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 a group of penicillin antibiotics known as beta-lactam ring penicillins. It has a bactericidal effect by inhibiting cell wall synthesis in sensitive bacteria. Oxacillin is often used to treat infections caused by penicillinase-producing strains of staphylococci.
2. Ampicillin: Ampicillin also belongs to the group of penicillins 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 infections of the respiratory tract, urinary tract, skin, soft tissue and others.

The combination of ampicillin and oxacillin in the drug Ampiox allows you 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 can be prescribed for the treatment of 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 usually contain antibiotics in the form of powder or granules filled in gel shells.
2. Powder for the preparation of an injection solution: Ampiox can also be supplied in the form of a powder for the preparation of an injection solution. This solution is used for intravenous or intramuscular administration of an antibiotic.

Pharmacodynamics

1. Ampicillin:

   • Ampicillin belongs to the group of semisynthetic penicillins and is a beta-lactam antibiotic.
   • It exerts a bactericidal effect by inhibiting enzymes responsible for transpeptidation, which disrupts cell wall synthesis in susceptible 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 sensitive bacteria, which leads to their death.

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

Ampiox has activity against various bacteria, including both gram-positive and gram-negative organisms. 

1. Gram-positive bacteria:

   • Staphylococci, including penicillinase-producing strains (MRSA) and some methicillin-sensitive 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 sensitive to ampicillin and oxacillin.
   • Some anaerobic bacteria, such as Prevotella and Fusobacterium, especially when they are sensitive to penicillin antibiotics.

Pharmacokinetics

1. Absorption: Ampicillin and oxacillin are usually well absorbed from the gastrointestinal tract after oral administration. They can be administered either orally or in the form of injections.
2. Distribution: Both antibiotics are distributed throughout the tissues and organs of the body, including the lungs, liver, mucous membranes, bladder and others. They can cross the placental barrier and be excreted into 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 required in patients with impaired renal function.
5. Half-life: The half-life of ampicillin and oxacillin in the body is approximately 1-1.5 hours. This means that the drug may require frequent dosing to maintain stable blood concentrations.
6. Time Parameters: Frequent dosing, usually every 4-6 hours throughout the day, may be required to maintain effective levels of the antibiotic in the blood and tissues.
7. Influencing Factors: The pharmacokinetics of ampicillin and oxacillin may be altered by impaired renal or hepatic function, which may require dosage adjustments. 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 weight and condition of the child. Typically, the dosage is 12.5-25 mg of ampicillin and 6.25-12.5 mg of 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 4-6 hours depending on the severity of the infection.
   • For children, the dosage also depends on the weight and condition of the child. Typically, 25-50 mg of ampicillin and oxacillin per 1 kg of body weight every 6 hours is recommended.

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

4. Principles of administration: Take the drug in accordance with your doctor's recommendations and the instructions on the package. Take the tablets or capsules whole, do not split them, and wash them down with water. Injections are usually performed intramuscularly or intravenously.

Use Ampioxa during pregnancy

Use of Ampicillin during pregnancy

1. Effect on fetal and newborn development: Studies have shown that ampicillin has no toxic effects on the developing fetus, but may reduce the body weight of the offspring and the weight of the placenta. At the same time, oxacillin can negatively affect pregnancy, childbirth, the fetus and the newborn. This indicates that ampicillin can be used during pregnancy, whereas oxacillin is associated with higher risks (Korzhova et al., 1981).
2. Placental Transmission 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 amniotic fluid continues to increase until 8 hours after administration and then slowly decreases. This makes ampicillin useful for treating infections in pregnant women and preventing intrauterine infections (Bray et al., 1966).
3. Pharmacokinetics of Ampicillin during Pregnancy: Plasma levels of ampicillin in pregnant women were significantly lower compared to non-pregnant women, which is associated with increased volume of distribution and renal clearance during pregnancy. This indicates the need for dosage adjustments 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 the concentration of conjugated estrogens and progesterone in plasma. This may indicate the effect of ampicillin on hormone metabolism, which requires additional monitoring with 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, reducing the relative weight of the thymus and spleen, but increasing the cellularity of the thymus and lymph nodes. These data indicate the need for careful 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 negative effects on pregnancy, childbirth, the fetus and the newborn. One study found that the use of oxacillin was associated with a high risk to the mother, fetus, and newborn, indicating the need for cautious use of this antibiotic during pregnancy (Korzhova et al., 1981).
2. Transmission through the placenta: Research 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 can 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. Teratogenic Studies: One study conducted in a human population showed that the use of oxacillin during pregnancy does not increase the risk of congenital anomalies in newborns. This study included 14 cases with congenital anomalies and 19 controls and found no increased risk of terratogenic effects (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 the use of Ampiox.
2. History of allergic reactions: Patients with a previous history of allergic reactions to penicillins should be especially careful 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, as its use may contribute to 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 the possible lack of effectiveness of the drug.
7. Conditions requiring special caution: For example, in case of impaired renal or liver function, as well as in pregnant and lactating women, the use of Ampiox requires special caution 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 experience cross-allergy to ampicillin and oxacillin.
2. Diarrhea: Ampicillin and oxacillin may cause diarrhea or loose stools in some patients.
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. Liver and kidney dysfunction: Some patients may experience temporary liver or kidney dysfunction when taking ampicillin and oxacillin.
7. Other reactions: These include headache, crystalluria, anemia, increased activity of 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 functioning of the kidneys or liver.
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 concentration of ampicillin and oxacillin in the blood by reducing their excretion by the kidneys.
2. Methotrexate: Concomitant use of methotrexate and ampicillin may increase the toxicity of methotrexate.
3. Anticoagulants (eg, warfarin): Ampicillin and oxacillin may increase the effect of anticoagulants, which may lead to increased clotting times and bleeding risks.
4. Contraceptives containing estrogens: Ampicillin may reduce the effectiveness of oral contraceptives by increasing their metabolism in the liver.
5. Preparations containing aluminum, magnesium, iron or calcium: These may reduce the bioavailability of ampicillin and oxacillin due to the formation of insoluble complexes.
6. Antifungal drugs such as ketoconazole or fluconazole: These may reduce 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.