dolasetron

doe-LAS-e-tron MES-i-late

Commonly used brand name(s)

In the U.S.

• Anzemet

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiemetic

Pharmacologic Class: Dolasetron

Uses For dolasetron

Dolasetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. It is also used to prevent nausea and vomiting that may occur after surgery. Dolasetron works to block the signals to the brain that cause nausea and vomiting.

dolasetron is available only with your doctor's prescription.

Before Using dolasetron

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 dolasetron, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dolasetron 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dolasetron in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dolasetron in the elderly. However, elderly patients are more likely to have heart rhythm problems (e.g., prolonged QT, PR, and QRS interval), which may require caution in patients receiving dolasetron.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 dolasetron, 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 dolasetron with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Apomorphine


• Bepridil


• Cisapride


• Dronedarone


• Levomethadyl


• Mesoridazine


• Pimozide


• Sparfloxacin


• Thioridazine


• Ziprasidone

Using dolasetron 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.

• Acecainide


• Ajmaline


• Alfuzosin


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Dibenzepin


• Disopyramide


• Dofetilide


• Doxepin


• Droperidol


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Isoflurane


• Isradipine


• Lapatinib


• Levofloxacin


• Lidoflazine


• Lopinavir


• Lorcainide


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirmenol


• Posaconazole


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Risperidone


• Salmeterol


• Saquinavir


• Sematilide


• Sertindole


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Zolmitriptan


• Zotepine

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 dolasetron. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or


• Congestive heart failure or


• Kidney disease—Patients with these conditions should be monitored with an electrocardiogram (ECG) while using dolasetron.

• Heart block, without a pacemaker or


• Heart rhythm problems (e.g., congenital long QT syndrome)—Should not be used in patients with these conditions.

• Heart disease or


• Heart rhythm problems (e.g., atrial fibrillation, prolonged QT, PR, and QRS interval) or


• Sick sinus syndrome (type of abnormal heart rhythm)—Use with caution. May increase risk for more serious heart rhythm problems (such as torsade de pointes) and ECG monitoring is recommended.

Proper Use of dolasetron

Take dolasetron only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If your child cannot swallow the tablets, the injection solution mixed with apple or apple-grape juice may be given. The mixed medicine may be stored up to 2 hours at room temperature before use.

Dosing

The dose of dolasetron 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 dolasetron. 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 oral dosage form (tablets):
  
  • For prevention of nausea and vomiting after treatment with cancer medicines:
    
    • Adults—100 milligrams (mg) given within 1 hour before starting cancer treatment.
    
    
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.8 milligrams (mg) per kilogram (kg) of body weight given within 1 hour before starting cancer treatment. However, the dose is usually not more than 100 mg.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of nausea and vomiting after surgery:
    
    • Adults—100 milligrams (mg) given within 2 hours before surgery.
    
    
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.2 milligrams (mg) per kilogram (kg) of body weight given within 2 hours before surgery. However, the dose is usually not more than 100 mg.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of dolasetron, take 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. Do not double doses.

If you miss a dose of dolasetron, and you feel nauseated or you vomit, take the missed dose as soon as possible.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using dolasetron

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

dolasetron can cause changes in heart rhythms, such as conditions called QT, PR, and QRS prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Do not stop taking dolasetron without checking first with your doctor. Your doctor may gradually reduce the amount you are using before stopping completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

dolasetron 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 immediately if any of the following side effects occur:

More common

• Chest pain or discomfort


• lightheadedness, dizziness, or fainting


• shortness of breath


• slow or irregular heartbeat


• unusual tiredness or weakness

Less common

• Chills


• decrease in the amount of urine


• fast, pounding, or irregular heartbeat or pulse


• fever

Less common or rare

• Agitation


• black, tarry stools


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• blurred vision


• burning while urinating


• changes in skin color


• coma


• confusion


• cough


• depression


• difficult or labored breathing


• difficult or painful urination


• difficulty with swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• frequent urination


• headache


• hives or welts


• hostility


• increased volume of pale, dilute urine


• irritability


• itching of the skin


• lethargy


• muscle twitching


• nausea


• noisy breathing


• numbness and tingling of the face, fingers, or toes


• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion


• pain, tenderness, or swelling of the foot or leg


• pale skin


• pale, bluish-colored, or cold hands or feet


• pinpoint red or purple spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid weight gain


• redness of the skin


• seizures


• skin rash


• stupor


• sweating


• swelling of the face, ankles, or hands


• tightness in the chest


• tingling of the hands or feet


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual weight gain or loss


• weak or absent pulses in the legs


• wheezing

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

• Diarrhea

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• pain


• stomach discomfort, upset, or pain

Less common or rare

• Abnormal dreams


• agitation


• bad, unusual, or unpleasant (after) taste


• bloating


• bloody nose


• change in color vision


• change in taste


• changes in vision


• continuing ringing or buzzing or other unexplained noise in the ears


• darkened urine


• difficulty having a bowel movement (stool)


• difficulty seeing at night


• difficulty with moving


• feeling of constant movement of self or surroundings


• feeling of unreality


• feeling of warmth


• hearing loss


• increased sensitivity of the eyes to sunlight


• increased sweating


• joint pain


• loss of appetite


• muscle aching or cramping


• muscle pain or stiffness


• pain or burning sensation at the injection site


• pains in the stomach, side, or abdomen, possibly radiating to the back


• redness of the face, neck, arms, and occasionally, upper chest


• sensation of spinning


• sense of detachment from self or body


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• swollen joints


• trembling or shaking of the hands or feet


• unsteadiness, trembling, or other problems with muscle control or coordination


• vomiting


• weight loss


• yellow eyes or skin

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.

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dapsone

Generic Name: dapsone (DAP sone)

Brand Names:

What is dapsone?

Dapsone is an antiinfective medication.

Dapsone is used in the treatment of dermatitis herpetiformis (a skin condition) and leprosy (Hansen's disease).

Dapsone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about dapsone?

In rare cases, dapsone has been associated with serious, and sometimes fatal blood and liver problems. Contact your doctor immediately if you experience a sore throat, fever, pale skin, bruising or pinpoint red spots on the skin, or yellowing of the skin or eyes. These may be symptoms of blood or liver problems. Contact your doctor immediately if you develop a rash while taking dapsone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions.

What should I discuss with my healthcare provider before taking dapsone?

Do not take dapsone without first talking to your doctor if you have

• 
  

  glucose 6-phosphate dehydrogenase (G6PD) deficiency;

  
  


• 
  

  methemoglobin reductase deficiency (hemoglobin M); or

  
  


• liver disease.

You may not be able to take dapsone, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Dapsone is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take dapsone without first talking to your doctor if you are pregnant or could become pregnant during treatment. Dapsone passes into breast milk and may affect a nursing baby. Do not take dapsone without first talking to your doctor if you are nursing a baby.

How should I take dapsone?

Take dapsone exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Taking dapsone with food may decrease stomach upset, should it occur.

It is important to take dapsone regularly to get the most benefit.

Your doctor may want you to have blood tests or other forms of monitoring during treatment with dapsone.

Store dapsone at room temperature away from moisture and heat.

See also: Dapsone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication, unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a dapsone overdose may include nausea, vomiting, excitation, seizures, and bluish skin color.

What should I avoid while taking dapsone?

Avoid prolonged exposure to sunlight. Dapsone may increase the sensitivity of the skin to sunlight and sunburn may be more likely to occur. If exposure to the sun is unavoidable, wear a sunscreen and protective clothing.

Dapsone side effects

In rare cases, dapsone has been associated with serious, and sometimes fatal blood and/or liver problems. Contact your doctor immediately if you experience a sore throat, fever, pale skin, bruising or pinpoint red spots on the skin, or yellowing of the skin or eyes. These may be symptoms of blood or liver problems. Contact your doctor immediately if you develop a rash while taking dapsone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions. If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  bluish skin color;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  numbness or tingling;

  
  


• 
  

  abdominal pain;

  
  


• 
  

  difficulty breathing;

  
  


• 
  

  dark colored urine or pale colored stools; or

  
  


• 
  

  unusual tiredness.

  
  

Other, less serious side effects may be more likely to occur. Notify your doctor if you experience

• 
  

  nausea or vomiting;

  
  


• 
  

  blurred vision;

  
  


• 
  

  ringing in the ears;

  
  


• 
  

  headache;

  
  


• 
  

  insomnia; or

  
  


• 
  

  increased sensitivity of the skin to sunlight.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Dapsone Dosing Information

Usual Adult Dose for Leprosy -- Lepromatous:

50 to 100 mg orally once a day for 2-5 years.

Usual Adult Dose for Leprosy -- Tuberculoid:

100 mg orally once a day for 6 months. Rifampin is additionally recommended to reduce the incidence of dapsone resistance. If the disease relapses, this regimen should be repeated.

Usual Adult Dose for Dermatitis Herpetiformis:

50 mg orally once a day continued on a life-long basis. Dosage may be advanced to 300 mg/day. Dosage reduction to a minimum maintenance level as soon as possible is recommended.

Usual Adult Dose for Pneumocystis Pneumonia:

100 mg orally once a day for 14 to 21 days. Used in combination with trimethoprim.

Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:

100 mg orally twice a week. Therapy should be continued on a life-long basis. The addition of pyrimethamine appears to significantly increase the activity of dapsone for PCP prophylaxis.

Usual Adult Dose for Toxoplasmosis -- Prophylaxis:

100 mg orally twice a week continued on a life-long basis.

Usual Pediatric Dose for Leprosy:

1 to 2 mg/kg (up to 100 mg) orally once a day.

Usual Pediatric Dose for Pneumocystis Pneumonia Prophylaxis:

> 1 month:
2 mg/kg/day (up to 100 mg) orally once a day.

Alternate dosing:
> 1 month:
4 mg/kg orally once weekly. Maximum dose = 200 mg.

Usual Pediatric Dose for Toxoplasmosis -- Prophylaxis:

> 1 month:

2 mg/kg/day (or 15 mg/m2) orally once a day. Maximum dose = 25 mg. Dapsone should be administered as part of combination therapy for prophylaxis of toxoplasmosis.

What other drugs will affect dapsone?

Many other drugs can interact with dapsone, especially those that may also affect the blood. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with dapsone without first talking to your doctor.

More dapsone resources

• Dapsone Dosage
• Dapsone Use in Pregnancy & Breastfeeding
• Drug Images
• Dapsone Drug Interactions
• Dapsone Support Group
• 6 Reviews for Dapsone - Add your own review/rating

• dapsone Advanced Consumer (Micromedex) - Includes Dosage Information


• Dapsone Prescribing Information (FDA)


• Dapsone Professional Patient Advice (Wolters Kluwer)


• Dapsone Monograph (AHFS DI)


• Dapsone MedFacts Consumer Leaflet (Wolters Kluwer)

Compare dapsone with other medications

• Bullous Pemphigoid
• Dermatitis Herpetiformis
• Leprosy
• Leprosy, Lepromatous
• Leprosy, Tuberculoid
• Leukocytoclastic Vasculitis
• Pemphigoid
• Pemphigus
• Pneumocystis Pneumonia
• Pneumocystis Pneumonia Prophylaxis
• Toxoplasmosis, Prophylaxis

Where can I get more information?

• Your pharmacist has more information about dapsone written for health professionals that you may read.

dapsone topical

Generic Name: dapsone topical (dap zone top ick all)

Brand Names: Aczone

What is dapsone topical?

Dapsone topical is an antiinfective medication.

Dapsone topical is a medicine used to help treat acne.

Dapsone topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about dapsone topical?

Contact your doctor immediately if you develop a rash while using dapsone topical. In rare cases, dapsone topical has been associated with serious, and sometimes fatal, skin reactions.

What should I discuss with my healthcare provider before using dapsone topical?

Do not use dapsone topical without first talking to your doctor if you have

• 
  

  glucose 6-phosphate dehydrogenase (G6PD) deficiency;

  
  


• 
  

  anemia; or

  
  


• liver disease.

You may not be able to use dapsone topical, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Dapsone topical is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use dapsone topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. Dapsone topical passes into breast milk and may affect a nursing baby. Do not use dapsone topical without first talking to your doctor if you are nursing a baby.

How should I use dapsone topical?

Use dapsone topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash the areas of your skin where you will apply dapsone topical. Gently pat your skin dry with a clean towel.

Apply a thin layer of dapsone topical to the areas of your skin that have acne. A pea-sized amount of dapsone topical will usually be enough.

Rub the medicine in gently and completely. Make sure to put the cap back on the dapsone topical tube. Close it tightly and put the tube back in its original box..

Keep dapsone topical away from your mouth and eyes.

If your acne does not get better after using dapsone topical for 12 weeks, talk to your doctor about other treatments for acne.

Store dapsone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and use only the next regularly scheduled dose.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Do not swallow dapsone topical. If you swallow dapsone topical, call your doctor or poison control center right away.

What should I avoid while using dapsone topical?

Avoid prolonged exposure to sunlight. Dapsone topical may increase the sensitivity of the skin to sunlight and sunburn may be more likely to occur. If exposure to the sun is unavoidable, protective clothing.

Dapsone topical side effects

The most common side effects of dapsone topical are dryness, redness, oiliness and peeling of the skin being treated. Call your doctor if you have excessive tiredness or any side effects that do not go away or bother you.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Dapsone topical Dosing Information

Usual Adult Dose for Acne:

Apply a pea-size amount topically to affected area twice a day. Gently wash and pat area dry prior to application. Completely rub into skin in a gentle manner.

Usual Pediatric Dose for Acne:

12 to 18 years:

Apply a pea-size amount topically to affected area twice a day. Gently wash and pat area dry prior to application. Completely rub into skin in a gentle manner.

What other drugs will affect dapsone topical?

Avoid using other topical medications, harsh or abrasive soaps, or cosmetics on the affected area without first talking to your doctor.

Drugs other than those listed here may also interact with dapsone topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More dapsone topical resources

• Dapsone topical Dosage
• Dapsone topical Use in Pregnancy & Breastfeeding
• Dapsone topical Drug Interactions
• Dapsone topical Support Group
• 35 Reviews for Dapsone - Add your own review/rating

• Aczone Prescribing Information (FDA)


• Aczone topical Monograph (AHFS DI)


• Aczone Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Aczone Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Aczone Consumer Overview

Compare dapsone topical with other medications

• Acne

Where can I get more information?

• Your pharmacist has more information about dapsone topical written for health professionals that you may read.

darbepoetin alfa Injection

dar-be-POE-e-tin AL-fa

Injection route(Solution)

Erythropoiesis-stimulating agents (ESAs) increase the risks for death, myocardial infarction, stroke, and other serious cardiovascular events. In patients with chronic kidney disease (CKD), patients are at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of 11 g/dL or higher in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. Therefore, in CKD patients, use at the lowest sufficient dose is recommended. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies. In patients with cancer, use the lowest ESA dose needed to avoid RBC transfusions and serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program (www.esa-apprise.com or 1-866-284-8089) to prescribe and/or dispense darbepoetin alfa to patients with cancer. Patients receiving myelosuppressive therapy should not be treated with ESAs when the anticipated outcome is cure .

Commonly used brand name(s)

In the U.S.

• Aranesp

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Erythropoietic

Uses For darbepoetin alfa

Darbepoetin alfa injection causes the bone marrow to produce red blood cells. If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly. Darbepoetin may be used for patients on kidney dialysis or for those not on dialysis. Anemia can also occur in people who are receiving chemotherapy to treat cancer. Darbepoetin alfa is used to treat severe anemia in these patients.

darbepoetin alfa is available only with your doctor's prescription.

Before Using darbepoetin alfa

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 darbepoetin alfa, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to darbepoetin alfa 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darbepoetin alfa injection in children with chronic kidney failure who are 1 year of age and older. Safety and efficacy have not been established in children with chronic kidney failure who are younger than 1 year of age.

Appropriate studies have not been performed on the relationship of age to the effects of darbepoetin alfa injection in children with cancer. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darbepoetin alfa injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 darbepoetin alfa, 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 darbepoetin alfa 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.

• Thalidomide

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 darbepoetin alfa. Make sure you tell your doctor if you have any other medical problems, especially:

• Aluminum poisoning, severe or


• Bleeding, severe or


• Bone marrow fibrosis (osteofibrosis cystica) or


• Folic acid deficiency or


• Infections, inflammation, or cancer or


• Iron deficiency or


• Vitamin B12 deficiency—May cause a delay in response to treatment.

• Blood clots (history of) or other problems with the blood or


• Congestive heart failure or


• Heart attack, history of or


• Heart bypass surgery or


• Heart or blood vessel disease or


• Stroke, history of or


• Thrombosis, at risk for—The chance of side effects may be increased.

• Bone marrow problems (e.g., hemolytic anemia, sickle cell anemia, porphyria, thalassemia)—Use of darbepoetin alfa injection has not been established in patients with these conditions.

• Hypertension (high blood pressure), uncontrolled or


• Pure red cell aplasia (rare bone marrow disease)—Should not be used in patients with these conditions.

• Seizures, history of—May make this condition worse.

Proper Use of darbepoetin alfa

For cancer patients: It is very important that you understand and become familiar with the Aranesp® Medication Guide. You may also be asked to sign the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) acknowledgement form. Direct any questions to your doctor or pharmacist before starting darbepoetin alfa therapy.

darbepoetin alfa comes with a patient instructions insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Darbepoetin alfa is usually given by a doctor. However, medicines given by injection are sometimes used at home. If you will be using darbepoetin alfa at home, your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

darbepoetin alfa is available in 3 forms. You may use a vial, a prefilled syringe with an UltraSafe® Needle Guard, or a prefilled SureClick™ autoinjector.

If you need a full dose of darbepoetin alfa, use the prefilled SureClick™ autoinjector unless your doctor tells you otherwise.

darbepoetin alfa may be given as a shot under your skin or into a vein. If your doctor tells you to inject it a certain way, follow your doctor's instructions.

If you are giving darbepoetin alfa at home:

• Use a new needle and syringe each time you inject your medicine.


• Do not use more medicine or use it more often than your doctor tells you to.


• You will be shown the body areas where this shot can be given.


• Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Do not shake the container of medicine before you use it, and do not use darbepoetin alfa if it has been frozen.

You might not use all of the medicine in each vial (glass container) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Carefully follow your doctor's instructions about any special diet. You may need to eat foods that contain iron, folic acid, or vitamin B12 such as eggs, certain cereals, meats, and vegetables, or you may take an iron, folic acid, or vitamin B12 supplement while you are using darbepoetin alfa.

Dosing

The dose of darbepoetin alfa 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 darbepoetin alfa. 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 injection dosage form:
  
  • For anemia from chronic kidney failure:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.45 to 0.75 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once a week or once every 2 weeks. Your doctor may adjust the dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For anemia from cancer chemotherapy:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 2.25 micrograms (mcg) per kilogram (kg) of body weight once a week or 500 mcg once every 3 weeks injected under the skin. Your doctor may adjust the dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from bright light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using darbepoetin alfa

People with severe anemia usually feel very tired and sick. When darbepoetin alfa begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. But darbepoetin alfa only corrects anemia. It has no effect on kidney disease, cancer, or any other medical problem that needs regular medical attention. Even if you are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments.

It is very important that your doctor check your blood regularly while you are using darbepoetin alfa. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

Darbepoetin alfa may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using darbepoetin alfa and check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

darbepoetin alfa may increase your risk of having blood clots. This is more likely in patients who use high doses of darbepoetin alfa, or who use darbepoetin alfa before major surgery. If you have chest pain; shortness of breath; or pain, redness, or swelling in your arms or legs while using darbepoetin alfa, call your doctor right away. If you are getting kidney dialysis treatments, tell your doctor right away if you notice blood clots at your injection site. Your doctor may give you a blood thinner before surgery to help prevent blood clots.

darbepoetin alfa may also increase your risk of having serious heart and blood vessel problems such as a heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

When used in patients with certain types of cancer (e.g., breast, cervix, lymphoid, lung, head, or neck cancer), darbepoetin alfa has shortened survival time and worsened the cancer in some patients. If you are concerned about this, talk with your doctor.

Darbepoetin alfa sometimes causes convulsions (seizures), especially during the first few months of treatment. During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause a serious injury if a seizure occurs while you are performing them.

One form of darbepoetin alfa injection has an ingredient that comes from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using darbepoetin alfa.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by darbepoetin alfa treatment) may need to be on a special diet or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.

In addition to darbepoetin alfa, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully. Darbepoetin alfa will not work well if you do not have enough iron or vitamins in your body.

darbepoetin alfa 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 immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• accumulation of pus


• arm, back, or jaw pain


• blurred vision


• breathing problems (irregular, noisy, or trouble when resting)


• chest pain, discomfort, tightness, or heaviness


• chills


• confusion


• cough producing mucus


• decrease in the amount of urine


• diarrhea


• dilated neck veins


• dizziness, fainting, or lightheadedness


• dry mouth


• fast, slow, or irregular heartbeat


• fatigue or tiredness (extreme or unusual)


• fever


• headache


• nausea


• pain, tenderness, swelling, or warmth over injection site


• pounding in the ears


• rapid breathing


• rapid or pounding pulse


• shortness of breath


• skin discoloration at the injection site


• sunken eyes


• sweating


• swelling of the ankles, face, fingers, feet, hands, or lower legs


• thirst


• trouble with breathing


• unconsciousness


• vomiting


• weight gain


• wheezing


• wrinkled skin

Less common

• Anxiety


• convulsions


• difficulty with speaking (slow speech or unable to speak)


• double vision


• trouble with thinking


• trouble with walking


• unable to move the arms, legs, or face muscles (including numbness and tingling)

Rare

• Fever and sore throat


• hives


• itching


• pale skin


• skin rash


• unusual tiredness or weakness

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

• Constipation


• general feeling of discomfort or illness


• lack or loss of strength


• loss of appetite


• muscle aches, pains, or stiffness


• pain in the joints


• runny nose


• shivering


• sneezing


• trouble with sleeping

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: darbepoetin alfa Injection 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.

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• Darbepoetin alfa Injection Drug Interactions
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• 1 Review for Darbepoetin alfa Injection - Add your own review/rating

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• Anemia Associated with Chronic Renal Failure
• Anemia, Chemotherapy Induced

Dapsone

Dapsone Tablets, USP

25 mg & 100 mg

DESCRIPTION

Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils.

Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.

Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.

CLINICAL PHARMACOLOGY

Actions: The mechanism of action in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae.

Absorption and Excretion: Dapsone, when given orally, is rapidly and almost completely absorbed. About 85 percent of the daily intake is recoverable from the urine mainly in the form of water-soluble metabolites. Excretion of the drug is slow and a constant blood level can be maintained with the usual dosage.

Blood Levels: Detected a few minutes after ingestion, the drug reaches peak concentration in 4-8 hours. Daily administration for at least eight days is necessary to achieve a plateau level. With doses of 200 mg daily, this level averaged 2.3 μg/ml with a range of 0.1-7.0 μg/ml. The half-life in the plasma in different individuals varies from ten hours to fifty hours and averages twenty-eight hours. Repeat tests in the same individual are constant. Daily administration (50 - 100 mg) in leprosy patients will provide blood levels in excess of the usual minimum inhibitory concentration even for patients with a short Dapsone half-life.

INDICATIONS AND USAGE

Dermatitis herpetiformis: (D.H.)

Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.

CONTRAINDICATION

Hypersensitivity to Dapsone and/or its derivatives.

WARNINGS

The patient should be warned to respond to the presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice. Deaths associated with the administration of Dapsone have been reported from agranulocytosis, aplastic anemia and other blood dyscrasias. Complete blood counts should be done frequently in patients receiving Dapsone. The FDA Dermatology Advisory Committee recommended that, when feasible, counts should be done weekly for the first month, monthly for six months and semi-annually thereafter. If a significant reduction in leucocytes, platelets or hemopoiesis is noted, Dapsone should be discontinued and the patient followed intensively. Folic acid antagonists have similar effects and may increase the incidence of hematologic reactions; if co-administered with Dapsone the patient should be monitored more frequently. Patients on weekly pyrimethamine and Dapsone have developed agranulocytosis during the second and third month of therapy.

Severe anemia should be treated prior to initiation of therapy and hemoglobin monitored. Hemolysis and methemoglobin may be poorly tolerated by patients with severe cardiopulmonary disease.

Cutaneous reactions, especially bullous, include exfoliative dermatitis and are probably one of the most serious, though rare, complications of sulfone therapy. They are directly due to drug sensitization. Such reactions include toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria and erythema nodosum. If new or toxic dermatologic reactions occur, sulfone therapy must be promptly discontinued and appropriate therapy instituted. Leprosy reactional states, including cutaneous, are not hypersensitivity reactions to Dapsone and do not require discontinuation. See special section.

PRECAUTIONS

General: Hemolysis and Heinz body formation may be exaggerated in individuals with a glucose-6-phosphate dehydrogenase (G6PD) deficiency, or methemoglobin reductase deficiency, or hemoglobin M. This reaction is frequently dose-related. Dapsone should be given with caution to these patients or if the patient is exposed to other agents or conditions such as infection or diabetic ketosis capable of producing hemolysis. Drugs or chemicals which have produced significant hemolysis in G6PD or methemoglobin reductase deficient patients include Dapsone, sulfanilamide, nitrite, aniline, phenylhydrazine, napthalene, niridazole, nitro-furantoin and 8-amino-antimalarials such as primaquine.

Toxic hepatitis and cholestatic jaundice have been reported early in therapy. Hyperbilirubinemia may occur more often in G6PD deficient patients. When feasible, baseline and subsequent monitoring of liver function is recommended; if abnormal, Dapsone should be discontinued until the source of the abnormality is established.

Drug Interactions: Rifampin lowers Dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions.

A modest interaction has been reported for patients receiving 100 mg Dapsone daily in combination with trimethoprim 5 mg/kg q6h. On Day 7, the serum Dapsone levels averaged 2.1 ± 1.0 μg/mL in comparison to 1.5 ± 0.5 μg/mL for Dapsone alone. On Day 7, trimethoprim levels averaged 18.4 ± 5.2 μg/mL in comparison to 12.4 ± 4.5 μg/mL for patients not receiving Dapsone. Thus, there is a mutual interaction between Dapsone and trimethoprim in which each raises the level of the other about 1.5 times.

A crossover study1 designed to assess the potential of a drug interaction between Dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic HIV positive volunteers (average CD4 count 524 cells/mm3) demonstrated that there was not a significant drug intreraction between Dapsone and trimethoprim. However, an earlier report2 also by Lee et al, in 78 HIV infected patients with acute Pneumocystis carinii pneumonia, receiving Dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of Dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.

Carcinogenesis, mutagenesis: Dapsone has been found carcinogenic (sarcomagenic) for male rats and female mice causing mesenchymal tumors in the spleen and peritoneum, and thyroid carcinoma in female rats. Dapsone is not mutagenic with or without microsomal activation in S. typhimurium tester strains 1535, 1537, 1538, 98, or 100.

Pregnancy: Teratogenic Effects. Pregnancy Category C: Animal reproduction studies have not been conducted with Dapsone. Extensive, but uncontrolled experience and two published surveys on the use of Dapsone in pregnant women have not shown that Dapsone increases the risk of fetal abnormalities if administered during all trimesters of pregnancy or can affect reproduction capacity. Because of the lack of animal studies or controlled human experience, Dapsone should be given to a pregnant woman only if clearly needed. In general, for leprosy, USPHS at Carville recommends maintenance of Dapsone. Dapsone has been important for the management of some pregnant D.H. patients.

Nursing Mothers: Dapsone is excreted in breast milk in substantial amounts. Hemolytic reactions can occur in neonates. See section on hemolysis. Because of the potential for tumorgenicity shown for Dapsone in animal studies a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of drug to the mother.

Pediatric Use: Pediatric patients are treated on the same schedule as adults but with correspondingly smaller doses. Dapsone is generally not considered to have an effect on the later growth, development and functional development of the pediatric patient.

Adverse Reactions

In addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on Dapsone.

Hematologic Effects: Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency. Almost all patients demonstrate the inter-related changes of a loss of 1-2g of hemoglobin, an increase in the reticulocytes (2-12%), a shortened red cell life span and a rise in methemoglobin. G6PD deficient patients have greater responses.

Nervous System Effects: Peripheral neuropathy is a definite but unusual complication of Dapsone therapy in non-leprosy patients. Motor loss is predominant. If muscle weakness appears, Dapsone should be withdrawn. Recovery on withdrawal is usually substantially complete. The mechanism of recovery is reported by axonal regeneration. Some recovered patients have tolerated retreatment at reduced dosage. In leprosy this complication may be difficult to distinguish from a leprosy reactional state.

Body As A Whole: In addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug-induced Lupus erythematosus and an infectious mononucleosis-like syndrome. In general, with the exception of the complications of severe anoxia from overdosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.

OVERDOSAGE

Nausea, vomiting, hyperexcitability can appear a few minutes up to 24 hours after ingestion of an overdosage. Methemoglobin induced depression, convulsions or severe cyanosis requires prompt treatment. In normal and methemoglobin reductase deficient patients, methylene blue, 1-2 mg/kg of body weight, given slowly intravenously, is the treatment of choice. The effect is complete in 30 minutes, but may have to be repeated if methemoglobin reaccumulates. For non-emergencies, if treatment is needed, methylene blue may be given orally in doses of 3-5 mg/kg every 4-6 hours. Methylene blue reduction depends on G6PD and should not be given to fully expressed G6PD deficient patients.

DOSAGE AND ADMINISTRATION

Dermatitis herpetiformis: The dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. If full control is not achieved within the range of 50-300 mg daily, higher doses may be tried. Dosage should be reduced to a minimum maintenance level as soon as possible. In responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. There is no effect on the gastrointestinal component of the disease. Dapsone levels are influenced by acetylation rates. Patients with high acetylation rates, or who are receiving treatment affecting acetylation may require an adjustment in dosage.

A strict gluten free diet is an option for the patient to elect, permitting many to reduce or eliminate the need for Dapsone; the average time for dosage reduction is 8 months with a range of 4 months to 2 1/2 years and for dosage elimination 29 months with a range of 6 months to 9 years.

Leprosy: In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs. In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy. For advice and other drugs, the USPHS at Carville, LA (1-800-642-2477) should be contacted. Before using other drugs consult appropriate product labeling.

In bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of Dapsone 100 mg daily with six months of Rifampin 600 mg daily. Under WHO, daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. The Dapsone is continued until all signs of clinical activity are controlled - usually after an additional six months. Then Dapsone should be continued for an additional three years for tuberculoid and indeterminate patients and for five years for borderline tuberculoid patients.

In lepromatous and borderline lepromatous patients, the recommendation is the co-administration of Dapsone 100 mg daily with two years of Rifampin 600 mg daily. Under WHO daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. One may elect the concurrent administration of a third anti-leprosy drug, usually either Clofazamine 50-100 mg daily or Ethionamide 250-500 mg daily. Dapsone 100 mg daily is continued 3-10 years until all signs of clinical activity are controlled with skin scrapings and biopsies negative for one year. Dapsone should then be continued for an additional 10 years for borderline patients and for life for lepromatous patients.

Secondary Dapsone resistance should be suspected whenever a lepromatous or borderline lepromatous patient receiving Dapsone treatment relapses clinically and bacteriologically, solid staining bacilli being found in the smears taken from the new active lesions. If such cases show no response to regular and supervised Dapsone therapy within three to six months or good compliance for the past 3-6 months can be assured, Dapsone resistance should be considered confirmed clinically. Determination of drug sensitivity using the mouse footpad method is recommended and, after prior arrangement, is available without charge from the USPHS, Carville, LA. Patients with proven Dapsone resistance should be treated with other drugs.

LEPROSY REACTIONAL STATES

Abrupt changes in clinical activity occur in leprosy with any effective treatment and are known as reactional states. The majority can be classified into two groups. The “Reversal” reaction (Type 1) may occur in borderline or tuberculoid leprosy patients often soon after chemotherapy is started. The mechanism is presumed to result from a reduction in the antigenic load: the patient is able to mount an enhanced delayed hypersensitivity response to residual infection leading to swelling (“Reversal”) of existing skin and nerve lesions. If severe, or if neuritis is present, large doses of steroids should always be used. If severe, the patient should be hospitalized. In general anti-leprosy treatment is continued and therapy to suppress the reaction is indicated such as analgesics, steroids, or surgical decompression of swollen nerve trunks. USPHS at Carville, LA should be contacted for advice in management.

Erythema nodosum leprosum (ENL) (lepromatous reaction) (Type 2 reaction) occurs mainly in lepromatous patients and small numbers of borderline patients. Approximately 50% of treated patients show this reaction in the first year. The principal clinical features are fever and tender erythematous skin nodules sometimes associated with malaise, neuritis, orchitis, albuminuria, joint swelling, iritis, epistaxis or depression. Skin lesions can become pustular and/or ulcerate. Histologically there is a vasculitis with an intense polymorphonuclear infiltrate. Elevated circulating immune complexes are considered to be the mechanism of reaction. If severe, patients should be hospitalized. In general, anti-leprosy treatment is continued. Analgesics, steroids, and other agents available from USPHS, Carville, LA, are used to suppress the reaction.

HOW SUPPLIED

Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed “25” above and “102” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 30 tablets (2 x 15). The blisters are light and child-resistant. NDC 49938-102-30.

Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed “100” above and “101” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 30 tablets (2 x 15).The blisters are light and child-resistant. NDC 49938-101-30.

Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed “25” above and “102” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 28 tablets (2 x 14). The blisters are light and child-resistant. NDC 49938-102-28.

Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed“100" above and “101” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 28 tablets (2 x 14). The blisters are light and child-resistant. NDC 49938-101-28.

REFERENCES

1. Lee, B., et al., Zidovudine, Trimethoprim, and Dapsone Pharmacokinetic Interactions in Patients with HIV Infection. Antimicrobial Agents and Chemotherapy, May 1996; 1231-1236.


2. Lee, B., et al., Dapsone, Trimethoprim, and Sulfamethoxazole Plasma Levels During Treatment of Pneumocystis Carinii Pneumonia in Patients with AIDS, Annals of Internal Medicine, 1989; 110:606-611.

Store at 20°- 25° C (68°- 77°F). [see USP Controlled Room Temperature]. Protect from light.

Rx only. Keep this and all medication out of the reach of children.

JACOBUS PHARMACEUTICAL CO., INC.

P.O. Box 5290

Princeton, NJ 08540

Revised August 2009

0826A09

Principal Display Panel – 25 mg Carton Label

NDC 49938-102-30

Dapsone

Tablets USP

25 mg

30 Tablets (2 x 15 unit of use)

Rx Only

To be sold as a single unit

Principal Display Panel – 100 mg Carton Label

NDC 49938-101-30

Dapsone

Tablets USP

100 mg

30 Tablets (2 x 15 unit of use)

Rx Only

To be sold as a single unit

Dapsone  Dapsone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49938-101 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dapsone (Dapsone) Dapsone 100 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN

Product Characteristics Color white (white) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code JACOBUS;100;101 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49938-101-30 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 15 TABLET In 1 BLISTER PACK This package is contained within the CARTON (49938-101-30) 2 49938-101-28 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 14 TABLET In 1 BLISTER PACK This package is contained within the CARTON (49938-101-28)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA086842	08/15/2008

Dapsone  Dapsone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49938-102 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dapsone (Dapsone) Dapsone 25 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN

Product Characteristics Color white (white) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code JACOBUS;25;102 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49938-102-30 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 15 TABLET In 1 BLISTER PACK This package is contained within the CARTON (49938-102-30) 2 49938-102-28 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 14 TABLET In 1 BLISTER PACK This package is contained within the CARTON (49938-102-28)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA086841	08/15/2008

Labeler - Jacobus Pharmaceutical Company, Inc. (088805734)

Revised: 07/2011Jacobus Pharmaceutical Company, Inc.

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Dolasetron Tablets

Pronunciation: doe-LAS-e-tron
Generic Name: Dolasetron
Brand Name: Anzemet

Dolasetron is used for:

Preventing nausea and vomiting associated with cancer chemotherapy. It may also be used to prevent nausea and vomiting after surgery.

Dolasetron is a serotonin 5-HT₃ receptor blocker. It works by blocking a substance thought to be a cause of nausea and vomiting in certain situations.

Do NOT use Dolasetron if:

• you are allergic to any ingredient in Dolasetron


• you have a certain type of irregular heartbeat (congenital long QT syndrome), or uncorrected low blood potassium or magnesium levels


• you have or are at risk of complete heart block and do not have a pacemaker


• you are taking apomorphine or nilotinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dolasetron:

Some medical conditions may interact with Dolasetron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of heart problems (eg, slow or irregular heartbeat, sick sinus syndrome, heart attack, heart failure), kidney problems, or low potassium or magnesium levels in the blood


• if you are taking medicines that may cause a certain type of irregular heartbeat (eg, flecainide, verapamil, quinidine)

Some MEDICINES MAY INTERACT with Dolasetron. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anthracyclines (eg, doxorubicin), antiarrhythmics (eg, amiodarone, dofetilide, sotalol), arsenic, astemizole, bepridil, chloroquine, cimetidine, cisapride, diuretics (eg, furosemide), domperidone, droperidol, halofantrine, haloperidol, histone deacetylase inhibitors (eg, romidepsin), iloperidone, ketolides (eg, telithromycin), macrolides (eg, erythromycin), maprotiline, methadone, nilotinib, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolones (eg, levofloxacin), streptogramins (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, tricyclic antidepressants (eg, nortriptyline), tyrosine kinase inhibitors (eg, sunitinib), or ziprasidone because the risk of irregular heart rhythm is increased


• Apomorphine because the risk of severe low blood pressure or loss of consciousness may be increased


• Rifampin because it may decrease Dolasetron's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dolasetron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dolasetron:

Use Dolasetron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Dolasetron by mouth with or without food.


• Take your dose of Dolasetron as directed before the start of your cancer treatment or surgery.


• Swallow Dolasetron whole. Do not break, crush, or chew before swallowing. Crushing or chewing the tablets may lead to increased side effects or decreased effectiveness, and the tablets will have a bitter, unpleasant taste.


• If you miss a dose of Dolasetron, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Dolasetron.

Important safety information:

• Dolasetron may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Dolasetron with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Dolasetron may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do NOT take more than the recommended dose of Dolasetron without checking with your doctor.


• If you are taking Dolasetron to prevent nausea and vomiting associated with cancer chemotherapy, take Dolasetron only on the days that you take your cancer treatment unless otherwise directed by your doctor. If you continue to experience moderate to severe vomiting while taking Dolasetron, check with your doctor.


• Tell your doctor or dentist that you take Dolasetron before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including electrocardiograms (ECGs) and blood potassium or magnesium levels, may be performed while you use Dolasetron. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Dolasetron with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat.


• Do not give Dolasetron to CHILDREN who are unable to swallow tablets.


• Dolasetron should be used with extreme caution in CHILDREN younger than 2 years; safety and effectiveness in these children have not been confirmed.


• Caution is advised when using Dolasetron in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dolasetron while you are pregnant. It is not known if Dolasetron is found in breast milk. If you are or will be breast-feeding while you use Dolasetron, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Dolasetron:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; diarrhea; dizziness; headache; indigestion; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in heartbeat (including fast, slow, or irregular heartbeat); chest pain; fainting; lightheadedness; numbness or pain of an arm or leg; pounding in the chest; shortness of breath; sudden, severe headache, stomach pain, dizziness, or vomiting; sudden vision changes; urination problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dolasetron side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular heartbeat; severe dizziness.

Proper storage of Dolasetron:

Store Dolasetron at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dolasetron out of the reach of children and away from pets.

General information:

• If you have any questions about Dolasetron, please talk with your doctor, pharmacist, or other health care provider.


• Dolasetron is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dolasetron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dolasetron resources

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

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