Each 5 ml contains after reconstitution Cefdinir 125mg

Egynir, is a broad spectrum semisynthetic cephalosporin antibiotic for oral administration. The bactericidal mode of action of Egynir is a result of the inhibition of cell wall synthesis.

Egynir is highly beta-lactmase stable and as a result, many organisms resistant to penicillins and some cephalosporins, due to the presence of beta-lactamases, are susceptible to Egynir.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Egynir and other antibacterial drugs, Egynir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 

Egynir (cefdinir) capsules and Egynir (cefdinir) for oral suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Community-Acquired Pneumonia 

Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including βlactamase producing strains) .

Acute Exacerbations of Chronic Bronchitis 

Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including βlactamase producing strains). 

Acute Maxillary Sinusitis 

Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). 

Pharyngitis/Tonsillitis 

Caused by Streptococcus pyogenes.

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. 

Uncomplicated Skin and Skin Structure Infections 

Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). 
Pharyngitis/Tonsillitis 
Caused by Streptococcus pyogenes 

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. 
Uncomplicated Skin and Skin Structure Infections 
Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. 

Adults

The recommended daily dose of Egynir is 600mg. this may be given as a 300mg capsule once every 12 hours or as two 300mg capsules once daily.
Egynir should be administred twice daily in pneumonia or skin infections.
 

Children

The recommended dose is 7 mgkg suspension every 12 hours or 14 mgkg once daily up to maximum of 600mg per day. Egynir suspension should be administered twice daily in skin infections in children.

 

After reconstitution

Children weighing more than 43kg should receive the maximum daily dose of 600mg Renal impairment: cefdinir is renally excreted.

Adults

when creatinine clearance < 30 mlmin, the dose og Egynir should be 300 mg given once daily.

Children

pediatric patients with a creatinine clearance of <30 mlmin1.73 m2 should receive Egynir 7 mgkg (up to 300 mg) given once daily.
In patients on hemodialysis the recommended dosage is 300 mg or 7 mgkg every other day.

Cefdinir is contraindicated in patients with known allergy to the cephalosporins or penicillin group of antibiotic.

Before therapy with Egynir is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity to Cedinir, other cephalosporins or penicillins 
IF CEFDINIR IS TO BE GIVEN TO PENICILLINSENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSSHYPERSENSITIVITY 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. 

Prescribing Egynir in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.

Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.

In patients with transient or persistent renal insufficiency (creatinine clearance < 30 mL/min), the total daily dose of Egynir should be reduced because high and prolonged plasma concentrations of cefdinir can result following recommended doses

Antacids and iron supplements-Egynir should be taken at least 2 hours before or after the antacid or iron supplement.

Probenecid- probenecid inhibits the renal excretion of cefdinir resulting in higher serum concentrations and longer half life.

Side effects are mild and transient in nature; most of them being diarrhea, abdominal pain, nausea, vomiting, skin rash, transient elevation in liver enzymes.

Adverse events associated with cefdinir capsules trials in adult and adolescent patients:
-Incidence ≥ 1%
Diarrhea, vaginal moniliasis, nausea, headache, abdominal pain, vaginitis.
-Incidence < 1% but > 0.1%
 Rash, dyspepsia, flatulence, vomiting, abnormal stool, anorexia, constipation, dizziness, dry mouth, asthenia, insomnia, leucorrhea, moniliasis, pruritus and somnolence.
Adverse events associated with cefdinir suspension trials in pediatric patients:
Diarrhea, rash, vomiting, abdominal pain, leucopenia, cutaneous moniliasis, vaginal moniliasis, vaginitis, abnormal stool, dyspepsia, hyperkinesia, increased AST, maculopapular rash and nausea. 

Cefdinir is removed from the body by haemodialysis. No information regarding cefdinir overdosage is available but overdosage with β-lactam antibiotics has resulted in nausea, vomiting, epigastric distress, diarrhea and convulsions.

Store at temperature not exceeding 30?C , in dry place , protected from light,
Keep out of reach of children 
Should be used with in  10 days after reconstitution at a temperature  2-8 ºC.

-Egynir Capsules are supplied in carton box contains (ALPVC) strip of 10 capsules.
Excepient: Avicel 102, Aerosil, magnesium stearate, gelatin, titanium dioxide, brilliant blue, erythrosine, carmoisine, brilliant blue.

-Egynir powder for suspension is supplied in plastic bottle of 28.44 gm powder to be 60 ml suspension after reconstitution and measuring cap.
Excepient: Xanthan gum, Citric acid, Sodium benzoate, Sucrose, Avicel 611, Strawberry Flavor, Sodium citrate.