Pronunciation:

SEF-di-nir

Brand Names:

• Omnicef

Dosage Forms:

• Capsule
• Powder for Suspension

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

3rd Generation Cephalosporin

Uses of This Medicine:

Cefdinir is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefdinir in children. However, safety and efficacy have not been established in infants younger than 6 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefdinir in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefdinir.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levoketoconazole
• Levonorgestrel
• Mestranol
• Methotrexate
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iron

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation in gut), history of or
• Diarrhea, severe, history of—Use with caution. May make these conditions worse.

• Diabetes—The oral liquid form of this medicine contains sucrose (table sugar), which can make this condition worse.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If you are taking aluminum or magnesium-containing antacids, iron supplements, or multivitamins, do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or after taking cefdinir. These medicines may keep cefdinir from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or suspension):
  • For infections:
    • Adults and teenagers—300 milligrams (mg) every twelve hours or 600 mg once a day, taken for 5 to 10 days.
    • Infants and children 6 months up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 7 milligrams (mg) per kilogram (kg) of body weight every twelve hours or 14 milligrams (mg) per kilogram (kg) of body weight per day, taken for 5 to 10 days. However, the dose is usually not more than 600 mg per day.
    • Infants up to 6 months of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Throw away any unused medicine after 10 days.

Precautions While Using This Medicine:

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Cefdinir may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you or your child have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

Rare

Black, tarry stools

chest pain

chills

cough

fever

painful or difficult urination

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Abdominal or stomach cramps or tenderness

back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloating

blood in the urine or stools

bloody nose

bloody or cloudy urine

bloody, black, or tarry stools

blue lips, fingernails, or skin

bruising

chest pain or discomfort

clay-colored stools

cold, clammy skin

confusion

coughing or vomiting blood

cracks in the skin

dark-colored urine

diarrhea, watery and severe, which may also be bloody

difficult or troubled breathing

difficulty with breathing or swallowing

dilated neck veins

dizziness

extreme fatigue

fast heartbeat

fast, weak pulse

feeling of discomfort

general body swelling

general tiredness and weakness

headache

heavier menstrual periods

high fever

hives

hoarseness

increased thirst

inflammation of the joints

irregular breathing

irregular heartbeat

irregular, fast or slow, or shallow breathing

itching

joint or muscle pain

light-colored stools

lightheadedness

loss of appetite

loss of consciousness

loss of heat from the body

muscle aches

muscle cramps or spasms

muscle pain or stiffness

nausea or vomiting

noisy breathing

nosebleeds

pain in the ankles or knees

pain or discomfort in the arms, jaw, back, or neck

painful, red lumps under the skin, mostly on the legs

pale skin

persistent bleeding or oozing from puncture sites, mouth, or nose

pinpoint red spots on the skin

problems with bleeding or clotting

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rash

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

scaly skin

seizures

severe stomach pain

slow or irregular breathing

sudden decrease in the amount of urine

sweating

swelling of the face, fingers, feet, or lower legs

swollen lymph glands

tightness in the chest

unpleasant breath odor

unusual weight loss

upper right abdominal or stomach pain

vomiting of blood

weight gain

wheezing

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Itching of the vagina or genital area

pain during sexual intercourse

thick, white vaginal discharge with no odor or with a mild odor

vaginal yeast infection

Rare

Acid or sour stomach

belching

constipation

dry mouth

excess air or gas in the stomach or intestines

full feeling

heartburn

increase in body movements

increased clear or white vaginal discharge

indigestion

lack or loss of strength

passing gas

rash with flat lesions or small raised lesions on the skin

sleepiness or unusual drowsiness

soreness or redness around the fingernails and toenails

stomach discomfort, upset, or pain

unable to sleep

Incidence not known

Burning, dry, or itching eyes

discharge, excessive tearing

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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