Omnicef

DRUG DESCRIPTION

  Proprietary name: OMNICEF
Established name: cefdinir
Route of administration: ORAL (C38288)
Active ingredients (moiety): cefdinir (cefdinir)
# Strength Form Inactive ingredients
1 300 MILLIGRAM CAPSULE (C25158) carboxymethylcellulose calcium, NF, polyoxyl 40 stearate, NF, magnesium stearate, NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, NF, gelatin, NF, silicon dioxide, NF, sodium lauryl sulfate, NF
2 125 MILLIGRAM POWDER, FOR SUSPENSION (C42975) sucrose, NF, citric acid, USP, sodium citrate, USP, sodium benzoate, NF, xanthan gum, NF, guar gum, NF, artificial strawberry and cream flavors, silicon dioxide, NF, magnesium stearate, NF
3 250 MILLIGRAM POWDER, FOR SUSPENSION (C42975) sucrose, NF, citric acid, USP, sodium citrate, USP, sodium benzoate, NF, xanthan gum, NF, guar gum, NF, artificial strawberry and cream flavors, silicon dioxide, NF, magnesium stearate, NF

OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6?, 7? (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:

OMNICEF®
  (cefdinir) capsules  Structural Formula Illustration

OMNICEF Capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, NF; polyoxyl 40 stearate, NF; and magnesium stearate, NF. The capsule shells contain FD&C Blue #1; FD&C Red #40; D&C Red #28; titanium dioxide, NF; gelatin, NF; silicon dioxide, NF; and sodium lauryl sulfate, NF.

OMNICEF (cefdinir) for Oral Suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: sucrose, NF; citric acid, USP; sodium citrate, USP; sodium benzoate, NF; xanthan gum, NF; guar gum, NF; artificial strawberry and cream flavors; silicon dioxide, NF; and magnesium stearate, NF.

What are the possible side effects of cefdinir (Omnicef, Omnicef Omni-Pac)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • chest pain;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice...

Read All Potential Side Effects and See Pictures of Omnicef »

What are the precautions when taking cefdinir (Omnicef)?

Before taking cefdinir, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporin antibiotics (e.g., cephalexin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, intestinal disease (colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug does not...

Read All Potential Precautions of Omnicef »


Omnicef Consumer (continued)

SIDE EFFECTS: Diarrhea or nausea may occur. If either of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause your stools to turn a reddish color, especially if you also take iron products. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever), easy bruising/bleeding, change in the amount of urine, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cefdinir, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporin antibiotics (e.g., cephalexin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, intestinal disease (colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug does not pass into breast milk. Consult your doctor before breast-feeding.


Omnicef Patient Information Including Side Effects

Brand Names: Omnicef, Omnicef Omni-Pac

Generic Name: cefdinir (Pronunciation: SEF dih neer)

  • What is cefdinir (Omnicef)?
  • What are the possible side effects of cefdinir (Omnicef)?
  • What is the most important information I should know about cefdinir (Omnicef)?
  • What should I discuss with my healthcare provider before taking cefdinir (Omnicef)?
  • How should I take cefdinir (Omnicef)?
  • What happens if I miss a dose (Omnicef)?
  • What happens if I overdose (Omnicef)?
  • What should I avoid while taking cefdinir (Omnicef)?
  • What other drugs will affect cefdinir (Omnicef)?
  • Where can I get more information?

What is cefdinir (Omnicef)?

Cefdinir is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefdinir is used to treat many different types of infections caused by bacteria.

Cefdinir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cefdinir (Omnicef)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • chest pain;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

  • constipation, loss of appetite, bloating, gas, upset stomach;
  • nausea, vomiting, stomach pain, mild diarrhea;
  • headache, dizziness;
  • stiff or tight muscles;
  • feeling restless or hyperactive;
  • dry mouth;
  • unusual or unpleasant taste in your mouth;
  • diaper rash in an infant taking liquid cefdinir;
  • mild itching or skin rash; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cefdinir (Omnicef)?

Do not take this medication if you are allergic to cefdinir, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefdinir will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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