Generic Mupirocin 2.0% Cream (T-Bact Cream 10g) – Product Information
Generic Mupirocin 2.0% Cream (T-Bact Cream) is an antibiotic. Antibiotics work by killing bacteria which can cause infection.
T-Bact Cream (Mupirocin 2% Cream) contains Mupirocin I.P. 2.0% w/w in a non-greasy base. T-Bact cream can be used to treat small wounds which have become infected. These wounds may include small cuts and abrasions or stitches. T-Bact cream is also used for impetigo. T-Bact Cream is for use on your skin only.
We also stock Flutivate cream (Fluticasone Propionate 0.005% Cream) which is used for the treatment of eczema, psoriasis, allergies and rash.
Name of Drug
T-Bact Cream (Mupirocin USP 2.0% w/w). T-Bact Cream is sometimes referred to as Generic Bactroban Cream.
Manufacturer
T-Bact Cream is marketed in India by the trademark holder GlaxoSmithKline Pharmaceuticals Limited, India.
Website: gsk-india.com
Active Pharmaceutical Ingredient
The active pharmaceutical ingredient in T-Bact Cream is Mupirocin USP 2.0% w/w.
Mechanism of Action
Mupirocin 2.0% cream is a topical antibiotic that inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl-transfer RNA (tRNA) synthetase. This binding prevents the amino acid isoleucine from being incorporated into protein chains, causing the bacteria to stop growing and eventually die.
Mupirocin is a novel antibiotic produced through fermentation of Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis. Due to this particular mode of action and its unique chemical structure, Mupirocin does not show any cross-resistance with other clinically available antibiotics.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Uses of T-Bact Cream
T-Bact Cream (Generic Mupirocin 2.0% Cream) is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections, e.g. Staphylococcus aureus, including methicillin- resistant strains, other staphylococci, streptococci. It is also active against Gram- negative organisms such as Escherichia coli and Haemophilus influenzae. Mupirocin Cream is used for skin infections, e.g. impetigo, folliculitis, furunculosis.
T-Bact Cream is indicated for the topical treatment of the following primary and secondary skin infections due to susceptible pathogens: primary pyodermas such as impetigo, folliculitis, furunculosis, ecthyma; secondary infected dermatoses such as eczema, psoriasis, atopic dermatitis, herpes, epidermolysis bullosa, icthyosis, and infected traumatic lesions such as ulcers, minor burns, cuts, abrasions, lacerations, wounds, biopsy sites, surgical incisions and insect bites.
Prophylactically, T-Bact Cream may be used to prevent bacterial contamination in minor burns, biopsy sites, incisions and other clean lesions. For abrasions, minor cuts and wounds the prophylatic use of T-Bact may prevent the development of infection and permit wound healing.
Drug Class and Mechanism
Unlike most other antibiotics which act on either bacterial DNA or the walls of bacteria, Mupirocin the active ingredient present in T-Bact Cream blocks the activity of an enzyme called isoleucyl-tRNA synthetase within the bacteria. This enzyme is necessary in order for the bacteria to make proteins. Without the ability to make proteins, the bacteria die. Because of its unique mechanism of action, there is little chance that bacteria will have become resistant to Mupirocin because of exposure to other antibiotics.
Mupirocin 2.0% Cream – Dosage
Adults (Including Elderly/Hepatically Impaired) And Children
A small amount of T-Bact Cream should be applied to the affected area three times daily for up to 10 days, depending on the response. The area treated may be covered with a gauze dressing if required.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.
For the medication to work effectively, a consistent amount needs to be present at the site of infection. Applying extra, or doubling up, can lead to increased risk of side effects or bacterial resistance. Keep using the cream for the full time prescribed, even if the infection appears to be cleared.
Missed Dosage Instructions for T-Bact Cream
If you miss a dose of Mupirocin 2.0% Cream, apply it as soon as you remember.
However, if it is almost time for your next scheduled dose, skip the missed dose entirely and resume your regular schedule. Do not apply a double dose to make up for a missed one.
Contraindications
T-Bact Cream is contraindicated in persons with a hypersensitivity (allergy) to Mupirocin or any of the other ingredients of this medicine.
Storage Instructions for T-Bact Cream
You should keep T-Bact Cream in the original pack at room temperature. Do not freeze the cream.
Keep this medicine where children cannot reach it, such as in a locked cupboard.
Warnings and Precautions to be taken when using Mupirocin 2.0% Cream (T-Bact Cream)
Before using Mupirocin 2.0% Cream (T-Bact Cream) please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.
Do not use T-Bact Cream on children below 2 years. If a reaction suggesting sensitivity or chemical irritation should occur with the use of this medicine, treatment should be discontinued and an appropriate alternative therapy for the treatment of the infection should be initiated.
Mupirocin Ointment, 2% is not for ophthalmic use.
Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching or rash occurs. If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner.
The effect of the concurrent application of Mupirocin Cream, 2% and other medical products is unknown.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.
Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin Ointment, treatment should be discontinued, the product should be washed off and appropriate therapy instituted.
As with other antibacterial products, prolonged use of this medicine may result in overgrowth of non-susceptible organisms. 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 Mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Mupirocin Ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.
Side Effects of T-Bact Cream (Mupirocin Cream)
The side effects noticed during trials of T-Bact Cream are burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Listed below are the other Possible side effects:
- Headache, nausea and diarrhoea
- Allergic reactions can occur if T-Bact Cream is applied to open or infected wounds.
- Tell your doctor immediately if you notice any of the following:
- Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting.
- These could be symptoms of an allergic reaction.
Overdosage
Overdosage of Mupirocin 2.0% Cream is unlikely to be dangerous due to its low toxicity. If too much is applied, it may cause skin irritation (burning, itching, redness).
The toxicity of Mupirocin is very low. In the event of accidental ingestion of the ointment, symptomatic treatment should be given.
In case of erroneous oral intake of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency because of the possible side effects of polyethylene glycol.
There is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.
In case of accidental ingestion, seek medical attention immediately.
T-Bact Cream (Mupirocin 2% Cream) During Pregnancy
Mupirocin 2% Cream is classified by the US FDA as Pregnancy Category B.
Reproduction studies have been performed in rats and rabbits with Mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of harm to the fetus due to Mupirocin. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether Mupirocin is excreted in human milk.Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Cream, 2% is administered to a nursing woman.
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