Prescribing Info

SPECTRACEF is taken by mouth with meals, usually twice daily or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Taking SPECTRACEF at evenly spaced intervals is important because as with most antibiotics, it works best when the amount of medicine in your body is kept at a constant level.

Continue taking SPECTRACEF until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Inform your doctor if your condition persists or worsens.

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SPECTRACEF Dosing:

Dosing

SPECTRACEF Indications:

Acute Bacterial Exacerbation of Chronic Bronchitis

Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only) or Moraxella catarrhalis (including ß-lactamase-producing strains).

Community-Acquired Pneumonia

Community-Acquired Pneumonia caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains).

Pharyngitis/Tonsillitis

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: SPECTRACEF is effective in the eradication of Streptococcus pyogenes from the oropharynx. SPECTRACEF has not been studied for the prevention of rheumatic fever following Streptococcus pyogenes Pharyngitis/Tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin-Structure Infections

Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including ß-lactamase-producing strains) or Streptococcus pyogenes.


Warning

Notify your medical provider if you have had allergic reactions to penicillin or cephalosporin antibiotics.

If you have a history of gastrointestinal disease, particularly colitis, take SPECTRACEF with caution and under the direction of a medical provider. If you develop diarrhea while taking SPECTRACEF, check with your doctor. The problem could be a sign of a serious condition.

Be sure to tell your doctor if you have kidney problems as your dosage may have to be lowered.

Only use SPECTRACEF for short-term treatment. Taking it longer than prescribed could lead to a deficiency of the amino acid carnitine.

Repeated use of SPECTRACEF may result in an overgrowth of bacteria that do not respond to the medication and can cause a secondary infection. Therefore, do not save this medication for use at another time. Take SPECTRACEF only as directed by your medical provider.

Dose adjustment for moderate or severe renal impairment

The recommended maximum dose for patients with moderate renal impairment is 200 mg BID, and for patients with severe renal impairment 200 mg QD. The appropriate dose in patients with end-stage renal disease has not been determined.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF and other antibacterial drugs, SPECTRACEF should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

SPECTRACEF is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components. SPECTRACEF is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of SPECTRACEF causes renal excretion of carnitine. SPECTRACEF tablets contain sodium casseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF.

Prescribing Information