What is Beta-lactam Antibiotics Tablets?

Therapeutic Indication

These are the medicines indicated for the following infections in adults and children.

Acute bacterial sinusitis.

• Acute Otitis media
• Acute streptococcal tonsillitis and pharyngitis
• Acute exacerbations of chronic bronchitis
• Community acquired pneumonia
• Acute cystitis
• Asymptomatic Bacteriuria in pregnancy
• Acute pyelonephritis
• Typhoid and paratyphoid fever
• Dental abscess with spreading cellulitis
• Prosthetic joint infections
• Helicobacter pylori eradication
• Lyme disease

Therapeutic Class

Beta-lactam Anti-biotics

Pharmacological Properties

Pharmacodynamic view

Beta lactam antibiotics inhibits one or more enzymes in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

Beta-lactam antibiotics are susceptible to degradation by beta-lactam ases produced by resistant bacteria and therefore the spectrum of activity of Beta-lactam antibiotics alone does not include organisms which produce these enzymes.

Pharmacokinetics view

• Absorption

Beta-lactam antibiotics fully dissociates in aqueous solution at physiological pH. It is rapidly and well absorbed by the oral route of administration. Following oral administration, Beta-lactam antibiotics is approximately 70% bioavailable. The time to peak plasma concentration (T_max) is approximately one hour.

• Distribution

About 18% of total plasma amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.4 l/kg.

Following intravenous administration, Beta-lactam antibiotics has been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Beta-lactam antibiotics does not adequately distribute into the cerebrospinal fluid.

From animal studies there is no evidence for significant tissue retention of drug-derived material. Beta-lactam antibiotics, like most penicillins, can be detected in breast milk

• Elimination

The major route of elimination for Beta-lactam antibiotics is via the kidney.

Beta-lactam antibiotics has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of the Beta-lactam antibiotics is excreted unchanged in urine during the first 6 hours after administration of a single 250 mg or 500 mg dose of Beta-lactam antibiotics. Various studies have found the urinary excretion to be 50-85% for Beta-lactam antibiotics over a 24 hour period.

Dosage and Method of Administration

The dose of Beta lactam antibiotics that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents
• The severity and the site of the infection
• The age, weight and renal function of the patient; as shown below

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.

Method of Administration

Oral/I.M/I.V.

Interactions

• Probenecid:

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of Beta-lactam antibiotics.

• Allopurinol:

Concurrent administration of allopurinol during treatment with Beta-lactam antibiotics can increase the likelihood of allergic skin reactions.

• Tetracyclines :

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of Beta-lactam antibiotics.

• Oral anticoagulants:

Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of Beta-lactam antibiotics.

• Methotrexate

Beta-lactam antibiotics may reduce the excretion of methotrexate causing a potential increase in toxicity.

Contraindications

Beta-lactam antibiotics should not be used in either of any case listed below:

If patients having Hypersenstivity to the active substance or any of an excipients present in the final product.

Side Effects

Diarrhoea, nausea, vomiting, skin rash , dizziness & convulsion (very rare)

Pregnancy and Lactation

• Pregnancy:

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of Beta-lactam antibiotics during pregnancy in humans do not indicate an increased risk of congenital malformations. Beta-lactam antibiotics may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

• Breastfeeding

Beta-lactam antibiotics is excreted into breast milk in small quantities with the possible risk of sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Beta-lactam antibiotics should only be used during breast-feeding after benefit/risk assessment by the physician in charge.

• Precautions

Care is advised in the administration of Beta-lactam to patients with hypersensitivity reactions, renal impairment, convulsions, skin reaction etc.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

• Overdose

In case of overdose treatment should be symptomatic and supportive.

• Storage Condition

Do not store above 25ºC.

Store in the original package in order to protect from moisture.