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(spar-FLOX-ah-sin)

Zagam

Class: Antibiotic/fluoroquinolone

 Action Interferes with microbial DNA synthesis.

 Indications Treatment of community acquired pneumonia or bacterial exacerbation of chronic bronchitis caused by susceptible organisms.

 Contraindications History of hypersensitivity or photosensitivity reactions; drugs known to prolong the electrocardiogram QT_c interval such as disopyramide and amiodarone or patients with underlying QT_c prolongation (torsades de pointes has been reported in such patients); patients whose lifestyle or occupation prevents avoidance of sun, bright natural light, or UV rays while taking this drug and for 5 days after treatment is stopped; tendonitis or tendon rupture associated with quinolone use.

 Route/Dosage

ADULTS: PO 400 mg on day 1 (loading dose) followed by 200 mg qd for a total 10 days of therapy.

Renal function impairment (CrCl < 50 mL)

ADULTS: PO 400 mg on day 1 (loading dose) followed by 200 mg every 48 hr for a total of 9 days of therapy.

 Interactions

Aluminum-magnesium antacids, sucralfate, zinc, iron salts: Reduced absorption leading to lower bioavailability and efficacy. Bepridil, cisapride, erythromycin, pentamidine, phenothiazines and related antipsychotics, tricyclic antidepressants, any other drug known to prolong the QT_c interval: Increased risk of torsades de pointes or other malignant ventricular arrhythmias.

 Lab Test Interferences False-negative results for Mycobacterium tuberculosis cultures.

 Adverse Reactions

CNS: Headache; dizziness; insomnia; somnolence. CV: QT_c prolongation (possibly leading to serious ventricular arrhythmias); vasodilation. DERM: Photosensitivity; pruritus; rash. EENT: Taste perversion. GI: Diarrhea; nausea; dyspepsia; abdominal pain; dry mouth; vomiting; flatulence. GU: Vaginal moniliasis. OTHER: Asthenia.

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Safety and efficacy not established. Phototoxicity: Moderate to severe phototoxic reactions have been reported. Patients must avoid exposure to direct or indirect sunlight or other sources of UV light while taking this medication and for 5 days thereafter. Patients must discontinue therapy at first sign or symptom of a phototoxic reaction (eg, sensation of skin burning; redness; swelling; blistering; rash; itching: dermatitis). Convulsions and toxic psychosis: CNS stimulation, lowering of the seizure threshold, and psychotic reactions have been reported. Use with caution in patients with seizures or other CNS disorders. Hypersensitivity reactions: Acute anaphylactic reactions and serious dermatologic hypersensitivity reactions have been reported. Stop sparfloxacin if a rash or any other sign of photosensitivity develops. Pseudomembranous colitis: Consider possibility in patients with diarrhea. Tendonitis: Inflammation and rupture of tendons has been associated with the use of fluoroquinolone antibiotics. Renal function impairment: Dose adjustment necessary of CrCl < 50 mL/min. Superinfection: Use of antibiotics may result in bacterial or fungal overgrowth. QT interval: May be prolonged in some patients.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Administer without regard to meals but with a full glass of water.
• Administer antacids, sucralfate, zinc, and iron salts ³ 4 hr after sparfloxacin administration.
• Store at room temperature in tightly closed container.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Obtain specimens as ordered for culture and sensitivity before beginning treatment.
• Monitor signs and symptoms of infection throughout course of therapy.
• Obtain baseline CBC, renal, and liver function tests and electrolytes.
• Monitor intake and output.
• Monitor for symptoms of superinfections such as vaginitis, stomatitis, and diarrhea. Notify physician if present.
• Notify physician if symptoms of pseudomembranous colitis occur (loose or foul-smelling stools).
• Discontinue immediately and notify physician at the first appearance of a skin rash or any other signs of hypersensitivity and institute support measures.
• Discontinue immediately if signs of increased intracranial pressure, or central nervous system reactions such as restlessness, agitation, tremors, confusion, hallucinations, or other signs of psychoses should appear.

OVERDOSAGE: SIGNS & SYMPTOMS   Possible QTc prolongation

 Patient/Family Education

• Instruct patient to take medication as directed with a full glass of water without regard to meals.
• Instruct patient that sparfloxacin may be taken with food or milk. However, mineral supplements, vitamins with iron, zinc calcium and magnesium-and aluminum-containing antacids, and sucralfate should be taken 4 hr after antibiotic administration.
• Instruct patients to drink fluids liberally while taking medication.
• Advise patient to avoid exposure to direct or indirect sunlight (including through glass, while using sunscreen or sunblocks, reflected sunlight, and cloudy weather) and exposure to artificial UV light during treatment with sparfloxacin and for ³ 5 days after therapy. If exposure to sun cannot be avoided, patients should cover as much of the skin as possible with clothing.
• Caution patient to discontinue sparfloxacin therapy at first sign or symptom of phototoxicity (eg, sensation of skin burning, redness, swelling, blisters, rash, itching. dermatitis) and to contact the primary care provider at once.
• Advise patient who has experienced a phototoxic reaction to the medicine to avoid further exposure to sunlight or artificial UV light until completely recovered from the reaction or for 5 days following discontinuation of treatment, whichever is longer. In rare cases, reactions have recurred up to several weeks following discontinuation.
• Advise patient not to drive, operate machinery, or engage in other activities that require mental alertness and coordination until they know how reaction to sparfloxacin is known (eg, dizziness, light-headedness).
• Instruct patient to discontinue medication and inform primary caregiver if pain or inflammation of a tendon is experienced and to rest and not exercise until tendonitis or tendon rupture has been ruled out.
• Instruct patient to report these symptoms to physician: diarrhea, foul-smelling stools, stomatitis, vaginitis, black “furry” appearance of tongue.
• Instruct patient to discontinue the drug and to contact physician at the first sign of a skin rash or other allergic reaction.
• Instruct patient to complete full course of therapy, even if symptoms of infection have resolved.
• Advise patient to consult with physician before taking any other medications including otcs.

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