Cefditoren pivoxil (Oral)

Cefditoren is used to treat infections caused by bacteria. It works by killing bacteria or stopping their growth.

Cefditoren pivoxil is used to treat certain throat and lung infections, such as bronchitis and tonsillitis. It is also used to treat some skin infections.

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

If your symptoms do not get better within a few days or if they get worse, contact your doctor.

In some patients, cefditoren may cause diarrhea:

• Severe diarrhea may indicate a serious side effect. Do not take any diarrhea medicine without first consulting your doctor. Diarrhea medicines may worsen your diarrhea or prolong it.
• If you have any questions about this or if mild diarrhea continues or worsens, consult your health care professional.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision should be made between you and your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research on this medicine has only been conducted with adult patients, and there is no specific information comparing the use of cefditoren in children under 12 years old to other age groups.

Geriatric

This medicine has been tested and does not appear to cause different side effects or problems in older adults compared to younger adults.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the baby when used while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may increase the 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 adjust the dose or how often you use one or both 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used during or around mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Carnitine deficiency—May be worsened by cefditoren

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, you 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 the eye or eyelid, watering of the eyes, trouble 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 the 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. Your health care professional may also 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, 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 the stomach
• fever
• flatulence, such as passing gas
• fungal infection
• gastritis, such as burning feeling in the chest or stomach, tenderness in the 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, trouble breathing, unexplained weight loss, vomiting
• increased appetite
• insomnia, such as sleeplessness
• leukorrhea, such as increase in the 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 the mouth, tongue, or throat
• pain
• peripheral edema, such as bloating or swelling of the 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 the throat, fever, hoarseness, runny nose, tender swollen glands in the neck, trouble 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 the eyes and cheekbones, fever, stuffy or runny nose, headache, cough, shortness of breath or trouble breathing, tightness of the 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 the 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 health care professional.

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

In the U.S.

• Spectracef

Pharmacologic Class: 3rd Generation Cephalosporin

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.

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