CEFDINIR 125

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COMPOSITION:

Cefdinir................................125 mg

Excipients q.s..................... 1 sachet

(Kyron T112B, colloidal silicon dioxide, aspartame, sodium citrate, anhydrous citric acid, sodium benzoate, orange-flavored powder, povidone K30, sunset yellow, mannitol).

DOSAGE FORM: Granules for oral suspension.

PRESENTATION: Box of 24 sachets x 1.5 g

PHARMACODYNAMICS: Cefdinir is classified as a third generation cephalosporin. Bactericidal activity of cefdinir results from inhibition of bacterial cell wall synthesis. Experiments in vitro and clinical studies showed that cefdinir has an expanded spectrum of activity against gram-negative bacteria e.g. Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including beta - lactamase producing strains) and gram-positive bacteria e.g. Staphylococcus aureus (including beta - lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains), Streptococcus pyogenes. In addition, the results in vitro showed that cefdinir is active against gram-negative bacteria including Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabili and gram-positive bacteria including Staphylococcus epidermidis (methicillin-susceptible strains), Streptococcus agalactiae, Viridans group streptococci. Cefdinir is not affected by some beta - lactamases. Particularly, cefdinir has been shown to be active against gram-positive bacteria, including Staphylococcus sp., Streptococcus sp., resistant to other previously oral cephalosporins. Methicillin-resistant Enterococci (Enterococcus faecalis), Pseudomonas, Enterobacter and Staphylococci are resistant to cefdinir.

A mechanism of bacterial resistance to cefdinir is the reduction of cefdinir affinity to target proteins or the reduction of permeability of bacterial cell membranes to the drug. Cefdinir is highly durable to the hydrolysis of beta-lactamase encoded by plasmid-medicated and chromosome-medicated factors. Cefdinir is stable in the presence of some, but not all, beta-lactamases because resistance to cefdinir is primarily through hydrolysis by some beta-lactamases.

PHARMACOKINETICS: Following oral administration of cefdinir, peak plasma concentrations are attained 2 - 4 hours. Estimated absolute bioavailability is 25% following administration of the oral suspension. 

Cefdinir is distributed into middle ear fluid, tonsils, sinus tissue, bronchial tissue, lung mucosa, etc. at different plasma concentrations. In pediatric patients with acute bacterial otitis media who received single 7- or         14-mg/kg oral doses of cefdinir, median concentrations of the drug in middle ear fluid are 3 hours. The mean volume of distribution of cefdinir in adult subjects is 0.35 L/kg (± 0.29); in pediatric subjects (age 6 months - 12 years), cefdinir is 0.67 L/kg (± 0.38). Cefdinir is 60 - 70% bound to plasma proteins; binding is independent of drug concentration. In pediatric patients 6 months to 12 years of age who received a single 7-mg/kg oral dose of cefdinir as the suspension, peak plasma concentrations were attained 2.2 hours after the dose. Single 14-mg/kg oral doses in these patients resulted in peak plasma concentrations averaging at 1.8 hours after the dose. Concomitant administration of cefdinir oral suspension with a high-fat meal decreases peak plasma concentrations and AUC of the drug by 44% and 33%. There is no evidence that cefdinir accumulates in plasma following multiple doses in patients with normal renal function receiving the drug twice daily.

Cefdinir is not appreciably metabolized. The drug is eliminated principally by renal excretion. In adults with normal renal function, the mean plasma elimination half-life of cefdinir is 1.7 - 1.8 hours. Clearance of cefdinir is decreased in patients with impaired renal function. In patients with creatinine clearances of 30 -               60 ml/minute, peak plasma concentrations and plasma elimination half-life of the drug are increased approximately twofold and the AUC is increased approximately threefold. In patients with creatinine clearances less than 30 ml/minute, peak plasma concentrations are increased approximately twofold but plasma elimination half-life and AUC are increased approximately fivefold and sixfold, respectively. Cefdinir is removed by hemodialysis. A 4-hour period of dialysis removes approximately 63% of the drug and decreases the apparent elimination half-life of cefdinir in patients with substantial renal impairment from 16 to 3.2 hours.

INDICATIONS: For the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Children 6 months to under 13 years: pharyngitis, tonsillitis, acute maxillary sinusitis, acute otitis media, uncomplicated skin and skin structure infections.

Adults and children aged 13 years and more: pharyngitis and tonsillitis, acute exacerbations of chronic bronchitis, acute maxillary sinusitis, community acquired pneumonia, uncomplicated skin and skin structure infections.

CONTRAINDICATIONS: Known allergy to the cephalosporin class of antibiotics or any ingredients of the drug.

PRECAUTIONS: Prior to initiation of cefdinir therapy, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.

Prolonged treatment may result in bacterial and fungal superinfections; especially Clostridium difficile infection which causes diarrhea and colitis.

The cefdinir therapy should be pursued completely whether the symptoms are no longer only after several days of treatment. Premature discontinuation can cause more development of bacteria and recurrent infections and treatment will not be effective with cefdinir or other antibiotics.

Cefdinir should be used with caution in renal impairment patients.

Safety and efficacy in neonates and infants less than 6 months of age have not been established.

The drug should be used with caution in patients with diabetes and phenylketonuria because it contains aspartame.

PREGNANCY AND LACTATION: Pregnancy: Studies in experimental animals have showed that cefdinir is relatively safe when used during pregnancy; there are however, no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.  

Lactation: Following administration of single 600-mg doses, cefdinir was not detected in human breast milk. Cefdinir should be used with caution in nursing mothers.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Cefdinir may cause headache, dizziness; use with caution in drivers and machine users.

INTERACTIONS: Cefdinir should be taken at least 2 hours before or after the antacid or iron supplements by reduction of bioavailability.

Probenecid inhibits the renal excretion of cefdinir.

Influence on the preclinical results: The administration of cefdinir may result in a false-positive reaction for glucose in urine using Benedict's solution, Fehling's solution, or Clinitest. A positive direct Coombs' test may occur.

ADVERSE EFFECTS:

Clinical trials: 2289 pediatric patients (1783 US and 506 international) were treated with the recommended dose of cefdinir suspension (14 mg/kg/day). No deaths or permanent disabilities were attributed to cefdinir. Forty of 2289 (2%) patients discontinued medication due to adverse events thought by the investigators to be associated with cefdinir therapy. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. 5 of 2289 (0.3%) patients were discontinued due to rash thought related to cefdinir administration.

The following adverse events were reported in 1783 cefdinir treated patients in US trials.

Infections: skin candida, vulvovaginal candidiasis, vaginal infection.

Blood and lymphatic system disorders: leukopenia.

Nervous system disorders: hyperkinesia.

Gastrointestinal disorders: diarrhea, nausea, abdominal pain, dyspepsia, vomiting, abnormal faeces.

Skin and subcutaneous tissue disorders: rash, rash maculo-papular.

Investigations: aspartate aminotransferase increased.

Laboratory value changes:

The following laboratory value changes of possible clinical significance, irrespective of relationship to cefdinir therapy, were seen during clinical trials. Those that occurred with an incidence larger or equal to 1%.

Investigations: lymphocyte count increased, lymphocyte count decreased, blood alkaline phosphatase increased, blood bicarbonate decreased, eosinophil count increased, blood lactate dehydrogenase increased, platelet count increased, band neutrophil count increased, band neutrophil count decreased, protein urine present.

In addition to the events reported during the clinical trials, the following adverse events and altered laboratory tests have been reported during extensive post marketing experience, beginning with approval in Japan in 1991.

Infections: pseudomembranous colitis, pneumonia.

Blood and lymphatic system disorders: pancytopenia, agranulocytosis, disseminated intravascular coagulation, aplastic anaemia, leukopenia, thrombocytopenia, granulocytopenia, idiopathic thrombocytopenia purpura, haemolytic anemia, haemorrhagic diathesis, coagulopathy, neutropenia.

Immune system disorders: anaphylactic reaction, hypersensitivity.

Nervous system disorders: loss of consciousness, dyskinesia.

Eye disorders: conjunctivitis.

Cardiac disorders: cardiac failure, myocardial infraction.

Vascular disorders: shock, hypertension, haemorrhage.

Respiratory, thoracic and mediastinal disorders: acute respiratory failure, laryngeal oedema, interstitial lung disease, asthma, eosinophilic pneumonia, suffocation feeling.

Gastrointestinal disorders: enterocolitis haemorrhagic, upper gastrointestinal haemorrhage, diarrhea haemorrhagic, peptic ulcer, ileus, melaena, enterocolitis, stomatitis.

Hepatobiliary disorders: hepatitis fulminant, hepatic failure, hepatitis acute, cholestasis jaundice.

Skin and subcutaneous tissue disorders: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative, erythema nodosum, leukocytolastic vasculitis.

Musculoskeletal and connective tissue disorders: rhabdomyolysis.

Renal and urinary disorders: renal failure acute, nephropathy, nephropathy toxic.

General disorders and administration site conditions: face oedema, pyrexia, chest pain.

Investigations: blood amylase increased.

Inform your doctor or pharmacist of undesirable effects encountered during the treatment.

OVERDOSAGE: Symptoms following overdosage with cefdinir have included nausea, vomiting, epigastric distress, diarrhea, and seizures.

Symptomatic treatment is mainly applied and the drug should be removed from the body. Hemodialysis removes cefdinir from the body.

DOSAGE & ADMINISTRATION:

Dissolve a sufficient amount of water (about 5 - 10 ml for a sachet), stir well before oral administration.

The total daily dose for all infections is 14 mg per kg body-weight, up to a maximum dose of 600 mg per day.

Children 6 months to under 13 years of age:

Pharyngitis, tonsillitis: 7 mg/ kg body-weight twice daily for 5 - 10 days.

                          Or 14 mg/ kg body-weight daily for 10 days.

Acute maxillary sinusitis: 7 mg/ kg body-weight twice daily for 10 days.

                             Or 14 mg/ kg body-weight daily for 10 days.

Acute otitis media: 7 mg/ kg body-weight twice daily for 5 - 10 days.

                      Or 14 mg/ kg body-weight daily for 10 days.

Uncomplicated skin and skin structure infections: 7 mg/ kg body-weight twice daily for 10 days.

For patients with renal impairment (Clcr < 30 ml/ min): 7 mg/ kg body-weight daily.

Adolescents aged 13 years or older/ weighed > 43 kg and adults:

A suitable dosage form should be recommended with the following dosage:

Pharyngitis and tonsillitis: 300 mg twice daily for 5 - 10 days.

                               Or 600 mg once daily for 10 days.

Acute exacerbations of chronic bronchitis: 300 mg twice daily for 5 - 10 days.

                                                 Or 600 mg once daily for 10 days.

Acute maxillary sinusitis: 300 mg twice daily for 10 days.

                             Or 600 mg once daily for 10 days.

Community acquired pneumonia: 300 mg twice daily for 10 days.

Uncomplicated skin and skin structure infections: 300 mg twice daily for 10 days.

For patients with renal impairment (Clcr < 30 ml/ min): 300 mg once daily.

Or as directed by a physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is for prescription only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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