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Nilandron®

Interstitial Pneumonitis

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.


Lanoxin, Fortaz, and Zinacef are registered trademarks of the GlaxoSmithKline group of companies.
Zantac is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc, used under license.

Fortaz® (ceftazidime for injection)
Fortaz® (ceftazidime for injection) Fortaz (ceftazidime for injection) is a semisynthetic, broad-spectrum, ß-lactam antibiotic indicated for the treatment of patients with infections caused by susceptible strains in the following diseases:

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  • Lower respiratory tract infections
  • Skin and skin-structure infections
  • Urinary tract infections
  • Bacterial septicemia
  • Bone and joint infections
  • Gynecologic infections
  • Intra-abdominal infections
  • Central nervous system infections
(See the Indications and Usage section of the complete Prescribing Information for a listing of the specific bacterial strains for which FORTAZ is indicated to treat for each of the aforementioned diseases.)

Important Safety Information about FORTAZ

FORTAZ is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibiotics.

Before therapy with FORTAZ is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to ceftazidime, cephalosporins, penicillins, or other drugs. If FORTAZ is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to FORTAZ occurs, its use should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including FORTAZ, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhea following antibiotic use, and careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

FORTAZ is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported. (See the Adverse Reactions section of the complete Prescribing Information.)

Please see full Prescribing Information for FORTAZ.

Lanoxin, Fortaz, and Zinacef are registered trademarks of the GlaxoSmithKline group of companies.
Zantac is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc, used under license.

Kayexalate
(sodium polystyrene sulfonate)
KAYEXALATE is indicated for the treatment of hyperkalemia.

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Important Safety Information about Kayexalate

KAYEXALATE is contraindicated in patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, patients with obstructive bowel disease, and neonates with reduced gut motility (post-operatively or drug-induced). In neonates, KAYEXALATE should not be given by the oral route.

Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with KAYEXALATE use. Risk factors for gastrointestinal adverse events were present in many of the cases, including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. The majority of these cases reported the concomitant use of sorbitol; therefore, the concomitant administration of sorbitol is not recommended (see the Drug Interactions section of the complete Prescribing Information).

KAYEXALATE should only be used in patients who have normal bowel function. KAYEXALATE should not be used in patients who have not had a bowel movement post-surgery or are at risk for developing constipation or impaction. Use should be discontinued in patients who develop constipation.

Treatment with KAYEXALATE alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Serious potassium deficiency can occur from therapy with KAYEXALATE. The effect must be carefully controlled by frequent serum potassium determinations within each 24-hour period. The level at which treatment with KAYEXALATE should be discontinued must be determined individually, based on factors such as the patient’s clinical condition and electrocardiogram (see the Warnings section of the complete Prescribing Information for a listing of early clinical signs of severe hypokalemia). The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range".

KAYEXALATE is not totally selective for potassium in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Patients receiving KAYEXALATE should be monitored for all applicable electrolyte disturbances.

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with KAYEXALATE. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given KAYEXALATE with magnesium hydroxide as laxative.

Please see full Prescribing Information for KAYEXALATE.

Lanoxin® (digoxin) Tablets
Lanoxin® (digoxin) Tablets is a cardiac (or digitalis) glycoside indicated for the treatment of mild to moderate heart failure and for the control of ventricular response rate in patients with chronic atrial fibrillation.

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Important Safety Information about Lanoxin® (digoxin) Tablets

Digitalis glycosides are contraindicated in patients with ventricular fibrillation and in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.

Because digoxin slows sinoatrial and atrioventricular (AV) conduction, the drug commonly prolongs the PR interval. Digoxin may cause severe sinus bradycardia or sinoatrial block in patients with preexisting sinus node disease and may cause advanced or complete heart block in patients with preexisting incomplete AV block; in such patients consideration should be given to the insertion of a pacemaker before treatment with digoxin.

After intravenous digoxin therapy, some patients with paroxysmal atrial fibrillation or flutter and a coexisting accessory AV pathway (ie, Wolff-Parkinson-White Syndrome) have developed increased antegrade conduction across the accessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conduction down the accessory pathway has been blocked (either pharmacologically or surgically), digoxin should not be used in such patients. The treatment of paroxysmal supraventricular tachycardia in such patients is usually direct-current cardioversion.

Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction (restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale) may be particularly susceptible to digoxin toxicity. Patients with idiopathic hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic effects of digoxin. Digoxin should generally be avoided in these patients, though it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation.

In a large mortality trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking LANOXIN compared with 0.9% in patients taking placebo, and the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances. Similar adverse experiences were observed in 2 randomized, double-blind, placebo-controlled trials of LANOXIN tablets or placebo. Because some patients may be particularly susceptible to side effects of digoxin, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants.

Please see full Prescribing Information for LANOXIN Tablets

Lanoxin, Fortaz, and Zinacef are registered trademarks of the GlaxoSmithKline group of companies.
Zantac is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc, used under license.

Lanoxin® (digoxin) Injection
Lanoxin® (digoxin) Injection is a cardiac (or digitalis) glycoside indicated for the treatment of mild to moderate heart failure and for the control of ventricular response rate in patients with chronic atrial fibrillation.

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Important Safety Information about LANOXIN Tablets and LANOXIN Injection

Digitalis glycosides are contraindicated in patients with ventricular fibrillation and in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.

Because digoxin slows sinoatrial and atrioventricular (AV) conduction, the drug commonly prolongs the PR interval. Digoxin may cause severe sinus bradycardia or sinoatrial block in patients with preexisting sinus node disease and may cause advanced or complete heart block in patients with preexisting incomplete AV block; in such patients consideration should be given to the insertion of a pacemaker before treatment with digoxin.

After intravenous digoxin therapy, some patients with paroxysmal atrial fibrillation or flutter and a coexisting accessory AV pathway (ie, Wolff-Parkinson-White Syndrome) have developed increased antegrade conduction across the accessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conduction down the accessory pathway has been blocked (either pharmacologically or surgically), digoxin should not be used in such patients. The treatment of paroxysmal supraventricular tachycardia in such patients is usually direct-current cardioversion.

Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction (restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale) may be particularly susceptible to digoxin toxicity. Patients with idiopathic hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic effects of digoxin. Digoxin should generally be avoided in these patients, though it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation.

In a large mortality trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking LANOXIN compared with 0.9% in patients taking placebo, and the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances. Similar adverse experiences were observed in 2 randomized, double-blind, placebo-controlled trials of LANOXIN tablets or placebo. Because some patients may be particularly susceptible to side effects of digoxin, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants.

Please see full Prescribing Information for LANOXIN Injection.

Lanoxin, Fortaz, and Zinacef are registered trademarks of the GlaxoSmithKline group of companies.
Zantac is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc, used under license.

Nilandron®(nilutamide)
NILANDRON® Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2). For maximum benefit, NILANDRON treatment must begin on the same day as, or on the day after, surgical castration.

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Important Safety Information about NILANDRON Tablets

NILANDRON Tablets are contraindicated in patients with severe hepatic impairment, patients with severe respiratory insufficiency, and patients with hypersensitivity to nilutamide or any component of NILANDRON Tablets.

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials of NILANDRON, and in 17% of patients in a small study (N=47) in Japanese subjects. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy.

A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.

Rare cases of death or hospitalization due to severe liver injury have been reported post-marketing in association with the use of NILANDRON. Hepatotoxicity in these reports generally occurred within the first 3 to 4 months of treatment. Serum transaminase levels should be measured prior to starting treatment with NILANDRON, at regular intervals for the first 4 months of treatment, and periodically thereafter. Liver function tests should also be obtained at the first sign or symptom suggestive of liver dysfunction. If at any time a patient has jaundice or their ALT rises above 2 times the upper limit of normal, NILANDRON should be immediately discontinued with close follow-up of liver function tests until resolution.

Foreign post-marketing surveillance has revealed isolated cases of aplastic anemia in which a causal relationship with NILANDRON could not be ascertained.

In clinical trials, 13% to 57% of patients receiving NILANDRON reported a delay in adaptation to dark, ranging from seconds to a few minutes, when passing from a lighted area to a dark area. This effect sometimes does not abate as drug treatment is continued. Patients who experience this effect should be cautioned about driving at night or through tunnels. This effect can be alleviated by the wearing of tinted glasses.

Interstitial Pneumonitis

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.


Please see full Prescribing Information for NILANDRON.

Plaquenil® (hydroxychloroquine)
PLAQUENIL® is indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and acute or chronic rheumatoid arthritis, in patients who have not responded satisfactorily to drugs with less potential for serious side effects.

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Important Safety Information about PLAQUENIL

PLAQUENIL is contraindicated in patients with retinal or visual field changes attributable to any 4-aminoquinoline compound and in patients with known hypersensitivity to 4-aminoquinoline compounds.  PLAQUENIL should not be used for long-term therapy in children.

PLAQUENIL is not effective against chloroquine-resistant strains of P. falciparum.  Treatment with quinine or other specific forms of therapy is therefore advised for patients infected with a resistant strain of parasites.

Irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy.  The risk of retinal damage is small with daily doses of up to 6.5 mg/kg ideal body weight.  Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. 

Before starting a long-term treatment, both eyes should be carefully examined for visual acuity, central visual field, and color vision. Examination should also include fundoscopy. These examinations should be repeated at least annually. Retinal toxicity is largely dose-related.  Examinations should be more frequent and adapted to the patient in the following situations: daily dosage exceeding 6.5 mg/kg ideal body weight (absolute body weight used as a guide to dosage could result in an overdosage in the obese), renal insufficiency, cumulative dose more than 200 g, elderly, impaired visual acuity.

If any visual disturbance occurs (visual acuity, color vision), PLAQUENIL should be immediately discontinued and the patient closely observed for possible progression of the abnormality.  Retinal changes (and visual disturbances) may progress even after cessation of the therapy (see Adverse Reactions section of the complete Prescribing Information).

Suicidal behavior has been reported in very rare cases in patients treated with hydroxychloroquine.

Children are especially sensitive to the 4-aminoquinoline compounds. A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses (0.75 g or 1 g in one 3-year-old child).  Patients should be strongly warned to keep these drugs out of the reach of children.

Use of PLAQUENIL in patients with psoriasis may precipitate a severe attack of psoriasis.  When used in patients with porphyria the condition may be exacerbated.  PLAQUENIL should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.

Dermatologic reactions to PLAQUENIL may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis.

Periodic blood cell counts should be made if patients are given prolonged therapy.  If any severe blood disorder appears which is not attributable to the disease under treatment, discontinuation of PLAQUENIL should be considered.

Following overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes, including rhythm and conduction disorders leading to sudden, potentially fatal, respiratory and cardiac arrest.  Immediate medical attention is required.  Treatment is symptomatic and must be prompt with immediate evacuation of the stomach by emesis or gastric lavage until the stomach is completely emptied.

Please see full Prescribing Information for PLAQUENIL.

Zantac®
(ranitidine hydrochloride) Injection
Zantac (ranitidine hydrochloride) Injection is a histamine H2-receptor antagonist indicated for the treatment of some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.

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Important Safety Information about ZANTAC Injection and ZANTAC Injection Premixed

ZANTAC Injection and ZANTAC Injection Premixed are contraindicated in patients known to have hypersensitivity to the drug.

In controlled studies in normal volunteers, elevations in serum glutamic pyruvic transaminase (SGPT) have been observed when H2-antagonists have been administered intravenously at greater-than-recommended dosages for 5 days or longer. Therefore, in patients receiving IV ranitidine at dosages ≥100 mg 4 times daily for periods of 5 days or longer, SGPT levels should be monitored daily (starting on Day 5 of treatment) for the remainder of IV ranitidine therapy.

Bradycardia in association with rapid administration of ZANTAC Injection has been reported rarely, usually in patients with predisposing factors for cardiac rhythm disturbances; therefore, recommended rates of administration should not be exceeded (see the Dosage and Administration section of the complete Prescribing Information).

Rare reports suggest that ZANTAC may precipitate acute porphyric attacks in patients with acute porphyria. ZANTAC should, therefore, be avoided in patients with a history of acute porphyria.

Transient pain at the site of IM injection of ZANTAC has been reported. Transient local burning or itching has been reported with IV administration of ZANTAC. Headache, sometimes severe, seems to be related to the administration of ZANTAC.

Please see full Prescribing Information for ZANTAC Injection.

Lanoxin, Fortaz, and Zinacef are registered trademarks of the GlaxoSmithKline group of companies.
Zantac is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc, used under license.

Zinacef® (cefuroxime for injection)
Zinacef (cefuroxime for injection) is a semisynthetic, broad-spectrum, cephalosporin antibiotic indicated for the treatment of patients with infections caused by susceptible strains in the following diseases:

Click here to view Full Prescribing and Important Safety Information
  • Lower respiratory tract infections
  • Urinary tract infections
  • Skin and skin-structure infections
  • Septicemia
  • Meningitis
  • Gonorrhea
  • Bone and joint infections
(See the Indications and Usage section of the complete Prescribing Information for a listing of the specific bacterial strains for which ZINACEF is indicated to treat for each of the aforementioned diseases.)

Important Safety Information about ZINACEF

ZINACEF is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Before therapy with ZINACEF is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. ZINACEF should be given cautiously to penicillin-sensitive patients. Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to ZINACEF occurs, its use should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZINACEF, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhea following antibiotic use, and careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

ZINACEF is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely. (See the Adverse Reactions section of the complete Prescribing Information.)

Please see full Prescribing Information for ZINACEF.

Lanoxin, Fortaz, and Zinacef are registered trademarks of the GlaxoSmithKline group of companies.
Zantac is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc, used under license.