Meiact - General Information:

Meiact is a third-generation cephalosporin antibiotic for oral use. It is commonly marketed under the trade name Spectracef by Cornerstone BioPharma.

Pharmacology:

Meiact pivoxil is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren. Meiact is a cephalosporin with antibacterial activity against gram-positive and gram-negative pathogens. Meiact 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).

Meiact for patients

Patients should be counseled that antibacterial drugs including SPECTRACEF should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When SPECTRACEF is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by SPECTRACEF or other antibacterial drugs in the future.

SPECTRACEF (cefditoren pivoxil) should be taken with meals to enhance absorption.

SPECTRACEF may be taken concomitantly with oral contraceptives.

It is not recommended that SPECTRACEF be taken concomitantly with antacids or other drugs taken to reduce stomach acids.

SPECTRACEF tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF.

Meiact Interactions

Oral Contraceptives

Multiple doses of cefditoren pivoxil had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.

Antacids

Co-administration of a single dose of an antacid which contained both magnesium (800 mg) and aluminum (900 mg) hydroxides reduced the oral absorption of a single 400 mg dose of cefditoren pivoxil administered following a meal, as evidenced by a 14% decrease in mean Cmax and an 11% decrease in mean AUC. Although the clinical significance is not known, it is not recommended that cefditoren pivoxil be taken concomitantly with antacids.

H2-Receptor Antagonists

Co-administration of a single dose of intravenously administered famotidine (20 mg) reduced the oral absorption of a single 400 mg dose of cefditoren pivoxil administered following a meal, as evidenced by a 27% decrease in mean Cmax and a 22% decrease in mean AUC. Although the clinical significance is not known, it is not recommended that cefditoren pivoxil be taken concomitantly with H2 receptor antagonists.

Probenecid

As with other b-lactam antibiotics, co-administration of probenecid with cefditoren pivoxil resulted in an increase in the plasma exposure of cefditoren, with a 49% increase in mean Cmax, a 122% increase in mean AUC, and a 53% increase in half-life.

Drug/Laboratory Test Interactions

Cephalosporins are known to occasionally induce a positive direct Coombs test. A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedicts or Fehlings solution or with CLINITEST tablets), but not with enzyme-based tests for glycosuria (e.g., CLINISTIX, TES-TAPE). As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefditoren pivoxil.

Meiact Contraindications

SPECTRACEF is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components.

SPECTRACEF is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of SPECTRACEF causes renal excretion of carnitine.

SPECTRACEF tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF.

Additional information about Meiact

Meiact Indication: 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 microorganisms in acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, pharyngitis/tonsillitis, and uncomplicated skin and skin-structure infections.
Mechanism Of Action: The bactericidal activity of cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Meiact is stable in the presence of a variety of b-lactamases, including penicillinases and some cephalosporinases.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Cefditoren
Synonyms: Cefditoren Pivaloyloxymethyl Ester; CDTR-PI; Cefditoren Pivoxil
Drug Category: Anti-Bacterial Agents
Drug Type: Small Molecule; Approved
Other Brand Names containing Cefditoren: Meiact; Spectracef;
Absorption: 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%.
Toxicity (Overdose): 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.
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.
Biotransformation: Hydrolysis of cefditoren pivoxil to its active component, cefditoren, results in the formation of pivalate. Cefditoren is not appreciably metabolized.
Half Life: Mean terminal elimination half-life is 1.6 ± 0.4 hours in young healthy adults.
Dosage Forms of Meiact: Tablet Oral
Chemical IUPAC Name: (6R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(Z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Chemical Formula: C19H18N6O5S3
Cefditoren on Wikipedia: http://en.wikipedia.org/wiki/Cefditoren
Organisms Affected: Enteric bacteria and other eubacteria

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