Amoxicillin 500 mg Capsules

Composition:

Each capsule contains:
Amoxicillin trihydrate BP equivalent to 500 mg of amoxicillin.

Excipients:
Magnesium stearate, purified talc, empty hard gelatin capsule shell (bovine gelatin extract, sodium lauryl sulfate, purified water, titanium dioxide).

Indications:

Amoxicillin is indicated for the treatment of the following infections in adults and children:

• Acute bacterial sinusitis

• Acute streptococcal tonsillitis and pharyngitis

• Acute exacerbation of chronic bronchitis / COPD

• Community-acquired pneumonia

• Acute otitis media

• Acute cystitis

• Acute pyelonephritis

• Asymptomatic bacteriuria during pregnancy

• Typhoid and paratyphoid fever

• Dental abscess with spreading cellulitis

• Prosthetic joint infections

• Eradication ofHelicobacter pylori

• Lyme disease

• Endocarditis prophylaxis

Official guidelines on the proper use of antibacterial agents should be considered.

Pregnancy:

Animal studies do not indicate direct or indirect harmful effects on reproductive toxicity. Limited data on the use of amoxicillin in pregnant women do not suggest an increased risk of congenital malformations. Amoxicillin may be used during pregnancy when the potential benefits outweigh the potential risks.

Breastfeeding:

Amoxicillin is excreted in small amounts in breast milk, which may pose a risk of sensitization. In breastfed infants, diarrhea and mucosal fungal infections may occur, so breastfeeding may need to be discontinued. During breastfeeding, amoxicillin should only be used after a careful benefit/risk assessment by the physician.

Fertility:

There are no human data on the effect of amoxicillin on fertility. Animal reproductive studies have shown no effect on fertility.

Dosage:

The dose of amoxicillin for treating infections should be individualized based on:

• Likely pathogens and their expected susceptibility to antibacterial agents

• Site and severity of infection

• Patient’s age, body weight, and renal function

The duration of therapy depends on the type of infection and the patient’s clinical response.

Method of Administration:

Amoxicillin is intended for oral use.
Food does not interfere with its absorption.
Treatment may begin with intravenous administration and continue with oral formulations.
Capsules should be swallowed whole with water andshould not be opened or chewed.
Capsules are not suitable for patients who cannot swallow them.

Storage:

Store below 30°C.
Protect from light and moisture.
Keep all medicines out of the reach of children.