Monday, September 12, 2016

Stelara


Pronunciation: US-te-KIN-ue-mab
Generic Name: Ustekinumab
Brand Name: Stelara


Stelara is used for:

Treating certain patients with moderate to severe plaque psoriasis. It may also be used for other conditions as determined by your doctor.


Stelara is a monoclonal antibody. It works by blocking certain substances in the body that affect inflammation and the body's immune system.


Do NOT use Stelara if:


  • you are allergic to any ingredient in Stelara

  • you will be receiving a live vaccine (eg, measles, mumps)

  • you have had a Bacillus Calmette-Guerin (BCG) vaccine within the past year

  • you have a severe infection (eg, sepsis) or any other active infection

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



Before using Stelara:


Some medical conditions may interact with Stelara. 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, including rubber or latex

  • if you have a history of an infection that keeps coming back, tuberculosis (TB) infection or positive TB skin test, cancer, or a neurological disorder called reversible posterior leukoencephalopathy syndrome (RPLS)

  • if you have immune system problems, you have or a member of your household has recently received a vaccine, or you are scheduled to receive a vaccine or to have surgery

  • if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection

  • if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB

  • if you are having phototherapy or you take medicine that may decrease your immune system (eg, cyclosporine)

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


  • Cyclosporine or warfarin because the risk of their side effects may be increased

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


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


  • Stelara comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Stelara refilled.

  • Stelara is usually given as an injection at your doctor's office, hospital, or clinic.

  • Stelara is colorless to light yellow and may contain a few small white particles. Do not use Stelara if it contains other particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

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

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



Important safety information:


  • Patients should receive a TB skin test before using Stelara. Patients who test positive for TB should begin treatment for TB before starting Stelara. All patients should also be monitored for signs of TB while using Stelara even if their TB test is negative.

  • Serious infections, including tuberculosis, fungal infection, and other types of infections, have occurred in patients using Stelara. Avoid contact with people who have colds or infections. Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; increased or painful urination; persistent diarrhea or stomach pain).

  • Stelara may increase the risk of developing certain types of cancer. Discuss any questions or concerns with your doctor.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. It is not known if using Stelara for more than 2 years is safe and effective.

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

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Stelara. Talk with your doctor before you or a member of your household receives any vaccine.

  • Do not receive a Bacillus Calmette-Guerin (BCG) vaccine for 1 year before, during, or 1 year after treatment with Stelara.

  • Lab tests, including TB tests, may be performed while you use Stelara. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Stelara should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stelara while you are pregnant. Stelara is found in breast milk. If you are or will be breast-feeding while you use Stelara, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Stelara:


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:



Headache; mild redness at the injection site; mild sore throat; tiredness; upper respiratory infection.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in a mole; confusion; open sore that does not heal; persistent pain, swelling, or redness at the injection site; seizures; severe or persistent headache; signs of infection (eg, fever, chills, or persistent sore throat; cough; muscle aches; shortness of breath; warm, red, or painful skin; increased or painful urination; stomach pain or diarrhea; blood in phlegm; unexplained weight loss); unusual lump or skin growth; unusual tiredness or weakness; vision changes.



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: Stelara 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 ( http://www.aapcc.org), or emergency room immediately.


Proper storage of Stelara:

Stelara is usually handled and stored by a health care provider. If you are using Stelara at home, store Stelara as directed by your pharmacist or health care provider. Keep Stelara out of the reach of children and away from pets.


General information:


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

  • Stelara 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 Stelara. 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 Stelara resources


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


  • Stelara Prescribing Information (FDA)

  • Stelara Consumer Overview

  • Stelara Monograph (AHFS DI)

  • Stelara Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ustekinumab Professional Patient Advice (Wolters Kluwer)



Compare Stelara with other medications


  • Psoriasis

Sterile Water for Irrigation





Sterile Water for Irrigation Description


Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0)


The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests—Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.



Sterile Water for Irrigation - Clinical Pharmacology


Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products.


Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.



Indications and Usage for Sterile Water for Irrigation


Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).



Contraindications


Not for injection.



Warnings


Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures.


After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.


Discard unused portion of irrigating solution since it contains no preservative.



Precautions


Use only if solution is clear and container and seal are intact.



Adverse Reactions


None known.



Overdosage


None known.



Sterile Water for Irrigation Dosage and Administration



Irrigation


Use as directed by physician.


This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.



Nutrient Mixtures


Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.



How is Sterile Water for Irrigation Supplied


Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 per case; the 2000 mL are packaged 8 per case and the 4000 mL are packaged 4 per case.




















NDCCat. No.Size
Sterile Water for Irrigation USP

(Canada DIN 01963961)
0264-2101-00R5000-011000 mL
0264-2101-10R5001-01500 mL
0264-2101-50R5005-012000 mL
0264-2101-70R50074000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.


Do not warm above 150°F (66°C).



Rx only


Revised: January 2008


PIC is a trademark of B. Braun Medical Inc.


Made in USA



Directions For Use


Aseptic technique is required.


  1. Caution – Before use, perform the following checks:
    (a)

    Read the label. Ensure solution is the one ordered and is within the expiration date.

    (b)

    Invert container and inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.


Use only if solution is clear and container and seal are intact.


Single unit container.

Discard unused portion.

Not for injection.


2.

Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.


3.

Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour.


4.

Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.


B. Braun Medical Inc.

Irvine, CA USA 92614-5895


In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4


©2008 B. Braun Medical Inc.


Y36-002-647








STERILE WATER 
water  irrigant










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0264-2101
Route of AdministrationIRRIGATIONDEA Schedule    








INGREDIENTS
Name (Active Moiety)TypeStrength
Water (water)Active1 MILLILITER  In 1 MILLILITER


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






































Packaging
#NDCPackage DescriptionMultilevel Packaging
10264-2101-0016 CONTAINER In 1 CASEcontains a CONTAINER
11000 mL (MILLILITER) In 1 CONTAINERThis package is contained within the CASE (0264-2101-00)
20264-2101-1016 CONTAINER In 1 CASEcontains a CONTAINER
2500 mL (MILLILITER) In 1 CONTAINERThis package is contained within the CASE (0264-2101-10)
30264-2101-508 CONTAINER In 1 CASEcontains a CONTAINER
32000 mL (MILLILITER) In 1 CONTAINERThis package is contained within the CASE (0264-2101-50)
40264-2101-704 CONTAINER In 1 CASEcontains a CONTAINER
44000 mL (MILLILITER) In 1 CONTAINERThis package is contained within the CASE (0264-2101-70)

Revised: 02/2009B. Braun Medical Inc.

More Sterile Water for Irrigation resources


  • Sterile Water for Irrigation Support Group
  • 0 Reviews · Be the first to review/rate this drug

Sterile Water Irrigation




Directions for Use of Flexible Plastic Irrigation Containers

If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.



DIRECTIONS FOR USE


Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired.


Use Aseptic Technique.


  1. Suspend container using hanger hole.

  2. Remove plastic protector from outlet port at bottom of container.

  3. Attach irrigation set. Refer to complete directions accompanying set.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.


Baxter Healthcare Corporation


Deerfield, Il 60015 USA


Printed in USA


©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation. All rights reserved.


7-19-4-268


Rev. July 1997



PACKAGE LABEL.PRINCIPLE DISPLAY PANEL


Sterile Water for Irrigation USP Container Label



NOT FOR INJECTION


5000 mL


2B7119


NDC 0338-0003-49


STERILE WATER


For Irrigation USP


FOR IRRIGATION ONLY PREPARED BY DISTILLATION


NO ANTIMICROBIAL AGENT OR OTHER SUBSTANCE HAS


BEEN ADDED pH 5.5 (5.0 to 7.0) OSMOLARITY


0 mOsmol/L (CALC) STERILE NONPYROGENIC


SINGLE DOSE CONTAINER


DO NOT USE UNLESS SOLUTION IS CLEAR


DISCARD UNUSED PORTION


CAUTIONS THIS SOLUTION IS NOT ISOTONIC AND IS


HEMOLYTIC SQUEEZE AND INSPECT INNER BAG


WHICH MAINTAINS PRODUCT STERILITY DISCARD IF


LEAKS ARE FOUND RX ONLY STORE UNIT IN


MOISTURE BARRIER OVERWRAP AT ROOM


TEMPERATURE (25°C) UNTIL READY TO USE AVOID


EXCESSIVE HEAT SEE INSERT


Sterile Water


H2O


For Irrigation USP


UROMATIC CONTAINER PL 146 PLASTIC


BAXTER HEALTHCARE CORPORATION


DEERFIELD IL 60015 USA


MADE IN USA


BAXTER UROMATIC AND


PL 146 ARE TRADEMARKS OF


BAXTER INTERNATIONAL INC


FOR PRODUCT INFORMATION


1-800-933-0303


Sterile Water for Irrigation USP Carton Label



STERILE WATER FOR IRRIGATION, USP


UROMATIC CONT


2-5000ML


SECONDARY BAR CODE


(17) YYMM00 (10) XXXXX


PRIMARY BAR CODE


(01) 50303380003490


LOT XXXXX


EXP XXXXX


2B7119









STERILE WATER 
water  irrigant










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0338-0003
Route of AdministrationIRRIGATIONDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER)WATER1 mL  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
10338-0003-441000 mL In 1 BAGNone
20338-0003-462000 mL In 1 BAGNone
30338-0003-473000 mL In 1 BAGNone
40338-0003-495000 mL In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA01786605/30/1980


Labeler - BAXTER HEALTHCARE CORPORATION (005083209)









Establishment
NameAddressID/FEIOperations
BAXTER HEALTHCARE CORPORATION059140764MANUFACTURE
Revised: 12/2009BAXTER HEALTHCARE CORPORATION




More Sterile Water Irrigation resources


  • Sterile Water Irrigation Support Group
  • 0 Reviews · Be the first to review/rate this drug

Salofalk Oral, Rectal


Generic Name: salicylate (Oral route, Rectal route)


Commonly used brand name(s)

In the U.S.


  • Amigesic

  • Asacol

  • Azulfidine

  • Azulfidine Entabs

  • Bayer

  • Canasa

  • Colazal

  • Dipentum

  • Doan's Extra Strength

  • Doan's Regular

  • Dolobid

  • Ecotrin

  • Kaopectate

  • Pepto Bismol

  • Salflex

  • Tricosal

  • Trilisate

In Canada


  • Alti-Sulfasalazine

  • Arthropan

  • Asacol 800

  • Bismuth Extra Strength

  • Bismuth Original Formula

  • Mesasal

  • Pentasa

  • Pepto-Bismol

  • Pms-Asa Suppository Adult

  • Pms-Asa Suppository Children

  • Salazopyrin

  • Salofalk

Available Dosage Forms:


  • Tablet, Enteric Coated

  • Tablet, Extended Release

  • Suppository

  • Tablet

  • Capsule

  • Tablet, Chewable

  • Tablet, Effervescent

  • Capsule, Delayed Release

  • Gum

  • Tablet, Delayed Release

  • Enema

  • Capsule, Extended Release

  • Liquid

  • Solution

  • Suspension

Uses For Salofalk


Aspirin may also be used to lessen the chance of heart attack, stroke, or other problems that may occur when a blood vessel is blocked by blood clots. Aspirin helps prevent dangerous blood clots from forming. However, this effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.


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


The caffeine present in some of these products may provide additional relief of headache pain or faster pain relief.


Some salicylates are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of these medicines for your medical condition.


Importance of Diet


Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (as for arthritis) can add a large amount of sodium to your diet. Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mg of sodium in each 650-mg tablet.


Before Using Salofalk


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.


Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.


Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.


Geriatric


Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.


Pregnancy


Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.


Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.


Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.


Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).


Breast Feeding


Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).


Caffeine passes into the breast milk in small amounts.


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


  • Influenza Virus Vaccine, Live

  • Ketorolac

  • Pentoxifylline

Using medicines in this class 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

  • Acenocoumarol

  • Alteplase, Recombinant

  • Anisindione

  • Ardeparin

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Certoparin

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Desvenlafaxine

  • Dicumarol

  • Dipyridamole

  • Duloxetine

  • Enoxaparin

  • Eptifibatide

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Ketoprofen

  • Lepirudin

  • Methotrexate

  • Milnacipran

  • Nadroparin

  • Naproxen

  • Nefazodone

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Phenindione

  • Phenprocoumon

  • Protein C

  • Reteplase, Recombinant

  • Reviparin

  • Riluzole

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Tacrolimus

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Varicella Virus Vaccine

  • Venlafaxine

  • Vilazodone

  • Warfarin

  • Zimeldine

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Overactive thyroid or

  • Stomach ulcer or other stomach problems—Salicylates may make your condition worse.

  • Asthma, allergies, and nasal polyps (history of) or

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or

  • High blood pressure (hypertension) or

  • Kidney disease or

  • Liver disease—The chance of side effects may be increased.

  • Gout—Salicylates can make this condition worse and can also lessen the effects of some medicines used to treat gout.

  • Heart disease—The chance of some side effects may be increased. Also, the caffeine present in some aspirin products can make some kinds of heart disease worse.

  • Hemophilia or other bleeding problems—The chance of bleeding may be increased, especially with aspirin.

Proper Use of salicylate

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


Take this medicine after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.


Take tablet or capsule forms of this medicine with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.


For patients taking aspirin (including buffered aspirin and/or products containing caffeine):


  • Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.

  • If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.

  • Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.

  • There are several different forms of aspirin or buffered aspirin tablets. If you are using:
    • chewable aspirin tablets, they may be chewed, dissolved in liquid, crushed, or swallowed whole.

    • delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them up before taking.

    • extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them whole. Others should not be broken up and must be swallowed whole.


To use aspirin suppositories:


  • If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

  • To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To take choline and magnesium salicylates (e.g., Trilisate) oral solution:


  • The liquid may be mixed with fruit juice just before taking.

  • Drink a full glass (8 ounces) of water after taking the medicine.

To take enteric-coated sodium salicylate tablets:


  • The tablets must be swallowed whole. Do not crush them or break them up before taking.

Unless otherwise directed by your medical doctor or dentist:


  • Do not take more of this medicine than recommended on the label, to lessen the chance of side effects.

  • Children up to 12 years of age should not take this medicine more than 5 times a day.

When used for arthritis (rheumatism), this medicine must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of this medicine.


Dosing


The dose medicines in this class 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 these medicines. 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 aspirin

  • For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.

      • Children 11 to 12 years of age—320 to 480 mg every four hours as needed.

      • Children 9 to 11 years of age—320 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—320 to 325 mg every four hours as needed.

      • Children 4 to 6 years of age—240 mg every four hours as needed.

      • Children 2 to 4 years of age—160 mg every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (chewing gum):
    • For pain:
      • Adults and teenagers—2 tablets every four hours as needed.

      • Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.

      • Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.

      • Children up to 3 years of age—Dose must be determined by your doctor.



  • For long-acting oral dosage form (extended-release tablets):
    • For pain:
      • Adults and teenagers—1 or 2 tablets twice a day.

      • Children—The long-acting aspirin tablets are too strong for use in children.


    • For arthritis:
      • Adults and teenagers—1 or 2 tablets twice a day, at first. Your doctor will then adjust your dose as needed.

      • Children—The long-acting aspirin tablets are too strong for use in children.



  • For rectal dosage form (suppositories):
    • For pain or fever:
      • Adults and teenagers—325 to 650 mg every four hours as needed.

      • Children 11 to 12 years of age—325 to 480 mg every four hours as needed.

      • Children 9 to 11 years of age—325 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—325 mg every four hours as needed.

      • Children 4 to 6 years of age—240 mg every four hours as needed.

      • Children 2 to 4 years of age—160 mg every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.



  • For aspirin and caffeine

  • For oral dosage forms (capsule):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 9 to 12 years of age—325 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—325 mg every four hours as needed.

      • Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 9 to 12 years of age—325 to 400 mg every four hours as needed.

      • Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kg (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For buffered aspirin

  • For oral dosage forms (tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.

      • Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.

      • Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.

      • Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.

      • Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For buffered aspirin and caffeine

  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers—325 or 421 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.

      • Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.

      • Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.

      • Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.

      • Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.

      • Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For choline salicylate

  • For oral dosage form (oral solution):
    • For pain or fever:
      • Adults and teenagers—One-half or three-fourths of a teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.

      • Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.

      • Children 6 to 11 years of age—2.5 mL (one-half of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.

      • Children 4 to 6 years of age—1.66 mL every four hours as needed. This amount should be measured by a special dropper or measuring spoon.

      • Children 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.

      • Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.



  • For choline and magnesium salicylates

  • For oral dosage forms (oral solution or tablets):
    • For pain or fever:
      • Adults and teenagers—A total of 2000 to 3000 milligrams (mg) a day, divided into two or three doses.

      • Children weighing more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.

      • Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.



  • For magnesium salicylate

  • For oral dosage form (tablets):
    • For pain:
      • Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight hours, up to a maximum of 8 tablets a day.

      • Children—Dose must be determined by your doctor.



  • For salsalate

  • For oral dosage forms (capsules or tablets):
    • For arthritis:
      • Adults and teenagers—500 to 1000 milligrams (mg) two or three times a day, to start. Your doctor will then adjust your dose as needed.

      • Children—Dose must be determined by your doctor.



  • For sodium salicylate

  • For oral dosage forms (tablets or delayed-release [enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers—325 or 650 milligrams (mg) every four hours as needed.

      • Children 6 years of age and older—325 mg every four hours as needed.

      • Children up to 6 years of age—This medicine is too strong for use in children younger than 6 years of age.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.



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


Keep out of the reach of children.


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


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Salofalk


Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with this medicine may cause an overdose.


If you will be taking salicylates for a long time (more than 5 days in a row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.


Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.


Check with your medical doctor or dentist:


  • If you are taking this medicine to relieve pain and the pain lasts for more than 10 days (5 days for children) or if the pain gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs medical or dental treatment.

  • If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, if the fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.

  • If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

  • If you are taking this medicine regularly, as for arthritis (rheumatism), and you notice a ringing or buzzing in your ears or severe or continuing headaches. These are often the first signs that too much salicylate is being taken. Your doctor may want to change the amount of medicine you are taking every day.

For patients taking aspirin to lessen the chance of heart attack, stroke, or other problems caused by blood clots:


  • Take only the amount of aspirin ordered by your doctor. If you need a medicine to relieve pain, a fever, or arthritis, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so that you will know ahead of time what medicine to take.

  • Do not stop taking this medicine for any reason without first checking with the doctor who directed you to take it.

Taking certain other medicines together with a salicylate may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with a salicylate for more than a few days, unless your doctor has directed you to do so and is following your progress:


  • Acetaminophen (e.g., Tylenol)

  • Diclofenac (e.g., Voltaren)

  • Diflunisal (e.g., Dolobid)

  • Etodolac (e.g., Lodine)

  • Fenoprofen (e.g., Nalfon)

  • Floctafenine (e.g., Idarac)

  • Flurbiprofen, oral (e.g., Ansaid)

  • Ibuprofen (e.g., Motrin)

  • Indomethacin (e.g., Indocin)

  • Ketoprofen (e.g., Orudis)

  • Ketorolac (e.g., Toradol)

  • Meclofenamate (e.g., Meclomen)

  • Mefenamic acid (e.g., Ponstel)

  • Nabumetone (e.g., Relafen)

  • Naproxen (e.g., Naprosyn)

  • Oxaprozin (e.g., Daypro)

  • Phenylbutazone (e.g., Butazolidin)

  • Piroxicam (e.g., Feldene)

  • Sulindac (e.g., Clinoril)

  • Tenoxicam (e.g., Mobiflex)

  • Tiaprofenic acid (e.g., Surgam)

  • Tolmetin (e.g., Tolectin)

For diabetic patients:


  • False urine sugar test results may occur if you are regularly taking large amounts of salicylates, such as:
    • Aspirin: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), or 3 or more 800-mg (or higher strength), doses a day.

    • Buffered aspirin or

    • Sodium salicylate: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), doses a day.

    • Choline salicylate: 4 or more teaspoonfuls (each teaspoonful containing 870 mg) a day.

    • Choline and magnesium salicylates: 5 or more 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more 1000-mg tablets, a day.

    • Magnesium salicylate: 7 or more regular-strength, or 4 or more extra-strength, tablets a day.

    • Salsalate: 4 or more 500-mg doses, or 3 or more 750-mg doses, a day.


  • Smaller doses or occasional use of salicylates usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
    • you are not sure how much salicylate you are taking every day.

    • you notice any change in your urine sugar test results.

    • you have any other questions about this possible problem.


Do not take aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.


For patients taking buffered aspirin, choline and magnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):


  • Buffered aspirin, choline and magnesium salicylates, or magnesium salicylate can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your health care professional how long you should wait between taking a medicine for infection and taking buffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too close together may lessen the effects of the salicylate.


For patients taking this medicine by mouth:


  • Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine, especially if you are taking it in high doses or for a long time. Check with your doctor if you have any questions about this.

For patients using aspirin suppositories:


  • Aspirin suppositories may cause irritation of the rectum. Check with your doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the week before the test.


For patients taking one of the products that contain caffeine:


  • Caffeine may interfere with the result of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for at least 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of these medicines may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.


Salofalk 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.


Get emergency help immediately if any of the following side effects occur:


Symptoms of overdose in children
  • Changes in behavior

  • drowsiness or tiredness (severe)

  • fast or deep breathing

  • Any loss of hearing

  • bloody urine

  • confusion

  • convulsions (seizures)

  • diarrhea (severe or continuing)

  • difficulty in swallowing

  • dizziness, lightheadedness, or feeling faint (severe)

  • drowsiness (severe)

  • excitement or nervousness (severe)

  • fast or deep breathing

  • flushing, redness, or other change in skin color

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • increased sweating

  • increased thirst

  • nausea or vomiting (severe or continuing)

  • shortness of breath, troubled breathing, tightness in chest, or wheezing

  • stomach pain (severe or continuing)

  • swelling of eyelids, face, or lips

  • unexplained fever

  • uncontrollable flapping movements of the hands (especially in elderly patients)

  • vision problems

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


Less common or rare
  • Abdominal or stomach pain, cramping, or burning (severe)

  • bloody or black, tarry stools

  • headache (severe or continuing)

  • ringing or buzzing in ears (continuing)

  • skin rash, hives, or itching

  • unusual tiredness or weakness

  • vomiting of blood or material that looks like coffee grounds

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 cramps, pain, or discomfort (mild to moderate)

  • heartburn or indigestion

  • nausea or vomiting

Less common
  • Trouble in sleeping, nervousness, or jitters (only for products containing caffeine)

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.



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.

Salicylic Acid Foam




Salicylic Acid

Salicylic Acid Foam Description


Salicylic Acid 6% Emollient Foam is a keratolytic that contains 6% salicylic acid USP incorporated into an aqueous based ammonium lactate vehicle. Each gram of Salicylic Acid 6% Emollient Foam contains 6% w/w salicylic acid USP, aloe, ammonium lactate, ceteth-10 phosphate, ceteth-20 phosphate, cetostearyl alcohol NF, dicetyl phosphate, dl alpha tocopheryl acetate USP, edetate disodium dihydrate USP, glycerin USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium hydroxide NF, white petrolatum USP.


Also contains: Propellant HFA-134a(1,1,1,2-tetrafluo-roethane).


Salicylic Acid USP is the 2-hydroxy derivative of benzoic acid having the following Structure:




Salicylic Acid Foam - 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.1,2 The meachanism of action has been attributed to a dissolution of intercellular cement substance.3 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 Halprin4 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.5 (See PRECAUTIONS.)


The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%).4 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.5


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.5 (See WARNINGS.) Ammonium lactate, a salt of lactic acid, is a powerful humectant with exfoliating properties.



Indications and Usage for Salicylic Acid Foam


For Dermatologic Use: Salicylic Acid 6% Emollient Foam 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: Salicylic Acid 6% Emollient Foam 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


Salicylic Acid 6% Emollient Foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. Salicylic Acid 6% Emollient Foam should not be used in children under 2 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. 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 others 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 Salicylic Acid 6% Emollient Foam 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 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.


Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).


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



Precautions


For EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excessive keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Keep this and all medications out of reach of children.



Drug Interactions


The following interactions are from a published review5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Emollient Foam 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
 Tolbutamide; 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 phenylbultazone


 inhibited.


The following alterations of laboratory tests have been reported during salicylate therapy6: 




















 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 (2-5g 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 >4.8g q.d. Salicylate. 
 Vanilmandelic acid False reduced values. 
 Uric acid May increase or decrease depending on dose. 
 Prothrombin Decreased levels; slightly increased prothrombin time.

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. Salicylic Acid 6% Emollient Foam 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 Salicylic Acid 6% Emollient Foam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used 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 Salicylic Acid 6% Emollient Foam. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.



Adverse Reactions


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



Overdosage


See Warnings.



Salicylic Acid Foam Dosage and Administration


Important: Prime Can Before Initial Use.


To Prime can: Grasp can in one hand. Shake can vigorously (until product moves inside can). Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times. Hold can upright and direct initial spray to a non-skin surface, such as into cap of can. DO NOT spray directly on the skin as the initial spray may expel cold, liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.


Before Each Use: Shake can vigorously. Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times.


During Use: Holding can upright, dispense Salicylic Acid 6% Emollient Foam into palm of hand and apply thoroughly to affected area twice per day, or as directed by a physician. Rub in completely. Wipe off any excess foam from actuator after use. The preferable method of use is to apply Salicylic Acid 6% Emollient Foam thoroughly to the affected area and to cover the treated 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 Salicylic Acid 6% Emollient Foam will usually maintain the remission. In those areas where the placement of a protective covering is difficult or impossible, application of Salicylic Acid 6% Emollient Foam 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 Salicylic Acid 6% Emollient Foam will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism. 



How is Salicylic Acid Foam Supplied


Salicylic Acid 6% Emollient Foam is supplied in 60g (NDC# 49808-167-60) aluminum cans.


Store at room temperature 59° - 77°F (15° - 25°C).


Protect from freezing.


Store upright.



REFERENCES


  1. Davies M, Marks R: Br J Dermatol 95: 187–192, 1976.

  2. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.

  3. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.

  4. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975. 

  5. Goldsmith LA: Int J Dermatol 18: 32-36, 1979.

  6. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.


Manufactured for :


Metacon Labs


866-777-4633


www.metaconlabs.com



Patent Pending


P/N 2619 Rev. 0




Rx only


Salicylic Acid 6% 


Emollient Foam


In An Ammonium Lactate Vehicle


NDC 49808-167-60


Net Weight 60g










SALICYLIC ACID 
salicylic acid  aerosol, foam










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49808-167
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID)SALICYLIC ACID6 g  in 100 g




























Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
ALPHA-TOCOPHEROL ACETATE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
PETROLATUM 
GLYCERIN 
EDETATE SODIUM 
ALOE 
SODIUM HYDROXIDE 
AMMONIUM LACTATE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
149808-167-601 CAN In 1 CARTONcontains a CAN
160 g In 1 CANThis package is contained within the CARTON (49808-167-60)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/01/201012/31/2011


Labeler - Metacon Labs (793223707)

Registrant - Onset Dermatologics LLC (964275155)









Establishment
NameAddressID/FEIOperations
Metacon Labs793223707Manufacture
Revised: 11/2011Metacon Labs

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Salicylic Acid/Sulfur Shampoo


Pronunciation: SAL-i-SIL-ik AS-id/SUL-fur/hye-droe-KOR-ti-sone
Generic Name: Salicylic Acid/Sulfur
Brand Name: Scalacort DK


Salicylic Acid/Sulfur Shampoo is used for:

Reducing itching, flaking, irritation, redness, scaling, and swelling associated with dandruff and other skin conditions.


This shampoo is a topical salicylate medicine. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.


This lotion is a topical corticosteroid medicine. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.


Do NOT use Salicylic Acid/Sulfur Shampoo if:


  • you are allergic to any ingredient in Salicylic Acid/Sulfur Shampoo

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



Before using Salicylic Acid/Sulfur Shampoo:


Some medical conditions may interact with Salicylic Acid/Sulfur Shampoo. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

  • if you have liver or kidney problems, skin irritation, eczema, diabetes, or poor blood circulation

  • if you have a skin infection, thinning of the skin, tuberculosis (TB), a history of a positive TB test, measles, chickenpox, shingles, or have recently had a vaccination

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


  • Anticoagulants, (eg, heparin, warfarin), aspirin, methotrexate, or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Salicylic Acid/Sulfur Shampoo.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Salicylic Acid/Sulfur Shampoo 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 Salicylic Acid/Sulfur Shampoo:


Use Salicylic Acid/Sulfur Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Shake the medicated shampoo and lotion well before each use.

  • Wet your hair and shampoo for a full 5 minutes. Rinse and repeat. Be sure to wash your hands after each use.

  • Apply a small amount of lotion to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after applying Salicylic Acid/Sulfur Shampoo.

  • Do not bandage or wrap the affected area unless directed otherwise by your doctor.

  • If you miss a dose of Salicylic Acid/Sulfur Shampoo, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Salicylic Acid/Sulfur Shampoo.



Important safety information:


  • Salicylic Acid/Sulfur Shampoo may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. If you use topical products too often, your condition may become worse.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • Salicylic Acid/Sulfur Shampoo is for external use only. Avoid getting it in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes.

  • Be sure to apply Salicylic Acid/Sulfur Shampoo only to the affected area and not to normal, healthy skin.

  • Do not use any other medicines or drying products on your skin unless instructed otherwise by your doctor.

  • This shampoo contains a salicylate, which has been linked to a serious illness called Reye syndrome. Do not use Salicylic Acid/Sulfur Shampoo on a child or teenager during or after the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

  • This product has a salicylate and corticosteroid in it. Before you start any new medicine, check the label to see if it has a salicylate and/or corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not use Salicylic Acid/Sulfur Shampoo for other skin conditions at a later time.

  • If this medicated lotion was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.

  • Check with your doctor before having vaccinations while you are using Salicylic Acid/Sulfur Shampoo.

  • Salicylic Acid/Sulfur Shampoo should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Salicylic Acid/Sulfur Shampoo.

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


Possible side effects of Salicylic Acid/Sulfur Shampoo:


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; inflamed hair follicles; mild skin irritation (eg, dryness, peeling, redness, scaling, or stinging).



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); infection; itching, burning, pain, redness, or swelling of the skin not present before using Salicylic Acid/Sulfur Shampoo; skin thinning and discoloration.



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.



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. Salicylic Acid/Sulfur Shampoo may be harmful if swallowed.


Proper storage of Salicylic Acid/Sulfur Shampoo:

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


General information:


  • If you have any questions about Salicylic Acid/Sulfur Shampoo, please talk with your doctor, pharmacist, or other health care provider.

  • Salicylic Acid/Sulfur Shampoo 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 Salicylic Acid/Sulfur Shampoo. 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.

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