Spectracef 200 mg

Spectracef 200 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Spectracef 200 mg inhibits the synthesis of bacterial cell wall. It has high affinity to penicillin-binding proteins (PBPs) in various bacteria, showing a bactericidal effect.

Spectracef 200 mg pivoxil is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren. Spectracef 200 mg is a cephalosporin with antibacterial activity against gram-positive and gram-negative pathogens. Spectracef 200 mg is effective against Staphylococcus aureus (methicillin-susceptible strains, including b-lactamase-producing strains), penicillin-susceptible strains of Staphylococcus aureus and Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae (including b-lactamase-producing strains), Haemophilus parainfluenzae (including b-lactamase-producing strains), Moraxella catarrhalis (including b-lactamase-producing strains), Streptococcus agalactiae, Streptococcus Groups C and G, and Streptococcus, viridans group (penicillin-susceptible and -intermediate strains).

Trade Name Spectracef 200 mg
Availability Discontinued
Generic Cefditoren
Cefditoren Other Names Cefditoren, Cefditoreno
Related Drugs amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, Augmentin
Type
Formula C19H18N6O5S3
Weight Average: 506.578
Monoisotopic: 506.050079786
Protein binding

Binding of cefditoren to plasma proteins averages 88% from in vitro determinations, and is concentration-independent at cefditoren concentrations ranging from 0.05 to 10 mg/mL.

Groups Approved, Investigational
Therapeutic Class Third generation Cephalosporins
Manufacturer
Available Country Portugal
Last Updated: September 19, 2023 at 7:00 am
Spectracef 200 mg
Spectracef 200 mg

Uses

Spectracef 200 mg 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

Spectracef 200 mg 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 Spectracef 200 mg works

The bactericidal activity of cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Spectracef 200 mg is stable in the presence of a variety of b-lactamases, including penicillinases and some cephalosporinases.

Dosage

Spectracef 200 mg 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.

Spectracef 200 mg should be taken after meals.

Side Effects

The most common side effects of Spectracef 200 mg 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.

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. Spectracef 200 mg should be used during pregnancy only if clearly needed.

Lactation: Animal studies show that Spectracef 200 mg excreted in breast milk. Caution should be exercised when Spectracef 200 mg 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 Spectracef 200 mg 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 Spectracef 200 mg 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

You find simplified version here Spectracef 200 mg

Spectracef 200 mg contains Cefditoren see full prescribing information from innovator Spectracef 200 mg Monograph, Spectracef 200 mg MSDS, Spectracef 200 mg FDA label

*** Taking medicines without doctor's advice can cause long-term problems.
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