Description and Composition of Simbat-N
Simbat-N is a cream that provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin. It is strictly for external use only and contains as its active pharmaceutical ingredients:
- Clotrimazole 1% w/w
- Neomycin sulphate 0.5% w/w
- Betamethasone Dipropionate 0.05% w/w.
In addition, it also contains inactive ingredients called excipients in sufficient quantities.
Pharmacodynamic properties of Simbat-N
Betamethasone dipropionate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and is often effective in the less responsive conditions such as psoriasis.
Neomycin sulphate is a broad-spectrum bactericidal antibiotic effective against the majority of bacteria commonly associated with skin infections.
Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. It also exhibits activity against Trichomonas, Staphylococci, Streptococci and Bacteroides. It has no effect on Lactobacilli. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc. The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection.
Pharmacokinetic properties of Simbat-N
Betamethasone dipropionate can be absorbed from normal intact skin. Inflammation and or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of Betamethasone dipropionate. Once absorbed through the skin. Betamethasone dipropionate is handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.
Neomycin is either not absorbed or is absorbed only minimally through intact skin. Any neomycin which is absorbed will be rapidly excreted by the kidneys in an unchanged state.
Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.
Indications and Uses of Simbat-N
What is Simbat-N used for?
Simbat-N provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin. Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness and scaling.
Many times the inflammatory skin disorders which respond to topical corticosteroids are superadded with bacterial and/or fungal infections of the skin. In these conditions, treatment with anti-inflammatory agents alone is not sufficient and a proper antibiotic has to be added in the regimen. Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of the skin. Neomycin Sulphate is a broad spectrum antibacterial.
Hence this Cream effectively controls inflammatory disorders superadded with bacterial and/or fungal infections of the skin.
Dosage & Administration of Simbat-N
Simbat-N should be thinly and evenly applied to the affected area two to three times a day with a gentle rub. Funbact A is for external use only
Contraindications of Simbat-N
Hypersensitivity to Clotrimazole, Neomycin Sulphate and Betamethasone Dipropionate Or any of the excipients.
Warnings and Precautions:
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing’s syndrome, can occur even without occlusion. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency. If infection persists, systemic chemotherapy is required. Withdraw topical corticosteroid if there is a spread of infection. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be deansed before a fresh dressing is applied. Extended or recurrent application may increase the risk of contact sensitisation. Extension of infection may occur due to the masking fed of the steroid. Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity, and neomycin has nephrotoxic, potential. In renal impairment the plasma clearance of neomycin is reduced.
Pregnancy and Lactation
Can a pregnant or a breastfeeding woman use Simbat-N?
Clotrimazole can be used during pregnancy, but only under the supervision of a physician
There is little Information to demonstrate the possible effect of locally applied neomycin in pregnancy and lactation However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity. To date, no other relevant epidemiological data are available. There are no adequate and well controlled studies of the teratogenic potential of topically applied Betamethasone dipropionate in pregnant women. Therefore this cream should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
It is unknown whether it is excreted in breast milk, so it should be given with caution to lactating mothers
Drugs Interactions with Simbat-N
When used together, this product may cause damage to latex contraceptives, Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least 5 days after using the product Following significant systemic absorption, neomycin sulphate can intensity and prolong the respiratory depressant effects of neuromuscular blocking agents
Side Effects of Simbat-N
There are reports of local skin irritation, burning, pruritus, pigmentation changes, allergic contact dermatitis and hypertrichosis with topical steroids. This Cream preparation is usually well tolerated, but it signs of hypersensitivity appear application should be stopped immediately. Side effects includes some of the Immune system disorders: allergic reaction (syncope, hypotension, dyspnoea, urticaria) Skin and subcutaneous tissue disorders: blisters, discomfort pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning
Overdosage of Simbat-N and Its Treatment
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing’s syndrome may appear and in this situation topical steroids should be discontinued gradually under medical supervision. Also, consideration should be given to significant systemic absorption of neomycin sulphate. If this is suspected, use of the product should be stopped and the patient’s general status, hearing ability 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. In the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). It should be carried out only if the airway can be protected adequately.
Store in a cool place. Do not freeze. Keep medicine out of reach of children.