Samnir

SAMNIR 100 MG CAPSULE: Each capsule contains Cefdinir 100 mg.
SAMNIR SUSPENSION: (Granule reconstituted to suspension): Each 5 ml (when mixed with water as directed) contains Cefdinir 125 mg.
After reconstituted, yield suspension with white to slightly yellow color.

Pharmacology: Pharmacodynamics: Cefdinir, a third-generation cephalosporin, is stable in the presence of some β-lactamases which is produced by the bacteria. Bactericidal activity results from Cefdinir inhibition of cell wall synthesis. It has bactericidal activity against gram-positive, gram-negative and including β-lactamases producing bacteria. Cefdinir is active in vitro against the following microorganisms which are Staphylococcus epidermidis (methicillin-susceptible strains), Staphylococcus aureus (methicillin-susceptible strains including β-lactamase-producing strains), Streptococcus pyogenes (Group A β-hemolytic streptococci), Streptococcus agalactiae (Group B), Streptococcus pneumoniae (penicillin-susceptible strains), Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase-producing strains), Klebsiella pneumoniae and Moraxella catarrhalis (including β-lactamase-producing strains). Cefdinir is inactive against most strains of Pseudomonas, Enterobacter, Enterococci, methicillin or oxacillin-resistant Staphylococci, penicillin-resistant Streptococci, Legionella pneumophila, Mycoplasma and Chlamydia pneumonia.
Pharmacokinetics: Cefdinir is rapidly absorbed after oral administration. The estimated absolute bioavailability of the suspension formulation is slightly greater than that of the capsule formulation. Cefdinir is 60-70% bound to plasma proteins; binding is independent of drug concentration. Cefdinir is distributed into blister fluid, middle ear fluid, tonsils, sinus tissue and bronchial mucosa. Cefdinir is less metabolized and eliminated unchanged in urine. Cefdinir is removed by hemodialysis. Clearance of Cefdinir is decreased in patients with impaired renal function.

SAMNIR is used for the treatment of patients with infections caused by susceptible strains of the bacteria (in the list as follows).
Upper respiratory tract infections; acute bacterial otitis media, acute maxillary sinusitis, acute recurrent or chronic tonsil/pharyngitis.
Lower respiratory tract infections; community-acquired pneumonia, acute exacerbation of chronic bronchitis, secondary bacterial infections of acute bronchitis.
Uncomplicated skin and skin structure infections.
NOTE: Cefdinir has not been shown effective in the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis.

Mode of administration: The dose and amount of drug usage depend on the age, severity of the disease and the patient's condition.
Cefdinir should be taken continuously in the specified period or to be used as directed by the physician.
SAMNIR 100 MG CAPSULE: Adults and adolescents 13 years of age or older dosage: For oral use, the dosage is 100 mg 3 times daily (every 8 hours) or to be used as directed by the physician.
Pharyngitis and Tonsillitis: 300 mg 2 times daily (every 12 hours) for 5-10 days or 600 mg once daily for 10 days.
Acute exacerbations of chronic bronchitis: 300 mg 2 times daily (every 12 hours) for 5-10 days or 600 mg once daily for 10 days.
Acute maxillary sinusitis: 300 mg 2 times daily (every 12 hours) or 600 mg once daily for 10 days.
Community-acquired pneumonia: 300 mg 2 times daily (every 12 hours) for 10 days.
SAMNIR SUSPENSION: Infants and children (6 months through 12 years) dosage: The maximum dosage is 14 mg/kg/day. Cefdinir may be taken 7 mg/kg every 12 hours for 5-10 days or 14 mg/kg every 24 hours for 10 days. The drug usage depends on the severity of the disease or as directed by the physician. The recommend dosage and duration of treatment for children are described in the following charts. (See Table 1.)

Click on icon to see table/diagram/image

The dosages of treatment for children are described by body weight in the following chart. (See Table 2.)

Click on icon to see table/diagram/image

Preparation of suspension: Tap bottle to loosen powder. Open cap and add the labeled amount of water into the bottle. Close the cap and shake the bottle well to wet powder and mix thoroughly. Add the labeled amount of water into the bottle to reconstitute the suspension which contains Cefdinir 125 mg/5 ml. Shake well before use. After reconstitution, suspension should be taken within 10 days.
Dosage in renal impairment: Patients with creatinine clearance greater than 30 mL/minute/1.73 m² may receive the usual dosage of Cefdinir. It is not necessary to adjust dose of Cefdinir in this case.
Patients with renal impairment (creatinine clearance less than 30 mL/minute/1.73 m²) or patients on hemodialysis were recommended to adjust dose of Cefdinir.
Adults with renal impairment (creatinine clearance less than 30 mL/minute/1.73 m²) should receive Cefdinir in a dosage of 300 mg once daily.
Children with renal impairment (creatinine clearance less than 30 mL/minute/1.73 m²) should receive Cefdinir in a dosage of 7 mg/kg (up to 300 mg) once daily.
Dosage in patients on hemodialysis: The recommended initial dosage regimen of Cefdinir for patient on hemodialysis is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent dose (300 mg or 7 mg/kg) are then administered every other day. If the interval between dialysis session exceeds 48 hours, an additional dose of 300 mg (or 7 mg/kg) should be given 48 hours after the last dialysis session.
Dosage in hepatic impairment: Dosage adjustment is not required.

Overdose and Treatment: Acute ingestion of large doses of Cefdinir may result in nausea, vomiting, abdominal pain, diarrhea and convulsions, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with Cefdinir therapy occur, the drug should be discontinued. Anticonvulsant therapy may be given if clinically indicated. Moreover, hemodialysis will aid in the removal of Cefdinir from the body.

Hypersensitivity to Cefdinir, any component of the formulation, or other cephalosporins, or related antibiotics.

1. This drug is contraindicated in patients with known hypersensitivity.
2. Using this drug in patients with hypersensitivity to penicillins can cause severe to fatal allergic reaction.
3. Stop using this drug and immediately consult the doctor when manifesting any signs and symptoms such as fever, skin rash, blisters, detachment of skin and epithelial lining in oral cavity, throat, nose, genital organ and conjunctivitis after taking the drug.

Prior to initiation of Cefdinir therapy, careful inquiry should be made concerning previous hypersensitivity reactions to other cephalosporins including penicillins. Because there is evidence of cross-allergenicity among cephalosporins and other β-lactam antibiotics, including penicillins. Cefdinir should be used with caution in patients with a history of hypersensitivity to penicillins, other cephalosporins and patients with a personal or familial predisposition to allergic reactions such as asthma, rash or urticaria.
Cefdinir is broad-spectrum antibiotic, prolonged treatment may result in the possible overgrowth of resistant organisms. If superinfection occurs during therapy, appropriate alternative therapy should be administered.
Dose adjustment is needed. Use with caution in patients with impaired renal function.
As with all broad-spectrum antibiotics, Cefdinir should be used with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In severe cases, consideration should be given to management with fluids, electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile.
Use in Children: Safety and efficacy of Cefdinir in neonates and infants younger than 6 months of age have not been established, then Cefdinir should not be used in neonates and infants younger than 6 months of age.

There are no adequate and controlled studies using Cefdinir in pregnant women. Cefdinir should be administered to pregnant patients or women suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
Although Cefdinir was not detected in human milk, the drug should be used with caution in nursing women.

Adverse effects usually are transient and mild in severity. The adverse effects that may be occurred are diarrhea, rash, vomiting, skin candida, abdominal pain, leucopenia, vulvovaginal candidiasis, vaginal infection, dyspepsia, hyperkinesia, increase in AST, maculopapular rash, nausea. In addition, adverse effects may be occurred: Lymphocytes increased/decreased, alkaline phosphatase increased, bicarbonate decreased, eosinophils increased, lactate dehydrogenase increased, platelets increased, polymorphonuclear neutrophils increased/decreased, proteinuria, Stevens-Johnson syndrome, conjunctivitis, toxic epidermal necrolysis, stomatitis, erythema multiforme, fulminant hepatitis, cholestasis, hepatitis (acute), granulocytes decreased, melaena, hepatic failure, jaundice, anaphylactic shock, face and laryngeal edema, exfoliative dermatitis, suffocation feeling, enterocolitis (acute), bloody stool, pseudomembranous colitis, pancytopenia, pneumonia (drug-induced), hemolytic anemia, thrombocytopenia, fever, chest pain, respiratory failure, asthma, renal failure (acute), haemorrhagic diathesis, coagulopathy, peptic ulcer, loss of consciousness, cardiac failure, hypertension, myocardial infarction, involuntary movement, rhabdomyolysis.
NOTE: The administration of Cefdinir may result in a false-positive reaction for ketones in the urine with tests using nitroprusside. A false-positive reaction for glucose in the urine may occur with tests using some diagnostic test kits, Benedict's solution, or Fehling's solution. Including, a false-positive results may occur in the direct Coombs' test.
If any abnormal symptoms are observed, SAMNIR should be discontinued and appropriate dose adjustment should be taken.

Concomitant administration of Cefdinir and antacid reduces the Cefdinir absorption. If antacid is required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after antacid.
Concomitant administration of Cefdinir and therapeutic iron supplement reduces the Cefdinir absorption. If therapeutic iron supplement is required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the therapeutic iron supplement. Red stools is observed in infants given Cefdinir while being fed with infant formula containing therapeutic iron supplement. It was considered important to be aware of the interaction because of the risk being mistaken as a sign of gastrointestinal bleeding.
Concomitant administration of Cefdinir and probenecid increases the Cefdinir plasma level and prolonged elimination half-life.

SAMNIR 100 MG CAPSULE: Store below 30°C.
SAMNIR SUSPENSION: Dry powder: Store below 25°C.
Reconstituted suspension: Store in 25-30°C for 7 days or store in the refrigerator (2-8°C) for up to 10 days.

Cephalosporins

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

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