Moxacil PFS

Indications

Moxacil serves as an effective treatment for infections caused by susceptible ß-lactamase negative strains of microorganisms. These encompass:

• Infections of the ear, nose, and throat (such as otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
• Lower respiratory tract infections (including pneumonia, acute and chronic bronchitis, lung abscess, empyema, bronchiectasis)
• Skin and soft tissue infections (like cellulitis, carbuncles, furunculosis, infected wounds, abscess)
• Genito-urinary tract infections (such as pyelonephritis, cystitis, and urethritis)
• Venereal disease (such as acute uncomplicated gonorrhea)
• Short-term therapy for dental abscess
• Combination therapy with Clarithromycin and Lansoprazole (triple therapy) for H. pylori infection and duodenal ulcer disease treatment and recurrence prevention.

Pharmacology

Amoxicillin, a broad-spectrum penicillin, exhibits effectiveness against a wide array of Gram-positive and Gram-negative bacteria by inhibiting cell wall biosynthesis. It remains stable in gastric acid and is quickly absorbed post-oral administration, achieving peak plasma concentration within 1 to 2 hours. Amoxicillin is widely distributed across body tissues and fluids at varying concentrations.

Dosage

For adults: Initiate with 250 mg three times daily, escalating to 500 mg three times daily for severe infections.

For children (up to 10 years of age): Begin with 125 mg three times daily, with the option to increase to 250 mg three times daily for severe infections.

Dosage recommendations for various infections include:

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: 1 g three times daily for adults and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: 500-1000 mg three times daily.
• Dental abscess: 3 gm, repeated after 10-12 hours.
• Urinary tract infections: 3 gm, repeated after 10-12 hours.
• Gonorrhea: Single dose of 2-3 gm with Probenecid 1 gm (Probenecid contraindicated in children under 2 years).
• Adjustments may be necessary in renal impairment.

Administration

Reconstituted suspension can be administered by mixing the required amount with milk, fruit juice, or water, and should be consumed promptly.

Interaction

Concurrent use of Moxacil and Probenecid may elevate and prolong Moxacil blood levels. Moxacil may alter gut flora, potentially reducing estrogen reabsorption and combined oral estrogen/progesterone contraceptives’ efficacy.

Contraindications

Amoxicillin is contraindicated in patients hypersensitive to penicillin.

Side Effects

Side effects, typically mild and transient, may include diarrhea, indigestion, or occasionally rash. Pseudo-membranous colitis has been rarely reported.

Pregnancy & Lactation

US FDA categorizes Amoxicillin as pregnancy category B. However, due to insufficient well-controlled studies in pregnant women, caution is advised regarding its use during pregnancy. Amoxicillin excretion in human milk suggests cautious administration to lactating mothers.

Precautions & Warnings

Superinfections with mycotic or bacterial pathogens may occur during therapy. If superinfections manifest, discontinuation of Moxacil is recommended, followed by appropriate therapy.

Therapeutic Class

Broad-spectrum penicillins

Reconstitution

Amoxicillin 500 mg Injection:

• Intramuscular: Reconstitute by adding 2.5 ml water for injection to the Amoxicillin 500 mg injection vial.
• Intravenous: Dissolve Amoxicillin 500 mg injection in 10 ml water for injection.

Storage Conditions

Store in a dry place away from light and heat, out of reach of children.