Duactilam

Duactilam is a combination drug that contains two active ingredients: ampicillin and sulbactam.

1. Ampicillin is an antibiotic from the semi-synthetic penicillin group that works by killing bacteria or preventing their proliferation. It is effective against a wide range of bacterial infections, including upper and lower respiratory tract infections, urinary tract infections, skin infections, soft tissue infections, gastrointestinal tract infections, and others.
2. Sulbactam is a beta-lactamase that increases the effectiveness of ampicillin. It inhibits the action of beta-lactamase, an enzyme that can break down ampicillin, making it more effective against bacteria that produce this enzyme and are resistant to the antibiotic.

Duactilam is used to treat infections caused by bacteria sensitive to its components and can be used for a variety of medical conditions where antibacterial therapy is required.

Indications Duaktilama

1. Respiratory tract infections:

   • Acute and chronic bronchitis
   • Pneumonia
   • Upper respiratory tract infections, including sinusitis and tonsillitis

2. Urinary tract infections:

   • Acute and chronic pyelonephritis
   • Cystitis
   • Urethritis

3. Skin and soft tissue infections:

   • Abscesses
   • Phlegmon
   • Infected wounds

4. Bone and joint infections:

   • Osteomyelitis
   • Arthritis of bacterial origin

5. Intra-abdominal infections:

   • Peritonitis
   • Cholecystitis
   • Infections after abdominal surgery

6. Gynecological infections:

   • Inflammatory diseases of the pelvic organs
   • Infections after gynecological surgeries

7. Sepsis and bacterial endocarditis.

Release form

Duactilam is available as a powder for solution for injection.

Pharmacodynamics

Duactilam is a combination drug consisting of ampicillin, an antibiotic from the penicillin group, and sulbactam, which is a beta-lactamase inhibitor. Ampicillin works by killing bacteria or preventing them from multiplying by weakening their cell walls, and sulbactam improves the activity of ampicillin by protecting it from the action of beta-lactamases. Thus, Duactilam is effective against a wide range of bacterial infections.

Duactilam is active against a broad spectrum of bacteria, including some gram-positive and gram-negative organisms. These may include bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Escherichia coli and others, but specific susceptibility to the drug may vary depending on the region and time.

Pharmacokinetics

1. Absorption: After oral administration of Duactilam, both components - ampicillin and sulbactam - are absorbed from the gastrointestinal tract. They are rapidly and completely absorbed into the blood.
2. Distribution: Both components have good distribution in body tissues and fluids. They penetrate into many tissues and organs, including the lungs, joints, pleura, skin, bladder, prostate, uterus and other organs.
3. Metabolism: Ampicillin and sulbactam are metabolized in the liver. However, their metabolism is minor.
4. Excretion: Both components are excreted primarily by the kidneys through filtration during the day. Part of the dose may be excreted in the bile.

Typically, the half-life of Duactilam is about 1-1.5 hours.

Dosing and administration

Adults and adolescents over 12 years of age:

• The recommended dose is 1.5-3 g every 6-8 hours depending on the severity of the infection.
• The maximum daily dose should not exceed 12 g.

Children:

• The dosage is calculated based on the child’s body weight: 150 mg/kg per day, divided into 3-4 administrations.
• For newborns (up to 1 week), the dosage is 75 mg/kg per day, divided into 2 administrations.
• For children from 1 to 4 weeks old, the dosage is 100 mg/kg per day, divided into 3 administrations.

Patients with renal insufficiency:

• With creatinine clearance of 15-30 ml/min, the interval between administrations should be at least 12 hours.
• If creatinine clearance is less than 15 ml/min, the interval between administrations should be at least 24 hours.

Instructions for preparation and administration:

1. Preparation of solution:

   • The powder is dissolved in an appropriate volume of sterile water for injection or saline solution.
   • The solution should be used immediately after preparation.

2. Introduction:

   • Duactil is administered intramuscularly or intravenously.
   • When administered intravenously, the solution should be administered slowly (over 30 minutes).
   • For intramuscular injections, the solution must be prepared under sterile conditions and injected deep into the muscle.

Duration of treatment:

• Determined by the physician and depends on the severity of the infection, the patient's response to treatment, and laboratory test results.
• It is important to complete the full course of antibiotics, even if symptoms disappear early, to avoid the development of bacterial resistance.

Use Duaktilama during pregnancy

The question of its safety and effectiveness during pregnancy is important to ensure the well-being of both mother and fetus.

Efficiency and research results

1. Pharmacokinetics in pregnancy: Studies have shown that pregnancy significantly increases the rate of elimination of ampicillin and sulbactam, requiring dosage adjustments to achieve therapeutic effect (Chamberlain et al., 1993).
2. Prevention of infections after cesarean section: Ampicillin/sulbactam was found to be as effective as cefotetan in preventing postoperative infections in high-risk women after cesarean section (Bracero, 1997).
3. Treatment of neonatal infections: The drug, given to the mother before delivery, significantly reduced colonization and bacteremia in neonates, indicating its effectiveness in preventing neonatal infections (Mcduffie et al., 1996).
4. Premature rupture of membranes: Ampicillin/sulbactam was not associated with an increased risk of necrotizing enterocolitis in neonates and was effective in prolonging the time to delivery (Ehsanipoor et al., 2007).
5. Treatment of gynecological infections: Ampicillin/sulbactam has shown high efficacy in the treatment of various gynecological infections, including endometritis and infections following first trimester abortions (Giamarellou et al., 1986).

Duactilam is an effective and safe drug for the treatment and prevention of various bacterial infections during pregnancy. However, due to altered pharmacokinetics during pregnancy, careful adjustment of dosage and administration intervals is recommended to achieve optimal therapeutic effect.

Contraindications

Contraindications to the use of Duactilam may include:

1. Known allergy or hypersensitivity to ampicillin, sulbactam or other penicillin antibiotics, cephalosporins or other components of the drug.
2. History of serious allergic reaction (including anaphylaxis) to previous antibiotic use.
3. Pre-existing porphyria while taking ampicillin.
4. Severe liver or kidney dysfunction.
5. History of antibiotic-associated colitis.
6. The presence of infections caused by viruses, such as the flu or cold, for which antibiotics are not an effective treatment.

Side effects Duaktilama

Side effects of Duactilam may include allergic reactions such as urticaria or angioedema, as well as diarrhea, nausea, vomiting, dyspepsia and dysbacteriosis. In rare cases, anemia, leukopenia, thrombocytopenia, and liver or kidney dysfunction may occur.

Overdose

Overdose of Duactilam may result in increased side effects such as diarrhea, nausea, vomiting, and other possible drug-related reactions.

Interactions with other drugs

1. Antibiotics: Using Duactilam with other antibiotics, especially tetracyclines or macrolides, may reduce their effectiveness.
2. Antiepileptic drugs: Duactilam may decrease the blood levels of antiepileptic drugs such as carbamazepine and phenytoin, which may reduce their effectiveness.
3. Antifungal drugs: Using Duactilam concomitantly with antifungal drugs such as ketoconazole or fluconazole may increase the concentration of ampicillin in the blood.
4. Anticonvulsants: Interaction of Duactilam with anticonvulsants such as benzodiazepines may enhance their adverse effects such as sedation and decreased reaction time.
5. Methotrexate: Using Duactilam with methotrexate may increase the toxic effects of methotrexate on the body.