STARMOVEN 625 TABLETS

Indications

• Bacterial infections of the respiratory tract, such as pneumonia and bronchitis
• Otitis media (middle ear infections)
• Sinusitis
• Skin and soft tissue infections
• Urinary tract infections
• Gonorrhea
• Helicobacter pylori eradication (as part of combination therapy for peptic ulcer disease)

Dosage

Children: Refer to the BNF for Children for appropriate dosing based on the child's age, weight, and clinical condition.

Adults: Refer to specific guidelines or the BNF for appropriate adult dosing based on the indication and severity of the infection.

Mechanism of action

Amoxicillin exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding inhibits the transpeptidation enzyme necessary for cross-linking peptidoglycan layers, ultimately disrupting cell wall synthesis and leading to cell death.

Pharmacodynamics

The pharmacodynamic properties of amoxicillin include its ability to exhibit time-dependent killing, with its efficacy linked to the time that serum concentrations remain above the minimum inhibitory concentration (MIC) for the target organism. Resistance can occur through the production of beta-lactamases, which hydrolyze the beta-lactam ring, rendering the antibiotic ineffective.

Pharmacokinetics

Amoxicillin is well absorbed from the gastrointestinal tract, with bioavailability ranging from 70% to 90%. It is widely distributed in body tissues and fluids, including the lungs, liver, and kidneys. Amoxicillin is minimally metabolized in the liver, with approximately 50-70% of the drug excreted unchanged in the urine. Its half-life is approximately 1 to 1.5 hours, necessitating multiple dosing to maintain effective plasma levels.

Contra-indications

• Hypersensitivity to penicillins
• History of severe allergic reactions to beta-lactam antibiotics

Adverse effects

• Nausea
• Vomiting
• Diarrhea
• Rash
• Allergic reactions
• Anaphylaxis
• Clostridium difficile-associated diarrhea

Interactions

• Probenecid may increase amoxicillin plasma levels
• Oral contraceptives may have reduced efficacy when used with amoxicillin
• Anticoagulants may have increased effects when used with amoxicillin

Precautions

• Use with caution in patients with renal impairment
• Monitor for signs of an allergic reaction
• Consider alternative therapy in patients with a history of gastrointestinal disease

Pregnancy

Amoxicillin is generally considered safe during pregnancy and is often used to treat infections in pregnant women.

Breast-feeding

Amoxicillin is excreted in breast milk, but is usually considered safe for use during breastfeeding.

Storage

Store at room temperature, away from moisture and heat. Reconstituted solutions should be refrigerated and used within a specified time frame.

Formulations

• Capsules
• Tablets
• Oral suspension
• Injection

Indications

• Bacterial infections caused by beta-lactamase-producing organisms
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Intra-abdominal infections

Dosage

Children: Refer to the BNF for Children for appropriate dosing information, as it varies depending on the specific clinical scenario and age of the child.

Adults: Refer to the specific combination product's dosing guidelines, as doses often vary depending on the co-administered antibiotic.

Mechanism of action

Clavulanate works by irreversibly binding to the active site of beta-lactamase enzymes, which are produced by certain bacteria to confer resistance against beta-lactam antibiotics. By inhibiting these enzymes, clavulanate allows the co-administered antibiotic, such as amoxicillin, to retain its antibacterial properties, thereby increasing its effectiveness in treating infections caused by resistant organisms.

Pharmacodynamics

Clavulanate exhibits pharmacodynamic properties that are primarily based on its ability to inhibit beta-lactamase enzymes. The combination of clavulanate with a penicillin enhances the spectrum of activity of the penicillin against beta-lactamase-producing bacteria. The efficacy of this combination is particularly important in treating infections where resistant strains are prevalent.

Pharmacokinetics

Clavulanate is rapidly absorbed from the gastrointestinal tract and reaches peak plasma concentrations within one hour post-administration. It is primarily excreted by the kidneys, with about 60-70% of an oral dose being eliminated unchanged in the urine. The half-life of clavulanate is approximately 1 hour. It is also noted that clavulanate is not extensively metabolized in the liver, which is significant for its safety profile.

Contra-indications

• Hypersensitivity to clavulanate or any component of the formulation
• Severe hepatic impairment
• History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin-clavulanate

Adverse effects

• Nausea
• Vomiting
• Diarrhea
• Rash
• Allergic reactions
• Hepatic enzyme elevation
• Clostridium difficile-associated diarrhea

Interactions

• Probenecid may increase the serum concentration of clavulanate
• Antibiotics may affect the efficacy of oral contraceptives
• May enhance the anticoagulant effect of warfarin

Precautions

• Use with caution in patients with renal impairment
• Monitor liver function in patients with a history of liver disease
• Caution in patients with a history of allergic reactions

Pregnancy

Clavulanate is classified as category B; animal studies have not demonstrated risk to the fetus, but caution is advised when prescribing during pregnancy.

Breast-feeding

Clavulanate is excreted in breast milk, and caution is advised when administered to nursing mothers as effects on the infant are unknown.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Tablets
• Oral suspension
• Injectable forms