone):
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 |
Reproductive studies in animals have not been performed with topical hydroquinone. It is not known whether hydroquinone can cause fetal harm when used topically by pregnant women. Topical hydroquinone should be used during pregnancy only when clearly needed.
Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:36.) Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area).
In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral dosages of 10 mg/kg daily or greater, but none were observed at 5 mg/kg daily (83 times the maximum human systemic dosage normalized for total body surface area), although increased skeletal variations were observed at all dosages. Dose-related increased embryolethality and abortion also were reported. Similar results also have been reported in pigtail macaques.
Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). Bone anomalies (short (13%) or bent (6%) humerus, incompletely ossified os parietal (14%)) also have been reported in rats when tretinoin 10 mg/kg daily was applied dermally.
Topical tretinoin cream was associated with an increased incidence of cleft palate and hydrocephaly in rabbits when administered in a dosage 91 times the topical human dosage (based on topical application of 1 g of 0.1% tretinoin cream in a 50-kg adult). In New Zealand white rabbits treated with topical tretinoin at dosages 80 times the recommended human topical clinical dosage, an increased incidence of domed head and hydrocephaly was noted in some of the fetuses, typical of retinoid-induced fetal malformations in this species; no abnormalities were observed at dosages 3 times the maximum human systemic dosage of tretinoin after topical administration of 0.1% tretinoin gel (microsphere formulation), normalized for total body surface area.
In addition, topical tretinoin in formulations other than the gel (microsphere formulation) was not teratogenic when given in dosages of 42 or 27 times the maximum human systemic topical dosage in rats or rabbits, respectively. However, delayed ossification of several bones, occurred in rabbits and a dose-dependent incease in supernumerary ribs was observed in rats at these topical dosages. Oral tretinoin was fetotoxic in rats at dosages 21 times the maximum human systemic dosage normalized for total body surface area, resulting in skeletal variations and increased intrauterine death in rats.
Topical tretinoin has been shown to be fetotoxic in rabbits when administered in dosages 8 times the maximum human systemic dosage applied topically and normalized for total body surface area), resulting in fetal resorption and variations in ossification. When given subcutaneously to rabbits, tretinoin was teratogenic at a dosage of 2 mg/kg daily but not at 1 mg/kg daily. These dosages are approximately 400 and 200 times, respectively, the human topical dosage of tretinoin cream (based on topical application of 1 g of 0.025% tretinoin cream in a 50-kg adult).
With widespread use of any drug, a small number of birth defect reports associated with the administration of the drug would be expected by chance alone. During 2 decades of clinical use of one formulation of topical tretinoin (Retin-A(R)), 30 cases of temporally associated congenital malformations have been reported. Although no definite pattern of teratogenicity and no causal associations have been established from these cases, 5 of the reports described the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain).
The relevance of these spontaneous reports in terms of risk to the fetus is unknown. To date, there have been no adequate and well-controlled studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known. The manufacturer of some topical tretinoin preparations (e.g., Retin-A(R)) state that topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while manufacturers of other tretinoin formulations (e.g., Avita(R) cream, Renova(R) emollient cream) state that these products should not be used during pregnancy.
Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:36.) Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area).
In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral dosages of 10 mg/kg daily or greater, but none were observed at 5 mg/kg daily (83 times the maximum human systemic dosage normalized for total body surface area), although increased skeletal variations were observed at all dosages. Dose-related increased embryolethality and abortion also were reported. Similar results also have been reported in pigtail macaques.
Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). Bone anomalies (short (13%) or bent (6%) humerus, incompletely ossified os parietal (14%)) also have been reported in rats when tretinoin 10 mg/kg daily was applied dermally.
Topical tretinoin cream was associated with an increased incidence of cleft palate and hydrocephaly in rabbits when administered in a dosage 91 times the topical human dosage (based on topical application of 1 g of 0.1% tretinoin cream in a 50-kg adult). In New Zealand white rabbits treated with topical tretinoin at dosages 80 times the recommended human topical clinical dosage, an increased incidence of domed head and hydrocephaly was noted in some of the fetuses, typical of retinoid-induced fetal malformations in this species; no abnormalities were observed at dosages 3 times the maximum human systemic dosage of tretinoin after topical administration of 0.1% tretinoin gel (microsphere formulation), normalized for total body surface area.
In addition, topical tretinoin in formulations other than the gel (microsphere formulation) was not teratogenic when given in dosages of 42 or 27 times the maximum human systemic topical dosage in rats or rabbits, respectively. However, delayed ossification of several bones, occurred in rabbits and a dose-dependent incease in supernumerary ribs was observed in rats at these topical dosages. Oral tretinoin was fetotoxic in rats at dosages 21 times the maximum human systemic dosage normalized for total body surface area, resulting in skeletal variations and increased intrauterine death in rats.
Topical tretinoin has been shown to be fetotoxic in rabbits when administered in dosages 8 times the maximum human systemic dosage applied topically and normalized for total body surface area), resulting in fetal resorption and variations in ossification. When given subcutaneously to rabbits, tretinoin was teratogenic at a dosage of 2 mg/kg daily but not at 1 mg/kg daily. These dosages are approximately 400 and 200 times, respectively, the human topical dosage of tretinoin cream (based on topical application of 1 g of 0.025% tretinoin cream in a 50-kg adult).
With widespread use of any drug, a small number of birth defect reports associated with the administration of the drug would be expected by chance alone. During 2 decades of clinical use of one formulation of topical tretinoin (Retin-A(R)), 30 cases of temporally associated congenital malformations have been reported. Although no definite pattern of teratogenicity and no causal associations have been established from these cases, 5 of the reports described the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain).
The relevance of these spontaneous reports in terms of risk to the fetus is unknown. To date, there have been no adequate and well-controlled studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known. The manufacturer of some topical tretinoin preparations (e.g., Retin-A(R)) state that topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while manufacturers of other tretinoin formulations (e.g., Avita(R) cream, Renova(R) emollient cream) state that these products should not be used during pregnancy.
Since it is not known if topical hydroquinone is absorbed or distributed into human milk, the drug should be used with caution in nursing women. It is not known whether topically applied tretinoin is excreted in human milk. Caution should be exercised when topical tretinoin is administered to a nursing woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MELONDIS PLUS (hydroquinone/tretinoin/hydrocortisone)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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