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Other strengths and forms by Advanced Chemical Industries PLC.
Indications & Uses
Lefabac is indicated for:
Pharmacology
Lefamulin Acetate is a semi-synthetic antibacterial that can be given by mouth or into a vein. It works in a new way, and this gives it an advantage against resistant bacteria that cause pneumonia. Lefamulin belongs to the pleuromutilin group and acts on the whole body (it is a systemic antibacterial).
The medicine stops bacteria from making their proteins. It does this by binding to the A- and P-sites of the peptidyl transferase center (PTC) in domain V of the 23s rRNA of the 50S subunit. The binding happens through hydrogen bonds, hydrophobic interactions and Van der Waals forces.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
These have not been studied in patients with moderate or severe hepatic impairment and are not recommended for them. Patients with mild hepatic impairment don't need a dosage adjustment of the tablets.
Important administration instructions
Dosage for other forms (4)
For adults with CABP, the dose of Lefamulin is 150 mg by intravenous infusion every 12 hours, given over 60 minutes, for 5 to 7 days. The doctor may switch the patient to Lefamulin Tablets 600 mg every 12 hours to complete the course. Lefamulin tablet 600 mg can also be taken by mouth every 12 hours for 5 days. Patients with severe hepatic impairment need a dosage adjustment.
Dosage adjustment for patients with hepatic impairment
For patients with severe hepatic impairment, reduce the dose to 150 mg infused intravenously over 60 minutes every 24 hours. Patients with mild or moderate hepatic impairment don't need any adjustment of the injection dose.
Give it by intravenous infusion over 60 minutes. Before use, it must be diluted in a 250 ml solution of citrate buffered 0.9% sodium chloride for injection, which is supplied with the injection.
Take them at least 1 hour before a meal or 2 hours after a meal. Do not crush or divide the tablet.
Missed dose: If a dose is missed, the patient should take it as soon as possible, at any time up to 8 hours before the next scheduled dose. If less than 8 hours remain before the next scheduled dose, the patient should not take the missed dose and should carry on with the next scheduled dose.
Preparation of Lefamulin Injection for intravenous infusion
Dilute the entire 15 ml vial of Lefamulin Injection into the diluent bottle supplied with it, which contains 250 ml citrate buffered 0.9% sodium chloride solution. Use aseptic technique when adding the injection to the diluent bottle, and mix thoroughly. Use the diluent bottle only if the solution is clear and the container is undamaged. Do not use the diluent bottle in series connections. Do not add other additives to the diluent bottle, because their compatibility with Lefamulin Injection has not been established.
Side Effects
Lefamulin Acetate can prolong the QT interval. So doctors should avoid it in patients who already have known QT prolongation or ventricular arrhythmias, and in patients taking other drugs that may prolong the QT interval. Diarrhea caused by Clostridioides difficile (called CDAD) has been reported with nearly all systemic antibacterial agents, and Lefamulin Acetate is no exception. It can range from mild diarrhea to fatal colitis.
Cautions & Contraindications
Warnings & Precautions
Clostridium Difficile-Associated Disease (CDAD) has been reported with many antibacterial agents, including Lefamulin Acetate IV. CDAD can range from mild diarrhea to fatal colitis. So if a patient has diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon or perforation of the colon after any antibacterial agent, this diagnosis should be considered. Lefamulin Acetate IV can prolong the QT interval of the electrocardiogram (ECG) in some patients. Avoid using it in the following patients. First, those with known prolongation of the QT interval. Second, those with ventricular arrhythmias including torsades de pointes. Third, those receiving Class IA (for example, quinidine, procainamide) or Class IIIA (for example, amiodarone, sotalol) antiarrhythmic agents. Last, those receiving other drugs that prolong the QT interval, such as antipsychotics, erythromycin, pimozide, moxifloxacin and tricyclic anti-depressants.
Contraindications
Lefamulin Acetate must not be given to anyone with a known hypersensitivity to lefamulin, to any other pleuromutilin class drug, or to any of the components of the lefamulin product. It must also not be used together with CYP3A4 substrates that prolong the QT interval. Lefamulin is not recommended for pregnant women, or for patients below 18 years of age.
Pregnancy & Breastfeeding
Pregnancy: No clinical studies have been done in pregnant women. Animal studies show that Lefamulin Acetate led to more stillbirths. Malformations were also seen in rats, at systemic exposures lower than the exposure in CAP patients. Lefamulin IV should be used during pregnancy only if the likely benefit justifies the possible risk to the mother and the fetus.
Lactation: There are no data on whether Lefamulin Acetate passes into human milk, what it does to a breastfed infant, or whether it affects milk production. Animal studies show that Lefamulin was concentrated in the milk of lactating rats. Because serious adverse reactions are possible, including QT interval prolongation, a woman should pump and discard her milk for the whole course of Lefamulin IV and for 2 days after the final dose.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
If someone takes too much Lefamulin Acetate IV, treat them by watching them closely and giving general supportive care. The stomach should be emptied. Keep the person adequately hydrated and monitor their electrolytes. Electrocardiogram (ECG) monitoring is recommended. Hemodialysis won't remove a significant amount of Lefamulin Acetate IV from the systemic circulation.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
IV infusion: Store in a refrigerator at 2°C to 8°C. Don't freeze it, and protect it from light. Keep it out of the reach of children.
Tablet: Don't store above 30°C. Don't refrigerate or freeze. Keep the tablets in a dry place, protect them from light, and keep them out of the reach of children.
Common questions about Lefabac 600 mg
What is Lefabac 600 mg Tablet?
Lefabac 600 mg Tablet is a medicine that contains Lefamulin Acetate. It is made by Advanced Chemical Industries PLC. It belongs to the Other antibacterial preparation group of medicines.
What is Lefabac used for?
Lefabac is used for: Pneumonia.
What are the side effects of Lefabac?
Lefamulin Acetate can prolong the QT interval. So doctors should avoid it in patients who already have known QT prolongation or ventricular arrhythmias, and in patients taking other drugs that may prolong the QT interval.
Can I take Lefabac during pregnancy or while breastfeeding?
Pregnancy: No clinical studies have been done in pregnant women. Animal studies show that Lefamulin Acetate led to more stillbirths. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Lefabac?
If someone takes too much Lefamulin Acetate IV, treat them by watching them closely and giving general supportive care. The stomach should be emptied. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Lefabac?
IV infusion: Store in a refrigerator at 2°C to 8°C. Don't freeze it, and protect it from light.
Is there a cheaper medicine with the same ingredient?
Lefabac is already among the lowest-priced brands of Lefamulin Acetate at this strength.
Do I need a prescription for Lefabac?
Lefabac is a prescription (Rx) medicine. Take it as your doctor advises.