Betnovate-GM Online



How and where to order Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) 0.12% / 0.1% / 2% 20 g tubes of topical ointment or cream online on Wyndmoor Hills Health Care & Rehab Center website:

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Betamethasone with Gentamicin and Miconazole (trade names include Betnovate-GM, Betamil-GM, Betnederm-GM, 4 Derm, Betacort Plus, Conazole, Factor Dermico, Gentasol, Hifamonil) is a combined dermatological medication from corticosteroids (Betamethasone), antibiotics (Gentamicin) and antifungals (Miconazole) pharmacological groups with anti-inflammatory and immunosuppressive properties. This medicine is used to reduce redness, itching, and swelling of the skin, in steroid responsive dermatoses with bacterial and fungal infections. Betnovate-GM is also prescribed for various types of eczema, skin inflammation due to allergies or irritants, psoriasis, seborrhoeic dermatitis, wounds, thickened skin rash, inflammatory skin diseases, in veterinary medicine, and for other medical purposes.


Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) cream


Related medications:

  • Betamethasone, Clotrimazole (Lotrisone)
  • Butoconazole (Gynofort)
  • Chlorhexidine (Corsodyl)
  • Chlorhexidine, Metronidazole (Metrogyl DG)
  • Clotrimazole (Femcare)
  • Fluconazole (Diflucan)
  • Griseofulvin (Grifulvin)
  • Itraconazole (Sporanox)
  • Ketoconazole (Nizoral)
  • Luliconazole (Luzu)
  • Miconazole (Monistat)
  • Neomycin (Mycifradin)
  • Nystatin (Mycostatin)
  • Ornidazole (Tiberal)
  • Sertaconazole (Zalain)
  • Terbinafine (Lamisil)
  • Tetracycline (Sumycin)
  • Tiabendazole (Mintezol)
  • Voriconazole (Vfend)


    Pharmacological and medical categories:

  • Anti-infective drugs
  • Anti-inflammatory medications
  • Immunosuppressive medicines
  • Topical corticosteroids with antibiotics and antifungals
  • Topical chemotherapeutics used in the treatment of dermatological diseases
  • Veterinary, pet meds
  • Wound care products


    ATC codes:

  • D - Dermatologicals
  • D01 - Antifungals for dermatological use
  • D01A - Antifungals for topical use
  • D01AC - Imidazole and triazole derivatives
  • D01AC52 - Miconazole, combinations

  • D07 - Corticosteroids, dermatological preparations
  • D07C - Corticosteroids, combinations with antibiotics
  • D07CC - Corticosteroids, potent, combinations with antibiotics
  • D07CC01 - Betamethasone and antibiotics


    ICD-10 codes:

  • Other bacterial diseases - A30-A49
  • Mycoses - B35-B49
  • Dermatitis and eczema - L20-L30
  • Seborrheic dermatitis - L21
  • Pruritus - L29
  • Pruritus, unspecified - L29.9
  • Other and unspecified dermatitis - L30
  • Psoriasis - L40
  • Other disorders of the skin and subcutaneous tissue - L80-L99
  • Other disorders of skin and subcutaneous tissue, not elsewhere classified - L98
  • Symptoms and signs involving the skin - R20-R23
  • Rash and other nonspecific skin eruption - R21
  • Localized swelling, mass and lump of skin and subcutaneous tissue - R22
  • Localized swelling, mass and lump, unspecified - R22.9


    Indications and usage:

    Betnovate-GM cream or ointment is indicated for steroid responsive dermatosis associated with mixed infection.


    Dosage and administration:

    Betnovate-GM cream is indicated for topical use only.

    This medication is especially appropriate for moist or weeping surfaces.

    Betnovate-GM should not be used continuously for more than one week without re-evaluation by the physician.

    Adults and adolescents

    Apply thinly and gently rub in using only enough to cover the entire affected area twice daily until improvement occurs. As with other highly active topical corticosteroid preparations, therapy should be discontinued when control is achieved. In the more responsive conditions this may be within a few days. If the condition worsens or does not improve within seven days, treatment and diagnosis should be re-evaluated. If a longer course is necessary, it is recommended that treatment should not be continued for more than four weeks. However, treatment should not be continued for more than seven days without medical supervision. Repeated short courses of Betnovate-GM cream may be used to control exacerbations. If continuous corticosteroid treatment is necessary, a less potent preparation which does not contain gentamicin should be used.

    Allow adequate time for absorption after each application before applying an emollient. Patients should be advised to wash their hands after applying Betnovate-GM, unless it is the hands that are being treated.

    In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of Betnovate-GM can be enhanced, if necessary, by occluding the treatment area with polythene film.

    Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion.

    Children aged 2 years and over

    Betnovate-GM (Betamethasone, Gentamicin, Miconazole) is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus this drug is contraindicated in neonates and infants (less than 2 years).

    Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.

    Care should be taken when using Betnovate-GM to ensure the amount applied is the minimum that provides therapeutic benefit.

    Elderly

    Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) is suitable for use in the elderly. Clinical studies have not identified difference in responses between the elderly and younger patients. The greater frequency of decreased hepatic and renal function in the elderly may delay elimination if systemic absorption occurs. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

    Renal impairment

    Dosage should be reduced in patients with reduced renal function.


    Dosage forms and strengt:

    Betnovate-GM cream for topical use (skin cream) or topical ointment contains: Betamethasone Valerate IP equivalent to Betamethasone 0.10 % w/w Gentamicin Sulfate IP equivalent to Gentamicin 0.10 % w/w Miconazole Nitrate IP 2.0 % w/w Chlorocresol IP 0.1 % w/w (as preservative) in a non-greasy base.


    Overdosage:

    Symptoms and signs

    Topically applied betamethasone valerate may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur.

    Treatment

    In the event of overdose, Betnovate-GM should be withdrawn gradually by reducing the frequency of application, or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.

    Consideration should be given to significant systemic absorption of gentamicin sulfate. If this is suspected, use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored.

    Haemodialysis and peritoneal dialysis will aid removal from the blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.

    Excessive topical use of miconazole nitrate can result in skin irritation, which usually disappears after discontinuation of therapy.

    Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) cream is intended for cutaneous use, not oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.

    Further management should be as clinically indicated or as recommended by the National Poisons Centre, where available.


    Contraindications:

    Betnovate-GM cream is contraindicated in patients who have demonstrated hypersensitivity to betamethasone valerate, gentamicin sulfate, miconazole nitrate, other imidazole derivatives, or any components of the formulation.

    The following conditions should not be treated with Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate):

  • acne vulgaris
  • rosacea
  • perioral dermatitis
  • perianal and genital pruritus
  • pruritus without inflammation
  • primary cutaneous viral infections (e.g. herpes simplex, chickenpox)
  • primary infected skin lesions caused by infection with fungi, bacteria, or yeast
  • otitis externa with known or suspected perforation of the ear drum because of the risk of ototoxicity
  • myasthenia gravis
  • children under two years of age


    Warnings:

    Pseudomembranous colitis

    Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied Betnovate-GM, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

    Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression

    Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids.

    If either of the above is observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency.

    Risk factors for increased corticosteroidal systemic effects are:

  • duration of exposure
  • potency and formulation of topical corticosteroid
  • application to a large surface area
  • increasing hydration of the stratum corneum
  • use on occluded areas of skin e.g. on intertriginous areas or under occlusive dressings (nappies may act as an occlusive dressing)
  • use on thin skin areas such as the face
  • use on broken skin or other conditions where the skin barrier may be impaired.

    Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) cream should be used with caution in patients with a history of local hypersensitivity to betamethasone, or to any of the other ingredients in the preparation. Local hypersensitivity reactions may resemble symptoms of the condition under treatment. If signs of hypersensitivity appear, application should be stopped immediately.

    Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole cream and with other miconazole topical formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.


    Precautions:

    Use in children

    In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.

    Long-term continuous therapy should be avoided, particularly in children, as adrenal suppression can occur readily even without occlusion. If Betnovate-GM is required for use in children, it is recommended that the treatment should be limited to only a few days and reviewed weekly.

    Prolonged use

    Long-term continuous topical therapy with Betnovate-GM cream should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur.

    Application to the face

    Application to the face is undesirable as, more than other areas of the body, this area may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. If used on the face, treatment should be limited to only a few days.

    Application to eyelids

    If Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) cream applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure.

    Visual disturbance

    Visual disturbance has been reported by patients using systemic and/or topical corticosteroids. If a patient has blurred vision or other visual disturbances, consider evaluation of possible causes which may include cataract, glaucoma or central serous chorioretinopathy.

    Use in psoriasis

    Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis (see Undesirable Effects) and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

    Infection risk with occlusion

    Bacterial infection is encouraged by the warm, moist conditions within skin folds and caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.


    Adverse reactions, side effects:

    Adverse drug reactions of Betnovate-GM cream (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common ( >= 1/10), common ( >= 1/100 and < 1/10), uncommon ( >= 1/1,000 and < 1/100), rare ( >= 1/10,000 and < 1/1,000) and very rare ( < 1/10,000), including isolated reports.

    Betamethasone Valerate

    Infections and Infestations

    Very rare: opportunistic infection

    Immune System Disorders

    Very rare: local hypersensitivity

    Endocrine Disorders

    Very rare: hypothalamic-pituitary adrenal (HPA) axis suppression Cushingoid features (e.g. central obesity, moon face), delayed weight gain/growth retardation in children, glaucoma, osteoporosis, hyperglycaemia/glucosuria, hypertension, cataract, increased weight/obesity, decreased endogenous cortisol levels, trichorrhexis, alopecia.

    Skin and Subcutaneous Tissue Disorders

    Common: local skin burning / skin pain, pruritus
    Very rare: dermatitis, allergic contact dermatitis, rash, erythema, urticaria, skin thinning, skin atrophy, pustular psoriasis, skin dryness, skin wrinkling, striae, pigmentation changes, telangiectasias, hypertrichosis, exacerbation of underlying symptoms.
    Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

    General Disorders and Administration Site Conditions

    Very rare: application site irritation/pain

    Miconazole Nitrate

    Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with miconazole nitrate that meet threshold criteria are included below too. Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.

    Adverse reactions reported in clinical trials and post-marketing experience:

    Immune System Disorders: anaphylactic reaction, hypersensitivity.

    Skin and Subcutaneous Tissue Disorders: skin burning sensation, skin inflammation, skin hypopigmentation, angioedema, urticaria, contact dermatitis, rash, erythema, pruritus.

    General Disorders and Administration Site Conditions: application site irritation, application site burning, application site pruritus, application site reaction NOS, application site warmth.

    Gentamicin Sulfate

    In the event of irritation, sensitization or super-infection, treatment with Betnovate-GM should be discontinued and appropriate therapy instituted.

    Adverse reactions reported with Gentamicin Sulfate:

    Ear and Labyrinth Disorders: local sensitivity, ototoxicity, vestibular disorder, hearing loss.

    Skin and Subcutaneous Tissue Disorders: burning sensation, stinging, itching (pruritus), dermatitis.

    To report suspected side effects of Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) cream contact GlaxoSmithKline pharmaceutical company, or your local FDA.


    Drug interactions:

    CYP3A4 inhibitors

    Co-administered with Betnovate-GM cream drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

    Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

    Systemic aminoglycoside therapy

    Possibility of cumulative toxicity should be considered when gentamicin sulfate (containing in Betnovate-GM) is applied topically in combination with systemic aminoglycoside therapy.


    Use in specific populations:

    Fertility

    There are no data in humans to evaluate the effect of betamethasone valerate with gentamicin and miconazole on fertility.

    Pregnancy

    There are limited data from the use of betamethasone valerate with gentamicin and miconazole in pregnant women.

    Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established.

    There are no adequate data from the use of gentamicin in pregnant women. Studies in animals have shown reproductive toxicity. Gentamicin crosses the placenta. Because of the potential risk of inner ear and renal damage to the foetus, gentamicin should not be used in pregnancy unless in case of a life-threatening indication and if the benefit outweighs the risk.

    In animals, miconazole nitrate has shown no teratogenic effects but is fetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

    The use of Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) cream is not recommended in pregnancy.

    Lactation

    The safe use of betamethasone valerate with gentamicin and miconazole during lactation has not been established.

    It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.

    Gentamicin is excreted in human breast milk and was detected in low concentrations in serum of breast-fed children. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from gentamicin therapy. Diarrhoea and fungus infection of the mucous membranes could occur in the breast-fed infant, so that nursing might have to be discontinued. The possibility of sensitisation should be borne in mind.

    Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether Miconazole is excreted in human breast milk.

    Thus, use of Betnovate-GM is not recommended in lactation.


    Pregnancy categories:

  • C - Australia
  • C - United States (Risk cannot be ruled out)


    Salts and other forms:

  • Betamethasone with Gentamicin and Miconazole
  • Betamethasone with Gentamicin and Miconazole Nitrate
  • Betamethasone Dipropionate with Gentamicin and Miconazole Nitrate
  • Betamethasone Dipropionate with Gentamicin Sulfate and Miconazole Nitrate
  • Betamethasone Valerate with Gentamicin and Miconazole
  • Betamethasone Valerate with Gentamicin and Miconazole Nitrate
  • Betamethasone Valerate with Gentamicin Sulfate and Miconazole
  • Betamethasone Valerate with Gentamicin Sulfate and Miconazole Nitrate


    Synonyms, international and chemical names:

  • Garamycin
  • Gentamcin
  • Gentamicin Sulphate
  • Gentamicina
  • Gentamicine
  • Gentamicinum
  • Gentamycin
  • Gentamycyna
  • Jantamisin
  • Xentamicina

  • Betadexamethasone
  • Betametason
  • Betametasona
  • Betametasone
  • Beta-Methasone
  • Betamethasonum
  • Betamethasonvalerat
  • Betamethazone

  • Benzoylmetronildazole
  • Miconazol
  • Miconazolnitrat
  • Miconazolo
  • Miconazolum
  • Nitrato de Miconazol


    Brands, generics, trade names:

  • 4 Derm - Terbol Laboratorios
  • Betacort Plus - Pablo Cassara Laboratorios
  • Betamil-GM - Merck
  • Betnederm-GM - Cipla
  • Betnovate-GM - GlaxoSmithKline
  • Conazole - Drug Houses of Australia, U.S. Summit
  • Cuta Crema - Fortbenton Laboratorio Farmaceutico
  • Dermosona - Federacion Argentina de Cooperativas Farmaceuticas
  • Factor Dermico - Casasco Laboratorios
  • Gentasol - Monserrat y Eclair
  • Hifamonil - Raymos Laboratorios
  • Macril - Andromaco Laboratorios
  • Lupiderm-GM - Lupin Pharmaceuticals
  • Stemin-GM - Ind-Swift


    APIs used in medicine in combinations with miconazole, betamethasone and gentamicin:

  • Chlorocresol
  • Clioquinol
  • Clobetasol Propionate
  • Clobetasone Butyrate
  • Neomycin Sulfate
  • Zinc Sulfate


    Here is a list of popular medications containing betamethasone with gentamicin and miconazole as main active pharmaceutical ingredients; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:

    Trade name of the drug Pharmaceutical forms and doses Companies
    Betamil-GM
  • Cream; Topical; Betamethasone Dipropionate 0.05%; Gentamicin Sulfate 0.1%; Miconazole Nitrate 2%
  • Merck
  • Betnovate-GM
  • Cream; Topical; Betamethasone Valerate 0.12%; Gentamicin Sulfate 0.1%; Miconazole Nitrate 2%
  • GlaxoSmithKline
  • Macril
  • Cream; Topical; Betamethasone Valerate 0.1%; Gentamicin Sulfate 0.1%; Miconazole Nitrate 2%
  • Andromaco Laboratorios
  • Urufarma



  • References:

  • Betamethasone main article on Wikipedia: https://en.wikipedia.org/wiki/Betamethasone
  • Betamethasone Valerate main article on Wikipedia: https://en.wikipedia.org/wiki/Betamethasone_valerate
  • Betamethasone compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone
  • Betamethasone Valerate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone-valerate
  • Gentamicin compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Gentamicin
  • Gentamicin Sulfate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Gentamicin_-sulfate
  • Miconazole compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Miconazole
  • Miconazole Nitrate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Miconazole-nitrate
  • Betamethasone medicine on DrugBank: https://go.drugbank.com/drugs/DB00443
  • Betamethasone Valerate on DrugBank: https://go.drugbank.com/salts/DBSALT000849
  • Gentamicin medicine on DrugBank: https://go.drugbank.com/drugs/DB00798
  • Gentamicin Sulfate on DrugBank: https://go.drugbank.com/salts/DBSALT000690
  • Miconazole medicine on DrugBank: https://go.drugbank.com/drugs/DB01110
  • Miconazole Nitrate on DrugBank: https://go.drugbank.com/salts/DBSALT001242
  • Betamethasone Topical FAQ on MedlinePlus (revised 02/15/2018): https://medlineplus.gov/druginfo/meds/a682799.html
  • Gentamicin Topical FAQ on MedlinePlus (revised 06/15/2019): https://medlineplus.gov/druginfo/meds/a619033.html
  • Miconazole Topical FAQ on MedlinePlus (revised 11/15/2018): https://medlineplus.gov/druginfo/meds/a618061.html
  • Betamethasone Valerate cream drug label info on DailyMed (revised April 18, 2017): https://dailymed.nlm.nih.gov/dailymed/lookup...
  • Gentamicin Sulfate cream drug label info on DailyMed (revised June 4, 2021): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
  • Miconazole Nitrate cream drug label info on DailyMed (revised March 10, 2021): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
  • Betamethasone containing drugs on Drugs-About.com: https://drugs-about.com/ing/betamethasone.html
  • Gentamicin containing drugs on Drugs-About.com: https://drugs-about.com/ing/gentamicin.html
  • Miconazole containing drugs on Drugs-About.com: https://drugs-about.com/ing/miconazole.html
  • Betnovate-GM for sale on Pharma Doctor: https://pharma-doctor.com/betamethasone-gentamicin-miconazole.html
  • Betnovate-GM (Betamethasone Valerate, Gentamicin Sulfate, Miconazole Nitrate) skin cream official prescribing information from GlaxoSmithKline pharmaceutical company (revised 24 Sep 2020): https://india-pharma.gsk.com/media/701021/betnovate-gm.pdf

    Revised: August 2021



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