DIPROGENTA Betamethasone Dipropionate / Gentamicin Sulfate 500mcg / 1mg per g Cream 5g
RXDRUG-DRP-6238
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Features
Brand
Diprogenta
Full Details
Dosage Strength
500 mcg / 1 mg per g
Drug Ingredients
- Betamethasone
- Gentamicin
Drug Packaging
Cream 5g
Generic Name
Betamethasone Dipropionate / Gentamicin Sulfate
Dosage Form
Cream
Registration Number
DRP-6238
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment is indicated for the relief of the inflammatory manifestations of corticosteroid responsive dermatoses when complicated by secondary infection, caused by organisms susceptible to gentamicin or when the possibility of such infections is suspected. Such disorders include: psoriasis, contact dermatitis (dermatitis venenata), atopic dermatitis (infantile eczema, allergic dermatitis), neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), intertrigo, dyshidrosis (pompholyx), seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, stasis dermatitis, and anogenital and senile pruritus.
Dosage/Direction for Use
Dose: A thin film of Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment should be applied to cover completely the affected area twice daily, in the morning and at night.
Frequency of application should be determined by the physician according to the severity of the condition. For some patients, adequate maintenance therapy may be achieved with less frequent application.
Duration of Treatment: Duration of therapy varies depending upon the extent and location of disease and patient response. However, if clinical improvement is not achieved by three to four weeks, diagnosis should be reviewed.
Method of Administration: For dermatologic use only.
Frequency of application should be determined by the physician according to the severity of the condition. For some patients, adequate maintenance therapy may be achieved with less frequent application.
Duration of Treatment: Duration of therapy varies depending upon the extent and location of disease and patient response. However, if clinical improvement is not achieved by three to four weeks, diagnosis should be reviewed.
Method of Administration: For dermatologic use only.
Overdosage
Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease.
A single overdose of gentamicin would not be expected to produce symptoms. Excessive or prolonged use of topical antibiotics may lead to overgrowth of lesions by fungi or non-susceptible organisms.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
If overgrowth by non-susceptible organisms occurs, stop treatment with Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment and institute appropriate therapy.
A single overdose of gentamicin would not be expected to produce symptoms. Excessive or prolonged use of topical antibiotics may lead to overgrowth of lesions by fungi or non-susceptible organisms.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
If overgrowth by non-susceptible organisms occurs, stop treatment with Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment and institute appropriate therapy.
Contraindications
Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment is contraindicated in those patients with a history of sensitivity reactions to any of its components.
Special Precautions
If irritation or sensitization develops with the use of Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment, treatment should be discontinued and appropriate therapy instituted.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of topically applied gentamicin may be increased if extensive body surface areas are treated, especially over prolonged time periods or in the presence of dermal disruption. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Cautious use is recommended under these conditions, particularly in infants and children.
Prolonged use of topical antibiotics occasionally allows overgrowth of non-susceptible organisms, including fungi. If this occurs or if irritation, sensitization or superinfection develops, treatment with gentamicin should be discontinued and appropriate therapy instituted.
Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment is not for ophthalmic use.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled, and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Use in Children: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headache and bilateral papilledema.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of topically applied gentamicin may be increased if extensive body surface areas are treated, especially over prolonged time periods or in the presence of dermal disruption. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Cautious use is recommended under these conditions, particularly in infants and children.
Prolonged use of topical antibiotics occasionally allows overgrowth of non-susceptible organisms, including fungi. If this occurs or if irritation, sensitization or superinfection develops, treatment with gentamicin should be discontinued and appropriate therapy instituted.
Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment is not for ophthalmic use.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled, and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Use in Children: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headache and bilateral papilledema.
Use In Pregnancy & Lactation
Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic adsorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic adsorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Adverse reactions to Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment therapy have been reported very rarely and include hypersensitivity and skin discoloration.
Treatment with gentamicin has produced transient irritation (erythema and pruritus) that usually did not require discontinuance of treatment.
Reported adverse reactions with the use of topical corticosteroids, especially under occlusive dressings, include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform
eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
Treatment with gentamicin has produced transient irritation (erythema and pruritus) that usually did not require discontinuance of treatment.
Reported adverse reactions with the use of topical corticosteroids, especially under occlusive dressings, include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform
eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
Storage
Store below 30°C.
Action
Pharmacotherapeutic Group: Topical corticosteroid and anti-infective in combination.
Pharmacology: Pharmacodynamics: Mechanism of Action: Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment combines the sustained anti-inflammatory, antipruritic and vasoconstrictive actions of betamethasone dipropionate with the wide-spectrum bactericidal antibiotic activity of gentamicin sulfate.
Pharmacodynamic Effects: Bacteria susceptible to gentamicin include sensitive strains of Staphylococcus aureus (coagulase positive, coagulase negative and some penicillinase-producing strains) and the gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Toxicology: Nonclinical Toxicology: The effect of subacute administration of Betamethasone/Gentamicin (DIPROGENTA) Ointment on both the intact and abraded skin of rabbits and guinea pigs was studied under the conditions of the study. No adverse effects were observed on the intact and abraded skin. No systemic effects were seen that could be attributed to percutaneous absorption of corticosteroids.
The anti-bacterial activity, toxicity, local and systemic tolerance, local anti-inflammatory activity and side effects of Betamethasone/Gentamicin (DIPROGENTA) Ointment was determined. Betamethasone/Gentamicin (DIPROGENTA) Ointment had potent anti-bacterial activity and marked local anti-inflammatory effects. It was non-toxic and had extremely good systemic tolerance. There was no evidence of undesirable side effects at the dosage and route recommended for clinical use.
Pharmacology: Pharmacodynamics: Mechanism of Action: Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment combines the sustained anti-inflammatory, antipruritic and vasoconstrictive actions of betamethasone dipropionate with the wide-spectrum bactericidal antibiotic activity of gentamicin sulfate.
Pharmacodynamic Effects: Bacteria susceptible to gentamicin include sensitive strains of Staphylococcus aureus (coagulase positive, coagulase negative and some penicillinase-producing strains) and the gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Toxicology: Nonclinical Toxicology: The effect of subacute administration of Betamethasone/Gentamicin (DIPROGENTA) Ointment on both the intact and abraded skin of rabbits and guinea pigs was studied under the conditions of the study. No adverse effects were observed on the intact and abraded skin. No systemic effects were seen that could be attributed to percutaneous absorption of corticosteroids.
The anti-bacterial activity, toxicity, local and systemic tolerance, local anti-inflammatory activity and side effects of Betamethasone/Gentamicin (DIPROGENTA) Ointment was determined. Betamethasone/Gentamicin (DIPROGENTA) Ointment had potent anti-bacterial activity and marked local anti-inflammatory effects. It was non-toxic and had extremely good systemic tolerance. There was no evidence of undesirable side effects at the dosage and route recommended for clinical use.
MedsGo Class
Topical Anti-Infectives with Corticosteroids
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