Avosil Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

• Akurza


• Aliclen


• Avosil


• Betasal


• Compound W


• Corn Removing


• Dermarest Psoriasis


• DHS Sal


• Drytex


• Duofilm


• Duoplant


• Durasal


• Freezone


• Fung-O


• Gets-It Corn/Callus Remover


• Gordofilm


• Hydrisalic


• Ionil


• Ionil Plus


• Keralyt


• Keralyt Scalp


• Lupicare


• Mediplast


• Mg217 Sal-Acid


• Mosco Corn & Callus Remover


• Neutrogena


• Occlusal-HP


• Off-Ezy


• Oxy Balance


• P & S


• Palmer's Skin Success Acne Cleanser


• Propa pH


• Salac


• Sal-Acid Plaster


• Salactic Film


• Salex


• Salitop


• Salkera


• Sal-Plant Gel


• Salvax


• Seba-Clear


• Stri-Dex


• Thera-Sal


• Therasoft Anti-Acne


• Tinamed


• Ti-Seb


• Virasal


• Wart-Off Maximum Strength


• Zapzyt

In Canada

• Acnex


• Acnomel Acne Mask


• Clear Away Wart Removal System


• Compound W One-Step Wart Remover


• Compound W Plus


• Dr. Scholl's Clear Away One Step Plantar Wart Remover


• Dr. Scholl's Cushlin Ultra Slim Callus Removers


• Dr. Scholl's Cushlin Ultra Slim Corn Removers


• Duoforte 27


• Freezone - One Step Callus Remover Pad


• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap


• Lotion


• Liquid


• Foam


• Ointment


• Gel/Jelly


• Solution


• Cream


• Pad


• Paste


• Shampoo


• Dressing


• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Avosil

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Avosil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Argatroban


• Bivalirudin


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Dipyridamole


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lepirudin


• Nefazodone


• Paroxetine


• Protein C


• Rivaroxaban


• Sertraline


• Sibutramine


• Ticlopidine


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Ardeparin


• Azilsartan Medoxomil


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Certoparin


• Chlorothiazide


• Chlorthalidone


• Clopamide


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Eprosartan


• Ethacrynic Acid


• Furosemide


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Irbesartan


• Losartan


• Methyclothiazide


• Metolazone


• Nadroparin


• Olmesartan Medoxomil


• Parnaparin


• Phenindione


• Phenprocoumon


• Piretanide


• Polythiazide


• Probenecid


• Reviparin


• Tamarind


• Tasosartan


• Telmisartan


• Tinzaparin


• Torsemide


• Trichlormethiazide


• Valsartan


• Warfarin


• Xipamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or


• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or


• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Avosil. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.


• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.


• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Cut the plaster to fit the wart, corn, or callus and apply.


• For corns and calluses:
  
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  
  
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
  
  


• For warts:
  
  • Depending on the product, either:
    
    • Apply plaster and repeat every 48 hours as needed, or
      
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
      
      
    
    
  
  
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
  
  


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.


• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.


• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• This medicine is flammable. Do not use it near heat or open flame or while smoking.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Avoid breathing in the vapors from the medicine.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.


• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.


• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.


• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cream dosage form:
  
  • For corns and calluses:
    
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
    
    
  
  


• For gel dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 5% gel one time a day.
    
    
  
  
  • For psoriasis:
    
    • Adults and children—Use the 5% gel one time a day.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 5 to 26% gel one time a day.
    
    
  
  


• For lotion dosage form:
  
  • For acne:
    
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
    
    
  
  
  • For dandruff and antiseborrhic dermatitis of the scalp:
    
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    
    
  
  


• For ointment dosage form:
  
  • For acne:
    
    • Adults and children—Use the 3 to 6% ointment as needed.
    
    
  
  
  • For psoriasis and seborrheic dermatitis:
    
    • Adults and children—Use the 3 to 10% ointment as needed.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
    
    
  
  


• For pads dosage form:
  
  • For acne:
    
    • Adults and children—Use one to three times a day.
    
    
  
  


• For plaster dosage form:
  
  • For corns, calluses, common warts, or plantar warts:
    
    • Adults and children—Use one time a day or one time every other day.
    
    
  
  


• For shampoo dosage form:
  
  • For dandruff or seborrheic dermatitis of the scalp:
    
    • Adults and children—Use on the scalp one or two times a week.
    
    
  
  


• For soap dosage form:
  
  • For acne:
    
    • Adults and children—Use as needed.
    
    
  
  


• For topical solution dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
    
    
  
  
  • For common warts and plantar warts:
    
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
    
    
  
  
  • For corns and calluses:
    
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Avosil

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Avosil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

• Dryness and peeling of skin


• flushing


• redness of skin


• unusually warm skin

Symptoms of salicylic acid poisoning

• Confusion


• diarrhea


• dizziness


• fast or deep breathing


• headache (severe or continuing)


• hearing loss


• lightheadedness


• nausea


• rapid breathing


• ringing or buzzing in ears (continuing)


• severe drowsiness


• stomach pain


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Skin irritation not present before use of this medicine (mild)


• stinging

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Avosil Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Avosil Topical resources

• Avosil Topical Side Effects (in more detail)
• Avosil Topical Use in Pregnancy & Breastfeeding
• Avosil Topical Drug Interactions
• Avosil Topical Support Group
• 1 Review for Avosil Topical - Add your own review/rating

Compare Avosil Topical with other medications

• Acne
• Dermatological Disorders
• Warts

Aredia

Generic Name: Pamidronate Disodium
Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: (3-Amino-1-hydroxypropylidene)bisphosphonic acid disodium salt pentahydrate
Molecular Formula: C₃H_9NNa₂O₇P₂•5H₂O
CAS Number: 109552-15-0

Special Alerts:

[Posted 10/13/2010] ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including alendronate (Fosamax), alendronate with cholecalciferol (Fosamax Plus D), risedronate (Actonel and Atelvia), risedronate with calcium carbonate (Actonel with Calcium), ibandronate (Boniva), tiludronate (Skelid), and zoledronic acid (Reclast) and their generic products. A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.

BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.

RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. For more information visit the FDA website at: and .

[Posted 03/11/2010] FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.

FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.

Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. For more information visit the FDA website at: and .

[Posted 11/12/2008] FDA issued an update to the Agency’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. For more information visit the FDA website at: , and .

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

[Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. For more information visit the FDA website at: and .

[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.

FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: and .

Introduction

Synthetic bisphosphonate; bone resorption inhibitor.^{1 3 4 5}

Uses for Aredia

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Hypercalcemia Associated with Malignancy

Used in conjunction with achievement and maintenance of adequate hydration for the treatment of moderate to severe hypercalcemia associated with malignant neoplasms, with or without bone metastases^{1 3 4 5}

Retreatment may be considered in patients with recurrent or refractory disease.¹

Paget’s Disease of Bone

Treatment of moderate to severe Paget’s disease of bone (osteitis deformans)^{1 6 7 8 9 11 13 15 16 25 26 40 15} in symptomatic patients with multiple bone involvement [polyostotic] and elevated concentrations of serum alkaline phosphatase and urinary hydroxyproline.^{7 8 13 20}

May prevent or slow progression of complications (e.g., deformities, arthritis, fractures, neurologic manifestations, spinal cord compression, heart failure) in patients with Paget’s Disease.^{11 26 40} May not reverse established complications (e.g., severe deformities, deafness).^{11 26 40}

Treatment in patients refractory to calcitonin or etidronate disodium.^{8 9 11 13 16}

Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma

Decreases the incidence and delays the development of bone-related complications (e.g., fractures or spinal cord compression, bone deterioration requiring radiotherapy or orthopedic surgery), and reduces bone pain and the need for supplemental analgesic therapy in patients with osteolytic metastases associated with breast cancer^{1 23 24 27} and in patients with osteolytic lesions of multiple myeloma.^{1 29}

Used as an adjunct to antineoplastic therapy for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.^{1 20 29}

Aredia Dosage and Administration

General

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Monitor standard laboratory and clinical parameters of renal function (including serum creatinine) and complete blood counts with differential and hematocrit and hemoglobin.¹

  
  


• 
  

  Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium) following initiation of therapy.¹

  
  

Hypercalcemia Associated with Malignancy

• 
  

  Adequately hydrate patients prior to treatment initiation and throughout treatment.¹ Avoid overhydration, especially in patients at risk for the development of cardiac failure.¹ Attempt to restore urine output to 2L/day throughout treatment.¹

  
  


• 
  

  Corticosteroid therapy may prove beneficial.¹

  
  

Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma

• 
  

  Adequately hydrate patients with osteolytic lesions of multiple myeloma and marked Bence-Jones proteinuria with 0.9% sodium chloride prior to treatment initiation.^{1 39}

  
  

Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

IV Administration

Administer by IV infusion.^{1 3 4 5 8 11 14 16 20 23 24 26 27 29 40}

Reconstitution

Reconstitute vial containing 30 or 90 mg of pamidronate disodium with 10 mL of sterile water for injection to provide a solution containing 3 or 9 mg /mL, respectively.¹

Allow the contents of the vials to dissolve completely before withdrawing a dose.¹

Dilution

Hypercalcemia Associated with Malignancy

Dilute the recommended daily dose in 1 L of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Paget’s Disease of Bone

Dilute 30 mg in 500 mL of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Osteolytic Bone Metastases of Breast Cancer

Dilute 90 mg in 250 mL of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Osteolytic Lesions of Multiple Myeloma

Dilute 90 mg in 500 mL of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Rate of Administration

Infuse slowly (i.e., >2 hours) to decrease the risk of adverse effects (e.g., infusion site reactions, renal impairment).^{6 17} (See Renal Effects under Cautions.)

For treatment of hypercalcemia associated with malignancy, infuse over at least 2–24 hours.¹

For treatment of Paget’s disease of bone, infuse over a 4-hour period once daily for 3 consecutive days.¹

For treatment of osteolytic bone metastases, infuse over a 2-hour period once every 3–4 weeks.¹

For treatment of osteolytic lesions of multiple myeloma, infuse over a 4-hour period once monthly.¹

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Dosage of pamidronate disodium is expressed in terms of the salt.¹

Adults

Hypercalcemia Associated with Malignancy

Moderate Hypercalcemia

IV

60–90 mg as a single dose over at least 2–24 hours in those with albumin-corrected serum calcium concentration approximately 12–13.5 mg/dL.¹

Consider retreatment if serum calcium concentrations do not return to normal or remain normal.¹ Repeat the dose appropriate for the degree of hypercalcemia no sooner than 7 days after the initial dose in order to allow full response to the initial dose.¹

Severe Hypercalcemia

IV

90-mg as a single dose over 2–24 hours in those with albumin-corrected serum calcium concentration >13.5 mg/dL.¹

Consider retreatment if serum calcium concentrations do not return to normal or remain normal.¹ Repeat the dose appropriate for the degree of hypercalcemia no sooner than 7 days after the initial dose in order to allow full response to the initial dose.¹

Paget’s Disease of Bone

IV

Initially, 30 mg, administered as a 4-hour infusion, once daily on 3 consecutive days (total cumulative dose 90 mg for the course).¹

Individualize the need for retreatment and base on patient response (e.g., increased serum alkaline phosphatase concentrations and urinary hydroxyproline).¹¹ When clinically indicated, retreat with the same dosage that was required for initial treatment.¹

Osteolytic Bone Metastases of Breast Cancer

IV

Initially, 90 mg, administered as a 2-hour infusion, given once every 3–4 weeks.¹ Optimum duration of such therapy is not known, but has been used at these intervals for 24 months.¹

Osteolytic Bone Lesions of Multiple Myeloma

IV

Initially, 90 mg, administered as a 4-hour infusion, given once monthly.¹ Optimum duration of therapy currently is not known, but monthly doses have been administered for 21 months.¹

Prescribing Limits

Adults

IV

Maximum 90 mg as a single dose.¹ Duration of IV infusion should be no less than 2 hours.¹

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with mild to moderate hepatic impairment; not studied in patients with severe hepatic impairment.¹

Renal Impairment

Withhold therapy in patients with bone metastases associated with solid tumors or with osteolytic lesions associated wtih multiple myeloma if renal function deteriorates (defined as an increase in serum creatinine concentration of at least 0.5 or 1 mg/dL in patients with normal [<1.4 mg/dL] or elevated [≥1.4 mg/dL] baseline serum creatinine concentrations, respectively) during therapy until serum creatinine concentrations return to within 10% of baseline levels.¹

Cautions for Aredia

Contraindications

• 
  

  Known hypersensitivity to pamidronate or other bisphosphonates.¹

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Fetal/Neonatal Morbidity

May cause fetal harm; use not recommended in pregnant women, and women of childbearing potential should avoid conception during therapy.¹ If patient becomes pregnant, apprise of potential fetal hazard.¹

Renal Effects

Possible renal toxicity (e.g., deterioration of renal function and potential renal failure).¹ Risk may be greater in patients with impaired renal function.¹ Monitor standard laboratory and clinical parameters of renal function (including serum creatinine) prior to each treatment.¹

May reduce the risk for renal toxicity by using the recommended duration of infusion (i.e., >2 hours), particularly in patients with preexisting renal insufficiency.¹

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Metabolic Effects

Asymptomatic hypophosphatemia,^{1 3 30 31 33} hypokalemia,¹ hypomagnesemia,^{1 33 38} and hypocalcemia reported.^{1 3 9 11 30 33} Rarely, symptomatic hypocalcemia, including tetany reported.¹

Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium) following initiation of therapy.¹ Institute short-term calcium and/or vitamin D therapy if hypocalcemia occurs.^{1 17 19}

Patients should be adequately hydrated throughout treatment of hypercalcemia of malignancy.¹ Avoid overhydration, especially in patients at risk for the development of cardiac failure.¹ Attempt to restore urine output to 2L/day throughout treatment.¹

Musculoskeletal Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Osteonecrosis and osteomyelitis of the jaws have been reported in cancer patients receiving bisphosphonates.^{1 41 42 43 44 45} Most patients were receiving concurrent chemotherapy and corticosteroids,¹ and the majority of cases were associated with dental procedures (e.g., tooth extraction).^{41 42 43 44 45}

A dental examination with appropriate preventive dentistry recommended prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).^{1 41 42 43} Such patients should avoid invasive dental procedures if possible during therapy.^{1 42 43}

In the treatment of Paget’s disease of bone, monitor patients periodically (e.g., serum alkaline phosphatase concentrations and urinary hydroxyproline) for recurrence of disease.^{7 8 9 13 17 25 40}

Hematologic Effects

Anemia, leukopenia, neutropenia, and thrombocytopenia reported.¹ Monitor complete blood counts with differential and hematocrit and hemoglobin.¹ Carefully monitor patients with preexisting anemia, leukopenia, or thrombocytopenia in the first 2 weeks of treatment initiation.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Not known if pamidronate is distributed into milk.¹ Use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 2}

Renal Impairment

Not studied in patients with severe renal impairment (serum creatinine concentration >5 mg/dL).¹ Not recommended for use in patients with severe renal impairment and bone metastases.¹ Carefully weigh the possible benefits and risks of therapy in other patients with severe renal impairment.¹ (See Renal Effects under Cautions.)

Common Adverse Effects

Hypercalcemia of malignancy: Infusion-site reactions (e.g., erythema, edema, induration, pain on palpation, thrombophlebitis), transient low-grade fever, hypokalemia, hypophosphatemia.^{1 3 9 10 16 20 22 30 33}

Paget’s disease of bone: Arthrosis, bone pain, hypertension, headache.¹

Osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma: Fatigue, dyspnea, anorexia, dyspepsia, abdominal pain, anemia, myalgia, headache, coughing.¹

Interactions for Aredia

Nephrotoxic Agents

Potential for increased risk of nephrotoxicity.¹ Use concomitantly with caution.¹

Specific Drugs

Drug	Interaction	Comments
Diuretics, loop	No effect on calcium-lowering effect of pamidronate1

Aredia Pharmacokinetics

Absorption

Onset

Hypercalcemia associated with malignancy: Reduction of serum calcium concentration usually is apparent within 1–3 days^{1 3 4 33 38} and generally is maximal within 5–7 days.^{3 4 38}

Paget’s disease of bone: Onset of therapeutic response usually is evident within the first week.^{1 17} Symptomatic relief of bone pain usually is evident within 0.5–3 months after therapy.^{8 13 40} The median time to appreciable therapeutic response (≥50% decrease from baseline) for serum alkaline phosphatase was approximately 1 month.¹ Plateau at 5–12 months after therapy.^{7 8 9 13 17 25 40}

Bone metastases of breast cancer: Decrease in bone pain usually is evident within 2 weeks.^{1 20}

Duration

Hypercalcemia associated with malignancy: Normocalcemia persists about 6–14 days following a single dose.^{1 3 30 33 38}

Paget’s disease of bone: Reduction in marker of bone formation (decrease of serum alkaline phosphatase concentrations) persist from 1–372 day(s).^{1 9 11 13 14 15 16 40}

Special Populations

In patients with hepatic impairment, increased mean AUC and peak plasma concentrations.¹

Distribution

Extent

Distributed mainly to bones, liver, spleen, teeth, and tracheal cartilage in rats.¹ Protracted binding of the drug to the bone mineral matrix.^{1 4 15 20 22 26}

Pamidronate crosses the placenta in rats; not known whether distributed into human milk.¹

Elimination

Metabolism

No evidence of metabolism.^{1 4 15 20 22 26}

Elimination Route

Urinary excretion is the sole means of elimination.¹

Half-life

Averages 28 hours.¹ Rate of elimination from bone not determined.¹

Special Populations

In cancer patients with renal impairment, decreased clearance compared with cancer patients without renal impairment.¹ Accumulation of pamidronate is not anticipated when recommended dose is repeated on a monthly basis.¹

In patients with hepatic impairment, decreased plasma clearance.¹ Not thought to be clinically relevant.¹

Stability

Storage

Parenteral

Powder for Injection

≤30°C.¹

Store reconstituted solution at 2–8°C for up to 24 hours.¹

ActionsActions

• 
  

  Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption.^{19 40}

  
  


• 
  

  Reduces biochemical markers of bone resorption, urinary calcium excretion, and urinary hydroxyproline in patients with breast cancer.^{10 20 28}

  
  


• 
  

  Hypocalcemic effect appears to result principally from inhibition of bone resorption and does not depend on cytotoxic activity or enhancement of renal calcium excretion.^{1 5 10 33 38}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Advise women to avoid pregnancy during therapy.¹ If patient becomes pregnant, apprise of potential fetal hazard.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pamidronate Disodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	30 mg	Aredia (with mannitol)	Novartis
		90 mg	Aredia (with mannitol)	Novartis

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Pharmaceutical Corporation. Aredia (pamidronate disodium) for injection for intraveous infusion prescribing information. East Hanover, NJ: 2004 Aug.

2. Ciba, Summit, NJ: Personal communication.

3. Gucalp R, Ritch P, Wiernik PH et al. Comparative study of pamidronate disodium and etidronate disodium in the treatment of cancer-related hypercalcemia. J Clin Oncol. 1992; 10:134-42. [PubMed 1727915]

4. Thiébaud, Jaeger P, Jacquet AF et al. Dose-response in the treatment of hypercalcemia of malignancy by a single infusion of the bisphosphonate AHPrBP. J Clin Oncol. 1988; 6:762-8. [PubMed 3367184]

5. Bilezikian JP. Management of acute hypercalcemia. N Engl J Med. 1992; 326:1196-203. [IDIS 295128] [PubMed 1532633]

6. Hosking DJ. Advances in the management of Paget’s disease of bone. Drugs. 1990; 40:829-40. [PubMed 2078998]

7. Cantrill JA, Buckler HM, Anderson DC. Low dose intravenous 3-amino-1-hydroxypropylidene-1,1-bisphosphonate (APD) for the treatment of Paget’s disease of bone. Ann Rheum Dis. 1986; 45:1012-8. [IDIS 224896] [PubMed 3813665]

8. Thiébaud D, Jaeger P, Gobelet C et al. A single infusion of the bisphosphonate AHPrBP (APD) as treatment of Paget’s disease of bone. Am J Med. 1988; 85:207-12. [IDIS 245310] [PubMed 3261129]

9. Ryan PJ, Sherry M, Gibson T et al. Treatment of Paget’s disease by weekly infusions of 3-aminohydroxypropylidene-1,1-bisphosphonate (APD). Br J Rheumatol. 1992; 31:97-101. [PubMed 1371084]

10. Fitton A, McTavish D. Pamidronate: a review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs. 1991; 41:289-318. [PubMed 1709854]

11. Bombassei GJ, Yocono M, Raisz LG. Effects of intravenous pamidronate therapy on Paget’s disease of bone. Am J Med Sci. 1994; 308:226-33. [IDIS 336364] [PubMed 7942981]

12. Ralston SH, Gallagher SJ, Patel U et al. Comparison of three intravenous bisphosphonates in cancer-associated hypercalcaemia. Lancet. 1989; II:1180-2.

13. Wimalawansa SJ, Gunasekera RD. Pamidronate is effective for Paget’s disease of bone refractory to conventional therapy. Calcif Tissue Int. 1993; 53:237-41. [PubMed 8275351]

14. Watts RA, Skingle SJ, Bhambhani MM et al. Treatment of Paget’s disease of bone with single dose intravenous pamidronate. Ann Rheum Dis. 1993; 52:616-8. [IDIS 319019] [PubMed 8215628]

15. Ryan PJ, Gibson T, Fogelman I. Bone scintigraphy following intravenous pamidronate for Paget’s disease of bone. J Nucl Med. 1992; 33:1589-93. [IDIS 302405] [PubMed 1517830]

16. Harinck HIJ, Papapoulos SE, Blanksma HJ et al. Paget’s disease of bone: early and late responses to three different modes of treatment with aminohydroxypropylidene bisphosphonate (APD). BMJ. 1987; 295:1301-5. [IDIS 236132] [PubMed 3120987]

17. Siris ES. Perspectives: a practical guide to the use of pamidronate in the treatment of Paget’s disease. J Bone Miner Res. 1994; 9:303-4. [PubMed 8191921]

18. Adamson BB, Gallacher SJ, Byars J et al. Mineralisation defects with pamidronate therapy for Paget’s disease. Lancet. 1993; 342:1459-60. [IDIS 322761] [PubMed 7902484]

19. Price RI, Gutteridge DH, Stuckey BGA et al. Rapid, divergent changes in spinal and forearm bone density following short-term intravenous treatment of Paget’s disease with pamidronate disodium. J Bone Miner Res. 1993; 8:209-17. [PubMed 8442439]

20. Glover D, Lipton A, Keller A et al. Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. Cancer. 1994; 74:2949-55. [IDIS 33940] [PubMed 7525038]

21. Salmon SE, Cassady JR. Plasma cell neoplasms. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: principles and practice of oncology. 4th ed. Philadelphia, PA: J. B. Lippincott; 1993:1984-2025.

22. Anon. Pamidronate. Med Lett Drugs Ther. 1992; 34:1-2. [PubMed 1728727]

23. Conte PF, Giannessi PG, Latreille J et al. Delayed progression of bone metastases with pamidronate therapy in breast cancer patients: a randomized, multicenter phase III trial. Ann Oncol. 1994; 5(Suppl 7):S41-4. [PubMed 7873461]

24. Theriault R, Lipton A, Leff R et al. Reduction of skeletal related complications in breast cancer patients with osteolytic bone metastases receiving hormone therapy, by monthly pamidronate sodium (Aredia) infusion. Proc Am Soc Clin Oncol. 1996; 15:122.

25. Michalsky M, Stepan JJ, Wilczek H et al. Galactosyl hydroxylysine in assessment of Paget’s bone disease. Clin Chim Acta. 1995; 234:101-8. [PubMed 7758208]

26. Fenton AJ, Gutteridge DH, Kent GN et al. Intravenous aminobisphosphonate in Paget’s disease: clinical, biochemical, histomorphometric and radiological responses. Clin Endocrinol. 1991; 34:197-204.

27. Hortobagyi GN, Porter L Blayney D et al. Reduction of skeletal related complications in breast cancer patients with osteolytic bone metastases receiving chemotherapy (CT), by monthly pamidronate sodium (PAM) (Aredia) infusion. Proc Am Soc Clin Oncol. 1996; 15:108.

28. Burckhardt P, Thiébaud D, Perey L et al. Treatment of tumor-induced osteolysis by APD. Recent Results Cancer Res. 1989; 116:54-66. [PubMed 2762665]

29. Berenson JR, Lichtenstein A, Porter L et al et al. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. N Engl J Med. 1996; 334:488-93. [IDIS 360513] [PubMed 8559201]

30. Gucalp R, Theriault R, Gill I et al. Treatment of cancer-associated hypercalcemia: double-blind comparison of rapid and slow intravenous infusion regimens of pamidronate disodium and saline alone. Arch Intern Med. 1994; 154:1935-44. [IDIS 335984] [PubMed 8074597]

31. Body JJ, Borkowski A, Cleeren A et al. Treatment of malignancy-associated hypercalcemia with intravenous aminohydroxypropylidene diphosphonate. J Clin Oncol. 1986; 4:1177-83. [PubMed 3016205]

32. Hall TG, Burns Schaiff RA. Update on the medical treatment of hypercalcemia of malignancy. Clin Pharm. 1993; 12:117-25. [IDIS 308105] [PubMed 8453860]

33. Nussbaum SR, Younger J, VandePol CJ et al. Single-dose intravenous therapy with pamidronate for the treatment of hypercalcemia of malignancy: comparison of 30-, 60-, and 90-mg dosages. Am J Med. 1993; 95:297-304. [IDIS 320030] [PubMed 8368227]

34. Reid IR, Cundy T, Ibbertson HK et al. Osteomalacia after pamidronate for Paget’s disease. Lancet. 1994; 343:855. [IDIS 327910] [PubMed 7908098]

35. Ghose K, Waterworth R, Trolove P et al. Uveitis associated with pamidronate. Aust N Z J Med. 1994; 24:320. [PubMed 7980223]

36. Ignoffo RJ, Tseng A. Focus on pamidronate: a biphosphonate compound for the treatment of hypercalcemia of malignancy. Hosp Formul. 1991; 26:774,776-7,781,784-86.

37. Thürlimann B, Waldburger R, Senn HJ et al. Mithramycin and pamidronate (APD) in symptomatic tumour-related hypercalcaemia—a comparative randomised crossover trial. In: Bijvoet OLM, Lipton A eds. Osteoclast inhibition in the management of malignancy-related bone disorders: an international symposium held during the 15th International Cancer Congress, Hamburg, Germany, August 1990. Lewiston, NY: Hogrefe & Huber Publishers; 1991:27-32.

38. Morton A, Dodwell DJ, Howell A. Disodium pamidronate (APD) for the management of hypercalcaemia of malignancy: comparative studies of single-dose versus daily infusions and of infusion duration. In: Burckhardt P, ed. Disodium pamidronate (APD) in the treatment of malignancy-related disorders: an international symposium held during the 13th Congress of the European Society for Medical Oncology (ESMO), Lugano, Switzerland, October 1988. Toronto: Hans Huber Publishers; 1989:85-100.

39. Potts JT Jr. Diseases of the parathyroid gland and other hyper- and hypocalcemic disorders. In: Wilson JD, Braunwald E, Isselbacher KJ et al, eds. Harrison’s principles of internal medicine. 12th ed. New York: McGraw-Hill Book Co; 1991:1902-21.

40. Harinck HIJ, Bijvoet OLM, Blanksma HJ et al. Efficacious management with aminobisphosphonate (APD) in Paget’s disease of bone. Clin Orthop Relat Res. 1987; 217:79-98. [PubMed 2951049]

41. Ruggiero SL, Mehrotra B, Rosenberg TJ et al. Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofacial Surg. 2004; 62:527-34.

42. Novartis. Zometa(zoledronic acid) injection prescribing information. East Hanover, NJ; 2004 Aug.

43. Hohneker JA. Dear doctor letter regarding osteonecrosis of the jaw in patients with cancer receiving bisphophonates. East Hanover, NJ: Novartis; 2004 September 24.

44. Ruggiero SL, Mehrotra B. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191.

45. Bone HG, Santora AC. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191-2.

More Aredia resources

• Aredia Side Effects (in more detail)
• Aredia Use in Pregnancy & Breastfeeding
• Aredia Drug Interactions
• Aredia Support Group
• 0 Reviews for Aredia - Add your own review/rating

• Aredia Prescribing Information (FDA)


• Aredia MedFacts Consumer Leaflet (Wolters Kluwer)


• Aredia Concise Consumer Information (Cerner Multum)


• Aredia Advanced Consumer (Micromedex) - Includes Dosage Information


• Pamidronate Prescribing Information (FDA)

Compare Aredia with other medications

• Breast Cancer, Bone Metastases
• Hypercalcemia
• Hypercalcemia of Malignancy
• Osteolytic Bone Lesions of Multiple Myeloma
• Paget's Disease

Zaroxolyn

Generic Name: metolazone

Dosage Form: Tablets, USP

DO NOT INTERCHANGE:

DO NOT INTERCHANGE Zaroxolyn TABLETS AND OTHER FORMULATIONS OF METOLAZONE THAT SHARE ITS SLOW AND INCOMPLETE BIOAVAILABILITY AND ARE NOT THERAPEUTICALLY EQUIVALENT AT THE SAME DOSES TO MYKROX® TABLETS, A MORE RAPIDLY AVAILABLE AND COMPLETELY BIOAVAILABLE METOLAZONE PRODUCT. FORMULATIONS BIOEQUIVALENT TO Zaroxolyn AND FORMULATIONS BIOEQUIVALENT TO MYKROX SHOULD NOT BE INTERCHANGED FOR ONE ANOTHER.

Zaroxolyn Description

Zaroxolyn Tablets (metolazone tablets, USP) for oral administration contain 2½, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class.

Metolazone has the molecular formula C16H16ClN3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:

Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents.

Inactive Ingredients: Magnesium stearate, microcrystalline cellulose and dye: 2½ mg-D&C Red No. 33; 5 mg-FD&C Blue No. 2; 10 mg-D&C Yellow No. 10 and FD&C Yellow No. 6.

Zaroxolyn - Clinical Pharmacology

Zaroxolyn (metolazone) is a quinazoline diuretic, with properties generally similar to the thiazide diuretics. The actions of Zaroxolyn result from interference with the renal tubular mechanism of electrolyte reabsorption. Zaroxolyn acts primarily to inhibit sodium reabsorption at the cortical diluting site and to a lesser extent in the proximal convoluted tubule. Sodium and chloride ions are excreted in approximately equivalent amounts. The increased delivery of sodium to the distal tubular exchange site results in increased potassium excretion. Zaroxolyn does not inhibit carbonic anhydrase. A proximal action of metolazone has been shown in humans by increased excretion of phosphate and magnesium ions and by a markedly increased fractional excretion of sodium in patients with severely compromised glomerular filtration. This action has been demonstrated in animals by micropuncture studies.

When Zaroxolyn Tablets are given, diuresis and saluresis usually begin within one hour and may persist for 24 hours or more. For most patients, the duration of effect can be varied by adjusting the daily dose. High doses may prolong the effect. A single daily dose is recommended. When a desired therapeutic effect has been obtained, it may be possible to reduce dosage to a lower maintenance level.

The diuretic potency of Zaroxolyn at maximum therapeutic dosage is approximately equal to thiazide diuretics. However, unlike thiazides, Zaroxolyn may produce diuresis in patients with glomerular filtration rates below 20 mL/min.

Zaroxolyn and furosemide administered concurrently have produced marked diuresis in some patients where edema or ascites was refractory to treatment with maximum recommended doses of these or other diuretics administered alone. The mechanism of this interaction is unknown (see WARNINGS and PRECAUTIONS, Drug Interactions).

Maximum blood levels of metolazone are found approximately eight hours after dosing. A small fraction of metolazone is metabolized. Most of the drug is excreted in the unconverted form in the urine.

Indications and Usage for Zaroxolyn

Zaroxolyn is indicated for the treatment of salt and water retention including:

• edema accompanying congestive heart failure;


• edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.

Zaroxolyn is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for Zaroxolyn in the treatment of hypertension. See package circular for MYKROX Tablets (UCB).

Usage In Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Zaroxolyn is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.

Contraindications

Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.

Warnings

Rapid Onset Hyponatremia And/Or Hypokalemia

Rarely, the rapid onset of severe hyponatremia and/or hypokalemia has been reported following initial doses of thiazide and non-thiazide diuretics. When symptoms consistent with severe electrolyte imbalance appear rapidly, drug should be discontinued and supportive measures should be initiated immediately. Parenteral electrolytes may be required. Appropriateness of therapy with this class of drugs should be carefully reevaluated.

Hypokalemia

Hypokalemia may occur with consequent weakness, cramps, and cardiac dysrhythmias. Serum potassium should be determined at regular and appropriate intervals, and dose reduction, potassium supplementation or addition of a potassium-sparing diuretic instituted whenever indicated. Hypokalemia is a particular hazard in patients who are digitalized or who have or have had a ventricular arrhythmia; dangerous or fatal arrhythmias may be precipitated. Hypokalemia is dose related.

Concomitant Therapy

Lithium

In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy.

Furosemide

Unusually large or prolonged losses of fluids and electrolytes may result when Zaroxolyn is administered concomitantly to patients receiving furosemide (see PRECAUTIONS, Drug Interactions).

Other Antihypertensive Drugs

When Zaroxolyn is used with other antihypertensive drugs, particular care must be taken to avoid excessive reduction of blood pressure, especially during initial therapy.

Cross-Allergy

Cross-allergy may occur when Zaroxolyn is given to patients known to be allergic to sulfonamide-derived drugs, thiazides, or quinethazone.

Sensitivity Reactions

Sensitivity reactions (e.g., angioedema, bronchospasm) may occur with or without a history of allergy or bronchial asthma and may occur with the first dose of Zaroxolyn.

Precautions

DO NOT INTERCHANGE :

DO NOT INTERCHANGE Zaroxolyn TABLETS AND OTHER FORMULATIONS OF METOLAZONE THAT SHARE ITS SLOW AND INCOMPLETE BIOAVAILABILITY AND ARE NOT THERAPEUTICALLY EQUIVALENT AT THE SAME DOSES TO MYKROX TABLETS, A MORE RAPIDLY AVAILABLE AND COMPLETELY BIOAVAILABLE METOLAZONE PRODUCT. FORMULATIONS BIOEQUIVALENT TO Zaroxolyn AND FORMULATIONS BIOEQUIVALENT TO MYKROX SHOULD NOT BE INTERCHANGED FOR ONE ANOTHER.

General

Fluid And Electrolytes

All patients receiving therapy with Zaroxolyn Tablets should have serum electrolyte measurements done at appropriate intervals and be observed for clinical signs of fluid and/or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. In patients with severe edema accompanying cardiac failure or renal disease, a low-salt syndrome may be produced, especially with hot weather and a low-salt diet. Serum and urine electrolyte determinations are particularly important when the patient has protracted vomiting, severe diarrhea, or is receiving parenteral fluids. Warning signs of imbalance are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting. Hyponatremia may occur at any time during long term therapy and, on rare occasions, may be life threatening.

The risk of hypokalemia is increased when larger doses are used, when diuresis is rapid, when severe liver disease is present, when corticosteroids are given concomitantly, when oral intake is inadequate or when excess potassium is being lost extrarenally, such as with vomiting or diarrhea.

Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Glucose Tolerance

Metolazone may raise blood glucose concentrations possibly causing hyperglycemia and glycosuria in patients with diabetes or latent diabetes.

Hyperuricemia

Zaroxolyn regularly causes an increase in serum uric acid and can occasionally precipitate gouty attacks even in patients without a prior history of them.

Azotemia

Azotemia, presumably prerenal azotemia, may be precipitated during the administration of Zaroxolyn. If azotemia and oliguria worsen during treatment of patients with severe renal disease, Zaroxolyn should be discontinued.

Renal Impairment

Use caution when administering Zaroxolyn Tablets to patients with severely impaired renal function. As most of the drug is excreted by the renal route, accumulation may occur.

Orthostatic Hypotension

Orthostatic hypotension may occur; this may be potentiated by alcohol, barbiturates, narcotics, or concurrent therapy with other antihypertensive drugs.

Hypercalcemia

Hypercalcemia may infrequently occur with metolazone, especially in patients taking high doses of vitamin D or with high bone turnover states, and may signify hidden hyperparathyroidism. Metolazone should be discontinued before tests for parathyroid function are performed.

Systemic Lupus Erythematosus

Thiazide diuretics have exacerbated or activated systemic lupus erythematosus and this possibility should be considered with Zaroxolyn Tablets.

Information For Patients

Patients should be informed of possible adverse effects, advised to take the medication as directed, and promptly report any possible adverse reactions to the treating physician.

Drug Interactions

Diuretics

Furosemide and probably other loop diuretics given concomitantly with metolazone can cause unusually large or prolonged losses of fluid and electrolytes (see WARNINGS).

Other Antihypertensives

When Zaroxolyn Tablets are used with other antihypertensive drugs, care must be taken, especially during initial therapy. Dosage adjustments of other antihypertensives may be necessary.

Alcohol, Barbiturates, And Narcotics

The hypotensive effects of these drugs may be potentiated by the volume contraction that may be associated with metolazone therapy.

Digitalis Glycosides

Diuretic-induced hypokalemia can increase the sensitivity of the myocardium to digitalis. Serious arrhythmias can result.

Corticosteroids Or ACTH

May increase the risk of hypokalemia and increase salt and water retention.

Lithium

Serum lithium levels may increase (see WARNINGS).

Curariform Drugs

Diuretic-induced hypokalemia may enhance neuromuscular blocking effects of curariform drugs (such as tubocurarine) – the most serious effect would be respiratory depression which could proceed to apnea. Accordingly, it may be advisable to discontinue Zaroxolyn three days before elective surgery.

Salicylates And Other Non-Steroidal Anti-Inflammatory Drugs

May decrease the antihypertensive effects of Zaroxolyn Tablets.

Sympathomimetics

Metolazone may decrease arterial responsiveness to norepinephrine, but this diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Insulin And Oral Antidiabetic Agents

See Glucose Tolerance under PRECAUTIONS, General.

Methenamine

Efficacy may be decreased due to urinary alkalizing effect of metolazone.

Anticoagulants

Metolazone, as well as other thiazide-like diuretics, may affect the hypoprothrombinemic response to anticoagulants; dosage adjustments may be necessary.

Drug/Laboratory Test Interactions

None reported.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Mice and rats administered metolazone 5 days/week for up to 18 and 24 months, respectively, at daily doses of 2, 10, and 50 mg/kg, exhibited no evidence of a tumorigenic effect of the drug. The small number of animals examined histologically and poor survival in the mice limit the conclusions that can be reached from these studies.

Metolazone was not mutagenic in vitro in the Ames Test using Salmonella typhimurium strains TA-97, TA-98, TA-100, TA-102, and TA-1535.

Reproductive performance has been evaluated in mice and rats. There is no evidence that metolazone possesses the potential for altering reproductive capacity in mice. In a rat study, in which males were treated orally with metolazone at doses of 2, 10, and 50 mg/kg for 127 days prior to mating with untreated females, an increased number of resorption sites was observed in dams mated with males from the 50 mg/kg group. In addition, the birth weight of offspring was decreased and the pregnancy rate was reduced in dams mated with males from the 10 and 50 mg/kg groups.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies performed in mice, rabbits, and rats treated during the appropriate period of gestation at doses up to 50 mg/kg/day have revealed no evidence of harm to the fetus due to metolazone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Zaroxolyn Tablets (metolazone tablets, USP) should be used during pregnancy only if clearly needed. Metolazone crosses the placental barrier and appears in cord blood.

Non-Teratogenic Effects

The use of Zaroxolyn Tablets in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult. It is not known what effect the use of the drug during pregnancy has on the later growth, development, and functional maturation of the child. No such effects have been reported with metolazone.

Labor And Delivery

Based on clinical studies in which women received metolazone in late pregnancy until the time of delivery, there is no evidence that the drug has any adverse effects on the normal course of labor or delivery.

Nursing Mothers

Metolazone appears in breast milk. Because of the potential for serious adverse reactions in nursing infants from metolazone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials. There is limited experience with the use of Zaroxolyn in pediatric patients with congestive heart failure, hypertension, bronchopulmonary dysplasia, nephrotic syndrome and nephrogenic diabetes insipidus. Doses used generally ranged from 0.05 to 0.1 mg/kg administered once daily and usually resulted in a 1 to 2.8 kg weight loss and 150 to 300 cc increase in urine output. Not all patients responded and some gained weight. Those patients who did respond did so in the first few days of treatment. Prolonged use (beyond a few days) was generally associated with no further beneficial effect or a return to baseline status and is not recommended.

There is limited experience with the combination of Zaroxolyn and furosemide in pediatric patients with furosemide-resistant edema. Some benefited while others did not or had an exaggerated response with hypovolemia, tachycardia, and orthostatic hypotension requiring fluid replacement. Severe hypokalemia was reported and there was a tendency for diuresis to persist for up to 24 hours after Zaroxolyn was discontinued. Hyperbilirubinemia has been reported in 1 neonate. Close clinical and laboratory monitoring of all children treated with diuretics is indicated. See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS.

Geriatric Use

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

Adverse Reactions

Zaroxolyn is usually well tolerated, and most reported adverse reactions have been mild and transient. Many Zaroxolyn related adverse reactions represent extensions of its expected pharmacologic activity and can be attributed to either its antihypertensive action or its renal/metabolic actions. The following adverse reactions have been reported. Several are single or comparably rare occurrences. Adverse reactions are listed in decreasing order of severity within body systems.

Cardiovascular

Chest pain/discomfort, orthostatic hypotension, excessive volume depletion, hemoconcentration, venous thrombosis, palpitations.

Central And Peripheral Nervous System

Syncope, neuropathy, vertigo, paresthesias, psychotic depression, impotence, dizziness/lightheadedness, drowsiness, fatigue, weakness, restlessness (sometimes resulting in insomnia), headache.

Dermatologic/Hypersensitivity

Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome, necrotizing angiitis (cutaneous vasculitis), skin necrosis, purpura, petechiae, dermatitis (photosensitivity), urticaria, pruritus, skin rashes.

Gastrointestinal

Hepatitis, intrahepatic cholestatic jaundice, pancreatitis, vomiting, nausea, epigastric distress, diarrhea, constipation, anorexia, abdominal bloating, abdominal pain.

Hematologic

Aplastic/hypoplastic anemia, agranulocytosis, leukopenia, thrombocytopenia.

Metabolic

Hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hypochloremic alkalosis, hyperglycemia, glycosuria, increase in serum urea nitrogen (BUN) or creatinine, hypophosphatemia, hypomagnesemia, hypercalcemia.

Musculoskeletal

Joint pain, acute gouty attacks, muscle cramps or spasm.

Other

Transient blurred vision, chills, dry mouth.

In addition, adverse reactions reported with similar antihypertensive-diuretics, but which have not been reported to date for Zaroxolyn include: bitter taste, sialadenitis, xanthopsia, respiratory distress (including pneumonitis), and anaphylactic reactions. These reactions should be considered as possible occurrences with clinical usage of Zaroxolyn.

Whenever adverse reactions are moderate or severe, Zaroxolyn dosage should be reduced or therapy withdrawn.

Overdosage

Intentional overdosage has been reported rarely with metolazone and similar diuretic drugs.

Signs And Symptoms

Orthostatic hypotension, dizziness, drowsiness, syncope, electrolyte abnormalities, hemoconcentration and hemodynamic changes due to plasma volume depletion may occur. In some instances depressed respiration may be observed. At high doses, lethargy of varying degree may progress to coma within a few hours. The mechanism of CNS depression with thiazide overdosage is unknown. Also, GI irritation and hypermotility may occur. Temporary elevation of BUN has been reported, especially in patients with impairment of renal function. Serum electrolyte changes and cardiovascular and renal function should be closely monitored.

Treatment

There is no specific antidote available but immediate evacuation of stomach contents is advised. Dialysis is not likely to be effective. Care should be taken when evacuating the gastric contents to prevent aspiration, especially in the stuporous or comatose patient. Supportive measures should be initiated as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function.

Zaroxolyn Dosage and Administration

Effective dosage of Zaroxolyn should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with Zaroxolyn should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.

Usual Single Daily Dosage Schedules

Suitable initial dosages will usually fall in the ranges given.

Edema of cardiac failure:

   Zaroxolyn 5 to 20 mg once daily.

Edema of renal disease:

   Zaroxolyn 5 to 20 mg once daily.

Mild to moderate essential hypertension:

   Zaroxolyn 2½ to 5 mg once daily.

New patients – MYKROX Tablets (metolazone tablets, USP) (see MYKROX package circular). If considered desirable to switch patients currently on Zaroxolyn to MYKROX, the dose should be determined by titration starting at one tablet (1/2 mg) once daily and increasing to two tablets (1 mg) once daily if needed.

Treatment Of Edematous States

The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible. The daily dose depends on the severity of the patient’s condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations. If antihypertensive drugs or diuretics are given concurrently with Zaroxolyn, more careful dosage adjustment may be necessary. For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period.

Treatment Of Hypertension

The time interval required for the initial dosage regimen to show effect may vary from three or four days to three to six weeks in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.

How is Zaroxolyn Supplied

Zaroxolyn Tablets (metolazone tablets, USP) are shallow biconvex, round tablets, and are available in three strengths:

2½ mg, pink, debossed “Zaroxolyn” on one side, and “2½” on reverse side.

   NDC 53014-975-71 Bottle of 100’s

5 mg, blue, debossed “Zaroxolyn” on one side, and “5” on reverse side.

   NDC 53014-850-71 Bottle of 100’s

10 mg, yellow, debossed “Zaroxolyn” on one side, and “10” on reverse side.

   NDC 53014-835-71 Bottle of 100’s

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children.

For Medical Information

Contact: Medical Affairs Department

Phone: (866) 822-0068

Fax: (770) 970-8859

UCB, Inc.

Smyrna, GA 30080

Zaroxolyn is a registered trademark of UCB Manufacturing, Inc., Rochester, NY 14623

© 2007, UCB, Inc., Smyrna, GA 30080

All rights reserved.

Rev. 1E 06/2007

4000671

Zaroxolyn  metolazone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53014-835 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength metolazone (metolazone) Active 10 MILLIGRAM  In 1 TABLET magnesium stearate Inactive   microcrystalline cellulose Inactive   D & C Yellow No. 10 Inactive   FD & C Yellow No. 6 Inactive

Product Characteristics Color YELLOW (YELLOW) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Zaroxolyn;10 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 53014-835-71 100 TABLET In 1 BOTTLE, PLASTIC None

Zaroxolyn  metolazone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53014-975 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength metolazone (metolazone) Active 2.5 MILLIGRAM  In 1 TABLET magnesium stearate Inactive   microcrystalline cellulose Inactive   D & C Red No. 33 Inactive

Product Characteristics Color PINK (PINK) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Zaroxolyn;2;1/2 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 53014-975-71 100 TABLET In 1 BOTTLE, PLASTIC None

Zaroxolyn  metolazone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53014-850 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength metolazone (metolazone) Active 5 MILLIGRAM  In 1 TABLET magnesium stearate Inactive   microcrystalline cellulose Inactive   FD & C Blue No. 2 Inactive

Product Characteristics Color BLUE (BLUE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Zaroxolyn;5 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 53014-850-71 100 TABLET In 1 BOTTLE, PLASTIC None

Revised: 01/2008UCB, Inc.

More Zaroxolyn resources

• Zaroxolyn Side Effects (in more detail)
• Zaroxolyn Dosage
• Zaroxolyn Use in Pregnancy & Breastfeeding
• Drug Images
• Zaroxolyn Drug Interactions
• Zaroxolyn Support Group
• 1 Review for Zaroxolyn - Add your own review/rating

• Zaroxolyn Concise Consumer Information (Cerner Multum)


• Zaroxolyn MedFacts Consumer Leaflet (Wolters Kluwer)


• Zaroxolyn Monograph (AHFS DI)


• Zaroxolyn Advanced Consumer (Micromedex) - Includes Dosage Information


• Metolazone Professional Patient Advice (Wolters Kluwer)

Compare Zaroxolyn with other medications

• Edema
• High Blood Pressure