BOTA-OXY20 WSP

Indications

• Bacterial infections
• Respiratory tract infections
• Skin infections
• Urinary tract infections
• Acne vulgaris
• Chlamydia infections
• Rickettsial infections
• Mycoplasma pneumonia

Dosage

Children: Refer to BNF for Children for specific dosing recommendations tailored to pediatric populations.

Adults: Refer to the relevant guidelines for specific dosing recommendations, as dosage may vary based on the type and severity of infection.

Mechanism of action

Oxytetracycline exerts its antibacterial effects by binding to the 30S ribosomal subunit of bacteria. This binding inhibits the binding of aminoacyl-tRNA to the mRNA-ribosome complex, thereby preventing protein synthesis. The inhibition of protein synthesis ultimately leads to the death of the bacteria or stops their growth.

Pharmacodynamics

The pharmacodynamic properties of oxytetracycline include its ability to target both dividing and non-dividing bacteria due to its mechanism of action. It has a time-dependent bacteriostatic effect, meaning that the duration of exposure to the drug is more important than the peak concentration achieved. Resistance can develop through various mechanisms, including efflux pumps and ribosomal protection proteins, reducing the effectiveness of the antibiotic.

Pharmacokinetics

Oxytetracycline is well absorbed after oral administration, with peak plasma concentrations occurring 1 to 2 hours post-dose. Its bioavailability can be affected by food and the presence of divalent or trivalent metal ions, which can form insoluble complexes. The drug is distributed widely throughout the body, penetrating various tissues and fluids. It is primarily excreted unchanged in the urine, with some metabolites present. The half-life of oxytetracycline in the plasma is approximately 6 to 12 hours.

Contra-indications

• Hypersensitivity to oxytetracycline or any of its components
• Pregnancy, especially during the second and third trimesters
• Children under 8 years of age due to the risk of permanent tooth discoloration
• Severe liver or kidney impairment

Adverse effects

• Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
• Photosensitivity reactions
• Allergic reactions including rash and anaphylaxis
• Discoloration of teeth and impaired bone growth in children
• Potential for hepatic toxicity
• Superinfection with non-susceptible organisms

Interactions

• Antacids and iron supplements may reduce the absorption of oxytetracycline
• Use with methoxyflurane may increase the risk of nephrotoxicity
• Concurrent use with anticoagulants may enhance the anticoagulant effect
• Tetracyclines may reduce the effectiveness of oral contraceptives

Precautions

• Use with caution in patients with impaired renal function
• Monitor for signs of superinfection during prolonged therapy
• Consider potential for photosensitivity; advise patients to avoid excessive sunlight
• Assess for potential allergic reactions prior to administration

Pregnancy

Oxytetracycline is contraindicated in pregnancy due to the risk of fetal harm, including permanent discoloration of teeth and potential effects on bone development.

Breast-feeding

Oxytetracycline is excreted in breast milk; caution is advised due to the potential for adverse effects in nursing infants, including risk of tooth discoloration.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

• Oral tablets
• Capsules
• Topical ointments or creams