دانازول
Danazol (Danazol)
دانازول

نام ژنریک

Danazol

شکل دارویی

اشكال دارويي:


Capsule: 100,200mg

موارد مصرف

موارد و مقدار مصرف


الف) آندومتريوز خفيف


بزرگسالان: دارو به صورت 100 تا 200 ميلي‌گرم دو بار در روز خوراكي به مدت 3 تا 6 ماه مصرف مي‌شود. درمان ممكن است تا 9 ماه ادامه يابد. ادامه درمان برحسب پاسخ بيمار است.


ب) آندومتريوز متوسط ـ شديد


بزرگسالان: دارو به صورت 400 ميلي‌گرم دو بار در روز خوراكي به مدت 3 تا 6 ماه مصرف مي‌شود. درمان ممكن است تا 9 ماه ادامه يابد.


پ) بيماري فيبروسيستيك پستان


بزرگسالان: مقدار mg/day 400-100 در دو مقدار منقسم مصرف مي‌شود و اين برنامه درماني به مدت 6-2 ماه به طور مداوم دنبال مي‌شود.


ت) پيشگيري از آنژيوادام ارثي


بزرگسالان: مقدار 200 ميلي‌گرم 3-2 بار در روز مصرف مي‌شود تا پاسخ مطلوب به‌دست آيد. مقدار مصرف بايد هر 3-1 ماه به نصف برسد. در صورت عود بيماري، دوز مجدداً به 200 ميلي‌گرم دو بار در روز افزايش يابد. تنظيم دوز با احتياط صورت گيرد.


موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: بيماري شديد قلبي يا كليوي (احتباس الكتروليت و مايعات ناشي از مصرف اين دارو ممكن است اين حالات را وخيم تر كند)، بيماري كبدي (اختلال در دفع اين دارو ممكن است موجب تجمع سمي آن شود)، خونريزي غيرطبيعي دستگاه تناسلي با علت نامشخص (دانازول ممكن است رشد بافتهاي سرطاني در پروستات يا پستان را تحريك كند)، زنان حامله و مادران شيرده (مطالعات انجام شده در حيوانات نشان داده است كه مصرف آندروژن‌ها در دوران حاملگي موجب عضلاني شدن جنين مي‌شود).


موارد احتياط: دارو سبب اثرات آندروژنيك برگشت‌ناپذير مي‌شود. استروئيدهاي آنابوليك باعث تغييرات ليپيدهاي خون و افزايش احتمال آترواسكلروز مي‌شود. مصارف طولاني مدت دارو باعث آدنوم‌هاي خوش‌خيم كبدي مي‌شود. دارو مي‌تواند باعث افزايش خوش‌خيم فشار داخل مغز شود (سودوتومورسربري)، بيمار را از نظر علائمي مانند سردرد، تهوع/ استفراغ، تغييرات بينايي و ادم پاپي مانيتور كنيد.ترومبوآمبوليسم و وقايع ترومبوتيك به دنبال مصرف دارو گزارش شده است. در موارد ديابت، احتباس مايعات (مانند بيماريهاي قلبي ـ عروقي، كليوي) بيماريهاي كبدي و پورفيري با احتياط استفاده شود. ايمني و اثربخشي دارو در كودكان اثبات نشده است. قبل از شروع درمان حتماً تست حاملگي انجام شود، متد غير هورموني پيشگيري از بارداري ضمن درمان استفاده شود.


عوارض جانبی دارو

عوارض جانبي


اعصاب مرکزي: سرگيجه، سردرد، اختلال در به خواب رفتن، خستگي، عصبانيت، رعشه، تحريك‌پذيري، اضطراب، افسردگي، پارستزي، ناپايداري رواني، سودو تومور سربري.


قلبي ـ عروقي: افزايش فشارخون.


پوست: آكنه، پرمويي، چرب شدن مو يا پوست.


چشم: اختلال بينايي.


دستگاه گوارش: گاستروآنتريت، تغيير اشتها، يبوست، اسهال، تهوع، استفراغ.


كبدي: يرقان برگشت‌پذير، اختلال كبدي.


ادراري ـ تناسلي: هماچوري، اثرات هيپواستروژنيك مثل فلاشينگ، تعريق، واژينيت (شامل خارش، خشكي و سوزش)، خونريزي واژينال، بي‌نظمي قاعدگي، تحريك‌پذيري.


ساير عوارض: اسپاسم يا كرامپهاي عضلاني، برافروختگي، تعريق، واژينيت، خونريزي مهبلي، ايجاد بي‌نظمي‌هاي قاعدگي، خيز، افزايش وزن بدن، خشن شدن صدا، بزرگ شدن كليتوريس، آتروفي بيضه، كاهش اندازه پستان، تغيير ميل جنسي.


مسموميت و درمان


هيچ‌گونه توصيه خاصي در دسترس نيست. معده را مي‌توان با واداشتن بيمار به استفراغ يا شستشو تخليه كرد. سپس، با مصرف زغال فعال مي‌توان جذب دارو را كاهش داد. درمان مصرف بيش از حد دارو حمايتي است.

موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


دانازول باعث افزايش سطح پلاسمايي كاربامازپين مي‌شود. بيمار را به دقت مانيتور كنيد.


دانازول ممكن است اثر داروهاي ضدانعقاد از گروه شبه وارفارين را تشديد كند و زمان پروترومبين را افزايش دهد.


اين دارو ممكن است غلظت‌هاي پلاسمايي سيكلوسپورين را افزايش دهد.


مکانیزم اثر

تداخل دارويي


دانازول باعث افزايش سطح پلاسمايي كاربامازپين مي‌شود. بيمار را به دقت مانيتور كنيد.


دانازول ممكن است اثر داروهاي ضدانعقاد از گروه شبه وارفارين را تشديد كند و زمان پروترومبين را افزايش دهد.


اين دارو ممكن است غلظت‌هاي پلاسمايي سيكلوسپورين را افزايش دهد.


فارماكوكینتیك

فارماكوكينتيك


جذب: مقدار جذب شده به مقدار مصرف بستگي ندارد. دو برابر كردن مقدار مصرف تنها به ميزان 40-34 درصد موجب افزايش جذب مي‌شود.


پخش: مشخص نيست.


متابوليسم: به 2-هيدروكسي ـ متيل اتيسترون متابوليزه مي‌شود.


دفع: مشخص نيست.


سایر اطلاعات

طبقه‌بندي فارماكولوژيك: آندروژن


طبقه‌بندي درماني: ضد استروژن، آندروژن


طبقه‌بندي مصرف در بارداري: رده X


نام‌هاي تجاري: Danogen


ملاحظات اختصاصي


1- از آنجايي كه مصرف اين دارو ممكن است موجب اختلال در عملكرد كبد شود، انجام آزمونهاي عملكرد كبد به طور مرتب ضروري است.


2- در درمان آندومتريوز و بيماري فيبروسيستيك پستان، مصرف دانازول بايد از دوران قاعدگي شروع شود.


3- قبل از شروع درمان با دانازول، بايد احتمال حاملگي رد شود. بيماران زن در طول درمان با دانازول از روشهاي مؤثر جلوگيري از حاملگي استفاده كنند.


4- اختلالات ترومبوتيك، ترومبوآمبوليسم، ترومبوز سينوس ساژيتال و سكتة مغزي به دنبال مصرف دارو گزارش شده است.


5- مصارف طولاني مدت باعث آدنوم‌هاي خوش‌خيم كبدي شده كه معمولاً بدون علامت بوده ولي ممكن است باعث خونريزي‌هاي حاد داخل شكمي شوند. تست‌هاي كبدي بيمار به دقت مانيتور شود.


6- موارد متعددي از افزايش خوش‌خيم فشار داخل مغز به دنبال مصرف دارو گزارش شده است. در صورت بروز ادم پاپي، سردرد، تهوع/ استفراغ، اختلالات بينايي، مصرف دارو متوقف شده و بيمار به نورولوژيست ارجاع شود.


7- قبل از شروع درمان جهت فيبروز كيستيك سينه، سرطان سينه در بيمار رد شود.


8- دانازول را بايد هنگامي استفاده كرد،‌ كه ساير درمان‌هاي موجود مؤثر نباشند.


نكات قابل توصيه به بيمار


1- در طول مصرف دانازول از روشهاي غير هورموني جلوگيري از حاملگي استفاده كنيد، زيرا قرصهاي هورموني جلوگيري كننده از حاملگي ممكن است در طول درمان با اين دارو تخمك‌گذاري را متوقف نسازند.


2- در صورت تغيير صدا يا بروز خصوصيات مردانه، مصرف دارو را فوراً قطع كنيد. برخي از اثرات آندروژنيك (مانند خشن شدن صدا) ممكن است با قطع مصرف دارو برگشت‌پذير نباشند.


3- طي مصرف دانازول براي درمان بيماري فيبروسيستيك، پستانها را به طور منظم بررسي كنيد. در صورت بزرگ شدن گره‌هاي پستان در طي درمان، فوراً به پزشك اطلاع دهيد.


4- آمنوره معمولاً از 8-6 هفته بعد از درمان با اين دارو در زنان بروز مي‌كند.


5- پيگيري مرتب مايع مني در مردان ممكن است لازم باشد.


6- به بيمار آموزش دهيد تا علائمي مانند تهوع، استفراغ، سردرد، اختلالات بينايي كه دال بر سودو تومور سربري مي‌باشد را گزارش دهد.


مصرف در سالمندان: دانازول در اين بيماران بايد با احتياط مصرف شود. مردان سالخورده بايد از نظر بروز هيپرتروفي پروستات تحت مراقبت باشند. در صورت بروز نشانه‌هاي هيپرتروفي پروستات يا كارسينوم پروستات، بايد مصرف دانازول قطع شود.


مصرف در شيردهي: به دليل احتمال بروز عوارض جانبي شديد در شيرخوار، قطع شيردهي يا قطع مصرف دارو (بسته به اهميت مصرف دارو در مادر) بايد صورت گيرد.


اثر بر آزمايشهاي تشخيصي


زمان پروترومبين (بخصوص در بيماراني كه داروهاي ضد انعقاد مصرف مي‌كنند) ممكن است افزايش يابد. دارو باعث افزايش آنزيمهاي كبدي مي‌شود.


Danazol (Danazol)

DANAZOL, USP
(generic formulation)

DRUG DESCRIPTION

Danazol is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, Danazol is 17α -Pregna-2,4-dien-20-yno [2,3-d ]-isoxazol-17-ol. The molecular formula is C22H27NO2. It has a molecular weight of 337.46 and the following structural formula:

DANAZOL Structural Formula Illustration

Danazol capsules for oral administration contain 200 mg Danazol.

Inactive Ingredients: Corn Starch, Lactose, Magnesium Stearate, Talc, D&C Yellow #10, D&C Red #28, FD&C Red #40, Gelatin, Silicon Dioxide, Sodium Lauryl Sulfate, Titanium Dioxide.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Endometriosis

Danazol is indicated for the treatment of endometriosis amenable to hormonal management.

Fibrocystic Breast Disease

Most cases of symptomatic fibrocystic breast disease may be treated by simple measures (e.g., padded brassieres and analgesics).

In infrequent patients, symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function. Danazol is usually effective in decreasing nodularity, pain, and tenderness. It should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy.

Hereditary Angioedema

Danazol is indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

DOSAGE AND ADMINISTRATION

Endometriosis

In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg given in two divided doses is recommended. Amenorrhea and rapid response to painful symptoms is best achieved at this dosage level. Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response. For mild cases, an initial daily dose of 200 mg to 400 mg given in two divided doses is recommended and may be adjusted depending on patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with Danazol. (See CONTRAINDICATIONS and WARNINGS.) It is essential that therapy continue uninterrupted for 3 to 6 months but may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted.

Fibrocystic Breast Disease

The total daily dosage of Danazol for fibrocystic breast disease ranges from 100 mg to 400 mg given in two divided doses depending upon patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with Danazol. A nonhormonal method of contraception is recommended when Danazol is administered at this dose, since ovulation may not be suppressed.

In most instances, breast pain and tenderness are significantly relieved by the first month and eliminated in 2 to 3 months. Usually elimination of nodularity requires 4 to 6 months of uninterrupted therapy. Regular menstrual patterns, irregular menstrual patterns, and amenorrhea each occur in approximately one-third of patients treated with 100 mg of Danazol. Irregular menstrual patterns and amenorrhea are observed more frequently with higher doses. Clinical studies have demonstrated that 50% of patients may show evidence of recurrence of symptoms within one year. In this event, treatment may be reinstated.

Hereditary Angioedema

The dosage requirements for continuous treatment of hereditary angioedema with Danazol should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be started on 200 mg, two or three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage by 50% or less at intervals of one to three months or longer if frequency of attacks prior to treatment dictates. If an attack occurs, the daily dosage may be increased by up to 200 mg. During the dose adjusting phase, close monitoring of the patient's response is indicated, particularly if the patient has a history of airway involvement.

HOW SUPPLIED

Capsules of 200 mg (orange), bottles of 100 (NDC 0955-0306-20).

Store at controlled room temperature, 15° C to 30° C (59° F to 86° F).

Caution: Federal law prohibits dispensing without prescription.

Manufactured for Sanofi-Synthelabo Inc. New York, NY 10016, by Nycomed Puerto Rico Inc. Barceloneta, Puerto Rico 00617. Issued August 1996. FDA revision date: 3/28/2001

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following events have been reported in association with the use of Danazol:

Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.

Other possible endocrine effects include menstrual disturbances in the form of spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with Danazol, persistent amenorrhea has occasionally been reported.

Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.

Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of Danazol of 400 mg or more. It is recommended that patients receiving Danazol be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported. (See WARNINGS and PRECAUTIONS.)

Abnormalities in laboratory tests may occur during therapy with Danazol including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.

The following reactions have been reported, a causal relationship to the administration of Danazol has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome; other: increased insulin requirements in diabetic patients, change in libido, elevation in blood pressure, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

Read the Danazol (danazol) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Prolongation of prothrombin time occurs in patients stabilized on warfarin. Therapy with Danazol may cause an increase in carbamazepine levels in patients taking both drugs.

Laboratory Tests: Danazol treatment may interfere with laboratory determinations of testosterone, androstenedione and dehydroepiandrosterone.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Use of Danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally a non-hormonal method of contraception should be used during therapy. If a patient becomes pregnant while taking Danazol, administration of the drug should be discontinued and the patient should be apprised of the potential risk to the fetus. Exposure to Danazol in utero may result in androgenic effects on the female fetus; reports of clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been received. (See PRECAUTIONS: Pregnancy, Teratogenic Effects.)

Thromboembolism, thrombotic and thrombophlebitic events including sagittal sinus thrombosis and life-threatening or fatal strokes have been reported.

Experience with long-term therapy with Danazol is limited. Peliosis hepatis and benign hepatic adenoma have been observed with long-term use. Peliosis hepatis and hepatic adenoma may be silent until complicated by acute, potentially life-threatening intra-abdominal hemorrhage. The physician therefore should be alert to this possibility. Attempts should be made to determine the lowest dose that will provide adequate protection. If the drug was begun at a time of exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause, periodic attempts to decrease or withdraw therapy should be considered.

Danazol has been associated with several cases of benign intracranial hypertension also known as pseudotumor cerebri. Early signs and symptoms of benign intracranial hypertension include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, the patients should be advised to discontinue Danazol immediately and be referred to a neurologist for further diagnosis and care.

A temporary alteration of lipoproteins in the form of decreased high density lipoproteins and possibly increased low density lipoproteins has been reported during Danazol therapy. These alterations may be marked, and prescribers should consider the potential impact on the risk of atherosclerosis and coronary artery disease in accordance with the potential benefit of the therapy to the patient.

Before initiating therapy of fibrocystic breast disease with Danazol, carcinoma of the breast should be excluded. However, nodularity, pain, tenderness due to fibrocystic breast disease may prevent recognition of underlying carcinoma before treatment is begun. Therefore, if any nodule persists or enlarges during treatment, carcinoma should be considered and ruled out.

Patients should be watched closely for signs of androgenic effects some of which may not be reversible even when drug administration is stopped.

PRECAUTIONS

Because Danazol may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or cardiac or renal dysfunction, require careful observation.

Since hepatic dysfunction manifested by modest increases in serum transaminase levels has been reported in patients treated with Danazol, periodic liver function tests should be performed (see WARNINGS and ADVERSE REACTIONS).

Administration of Danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria. (See CONTRAINDICATIONS.)

Carcinogenesis, Mutagenesis, Impairment of Fertility

No valid studies have been performed to assess the carcinogenicity of Danazol.

Pregnancy, Teratogenic Effects

(See CONTRAINDICATIONS.) Pregnancy Category X. Danazol administered orally to pregnant rats from the 6th through the 15th day of gestation at doses up to 250 mg/kg/day (7-15 times the human dose) did not result in drug-induced embryotoxicity or teratogenicity, nor difference in litter size, viability or weight of offspring compared to controls. In rabbits, the administration of Danazol on days 6-18 of gestation at doses of 60 mg/kg/day and above (2-4 times the human dose) resulted in inhibition of fetal development.

Nursing Mothers

(See CONTRAINDICATIONS.)

Pediatric Use

Safety and effectiveness in children have not been established.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Danazol should not be administered to patients with:

  1. Undiagnosed abnormal genital bleeding.
  2. Markedly impaired hepatic, renal, or cardiac function.
  3. Pregnancy. (See WARNINGS.)
  4. Breast feeding.
  5. Porphyria-Danazol can induce ALA synthetase activity and hence porphyrin metabolism.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Danazol suppresses the pituitary-ovarian axis. This suppression is probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of sex steroid metabolism, and interaction of Danazol with sex hormone receptors. The only other demonstrable hormonal effect is weak androgenic activity. Danazol depresses the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

Recent evidence suggests a direct inhibitory effect at gonadal sites and a binding of Danazol to receptors of gonadal steroids at target organs. In addition, Danazol has been shown to significantly decrease IgG, IgM and IgA levels, as well as phospholipid and IgG isotope autoantibodies in patients with endometriosis and associated elevations of autoantibodies, suggesting this could be another mechanism by which it facilitates regression of the disease.

Bioavailability studies indicate that blood levels do not increase proportionally with increases in the administered dose. When the dose of Danazol is doubled the increase in plasma levels is only about 35% to 40%.

Separate single dosing of 100 mg and 200 mg capsules of Danazol to female volunteers showed that both the extent of availability and the maximum plasma concentration increased by three-to-four fold, respectively, following a meal ( > 30 grams of fat), when compared to the fasted state. Further, food also delayed mean time to peak concentration of Danazol by about 30 minutes.

In the treatment of endometriosis, Danazol alters the normal and ectopic endometrial tissue so that it becomes inactive and atrophic. Complete resolution of endometrial lesions occurs in the majority of cases.

Changes in vaginal cytology and cervical mucus reflect the suppressive effect of Danazol on the pituitary-ovarian axis.

In the treatment of fibrocystic breast disease, Danazol usually produces partial to complete disappearance of nodularity and complete relief of pain and tenderness. Changes in the menstrual pattern may occur.

Generally, the pituitary-suppressive action of Danazol is reversible. Ovulation and cyclic bleeding usually return within 60 to 90 days when therapy with Danazol is discontinued.

In the treatment of hereditary angioedema, Danazol at effective doses prevents attacks of the disease characterized by episodic edema of the abdominal viscera, extremities, face, and airway which may be disabling and, if the airway is involved, fatal. In addition, Danazol corrects partially or completely the primary biochemical abnormality of hereditary angioedema by increasing the levels of the deficient C1 esterase inhibitor (C1EI). As a result of this action the serum levels of the C4 component of the complement system are also increased.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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