Mulina IV Infusion

Introduction

Lefamulin acetate is an antibiotic used for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). It belongs to a new class of antibiotics known as pleuromutilins. Lefamulin is effective against a variety of Gram-positive and Gram-negative bacteria, including strains resistant to other antibiotics.

Uses

Lefamulin acetate is indicated for:

Treatment of community-acquired bacterial pneumonia (CABP) in adults.
Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

It is typically used when other treatment options are not suitable or when infections are caused by bacteria resistant to conventional antibiotics.

Brand Name	Mulina
Type	IV Infusion
Weight	150 mg/15 ml
Generic	Lefamulin Acetate
Manufacturer	Beximco Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Lefamulin works by inhibiting bacterial protein synthesis. It binds to the 23S rRNA of the 50S ribosomal subunit, thereby blocking the peptidyl transferase activity and preventing the formation of peptide bonds. This disruption in protein synthesis inhibits bacterial growth and replication.

How Long Does It Take to Work?

The onset of action for Lefamulin can vary, but clinical improvement is often seen within a few days of starting treatment. The exact time to response depends on the severity of the infection and the individual patient's condition. Regular clinical evaluation and follow-up are necessary to assess the effectiveness of the therapy.

Absorption

Lefamulin is well-absorbed following oral administration. Peak plasma concentrations are typically reached within 1 to 2 hours. The absorption of Lefamulin is not significantly affected by food, allowing for flexible administration in relation to meals.

Route of Elimination

Lefamulin is primarily metabolized in the liver. The drug and its metabolites are excreted mainly via the feces, with a smaller portion eliminated through the urine. Its metabolism involves the cytochrome P450 enzyme system, particularly CYP3A4.

Dosage

Dosage of Lefamulin in Adult CABP Patients: Lefamulin 150 mg injection every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days (With the option to switch to Lefamulin Tablets 600 mg every 12 hours to complete the treatment course). Lefamulin tablet 600 mg orally every 12 hours for 5 days. For patients with severe hepatic impairment, dosage adjustment is required.

Dosage Adjustment for Patients with Hepatic Impairment-

Lefamulin Injection: Reduce the dosage of Lefamulin Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment. No dosage adjustment of Lefamulin Injection is needed for patients with mild or moderate hepatic impairment.
Lefamulin Tablets: Lefamulin Tablets have not been studied in and are not recommended for patients with moderate or severe hepatic impairment. No dosage adjustment of Lefamulin Tablets is needed for patients with mild hepatic impairment.

Important Administration instruction-

Lefamulin Injection: Administer Lefamulin Injection by intravenous infusion over 60 minutes. Must dilute in a 250 ml solution of citrate buffered 0.9% sodium chloride for injection supplied with Lefamulin Injection before use.
Lefamulin Tablets: Take Lefamulin Tablets at least 1 hour before a meal or 2 hours after a meal. Do not crush or divide Lefamulin Tablet.
Missed Dose: If a dose is missed, the patient should take the dose as soon as possible and anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and resume dosing at 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 Lefamulin injection that contains 250 ml citrate buffered 0.9% sodium chloride solution.
Use aseptic technique when adding Lefamulin Injection into the diluent bottle. 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 compatibilities with Lefamulin Injection have not been established.

For the treatment of community-acquired bacterial pneumonia (CABP), the recommended dosage of Lefamulin is 600 mg administered intravenously every 12 hours for 5 to 7 days. For acute bacterial skin and skin structure infections (ABSSSI), the dosage is typically 600 mg intravenously every 12 hours for 5 to 7 days. Dosage adjustments may be required based on individual patient factors and response to treatment.

Administration

Lefamulin is administered via intravenous infusion. The drug should be infused over 60 minutes. The treatment regimen includes twice-daily dosing for a specified duration depending on the type and severity of the infection.

Side Effects

Common side effects of Lefamulin include:

Nausea.
Diarrhea.
Headache.
Injection site reactions (e.g., pain, redness, swelling).

Serious side effects may include:

Hepatotoxicity (liver damage).
Severe allergic reactions.
Clostridium difficile-associated diarrhea (CDAD).

Toxicity

Toxicity from Lefamulin may include liver enzyme abnormalities and gastrointestinal disturbances. Regular monitoring of liver function and gastrointestinal symptoms is necessary to manage and mitigate potential toxic effects.

Precautions

Precautions include:

Monitoring for liver function abnormalities.
Assessment for signs of severe allergic reactions.
Monitoring for symptoms of Clostridium difficile-associated diarrhea.

Interaction

Lefamulin may interact with other medications, particularly those metabolized by the cytochrome P450 enzyme system. It is important to review all concurrent medications with a healthcare provider to avoid potential drug interactions and adjust treatment as needed.

Disease Interaction

Lefamulin should be used with caution in patients with pre-existing liver disease or those with a history of gastrointestinal disorders, particularly those prone to Clostridium difficile infection.

Drug Interaction

Drug interactions may occur with medications that affect liver enzyme activity, particularly CYP3A4. Inform healthcare providers of all medications being taken to manage interactions and adjust dosages as necessary.

Food Interactions

There are no specific food interactions with Lefamulin. The drug can be administered with or without food, and dietary intake does not significantly affect its absorption or efficacy.

Pregnancy Use

The safety of Lefamulin during pregnancy has not been well-established. It should be used during pregnancy only if the potential benefits outweigh the risks. Pregnant women should consult their healthcare provider to discuss the potential risks and benefits.

Lactation Use

It is not known whether Lefamulin is excreted in breast milk. Due to potential risks to the nursing infant, breastfeeding while on Lefamulin is generally not recommended. Women should discuss alternative feeding options with their healthcare provider.

Acute Overdose

Acute overdose of Lefamulin may lead to increased severity of side effects, including liver toxicity and gastrointestinal disturbances. Immediate medical attention is required to manage overdose symptoms and provide appropriate supportive care.

Contraindication

Lefamulin is contraindicated in patients with a known hypersensitivity to the drug or any of its components. It should be used with caution in patients with severe liver impairment or certain other conditions as determined by a healthcare provider.

Use Direction

Lefamulin should be used according to the prescribed dosage and administration schedule provided by the healthcare provider. Regular monitoring and follow-up are important to assess treatment response and manage any potential side effects.

Storage Conditions

Lefamulin should be stored at room temperature, away from moisture and heat. The medication should be kept in its original container and out of reach of children. The expiration date should be checked, and expired medications should be properly disposed of.

Volume of Distribution

The volume of distribution for Lefamulin is not typically specified in the clinical literature, as it is primarily considered in pharmacokinetic studies.

Half Life

The half-life of Lefamulin is approximately 4 to 6 hours. This duration affects the dosing schedule and frequency of administration.

Clearance

Lefamulin is cleared from the body primarily through hepatic metabolism, with metabolites excreted via the feces and urine. The rate of clearance can be influenced by liver function and other individual patient factors.

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