Ampicillin Oral Suspension BP

Name of Medicinal Product

Ampicillin Oral Suspension

Pharmaceutical form – Strength and Pack size

1. Pharmaceutical form: Dry Powder
2. Description: A yellow coloured crystalline powder which forms a yellowish coloured viscous suspension with the characteristic strawberry flavour packed in plastic bottles.
3. Strength: Each 5mL when reconstituted contains: Ampicillin Trihydrate BP equivalent to Ampicillin … 125mg
4. Pack Size: 100mL

Therapeutic Category

Penicillin Anti-Bacterial

Indications

• Ampicillin is a penicillin antibiotic that is used to treat or prevent many different types of infections such as bladder infections, pneumonia, gonorrhea, meningitis, or infections of the stomach or intestines.
• Ampicillin works by killing bacteria that cause infections

such as:

1. ear, nose and throat infections
2. bronchitis, pneumonia, chest infections
3. urinary tract infections
4. sexually transmitted infections
5. skin and soft tissue infections
6. gastrointestinal infections
7. blood poisoning.

Contra-indications

• Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients.
• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

Precautions / Warnings

Precautions

👉    General

• Prolonged use may promote the overgrowth of non-susceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken. 
• Patients with gonorrhea who also have syphilis should be given additional appropriate parenteral penicillin treatment. Treatment with ampicillin does not preclude the need for surgical procedures, particularly in staphylococcal infections.

👉    Laboratory Tests

• In prolonged therapy, and particularly with high dosage regimens, periodic evaluation of the renal, hepatic, and hematopoietic systems is recommended.
• In streptococcal infections, therapy must be sufficient to eliminate the organism (10 days minimum); otherwise the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated.
• Cases of gonococcal infection with a suspected lesion of syphilis should have darkfield examinations ruling out syphilis before receiving ampicillin. Patients who do not have suspected lesions of syphilis and are treated with ampicillin should have a follow- up serologic test for syphilis each month for four months to detect syphilis that may have been masked from treatment for gonorrhea.

Warnings

• Serious and occasional fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral administration, it has occurred in patients on oral penicillins. 
• These reactions are more apt to occur in individuals with a history at penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been well documented reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with cephalosporins. 
• Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. 
• Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

• Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ampicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. 
• Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by clostridium difficile, is one primary cause of "antibiotic-associated colitis". After the diagnosis of pseudomembranous colitis has bean established, therapeutic measures should be initiated. 
• Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Pregnancy and Lactation

Pregnancy

• Safe use during pregnancy hasn’t been established, but drug has been used to treat urinary tract infections in pregnant women without affecting the fetus.

Lactation

• Use cautiously. Ampicillin is distributed readily into breast milk; safety in breast-feeding women hasn’t been established.

Side effects / Adverse reactions

1. Central Nervous System: lethargy, hallucinations, seizures, anxiety, confusion, agitation, depression, dizziness, fatigue.
2. Cardio Vascular System: thrombophlebitis, vein irritation.
3. Gastro Intestinal: Nausea, vomiting, diarrhea, glossitis, stomatitis, gastritis, abdominal pain, enterocolitis, pseudomembranous colitis, black "hairy" tongue.
4. GU: Interstitial nephritis, nephropathy, vaginitis. Hematologic: anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, hemolytic anemia, agranulocytosis.
5. Other: hypersensitivity reactions (erythematous maculopapular rash, urticaria, anaphylaxis), overgrowth of non-susceptible organisms, pain at injection site.

Drug Interactions

1. Allopurinol: Appears to increase occurrence of rash from both drugs. Monitor patient closely.
2. Aminoglycoside antibiotics: Cause synergistic bactericidal effect against some strains of enterococci and group B streptococci. However, drugs are physically and chemically incompatible and are inactivated if mixed or given together. Don’t mix together.
3. Hormonal contraceptives: May decrease effects of hormonal contraceptives. Advise using alternative barrier method.
4. Methotrexate: Large doses of penicillins may interfere with renal tubular secretion of methotrexate, delaying elimination and elevating serum methotrexate level. Monitor patient for methotrexate toxicity.
5. Probenecid: Inhibits renal tubular secretion of ampicillin, raising its serum level. Avoid use together.

Dosage & Administration

• The dose of Ampicillin that is selected to treat an individual infection should take into account:

1. The expected pathogens and their likely susceptibility to antibacterial agents
2. The severity and the site of infection
3. The age, weight and renal function of the patient; as shown below
4. The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment.

👉The dose should be reduced in renal failure. The usual dose of Ampicillin Oral Suspension is as follows:

1. Adult: 250mg to 750 mg four times a day or more frequently according to the severity of infection.
2. Children under 10 years: half the adult dose four times a day. or As directed by the Physician.

👉   Dosage for genitourinary tract infections or gonorrhea

Adult dosage (ages 18–64 years): For genitourinary tract infections other than gonorrhea: Typical dosage is 500 mg four times per day. Severe or chronic infections may require larger doses.

👉 For gonorrhea: Typical dosage is 3.5 grams once, with 1 gram of probenecid.

Child dosage (children who weigh more than 20 kg): For genitourinary tract infections other than gonorrhea: Typical dosage is 500 mg four times per day.

Child dosage (children who weigh 20 kg or less): For genitourinary tract infections: Typical dosage is 100 mg/kg per day in four equally divided and spaced doses.

For gonorrhea: Typical dosage is 3.5 grams as a single dose.

Child dosage (children who weigh less than 20 kg): For genitourinary tract infections: Typical dosage is 100 mg/kg per day in four equally divided and spaced doses.

👉   Dosage for respiratory tract infections

Adult dosage (ages 18–64 years): Typical dosage is 250 mg four times per day.

Child dosage (children ages 0–17 years who weigh more than 20 kg): Typical dosage is 250 mg four times per day.

Child dosage (children ages 0–17 years who weigh 20 kg or less): Typical dosage is 50 mg/kg per day in equally divided and spaced doses three to four times per day.

👉   Dosage for gastrointestinal tract infections

Adult dosage (ages 18–64 years): Typical dosage is 500 mg four times per day.

Child dosage (children who weigh more than 20 kg): Typical dosage is 500 mg four times per day.

Child dosage (children who weigh 20 kg or less): Typical dosage is 100 mg/kg per day in four equally divided and spaced doses.

👉   Dosage for meningitis

Adult dosage (ages 18–64 years): As describe by Physician.

Child dosage (ages 0–17 years): As describe by Physician.

Over dosage

• Signs of overdose include neuromuscular sensitivity and seizures. After recent ingestion (within 4 hours), empty the stomach by induced emesis or gastric lavage; follow with activated charcoal to reduce absorption. Drug can be removed by hemodialysis.

Effects on ability to drive and use machines

• No data available on the effects of ability to drive and use machines.
• However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines

Shelf life

• 24 months from the date of manufacturing

Special precautions for storage

• Store in a cool place in well-closed container. Protect from light, heat and moisture.
• Keep out of reach of Children.
• Shake well before use.