SUMMARY OF SAFETY-RELATED DRUG LABELING CHANGES APPROVED BY FDA
November 1998

(Posted: 1/21/99)

Note: The following summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.

NB: Comparison made to 1999 Physicians' Desk Reference (PDR), if drug's labeling included in the PDR.

Compiled with the help of:
Erin Conley, Pharm.D. Candidate
University of Pittsburgh
School of Pharmacy
Pittsburgh, PA

ALDOMET (methyldopa)	ATROVENT (ipratropium bromide)	BACTRIM (trimethoprim/ sulfamethoxazole)	COZAAR (losartan potassium)
DIOVAN (valsartan)	HISMANAL (astemizole)	HYCAMTIN (topotecan HCl)	HYDRODIURIL (hydrochlorothiazide)
HYZAAR (losartan potassium/ hydrochlorothiazide)	MEZLIN (mezlocillin sodium)	MYCOSTATIN (nystatin)	NASONEX (mometasone furoate monohydrate)
NORPACE/ NORPACE CR (disopyramide phosphate)	PHENDIMETRAZINE TARTRATE	PROVENTIL (albuterol sulfate)	TASMAR (tolcapone)
VANTIN (cefpodoxime proxetil)	VIAGRA (sildenafil citrate)

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PRECAUTIONS:

Drug Interactions: Text added as new second to last paragraph -

"Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulfate or ferrous gluconate. This may adversely affect blood pressure control in patients treated with methyldopa. Coadministration of methyldopa with ferrous sulfate or ferrous gluconate is not recommended."

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Note: The words "infants" and "children" replaced with "pediatric patients" throughout labeling.

CONTRAINDICATIONS:

Section revised (new text in italics) -

"Bactrim is contraindicated in patients with a known hypersensitivity to trimethoprim or sulfonamides and in patients with documented megaloblastic anemia due to folate deficiency. Bactrim is also contraindicated in pregnant patients and nursing mothers, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus. Bactrim is contraindicated in ["infants" deleted] pediatric patients less than 2 months of age. Bactrim is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored."

PRECAUTIONS:

General: Subsection revised (new text in italics) -

"Bactrim should be given with caution to patients with impaired renal or hepatic function, to those with possible folate deficiency (eg, the elderly, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, and patients in malnutrition states) and to those with severe allergies or bronchial asthma. In glucose-6-phosphate dehydrogenase deficient individuals, hemolysis may occur. This reaction is frequently dose-related (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

"Cases of hypoglycemia in non-diabetic patients treated with Bactrim are seen rarely, usually occurring after a few days of therapy. Patients with renal dysfunction, liver disease, malnutrition or those receiving high doses of Bactrim are particularly at risk.

"Hematological changes indicative of folic acid deficiency may occur in elderly patients or in patients with preexisting folic acid deficiency or kidney failure. These effects are reversible by folinic acid therapy.

"Trimethoprim has been noted to impair phenylalanine metabolism, but this is of no significance in phenylketonuric patients on appropriate dietary restriction.

"As with all drugs containing sulfonamides, caution is advisable in patients with porphyria or thyroid dysfunction."

Use in the Elderly: Subsection revised (new text in italics) -

"There may be an increased risk of severe adverse reactions in elderly patients, particularly when complicating conditions exist, eg, impaired kidney and/or liver function, or concomitant use of other drugs. Severe skin reactions, generalized bone marrow suppression (see WARNINGS and ADVERSE REACTIONS sections) or a specific decrease in platelets (with or without purpura) are the most frequently reported severe adverse reactions in elderly patients. In those concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported. Appropriate dosage adjustments should be made for patients with impaired kidney function and duration of use should be as short as possible to minimize risks of undesired reactions (see DOSAGE AND ADMINISTRATION section). The trimethoprim component of Bactrim may cause hyperkalemia when administered to patients with underlying disorders of potassium metabolism, with renal insufficiency, or when given concomitantly with drugs known to induce hyperkalemia. Close monitoring of serum potassium is warranted in these patients. Discontinuation of Bactrim treatment is recommended to help lower serum potassium levels."

Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS): Subsection revised (new text in italics) -

"AIDS patients may not tolerate or respond to Bactrim in the same manner as non-AIDS patients. The incidence of side effects, particularly rash, fever, leukopenia and elevated aminotransferase (transaminase) values, with Bactrim therapy in AIDS patients who are being treated for Pneumocystis carinii pneumonia has been reported to be greatly increased compared with the incidence normally associated with the use of Bactrim in non-AIDS patients. The incidence of hyperkalemia appears to be increased in AIDS patients receiving Bactrim. Adverse effects are generally less severe in patients receiving Bactrim for prophylaxis. A history of mild intolerance to Bactrim in AIDS patients does not appear to predict intolerance of subsequent secondary prophylaxis. However, if a patient develops skin rash or any sign of adverse reaction, therapy with Bactrim should be reevaluated (see WARNINGS).

"High dosage of trimethoprim, as used in patients with Pneumocystis carinii pneumonia, induces a progressive but reversible increase of serum potassium concentrations in a substantial number of patients. Even treatment with recommended doses may cause hyperkalemia when trimethoprim is administered to patients with underlying disorders of potassium metabolism, with renal insufficiency, or if drugs known to induce hyperkalemia are given concomitantly. Close monitoring of serum potassium is warranted in these patients.

"During treatment, adequate fluid intake and urinary output should be ensured to prevent crystalluria. Patients who are 'slow acetylators' may be more prone to idiosyncratic reactions to sulfonamides."

Drug Interactions: Subsection revised (new text in italics) -

"In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported.

"It has been reported that Bactrim may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin. This interaction should be kept in mind when Bactrim is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed.

"Bactrim may inhibit the hepatic metabolism of phenytoin. Bactrim, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.

"Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations.

"There have been reports of marked but reversible nephrotoxicity with coadministration of Bactrim and cyclosporine in renal transplant recipients.

"Increased digoxin blood levels can occur with concomitant Bactrim therapy, especially in elderly patients. Serum digoxin levels should be monitored.

"Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin.

"Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if Bactrim is prescribed.

"The efficacy of tricyclic antidepressants can decrease when coadministered with Bactrim.

"Like other sulfonamide-containing drugs, Bactrim potentiates the effect of oral hypoglycemics.

"In the literature, a single case of toxic delirium has been reported after concomitant intake of trimethoprim/sulfamethoxazole and amantadine."

Carcinogenesis, Mutagenesis, Impairment of Fertility: Mutagenesis: Third sentence revised (new text in italics) -

"No chromosomal damage was observed in human leukocytes cultured in vitro with sulfamethoxazole and trimethoprim alone or in combination; the concentrations used exceeded blood levels of these compounds following therapy with Bactrim."

Impairment of Fertility: Subsection revised (new text in italics): -

"No adverse effects on fertility or general reproductive performance were observed in rats given oral dosages as high as 70 mg/kg/day trimethoprim plus 350 mg/kg/day sulfamethoxazole. These doses are 10.9-fold higher than the recommended human dose for trimethoprim and sulfamethoxazole."

Pregnancy: Teratogenic Effects: Pregnancy Category C: First and second paragraphs (new text in italics) -

"In rats, oral doses of 533 mg/kg sulfamethoxazole (16.7-fold higher than the recommended human dose) or 200 mg/kg trimethoprim (31.3-fold higher than the recommended human dose) produced teratologic effects manifested mainly as cleft palates."

"The highest dose which did not cause cleft palates in rats was 512 mg/kg sulfamethoxazole (16-fold higher than the recommended human dose) or 192 mg/kg trimethoprim (30-fold higher than the recommended human dose) when administered separately. In two studies in rats, no teratology was observed when 512 mg/kg of sulfamethoxazole (16-fold higher than the recommended human dose) was used in combination with 128 mg/kg of trimethoprim (20-fold higher than the recommended human dose). In one study, however, cleft palates were observed in one litter out of 9 when 355 mg/kg of sulfamethoxazole (11.1-fold higher than the recommended human dose) was used in combination with 88 mg/kg of trimethoprim (13.8-fold higher than the recommended human dose) ."

ADVERSE REACTIONS:

Hematologic: addition of "pancytopenia" and "purpura"

Genitourinary: addition of "nephrotoxicity in association with cyclosporine"

Metabolic and Nutritional (new subsection): "Hyperkalemia (see PRECAUTIONS: Use in the Elderly and Use in the Treatment of and Prophylaxis for Pneumocystis Carnii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS)."

Musculoskeletal: Text added as last sentence in subsection -

"Isolated cases of rhabdomyolysis have been reported with Bactrim, mainly in AIDS patients."

PRECAUTIONS:

General: Hypersensitivity: Sub-Subsection moved to beginning of subsection and revised (new text in italics) - "Angioedema. See ADVERSE REACTIONS, Post-Marketing Experience."

Information for Patients: Potassium Supplements (new subsection): "A patient receiving Cozaar should be told not to use potassium supplements or salt substitutes containing potasssium without consulting the prescribing physician (see PRECAUTIONS, Drug Interactions)."

ADVERSE REACTIONS:

Post-Marketing Experience:Hypersensitivity: Subsection revised (new text in italics) -

"Angioedema ["(involving" deleted] including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue [")" deleted] has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors."

Laboratory Test Findings: Creatinine, Blood Urea Nitrogen: Text added at end of subsection -

"(see PRECAUTIONS, Impaired Renal Function)."

ADVERSE REACTIONS:

Post-Marketing Experience (new subsection): -

"The following additional adverse reactions have been reported in post-marketing experience:
Hypersensitivity: There are rare reports of angioedema;
Digestive: Elevated liver enzymes and very rare reports of hepatitis."

WARNING BOX:

Fifth paragraph revised -

"Since astemizole is extensively metabolized by the liver, the use of astemizole in patients with ["significant" deleted] hepatic dysfunction is contraindicated."

CLINICAL PHARMACOLOGY:

Special Populations: Subsection revised -

"Elevated levels of unmetabolized astemizole, whether due to ["significant" deleted] hepatic dysfunction, concomitant use of interacting medications, or overdose, have been associated with QTC interval prolongation and serious cardiac events. (See WARNING BOX; CONTRAINDICATIONS; WARNINGS; PRECAUTIONS, Drug Interactions; ADVERSE REACTIONS; and DOSAGE AND ADMINISTRATION.)"

Hepatically Impaired (new subsection): "In a study involving sixteen subjects with mild or moderate hepatic impairment as determined by Pugh's classification, the mean AUC and C_max of unmetabolized astemizole showed clinically significant increases in subjects with hepatic impairment compared to eight subjects with normal hepatic function. The use of Hismanal in patients with hepatic dysfunction is contraindicated. (See WARNING BOX, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)"

Last paragraph of existing "Special Populations" subsection moved as last paragraph in "Hepatically Impaired" subsection and revised -

"["Interpatient variability in pharmacokinetic parameters may be greater in patients with liver disease as compared to normal subjects." deleted] Systematic evaluation of the pharmacokinetics in patients with ["hepatic or" deleted] renal dysfunction has not been performed."

CONTRAINDICATIONS:

Second sentence revised (new text in italics) -

"Astemizole is also contraindicated in patients with ["severe" deleted] hepatic ["impairment" deleted] dysfunction or who are taking other concomitant medications known to impair its metabolism."

PRECAUTIONS:

General: First sentence revised -

"Elevated concentrations of astemizole and/or its principal metabolite, desmethylastemizole, whether due to overdose, ["significant" deleted] hepatic dysfunction, or concomitant medications, have been associated with altered cardiac repolarization and/or serious cardiac arrhythmias."

DOSAGE AND ADMINISTRATION:

Second paragraph, second sentence revised -

"Use of Hismanal in patients with ["significant" deleted] hepatic dysfuntion or in patients taking ketoconazole, itraconazole, erythromycin, clarithromycin, mibefradil dihydrochloride, or quinine is contraindicated."

Third paragraph revised -

"Studies evaluating the need for dosage adjustments for patinets with ["hepatic or" deleted] renal dysfunction have not been performed. Since astemizole is extensively metabolized by the liver, use of Hismanal in patients with ["significant" deleted] hepatic dysfunction is contraindicated."

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PRECAUTIONS:

Pediatric Use: Existing text -

"Safety and effectiveness in children have not been established."

deleted and replaced with -

"There are no well-controlled clinical trials in pediatric patients. Information on dosing in this age group is supported by evidence from empiric use in pediatric patients and published literature regarding the treatment of hypertension in such patients (See DOSAGE AND ADMINISTRATION, Infants and Children)."

DOSAGE AND ADMINISTRATION:

Infants and Children: Text added to end of subsection -

"(See PRECAUTIONS, Pediatric Use.)"

PRECAUTIONS:

General: Hypersensitivity: Sub-Subsection moved to beginning of subsection and revised (new text in italics) - "Angioedema. See ADVERSE REACTIONS, Post-Marketing Experience."

ADVERSE REACTIONS:

Post-Marketing Experience:Hypersensitivity: Subsection revised (new text in italics) -

"Angioedema ["(involving" deleted] including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue [")" deleted] has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors."

DOSAGE AND ADMINISTRATION:

NB: Changes provide for a new tablet strength, 100 mg losartan potassium/25 mg hydrochlorothiazide.

Dose Titration by Clinical Effect: Subsection revised (new text in italics) -

"A patient whose blood pressure is not adequately controlled with losartan monotherapy (see above) may be switched to Hyzaar 50-12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Hyzaar 50-12.5 once daily or one tablet of Hyzaar 100-25 (losartan 100 mg/hydrochlorothiazide 25mg) once daily.

"A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to Hyzaar 50-12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response of Hyzaar 50-12.5 should be subsequently evaluated and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Hyzaar 50-12.5 once daily or one tablet of Hyzaar 100-25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.

"The usual dose of Hyzaar is one tablet of Hyzaar 50-12.5 once daily. More than two tablets of Hyzaar 50-12.5 once daily or more than one tablet of Hyzaar 100-25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy."

HOW SUPPLIED:

Storage: First sentence revised (new text in italics) -

"Store at ["controlled room temperature," deleted] 25^oC (77^oF); excursions permitted to 15-30^oC (59-86^oF) [see USP Controlled Room Temperature]."

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PRECAUTIONS:

Pregnancy: Teratogenic Effects: Category C: Subsection revised -

"Animal reproduction studies have not been conducted with nysatin ["patilles" deleted]. It is also not known whether nystatin ["pasatille" deleted] can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mycostatin Pastilles should be dispensed to a pregnant woman only if clearly needed."

Nursing Mothers (new subsection):

"It is not known whether nystatin is excreted in human milk. Although gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed for a nursing woman."

Pediatric Use: Existing text -

"See PRECAUTIONS, General."

deleted and replaced with -

"The use of Mycostatin Pastilles has not been systematically studied in pediatric patients."

ADVERSE REACTIONS:

First paragraph, first sentence revised (new text in italics) -

"Mycostatin Pastilles are generally well tolerated by all age groups, even during prolonged use."

CLINICAL PHARMACOLOGY:

Clinical Studies: Second paragraph revised (new text in italics) -

"In patients with seasonal allergic rhinitis, Nasonex Nasal Spray, 50 mcg demonstrated improvement in nasal symptoms (vs. placebo) within ["2 days after the first dose" deleted] 11 hours after the first dose based on one single-dose, parallel group study of patients in an outdoor 'park' setting (park study) and one environmental exposure unit (EEU) study, and within 2 days in 2 randomized, double-blind, placebo-controlled, parallel group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing."

PRECAUTIONS:

Information for patients: First paragraph, fifth sentence revised (new text in italics) -

"Improvement in nasal symptoms of allergic rhinitis has been shown to occur within ["2 days" deleted] 11 hours after the first dose based on one single-dose, parallel group study of patients in an outdoor 'park' setting (park study) and one environmental exposure unit (EEU) study and within 2 days after the first dose in 2 randomized, double-blind, placebo-controlled, parallel group seasonal allergic rhinitis studies."

ADVERSE REACTIONS:

Text added as last paragraph -

"In postmarketing surveillance of this product, cases of nasal burning and irritation, and rare cases of nasal septum perforation have been reported."

DOSAGE AND ADMINISTRATION:

Third paragraph revised (new text in italics) -

"Improvement in nasal symptoms ["generally occurs" deleted] of allergic rhinitis has been shown to occur within ["2 days" deleted] 11 hours after the first dose based on one single-dose, parallel group study of patients in an outdoor 'park' setting (park study) and one environmental exposure unit (EEU) study and within 2 days after the first dose in 2 randomized, double-blind, placebo-controlled, parallel group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks. Patients should use Nasonex Nasal Spray, 50 mcg only once daily at a regular interval."

Patient's Instructions for Use:

Caution: Last sentence -

"Improvement generally occurs within 2 days after initial treatment; the full benefit of Nasonex Nasal Spray, 50 mcg is usually achieved within 1 to 2 weeks."

deleted and replaced with -

"Based on single day studies done in a park during pollen season or in a controlled pollen exposure room, improvement in nasal symptoms of allergic rhinitis has been shown to occur within 11 hours after the first dose. In other studies that lasted up to 2 weeks, improvement in nasal symptoms of seasonal allergic rhinitis was shown to occur within 2 days after the first dose. The full benefit of Nasonex Nasal Spray, 50 mcg is usually achieved within 1 to 2 weeks."

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NORPACE (disopyramide phosphate) Capsules
and
NORPACE CR (disopyramide phosphate) Extended-Release Capsules
[November 10, 1999: Searle]

CLINICAL PHARMACOLOGY:

Drug Interactions (new subsection):

"Effects of other drugs on disopyramide pharmacokinetics: In vitro metabolic studies indicated that disopyramide is metabolized by cytochrome P450 3A4 and that inhibitors of this enzyme may result in elevation of plasma levels of disopyramide. Although specific drug interaction studies have not been done, cases of life-threatening interactions have been reported for disopyramide when given with clarithromycin and erythromycin."

PRECAUTIONS:

Drug Interactions:

Second paragraph deleted - note that this paragraph was added as a Feb98 labeling change -

"Patients taking disopyramide phosphate and erythromycin concomitantly may develop increased serum concentrations of disopyramide resulting in excessive widening of the QRS complex and/or prolongation of the Q-T interval (see WARNINGS.) Patients taking disopyramide phosphate and hepatic enzyme inhibitors concomitantly should be closely monitored."

Text added as new last paragraph -

"Although potent inhibitors of cytochrome P450 3A4 (eg, ketoconazole) have not been studied clinically, in vitro studies have shown that erythromycin and oleandomycin inhibit the metabolism of disopyramide. Cases of life-threatening interactions have been reported for disopyramide when given with clarithromycin and erythromycin indicating that coadministration of disopyramide with inhibitors of cytochrome 3A4 could result in potentially fatal interaction."

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PHENDIMETRAZINE TARTRATE Extended-release Capsules
[November 3, 1998: Eon]

CLINICAL PHARMACOLOGY:

Section revised (new text in italics)-

"Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological activity..."

PRECAUTIONS:

Carcinogenesis, Mutagenesis, Impairment of Fertility (new subsection):

"Studies with Phendimetrazine Tartrate sustained release have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility."

Pregnancy: Pregnancy Category C (new subsection):

"Animal reproduction studies have not been conducted with Phendimetrazine Tartrate sustained release. It is also not known whether Phendimetrazine Tartrate sustained release can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phendimetrazine Tartrate sustained release should be given to a pregnant woman only if clearly needed."

Nursing Mothers (new subsection):

"It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Phendimetrazine Tartrate sustained release capsules are administered to a nursing mother."

DRUG ABUSE AND DEPENDENCE:

Controlled Substance: Subsection revised (new text in italics) -

"Phendimetrazine tartrate extended-release capsules are defined by the Drug Enforcement Administration as a Schedule III controlled substance."

OVERDOSAGE:

Last two sentences revised (new text in italics) -

"If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent ["or peritoneal dialysis" deleted] should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use."

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PROVENTIL (albuterol sulfate) Tablets, Repetabs, Inhalation Aerosol, Syrup, Inhalation Solution 0.083% & Inhalation Solution 0.5%
[November 6 & 9, 1998: Schering]

[Labeling changes for other formulation not appearing in 1999 PDR: Sep98]

Labeling, as requested for all beta-agonists used for asthma and/or COPD, extensively revised. Contact the company for a copy of the new labeling/package insert.

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TASMAR (tolcapone) tablets
[November 16, 1998: Hoffman-La Roche]

[Other information regarding these changes: November 16, 1998 ( Letter) - Roche, ( Talk Paper) - FDA]

Labeling extensively revised. Contact the company for a copy of the new labeling/package insert.
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VANTIN (cefpodoxime proxetil) Tablets and Oral Suspension
[November 20, 1998: Pharmacia & Upjohn]

Labeling extensively revised to provide for the use of Vantin Oral Suspension for the treatment of acute otitis media in pediatric patients at a dose of 5mg/kg every 12 hours for 5 days and to provide for the use of Vantin Tablets and Oral Suspension for the treatment of acute maxillary sinusitis. Contact the company for a copy of the new labeling/package insert.

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VIAGRA (sildenafil citrate) Tablets
[November 24, 1998: Pfizer]

[Other information regarding these changes: November 24, 1998 (Important Prescribing Information) - Pfizer, (Talk Paper) - FDA]

Labeling extensively revised. See new labeling.

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