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In the U.S.—

Spectracef

• Antibacterial, systemic

Cefditoren (sef-da-TOR-en) 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, in the following dosage form:

Oral
• • Tablets (U.S.)

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 cefditoren, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cefditoren. Tell your doctor if you have ever had any unusual or allergic reaction to any of the cephalosporins, cephamycins, penicillins, penicillin-like medicines, or penicillamine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as milk protein, foods, preservatives, or dyes.

Pregnancy—Cefditoren has not been studied in pregnant women. However, studies in animals have shown that cefditoren causes miscarriages or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether cefditoren passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

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.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.”

Other medical problems—The presence of other medical problems may affect the use of cefditoren. 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

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—

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

The dose of cefditoren 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 cefditoren. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength 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. This will help to keep a constant amount of medicine in the blood or urine. 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—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

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 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• 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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/20/2001

Revised: 02/06/2002