Spectracef

DRUG DESCRIPTION

SPECTRACEF® (cefditoren pivoxil) tablets contain cefditoren pivox il, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren.

Chemically, cefditoren pivoxil is (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-aminothiazol-4-yl)-2-methoxy?­iminoacetamido]-3-[(Z)-2-(4-methylthiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. The empirical formula is C25H28N6O7S3 and the molecular weight is 620.73. The structural formula of cefditoren pivoxil is shown below:

SPECTRACEF®(cefditoren pivoxil) Structural Formula Illustration

The amorphous form of cefditoren pivoxil developed for clinical use is a light yellow powder. It is freely soluble in dilute hydrochloric acid and soluble at levels equal to 6.06 mg/mL in ethanol and < 0.1 mg/mL in water.

SPECTRACEF® (cefditoren pivoxil) tablets contain 200 mg or 400 mg of cefditoren as cefditoren pivoxil and the following inactive ingredients: croscarmellose sodium, D-mannitol, hydroxypropyl cellulose, hypromellose, magnesium stearate, sodium caseinate (a milk protein), and sodium tripolyphosphate. The tablet coating contains carnauba wax, hypromellose, polyethylene glycol, and titanium dioxide. Tablets are printed with ink containing D&C Red No. 27, FD&C Blue No. 1, propylene glycol, and shellac.

What are the possible side effects of cefditoren (Spectracef)?

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;
  • 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);
  • ...

Read All Potential Side Effects and See Pictures of Spectracef »

What are the precautions when taking cefditoren pivoxil (Spectracef)?

Before taking cefditoren, 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 (such as milk protein), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain metabolic disorders (e.g., carnitine deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, decreased muscle mass, stomach/intestinal disease (e.g., colitis).

Kidney function declines as...

Read All Potential Precautions of Spectracef »


Spectracef Consumer (continued)

SIDE EFFECTS: Diarrhea, headache, nausea/vomiting, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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 unlikely but serious side effects occur: shortness of breath, swelling of the ankles/feet, muscle weakness, increased hunger, increased thirst/urination, dark urine, persistent nausea/vomiting, yellowing eyes/skin, change in the amount of urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: new signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising, tiredness, fast/pounding heartbeat, seizures, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, 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. 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 rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 cefditoren, 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 (such as milk protein), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain metabolic disorders (e.g., carnitine deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, decreased muscle mass, stomach/intestinal disease (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Spectracef Patient Information Including Side Effects

Brand Names: Spectracef

Generic Name: cefditoren (Pronunciation: CEF di tor en)

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

What is cefditoren (Spectracef)?

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

Cefditoren is used to treat many different types of bacterial infections that can cause bronchitis, tonsillitis, pneumonia, or skin infection.

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

What are the possible side effects of cefditoren (Spectracef)?

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;
  • 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:

  • nausea, vomiting, stomach pain, mild diarrhea;
  • constipation, belching, upset stomach;
  • dry mouth, appetite changes;
  • headache, dizziness, feeling restless or hyperactive;
  • stiff or tight muscles;
  • muscle pain;
  • white patches or sores inside your mouth or on your lips;
  • unusual or unpleasant taste in your mouth;
  • trouble sleeping (insomnia), strange dreams;
  • runny or stuffy nose;
  • 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 cefditoren (Spectracef)?

Do not take cefditoren if you are allergic to milk protein (not lactose intolerance), or if you have a carnitine deficiency (a lack of a certain chemical in the body). Talk with your doctor if you are unsure.

You should not take cefditoren if you have ever had an allergic reaction to a penicillin or cephalosporin antibiotic (such as Ceftin, Cefzil, Keflex, Omnicef, 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, liver disease, or if you are malnourished.

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

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefditoren.

Your body will best absorb cefditoren if you take it with food.

Avoid taking cefditoren at the same time that you take any type of antacid or stomach acid reducer.

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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