HAGINIR 125 DT

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INFORMATION FOR MEDICAL STAFF

COMPOSITION:

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

Excipients q.s........................................ 1 tablet

(Pregelatinized starch (national 78-1551), microcrystalline cellulose M112, croscarmellose sodium, tutti frutti flavor, orange-flavored powder, sucralose, magnesium stearate).

PHARMACEUTICAL FORM: Dispersible tablet.

PHARMACODYNAMIC PROPERTIES:

ATC code: J01DD15

Haginir DT 125 contains the active ingredient cefdinir which 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.

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

Following oral administration, cefdinir is distributed into middle ear fluid, tonsils, sinus tissue, bronchial tissue, and lung mucosa, etc. at different plasma concentrations. In pediatric patients with acute bacterial otitis media, respective median middle ear fluid cefdinir concentrations are 3 hours after administration of single 7- or 14-mg/kg doses. Cefdinir is 60% to 70% bound to plasma proteins; binding is independent of 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 at 1.8 hours after the dose. Concomitant administration of cefdinir oral suspension with a high-fat meal decreased peak plasma concentrations and AUC of the drug by 44 and 33%, respectively. 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 decreases 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 the elimination half-life of cefdinir in patients with substantial renal impairment decreases from 16 to 3.2 hours.

PRESENTATION: Box of 2 blisters x 10 tablets.

THERAPEUTIC INDICATIONS:

For the treatment of 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.

DOSAGE & ADMINISTRATION: The tablet(s) should be dissolved in a sufficient amount of water (about 5-10 ml for one tablet), stirred well before use.

The total daily dose for all infections is 14 mg/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/day for 10 days.

Acute maxillary sinusitis: 7 mg/kg body weight twice daily for 10 days. Or 14 mg/kg body weight/day for 10 days.

Acute otitis media: 7 mg/kg body weight twice daily for 5 - 10 days. Or 14 mg/kg body weight/day for 10 days.

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

Patients with renal insufficiency (CrCl < 30 ml/min): 7 mg/kg body weight/day.

Or as directed by a physician.

CONTRAINDICATIONS:

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

PRECAUTIONS: Before therapy with cefdinir is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If an allergic reaction to cefdinir occurs, the drug should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine (adrenaline) and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, and airway management, as clinically indicated.

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

The cefdinir therapy should be pursued 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.

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 of the drug on works:

Cefdinir may cause headache, dizziness; use with caution in persons during using machines, driving, working at high places, and other cases.

INTERACTIONS:

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

Probenecid inhibits the renal excretion of cefdinir.

Iron supplements and foods fortified with iron: Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the supplement. The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on cefdinir absorption has not been studied. Concomitantly administered iron-fortified infant formula has no significant effect on cefdinir pharmacokinetics.

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.

UNDESIRABLE EFFECTS: Adverse effects reported with cefdinir are similar to those reported with other oral cephalosporins.

Diarrhea, the most frequent adverse effect, has been reported in 16% of adult or adolescent patients and in 8% of pediatric patients. Adverse effects usually are transient and mild in severity, but require discontinuance of the drug in up to 3% of patients.

Rarely: Nausea, vomiting, abdominal pain, anorexia, constipation, headache, dizziness, stomatitis, fungal infections, vitamin K deficiency, elevated liver enzymes, increased BUN (Blood urea nitrogen). Allergic reactions, anaphylaxis, Stevens - Johnson syndrome, erythema multiforme, toxicity, epidermal necrolysis, renal dysfunction, nephrotoxicity, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary tract, leukopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after cefdinir treatment.

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

Symptomatic treatment is mainly. Cefdinir is removed from the blood by hemodialysis.

Read the direction carefully before use.

For more information, please consult a physician.

The drug is for prescription only.

STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: June 5, 2018.

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