Ximeprox Drop

Indications

Ximeprox is prescribed for the management of infections caused by susceptible microorganisms, including:

• Acute Otitis Media: Caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, and Moraxella catarrhalis (including strains that produce beta-lactamase).
• Pharyngitis/Tonsillitis: Resulting from Streptococcus pyogenes.
• Acute Maxillary Sinusitis: Due to Haemophilus influenzae (including beta-lactamase producers), Streptococcus pneumoniae, and Moraxella catarrhalis.
• Community-Acquired Pneumonia: Caused by S. pneumoniae or H. influenzae (including beta-lactamase-producing strains).
• Acute Bacterial Exacerbation of Chronic Bronchitis: Attributed to S. pneumoniae, H. influenzae (only non-beta-lactamase-producing strains), or M. catarrhalis.
• Skin and Skin Structure Infections: Caused by Staphylococcus aureus and Streptococcus pyogenes.
• Uncomplicated Urinary Tract Infections: Due to E. coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.
• Uncomplicated Gonorrhea: Caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
• Rectal Gonococcal Infections in Women: Resulting from Neisseria gonorrhoeae (including penicillinase-producing strains).

Note: Please consult a registered medical practitioner before using this medication.

Pharmacology

Ximeprox contains Cefpodoxime, a third-generation cephalosporin that exhibits excellent stability against beta-lactamases and effectiveness against both Gram-positive and Gram-negative bacteria. It is indicated for treating infections even before the specific pathogen is identified. As a prodrug, Cefpodoxime is metabolized to its active form, Cefpodoxime. Approximately 29% to 33% of Cefpodoxime is excreted unchanged in the urine within 12 hours.

This medication is effective against a broad spectrum of Gram-positive and Gram-negative bacteria, including strains resistant to beta-lactamase. Susceptible organisms include:

• Gram-positive Bacteria: S. aureus (including penicillinase-producing strains), S. saprophyticus, S. pneumoniae, S. pyogenes, S. agalactiae, P. magnus.
• Gram-negative Bacteria: E. coli, K. pneumoniae, H. influenzae (including beta-lactamase producers and ampicillin-resistant strains), M. catarrhalis, N. gonorrhoeae (including penicillinase-producing strains), P. mirabilis, C. diversus, H. parainfluenzae, K. oxytoca, P. vulgaris, P. rettgeri.

Dosage & Administration Adults and Adolescents (13 years and older):

• Pharyngitis/Tonsillitis: 100 mg every 12 hours for 5 to 10 days
• Acute Maxillary Sinusitis: 200 mg every 12 hours for 10 days
• Community-Acquired Pneumonia: 200 mg every 12 hours for 14 days
• Acute Bacterial Exacerbations of Chronic Bronchitis: 200 mg every 12 hours for 10 days
• Skin and Skin Structure Infections: 400 mg every 12 hours for 7 to 14 days
• Uncomplicated Urinary Tract Infections: 100 mg every 12 hours for 7 days
• Uncomplicated Gonorrhea: Single dose of 200 mg
• Rectal Gonococcal Infections in Women: Single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years):

• Acute Otitis Media: 5 mg/kg body weight every 12 hours for 5 days
• Pharyngitis/Tonsillitis: 5 mg/kg body weight every 12 hours for 5 to 10 days
• Acute Maxillary Sinusitis: 5 mg/kg body weight every 12 hours for 10 days

Patients with Renal Dysfunction: In patients with severe renal impairment (creatinine clearance <30 ml/min), the dosing interval should be extended to every 24 hours.

Patients with Liver Cirrhosis: The pharmacokinetics of Cefpodoxime Proxetil in cirrhotic patients are comparable to those in healthy individuals, so no dose adjustment is necessary.

Note: Please consult a registered medical practitioner before using this medication.

Interactions

• Antacids: Concurrent use of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers can reduce peak plasma levels by 24% to 42% and absorption by 27% to 32%.
• Probenecid: Co-administration of probenecid can inhibit renal excretion of Cefpodoxime, leading to an approximately 31% increase in AUC.
• Nephrotoxic Drugs: Close monitoring of renal function is recommended when Ximeprox is used alongside known nephrotoxic agents.

Contraindications

Cefpodoxime Proxetil is contraindicated in individuals with a known allergy to Cefpodoxime or any cephalosporin antibiotics.

Side Effects

Ximeprox is generally well-tolerated, but possible side effects may include diarrhea, nausea, skin and vaginal fungal infections, abdominal pain, headache, chest pain, myalgia, dyspepsia, dizziness, vertigo, and cough. The incidence of fungal skin rashes may be higher in children compared to adults.

Pregnancy & Lactation

Cefpodoxime has shown no teratogenic or embryocidal effects in animal studies. However, adequate and well-controlled studies in pregnant women are lacking. This medication should only be used during pregnancy if absolutely necessary. Since Cefpodoxime is excreted in human milk, a decision must be made whether to discontinue breastfeeding or to stop the drug.

Precautions & Warnings

For patients with reduced urinary output due to renal insufficiency, the total daily dose of Ximeprox should be decreased. Caution is advised when administering Ximeprox to patients on potent diuretics. As with other broad-spectrum antibiotics, prolonged use may lead to the overgrowth of non-susceptible organisms, necessitating ongoing evaluation of the patient’s condition.

Therapeutic Class

Third Generation Cephalosporins

Reconstitution

To prepare a 50 ml suspension, add 30 ml (6 teaspoonfuls or using the provided cup) of cooled boiled water to the dry powder in the bottle. For ease of mixing, add water in two portions, shaking well after each addition until fully dissolved.

Note:

Shake the suspension well before each use. Keep the bottle tightly closed. Store the reconstituted suspension in a cool, dry place, preferably in the refrigerator. Discard any unused portion after 14 days.

Storage Conditions

Store in a dry location away from light and heat. Keep out of reach of children.