Bactovate
Bactovate Uses, Dosage, Side Effects, Food Interaction and all others data.
Betamethasone valerate is a potent topical corticosteroid. Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive actions when administered topically.
Corticosteroids bind to the glucocorticoid receptor inhibiting pro-inflammatory signals, while promoting anti-inflammatory signals. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients who require long-term treatment with a corticosteroid should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
| Trade Name | Bactovate |
| Generic | Betamethasone + Neomycin Sulphate (Topical) |
| Weight | 0.1% + 0.5% |
| Type | Cream |
| Therapeutic Class | |
| Manufacturer | Julphar Bangladesh Ltd |
| Available Country | Bangladesh |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Indicated in atopic, infantile & discoid eczema; prurigo nodularis; Psoriasis (excluding widespread plague psoriasis); lichen simplex or planus; contact sensitivity reactions; seborrhoeic dermatitis; discoid lupus erythematosus & adjunct to systemic steroid therapy in generalized erythroderma.
Bactovate is also used to associated treatment for these conditions: Acute Gouty Arthritis, Adrenal cortical hypofunctions, Alopecia Areata (AA), Ankylosing Spondylitis (AS), Berylliosis, Blepharitis allergic, Blepharoconjunctivitis, Bullous dermatitis herpetiformis, Bursitis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Corneal Inflammation, Dermatitis, Eczematous, Dermatomyositis, Dermatosis, Discoid Lupus Erythematosus (DLE), Edema of the cerebrum, Epicondylitis, Episcleritis, External ear inflammation, Eye allergy, Hypercalcemia of Malignancy, Inflammatory Reaction of the ear, Iridocyclitis, Iritis, Itching caused by Allergies, Keloid Scars, Keratitis interstitial, Keratoconjunctivitis, Leukemias, Lichen Planus (LP), Lichen simplex chronicus, Lupus Erythematosus, Malignant Lymphomas, Multiple sclerosis exacerbation, Mycosis Fungoides (MF), Necrobiosis lipoidica diabeticorum, Nephrotic Syndrome, Ocular Inflammation, Ocular injuries, Ophthalmia, Sympathetic, Pemphigus, Plaque psoriasis of the body, Plaque psoriasis of the scalp, Polymyositis, Post-Surgical Ocular Inflammation, Pruritus, Psoriasis, Psoriasis Vulgaris (Plaque Psoriasis), Psoriatic Arthritis, Psoriatic plaque, Pulmonary Tuberculosis (TB), Pure Red Cell Aplasia, Regional Enteritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Scleritis, Secondary thrombocytopenia, Severe Asthma, Severe Atopic Dermatitis, Skin Infections, Stevens-Johnson Syndrome, Systemic Lupus Erythematosus (SLE), Temporal Arteritis, Trichinosis, Tuberculous Meningitis, Ulcerative Colitis, Uveitis, Verrucous Lichen Planus (LP), Acquired immune hemolytic anemia, Acute nonspecific tenosynovitis, Acute rheumatic carditis, Bacterial blepharitis, Corticosteroid-responsive dermatoses, Eczematous rash, Exfoliative erythroderma, Granuloma annulare lesions, Idiopathic eosinophilic pneumonias, Non-suppurative Thyroiditis, Ocular bacterial infections, Severe Allergic rhinitis, Severe Contact dermatitis, Severe Serum sickness, Severe Transfusion Reactions, Severe drug hypersensitivity reactions, Superficial ocular infections, Symptomatic Sarcoidosis, Synovitis of osteoarthritis
How Bactovate works
Glucocorticoids inhibit neutrophil apoptosis and demargination, and inhibit NF-Kappa B and other inflammatory transcription factors. They also inhibit phospholipase A2, leading to decreased formation of arachidonic acid derivatives. In addition, glucocorticoids promote anti-inflammatory genes like interleukin-10.
Corticosteroids like betamethasone can act through nongenomic and genomic pathways. The genomic pathway is slower and occurs when glucocorticoids activate glucocorticoid receptors and initiate downstream effects that promote transcription of anti-inflammatory genes including phosphoenolpyruvate carboxykinase (PEPCK), IL-1-receptor antagonist, and tyrosine amino transferase (TAT). On the other hand, the nongenomic pathway is able to elicit a quicker response by modulating T-cell, platelet and monocyte activity through the use of existing membrane-bound receptors and second messengers.
Dosage
Bactovate dosage
Apply sparingly to the affected area 2 to 3 times daily until an improvement occurs.
Side Effects
Burning, itching, irritation, dryness, folliculitis, hypertrychosis acneiform eruptions, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliariamay be reported.
Toxicity
Chronic high doses of glucocorticoids can lead to the development of cataracts, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency. Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.
Precaution
Avoid long-term therapy particularly in infant & children; the treated area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Avoid contact with eyes.
Interaction
Increased hyperglycaemia and hypokalaemia with thiazide diuretics. Increased incidence of peptic ulcer or GI bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum concentration of salicylates and antimuscarinic agents.
Potentially Fatal: Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Enhanced effect in women taking oestrogens or oral contraceptives.
Volume of Distribution
In a study that included Indian women of reproductive age, the volume of distribution following a single intramuscular dose of betamethasone phosphate was 94,584±23,539 mL(s).
Elimination Route
The absorption and potency of any topical corticosteroid including betamethasone depends on the vehicle in which the steroid is delivered. For example, betamethasone dipropionate 0.05% ointment is classified as a highly potent topical steroid, while betamethasone dipropionate 0.05% cream or lotion is considered to be moderately potent.
There are several structural modifications that can determine the potency of a topical corticosteroid. For example, corticosteroids containing a halogen at specific carbons, or that contain esters are more potent due to enhanced lipophilicity. As such, there is a marked difference between topical products containing betamethasone dipropionate vs. betamethasone valerate. Betamethasone dipropionate contains 2 esters which enhances its potency, while betamethasone valerate has only one ester and is less potent.
It should be noted that the use of occlusive dressings with topical steroids significantly increases the absorption, increasing the risk for adverse effects.
Half Life
In a study that included Indian women of reproductive age, the half-life following a single intramuscular dose of betamethasone phosphate was 10.2 ± 2.5 hours.
Clearance
In a study that included Indian women of reproductive age, the CL/F following a single intramuscular dose of betamethasone phosphate was 6,466 ± 805 mL/hour.
Elimination Route
Corticosteroids are eliminated predominantly in the urine.
Pregnancy & Breastfeeding use
There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids and should not be used extensively for a prolonged period. Caution should be excercised when topical corticosteroids are administered in nursing women.
Contraindication
Betamethasone is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation. Betamethasone Eye/Ear/Nasal Drops is contraindicated in Herpes simplex virus infection of the eye; known sensitivity or allergy to any ingredient; red eye due to unknown causes; viral or fungal infections in the treatment area; tuberculosis, glaucoma etc.
Acute Overdose
Long-term intensive topical use may lead to systemic effects
Storage Condition
Protect from light. Do not freeze. Store between 15 °C and 30 °C.
Innovators Monograph
You find simplified version here Bactovate
FAQ
What does Bactovate used for?
Bactovate is used to treat various conditions of skin inflammation such as dermatitis and eczema. It also helps with skin infections and allergies. Bactovate should not be used for skin conditions other than for what it is prescribed, as it could make them worse.
How do apply Bactovate cream?
Bactovate cream should be applied to the affected area(s) of skin, once or twice a day. Only a thin layer of the cream should be used. Because betamethasone is a strong steroid, as your symptoms improve, you should start to use it less often, and continue to use an emollient cream to maintain the benefits in the longer term.
What is the use of Bactovate skin cream?
Betamethasone valerate is a potent topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. Neomycin sulphate is an aminoglycoside broad spectrum antibiotic.
Bactovate Topical preparations combining betamethasone valerate and neomycin sulphate are indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected, or likely to occur: Atopic dermatitis, Nummular dermatitis (discoid eczema), Prurigo nodularis, Psoriasis (excluding widespread plaque psoriasis), Lichen simplex chronicus, (neurodermatitis) and lichen planus, Seborrhoeic dermatitis, Irritant or allergic contact dermatitis, Insect bite reactions, Miliaria (prickly heat), Anal and genital intertrigo, Otitis externa (see Contraindications).
What is the Bactovate dosage for Adults?
Apply Bactovate thinly and gently rub in using only enough to cover the entire affected area once or twice daily for up to seven days, then change to another corticosteroid preparation not containing neomycin sulphate if further treatment is required. Allow adequate time for absorption after each application before applying an emollient.
In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of betamethasone valerate-neomycin sulphate 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 in such lesions; thereafter, improvement can usually be maintained by regular application without occlusion.
Treatment should not be continued for more than seven days without medical supervision. If the condition worsens or does not improve within seven days, treatment and diagnosis should be re-evaluated.
What is the Bactovate dosage for Child?
Bactovate 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 betamethasone valerate-neomycin sulphate is contraindicated in neonates and infants (less than 2 years) (see Contraindications).
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 betamethasone valerate-neomycin sulphate to ensure the amount applied is the minimum that provides therapeutic benefit
What is the Bactovate dosage for Elderly?
Betamethasone valerate-neomycin sulphate is suitable for use in the elderly. Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or 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
Is Bactovate safe during Pregnancy?
There are no data in humans to evaluate the effect of topical betamethasone valerate-neomycin sulphate on fertility. There are limited data from the use of topical betamethasone valerateneomycin sulphate in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see Non-clinical information). However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity (see Nonclinical information). Thus use of Bactovate is not recommended in pregnancy.
Is Bactovate safe during breastfeeding?
Use of Bactovate is not recommended in lactation.
What are the side effects of Bactovate?
Burning, itching, irritation, dryness, folliculitis, hypertrychosis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria may be reported.
What happens if I use too much Bactovate?
Long term use of Bactovate high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
How do I treat Bactovate side effects?
In the event of chronic overdose or misuse, topical corticosteroids 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 also be given to significant systemic absorption of neomycin sulphate (see Warnings and Precautions). 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. Blood levels of neomycin sulphate should also be determined. Haemodialysis may reduce the serum level of neomycin sulphate.
Further management should be as clinically indicated or as recommended by the National Poisons Centre, where available.
Can I use Bactovate on broken skin?
Do not use Bactovate on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water. Betamethasone dipropionate should come with a patient information leaflet.
