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[Not in 2000 PDR]

ADVERSE REACTIONS:

 Skin and Its Structures:

New text in bolded italics -

Alopecia occurs commonly in patients treated with cyclophosphamide. The hair can be expected to grow back after treatment with the drug or even during continued drug treatment, though it may be different in texture or color. Skin rash occurs occasionally in patients receiving the drug. Pigmentation of the skin and changes in nails can occur. Very rare reports of Stevens-Johnson syndrome and toxic epidermal necrolysis have been received during postmarketing surveillance; due to the nature of spontaneous adverse event reporting, a definitive causal relationship to cyclophosphamide has not been established.

ELIMITE (permethrin) Cream
[January 11, 2001: Allergan]

PRECAUTIONS:

 Geriatric Use:

  New subsection - 

Clinical studies of Elimite cream did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses

between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

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These supplemental new drug applications provide for distinguishing Epivir-HBV in the label and include changes to the WARNINGS, DESCRIPTION, MICROBIOLOGY, CLINICAL PHARMACOLOGY, PRECAUTIONS, ADVERSE EVENTS, and DOSAGE and

ADMINISTRATION sections of the label.

BOXED WARNING

New text underlined and in italics - 

EPIVIR TABLETS AND ORAL SOLUTION (USED TO TREAT HIV INFECTION) CONTAIN A HIGHER DOSE OF THE ACTIVE INGREDIENT (LAMIVUDINE) THAN EPIVIR-HBV  TABLETS AND ORAL SOLUTION (USED TO TREAT CHRONIC HEPATITIS B). PATIENTS WITH HIV INFECTION

New subsection - 

Important Differences Among Lamivudine-Containing Products: EPIVIR Tablets and Oral Solution contain a higher dose of the same active ingredient (lamivudine) than in EPIVIR-HBV Tablets and Oral Solution. EPIVIR-HBV was developed for patients with chronic hepatitis B. The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients dually infected with HIV and HBV. Lamivudine

has not been adequately studied for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. If treatment with EPIVIR-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely to result because of the subtherapeutic dose and the inappropriateness of monotherapy HIV treatment. If a decision is made to

administer lamivudine to patients dually infected with HIV and HBV, EPIVIR Tablets, EPIVIR Oral Solution, or COMBIVIR . (lamivudine/zidovudine) Tablets should be used as part of an appropriate combination regimen. COMBIVIR (a fixed-dose combination tablet of lamivudine and zidovudine) should not be administered concomitantly with either EPIVIR, EPIVIR-HBV, or RETROVIR.

PRECAUTIONS:

Subsection revised with revisions incorporated below:

 

Patients with HIV and Hepatitis B Virus Coinfection: Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. In non-HIV-infected patients treated with lamivudine for chronic hepatitis B, emergence of

lamivudine-resistant HBV has been detected and has been associated with diminished treatment response (see EPIVIR-HBV package insert for additional information). Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.

Subsection revised (new text bolded and in italics) -

Information for Patients:EPIVIR is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection,including opportunistic infections.Patients should remain under the care of a physician when using EPIVIR.Patients should be advised that the use of EPIVIR has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.

 

Patients should be advised that EPIVIR Tablets and Oral Solution contain a higher dose of the same active ingredient (lamivudine) as EPIVIR-HBV Tablets and Oral Solution.If a decision is made to include lamivudine in the HIV treatment regimen of a patient dually infected with HIV and HBV, the formulation and dosage of lamivudine in EPIVIR (not EPIVIR-HBV) should be used.

 

Patients should be advised that the long-term effects of EPIVIR are unknown at this time. EPIVIR Tablets and Oral Solution are for oral ingestion only. Patients should be advised of the importance of taking EPIVIR exactly as it is prescribed. Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis.

 

ADVERSE REACTIONS: New subsection - 

 

Lamivudine in Patients with Chronic Hepatitis B: 

Clinical trials in chronic hepatitis B used a lower dose of lamivudine (100 mg daily) than the dose used to treat HIV. The most frequent adverse events with lamivudine versus placebo were ear, nose, and throat infections (25%versus 21%);malaise and fatigue

(24%versus 28%);and headache (21%versus 21%),respectively.The most frequent laboratory abnormalities reported with lamivudine were elevated ALT, elevated serum lipase, elevated CPK, and posttreatment elevations of liver function tests. Emergence of HBV viral mutants during lamivudine

treatment, associated with reduced drug susceptibility and diminished treatment response,  was also reported (also see WARNINGS and PRECAUTIONS). Please see the complete prescribing information for EPIVIR-HBV Tablets and Oral Solution for more information.

New text in bolded, underlined italics - 

Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of lamivudine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine.

 

Digestive: Stomatitis.

Endocrine and Metabolic: Hyperglycemia.

General: Weakness.

Hemic and Lymphatic: Anemia, lymphadenopathy, splenomegaly.

Hepatic and Pancreatic: [replaced "Hepatobiliary Tract and Pancreas:"] Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment

exacerbation of hepatitis B (see WARNINGS and PRECAUTIONS).

Hypersensitivity: Anaphylaxis, urticaria.

Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis.

Nervous: Paresthesia, peripheral neuropathy.

Respiratory: Abnormal breath sounds/wheezing.

Skin: Alopecia, rash, pruritus.

To view the labeling for the DESCRIPTION, MICROBIOLOGY, CLINICAL PHARMACOLOGY, and DOSAGE and ADMINISTRATION sections, go to:

http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_january_2001.html

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ADVERSE REACTIONS:

Postintroduction Reports:

New subsection:

Adverse events reported since market introduction include: very rarely – retinal vein occlusion.

EXELON (rivastigmine tartrate)  Capsules & Oral Solution
[January 5, 2001: Norvartis]

WARNINGS:

Gastrointestinal Adverse Reactions:

New text in bolded, underlined italics -  

 

Exelon  (rivastigmine tartrate) use is associated with significant gastrointestinal adverse reactions, including nausea and vomiting, anorexia, and weight loss. For this reason, patients should always be started at a dose of 1.5 mg BID and titrated to their maintenance dose. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose (see Dosage

and Administration) to reduce the possibility of severe vomiting and its potentially serious sequelae (e.g., there has been one post-marketing report of severe vomiting with esophageal rupture following inappropriate reinitiation of treatment with a 4.5 mg dose after 8 weeks of treatment interruption.)

New text in bolded italics - 

Caregivers should be advised of the high incidence of nausea and vomiting associated with the use of the drug along with the possibility of anorexia and weight loss. Caregivers should be encouraged to monitor for these adverse events and inform the physician if they occur. It is critical to inform caregivers that if therapy has been interrupted for more than several days, the next dose should not be administered until they

have discussed this with the physician.

ADVERSE REACTIONS:

New subsection - 

Voluntary reports of adverse events temporally associated with Exelon that have been received since market introduction that are not listed above, and that may or may not be causally related to the drug include the following:

Skin and Appendages: Stevens-Johnson syndrome

Second paragraph revised (new text in bolded italics) - 

The ["recommended" deleted] starting dose of Exelon is 1.5 mg  BID. If this dose is well tolerated, after a minimum of two weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at

the previous dose. If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see Warnings).

The maximum dose is 6 mg BID (12 mg/day). Exelon should be taken with ["food" deleted] meals in divided doses in the morning and evening.

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FEMARA (letrozole) Tablets
[January 10, 2001: Novartis]

Labeling revised to incorporate information on a new indication: use of Femara for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Contact the company for a copy of the new labeling/package insert or go to the following link to view the new label.

 

 http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_january_2001.html

New information  regarding the  use of Fosamax 70 mg in men once weekly for the treatment to increase bone mass in men with osteoporosis included throughout labeling. Contact the company for a copy of the new labeling/package insert or go to the following link to view the new label.

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 New text in bolded italics - 

Table 6: Established and Other Potentially Significant Drug Interactions: Alteration in

Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction

What should I tell my doctor before taking KALETRA?

· If you are pregnant or planning to become pregnant: The effects of KALETRA on pregnant

women or their unborn babies are not known.

· If you are breast-feeding: Do not breast-feed if you are taking KALETRA. You should not

breast-feed if you have HIV. If you are a woman who has or will have a baby, talk with your

doctor about the best way to feed your baby. You should be aware that if your baby does not

already have HIV, there is a chance that HIV can be transmitted through breast-feeding.

· If you have liver problems: If you have liver problems or are infected with Hepatitis B or

Hepatitis C, you should tell your doctor before taking KALETRA.

· If you have diabetes: Some people taking protease inhibitors develop new or more serious

diabetes or high blood sugar. Tell your doctor if you have diabetes or an increase in thirst or

frequent urination.

· If you have hemophilia: Patients taking KALETRA may have increased bleeding.

· Keep KALETRA and all other medicines out of the reach of children.

· Refrigerated KALETRA capsules and oral solution remain stable until the expiration date

printed on the label. If stored at room temperature up to 77°F (25°C), KALETRA capsules

and oral solution should be used within 2 months.

· Avoid exposure to excessive heat.

 Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any

medicine away, it is out of the reach of children.

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use of Novantrone  for the treatment of patients with secondary progressive multiple sclerosis,

including progressive relapsing disease. Contact the company for a copy of the new labeling/package insert.

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PRECAUTIONS:

General:

New text in bolded italics - 

The third paragraph has been expanded with the addition of new wording -

 

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in hypovolemic patients and in those with diabetes mellitus or chronic hypertension and in the elderly.

          

In situations where other vasodilators or negative chronotropic agents are administered, co-administration of Precedex could have an additive pharmacodynamic effect and should be administered with caution.

PROSCAR (finasteride) Tablets
[January 30, 2001: Merck]

PRECAUTIONS:

Geriatric Use:

 

New subsection - 

 

Of the total number of subjects included in PLESS, 1480 and 105 subjects were 65 and over and 75 and over, respectively. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Clinical Studies).

 

Material concerning studies in the CLINICAL PHARMACOLOGY Section can be found by going to the link:

http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_january_2001.html

SERZONE (nefazodone HCl) Tablets
[January 23, 2001: Bristol-Myers Squibb]

PRECAUTIONS: [Not in 2000 PDR]

 

New text in bolded italics -

 

Drug Interactions:

Pharmacokinetics of Nefazodone in ‘Poor Metabolizers’ and Potential Interaction with Drugs that Inhibit and/or Are Metabolized by Cytochrome P450 Isozymes

CYP3A4 Isozyme—Nefazodone has been shown in vitroto be an inhibitor of CYP3A4. This is consistent with the interactions observed between nefazodone and triazolam, alprazolam, buspirone, atorvastatin, and simvastatin, drugs metabolized by this isozyme. Consequently, caution is indicated in the combined use of nefazodone with any drugs known to be metabolized by CYP3A4.

 

Information for Patients:

New subsection - 

Visual Disturbances

There have been reports of visual disturbances associated with the use of nefazodone, including blurred vision, scotoma, and visual trails. Patients should be advised to notify their physician if they develop visual disturbances. (See ADVERSE REACTIONS section.)

ADVERSE REACTIONS:

Incidence in Controlled Trials:

New subsection -  

Visual Disturbances

In controlled clinical trials, blurred vision occurred in 9% of nefazodone-treated patients compared to 3% of placebo-treated patients. In these same trials abnormal vision, including scotomata and visual trails, occurred in 7% of nefazodone-treated patients compared to 1% of placebo-treated (see Treatment-Emergent Adverse Experience table, above). Dose-dependendency was observed for these events in these

trials, with none of the scotomata and visual trails at doses below 300 mg/day. However, scotomata and visual trails observed at doses below 300 mg/day have been reported in postmarketing experience with SERZONE. (See PRECAUTIONS: Information for Patients section.)

Postintroduction Clinical Experience:

[Not in 2000 PDR]

Subsection reformatted (additional items in bolded italics) - 

Postmarketing experience with SERZONE has shown an adverse experience profile similar to that seen during the premarketing evaluation of nefazodone. Voluntary reports of adverse events temporally associ-ated with SERZONE have been received since market introduction that are not listed above and for which a causal relationship has not been established. These include:

Anaphylactic reactions; angioedema; convulsions (including grand mal seizures); galactorrhea; gynecomastia (male); liver necrosis and liver failure, in some cases leading to liver transplantation and/or death; priapism (see PRECAUTIONS section); prolactin increased; rhabdomyolysis involving patients receiving the combination of SERZONE and lovastatin or simvastatin (see PRECAUTIONS section); serotonin syndrome; and Stevens-Johnson syndrome.

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STADOL NS (butorphanol tartrate) Nasal Spray
[January 5, 2001: Bristol-Myers Squibb]

Last paragraph revised (new text in bolded italics) - 

"In renally impaired patients with creatine clearance <30 mL/min, the elimination half-life was approximately doubled and the total body clearance was approximately one half (10.5 hours [clearance 150 L/h] compared to 5.8 hours [clearance 260 L/h] in ["normals" deleted] healthy subjects). No effect  on Cmax or Tmax was observed after a single dose.

New last paragraph added - 

After intravenous administration to patients with hepatic impairment, the elimination half-life of butorphanol was approximately tripled and total body clearance was approximately one half (half-life 16.8 hours, clearance 92 L/h) compared to healthy subjects (half-life 4.8 hours, clearance 175 L/h). The exposure of hepatically impaired patients to butorphanol was significantly greater (about 2-fold) than that in healthy subjects. Similar results were seen after nasal administration. No effect on Cmax or Tmax was observed after a single intranasal dose." 

PRECAUTIONS:

Geriatric Use:

The following added to the second paragraph between the third and fourth sentences:

Elderly patients may be more sensitive to the side effects of butorphanol. In clinical studies of STADOL NS, elderly patients had an increased

frequency of headache, dizziness, drowsiness, vertigo, constipation, nausea and/or vomiting, and nasal congestion, compared with the younger

patients.

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STROMECTOL (ivermectin) Tablets
[January 4, 2001: Merck]

PRECAUTIONS:

General:

 New paragraph -

Rarely,patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide.This syndrome has been seen very rarely following the use of ivermectin; a cause and effect relationship has not been established.In individuals who warrant treatment with ivermectin for any reason and have had significant exposure to Loa loa-endemic areas of West and Central Africa, pretreatment assessment for loiasis and careful posttreatment follow-up should be implemented.

Geriatric Use:

New subsection -

Clinical studies of STROMECTOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.Other reported clinical experience has not identified differences in responses between the elderly and younger patients.In

general,treatment of an elderly patient should be cautious,reflecting the greater frequency of decreased hepatic,renal,or cardiac function,and of concomitant disease or other drug therapy.

SYPRINE (trientine HCl) Capsules
[January 17, 2001: Merck]

PRECAUTIONS:

Geriatric Use:

 New subsection - 

Clinical studies of SYPRINE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience is insufficient to determine differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

 

A part of the third paragraph has been revised to read as follows:

In addition, rare instances of congenital defects: aplasia cutis, as manifested by scalp defects; esophageal atresia with tracheoesophogeal fistula; and choanal atresia with absent/hypoplastic nipples, have occurred in infants born to mothers who received Tapazole

The fourth paragraph has been revised to read as follows:

Since the above congenital defects have been reported in offspring of patients treated with Tapazole, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism.

The Drug Interactions section has been revised to read as follows:

Anticoagulants (oral): The activity of oral anticoagulants may be potentiated by anti-vitamin-K activity attributed to Tapazole.

beta -adrenergic blocking agents: Hyperthyroidism may cause increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid.

Digitalis glycosides: Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; reduced dosage of digitalis glycosides may be required.

Theophylline: Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.

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Patient instructions accompanying the OCUMETER  Plus OPHTHALMIC DISPENSER

Contact the company to obtain instructions with photos.

INSTRUCTIONS FOR USE

Please follow these instructions carefully when using TRUSOPT *. Use TRUSOPT as prescribed by your doctor

1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after TRUSOPT.

2. Wash hands before each use.

3. Before using the medication, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.

[Photo]

 [Photo]

5. To open the bottle, unscrew the cap by turning as indicated by the arrows.

[Photo]

6. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.

[Photo]

7. Invert the bottle, grasping it with the thumb or index finger over the Finger Push Area as shown. Press lightly until a single drop is dispensed into the eye as directed by your doctor.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

Ophthalmic medications, if handled improperly, can become contaminated by common bacteria

known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.

WARNING: Keep out of reach of children.

If you have any questions about the use of TRUSOPT, please consult your doctor.

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