Bactogen
Bactogen Uses, Dosage, Side Effects, Food Interaction and all others data.
Bactogen inhibits protein synthesis of the bacteria by binding to isoleucyl transfer ribonucleic acid (RNA)-synthetase. It has bacteriostatic properties at Min inhibitory concentrations and bactericidal properties at the higher concentrations.
Bactogen is reported to be active against susceptible aerobic gram-positive cocci, such as Staphylococcus aureus, Staphylococcus epidermidis, and other beta-hemolytic streptococciStreptococcus pyogenes. It mediates its antibacterial activity by inhibiting the bacterial protein synthesis and formation of bacterial proteins essential for survival. The minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC). In one clinical study investigating the therapeutic effectiveness of topical mupirocin in impetigo, the therapeutic response rate was about 94 to 98% after one week following the end of therapy. In clinical studies of patients with primary and secondary skin infections, both elimination of the bacterial pathogen and clinical cure or improvement hav been demonstrated in over 90% of patients receiving topical mupirocin. Bactogen resistance as high as 81% has been reported previously. Resistance to mupirocin, which occurs more frequently in methicillin-resistant than methicillin-susceptible staphylococci, may occur with the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase.
| Trade Name | Bactogen |
| Generic | Mupirocin |
| Mupirocin Other Names | Mupirocin, Mupirocina, Mupirocine, Mupirocinum, Pseudomonic acid, Pseudomonic acid A |
| Weight | 2% w/w |
| Type | Cream |
| Formula | C26H44O9 |
| Weight | Average: 500.6222 Monoisotopic: 500.298533006 |
| Protein binding | The protein binding of mupirocin is reported to be over 95%. |
| Groups | Approved, Investigational, Vet approved |
| Therapeutic Class | Topical Antibiotic preparations |
| Manufacturer | Biogen Pharma |
| Available Country | Pakistan |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Bactogen ointment or cream is used for the topical treatment of impetigo due to Staphylococcus aureus and Streptococcus pyogenes. It is also used for folliculitis and furunculosis.
Bactogen is also used to associated treatment for these conditions: Impetigo, Impetigo caused by Staphylococcus aureus, Impetigo caused by streptococcus pyogenes, Secondary infection Skin infection, Staphylococcus aurea colonization of the nasal passage
How Bactogen works
Bactogen specifically and reversibly binds to bacterial isoleucyl transfer-RNA (tRNA) synthetase, which is an enzyme that promotes the conversion of isoleucine and tRNA to isoleucyl-tRNA. Inhibition of this enzyme subsequently leads to the inhibition of the bacterial protein and RNA synthesis. Bactogen is bacteriostatic at lower concentrations but it exerts bactericidal effects with prolonged exposure, killing 90-99% of susceptible bacteria over a 24 hour period.
Dosage
Bactogen dosage
Secondary skin infections:
- Adult: As 2% cream: Apply to affected area three times daily for up to 10 days; re-evaluate after 3-5 days if no clinical response.
- Child: ≥3 mth Same as adult dose.
Impetigo:
- Adult: As 2% oint: Apply to affected area three times daily for 5-10 days; re-evaluate after 3-5 days if no clinical response.
- Child: ≥2 mth Same as adult dose.
Side Effects
Burning, stinging, pruritus, pain, rash, erythema, dry skin, tenderness, cellulitis, pain or bleeding secondary to eczema, secondary wound infection, urticaria, swelling, increased exudates, contact dermatitis, furunculosis, exfoliative dermatitis. Rarely, systemic reactions (e.g. nausea, headache, dizziness, abdominal pain, ulcerative stomatitis, systemic allergic reactions).
Toxicity
LD50 and Nonclinical Toxicity
The oral LD50 value in rats is 5000 mg/kg. Studies evaluating the carcinogenic potential of mupirocin have not been performed. In various in vivo animal and in vitro bacterial assays, there was no evidence of genotoxicity caused by mupirocin. In reproduction studies using male and female rats, there were no signs of impaired fertility upon subcutaneous administration of mupirocin.
Use in special populations
Bactogen was found to be excreted in human milk. As there is limited data on the use of topical mupirocin in pregnant women, the use of this drug in these patients should be undertaken with caution. Based on the findings in clinical trials, topical mupirocin was shown to be safe and effective in pediatric patients aged 2 months to 16 years.
Precaution
Bactogen is not suitable for ophthalmic or intra-nasal use. When Bactogen ointment is used on the face, care should be taken to avoid the eyes. In common with other polyethylene-based ointments, this drug should be used with caution if there is evidence of moderate or severe renal impairment. As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fung.
Interaction
Chloramphenicol may interfere with the antibacterial action of mupirocin in RNA synthesis.
Food Interaction
No interactions found.Volume of Distribution
No information available.
Elimination Route
Systemic or percutaneous absorption of mupirocin following dermal application is expected to be minimal in adults and children. Occlusive dressings do not significantly enhance drug absorption, but damaged skin may allow enhanced penetration of the drug across the skin barrier.
Half Life
In healthy male volunteers, the elimination half-life of mupirocin was about 20 to 40 minutes following intravenous administration. The elimination half-life of monic acid was about 30 to 80 minutes.
Clearance
No information available.
Elimination Route
Any mupirocin reaching the systemic circulation is rapidly metabolized to form the inactive monic acid, which is eliminated by renal excretion. Following the application of Centany (mupirocin ointment),2% to a 400 cm2 area on the back of 23 healthy volunteers once daily for 7 days, the mean (range) cumulative urinary excretion of monic acid over 24 hrs following the last administration was 1.25% (0.2% to 3.0%) of the administered dose of mupirocin.
Pregnancy & Breastfeeding use
Use in Pregnancy: Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bactogen ointment is administered to a nursing woman.
Contraindication
This drug is contraindicated in individuals with a history of sensitivity reactions to Bactogen or any of the components of the preparation.
Special Warning
Pediatric Use: The safety and effectiveness of Bactogen ointment have been established in the age range of 2 months to 16 years. Use of the ointment in these age groups is supported by evidence from adequate and well-controlled studies of Bactogen in impetigo in pediatric patients.
Storage Condition
Store at or below 25° C. Do not freeze.
Innovators Monograph
You find simplified version here Bactogen
Bactogen contains Mupirocin see full prescribing information from innovator Bactogen Monograph, Bactogen MSDS, Bactogen FDA label
FAQ
What is Bactogen used for?
Bactogen topical cream is used to treat secondarily infected traumatic skin lesions due to specific bacteria. It is indicated as a topical treatment of localized bacterial infection, such as impetigo, folliculitis, and nose or perianal staphylococcal carriage. It may also be used to get rid of methicillin-resistant S. aureus when present in the nose without symptoms.
How safe is Bactogen?
Bactogen ointment proved to be effective and safe in the treatment of primary and secondary skin infections.
How does Bactogen work ?
Bactogen works by killing bacteria or preventing their growth.
What are the common side effects of Bactogen?
Common side effects of Bactogen are include :
- Blistering, crusting, irritation, itching, or reddening of the skin.
- canker sores.
- cracked, dry, scaly skin.
- pain, swelling, tenderness, warmth on the skin.
- sores, ulcers, or white spots on the lips or tongue or inside the mouth.
Is Bactogen safe during pregnancy?
Bactogen is recommended for use during pregnancy.
Is Bactogen safe during breastfeeding?
Bactogen is considered a low risk to the breastfeeding.
Does Bactogen interact with anything?
Bactogen has no known interactions with other drugs.
Can I drink alcohol with Bactogen?
Bactogen may recommend limiting or avoiding alcohol intake.
Can I drive after taking Bactogen ?
Bactogen ointment has no or negligible influence on the ability to drive and use machines.
How long does Bactogen take to work?
You should notice your skin starting to get better within a few days. If you haven't noticed any improvement after 4-5 days, check with your doctor for further advice.
What is the half life of Bactogen ?
The elimination half-life is 20—40 minutes for Bactogen and 30—80 minutes for monic acid.
What happens if I use too much Bactogen?
If you use too much Bactogen the bacteria this drug is treating may develop resistance. This means that your medication will no longer work to kill the bacteria. If you think you've used too much of this Bactogen, call your doctor.
Who should not take Bactogen?
Do not use Bactogen topical on a child without medical advice. The cream should not be used on a child younger than 3 months old. The ointment may be used on a child as young as 2 months old. It is not known whether this medicine will harm an unborn baby.
When should not I use Bactogen?
Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water. To help clear up your skin infection completely, keep using Bactogen for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.
What happens if I miss a dose?
Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
An overdose of mupirocin topical is not expected to be dangerous. Seek emergency medical attention if anyone has accidentally swallowed the medication.
What happen If I stop taking Bactogen?
If you stop using the Bactogen suddenly or don't use it at all: Your infection may not improve, and it may get worse.
Is Bactogen bad for kidneys?
Bactogen ointment contains polyethylene glycol, which in large amounts can cause kidney damage. You should not apply Bactogen ointment to open skin wounds or damaged skin, especially if you have kidney problems.
