Trinir

Each hard gelatin capsule contains: Cefdinir USP equivalent to anhydrous Cefdinir 300 mg.
Each 5 mL of reconstituted suspension contains: Cefdinir USP equivalent to anhydrous Cefdinir 125 mg.
Cap: Off white to yellow coloured, granular powder filled in blue/blue coloured, hard gelatin capsule of size 1.
Suspension: Yellow coloured, crystalline powder with characteristic odour.

Pharmacology: Pharmacodynamics: Cefdinir exhibits broad range in vitro activity against Gram-positive and Gram-negative aerobes. It exhibits superior activity against Gram-positive aerobes, compared with drugs like Cefixime, Ceftibuten, Cefuroxime and Cefpodoxime. In addition, it is stable to hydrolysis by many of the common beta-lactamases. The pharmacokinetic parameters of Cefdinir in children are similar to those obtained in adults using similar milligram per m² doses (300, 600 mg in adults= 7, 14 mg/kg in children, respectively).
Pharmacokinetics: Cefdinir is absorbed from the gastrointestinal tract after oral doses, peak plasma concentrations occurring 2 to 4 hours after a dose. Oral bioavailability has been estimated to range from 16 to 25%. It is widely distributed into tissues and is 60 to 70% bound to plasma proteins. Cefdinir is not appreciably metabolised and is excreted in the urine with an elimination half-life of 1.7 hours. Cefdinir is removed by dialysis.
Cap: Absorption: Maximal plasma Cefdinir concentrations occur 2 to 4 hours post dose following capsule or suspension administration. Plasma Cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, Cefdinir bioavailability is 120% relative to capsules.
Distribution: The mean volume of distribution (Vd_area) of Cefdinir in adult subjects is 0.35 L/kg (± 0.29); in pediatric subjects (age 6 months to 12 years), Cefdinir Vd_area is 0.67 L/kg (± 0.38).
Cefdinir is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.
Metabolism and Excretion: Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t_½) of 1.7 (± 0.6) hours. In healthy subjects with normal renal function, renal clearance is 2 (± 1) mL/min/kg, and apparent oral clearance is 11.6 (± 6) and 15.5 (± 5.4) mL/min/kg following doses of 300 and 600 mg, respectively. Mean percent of dose recovered unchanged in the urine following 300 and 600 mg doses is 18.4% (± 6.4) and 11.6% (± 4.6), respectively. Cefdinir clearance is reduced in patients with renal dysfunction.
Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis.

It is used to treat gonorrhea, otitis media, pharyngitis, lower respiratory tract infections such as bronchitis and urinary tract infections due to susceptible microorganisms.

It is given orally in a usual adult dose of 600 mg daily as a single dose or in two divided doses.
Children may be given 14 mg/kg daily up to a maximum of 600 mg daily. Doses may need to be reduced in patients with renal impairment. Or as prescribed by the physician.

Information on cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

There have been reports of reddish stools in patients given cefdinir with iron supplements.
Suspension: Before therapy with Cefdinir is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to Cefdinir, other cephalosporins, penicillins, or other drugs. If Cefdinir is to be given to penicillin sensitive patients, caution should be exercised because cross hypersensitivity among β-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefdinir occurs, the drug should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Use in Children: Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients (age 6 months through 12 years) is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.
Use in the Elderly: Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised.

Pregnancy: Teratogenic Effects: Pregnancy Category B.
Cefdinir was not teratogenic in rats at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m²/day) or in rabbits at oral doses up to 10 mg/kg/day (0.7 times the human dose based on mg/kg/day, 0.23 times based on mg/m²/day). Maternal toxicity (decreased body weight gain) was observed in rabbits at the maximum tolerated dose of 10 mg/kg/day without adverse effects on offspring. Decreased body weight occurred in rat fetuses at ≥100 mg/kg/day, and in rat offspring at ≥32 mg/kg/day. No effects were observed on maternal reproductive parameters or offspring survival, development, behavior, or reproductive function.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Suspension: Labor and Delivery: Cefdinir has not been studied for use during labor and delivery.
Nursing Mothers: Following administration of single 600-mg doses, cefdinir was not detected in human breast milk.

Cap: The adverse effects associated with cefdinir and other cephalosporins are broadly similar to those described for penicillins. The most common are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness and anaphylaxis.
There may be a positive response to the Coombs' test although hemolytic anaemia rarely occurs. Neutropenia and thrombocytopenia have occasionally been reported. Agranulocytosis has been associated rarely with some cephalosporins.
Postmarketing Experience: The following adverse experiences and altered laboratory tests, regardless of their relationship to Cefdinir, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1991: shock, anaphylaxis with rare cases of fatality, facial and laryngeal edema, feeling of suffocation, serum sickness-like reactions, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthmatic attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, coagulation disorder, disseminated intravascular coagulation, upper GI bleed, peptic ulcer, ileus, loss of consciousness, allergic vasculitis, possible Cefdinir-diclofenac interaction, cardiac failure, chest pain, myocardial infarction, hypertension, involuntary movements and rhabdomyolysis.
Suspension: Adverse effects cannot be anticipated. Diarrhea, nausea, vaginal infection and rash. Use Cefdinir with caution if patient suffers from colitis (inflammation of the bowel). Cefdinir has been known to cause colitis. If patient develops symptoms such as diarrhea while taking this medication, notify the doctor. The use of an antibiotic to kill one type of germ can sometimes promote the growth of other germs that are resistant to the drug. If a new infection (called a superinfection) occurs, alert the doctor. Patient may need to take a different antibiotic. If patient suffers from seizures, use Cefdinir with caution. If patient had a seizure while using Cefdinir, stop taking it and call the doctor immediately. If patient ever had an allergic reaction to a cephalosporin antibiotic, he/she should not take this medication. Note, if patient is allergic to penicillin, he/she may also be allergic to cephalosporins. The reaction can be extremely severe. Be sure to let the doctor know about any allergies the patient may have.

Absorption of Cefdinir is decreased by antacids or iron supplements and doses should be separated by an interval of at least 2 hours. Probenecid reduces the renal excretion of Cefdinir.

Suspension: Direction for Reconstitution: Shake bottle to loosen granules. Add boiled and cooled water up to the mark on the bottle to make the suspension. Store reconstituted suspension in a refrigerator at temperatures between 2° to 8°C. The reconstituted suspension is stable for 7 days.

Store at temperatures not exceeding 30°C.

Cephalosporins

J01DD15 - cefdinir ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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