Ampiox

Ampiox is a combination drug containing two active ingredients: oxacillin and ampicillin. Both of these ingredients belong to the group of antibiotics from the penicillin class and have a similar mechanism of action.

1. Oxacillin: Oxacillin belongs to the penicillin group of antibiotics known as beta-lactam penicillins. It is bactericidal by inhibiting cell wall synthesis in susceptible bacteria. Oxacillin is often used to treat infections caused by penicillinase-producing strains of staphylococci.
2. Ampicillin: Ampicillin is also a member of the penicillin family and has a similar mechanism of action to oxacillin. It is also bactericidal and is used to treat a wide range of bacterial infections, including respiratory tract infections, urinary tract infections, skin infections, soft tissue infections, and others.

The combination of ampicillin and oxacillin in the drug Ampiox allows to expand the spectrum of action and provide effective treatment of bacterial infections, including those caused by penicillinase-producing strains of staphylococci that may be resistant to one of the components of the drug.

Indications Ampioxa

1. Upper respiratory tract infections: Ampiox can be used to treat bacterial infections of the throat, nose, sinuses, larynx and other upper respiratory tract.
2. Lower respiratory tract infections: The drug may be prescribed to treat bacterial pneumonia, bronchitis and other lower respiratory tract infections.
3. Urinary tract infections: Ampiox can be used to treat cystitis, urethritis, pyelonephritis and other urinary tract infections.
4. Skin and soft tissue infections: The drug can be used to treat bacterial skin infections, including boils, cellulitis and other soft tissue infections.
5. Sepsis and septic endocarditis: In some cases, Ampiox may be prescribed to treat severe infections such as sepsis and septic endocarditis, especially in combination with other antibiotics.

Release form

1. Capsules: Ampiox capsules are also intended for oral administration. They typically contain antibiotics in powder or granule form, filled into gel shells.
2. Powder for injection solution: Ampiox is also available as a powder for injection solution. This solution is used for intravenous or intramuscular administration of the antibiotic.

Pharmacodynamics

1. Ampicillin:

   • Ampicillin belongs to the group of semi-synthetic penicillins and is a beta-lactam antibiotic.
   • It exerts a bactericidal effect by inhibiting enzymes responsible for transpeptidation, which disrupts cell wall synthesis in sensitive bacteria.
   • Ampicillin is active against a wide range of gram-positive and gram-negative bacteria, including streptococci, staphylococci, Haemophilus influenzae, Salmonella and others.

2. Oxacillin:

   • Oxacillin is also a semi-synthetic penicillin, but unlike ampicillin, it is resistant to penicillinases, which can destroy penicillins.
   • This makes oxacillin particularly effective against penicillinase-producing bacteria, such as methicillin-resistant staphylococci (MRSA).
   • Oxacillin also inhibits cell wall synthesis in susceptible bacteria, resulting in their death.

Both components, ampicillin and oxacillin, in a synergistic combination in the drug Ampiox, provide a broad spectrum of antibacterial coverage and effective treatment of various infections.

Ampiox has activity against a variety of bacteria, including both gram-positive and gram-negative organisms.

1. Gram-positive bacteria:

   • Staphylococci, including penicillinase-producing strains (MRSA) and some methicillin-susceptible strains.
   • Streptococci, including Streptococcus pneumoniae and Streptococcus pyogenes.
   • Enterococci.

2. Some gram-negative bacteria:

   • Gram-negative aerobic bacteria such as Haemophilus influenzae and Neisseria gonorrhoeae, especially when they are susceptible to ampicillin and oxacillin.
   • Some anaerobic bacteria, such as Prevotella and Fusobacterium, especially when they are sensitive to penicillin class antibiotics.

Pharmacokinetics

1. Absorption: Ampicillin and oxacillin are generally well absorbed from the gastrointestinal tract after oral administration. They can be administered either orally or by injection.
2. Distribution: Both antibiotics are distributed throughout the body's tissues and organs, including the lungs, liver, mucous membranes, bladder, and others. They can cross the placental barrier and be excreted in breast milk.
3. Metabolism: Ampicillin and oxacillin are metabolized extensively in the liver, where they are converted to inactive metabolites.
4. Excretion: Ampicillin and oxacillin are primarily excreted unchanged via the kidneys by filtration and active secretion. Dosage adjustments may be necessary in patients with renal impairment.
5. Half-life in the body: The half-life of ampicillin and oxacillin in the body is about 1-1.5 hours. This means that the drug may require frequent dosing to maintain stable blood levels.
6. Timing: To maintain effective levels of antibiotic in the blood and tissues, the drug may need to be taken frequently, usually every 4 to 6 hours throughout the day.
7. Influencing factors: The pharmacokinetics of ampicillin and oxacillin may be altered by renal or hepatic impairment, which may require dosage adjustment. It is also important to consider possible interactions with other drugs.

Dosing and administration

1. Tablets and capsules for oral administration:

   • The dosage is usually 250-500 mg ampicillin and 125-250 mg oxacillin every 6 hours, or 500-1000 mg ampicillin and 250-500 mg oxacillin every 8 hours, depending on the severity of the infection.
   • For children, the dosage is determined based on the child's weight and condition. Typically, the dosage is 12.5-25 mg ampicillin and 6.25-12.5 mg oxacillin per 1 kg of weight every 6 hours.

2. Injections:

   • For adults, the dosage may vary from 1 to 2 g of ampicillin and oxacillin every 4 to 6 hours depending on the severity of the infection.
   • For children, the dosage also depends on the child's weight and condition. Usually, 25-50 mg of ampicillin and oxacillin per 1 kg of weight every 6 hours is recommended.

3. Duration of the course: The duration of treatment is usually 7-14 days, but can be extended or shortened depending on the course of the infection and the response to treatment.

4. Directions for use: Take the medication as directed by your doctor and as directed on the package. Swallow the tablets or capsules whole, do not split them, and wash them down with water. Injections are usually given intramuscularly or intravenously.

Use Ampioxa during pregnancy

Use of Ampicillin During Pregnancy

1. Effect on fetal and neonatal development: Studies have shown that ampicillin has no toxic effect on the developing fetus, but may reduce the body weight of the offspring and the weight of the placenta. At the same time, oxacillin may adversely affect pregnancy, labor, the fetus and the neonate. This indicates that ampicillin can be used during pregnancy, while the use of oxacillin is associated with higher risks (Korzhova et al., 1981).
2. Placental Transfer of Ampicillin: Studies have shown that ampicillin rapidly crosses the placenta and reaches therapeutic concentrations in fetal serum and amniotic fluid. The concentration of ampicillin in the amniotic fluid continues to rise for up to 8 hours after administration and then slowly declines. This makes ampicillin useful for the treatment of infections in pregnant women and the prevention of intrauterine infections (Bray et al., 1966).
3. Pharmacokinetics of ampicillin during pregnancy: Plasma levels of ampicillin were significantly lower in pregnant women compared to non-pregnant women, due to an increase in the volume of distribution and renal clearance during pregnancy. This indicates that dosage adjustments are necessary to achieve therapeutic plasma concentrations (Philipson, 1977).
4. Effect of ampicillin on hormone levels: Administration of ampicillin to pregnant women in the last trimester caused a transient decrease in plasma concentrations of conjugated estrogens and progesterone. This may indicate an effect of ampicillin on hormone metabolism, which requires additional monitoring during long-term use (Adlercreutz et al., 1977).
5. Animal studies: Studies in mice have shown that ampicillin affects the development of the lymphatic system of the offspring, decreasing the relative weight of the thymus and spleen but increasing the cellularity of the thymus and lymph nodes. These data indicate the need for caution in the use of ampicillin during pregnancy (Skopińska-Różewska et al., 1986).

Use of Oxacillin During Pregnancy

1. Effects on the fetus and newborn: Studies have shown that oxacillin may have adverse effects on pregnancy, labor, the fetus, and the newborn. One study found that oxacillin use was associated with high risks to the mother, fetus, and newborn, indicating the need for caution in using this antibiotic during pregnancy (Korzhova et al., 1981).
2. Placental Transfer: A study has shown that oxacillin crosses the placenta into the amniotic fluid. Pharmacokinetic data have shown that oxacillin has a relatively low placental permeability coefficient, indicating limited transfer of oxacillin to the fetus (Bastert et al., 1975).
3. Immunological effects: Studies in mice have shown that oxacillin administered during pregnancy may affect the immune system of the offspring. Treatment of pregnant mice with oxacillin increased the immune response in the offspring, indicating a possible effect of oxacillin on the fetal immune system (Dostál et al., 1994).
4. Teratogenicity studies: One study conducted in the human population showed that the use of oxacillin during pregnancy did not increase the risk of congenital anomalies in the newborns. This study included 14 cases with congenital anomalies and 19 controls and did not show an increased risk of teratogenicity (Czeizel et al., 1999).

Contraindications

1. Individual intolerance: Patients with a known allergy to antibiotics from the penicillin group or to any of the components of the drug should avoid using Ampiox.
2. History of allergic reactions: In patients with a previous history of allergic reactions to penicillins, particular caution should be exercised when prescribing Ampiox.
3. Hypersensitivity to beta-lactam antibiotics: In patients with hypersensitivity to beta-lactam antibiotics, including penicillins, the use of Ampiox may be undesirable.
4. Infectious mononucleosis: Ampiox is not recommended for the treatment of infectious mononucleosis because its use may promote the development of a rash.
5. Cytomegalovirus infection and viral hepatitis: The use of Ampiox is not recommended for cytomegalovirus infection or viral hepatitis due to the possibility of developing erythema and dermatitis.
6. Systemic infections requiring hospitalization: In case of severe systemic infections requiring hospitalization, Ampiox may not be the best choice due to possible lack of efficacy of the drug.
7. Conditions requiring special care: For example, in case of impaired renal or hepatic function, as well as in pregnant and lactating women, the use of Ampiox requires special care and supervision by a physician.

Side effects Ampioxa

1. Allergic reactions: This may include skin rash, itching, hives, swelling of the face, throat or tongue, difficulty breathing, anaphylactic shock and other allergic reactions. Patients allergic to penicillins may have a cross-allergy to ampicillin and oxacillin.
2. Diarrhea: In some patients, taking ampicillin and oxacillin may cause diarrhea or loose stools.
3. Changes in gut flora: Taking antibiotics can disrupt the natural balance of gut flora, which can lead to diarrhea or candidiasis (also known as thrush).
4. Respiratory and urinary tract infections: Long-term use of antibiotics may contribute to the development of superinfections, such as respiratory and urinary tract infections caused by antibiotic-resistant microorganisms.
5. Digestive disorders: For example, dyspepsia, nausea, vomiting and other gastrointestinal disorders may occur in some patients.
6. Impaired liver and kidney function: In some patients, temporary impairment of liver or kidney function may occur when taking ampicillin and oxacillin.
7. Other reactions: These include headache, crystalluria, anemia, increased liver enzymes, and others.

Overdose

1. Increased allergic reactions such as skin rash, itching, swelling, difficulty breathing and anaphylactic shock.
2. Gastrointestinal disorders such as nausea, vomiting, diarrhea and dyspepsia.
3. Impaired kidney or liver function.
4. Blood function disorders such as anemia or thrombocytopenia.
5. Headache, dizziness, drowsiness or insomnia.

Interactions with other drugs

1. Probenecid: Probenecid may increase the blood concentration of ampicillin and oxacillin by decreasing their renal excretion.
2. Methotrexate: Concomitant use of methotrexate and ampicillin may increase the toxicity of methotrexate.
3. Anticoagulants (eg, warfarin): Ampicillin and oxacillin may enhance the effect of anticoagulants, which may lead to increased clotting time and increased risk of bleeding.
4. Contraceptives containing estrogens: Ampicillin may reduce the effectiveness of oral contraceptives by increasing their metabolism in the liver.
5. Medicines containing aluminum, magnesium, iron or calcium: They may reduce the bioavailability of ampicillin and oxacillin by forming insoluble complexes.
6. Antifungal drugs such as ketoconazole or fluconazole: These may decrease the effectiveness of ampicillin and oxacillin by inhibiting penicillinase activity.
7. Drugs that cause changes in gastrointestinal pH: Changes in pH may affect the absorption of ampicillin and oxacillin.