Proxecef Dt

Uses

Proxecef Dt is used for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below:

• Acute Bacterial Exacerbation of Chronic Bronchitis
• Community Acquired Pneumonia
• Pharyngitis
• Tonsillitis
• Uncomplicated Skin and Skin-Structure Infections

Proxecef Dt is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Bacterial Infections, Community Acquired Pneumonia (CAP), Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated skin and subcutaneous tissue bacterial infections

How Proxecef Dt works

The bactericidal activity of cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Proxecef Dt is stable in the presence of a variety of b-lactamases, including penicillinases and some cephalosporinases.

Dosage

Proxecef Dt dosage

Community-Acquired Pneumonia: 400 mg twice daily for 14 days.

Acute Exacerbation of Chronic Bronchitis: 400 mg twice daily for 10 days.

Pharyngotonsillitis and Acute Sinusitis: 200 mg twice daily for 10 days.

Uncomplicated Skin and Soft Structure Infections: 200 mg twice daily for 10 days.

Proxecef Dt should be taken after meals.

Side Effects

The most common side effects of Proxecef Dt are diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, vomiting, abnormal dreams, allergic reaction, anorexia, constipation, dizziness, dry mouth and fever.

Toxicity

Information on cefditoren pivoxil overdosage in humans is not available. However, with other b-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. In acute animal toxicity studies, cefditoren pivoxil when tested at the limit oral doses of 5100 mg/kg in rats and up to 2000 mg/kg in dogs did not exhibit any health effects of concern.

Precaution

Cefditor should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance< 30 ml/min)

Interaction

Co-administration of a single dose of an antacid and H2 receptor antagonists may reduce the oral absorption of cefditoren pivoxil. As with other beta-lactam antibiotics, co-administration of probenecid with cefditoren pivoxil resulted in an increase in the plasma exposure of cefditoren.

Food Interaction

• Avoid multivalent ions. Avoid antacids containing magnesium and aluminum hydroxides when possible, otherwise separate the administration of antacids and this drug by several hours.

[Moderate] ADJUST DOSING INTERVAL: Food enhances the oral absorption and bioavailability of cefditoren pivoxil.

According to the manufacturer, administration of cefditoren pivoxil following a high-fat meal increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) by 50% and 70%, respectively, compared to administration in the fasting state.

The absolute bioavailability of cefditoren pivoxil is approximately 14% under fasting conditions and 16% when given with a low-fat meal.

MANAGEMENT: To ensure maximal oral absorption, cefditoren pivoxil should be administered with or immediately after a meal.

Proxecef Dt Drug Interaction

Unknown: 5-hydroxytryptophan, 5-hydroxytryptophan, acetaminophen, acetaminophen, aspirin, aspirin, alprazolam, alprazolam, glimepiride, glimepiride, amoxicillin / clavulanate, amoxicillin / clavulanate, acetaminophen, acetaminophen, multivitamin, multivitamin, cholecalciferol, cholecalciferol, diclofenac, diclofenac

Proxecef Dt Disease Interaction

Major: colitis, carnitine deficiencyModerate: renal dysfunction, dialysis, liver disease, seizure disorders

Volume of Distribution

• 9.3 ± 1.6 L

Elimination Route

Following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. Under fasting conditions, the estimated absolute bioavailability of cefditoren pivoxil is approximately 14%. The absolute bioavailability of cefditoren pivoxil administered with a low fat meal (693 cal, 14 g fat, 122 g carb, 23 g protein) is 16.1 ± 3.0%.

Half Life

Mean terminal elimination half-life is 1.6 ± 0.4 hours in young healthy adults.

Clearance

• renal cl=4-5 L/h [oral administration]

Elimination Route

Pivalate is mainly eliminated (>99%) through renal excretion, nearly exclusively as pivaloylcarnitine.

Pregnancy & Breastfeeding use

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Proxecef Dt should be used during pregnancy only if clearly needed.

Lactation: Animal studies show that Proxecef Dt excreted in breast milk. Caution should be exercised when Proxecef Dt is administered to nursing women.

Contraindication

Contraindicated in patients hypersensitive to drug or other cephalosporins. Also contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. Because cefditoren tablets contain sodium caseinate, a milk protein, don't give to patients hypersensitive to milk protein (as distinct from those with lactose intolerance).

Acute Overdose

Information on Proxecef Dt overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of Proxecef Dt from the body, particularly if renal function is compromised.

Storage Condition

Store in a cool (below 25° C) and dry place protected from light.

Innovators Monograph

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