Sandimmune Solution

Pronunciation: SYE-kloe-SPOR-een
Generic Name: Cyclosporine
Brand Name: Sandimmune

Sandimmune Solution should always be used along with adrenal corticosteroids (eg, hydrocortisone), but not with other medicines that suppress the immune system. The risk of developing an infection or a certain type of cancer (lymphoma) may be increased by suppressing the immune system.

Sandimmune Solution cannot be switched with other forms of cyclosporine (eg, Neoral) without your doctor's approval.

If you are taking Sandimmune Solution for a long period of time, especially for a liver transplant, lab tests should be performed to monitor your progress or to check for side effects, such as toxicity or decreased effectiveness.

Sandimmune Solution is used for:

Preventing the rejection of organ transplants (kidney, liver, and heart). It is used in combination with adrenal corticosteroids. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents. It may also be used for other conditions as determined by your doctor.

Sandimmune Solution is an immunosuppressant. Exactly how Sandimmune Solution works is not known, but it may block certain white blood cells (lymphocytes).

Do NOT use Sandimmune Solution if:

• you are allergic to any ingredient in Sandimmune Solution


• you are taking bosentan, disulfiram, fluorouracil, an immunosuppressant (eg, azathioprine, tacrolimus), metronidazole, orlistat, or a potassium-sparing diuretic (eg, spironolactone)


• you are having radiation therapy for psoriasis


• you are going to be vaccinated with a live vaccine

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

Before using Sandimmune Solution:

Some medical conditions may interact with Sandimmune Solution. 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 liver, kidney, brain, or nerve problems; high blood potassium or uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; gout; an infection; or problems absorbing food or medicine; or have had a recent vaccination


• if your diet contains high amounts of potassium


• if you have a history of seizures


• if you are having phototherapy for psoriasis, or are having radiation treatment

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

• Many prescription and nonprescription medicines (eg, used for infections, inflammation, allergic reactions, asthma, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach and intestinal problems, endometriosis, HIV, seizures, blood clotting, weight loss, arthritis, psoriasis, depression, sleep, other conditions), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) may interact with Sandimmune Solution. They may increase the risk of side effects or decrease the effectiveness of this or other medicines


• Immunosuppressants (eg, azathioprine, tacrolimus ) because the risk of developing an infection or cancer may be increased


• Potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased


• Bosentan because the risk of its side effects and toxic effects may be increased by Sandimmune Solution


• Disulfiram, fluorouracil, or metronidazole because flushing, headache, fast or irregular heartbeat, shortness of breath, nausea, or vomiting may occur


• Orlistat because it may decrease Sandimmune Solution's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sandimmune Solution 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 Sandimmune Solution:

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

• Take Sandimmune Solution on a regular schedule with regard to food and time of day.


• Do not eat grapefruit or drink grapefruit juice while you use Sandimmune Solution.


• If you also take sirolimus, do not take it within 4 hours after taking Sandimmune Solution. Check with your doctor if you have questions.


• Follow your doctor's instructions on how to dilute Sandimmune Solution. Use a glass container to mix Sandimmune Solution. To improve the flavor, Sandimmune Solution may be mixed with room temperature milk, chocolate milk, or orange juice.


• Avoid frequently switching the liquid in which you mix Sandimmune Solution. Stir well and drink immediately (do not let it stand before drinking). Rinse glass with more liquid and drink again to make sure the entire dose is taken.


• Do not rinse the dosing syringe with water or any other liquid; this will affect the dose. After use, dry the outside of the dosing syringe with a clean towel and replace the protective cover. If the syringe needs to be cleaned, it must be completely dry before it is used again.


• If you miss a dose of Sandimmune Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Sandimmune Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Sandimmune Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not switch to another doseform or change brands of Sandimmune Solution without talking to your doctor. Products made by other companies may not work as well for you.


• Sandimmune Solution may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sandimmune Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor.


• Sandimmune Solution may lower the ability of your body to fight infection and may increase the risk of severe infections. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.


• Some people treated with Sandimmune Solution have developed severe kidney problems associated with the BK virus infection. Tell your doctor right away if you notice symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Discuss any questions or concerns with your doctor.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Sandimmune Solution. Talk with your doctor before you receive any vaccine.


• Sandimmune Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


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


• Diabetes patients - Sandimmune Solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including kidney and liver function; cyclosporine levels; and blood pressure, lipids, and electrolytes, may be performed while you use Sandimmune Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sandimmune Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: Sandimmune Solution may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sandimmune Solution while you are pregnant. Sandimmune Solution is found in breast milk. Do not breast-feed while taking Sandimmune Solution.

Possible side effects of Sandimmune Solution:

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:

Acne; dizziness; flushing; headache; increased hair growth; nausea; runny nose; sleeplessness; stomach discomfort; vomiting.

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); black, tarry stools; blood in the urine; change in the appearance of a mole; chest pain; confusion; dark urine; diarrhea; fast or irregular heartbeat; gum disease or overgrowth; increased or decreased urination; loss of coordination; mental or mood changes; muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness; shortness of breath; symptoms of infection (eg, chills, cough, fever, painful urination, sore throat); tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes; wheezing; yellowing of the skin or eyes.

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: Sandimmune 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.

Proper storage of Sandimmune Solution:

Store Sandimmune Solution at room temperature, below 86 degrees F (30 degrees C), in its original container. Store away from heat, moisture, and light. Do not store in refrigerator. Protect from freezing. Once opened, the contents must be used within 2 months. Do not store in the bathroom. Keep Sandimmune Solution out of the reach of children and away from pets.

General information:

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


• Sandimmune Solution 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 Sandimmune Solution. 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 Sandimmune resources

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

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Hyperol

Hyperol may be available in the countries listed below.

Ingredient matches for Hyperol

Urea

Urea peroxyde (a derivative of Urea) is reported as an ingredient of Hyperol in the following countries:

• Hungary

International Drug Name Search

Ceftriaxone MK

Ceftriaxone MK may be available in the countries listed below.

Ingredient matches for Ceftriaxone MK

Ceftriaxone

Ceftriaxone is reported as an ingredient of Ceftriaxone MK in the following countries:

• Bahamas


• Haiti


• Jamaica

International Drug Name Search

Dermesone

Dermesone may be available in the countries listed below.

Ingredient matches for Dermesone

Betamethasone

Betamethasone is reported as an ingredient of Dermesone in the following countries:

• Bahrain


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Nigeria


• Qatar


• Saudi Arabia


• Somalia


• Sudan


• United Arab Emirates


• Yemen

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Dermesone in the following countries:

• Oman

International Drug Name Search

Salitop 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 Salitop

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 Salitop

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 Salitop. 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 Salitop

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.

Salitop 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: Salitop Topical side effects (in more detail)

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More Salitop Topical resources

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

Compare Salitop Topical with other medications

• Acne
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Salitop Cream

salicylic acid

Dosage Form: cream
Salitop™ Cream (6% Salicylic Acid)

Salitop™ Lotion (6% Salicylic Acid)

Rx Only

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

Salitop Cream Description

Salitop™ Cream contains 6% w/w Salicylic Acid USP finely dispersed in an emulsion consisting of Ammonium Lactate, Behentrimonium Chloride, Cetyl Alcohol, Dimethicone 360, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Methylparaben, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Propylparaben, Purified Water and Trolamine.

Salitop™ Lotion contains 6% w/w Salicylic Acid USP finely dispersed in an emulsion consisting of Ammonium Lactate, Behentrimonium Chloride, Cetyl Alcohol, Dimethicone 360, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Methylparaben, Mineral Oil, PEG-100 Stearate, Propylparaben, Purified Water, Trolamine.

Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure:

This formulation is designed to provide sustained release of the active ingredient into the skin.

Salitop Cream - Clinical Pharmacology

Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to a dissolution of intercellular cement substance. In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin showed that the peak serum salicylate levels never exceeded 5 mg/100 mL even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 mL). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space (see PRECAUTIONS).

The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%). The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.

Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate (see PRECAUTIONS).

Indications and Usage for Salitop Cream

For Dermatologic Use

Salitop™ is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris and psoriasis (including body, scalp, palms and soles).

For Podiatric Use

Salitop™ is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

Contraindications

Salitop™ should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salitop™ should not be used on children under 12 years of age.

Warnings

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salitop™ should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Due to the potential risk of developing Reye's Syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

Precautions

For external use only. Avoid contact with eyes and other mucous membranes.

Pregnancy (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salitop™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salitop™, a decision should be make whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salitop™. It has been shown to lack mutagenic potential in the Ames Salmonella test.

DRUG INTERACTIONS

The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salitop™ is not known.

I.

Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:

DRUG	DESCRIPTION OF INTERACTION
Sulfonylureas	Hypoglycemia potentiated.
Methotrexate	Decreases tubular reabsorption; clinical toxicity from methotrexate can result.
Oral Anticoagulants	Increased bleeding.

II.

Drugs changing salicylate levels by altering renal tubular reabsorption.

DRUG	DESCRIPTION OF INTERACTION
Corticosteroids	Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.
Acidifying Agents	Increases plasma salicylate level.
Alkanizing Agents	Decreased plasma salicylate levels.

III.

Drugs with complicated interactions with salicylates:

DRUG	DESCRIPTION OF INTERACTION
Heparin	Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.
Pyrazinamide	Inhibits pyrazinamide-induced hyperuricemia.
Uricosuric Agents	Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited.

The following alterations of laboratory tests have been reported during salicylate therapy:

LABORATORY TESTS	EFFECT OF SALICYLATES
Thyroid Function	Decreased PBI; increased T3 uptake.
Urinary sugar	False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5 g q.d.).
5-Hydroxyindole-acetic acid	False negative with fluorometric test.
Acetone, ketone bodies	False positive FeCl3 in Gerhardt reaction; red color persists with boiling.
17-OH corticosteroids	False reduced values with >4.8 g q.d. salicylate.
Vanilmandelic acid	False reduced values.
Uric acid	May increase or decrease depending on dose.
Prothrombin	Decreased levels; slightly increased prothrombin time.

Adverse Reactions

Excessive erythema and scaling conceivably could result from use on open skin lesions.

Overdosage

See WARNINGS.

Salitop Cream Dosage and Administration

The preferable method of use is to apply Salitop™ thoroughly to the affected area and cover the area at night, after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salitop™ will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (see WARNINGS). Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salitop™ will not necessarily increase it's therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

How is Salitop Cream Supplied

Salitop™ Cream is available in 400 gram oval-shaped container, (NDC 51991-476-46).

Salitop™ Lotion is available in 14 fl. oz. (414 mL) bottles, (NDC 51991-477-47).

Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F). See USP Controlled Room Temperature.

Protect from freezing.

Dispense in original containers.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

IN-47646

Rev. 2/09

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured by:

Groupe Parima, Inc.

Montreal, Qc H4S 1X6 Canada

PRINCIPAL DISPLAY PANEL - 400 g Carton Label

Breckenridge

Pharmaceutical, Inc.

NDC 51991-476-46

SALITOP™

CREAM

(6% Salicylic Acid)

WARNING:

FOR DERMATOLOGICAL USE ONLY

NOT FOR:

• OPHTHALMIC USE


• ORAL USE


• INTRAVAGINAL USE

Rx Only

Net Wt. 400 g

SALITOP  salicylic acid  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-476 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (Salicylic Acid) Salicylic Acid 60 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Ammonium Lactate   Behentrimonium Chloride   Cetyl Alcohol   Dimethicone   Edetate Disodium   Glycerin   Glyceryl Monostearate   Methylparaben   Mineral Oil   Phenoxyethanol   Polyoxyl 100 Stearate   Propylparaben   Water   Trolamine

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-476-46 400 g In 1 CONTAINER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/01/2007	07/31/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Groupe Parima		252437850	MANUFACTURE

Revised: 12/2010Breckenridge Pharmaceutical, Inc.

More Salitop Cream resources

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

Compare Salitop Cream with other medications

• Acne
• Dermatological Disorders

Inhaled anti-infectives

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Inhaled anti-infectives are agents that act locally, in the lungs to treat infection. Inhaled antibiotics are used to treat bacterial infection and antiviral medicines treat viral infections. These anti-infectives are inhaled either as dry powder or as a solution via a nebulizer.

See also

Medical conditions associated with inhaled anti-infectives:

• Bacteremia
• Bacterial Infection
• Bone infection
• Burns, External
• Cystic Fibrosis
• Endocarditis
• Febrile Neutropenia
• Hepatitis C
• Influenza
• Influenza Prophylaxis
• Intraabdominal Infection
• Kidney Infections
• Leishmaniasis
• Meningitis
• Peritonitis
• Pneumocystis Pneumonia
• Pneumocystis Pneumonia Prophylaxis
• Pneumonia
• Rabbit Fever
• Respiratory Syncytial Virus
• Sepsis
• Shunt Infection
• Skin Infection
• Swine Flu
• Trypanosomiasis

Drug List:

Tobi-Solution

Copegus

Relenza

Ribapak

Nebcin

Nebupent-Solution

Pentam

Pentam-300

Rebetol

Ribasphere

Ribatab

Virazole-Solution