Pronunciation:

sef-di-TOE-ren pi-VOX-il

Brand Names:

• Spectracef

Classifications:

Pharmacologic—

3rd Generation Cephalosporin

Uses of This Medicine:

Cefditoren is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth.

Cefditoren pivoxil is used to treat some throat and lung infections, including bronchitis and tonsillitis. It is also used to treat some skin 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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cefditoren in children less than 12 years of age with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium Carbonate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Famotidine
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Probenecid

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:

• Carnitine deficiency—May be worsened by cefditoren

• Kidney disease—Cefditoren may need to be given at a lower dose

Proper Use of This Medicine:

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

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.

Cefditoren should be taken with food to increase absorption of the medicine.

• For oral dosage form (tablets):
  • For acute bacterial bronchitis:
    • Adults and children 12 years of age and older—400 milligrams (mg) twice a day for ten days.
    • Children under 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For bacterial throat infections or tonsillitis:
    • Adults and children 12 years of age and older—200 mg twice a day for ten days.
    • Children under 12 years of age—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—

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

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.

Precautions While Using This Medicine:

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

In some patients, cefditoren may cause diarrhea:

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines may make your 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 health care professional.

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:

Rare

Allergic reaction, such as, itching, pain, redness, or swelling of eye or eyelid, watering of eyes, troubled breathing or wheezing, severe skin rash or hives, flushing, headache, fever, chills, runny nose, increased sensitivity to sunlight, joint pain, swollen glands

leukopenia, such as, black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, shortness of breath, sore throat, sores, ulcers, or white spots on lips or in mouth, swollen glands, unusual bleeding or bruising, unusual tiredness, or weakness

pseudomembranous colitis, such as, abdominal or stomach cramps, pain, bloating, abdominal tenderness, diarrhea, watery and severe, which may also be bloody, fever, increased thirst, nausea or vomiting, unusual tiredness or weakness, or unusual weight loss

or thrombocythemia, such as, pain, warmth or burning in fingers, toes, and legs, dizziness, problems with vision or hearing

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:

More Common

Diarrhea

nausea

or vaginal moniliasis, such as, thick whitish discharge from the vagina or cervical canal

Less common

Abdominal pain

Dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, or stomach discomfort, upset or pain

or headache

Rare

Abnormal dreams

anorexia, such as, loss of appetite

asthenia, such as, lack or loss of strength

constipation

dizziness

dry mouth

dysgeusia, such as, taste perversion

eructation, such as, belching, bloated full feeling, excess air or gas in stomach

fever

flatulence, such as, passing of gas

fungal infection

gastritis, such as, burning feeling in chest or stomach, tenderness in stomach area, stomach upset, or indigestion

headache

hyperglycemia, such as, blurred vision, dry mouth, fatigue, flushed, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, loss of consciousness, nausea, stomachache, sweating, troubled breathing, unexplained weight loss, vomiting

increased appetite

insomnia, such as, sleeplessness

leukorrhea, such as, increase in amount of clear vaginal discharge, white vaginal discharge

mouth ulceration

myalgia, such as, muscle pain

nervousness

oral moniliasis, such as, sore mouth or tongue, white patches in mouth, tongue, or throat

pain

peripheral edema, such as, bloating or swelling of face, arms, hands, lower legs, or feet, rapid weight gain, tingling of hands or feet, unusual weight gain or loss

pharyngitis, such as, body aches or pain, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, tender, swollen glands in neck, trouble in swallowing, or voice changes

pruritus, such as, itching skin

rash

rhinitis, such as, stuffy nose, runny nose, or sneezing

sinusitis, such as, pain or tenderness around eyes and cheekbones, fever, stuffy or runny nose, headache, cough, shortness of breath or troubled breathing, tightness of chest or wheezing

somnolence, such as, sleepiness or unusual drowsiness

stomatitis, such as, swelling or inflammation of the mouth

sweating

urinary frequency

urticaria, such as, hives or welts, itching, redness of skin, or rash

vaginitis

vomiting

or weight loss

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.