Zagam Respipac Side Effects

Generic name: sparfloxacin

Note: This document contains side effect information about sparfloxacin. Some of the dosage forms listed on this page may not apply to the brand name Zagam Respipac.

Some side effects of Zagam Respipac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sparfloxacin: oral tablet

If you experience any of the following serious side effects, stop taking sparfloxacin (the active ingredient contained in Zagam Respipac) and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• irregular heartbeats;

• chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet;

• severe dizziness;

• seizures;

• confusion or hallucinations;

• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); or

• muscle or joint pain.

If you experience any of the following less serious side effects, continue taking sparfloxacin and talk to your doctor:

• nausea, vomiting, diarrhea, or constipation;

• headache, lightheadedness, or drowsiness;

• ringing in the ears; or

• increased sensitivity of the skin to sunlight.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to sparfloxacin: oral tablet

Cardiovascular

Cardiovascular side effects have included QTc interval prolongation (1.3%) and vasodilatation (1%). Palpitation, abnormal ECG, hypertension, tachycardia, bradycardia, shortened PR interval, angina pectoris, arrhythmia, atrial fibrillation, atrial flutter, complete AV block, first- and second-degree AV block, cardiovascular disorder, hemorrhage, migraine, peripheral vascular disorder, supraventricular extrasystoles, ventricular extrasystoles, and postural hypotension have been reported in less than 1% of patients. Cardiopulmonary arrest, cerebral thrombosis, embolism, torsade de pointes, and vasculitis have been reported during postmarketing experience.

QTc prolongation has been reported in otherwise healthy patients and in patients with a history of heart disease or who were on other potentially arrhythmogenic drugs. In one phase III trial with 813 patients, 2.9% of the overall population experienced QTc prolongation, 10 of whom exhibited moderate to severe delays in ventricular repolarization (QTc > 500 msec). There were no reports of arrhythmia during this investigation. QTc interval prolongation (QTc > 440 ms) was reported more often in elderly patients than in younger patients.

During postmarketing surveillance in Europe, 7 severe cardiovascular adverse events were associated with sparfloxacin use in an estimated 750,000 patients treated. All patients experiencing an event had identifiable risk factors for arrhythmia.

A 47-year-old woman developed torsade de pointes after six days of therapy with sparfloxacin and rifampin. The patient felt dizzy and lost consciousness. The QTc interval at the time was 600 msec. The QTc returned to baseline within one week of sparfloxacin discontinuation.

Dermatologic

In clinical trials, approximately 0.6% of patients experienced severe phototoxicity, defined as involving significant curtailment of normal activity. Reactions have occurred with and without the use of sunscreens. The manufacturer reports that some products containing ingredients blocking the UVA spectrum (octocrylene, or Parsol 1789) may provide some protection. Many over-the-counter products, however, do not provide enough UVA protection to diminish the risk of photosensitivity to sparfloxacin (the active ingredient contained in Zagam Respipac)

Dermatologic side effects have included photosensitivity reactions (3.6% to 7.9%), pruritus (3.3%), and rash (1.1%). Maculopapular rash, dry skin, herpes simplex, sweating, urticaria, vesiculobullous rash, exfoliative dermatitis, acne, alopecia, angioedema, contact dermatitis, fungal dermatitis, furunculosis, pustular rash, skin discoloration, herpes zoster, and petechial rash have been reported in less than 1% of patients. Bullous eruption, erythema nodosum, and hyperpigmentation have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (4.3% to 7.6%), diarrhea (3.2% to 4.6%), abdominal pain (1.8% to 2.4%), dyspepsia (1.6% to 2.3%), dry mouth (1.4%), vomiting (1.3%), and flatulence (1.1%). Constipation, anorexia, gingivitis, oral moniliasis, stomatitis, tongue disorder, tooth disorder, gastroenteritis, increased appetite, mouth ulceration, increased serum amylase, and increased serum lipase have been reported in less than 1% of patients. Pseudomembranous colitis has been reported with sparfloxacin (the active ingredient contained in Zagam Respipac) and other quinolone antibiotics. Dysgeusia, dysphagia, gastralgia, hiccough, intestinal perforation, painful oral mucosa, pancreatitis, and Quincke's edema have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (4.2% to 8.1%), dizziness (2% to 3.8%), somnolence (1.5%), and insomnia (1.9%). Paresthesia, hypesthesia, nervousness, somnolence, tremor, confusion, hyperesthesia, hyperkinesia, sleep disorder, hypokinesia, vertigo, abnormal gait, lightheadedness, euphoria, amnesia, and twitching have been reported in less than 1% of patients. Ataxia, convulsions, ebrious feeling, exacerbation of myasthenia gravis, numbness, peripheral neuropathy, and sensory disturbances have also been reported.

Renal

Renal side effects have included increased BUN and creatinine in less than 1% of patients. Acute renal failure, interstitial nephritis, hemolytic uremic syndrome, and renal calculi have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included increased white blood cells in 1.1% of patients and cyanosis, ecchymosis, lymphadenopathy, increased eosinophils, increased monocytes, and increased neutrophils in less than 1% of patients. Decreases in hematocrit, hemoglobin, lymphocytes, and red blood cells, as well as both increases and decreases in platelets and white blood cells have been reported in less than 1% of patients. Agranulocytosis, hemolytic anemia, prolongation of prothrombin time, thrombocytopenia, and thrombocytopenic purpura have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, joint disorder, myalgia, and rheumatoid arthritis in less than 1% of patients. Rhabdomyolysis, tendonitis, and tendon rupture have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included gout, peripheral edema, and thirst in less than 1% of patients. Acidosis and increases in serum triglycerides, serum cholesterol, blood glucose, and serum potassium have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included asthma, epistaxis, pneumonia, rhinitis, pharyngitis, bronchitis, hemoptysis, sinusitis, increased cough, dyspnea, laryngismus, lung disorder, and pleural disorder in less than 1% of patients. Interstitial pneumonia and laryngeal or pulmonary edema have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included vaginitis, dysuria, breast pain, dysmenorrhea, hematuria, menorrhagia, nocturia, polyuria, urinary tract infection, kidney pain, leukorrhea, metrorrhagia, vulvovaginal disorder, and increased urine glucose, urine protein, urine red blood cells, and urine white blood cells in less than 1% of patients. Albuminuria, candiduria, crystalluria, urinary retention, and vaginal candidiasis have been reported during postmarketing experience. Quinolone class antibiotics have been associated with renal calculi.

Ocular

Ocular side effects have included amblyopia, photophobia, conjunctivitis, diplopia, abnormal accommodation, blepharitis, eye pain, and lacrimation disorder in less than 1% of patients. Nystagmus and uveitis have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity reactions have included anaphylactic, anaphylactoid, and allergic reactions in less than 1% of patients. Quinolones have been associated with anaphylactic shock, angioedema, Stevens Johnson syndrome, toxic epidermal necrolysis, serum sickness, allergic pneumonitis, and rash. These reactions may be serious and occasionally fatal.

Hepatic

Hepatic side effects have included increased ALT (2%) and AST (2.3%). Increased alkaline phosphatase and total bilirubin have been reported in less than 1% of patients. Hepatic necrosis, hepatitis, jaundice, increased LDH, and increased GGTP have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety, manic reaction, abnormal dreams, abnormal thinking, depression, phobia, agitation, emotional lability, hallucinations, and toxic psychosis.

Oncologic

Oncologic side effects reported during postmarketing experience have included squamous cell carcinoma, although causality has not been established.

Other

Other side effects have included asthenia (1.7%) and taste perversion (1.4%). Ear pain, tinnitus, ear disorder, otitis media, fever, chest pain, generalized pain, cellulitis, back pain, chills, face edema, malaise, accidental injury, infection, mucous membrane disorder, and neck pain have been reported in less than 1% of patients. Anosmia has been reported during postmarketing experience.

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