Product Description:

What Omnicef is and what it is used for Cefdinir is a cephalosporin antibiotic that is used to treat many different types of infections caused by bacteria in the conditions listed below in pediatric patients:

• Acute bacterial otitis media.


• Acute maxillary sinusitis.


• Pharyngitis/tonsillitis.


• Uncomplicated skin and skin structure infections.


• Omnicef contains sodium, sodium benzoate and sucrose (sugar)
  Omnicef contains sodium. Each 5 ml contains 1.71 mg sodium.


• This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.
  Omnicef contains sodium benzoate.


• Each 5 ml contains 5.375 mg sodium benzoate.
  Omnicef contains sucrose (sugar).


• Each 5 ml contains 2.92 g sucrose (sugar).


• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Use:

• Follow all directions on your prescription label and read all medicine guides or instruction sheets. Use the medicine exactly as directed.
  Shake the oral suspension (liquid) before you measure a dose.


• Use the marked measuring spoon provided or use a medicine dose-measuring device (not a kitchen spoon).
  You may take Omnicef with or without food.
  Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.


• Skipping doses can increase your risk of infection that is resistant to medication.
  Cefdinir will not treat a viral infection such as the flu or a common cold.


• The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; 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, Omnicef should be administered twice daily in this infection.


• Pediatric patients (age 6 months through 12 years)

Acute bacterial otitis media:

• 7 mg/kg q12h or 14 mg/kg q24h


• 5 to 10 days

Acute maxillary sinusitis:

• 7 mg/kg q12h or 14 mg/kg q24h


• 10 days

Pharyngitis/Tonsillitis:

• 7 mg/kg q12h or 14 mg/kg q24h


• 5 to 10 days

Uncomplicated skin and skin structure infections:

• 7 mg/kg q12h


• 10 days

Omnicef Powder for Oral Suspension pediatric dosage chart Weight:

• 125 mg/5 ml


• 250 mg/5 ml


• 9 kg/20 lbs


• 5 ml q12h or 5 ml q24h


• Use 125 mg/5 ml product


• 18 kg/40 lbs


• 5 ml q12h or 10 ml q24h


• 5 ml q12h or 5 ml q24h


• 27 kg/60 lbs


• 5 ml q12h or 15 ml q24h


• 75 ml q12h or 7.5 ml q24h


• 36 kg/80 lbs


• 10 ml q12h or 20 ml q24h


• 5 ml q12h or 10 ml q24h


• ≥ 43 Kg*/95 lbs


• 12 ml q12h or 24 ml q24h


• 6 ml q12h or 12 ml q24h

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

Directions for mixing Omnicef:

• To reconstitute invert the bottle and shake to loosen powder.


• Add 36.5 ml of cooled boiled water in two portions, shake it after each addition until a homogenous suspension is achieved.


• When first reconstituted allow to stand for five minutes to ensure full dispersion.


• After mixing, the suspension can be stored at room temperature.


• The bottle should be kept tightly closed, and the suspension should be shaken well before each administration.


• The suspension may be used for 10 days, after which any unused portion must be discarded.

Caution & warnings:

Possible side effects:

• Like all medicines, this medicine can cause side effects, although not everybody gets them.


• Get emergency medical help if you have any of these signs of an allergic reaction (hives; difficulty breathing, swelling of your face or throat) or a severe skin reaction (fever, sore throat,


• burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• Fever, chills, body aches, flu symptoms


• Pale skin, easy bruising, unusual bleeding


• Seizure (convulsions)


• Fever, weakness, confusion


• Dark colored urine, jaundice (yellowing of the skin or eyes) or


• Kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• Nausea, vomiting, stomach pain, diarrhea


• Vaginal itching or discharge


• Headache or Rash (including diaper rash in an infant taking liquid cefdinir).


• This is not a complete list of side effects and others may occur.


• Call your doctor for medical advice about side effects.

Ingredients:

• The active substance is cefdinir. Each 5 ml contains 250 mg cefdinir.


• The other ingredients are citric acid anhydrous, sodium benzoate, trisodium citrate anhydrous, guar


• gum, xanthan gum, strawberry flavor, magnesium stearate, colloidal silicon dioxide and sugar.

What Omnicef looks like and contents of the pack:

• Omnicef 250 mg/5 ml Powder for Oral Suspension is a white to off-white powder with a characteristic


• Strawberry smell in amber glass bottle with a plastic child resistant cap (CRC) and a marked measuring spoon.


• After reconstitution, it is a white to off-white suspension with strawberry flavor.


• Pack size: 60 ml (after reconstitution).

Product Details:

• Brand: Omnicef
• Product Form: Suspension
• Product Type: Suspension