Alti-Sulfasalazine Oral, Rectal

Generic Name: sulfasalazine (Oral route, Rectal route)

sul-fa-SAL-a-zeen

Commonly used brand name(s)

In the U.S.

• Azulfidine


• Azulfidine Entabs


• Sulfazine


• Sulfazine EC

In Canada

• Alti-Sulfasalazine


• Salazopyrin

Available Dosage Forms:

• Suppository


• Enema


• Tablet


• Tablet, Enteric Coated

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Sulfonamide

Uses For Alti-Sulfasalazine

Sulfasalazine , a sulfa medicine, is used to prevent and treat inflammatory bowel disease, such as ulcerative colitis. It works inside the bowel by helping to reduce the inflammation and other symptoms of the disease. Sulfasalazine is sometimes given with other medicines to treat inflammatory bowel disease.

Sulfasalazine is also used to treat rheumatoid arthritis in patients who have not been helped by or who cannot tolerate other medicines for rheumatoid arthritis.

Sulfasalazine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, sulfasalazine is used in certain patients with the following medical conditions:

• Ankylosing spondylitis

Before Using Alti-Sulfasalazine

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

Sulfasalazine should not be used in children up to 2 years of age because it may cause brain problems. However, sulfasalazine has not been shown to cause different side effects or problems in children over the age of 2 years than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 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.

• Riluzole

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.

• Cyclosporine


• Digoxin


• Warfarin

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:

• Allergies, severe or


• Asthma, bronchial—The risk of an allergic reaction to sulfasalazine may be increased


• Blood problems or


• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Patients with these problems may have an increase in side effects affecting the blood

• Intestinal blockage—Sulfasalazine will not reach the site of action in the bowel

• Kidney disease or


• Liver disease—Patients with kidney disease or liver disease may have an increased chance of side effects

• Porphyria—Use of sulfasalazine may cause an attack of porphyria

• Urinary blockage—Sulfasalazine may not be eliminated properly, causing an increased risk of side effects

Proper Use of sulfasalazine

This section provides information on the proper use of a number of products that contain sulfasalazine. It may not be specific to Alti-Sulfasalazine. Please read with care.

Do not give sulfasalazine to infants and children up to 2 years of age, unless otherwise directed by your doctor. It may cause brain problems.

Sulfasalazine is best taken right after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your doctor.

Each dose of sulfasalazine should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of the sulfa medicine.

For patients taking the enteric-coated tablet form of this medicine:

• Swallow tablets whole. Do not break or crush.

Keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. Do not miss any doses.

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 prevention or treatment of inflammatory bowel disease:
  
  • For oral dosage forms (tablets, enteric-coated tablets):
    
    • Adults and teenagers—To start, 500 milligrams (mg) to 1000 mg (1 gram) every six to eight hours. Your doctor may then decrease the dose to 500 mg every six hours. Later, your doctor may change your dose as needed.
    
    
    • Children 2 years of age and over—Dose is based on body weight and must be determined by your doctor.
      
      • To start, the dose is usually:
        
        • 6.7 to 10 mg per kilogram (kg) (3.05 to 4.55 mg per pound) of body weight every four hours or
        
        
        • 10 to 15 mg per kg (4.55 to 6.82 mg per pound) of body weight every six hours or
        
        
        • 13.3 to 20 mg per kg (6.05 to 9.09 mg per pound) of body weight every eight hours.
        
        
      
      
      • Then, the dose is usually 7.5 mg per kg (3.41 mg per pound) of body weight every six hours.
      
      
    
    
    • Infants and children up to 2 years of age—Use is not recommended.
    
    
  
  
  • For rectal dosage form (enema):
    
    • Adults and teenagers—3 grams (1 unit), used rectally as directed, every night.
    
    
    • Children 2 years of age and over—Dose must be determined by your doctor.
    
    
    • Infants and children up to 2 years of age—Use is not recommended.
    
    
  
  


• For treatment of rheumatoid arthritis:
  
  • For oral dosage forms (tablets, enteric-coated tablets):
    
    • Adults and teenagers—To start, 500 mg to 1000 mg (1 gram) daily. Your doctor may increase your dose as needed, but the dose is generally not more than 3000 mg (3 grams) a day.
    
    
    • For children ages 6 and over—30 to 50 mg per kg of body weight daily, divided into two doses. The medicine is usually started at a lower amount and gradually increased to the actual amount over a month. Typically the amount that is needed does not exceed 2 grams per day. The dose must be determined by your doctor.
    
    
    • Infants and children up to 2 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

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 Alti-Sulfasalazine

It is very important that your doctor check your progress at regular visits. This medicine may cause blood problems, especially if it is taken for a long time.

If your symptoms (including diarrhea) do not improve within 1 or 2 months, or if they become worse, check with your doctor.

Sulfasalazine may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Sulfasalazine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may also cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If this reaction is especially bothersome, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of the bentiromide (e.g., Chymex) test for pancreas function are affected by this medicine.

Alti-Sulfasalazine 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

• Aching of joints


• fever


• headache (continuing)


• itching


• skin rash


• vomiting

Less common or rare

• Aching of joints and muscles


• back, leg, or stomach pains


• bloody diarrhea


• bluish fingernails, lips, or skin


• chest pain


• cough


• difficult breathing


• difficulty in swallowing


• chills, or sore throat


• general feeling of discomfort or illness


• loss of appetite


• pale skin


• redness, blistering, peeling, or loosening of skin


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

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

More common

• Increased sensitivity of skin to sunlight

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

• Abdominal or stomach pain or upset


• diarrhea


• loss of appetite


• nausea

In some patients this medicine may also cause the urine or skin to become orange-yellow. This side effect does not need medical attention.

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: Alti-Sulfasalazine Oral, Rectal side effects (in more detail)

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More Alti-Sulfasalazine Oral, Rectal resources

• Alti-Sulfasalazine Oral, Rectal Side Effects (in more detail)
• Alti-Sulfasalazine Oral, Rectal Use in Pregnancy & Breastfeeding
• Drug Images
• Alti-Sulfasalazine Oral, Rectal Drug Interactions
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• 7 Reviews for Alti-Sulfasalazine Oral, Rectal - Add your own review/rating

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Alemtuzumab

Class: Antineoplastic Agents
VA Class: AN900
Brands: Campath

• 
  

  Risk of serious and, rarely, fatal pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia.¹ Do not administer single doses >30 mg or cumulative weekly doses >90 mg, since these dosages have been associated with an increased incidence of pancytopenia.¹ (See Dosage under Dosage and Administration and see Hematologic Effects under Cautions.)

  
  


• 
  

  Possible serious or fatal infusion reactions.¹ Monitor patients carefully during infusions; discontinue therapy if indicated.¹ Gradual titration to the recommended maintenance dosage is required during initiation of therapy and after interruption of therapy for ≥7 days.¹ (See Dosage under Dosage and Administration and see Infusions Reactions under Cautions.)

  
  


• 
  

  Risk of serious and sometimes fatal bacterial, viral, fungal, and protozoan infections.¹ Prophylaxis against Pneumocystis jiroveci (formerly P. carinii) pneumonia and herpesvirus infections may decrease, but not eliminate, the occurrence of these infections.¹ (See General under Dosage and Administration and see Infectious Complications under Cautions.)

  
  

Introduction

Antineoplastic agent; recombinant DNA-derived humanized anti-CD52 monoclonal antibody.¹

Uses for Alemtuzumab

Chronic Lymphocytic Leukemia (CLL)

First-line therapy of B-cell chronic lymphocytic leukemia (B-CLL).^{1 6 31} Comparative efficacy and safety of alemtuzumab versus fludarabine as initial therapy for B-CLL notestablished.³

Treatment of B-cell CLL (B-CLL) in patients who have been treated with alkylating agents and who have not responded adequately to fludarabine therapy (designated an orphan drug by FDA for this use).^{1 6 7 8}

Under investigation for use in combination with fludarabine† for the second-line treatment of relapsed or refractory B-CLL.³⁰

Alemtuzumab Dosage and Administration

General

Premedication and Patient Monitoring

• 
  

  To minimize risk of IV infusion-related reactions, administer diphenhydramine hydrochloride 50 mg and acetaminophen 500–1000 mg 30 minutes prior to first alemtuzumab infusion and when dosage is escalated.¹ (See Infusion-related Effects under Cautions.)

  
  


• 
  

  Monitor patients carefully during or shortly after infusion for manifestations of infusion reactions (e.g., rigors, fever, bronchospasm, chills, nausea, vomiting, rash, urticaria, dyspnea, hypotension).¹

  
  


• 
  

  To minimize risk of injection site reactions, administer an antihistamine and acetaminophen prior to sub-Q† injections (e.g., 30 minutes before administration);^{34 35 36} in one study, premedication was gradually withdrawn following resolution of any injection-related reactions.³⁴

  
  

Anti-infective Prophylaxis

• 
  

  To minimize risk of serious opportunistic infections, give prophylactic anti-infectives upon initiation of alemtuzumab and continue for 2 months after completion of therapy or until CD4⁺ T-cell count ≥200/mm³ (whichever occurs later).¹ (See Infectious Complications under Cautions.)

  
  


• 
  

  Administer co-trimoxazole (sulfamethoxazole 800 mg and trimethoprim 160 mg per dose) twice daily 3 times weekly (or equivalent) for prophylaxis of Pneumocystis jiroveci (formerly P. carinii) pneumonia.¹

  
  


• 
  

  Administer famciclovir 250 mg twice daily (or equivalent) for prophylaxis of herpesvirus infection.¹

  
  

Administration

Administer by IV infusion.¹ May be administered by sub-Q injection†.^{34 35 36}

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion only.¹ Do not administer by rapid IV injection (e.g., IV push or bolus).¹

Do not mix with any other drug or administer any other drug simultaneously in the same IV line.¹

Vials are for single use only.¹

Dilution

Use strict aseptic technique since drug product contains no preservative.¹

Do not shake vial prior to use.^{1 5}

Withdraw appropriate dose of alemtuzumab concentrate into a syringe calibrated in increments of 0.01 mL when preparing a 3-mg dose or a 10-mg dose; for a 30-mg dose, use a syringe calibrated in increments of 0.1 mL.¹ To prepare a 3-mg dose, withdraw 0.1 mL of alemtuzumab concentrate into a 1-mL syringe; to prepare a 10-mg dose, withdraw 0.33 mL into a 1-mL syringe; and to prepare a 30-mg dose, withdraw 1 mL into either a 1- or 3-mL syringe.¹ Discard vial, including any unused portion, after withdrawal of dose.¹

Add appropriate dose of alemtuzumab concentrate to 100 mL of 0.9% sodium chloride or 5% dextrose injection; gently invert bag to mix solution.¹

Rate of Administration

Administer dose over 2 hours.¹

Dosage

Adults

CLL

Gradual titration to the recommended maintenance dosage is required during initiation of therapy and after interruption of therapy for ≥7 days.¹ In most patients, escalation to maintenance dosage can be accomplished in 3–7 days.¹

IV

Initially, 3 mg daily.^{1 4} When infusion-related toxicities are ≤grade 2, increase dosage to 10 mg daily.^{1 4} Continue at this dosage until infusion-related toxicities are ≤grade 2, and then increase to a maintenance dosage of 30 mg 3 times weekly on alternate days (i.e., Monday, Wednesday, Friday).^{1 4} Total duration of therapy, including initial dosage and dosage escalation, is 12 weeks.¹

Sub-Q†

In some clinical trials, dose was escalated from an initial dosage of 3 mg daily to a maintenance dosage of 30 mg 3 times weekly.^{34 35 36} If local skin erythema or edema occurred, dosage escalation phase was prolonged to 1 or 2 weeks.^{34 36} (See Injection Site Reactions under Cautions.)

Some experts recommend that sub-Q therapy be given for at least 12 weeks.³⁶ In a clinical trial in previously untreated patients, the drug was administered up to 18 weeks;³⁴ in another clinical trial in previously treated patients, total duration of therapy was up to 12 weeks.³⁵

Dosage Modification for Toxicity and Contraindications to Continued Therapy

Withhold therapy during serious adverse reactions until resolution of toxicity.¹ Discontinuance of therapy may be necessary.¹

Hematologic Toxicities

Adjust dosage and/or temporarily discontinue therapy if severe cytopenias (except lymphopenia) occur; permanently discontinue drug in patients with evidence of autoimmune hematologic toxicity (i.e., autoimmune anemia or thrombocytopenia).¹

No dosage modifications recommended for lymphopenia.¹

Dosage Adjustments for Hematologic Toxicities

Hematologic Measurements	Comments
For first occurrence of ANC <250/mm3 and/or platelets ≤25,000/mm3	Temporarily discontinue therapy.1 When ANC ≥500/mm3 and platelets ≥50,000/mm3, resume therapy at maintenance dosage (i.e., 30 mg 3 times weekly)1 If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated1
For second occurrence of ANC <250/mm3 and/or platelets ≤25,000/mm3	Temporarily discontinue therapy.1 When ANC ≥500/mm3 and platelets ≥50,000/mm3,1 resume therapy at 10 mg 3 times weekly;5 higher dosages not recommended1 5 If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated.1
For third occurrence of ANC <250/mm3 and/or platelets ≤25,000/mm3	Discontinue alemtuzumab permanently1
For first occurrence of a decrease of ANC and/or platelets by ≥50% from baseline value in patients initiating therapy with a baseline ANC ≤250/mm3 and/or baseline platelets ≤25,000/mm3	Temporarily discontinue therapy.1 When ANC and/or platelets return to baseline values, resume therapy at maintenance dosage (i.e., 30 mg 3 times weekly)1 5 If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated1
For second occurrence of a decrease of ANC and/or platelets by ≥50% from baseline value in patients initiating therapy with ANC of ≤250/mm3 and/or platelets ≤25,000/mm3	Temporarily discontinue therapy.1 When ANC and/or platelets return to baseline values, resume therapy at 10 mg 3 times weekly1 If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg 3 times weekly as tolerated1
For third occurrence of a decrease of ANC and/or platelets by ≥50% from baseline value in patients initiating therapy with ANC <250/mm3 and/or platelets ≤25,000/mm3	Discontinue alemtuzumab permanently1

Infusion Reactions

Withhold therapy in patients experiencing grade 3 or 4 infusion reactions.¹

Infectious Complications

If serious infection occurs, temporarily discontinue therapy; may reinitiate therapy following resolution of infection.¹

Withhold therapy during antiviral therapy for CMV infection or confirmed CMV viremia (defined as positive for CMV according to PCR in ≥2 consecutive samples obtained ≥1 week apart) and initiate anti-infective therapy (ganciclovir or equivalent).¹

Prescribing Limits

Adults

CLL

IV

Maximum 30 mg (as single dose) or 90 mg (as cumulative weekly dose); maximum 12 weeks total duration of therapy, including initial dosage and dosage escalation.¹ (See Boxed Warning and see Hematologic Effects under Cautions.)

Special Populations

Geriatric Patients

No dosage adjustment required.¹

Cautions for Alemtuzumab

Contraindications

• 
  

  None.¹

  
  

Warnings/Precautions

Warnings

Use under supervision of a qualified clinician experienced in therapy with antineoplastic agents.¹

Hematologic Effects

Risk of severe (sometimes fatal) autoimmune anemia, autoimmune thrombocytopenia, and prolonged myelosuppression.^{1 5} Hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have occurred in patients receiving recommended dosage.¹ Increased incidence of pancytopenia with higher than recommended dosages (i.e., single doses >30 mg or cumulative weekly doses >90 mg).¹ (See Boxed Warning.)

Withhold alemtuzumab in patients who develop severe cytopenias (except lymphopenia).¹ (See Dosage under Dosage and Administration.)

Discontinue therapy permanently in patients with autoimmune hematologic toxicity (i.e., autoimmune anemia or thrombocytopenia) or recurrent or persistent severe cytopenias (except lymphopenia).¹ Safety of reinitiating alemtuzumab in patients with autoimmune cytopenia or bone marrow aplasia not established.¹

Severe idiopathic thrombocytopenic purpura (ITP), sometimes fatal, reported in 3 patients receiving alemtuzumab in a clinical trial evaluating the drug for treatment of multiple sclerosis.³² Two of these patients received cumulative doses that exceeded the cumulative weekly dose limit.³²

Infusion Reactions

Risk of acute infusion reactions, including rigors, fever, bronchospasm, chills, nausea, vomiting, rash, urticaria, dyspnea, and hypotension occurring during or shortly after IV infusion, particularly during first week of therapy.¹

Serious, sometimes fatal, infusion-related reactions (e.g., syncope, pulmonary infiltrates, ARDS, respiratory arrest, cardiac arrhythmias, MI, acute cardiac insufficiency, cardiac arrest, angioedema, anaphylactoid shock) reported.^{1 9}

Monitor closely for adverse reactions during and shortly after infusion.¹ Withhold alemtuzumab in patients experiencing grade 3 or 4 infusion reactions.¹ Initiate medical management (e.g., glucocorticoids, epinephrine, meperidine) as clinically indicated.¹

Premedication and incremental dosage escalation used to prevent or ameliorate reactions.¹ (See Premedication and also see Dosage under Dosage and Administration.)

Acute systemic injection-related reactions, including fever and chills/rigors, also reported with sub-Q† injection of alemtuzumab, but appear to be more common with IV infusion.^{34 35 36}

Immunosuppression

Risk of severe and profound lymphopenia, which increases the potential for tranfusion-associated graft versus host disease (TA-GVHD).^{1 2} Administer only irradiated blood products unless immediate transfusion is required because of emergency.¹

Infectious Complications

Risk of serious (sometimes fatal) opportunistic bacterial, viral, fungal, or protozoan infections resulting from severe and profound lymphopenia.¹

Administer prophylactic anti-infectives against Pneumocystis jiroveci (formerly Pneumocystis carinii) and herpesvirus infections during alemtuzumab therapy and for at least 2 months after the last dose of alemtuzumab.^{1 3 4} (See Anti-infective Prophylaxis under Dosage and Administration.)

Risk of potentially serious or life-threatening CMV infection.¹ Monitor patient closely for CMV infection during and for at least 2 months following completion of alemtuzumab therapy.¹

If serious infection occurs, temporarily discontinue alemtuzumab;¹ reinitiate therapy following resolution of infection.¹

Therapy Monitoring

Monitor CBCs and platelet counts weekly during therapy;¹ more frequent monitoring may be required in patients with worsening anemia, neutropenia, or thrombocytopenia.¹ Following completion of alemtuzumab therapy, monitor CD4⁺ T-cell counts until levels return to ≥200/mm³.¹

Immunization

Avoid immunization with live virus vaccines during therapy with alemtuzumab (safety not established).¹

Other Warnings/Precautions

Immunogenicity

Potential of immunogenicity with the use of therapeutic proteins, such as alemtuzumab.¹ Development of antibodies to alemtuzumab reported infrequently during clinical trials; antibody development does not appear to affect tumor response.¹

Injection Site Reactions

Risk of localized skin and site reactions (e.g., erythema, edema, pruritus, pain) occurring with sub-Q† administration, especially during first 1–2 weeks of therapy; may occur more frequently in previously untreated patients.^{34 35 36}

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether alemtuzumab is distributed into milk;¹ however, human IgG distributes into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established.^{1 5}

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹

Hepatic Impairment

Pharmacokinetics not evaluated.¹ Safety and efficacy not established.⁵

Renal Impairment

Pharmacokinetics not evaluated.¹ Safety and efficacy not established.⁵

Common Adverse Effects

Infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (e.g., CMV viremia, CMV infection, other infections), adverse GI effects (nausea, vomiting, diarrhea, abdominal pain), adverse neurologic effects (insomnia, anxiety).¹

Interactions for Alemtuzumab

No formal drug interaction studies to date.^{1 5}

Alemtuzumab Pharmacokinetics

Distribution

Extent

Not known whether alemtuzumab crosses the placenta or is distributed into milk;¹ however, human IgG crosses the placenta and is distributed into milk.¹

Elimination

Elimination Route

Clearance decreases with repeated administration secondary to decreased receptor-mediated clearance (i.e., loss of CD52 receptors in periphery); AUC increases substantially (sevenfold) after 12 weeks of IV dosing in CLL patients receiving recommended dosages.¹

Half-life

Mean half-life is 11 hours (range: 2–32 hours) following the first 30-mg IV dose; mean half-life is 6 days (range: 1–14 days) following the last 30-mg IV dose.¹

Stability

Storage

Parenteral

Injection Concentrate

2–8°C.¹ Do not freeze; if accidentally frozen, thaw at 2–8°C before administration.¹ Protect from direct sunlight.¹

Following dilution, 15–30°C or under refrigeration (2–8°C); discard after 8 hours.^{1 5} Protect from light.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

No incompatibilities observed between alemtuzumab solution and PVC bags, PVC or polyethylene-lined PVC administration sets.¹

Parenteral

Solution Compatibility

Compatible1
Dextrose 5% in water
Sodium chloride 0.9%

ActionsActions

• 
  

  An IgG₁ kappa immunoglobulin containing human framework (i.e., variable and constant regions) and murine complementarity-determining regions.^{1 3}

  
  


• 
  

  Binds specifically to antigen CD52 (expressed on the surface of B and T cells; most monocytes, macrophages, and natural killer cells; and a subpopulation of granulocytes),^{1 2} triggering a host immune response causing lysis of normal and leukemic cells.^{1 5}

  
  


• 
  

  Mechanism of cell lysis is thought to involve complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.^{1 2}

  
  

Advice to Patients

• 
  

  Risk of hematologic toxicity, infectious complications, and infusion reactions.¹ Importance of immediately informing clinician if signs or symptoms of infusion reactions, cytopenias (bleeding, easy bruising, petechiae or purpura, pallor, weakness, or fatigue), or infections (fever) occur.¹

  
  


• 
  

  Advise patients of the importance of taking premedications and prophylactic anti-infectives as prescribed.¹

  
  


• 
  

  Advise patients that irradiation of blood products is required.¹

  
  


• 
  

  Advise patients that they should not be immunized with live viral vaccines if they have recently received treatment with alemtuzumab.¹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹ Advise women of childbearing potential and men to use effective contraceptive methods during therapy and for at least 6 months following completion of therapy.¹

  
  


• 
  

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

  
  


• 
  

  Importance of informing 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.

Alemtuzumab (recombinant DNA origin)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection concentrate, for IV infusion	30 mg/mL	Campath	Genzyzme

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Campath 30MG/ML Solution (GENZYME): 3/$6179.24 or 9/$18127.85

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 December 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Genzyme. Campath (alemtuzumab) prescribing information. Cambridge, MA; 2009 Aug.

2. Flynn JM, Byrd JC. Campath-1H monoclonal antibody therapy. Curr Opin Oncol. 2000; 12:574-81. [PubMed 11085457]

3. Food and Drug Administration. Oncologic drugs advisory committee sixty-sixth meeting. Bethesda, MD; December 2000. From FDA web site.

4. Keating MJ, Flinn I, Jain V et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002; 99:3554-61. [IDIS 483673] [PubMed 11986207]

5. Berlex Laboratories, Richmond, CA: Personal communication.

6. Chronic lymphocytic leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 May 16.

7. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; [May 5, 2003]. From FDA web site.

8. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]

9. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Campath (alemtuzumab) [May 2004]. From FDA web site.

10. Rai KR, Freter CE, Mercier RJ et al. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol. 2002; 20:3891-7. [IDIS 492956] [PubMed 12228210]

11. Adult non-Hodgkin’s lymphoma. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Jun 06.

12. Lenihan DJ, Alencar AJ, Yang D et al. Cardiac toxicity of alemtuzumab in patients with mycosis fungoides/Sezary syndrome. Blood. 2004; 104:655-8. [IDIS 520055] [PubMed 15073032]

13. Enblad G, Hagberg H, Erlanson M et al. A pilot study of alemtuzumab (anti-CD52 monoclonal antibody) therapy for patients with relapsed or chemotherapy-refractory peripheral T-cell lymphomas. Blood. 2004; 103:2920-4. [IDIS 515482] [PubMed 15070664]

14. Kennedy GA, Seymour JF, Wolf M et al. Treatment of patients with advanced mycosis fungoides and Sezary syndrome with alemtuzumab. Eur J Haematol. 2003; 71:250-6. [PubMed 12950233]

15. Lundin J, Hagberg H, Repp R et al. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003; 101:4267-72. [IDIS 500361] [PubMed 12543862]

16. Uppenkamp M, Engert A, Diehl V et al. Monoclonal antibody therapy with CAMPATH-1H in patients with relapsed high- and low-grade non-Hodgkin’s lymphomas: a multicenter phase I/II study. Ann Hematol. 2002; 81:26-32. [PubMed 11807632]

17. Khorana A, Bunn P, McLaughlin P et al. A phase II multicenter study of CAMPATH-1H antibody in previously treated patients with nonbulky non-Hodgkin’s lymphoma. Leuk Lymphoma. 2001; 41:77-87. [PubMed 11342359]

18. Lundin J, Osterborg A, Brittinger G et al. CAMPATH-1H monoclonal antibody in therapy for previously treated low-grade non-Hodgkin’s lymphomas: a phase II multicenter study. European Study Group of CAMPATH-1H Treatment in Low-Grade Non-Hodgkin’s Lymphoma. J Clin Oncol. 1998; 16:3257-63. [IDIS 414051] [PubMed 9779699]

19. Tang SC, Hewitt K, Reis MD et al. Immunosuppressive toxicity of CAMPATH1H monoclonal antibody in the treatment of patients with recurrent low grade lymphoma. Leuk Lymphoma. 1996; 24:93-101. [PubMed 9049965]

20. Osterborg A, Dyer MJ, Bunjes D et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol. 1997; 15:1567-74. [IDIS 383720] [PubMed 9193354]

21. Lundin J, Kennedy B, Dearden C et al. No cardiac toxicity associated with alemtuzumab therapy for mycosis fungoides/Sezary syndrome. Blood. 2005; 105:4148-9. [IDIS 535479] [PubMed 15867423]

22. Damaj G, Rubio MT, Audard V et al. Severe cardiac toxicity after monoclonal antibody therapy. Eur J Haematol. 2002; 68:324. [PubMed 12144543]

23. Herbert KE, Prince HM, Westerman DA. Pure red-cell aplasia due to parvovirus B19 infection in a patient treated with alemtuzumab. Blood. 2003; 101:1654. [IDIS 498239] [PubMed 12560244]

24. Crowley B, Woodcock B. Red cell aplasia due to parvovirus b19 in a patient treated with alemtuzumab. Br J Haematol. 2002; 119:279-80. [PubMed 12358942]

25. Pawson R, Dyer MJ, Barge R et al. Treatment of T-cell prolymphocytic leukemia with human CD52 antibody. J Clin Oncol. 1997; 15:2667-72. [IDIS 392532] [PubMed 9215839]

26. Dearden CE, Matutes E, Cazin B et al. High remission rate in T-cell prolymphocytic leukemia with CAMPATH-1H. Blood. 2001; 98:1721-6. [IDIS 469299] [PubMed 11535503]

27. Keating MJ, Cazin B, Coutre S et al. Campath-1H treatment of T-cell prolymphocytic leukemia in patients for whom at least one prior chemotherapy regimen has failed. J Clin Oncol. 2002; 20:205-13. [IDIS 475048] [PubMed 11773171]

28. Dearden CE, Matutes E, Cazin B et al. Very high response rates in previously untreated T-cell prolymphocytic leukaemia patients receiving alemtuzumab (Campath-1H) therapy. Blood. 2003; 102:644a.

29. Polman CH, Uitdehaag BM. New and emerging treatment options for multiple sclerosis. Lancet Neurol. 2003; 2:563-6. [PubMed 12941579]

30. Genzyme Corporation. Fludara plus alemtuzumab (Campath, MabCampath) vs Fludara alone in B-cell chronic lymphocytic leukemia (B-CLL) patients. National Cancer Institute: Clinical Trials (database). Protocol ID: CAM-314. Last accessed: 810/2008.

31. Hillmen P, Skotnicki AB, Robak T et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007; 25:5616-23. [PubMed 17984186]

32. FDA Alert: Alemtuzumab (marketed as Campath). Food and Drug Administration; 2005 Nov 30.^{(AHFS DI 2007rev: p.10, yellow)}

33. Rai KR, Peterson BL, Appelbaum FR et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med. 2000; 343:1750-7. [IDIS 456744] [PubMed 11114313]

34. Lundin J, Kimby E, Björkholm M et al. Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood. 2002; 100:768-73. [PubMed 12130484]

35. Stilgenbauer S, Zenz T, Winkler D et al. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009; 27:3994-4001. [PubMed 19597025]

36. Osterborg A, Foà R, Bezares RF et al. Management guidelines for the use of alemtuzumab in chronic lymphocytic leukemia. Leukemia. 2009; 23:1980-8. [PubMed 19626051]

More Alemtuzumab resources

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

• Alemtuzumab Professional Patient Advice (Wolters Kluwer)


• Alemtuzumab MedFacts Consumer Leaflet (Wolters Kluwer)


• alemtuzumab Concise Consumer Information (Cerner Multum)


• alemtuzumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Campath Prescribing Information (FDA)

Compare Alemtuzumab with other medications

• Chronic Lymphocytic Leukemia
• Rheumatoid Arthritis

Pitocin

Generic Name: oxytocin (Intravenous route, Intramuscular route)

ox-i-TOE-sin

Intravenous route(Solution)

Oxytocin is not indicated for elective induction of labor since the available data is inadequate to evaluate the benefits-to-risks considerations .

Intramuscular route(Solution)

Oxytocin is not indicated for elective induction of labor since the available data is inadequate to evaluate the benefits-to-risks considerations .

Commonly used brand name(s)

In the U.S.

• Pitocin

Available Dosage Forms:

• Solution

Therapeutic Class: Uterine Stimulant

Pharmacologic Class: Pituitary Hormone, Posterior

Uses For Pitocin

Oxytocin is a hormone used to help start or continue labor and to control bleeding after delivery. It is also sometimes used to help milk secretion in breast-feeding.

Oxytocin may also be used for other conditions as determined by your doctor.

In general, oxytocin should not be used to start labor unless there are specific medical reasons. Be sure you have discussed this with your doctor before receiving this medicine.

This medicine is available only with your doctor's prescription.

Novartis Pharmaceuticals removed Syntocinon® nasal spray from the market in March 1995.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, oxytocin is used in certain patients for the following:

• Testing the ability of the placenta to support a pregnancy.

Before Using Pitocin

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

No information is available on the relationship of age to the effects of oxytocin in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of oxytocin in geriatric patients.

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

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Bleeding problems (e.g., subarachnoid hemorrhage) or


• Hypertension (high blood pressure)—May make these conditions worse.

• Cephalopelvic disproportion or


• Cervical cancer or


• Fetal distress or


• Grand multiparity (giving birth more than five times) or


• Major surgery on the cervix or uterus (e.g., caesarean delivery), history of or


• Overdistended uterus or


• Premature fetus or


• Problems with uterine contraction (e.g., uterine atony, strong uterine contractions) or


• Toxemia, severe or


• Unfavorable fetal position (e.g., transverse lies) or


• Other conditions that may require caesarean delivery (e.g., cord prolapse, total placenta previa, vasa previa, or during an emergency)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of this medicine from the body.

Proper Use of Pitocin

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

Precautions While Using Pitocin

Oxytocin can be very useful for helping labor. However, there are certain risks with using it. Oxytocin causes contractions of the uterus. In women who are unusually sensitive to its effects, these contractions may become too strong. In rare cases, this may lead to tearing of the uterus. Also, if contractions are too strong, the supply of blood and oxygen to the fetus may be decreased.

Oxytocin may cause jaundice and eye problems such as retinal hemorrhage in some newborn infants. If you have concerns about this, ask your doctor.

This medicine may cause a serious condition called water intoxication. Tell your doctor right away if you start having have confusion, drowsiness, headache, or seizures while you are receiving this medicine.

Pitocin 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 or nurse immediately if any of the following side effects occur:

Rare

• Confusion


• convulsions (seizures)


• difficulty in breathing


• dizziness


• fast or irregular heartbeat


• headache (continuing or severe)


• hives


• pelvic or abdominal pain (severe)


• skin rash or itching


• vaginal bleeding (increased or continuing)


• weakness


• weight gain (rapid)

Incidence not known

• Abdominal pain or cramping


• blood clotting problem that causes prolonged bleeding


• chest pain or discomfort


• cough


• difficulty swallowing


• extra heartbeats


• fainting


• lightheadedness


• pounding or rapid pulse


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


• severe bleeding after giving birth


• shortness of breath


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Restlessness


• shakiness


• sleepiness


• slow to respond


• slurred speech


• unconsciousness

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:

Rare

• Nausea


• vomiting

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: Pitocin 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 Pitocin resources

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

• Pitocin MedFacts Consumer Leaflet (Wolters Kluwer)


• Pitocin Concise Consumer Information (Cerner Multum)


• Pitocin Monograph (AHFS DI)


• Pitocin Prescribing Information (FDA)


• Oxytocin Professional Patient Advice (Wolters Kluwer)


• Oxytocin Prescribing Information (FDA)


• Syntocinon Prescribing Information (FDA)

Compare Pitocin with other medications

• Abortion
• Labor Induction
• Postpartum Bleeding

Lupicare 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 Lupicare

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 Lupicare

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 Lupicare. 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 Lupicare

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.

Lupicare 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: Lupicare 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 Lupicare Topical resources

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

Compare Lupicare Topical with other medications

• Acne
• Dermatological Disorders
• Warts

PEG-3350 with Electolytes

Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)

Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs

What is PEG-3350 with Electolytes (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about PEG-3350 with Electolytes (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking PEG-3350 with Electolytes (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

• 
  

  a perforated bowel;

  
  


• 
  

  a bowel obstruction or severe constipation; or

  
  


• 
  

  colitis or toxic megacolon.

  
  

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  nausea or vomiting;

  
  


• 
  

  trouble swallowing; or

  
  


• 
  

  a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether polyethylene glycol electrolyte solution passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have serious side effects from this medicine.

How should I take PEG-3350 with Electolytes (polyethylene glycol electrolyte solution)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking PEG-3350 with Electolytes (polyethylene glycol electrolyte solution)?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

PEG-3350 with Electolytes (polyethylene glycol electrolyte solution) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of these serious side effects:

• 
  

  severe stomach pain or bloating;

  
  


• 
  

  no bowel movement within 2 hours after use; or

  
  


• 
  

  gagging, choking, or vomiting.

  
  

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

• 
  

  mild stomach cramps, gas, or bloating;

  
  


• 
  

  rectal pain or irritation;

  
  


• 
  

  nausea; or

  
  


• 
  

  passing gas.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect PEG-3350 with Electolytes (polyethylene glycol electrolyte solution)?

There may be other drugs that can interact with polyethylene glycol electrolyte solution. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More PEG-3350 with Electolytes resources

• PEG-3350 with Electolytes Side Effects (in more detail)
• PEG-3350 with Electolytes Use in Pregnancy & Breastfeeding
• PEG-3350 with Electolytes Support Group
• 1 Review for PEG-3350 with Electolytes - Add your own review/rating

• Colyte Advanced Consumer (Micromedex) - Includes Dosage Information


• Colyte Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Colyte Prescribing Information (FDA)


• GoLYTELY Solution (Jug) MedFacts Consumer Leaflet (Wolters Kluwer)


• MoviPrep Advanced Consumer (Micromedex) - Includes Dosage Information


• MoviPrep Prescribing Information (FDA)


• MoviPrep Consumer Overview


• MoviPrep MedFacts Consumer Leaflet (Wolters Kluwer)


• NuLYTELY Prescribing Information (FDA)


• NuLYTELY Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare PEG-3350 with Electolytes with other medications

• Bowel Preparation
• Constipation, Chronic
• Gastrointestinal Decontamination

Where can I get more information?

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

See also: PEG-3350 with Electolytes side effects (in more detail)