Lactabet 125 mg- Dry Powder for Oral Suspension

Composition

Each 5 mL of the oral suspension contains: 

• Cefdinir: 125 mg. 
• Excipient: S.Q. for 5 mL.

Indications

Adults and Adolescents:

• Community-Acquired Pneumonia: caused by haemophilus influenzae ( including β -lactamase producing strains ), streptococcus pneumoniae, and moraxella catarrhalis ( including β – lactamase producing strains ).
• Acute Exacerbations of Chronic Bronchitis: caused by haemophilus influenzae and parainfluenzae including β -lactamase producing strains, streptococcus pneumonia, ( penicillin-susceptible strains only )  , moraxella catarrhalis including β -lactamase  producing strains.
• Acute Maxillary Sinusitis: Caused by haemophillus influenzae,  streptococcus pneumoniae and moraxella catarrhalis.

Note: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx, but it has not been studied for the prevention of rheumatic fever following streptococcus pyogenes pharyngitis/ tonsillitis.

• Uncomplicated Skin and Skin Structure infections: caused by staph. aureus and strep. pyogenes.

Pediatric Patients:

• Acute Bacterial Otitis Media: Caused by haemophilus influenzae, sterptococcus pnemoniae,and moraxella catarrhalis.
• Pharyngitis & Tonsillitis: Caused by streptococcus pyogenes.

Note: Cefdinir is effective in the eradication of streptococcus  pyogenes from the oropharynxn,but it has not been  studied for the prevention  of rheumatic fever following streptococcus pyogenes pharyngitis & tonsillitis.

• Uncomplicated Skin and Skin Structure Infections: Caused by staphylococcus aureus and streptococcus pyogenes.

Dosage and administration

The total daily dose for all infections is 14 mg / kg , up to a maximum dose of 600 mg per day, once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections therefore Lactabet for oral suspension should be administered twice daily in this infection. Lactabet for oral suspension may be administered without regard to meals.

Pediatric Patients ( age 6 monthes through 12 years )

Pediatric Dosage Chart

Pediatric patients who weigh ≥ 43kg should receive the maximum daily dose of 600 mg.

Dose For Patients With Renal Insufficiency:

For adult patients with creatinine clearance < 30mL /min the dose of cefdinir should be 300 mg given once daily.

For pediatric patients with a creatinine clearance of < 30 mL /min / 1.73m2, the dose of cefdinir should be 7 mg / kg ( up to 300 mg ) given once daily.

Patients On Hemodialysis:

Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen 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 doses ( 300 mg or 7 mg / kg ) are then administered every other day.

Directions For Mixing Lactabet For Oral Suspension :

The amount of water to be added to prepare 60 ml of oral suspension is 38 ml , add water in 2 portions , shake well after each aliquot.

After mixing, the suspension can be stored at room temperature 25ºC, and may be used for 10 days , the suspension should be shaken well before each administration.