25218221 lotrisone insert

INFORMATION
TEAR AT PERFORATION
LOTRISONE® Cream
➧ GIVE TO PATIENT
LOTRISONE® Lotion
Patient’s Instructions
for Use
(clotrimazole and betamethasone dipropionate)
SHAKE WELL BEFORE EACH USE
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER
THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.
LOTRISONE® Cream
DESCRIPTION
LOTRISONE® Lotion
LOTRISONE Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, asynthetic corticosteroid, for dermatologic use.
(clotrimazole and betamethasone
Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CIN2, a molecular weight of dipropionate)
344.84, and the following structural formula: Patient Information Leaflet
What is LOTRISONE Cream or Lotion?
Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.
infections of the feet, groin and body, as Betamethasone dipropionate has the chemical name 9-fluoro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula: Cream or Lotion should be used for fungal to your doctor if your fungal infection does Cream and Lotion contain a corticosteroid.
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
or Lotion (see "What are the possible
Each gram of LOTRISONE Cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg side effects of LOTRISONE Cream and
betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetyl alcohol plus stearyl alcohol, Lotion?" below). LOTRISONE Cream or
ceteareth-30, propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid; benzyl alcohol as preservative. LOTRISONE Cream is smooth, uniform, and white to off-white in color.
Lotion is not to be used in the eyes, in the Each gram of LOTRISONE Lotion contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic base of purified water, mineral oil, white petrolatum, cetyl alcohol plus stearyl alcohol, ceteareth-30,propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid; benzyl alcohol as a preservative.
How do LOTRISONE Cream and Lotion
LOTRISONE Lotion may contain sodium hydroxide. LOTRISONE Lotion is opaque and white in color.
CLINICAL PHARMACOLOGY
Clotrimazole and Betamethasone Dipropionate
nations of an antifungal agent (clotrima- LOTRISONE Cream has been shown to be least as effective as clotrimazole alone in a different cream vehicle. No comparative studies have been conducted with LOTRISONE Lotion and clotrimazole alone. Use of corticosteroids in the treatment of a fungal infection may zole) and a corticosteroid (betamethasone lead to suppression of host inflammation leading to worsening or decreased cure rate. TION LEAFLET TO P
dipropionate). Clotrimazole works against Clotrimazole
Skin penetration and systemic absorption of clotrimazole following topical application of LOTRISONE Cream or Lotion have not been corticosteroid, is used to help relieve red- studied. The following information was obtained using 1% clotrimazole cream and solution formulations. Six hours after the application ness, swelling, itching, and other discom- of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from100 mcg/cm3 in the stratum corneum, to 0.5 to 1 mcg/cm3 in the reticular dermis, and 0.1 mcg/cm3 in the subcutis. No measurable amount of radioactivity (<0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mLof the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine.
Who should NOT use LOTRISONE Cream
Microbiology: Mechanism of Action: Clotrimazole is an imidazole antifungal agent. Imidazoles inhibit 14-α-demethylation of lanosterol
or Lotion?
in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electrontransport system, thereby inhibiting growth of fungi.
Activity In Vivo: Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in TIENT INFORMA
clinical infections as described in the INDICATIONS AND USAGE section: Epidermophyton floccosum, Trichophyton mentagrophytes,
and Trichophyton rubrum.
Activity In Vitro: In vitro, clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this
information is unknown.
Patients who are sensitive to clotrimazole Drug Resistance: Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles including clotrimazole has been reported in some Candida species. corticosteroids or imidazoles, or any ingre- No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes.
Betamethasone Dipropionate
Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the
How should I use LOTRISONE Cream or
vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. (See DOSAGE AND ADMINISTRATION section.) Topical
corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percuta- neous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical cortico-
steroids. (See DOSAGE AND ADMINISTRATION section.)
Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered cortico- steroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Studies performed with LOTRISONE Cream and Lotion indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high potency topical corticosteroids. Therefore, use is not recommended in for 4 weeks on the feet is recommended.
patients less than 17 years of age, in diaper dermatitis, and under occlusion.
ACH HERE AND GIVE P
CLINICAL STUDIES (LOTRISONE Cream)
In clinical studies of tinea corporis, tinea cruris, and tinea pedis, patients treated with LOTRISONE Cream showed a better clinical response at the first return visit than patients treated with clotrimazole cream. In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in patients treated with LOTRISONE Cream wereas good as or better than in those patients treated with clotrimazole cream. In these same clinical studies, patients treated with LOTRISONE Cream showed better clinical responses and mycological cure rates when compared with patients treated with betametha-sone dipropionate cream.
What other important information should
CLINICAL STUDIES (LOTRISONE Lotion)
I know about LOTRISONE Cream and
In the treatment of tinea pedis twice daily for 4 weeks, LOTRISONE Lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2. LOTRISONE Lotion was also shown to have a superior mycological cure rate 1. This medication is to be used for the compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study withLOTRISONE Lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.
In the treatment of tinea cruris twice daily for 2 weeks, LOTRISONE Lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, and pruritus after 3 days. It is unclear if the relief of symptoms after 3 days in this clinical study with LOTRISONE Lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.
The comparative efficacy and safety of LOTRISONE Lotion versus clotrimazole alone in a lotion vehicle have not been studied in the PHARMACIST — DET
treatment of tinea pedis or tinea cruris or tinea corporis. The comparative efficacy and safety of LOTRISONE Lotion and LOTRISONE INDICATIONS AND USAGE
LOTRISONE Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tineapedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum.
Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of LOTRISONE Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (eg, Microsporum canis) has not been established. Several cases of treatmentfailure of LOTRISONE Cream in the treatment of infections caused by Microsporum canis have been reported.
bandaged or otherwise covered or wrapped.
CONTRAINDICATIONS
LOTRISONE Cream or Lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other
corticosteroids or imidazoles, or to any ingredient in these preparations.
PRECAUTIONS
General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression
with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyper-glycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dress- ings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure.
Patients applying LOTRISONE Cream or Lotion to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary free cortisol If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to Lotion in the groin area, it is especially substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
In a small study, LOTRISONE Cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult or lotion sparingly. You should tell your subjects. Three of the eight normal subjects on whom LOTRISONE Cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal Cortrosyn test. The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing (See PRECAUTIONS - Pediatric Use section).
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS - Pediatric Use section.)
If irritation develops, LOTRISONE Cream or Lotion should be discontinued and appropriate therapy instituted.
THE SAFETY OF LOTRISONE CREAM OR LOTION HAS NOT BEEN DEMONSTRATED IN THE TREATMENT OF DIAPER
DERMATITIS. ADVERSE EVENTS CONSISTENT WITH CORTICOSTEROID USE HAVE BEEN OBSERVED IN PATIENTS TREATED WITH
LOTRISONE CREAM FOR DIAPER DERMATITIS. THE USE OF LOTRISONE CREAM OR LOTION IN THE TREATMENT OF DIAPER
DERMATITIS IS NOT RECOMMENDED.
What are the possible side effects of
Information for Patients: Patients using LOTRISONE Cream or Lotion should receive the following information and instructions:
LOTRISONE Cream and Lotion?
1. The medication is to be used as directed by the physician and is not recommended for use longer than the prescribed time period. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally.
2. This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the reported with topical corticosteroid med- physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.
ications: itching, irritation, dryness, infec- 3. This medication should only be used for the disorder for which it was prescribed.
4. Other corticosteroid-containing products should not be used with LOTRISONE without first talking with your physician.
tion of the hair follicles, increased hair, 5. The treated skin area should not be bandaged, covered, or wrapped so as to be occluded. (See DOSAGE AND ADMINISTRATION
acne, change in skin color, allergic skin reaction, skin thinning, and stretch marks.
6. Any signs of local adverse reactions should be reported to your physician.
7. Patients should avoid sources of infection or reinfection.
8. When using LOTRISONE Cream or Lotion in the groin area, patients should use the medication for 2 weeks only, and apply the cream or lotion sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks. 9. The safety of LOTRISONE Cream or Lotion has not been demonstrated in the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated with LOTRISONE Cream for diaper dermatitis. The use of LOTRISONE Cream or Lotion in the treatment of diaper dermatitis is not recommended. local skin reactions, including thinning skin Laboratory Tests: If there is a lack of response to LOTRISONE Cream or Lotion, appropriate confirmation of the diagnosis, including
possible mycological studies, is indicated before instituting another course of therapy.
The following tests may be helpful in evaluating HPA-axis suppression due to the corticosteroid components: Can LOTRISONE Cream or Lotion be
used if I am pregnant or plan to become
Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no laboratory animal studies with either the combination of clotrima-
zole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.
pregnant or if I am nursing?
Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal inthe in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.
tell your doctor if you are pregnant or plan In genotoxicity testing of clotrimazole, chromosomes of the spermatophores of Chinese hamsters, which had been exposed to five daily to become pregnant. Also, tell your doctor oral clotrimazole doses of 100 mg/kg body weight, were examined for structural changes during the metaphase. The results of this study showed that clotrimazole had no mutagenic effect.
Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in How should LOTRISONE Cream or Lotion
mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption be stored?
PHARMACIST
rates in both species. These doses are approximately 5- and 38-fold the human dose based on a mg/m2 comparison, respectively.
Oral doses of clotrimazole in mice resulted in decreased litter size at doses of 120 mg/kg and higher. This dose is approximately LOTRISONE Cream should be stored
10-fold the human dose based on a mg/m2 comparison. between 2°C and 30°C (36°F and 86°F).
A Segment I (fertility and general reproduction) study of clotrimazole was conducted in rats. Males and females were dosed orally LOTRISONE Lotion should only be stored
(diet admixture) at doses of 5, 10, 25, or 50 mg/kg/day for 10 weeks prior to mating. At 50 mg/kg (approximately 8 times the humandose based on a mg/m2 comparison), there was an adverse effect on maternal body weight gain and rearing of the offspring. Doses of in an upright position between 15°C and
25 mg/kg (approximately 4 times the human dose based on a mg/m2 comparison) and lower were well tolerated and produced no adverse 30°C (59°F and 86°F). Shake well before
effects on fertility or reproduction.
using LOTRISONE Lotion.
Pregnancy Category C: There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole
and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low
General advice about prescription
medicines
A Segment II (teratology) study in pregnant rats with intravaginal doses up to 100 mg/kg clotrimazole have revealed no evidence of harm to the fetus. This dose is approximately 17-fold the human dose based on a mg/m2 comparison.
Segment II (teratology) studies of clotrimazole were conducted by the oral (gavage) route in rats, mice, and rabbits. In rats adminis- tered 25, 50, 100, or 200 mg/kg/day, no increase in malformations was seen at doses up to 200 mg/kg. Doses of 100 and 200 mg/kg were embryotoxic (increased resorptions) as well as maternally toxic, while doses of 25 and 50 mg/kg were well tolerated by both ACH HERE AND GIVE P
the dams and the fetuses. These doses were approximately 4-, 8-, 17-, and 34-fold the human dose based on a mg/m2 comparison, In pregnant mice, clotrimazole at oral doses of 25, 50, 100, or 200 mg/kg/day was not teratogenic and was well tolerated by both the dams and the fetuses. These doses were approximately 2-, 4-, 8-, and 17-fold the human dose based on a mg/m2 comparison, respectively. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day. These doses were approximately 20-, 40-, and 61-fold the human dose based on a mg/m2 comparison, respectively. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg.
and Lotion. If you would like more infor- This dose is approximately one-fifth the human dose based on a mg/m2 comparison. The abnormalities observed included umbilical mation, talk with your doctor. You can ask hernias, cephalocele and cleft palates.
your pharmacist or doctor for information Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.
Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endo-
is written for health professionals.
genous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids couldresult in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when LOTRISONE Cream or Lotion is administered to a nursing woman.
Pediatric Use: Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with
LOTRISONE Cream. In open-label studies, 17 of 43 (39.5%) evaluable pediatric patients (aged 12 to 16 years old) using LOTRISONE
Cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label study,
8 of 17 (47.1%) evaluable pediatric patients (aged 12 to 16 years old) using LOTRISONE Cream for treatment of tinea cruris demonstrated
adrenal suppression as determined by cosyntropin testing. THE USE OF LOTRISONE CREAM OR LOTION IN THE TREATMENT OF
PATIENTS UNDER 17 YEARS OF AGE OR PATIENTS WITH DIAPER DERMATITIS IS NOT RECOMMENDED.
TIENT INFORMA
Because of higher ratio of skin surface area to body mass, pediatric patients under the age of 12 years are at a higher risk with LOTRISONE Cream or Lotion. The studies described above suggest that pediatric patients under the age of 17 years may also have this
risk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of
treatment. Adverse effects, including striae and growth retardation, have been reported with inappropriate use of LOTRISONE Cream in
infants and children. (See PRECAUTIONS and ADVERSE REACTIONS sections.)
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertensioninclude bulging fontanelles, headaches, and bilateral papilledema.
Geriatric Use: Clinical studies of LOTRISONE Cream and Lotion did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Postmarket adverse event reporting for LOTRISONE Cream in patients
aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin. THE USE OF LOTRISONE CREAM OR LOTION UNDER OCCLUSION, SUCH
TION LEAFLET TO P
AS IN DIAPER DERMATITIS, IS NOT RECOMMENDED.
ADVERSE REACTIONS
Adverse reactions reported for LOTRISONE Cream in clinical trials were paresthesia in 1.9% of patients, and rash, edema, and
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secondary infection, each in less than 1% of patients.
Adverse reactions reported for LOTRISONE Lotion in clinical trials were burning and dry skin in 1.6% of patients and stinging in less The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis,hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondaryinfection, skin atrophy, striae, and miliaria. In the pediatric population, reported adverse events for LOTRISONE Cream include growthretardation, benign intracranial hypertension, Cushing's syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria OVERDOSAGE
Amounts greater than 45 g/week of LOTRISONE Cream or 45 mL/week of LOTRISONE Lotion should not be used. Acute overdosage with
topical application of LOTRISONE Cream or Lotion is unlikely and would not be expected to lead to a life-threatening situation. LOTRISONE
Cream or Lotion should not be used for longer than the prescribed time period.
Topically applied corticosteroids, such as the one contained in LOTRISONE Cream or Lotion can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS section.)
DOSAGE AND ADMINISTRATION
Gently massage sufficient LOTRISONE Cream or Lotion into the affected skin areas twice a day, in the morning and evening.
LOTRISONE Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts
greater than 45 g per week of LOTRISONE Cream or amounts greater than 45 mL per week of LOTRISONE Lotion should not be used.
If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with LOTRISONE Cream or Lotion,
the diagnosis should be reviewed.
LOTRISONE Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than
45 g per week of LOTRISONE Cream or amounts greater than 45 mL per week of LOTRISONE Lotion should not be used. If a patient
with tinea pedis shows no clinical improvement after 2 weeks of treatment with LOTRISONE Cream or Lotion, the diagnosis should be
reviewed.
LOTRISONE Cream or Lotion should not be used with occlusive dressings.
HOW SUPPLIED
LOTRISONE Cream is supplied in 15-g (NDC 0085-0924-01) and 45-g tubes (NDC 0085-0924-02); boxes of one. Store between 2°C and
30°C (36°F and 86°F).
LOTRISONE Lotion is supplied in 30-mL bottles (NDC 0085-0809-01), box of one. Store at 25°C (77°F) in the upright position only;
excursions permitted between 15°C and 30°C (59°F and 86°F).
SHAKE WELL BEFORE EACH USE.
Schering Corporation/Key Pharmaceuticals, Inc.
Copyright 2000, 2001, Schering Corporation. All rights reserved.
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