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Summary Of Safety-Related Drug Labeling
Changes Approved By FDA Center for Drug
Evaluation and Research (CDER)
March 2002

(Posted: 04/29/2002)

How to Find a Safety-Related Labeling Change

Use the drop-down menu to select a product by brand name.

Additions: Color green and underlined: text addition example
Deletions: Color red and strikethrough: text deletion example



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ACTIQ (fentanyl citrate) Oral Trasmucosal

[March 12, 2002: Anesta Corporation]

PRECAUTIONS:

Information for Patients and Their Caregivers

Frequent consumption of sugar-containing products may increase the risk of dental caries (each ACTIQ unit contains approximately 2 grams of sugar [sucrose, liquid glucose]). The occurrence of dry mouth associated with the use of opioid medications (such as fentany) may add to the risk. Therefore, patients using ACTIQ should consult their dentist to ensure appropriate oral hygiene.

In the same subsection, toll free number changed from 1-888-818-4113 to 1-800-896-5855.

Disposal of Unopened Actiq Units When no Longer Needed subsection, toll free number changed from 1-800-615-0187 to 1-800-896-5855.

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ALOCRIL (nedocromil sodium) Ophthalmic Solution

[March 8, 2002: Allergan]

PRECAUTIONS

Information for Patients

When using unit-dose ALOCRIL ophthalmic solution, the individual vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration.

INFORMATION FOR THE PATIENT:

New patient label to reflect the information given above.

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AN-DTPA Kit for the Preparation of Technetium Tc99m Pentetate Injection

[March 20, 2002: CIS-US, Inc.]

PRECAUTIONS

Geriatrics Use

Clinical studies of AN-DTPA did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient 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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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AZACTAM (aztreonam) Injection

[March 25, 2002: Bristol-Myers Squibb]

 

PRECAUTIONS

Geriatric Use

Clinical studies of AZACTAM did not include sufficient numbers of subjects aged 65 years 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, dose selection for 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.

In elderly patients, the mean serum half-life of aztreonam increased and the renal clearance decreased, consistent with the age-related decrease in creatinine clearance.1-4 Since aztreonam is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, renal function should be monitored and dosage adjustments made accordingly (see DOSAGE AND ADMINISTRATION: Renal Impairment in Adult Patients and Dosage in the Elderly).

AZACTAM contains no sodium.

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BLOCADREN (timolol maleate) Tablets

[March 27, 2002: Merck]

ADVERSE REACTIONS

Body as a whole: "anaphylaxis" has been added.

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CEFTIN (cefuroxime axetil) Tablets & Oral Suspension

[March 29, 2002: GlaxoSmithKline]

PRECAUTIONS:

General

Fourth paragraph added -

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic activity potential was found for cefuroxime axetil in a battery of bacterial mutation tests. Positive results were obtained in an in vitro chromosome aberration assay, however, negative results were found in an in vivo micronucleus test at doses up to 1.5 g/kg. the micronucleus test and a battery of bacterial mutation tests. Reproduction studies in rats at doses up top 1000 mg/kg per day ( 9 times the recommended maximum human dose based on mg/m2) have revealed no impairment evidence of impaired fertility.

Pregnancy: Teratogenic Effects: Pregnancy category B. Reproduction studies have been performed in rats and mice at doses up to 3200 mg/kg per day (23 14 times the recommended maximum human dose based on mg/m2) and in rats at doses up to 1000 mg/kg per day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime axetil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

 

ADVERSE REACTIONS:

POSTMARKETING EXPERIENCE WITH CEFTIN PRODUCTS:

OBSERVRED DURING CLINICAL PRACTICE

In addition to adverse events reported from during clinical trials, the following events have been identified during clinical practice in patients treated with during post-approval use of Ceftin Tablets or with Ceftin for Oral Suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation. 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 combination of their seriousness, frequency of reporting, or potential causal connection to Ceftin.

Blood and Lymphatic: Increased prothrombin time.

General: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritis, rash, serum sickness-like reaction, and urticaria.

Gastrointestinal: Pseudomembranous colitis (see WARNINGS).

Hematologic: Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.

Hepatic Hepatobiliary Tract and Pancreas: Hepatic impairment including hepatitis and cholestasis, jaundice.

Neurologic: Seizure.

Skin: Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Urologic: Renal dysfunction.

CEPHALOSPORIN-CLASS ADVERSE REACTIONS:

First paragraph -

In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: renal dysfunction, toxic nephropathy, hepatic cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, increased prothrombin time, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, thrombocytopenia, leukopenia, elevated bilirubin, pancytopenia, and agranolocytosis.

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CUROSURF (poractant alfa) Intratracheal Suspension

[March 1, 2002:Dey]

 

DOSAGE AND ADMINISTRATION

FOR INTRATRACHEAL ADMINISTRATION ONLY

General

CUROSURF is administered intratracheally by instillation through a 5 French end-hole catheter, and briefly disconnecting the endotracheal tube from the ventilator. Alternatively, CUROSURF may be administered through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

Before administering CUROSURF, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering Curosurf. The infant should be allowed to stabilize before proceeding with dosing.

Initial Dose

The initial recommended dose of CUROSURF is 2.5 mL/kg birth weight. This dose may be determined from the CUROSURF dosing chart below.

For endotracheal tube instillation using a 5 French end-hole catheter.

Slowly withdraw the entire contents of the vial of CUROSURF into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Attach the pre-cut 8-cm 5 end-hole French catheter to the syringe. Fill the catheter with CUROSURF. Discard excess CUROSURF through the catheter so that only the total dose to be given remains in the syringe.

Immediately before CUROSURF administration, the infant’s ventilator settings should be changed to a rate of 40-60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO2>92%. Keep the infant in a neutral position (head and body in alignment without inclination). Briefly disconnect the endotracheal tube from the ventilator. Insert the pre-cut 5 French catheter into the endotracheal tube and instill the first aliquot (1.25 mL/kg birth weight) of CUROSURF. The infant should be positioned such that either the right or left side is dependent for this aliquot. After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant with 100% oxygen at a rate of 40- 60 breaths/minute for one minute. When the infant is stable, reposition the infant such that the other side is dependant and administer the remaining aliquot using the same procedures. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.

After completion of the dosing procedure, resume usual ventilator management and clinical care. In the clinical trials, ventilator management was modified to maintain a PaO2 of about 55 mmHg, PaCO2 of 35-45, and pH >7.3.

For endotrachel instillation using the secondary lumen of a dual lumen endotracheal tube

Slowly withdraw the entire contents of the vial of CUROSURF into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Do not attach 5 French end-hole catheter. Keep the infant in a neutral position (head and body in alignment without inclination). Administer CUROSURF through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation.

After completion of this dosing procedure, ventilatory management may require transient increases in FiO2, ventilatory rate, or PIP.

Repeat doses

Up to two repeat doses of 1.25 mL/kg birth weight each may be administered, using the same techniques described for the initial dose. Repeat doses should be administered, at approximately 12-hour intervals, in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dose

(sum of the initial and up to two repeat doses) is 5 mL/kg.

TABLE 4 - Unchanged

Directions for Use

CUROSURF should be inspected visually for discoloration prior to administration. The color of CUROSURF is white to creamy white. CUROSURF should be stored in a refrigerator at +2 to +8ºC (36-46°F). Before use, the vial should be slowly warmed to room temperature and gently turned upside-down, in order to obtain a uniform suspension. DO NOT SHAKE.

Unopened, unused vials of CUROSURF that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Do not warm to room temperature and return to refrigerated storage more than once. Protect from light. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.

Dosing Precautions

Transient episodes of bradycardia, decreased oxygen saturation, reflux of the surfactant into the endotracheal tube, and airway obstruction have occurred during the dosing procedure of CUROSURF. These events require interrupting the administration of CUROSURF and taking the appropriate measures to alleviate the condition. After stabilization, dosing may resume with appropriate monitoring.

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DIDRONEL (etidronate disodium) Tablets

[March 15, 2002:Procter and Gamble Pharmaceuticals]

 

PRECAUTIONS

Geriatric Use

Clinical studies of Didronel 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 elderly and younger patients. In general, dose.selection for 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. As stated in PRECAUTIONS, Didronel dosage should be reduced when reductions in glomerular filtration rates are present. In addition, patients with renal impairment should be closely monitored.

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EPIVIR (lamivudine) Tablets & Oral Solution

[March 1, 2002: GlaxoSmithKline]

ADVERSE REACTIONS

Observed During Clinical Practice

Hemic and Lymphatic "pure red cell aplasia" was added.

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FORTAZ (ceftazidime sodium & ceftazidime) Injection

[March 22 & 29, 2002: GlaxoSmithKline]

 

ADVERSE REACTIONS

Observed During Clinical Practice:

Hepatobiliary Tract and Pancreas:

Addition of "jaundice".

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GALZIN (zinc acetate) Capsules

[March 14, 2002: Teva]

CLINICAL TRIALS

Pregnant Patients

Included in a continuing single center United States trial are 19 symptomatic and presymptomatic women who became pregnant and continued Galzin therapy. These women delivered 26 live birth babies. At the time of delivery, the duration of zinc acetate therapy had ranged from 0.7 to 13.7 years. At the time of delivery all patients were using zinc acetate. The zinc acetate dosage at the start of pregnancy ranged from 25 to 50 mg two to three times a day. Two patients were being treated with penicillamine at the start of pregnancy and were switched to zinc acetate during the second month of pregnancy.

Urinary copper excretion was measured to monitor the copper status. Twenty-four hour urine excretion of copper indicated adequate control of copper levels in most patients before and during pregnancies. The results also indicated that during pregnancy, the mothers’ health was protected by zinc acetate therapy, and no adverse effects on liver or neurological functions were reported. Limited pregnancy outcome data indicates an incidence of miscarriages consistent with those in the general population. From this limited experience, the rate of birth defects is 7.7%, while that in the general population is 4%. (See PRECAUTIONS, Pregnancy).

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HYCAMPTIN (topotecan HCl) Injection

[March 6, 2002: SmithKline Beecham]

PRECAUTIONS

Information for Patients

General

Information for Patients: As with other chemotherapeutic agents, Hycamtin may cause asthenia, or fatigue; if these symptoms occur, caution should be observed when driving or operating machinery."

DOSAGE AND ADMINISTRATION

Sentence added as the sixth sentence in the first paragraph:

Doses should be similarly reduced if the platelet count falls below 25,000 cell/mm 3 .

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IOPIDINE (apraclonidine) Ophthalmic Solution 1%

[March 22, 2002: Alcon]

OVERDOSAGE:

While no instances of accidental or intentional ingestion of ophthalmic apraclonidine are known, overdose with the oral form of clonidine has been reported to cause hypotension, transient hypertension, asthenia, vomiting, irritability, diminished or absent reflexes, lethargy, somnolence, sedation or coma, pallor, hypothermia, bradycardia, conduction defects, arrhythmias, dryness of the mouth, miosis, apnea, respiratory depression, hypoventilation, and seizure

Ingestion of IOPIDINE 0.5% Ophthalmic Solution has been reported to cause bradycardia, drowsiness, and hypothermia.

Accidental or intentional ingestion of oral clonidine has been reported to cause apnea, arrhythmias, asthenia, bradycardia, conduction defects, diminished or absent reflexes, dryness of the mouth, hypotension, hypothermia, hypoventilation, irritability, lethargy, miosis, pallor, respiratory depression, sedation or coma, seizure, somnolence, transient hypertension, and vomiting.

Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Hemodialysis is of limited value since a maximum of 5% of circulating drug is removed.

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LACRISERT (Hydroxypropyl Cellulose)

Ophthalmic Insert

[March 20, 2002: Merck]

PRECAUTIONS

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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LIORESAL INTRATHECAL (Baclofen) Injection

[March 6, 2002: Medtronic]

Boxed WARNING

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). When appropriate, oral baclofen and/or diazepam rectal gel can be prescribed for emergency use. Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

WARNINGS

Withdrawal: Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death. In the first 9 years of post-marketing experience, 27 cases of withdrawal temporally related to the cessation of baclofen therapy were reported; six patients died. In most cases, symptoms of withdrawal appeared within hours to a few days following interruption of baclofen therapy. Common reasons for abrupt interruption of intrathecal baclofen therapy included malfunction of the catheter (especially disconnection), low volume in the pump reservoir, and end of pump battery life; human error may have played a causal or contributing role in some cases. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.

All patients receiving intrathecal baclofen therapy are potentially at risk for withdrawal. Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias. Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic- malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.

Rapid, accurate diagnosis and treatment in an emergency-room or intensive- care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal. The suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted. However, if restoration of intrathecal delivery is delayed, treatment with GABA-ergic agonist drugs such as oral or enteral baclofen, or oral, enteral, or intravenous benzodiazepines may prevent potentially fatal sequelae. Oral or enteral baclofen alone should not be relied upon to halt the progression of the intrathecal baclofen withdrawal syndrome.

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MIDAMOR (amiloride HCl) & MODURETIC

(amiloride HCl / hydrochlorothiazide) Tablets

[March 21, 2002: Merck]

PRECAUTIONS

Geriatric Use:

Clinical studies of (Midamor/Moduretic) did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient 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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CONTRAINDICATIONS, Impaired Renal Function.)

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MONODOX (doxycycline monohydrate)

[March 21, 2002: Watson]

 

CLINICAL PHARMACOLOGY

Microbiology subsection extensively revised. Contact the company for a copy of the new package insert/labeling.

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PURINETHOL (mercaptopurine) Tablets

[March 22, 2002: GlaxoSmithKline]

PRECAUTIONS

Drug Interactions

Inhibition of the anticoagulant effect of warfarin, when given with mercaptopurine, has been reported.

As there is in vitro evidence that aminosalicylate derivatives (e.g., olsalazine, mesalazine, or sulphasalazine) inhibit the TPMT enzyme, they should be administered with caution to patients receiving concurrent mercaptopurine therapy (see WARNINGS).

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RESCRIPTOR (delavirdine) Tablets

[March 14, 2002: Agouron]

 

PRECAUTIONS

Resistance/Cross-Resistance

Fat Redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Information for the Patient

Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time.

ADVERSE REACTIONS

Body as a Whole

Abdominal cramps, abdominal distention, abdominal pain (localized), abscess, allergic reaction, chills, edema (generalized or localized), epidermal cyst, fever, infection, infection viral, lip edema, malaise, Mycobacterium tuberculosis infection, neck rigidity, sebaceous cyst, and redistribution/accumulation of body fat (see PRECAUTIONS, Fat Redistribution).

PATIENT PACKAGE INSERT

"What are the possible side effects of RESCRIPTOR"

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

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RISPERDAL (risperidone) Tablets and Oral Solution

[March 3, 2002: Johnson & Johnson]

Labeling provides for the longer-term efficacy for risperidone in the treatment of schizophrenia. Contact the company for a copy of the new labeling/package insert.

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SEREVENT DISKUS (salmeterol xinafoate) Powder for Inhalation

[March 22, 2002: GlaxoSmithKline]

 

Labeling provides for the use of Serevent Diskus (salmeterol xinafoate) inhalation powder for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis). Contact the company for a copy of the new labeling/package insert.

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TAXOL (paclitaxel) Injection

[March 4, 2002: Bristol-Myers Squibb]

[Not in 2001 PDR]

ADVERSE REACTIONS

Adverse Event Experiences by Body System

Other Clinical Events

2 nd paragraph, "Stevens-Johnson syndrome, and toxic epidermal necrolysis" have been added.

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TENEX (guanfacine HCl) Tablets

[March 12, 2002: A. H. Robbins]

 

PRECAUTIONS

Geriatric Use:

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

In general, dose selection for an elderly patient 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 (see CLINICAL PHARMACOLOGY-Pharmacokinetics).

PRECAUTIONS

Pediatric Use:

There have been spontaneous postmarketing reports of mania and aggressive behavioral changes in pediatric patients with attention-deficit hyperactivity disorder (ADHD) receiving Tenex. The reported cases were from a single center. All patients have medical or family risk factors for bipolar disorder. All patients recovered upon discontinuation of guanfacine HCl.

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TOBI (tobramycin) Solution for Inhalation

[March 21, 2002: Chiron]

WARNINGS

Ototoxicity

Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with TOBI therapy during clinical studies. However, transient tinnitus occurred in eight TOBI-treated patients versus no placebo patients in the clinical studies. Tinnitus is may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution (see ADVERSE REACTIONS). In postmarketing experience, some patients receiving TOBI and extensive previous or concomitant parenteral aminoglycosides have reported hearing loss.

Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.

In postmarketing experience, patients receiving TOBI have reported hearing loss. Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus.

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TOPROL XL (metoprolol succinate) Tablets

[March 5, 2002: AstraZeneca]

CLINICAL PHARMACOLOGY

Clinical Trials

However, in the US subgroup (n=1071) and women (n=898), overall mortality and cardiovascular mortality appeared less affected.

ADVERSE REACTIONS

Post-Marketing Experience

GASTROINTESTINAL: hepatitis.

MUSCULOSKELETAL: arthralgia.

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Transderm Scop (scopolamine) Transdermal Delivery System

[March 22, 2002: Novartis Consumer Health]

 

CLINICAL PHARMACOLOGY

Pharmacokinetics

Clinical Results:

Transderm Scop provided significantly greater protection than that obtained with oral dimenhydrinate.

REFERENCES

Clissold study reference (No. 3) removed.

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ZERIT (stavudine) Capsules & Pediatric Oral Solution

[March 29, 2002:Bristol-Myers Squibb]

[Other safety related information: http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zerit]

[Other labeling changes not in 2002 PDR: http://www.fda.gov/medwatch/SAFETY/2002/Feb02.htm#zerit]

Labeling provides for the use of ZERIT (stavudine) in pediatric patients from birth to five weeks. Contact the company for a copy of the new labeling/package insert.

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ZOCOR (simvastatin) Tablets

[March 21, 2002: Merck]

Labeling provides for changes to the CLINICAL PHARMACOLOGY section of the Zocor package insert, which describe the influence of total cholesterol, LDL-C, Apo B, HDL-C, Apo A-1 and triglyceride levels on the risks of cardiovascular disease. Contact the company for a copy of the new labeling/package insert.

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