Monday, September 12, 2016

Silver Sulfadiazine Cream




SSD™ (1% Silver Sulfadiazine Cream)

SSD AF™ (1% Silver Sulfadiazine Cream)

Silver Sulfadiazine Cream Description


SSD (1% Silver Sulfadiazine) Cream and SSD AF (1% Silver Sulfadiazine) Cream are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base.


Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine


Inactive Ingredients: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative.


Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown:




Silver Sulfadiazine Cream - Clinical Pharmacology


Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast.  Results from in vitro testing are listed below. Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.


Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect.






































































Results of In Vitro Testing 1% Concentration of Silver SulfadiazineNumber of Sensitive Strains / Total Number of Strains Tested
Genus and Species50 ug/mL100 ug/mL
Pseudomonas aeruginosa130/130130/130
Pseudomonas maltophilia7/77/7
Enterobacter species48/5050/50
Enterobacter cloacae24/2424/24
Klebsiella species53/5454/54
Escherichia coli63/6363/63
Serratia species27/2828/28
Proteus mirabilis53/5353/53
Morganella morganii10/1010/10
Providencia rettgeri2/22/2
Proteus vulgaris2/22/2
Providencia species1/11/1
Citrobacter species10/1010/10
Acinetobacter calcoaceticus10/1111/11
Stahylococcus aureus100/101101/101
Staphylococcus epidermidis51/5151/51
B-Hemolytic Streptococcus4/44/4
Enterococcus species52/5353/53
Corynebacterium diphtheriae2/22/2
Clostridium perfringens0/22/2
Candida albicans43/5050/50

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.



Indications and Usage for Silver Sulfadiazine Cream


Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.



Contraindications


Silver Sulfadiazine Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation.


Because sulfonamide therapy is known to increase the possibility of kernicterus, Silver Sulfadiazine Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.



Warnings


There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction.


Fungal proliferation in and below the eschar may occur. However, the incidence of clinically reported fungal superinfection is low.


The use of Silver Sulfadiazine Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.



Precautions


General: If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved.


In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes.


Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals.


Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.



Carcinogenesis and Mutagenesis and Impairment of Fertility


Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silver Sulfadiazine Cream revealed no evidence of carcinogenicity.


Pregnancy: Pregnancy Category B. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in Silver Sulfadiazine Cream and has revealed no evidence of harm to the fetus due to silver sulfadiazine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. (See CONTRAINDICATIONS)



Nursing Mothers


It is not known whether Silver Sulfadiazine Cream is excreted in human milk. However, sulfonamides are known to be excreted in human milk, and all sulfonamides derivatives are known to increase the possibility of kernicterus. Because of the possibility for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in children have not been established. (See CONTRAINDICATIONS)



Adverse Reactions


Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy. Rebound to normal leukocyte levels follows onset within two to three days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leukopenia in various reports averages about 20%. A higher incidence has been seen in patients treated concurrently with cimetidine.


Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.


Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.


Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, including agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia and hemolytic anemia, dermatologic and and allergic reactions, including Stevens-Johnson syndrome and exfoliative dermatitis, gastrointestinal reactions, hepatitis and hepatocellular necrosis, CNS reactions, and toxic nephrosis.



Silver Sulfadiazine Cream Dosage and Administration



FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE:


Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; and Silver Sulfadiazine Cream is applied under sterile conditions. The burn areas should be covered with Silver Sulfadiazine Cream at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used.


Reapply immediately after hydrotherapy.


Treatment with Silver Sulfadiazine Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.



How is Silver Sulfadiazine Cream Supplied


SSD™ (1% Silver Sulfadiazine) Cream: white to off-white cream.













50 gram jar 
400 gram jar 
25 gram tube 
50 gram tube 
85 gram tube 

SSD AF™ (1% Silver Sulfadiazine) Cream: white to off-white cream.







50 gram jar 
400 gram jar 

Store at controlled room temperature 15° - 30°C (59° - 86°F)


SSD is a trademark of Dr. Reddy's Laboratories Louisiana, LLC


Manufactured for


Par Pharmaceutical Companies, Inc.


Spring Valley, NY 10977


Manufactured by


Dr. Reddy's Laboratories Louisiana, LLC


Shreveport, LA 71106


Repacked by


H.J. Harkins Company, Inc.


Nipomo, CA 93444


Aug 2011



PRINCIPAL DISPLAY PANEL – 50 GRAM TUBE










SILVER SULFADIAZINE 
silver sulfadiazine  cream










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)52959-635 (49884-600)
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILVER SULFADIAZINE (SILVER SULFADIAZINE)SILVER SULFADIAZINE10 g  in 1000 g
























Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
ISOPROPYL MYRISTATE 
METHYLPARABEN0.3 mg  in 1 g
PETROLATUM 
POLYOXYL 40 STEARATE 
PROPYLENE GLYCOL 
SORBITAN MONOOLEATE 
STEARYL ALCOHOL 
SODIUM HYDROXIDE 
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
152959-635-00400 g In 1 VIALNone
252959-635-2525 g In 1 VIALNone
352959-635-5050 g In 1 VIALNone
452959-635-8585 g In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01857809/18/1997


Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Louisiana, LLC (830397282)









Establishment
NameAddressID/FEIOperations
Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Louisiana, LLC830397282manufacture
Revised: 11/2011H.J. Harkins Company, Inc.

More Silver Sulfadiazine Cream resources


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


Compare Silver Sulfadiazine Cream with other medications


  • Burns, External

Sinex Ultra Fine Mist


Generic Name: phenylephrine nasal (FEN il EFF rin)

Brand Names: 4-Way, 4-Way Menthol, Afrin 4 Hour Extra Moisturizing, Little Noses Decongestant, Neo-Synephrine Extra Strength Nasal, Neo-Synephrine Mild Nasal, Neo-Synephrine Nasal, Sinex Nasal Spray, Sinex Ultra Fine Mist


What is Sinex Ultra Fine Mist (phenylephrine nasal)?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


Phenylephrine nasal is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.


Phenylephrine nasal may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Sinex Ultra Fine Mist (phenylephrine nasal)?


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

You should not use this medication if you are allergic to phenylephrine.


Do not use phenylephrine nasal if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you use phenylephrine before these other drugs have cleared from your body.

Before using phenylephrine nasal, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, diabetes, glaucoma, a thyroid disorder, or an enlarged prostate or urination problems.


Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, and other decongestants.


Never use more of this medicine than directed on the label or prescribed by your doctor.


Call your doctor if your symptoms do not improve after 3 days of using phenylephrine nasal, or if they get worse and you also have a fever. Using phenylephrine nasal too long can damage the lining of your nasal passages and lead to chronic nasal congestion.

What should I discuss with my healthcare provider before using Sinex Ultra Fine Mist (phenylephrine nasal)?


You should not use this medication if you are allergic to phenylephrine.


Do not use phenylephrine nasal if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you use phenylephrine before these other drugs have cleared from your body.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:



  • heart disease, heart rhythm disorder;




  • high blood pressure;




  • diabetes;




  • glaucoma;




  • a thyroid disorder; or




  • an enlarged prostate or urination problems.




FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before using phenylephrine nasal, tell doctor if you are pregnant. Phenylephrine nasal may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

How should I use Sinex Ultra Fine Mist (phenylephrine nasal)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine should be used only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Phenylephrine nasal is usually used every 4 hours. Follow the directions on the medicine label. Never use more of this medicine than directed on the label or prescribed by your doctor. Using phenylephrine nasal too long can damage the lining of your nasal passages and lead to chronic nasal congestion.


Gently blow your nose to clear any mucus before using this medication.


To use the nasal spray, insert the tip of the spray bottle into your nostril, past the middle of the inside of your nose (the nasal septum). Gently press your other nostril closed with your finger.


Keep your head upright, and squeeze the bottle while breathing in deeply through your nose. Sniff quickly a few times to get the medicine deep into your nasal passages.


Repeat these steps to use the medicine in your other nostril if needed.


After each use, clean the tip of the spray bottle with a clean tissue or rinse it with hot water, making sure that no water gets into the medicine bottle. Keep the cap on the bottle when not in use.


To use the nasal drops, lie on your back with your head tilted back. Insert the correct number of drops and remain lying in this position for several minutes. Gently turn your head from side to side.


Call your doctor if your symptoms do not improve after 3 days of using phenylephrine nasal, or if they get worse and you also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have used phenylephrine nasal within the past few days.


Store at room temperature away from moisture and heat. To prevent the spread of infection, do not share this medication with anyone else.

What happens if I miss a dose?


Since phenylephrine nasal is usually used only when needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or drowsiness, slow heart rate, and fainting.


What should I avoid while using Sinex Ultra Fine Mist (phenylephrine nasal)?


Avoid getting this medication in your eyes. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Phenylephrine is contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains phenylephrine.

Sinex Ultra Fine Mist (phenylephrine nasal) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using phenylephrine and call your doctor at once if you have a serious side effect such as:

  • severe sneezing, runny or stuffy nose, redness or swelling in your nose, or other worsening nasal symptoms (may be a sign of overuse of phenylephrine nasal);




  • severe stinging, burning, or irritation inside your nose;




  • severe dizziness, restless feeling, nervousness, or insomnia;




  • mood changes, unusual thoughts or behavior;




  • feeling like you might pass out;




  • slow, fast, or pounding heartbeat;




  • tremors or shaking; or




  • urinating less than usual or not at all.



Less serious side effects may include:



  • temporary sneezing;




  • mild burning, dryness, cold feeling, or irritation inside your nose;




  • headache, dizziness, weakness;




  • sweating, nausea;




  • feeling excited or restless (especially in children); or




  • mild sleep problems.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Sinex Ultra Fine Mist (phenylephrine nasal)?


Tell your doctor about all other medications you use, especially:



  • other decongestants;




  • medicine to treat diabetes;




  • medicines to treat high blood pressure such as reserpine, guanethidine (Ismelin), methyldopa (Aldomet), and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This list is not complete and other drugs may interact with phenylephrine nasal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Sinex Ultra Fine Mist resources


  • Sinex Ultra Fine Mist Use in Pregnancy & Breastfeeding
  • Sinex Ultra Fine Mist Drug Interactions
  • Sinex Ultra Fine Mist Support Group
  • 0 Reviews for Sinex Ultra Fine Mist - Add your own review/rating


  • Rhinall Advanced Consumer (Micromedex) - Includes Dosage Information

  • Rhinall Solution MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Sinex Ultra Fine Mist with other medications


  • Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about phenylephrine nasal.


Salbutamol Respirator Solution



Generic Name: albuterol (Inhalation route)

al-BUE-ter-ol

Commonly used brand name(s)

In the U.S.


  • Accuneb

  • ProAir HFA

  • Proventil

  • Proventil HFA

  • ReliOn Ventolin HFA

  • Ventolin

  • Ventolin HFA

In Canada


  • Alti-Salbutamol Inhalation Aerosol

  • Apo-Salvent

  • Salbutamol

  • Salbutamol Nebuamp

  • Salbutamol Respirator Solution

  • Ventolin Inhaler

  • Ventolin Nebules P.F.

  • Ventolin Respirator

  • Ventolin Rotacaps

Available Dosage Forms:


  • Aerosol Powder

  • Solution

  • Capsule

  • Powder

Therapeutic Class: Bronchodilator


Pharmacologic Class: Sympathomimetic


Uses For Salbutamol Respirator Solution


Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).


Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.


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


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


  • Hyperkalemia (too much potassium in the blood).

Before Using Salbutamol Respirator Solution


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


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in children 4 years of age and older and albuterol inhalation solution (e.g., Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the aerosol in children younger than 4 years of age and for the solution in children younger than 2 years of age.


Geriatric


No information is available on the relationship of age to the effects of albuterol inhalation solution (e.g., Accuneb®) in geriatric patients.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving albuterol.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking 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.


  • Acebutolol

  • Alprenolol

  • Arotinolol

  • Atenolol

  • Atomoxetine

  • Befunolol

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bopindolol

  • Brofaromine

  • Bucindolol

  • Bupranolol

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Clorgyline

  • Dilevalol

  • Esmolol

  • Furazolidone

  • Iproniazid

  • Isocarboxazid

  • Labetalol

  • Landiolol

  • Lazabemide

  • Levobetaxolol

  • Levobunolol

  • Linezolid

  • Mepindolol

  • Metipranolol

  • Metoprolol

  • Moclobemide

  • Nadolol

  • Nebivolol

  • Nialamide

  • Nipradilol

  • Oxprenolol

  • Pargyline

  • Penbutolol

  • Phenelzine

  • Pindolol

  • Procarbazine

  • Propranolol

  • Rasagiline

  • Selegiline

  • Sotalol

  • Talinolol

  • Tertatolol

  • Timolol

  • Toloxatone

  • Tranylcypromine

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:


  • Diabetes or

  • Heart or blood vessel disease or

  • Heart rhythm problems (e.g., arrhythmia) or

  • Hypertension (high blood pressure) or

  • Hyperthyroidism (overactive thyroid) or

  • Hypokalemia (low potassium in the blood) or

  • Seizures, history of—Use with caution. May make these conditions worse.

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

Proper Use of albuterol

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


Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.


The albuterol inhalation solution (e.g., Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.


To use the inhalation solution in the nebulizer:


  • Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.

  • Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.

  • Connect the nebulizer to the face mask or mouthpiece.

  • Use the face mask or mouthpiece to breathe in the medicine.

  • Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.

  • Clean all the parts of the nebulizer after each use.

The albuterol inhalation aerosol (e.g., Proair® HFA) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.


To use the aerosol inhaler:


  • The inhaler should be at room temperature before you use it.

  • Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.

  • Remove the cap and look at the mouthpiece to make sure it is clean.

  • Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.

  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.

  • Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.

  • Hold your breath for about 10 seconds, then breathe out slowly.

  • If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.

  • When you have finished all of your doses, rinse your mouth with water and spit the water out.

  • Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.

  • If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.

  • After using the inhaler, wash the mouthpiece again and dry it completely.

  • If the mouthpiece becomes blocked, washing it will help.

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 inhalation aerosol dosage form (inhaler):
    • For preventing bronchospasm:
      • Adults, teenagers, and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.

      • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.


    • For preventing exercise-induced bronchospasm:
      • Adults, teenagers, and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.

      • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.



  • For inhalation solution dosage form (used with a nebulizer):
    • For preventing bronchospasm:
      • Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.

      • Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.

      • Children younger than 2 years of age—Use and dose must be determined by your child's doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.


Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Salbutamol Respirator Solution


It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.


This medicine should not be used together with other inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).


This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.


Talk to your doctor or get medical help right away if:


  • Your symptoms do not improve or they become worse after using this medicine.

  • Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.


Albuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.


Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.


Salbutamol Respirator Solution Side Effects


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


Check with your doctor immediately if any of the following side effects occur:


More common
  • Fast, irregular, pounding, or racing heartbeat or pulse

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

  • trembling or shaking of the hands or feet

Less common
  • Abdominal or stomach pain

  • bladder pain

  • bloody or cloudy urine

  • chest discomfort

  • chest pain

  • cough or hoarseness

  • cough producing mucus

  • diarrhea

  • difficult or labored breathing

  • difficulty with swallowing

  • dizziness

  • feeling of warmth

  • fever or chills

  • frequent urge to urinate

  • hives

  • itching

  • loss of appetite

  • lower back or side pain

  • nausea

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

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

  • runny nose

  • shortness of breath

  • skin rash

  • sore throat

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • tightness in the chest

  • unusual tiredness or weakness

  • weakness

  • wheezing

Rare
  • Hives or welts

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • noisy breathing

  • redness of the skin

  • swelling of the mouth or throat

  • trouble breathing

Incidence not known
  • Agitation

  • anxiety

  • arm, back, or jaw pain

  • chest tightness or heaviness

  • confusion

  • convulsions

  • decreased urine

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

  • drowsiness

  • dry mouth

  • extra heartbeats

  • fainting

  • flushed, dry skin

  • fruit-like breath odor

  • hallucinations

  • headache

  • increased hunger

  • increased thirst

  • increased urination

  • irritability

  • lightheadedness

  • muscle pain or cramps

  • nervousness

  • nightmares

  • numbness or tingling in the hands, feet, or lips

  • pounding in the ears

  • rapid, deep breathing

  • restlessness

  • shakiness

  • slow or fast heartbeat

  • stomach cramps

  • sweating

  • unexplained weight loss

  • unusual feeling of excitement

  • 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
  • Body aches or pain

  • congestion

  • fever

  • runny nose

  • tender, swollen glands in the neck

  • trouble with swallowing

  • voice changes

Less common
  • Difficult, burning, or painful urination

  • earache

  • headache, severe and throbbing

  • muscle or bone pain

  • pain

  • redness of the skin

  • redness or swelling in the ear

  • redness, swelling, or soreness of the tongue

  • sleeplessness

  • sneezing

  • stuffy nose

  • swelling

  • tenderness

  • trouble in holding or releasing urine

  • trouble sleeping

  • unable to sleep

  • warmth on the skin

Rare
  • Sleepiness or unusual drowsiness

Incidence not known
  • Bad, unusual, or unpleasant (after) taste

  • change in taste

  • feeling of constant movement of self or surroundings

  • gagging

  • rough, scratchy sound to voice

  • sensation of spinning

  • tightness in the throat

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: Salbutamol Respirator side effects (in more detail)



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


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


More Salbutamol Respirator Solution resources


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


Compare Salbutamol Respirator Solution with other medications


  • Asthma, acute
  • Asthma, Maintenance
  • Bronchospasm Prophylaxis
  • COPD, Acute
  • COPD, Maintenance

Silvadene Topical


Generic Name: silver sulfadiazine (Topical route)


SIL-ver sul-fa-DYE-a-zeen


Commonly used brand name(s)

In the U.S.


  • Silvadene

  • SSD

  • SSD AF

  • Thermazene

In Canada


  • Flamazine

  • Ssd

Available Dosage Forms:


  • Cream

Therapeutic Class: Antibacterial


Chemical Class: Sulfonamide


Uses For Silvadene


Silver sulfadiazine , a sulfa medicine, is used to prevent and treat bacterial or fungus infections. It works by killing the fungus or bacteria.


Silver sulfadiazine cream is applied to the skin and/or burned area(s) to prevent and treat bacterial or fungus infections that may occur in burns. This medicine may also be used for other problems as determined by your doctor.


Other medicines are used along with this medicine for burns. Patients with severe burns or burns over a large area of the body must be treated in a hospital.


Silver sulfadiazine is available only with your doctor's prescription.


Before Using Silvadene


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


Use is not recommended in premature or newborn infants up to 2 months of age. Sulfa medicines may cause liver problems in these infants. Although there is no specific information comparing use of silver sulfadiazine in older infants and children with use in other age groups, this medicine is not expected to cause different side effects or problems in older infants and children than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of silver sulfadiazine in the elderly with use in other age groups.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Blood problems or

  • Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Use of this medicine may cause blood problems or make them worse

  • Kidney disease or

  • Liver disease—In persons with these conditions, use may result in higher blood levels of this medicine; a smaller dose may be needed

  • Porphyria—Use of this medicine may result in a severe attack of porphyria

Proper Use of silver sulfadiazine

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


This medicine should not be used on premature or newborn infants up to 2 months of age, unless otherwise directed by your doctor. It may cause liver problems in these infants.


To use:


  • Before applying this medicine, cleanse the affected area(s). Remove dead or burned skin and other debris.

  • Wear a sterile glove to apply this medicine. Apply a thin layer (about 1/16 inch) of silver sulfadiazine to the affected area(s). Keep the affected area(s) covered with the medicine at all times.

  • If this medicine is rubbed off the affected area(s) by moving around or if it is washed off during bathing, showering, or the use of a whirlpool bath, reapply the medicine.

  • After this medicine has been applied, the treated area(s) may be covered with a dressing or left uncovered as desired.

To help clear up your skin and/or burn infection completely, keep using silver sulfadiazine for the full time of treatment. You should keep using this medicine until the burned area has healed or is ready for skin grafting. Do not miss any doses.


Dosing


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


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


  • For topical dosage form (cream):
    • For burn wound infections:
      • Adults and children 2 months of age and older—Use one or two times a day.

      • Premature and newborn infants up to 2 months of age—Use and dose must be determined by the doctor.



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 Silvadene


It is important that your doctor check your progress at regular visits.


If your skin infection or burn does not improve within a few days or weeks (for more serious burns or burns over larger areas), or if it becomes worse, check with your doctor.


This medicine may rarely stain skin brownish gray.


Silvadene 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:


Rare
  • Blistering, peeling or loosening of skin

  • bloody or cloudy urine

  • chills or fever

  • cough

  • decreased amount of urine or less frequent urination

  • increased sensitivity of skin to sunlight, especially in patients with burns on large areas

  • intense itching of burn wounds

  • pain at site of application

  • painful or difficult urination

  • red skin lesions, often with a purple center

  • shortness of breath

  • sore throat

  • sores, ulcers or white spots on lips or in mouth

  • swollen glands

  • unusual bleeding or bruising

  • unusual tiredness or weakness

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


More common
  • Burning feeling on treated area(s)

Less common or rare
  • Brownish-gray skin discoloration

  • itching or skin rash

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: Silvadene Topical side effects (in more detail)



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


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


More Silvadene Topical resources


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


Compare Silvadene Topical with other medications


  • Burns, External

Salicylic Acid


Class: Keratolytic Agents
ATC Class: D01AE12
VA Class: DE500
CAS Number: 69-72-7
Brands: Aveeno Clear Complexion, Clearasil, Compound W, Denorex, Dermarest, DHS Sal, Dr Scholl’s, DuoFilm, Freezone, Hydrisalic, Ionil Plus, Keralyt, Kerasal, Mediplast, Meted, MG 217 Sal-Acid, Neutrogena Rapid Clear, Neutrogena T-Sal, Noxzema, Occlusal, Oxy, P&S, Psoriasin, Sal-Acid, Salactic, Salex, Sal-Plant, Sebasorb , Stridex, Tarsum , Trans-Ver-Sal, Versiclear, Wart-off

Introduction

Keratolytic agent; derivative of benzoic acid.a o


Uses for Salicylic Acid


Acne


Salicylic acid is used alone or in combination with other drugs (e.g., resorcinol, sulfur) for the symptomatic treatment of acne.a c k


Seborrheic Dermatitis and Psoriasis


Salicylic acid is used for self-medication to control seborrheic dermatitis of the body and scalp, psoriasis of the body and scalp, dandruff, and other scaling dermatoses.a f l m o q r s


Cream, lotion, and gel (6% salicylic acid) used to aid in the exfoliation of dry, scaly skin associated with psoriasis.l o p


Hyperkeratosis


Salicylic acid is used topically as self-medication for its keratolytic and caustic effect in the removal of common and plantar warts;a d h j l also used to remove corns and calluses.a e i n o p


Salicylic acid is used for treatment of localized hyperkeratosis that occurs on the palms and soles.a l o


Tinea Versicolor


Salicylic acid is used in combination with an antifungal (sodium thiosulfate) for the treatment of tinea versicolor (Malassezia furfur) infection.g


Salicylic Acid Dosage and Administration


General



  • Consult a clinician prior to initiating self-medication for a condition that covers a large area of the body.f m q r



Administration


Topical Administration


Apply topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, or solution.h i j k l m n o q r s t


For external use only;c d e f h i j k not for ophthalmic, oral, or intravaginal use.l o p If contact with the eye(s) occurs, wash thoroughly with water.d e f h k m n q r


Rinse hands thoroughly after topical application, unless hands are being treated.l o p


Do not use systemically because of severe irritating effect on GI mucosa and other tissues.a b


Apply salicylic acid 6% cream (Salex), lotion (Salex), or gel (Keralyt, Hydrisalic) topically to affected area(s) at bedtime.l o p Hydrate affected area of skin (e.g., with wet packs or baths) for ≥5 minutes prior to application and cover with occlusive dressing.l o p In the morning, wash affected area of skin; may apply a bland emollient if affected skin is irritated or excessively dry.l o If occlusion is not possible, may apply more frequently.l o p However, excessive, repeated application does not necessarily increase therapeutic benefit and may increase risk of adverse local effects and salicylism.l (See Salicylate Toxicity under Cautions.)


Acne (Self-medication)

Apply topically using appropriate preparations containing salicylic acid 0.5–2%.c


Cleanse and dry the affected area prior to topical application.c


Apply a thin layer of appropriate salicylic acid preparation (e.g., cream, gel, lotion) to affected areas.c


Apply cake or cleansing solution with water, in place of regular soap; rinse thoroughly with warm water and pat dry.c k


Seborrheic Dermatitis and Psoriasis (Self-medication)

Apply topically using appropriate preparations containing salicylic acid 1.8–3%.f


Apply cream, lotion, ointment, gel, or solution to affected areas of skin.f


Apply preparations formulated as soaps or shampoo to affected area(s) in place of regular soap or shampoo.f m


Hyperkeratosis

Corn and Callus Removal (Self-medication): Apply topically using appropriate preparations containing salicylic acid 12–40% (e.g., plaster, solution in flexible collodion) or 3% (gel).e


Do not apply on irritated or infected skin.e n


Cleanse and dry the affected area prior to topical application.e i n


Trim plaster to fit completely over the callus or corn and apply.e i


Apply a small amount of solution in flexible collodion with an applicator to sufficiently cover corn or callus and allow to dry.e n


Apply a small amount of solution or gel (e.g., 1 drop at a time) with an applicator to sufficiently cover corn or callus; allow to dry.e h


May soak affected area(s) in warm water for 5 minutes to aid in corn or callus removal.e i n


Wart Removal (Self-medication): Apply topically using appropriate preparations containing salicylic acid 12–40% (plaster) or 5–17% (solution in flexible collodion).d h j


Do not use on moles, birthmarks, warts with hair(s) growing from them, genital warts, or warts on the face or mucous membranes.d h j


Do not apply on irritated, reddened, or infected skin.d


Cleanse and dry the affected area prior to topical application; may soak affected area(s) in warm water for 5 minutes.d


Trim plaster to fit completely over the wart and apply.d j


Prior to application of plaster in a karaya gum and polyethylene glycol vehicle (Trans-Ver-Sal), gently smooth wart with emery board, and carefully apply a drop of warm water to wart, using a cotton-tipped applicator. Trim plaster to completely fit over wart; if necessary, secure plaster in place with medical tape.j Ensure that the plaster does not touch unaffected surrounding skin.j


Apply a small amount of solution or gel (e.g., one drop at a time) with an applicator to sufficiently cover wart(s); allow to dry.d h


Dosage


Pediatric Patients


Acne

Topical

Self-medication: Apply appropriate 0.5–2% salicylic acid preparation 1–3 times daily.c Initially, apply once daily, then gradually increase to 2 or 3 times daily, if necessary.c If dryness or peeling occurs, reduce application to once daily or every other day.c


Seborrheic Dermatitis and Psoriasis

Scalp

Topical

Self-medication for children >2 years of age: Apply 3% salicylic acid solution to affected area(s) of the scalp 1–4 times daily or as directed by a clinician.f s


Apply 2–3% salicylic acid shampoo to wet hair and massage into scalp.m Leave lather on scalp for 2 minutes, then rinse thoroughly; repeat if necessary.m Use at least twice weekly or as directed by a clinician.f m


Apply combination (salicylic acid and coal tar) shampoo to scalp evenly before bathing.u Allow to remain on scalp for 5 minutes; add water and lather, and then rinse thoroughly.u Gradually increase treatment times to 1 hour, or as directed by a clinician.u Alternatively, apply to wet hair and lather; allow to remain on scalp for up to 10 minutes, then rinse.u Use daily until itching and flaking improve, then reduce to twice weekly or as directed by a clinician.u


Body (Excluding Scalp)

Topical

Self-medication for children >2 years of age: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, ointment, lotion, gel) to affected area(s) 1–4 times daily or as directed by a clinician.f q r


Apply 2–3% salicylic acid shampoo to affected area(s) of the body in place of soap.m Leave lather on for 2 minutes, then rinse thoroughly; repeat if necessary.m Use at least twice weekly or as directed by a clinician.f m


Children ≥2 years old: Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude.l o p When improvement occurs, apply occasionally to maintain remission.l o p In areas where occlusion is difficult or impossible, apply more frequently.l o p


Hyperkeratosis

Corn and/or Callus Removal

Topical

Children ≥2 years of age: Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude.l o p In areas where occlusion is difficult or impossible, apply more frequently.o


Self-medication for children >12 years of age: Apply 3% salicylic acid gel to calloused skin once daily or as directed by a clinician.t


Wart Removal

Topical

Children ≥2 years of age: Apply 15% salicylic acid plaster in a karaya gum and polyethylene glycol vehicle once daily at bedtime; leave in place for ≥8 hours, then remove and discard.d j Repeat every 24 hours as needed until wart is completely removed or for up to 12 weeks.d j


Tinea Versicolor

Topical

Children >12 years of age: Apply combination lotion (salicylic acid 1% and sodium thiosulfate 25%) in a thin film to all affected area(s) twice daily or as directed by a clinician.v


Adults


Acne

Topical

Self-medication: Apply appropriate 0.5–2% salicylic acid preparation 1–3 times daily.c Initially, apply once daily, then gradually increase to 2 or 3 times daily, if necessary.c If dryness or peeling occurs, reduce application to once daily or every other day.c


Seborrheic Dermatitis and Psoriasis

Scalp

Topical

Self-medication: Apply 3% salicylic acid solution to affected area(s) of the scalp 1–4 times daily or as directed by a clinician.f s


Self-medication: Apply 2–3% salicylic acid shampoo to wet hair and massage into scalp.f m Leave lather on for several minutes, then rinse thoroughly; repeat if necessary.f m Use at least twice weekly or as directed by a clinician.f m


Apply combination (salicylic acid and coal tar) shampoo to scalp evenly before bathing.u Allow to remain on scalp for 5 minutes and then rinse thoroughly.u Gradually increase treatment times to 1 hour, or as directed by a clinician.u Alternatively, apply to wet hair; allow to remain on scalp for up to 10 minutes, then rinse.u Use daily until itching and flaking improve, then reduce to twice weekly or as directed by a clinician.u


Body (Excluding Scalp)

Topical

Self-medication: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, ointment, lotion, gel) to affected area(s) 1–4 times daily or as directed by a clinician.f q r


Self-medication: Apply 2–3% salicylic acid shampoo to affected area(s) of the body in place of soap.m Leave lather on for 2 minutes, then rinse thoroughly; repeat if necessary.m Use at least twice weekly or as directed by a clinician.f m


Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude.l o p When improvement occurs, apply occasionally to maintain remission.l o p In areas where occlusion is difficult or impossible, apply more frequently.l o p


Hyperkeratosis

Corn and/or Callus Removal

Topical

Self-medication: Apply 12–40% salicylic acid plaster to corn or callus and cover with cushion provided by manufacturer.e i After 48 hours, remove cushion and plaster.e i May cover with cushion provided by manufacturer.i Repeat every 48 hours as needed until corn or callus is removed, for up to 14 days.e i


Self-medication: Apply 12–17.6% salicylic acid solution or gel in flexible collodion (e.g., 1 drop at a time) to sufficiently cover corn or callus.e n Repeat once or twice daily as needed for up to 14 days.e n


Self-medication: Apply 3% salicylic acid gel to calloused skin once daily or as directed by a clinician. t


Apply 6% salicylic acid gel, cream, or lotion to the affected area(s) at bedtime and occlude.l o p In areas where occlusion is difficult or impossible, apply more frequently.p o


Wart Removal

Topical

Self-medication: Apply 12–40% salicylic acid plaster to wart.d After 48 hours, remove and repeat as needed until wart is completely removed or for up to 12 weeks.d


Self-medication: Apply 5–17% salicylic acid solution or gel in flexible collodion (e.g., 1 drop at a time) to sufficiently cover wart(s).d h Repeat once or twice daily for up to 12 weeks.d h


Apply 15% salicylic acid plaster in a karaya gum and polyethylene glycol vehicle to wart(s) once daily at bedtime; leave in place for ≥8 hours, then remove and discard.d j Repeat every 24 hours as needed until wart is completely removed for up to 12 weeks.d j


Tinea Versicolor

Topical

Self-medication: Apply combination lotion (salicylic acid 1% and sodium thiosulfate 25%) in a thin film to affected areas twice daily or as directed by a clinician.g


Prescribing Limits


Pediatric Patients


Acne

Topical

Self-medication: Apply a maximum 3 times daily.c


Seborrheic Dermatitis and Psoriasis

Scalp

Topical

Self-medication for children >2 years of age: Apply 3% salicylic acid solution a maximum 4 times daily or as directed by a clinician.f s


Body (Excluding Scalp)

Topical

Self-medication for children >2 years of age: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, lotion, ointment, gel) a maximum 4 times daily or as directed by a clinician.f


Adults


Acne

Topical

Self-medication: Apply a maximum 3 times daily.c


Seborrheic Dermatitis and Psoriasis

Scalp

Topical

Self-medication: Apply 3% salicylic acid solution for a maximum 4 times daily or as directed by a clinician.f s


Body (Excluding Scalp)

Topical

Self-medication: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, lotion, ointment, gel) a maximum 4 times daily or as directed by a clinician.f


Hyperkeratosis

Corn and/or Callus Removal

Topical

Self-medication: Apply plaster or solution or gel in flexible collodion a maximum 14 days.e i n


Wart Removal

Topical

Self-medication: Apply plaster or solution or gel in flexible collodion a maximum 12 weeks.d h j


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time; however, manufacturer recommends that treatment area should be limited.l o


Renal Impairment


No specific dosage recommendations at this time; however, manufacturer recommends that treatment area should be limited.l o


Cautions for Salicylic Acid


Contraindications



  • Known sensitivity to salicylic acid or any other ingredient in the formulation.l o




  • 6% salicylic acid cream, lotion, and gel: Children <2 years of age.l o



Warnings/Precautions


Warnings


Salicylate Toxicity

Risk of salicylate toxicity (e.g., nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, psychic disturbances) after prolonged or excessive topical use over large areas.l o p If salicylic acid toxicity occurs, immediately discontinue; administer fluids to promote urinary excretion, and administer sodium bicarbonate (oral or IV) if clinically necessary.l o


Avoid other salicylates (e.g., aspirin, salicylate athletic creams) to minimize exposure to salicylic acid.l o (See Interactions under Cautions.)


Use of Fixed Combinations

When used in fixed combination with urea, coal tar, and sodium thiosulfate, consider the cautions, precautions, and contraindications associated with these agents.g u


General Precautions


Topical Effects

Possible excessive erythema or scaling if applied to open skin lesions.l o p


If excessive burning, irritation, stinging, or peeling occurs, discontinue use and consult a clinician.g o


Possible necrosis of normal skin with overuse.a


Concomitant Illnesses

Do not use salicylic acid wart, corn, and callus removal preparations in patients with diabetes or with poor blood circulation.d h n


Specific Populations


Pregnancy

Category C.l o


Lactation

Discontinue nursing or the drug.l o If used by nursing women, avoid applying to the chest area.l


Pediatric Use

Salicylic acid 6% cream, lotion, and gel and 15% plaster not recommended in children <2 years of age.l j o (See Contraindications.)


Increased risk of salicylate toxicity with prolonged, excessive use in children <12 years of age.l o Limit treatment area and monitor for possible signs of salicylate toxicity.l o (See Salicylate Toxicity under Cautions.)


Use of salicylates in children with varicella infection or influenza-like illnesses reportedly is associated with an increased risk of developing Reye’s syndrome.b l o US Surgeon General, AAP Committee on Infectious Diseases, FDA, and other authorities advise that salicylates not be used in children and teenagers with varicella or influenza, unless directed by a clinician.b l o


Hepatic Impairment

Possible salicylate toxicity after prolonged topical use over large areas, especially in patients with substantial hepatic impairment.l o p Limit treatment area and monitor for possible signs of salicylate toxicity.l o (See Salicylate Toxicity under Cautions.)


Renal Impairment

Possible salicylate toxicity after prolonged topical use over large areas, especially in patients with substantial renal impairment.l o p Limit treatment area and monitor for possible signs of salicylate toxicity.l o (See Salicylate Toxicity under Cautions.)


Common Adverse Effects


Erythema,l o p scaling,l o p burning,g o stinging,g o peeling.c


Interactions for Salicylic Acid


Topical Acne Preparations


Cumulative irritant or drying effect.c k If excessive dryness occurs, use only one topical medication unless directed by a clinician.c


Topical Salicylate Preparations


Increased risk of salicylate toxicity.l o


Protein-bound Drugs


Potential for salicylate to displace or to be displaced by other protein-bound drugs.b l o


Specific Drugs




































Drug



Interaction



Comments



Acidifying agents



Drugs that decrease urine pH may decrease salicylate excretionl



Anticoagulants (warfarin, heparin)



Increased risk of bleedingb l o


May displace warfarin from protein-binding sites, leading to prolongation of PT and bleeding timeb l o



Antidiabetic agents (sulfonylureas)



Potential for increased hypoglycemic effectb l o



Aspirin



Increased risk of salicylate toxicityl



Avoid concomitant usel



Corticosteroids



Decreased plasma salicylate concentrationsb


Potential increased plasma salicylate concentrations and salicylate toxicity when corticosteroids are discontinuedb l o



Diuretics



Increased plasma salicylate concentrationsl o



Methotrexate



Possible increased methotrexate toxicity because of displacement from protein binding sitesb l o



Pyrazinamide



Possible prevention or reduction of hyperuricemia associated with pyrazinamideb l o



Sulfur



Possible synergistic keratolytic effecta



Uricosuric agents (probenecid, sulfinpyrazone)



Reduced uricosuric effect of uricosuric agentsb l o


Salicylic Acid Pharmacokinetics


Absorption


Bioavailability


Rapidly and well absorbed percutaneously following topical application.b l


Following topical application of salicylic acid 6% gel, >60% absorbed, with peak plasma concentration usually attained within 5 hours (under occlusion).l o


Onset


In vitro, plaster (Trans-Ver-Sal) released about 16, 48, 65, 79, 89, and 100% of the salicylic acid dose by 0.5, 1, 2, 4, 8, and 24 hours, respectively.a


Plasma Concentrations


Following topical application of salicylic acid 6% gel, peak serum salicylate concentrations were <50 mcg/mL; concentrations >300 mcg/mL generally associated with salicylate toxicity.l o


Distribution


Extent


Distributed in extracellular space.l o


Plasma Protein Binding


50–80%.l o


Special Populations


Patients with a contracted extracellular space secondary to dehydration or diuretics may have increased plasma salicylate levels.l o


Elimination


Elimination Route


Excreted principally in urine as salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%).l o


Stability


Storage


Topical


Cream, Lotion

20–25°C.l Do not freeze.l


Store combination lotion (salicylic acid 1% and sodium thiosulfate 25%) at 15–30°C.g


Solution

Solution in flexible collodion: Tightly closed containers at 15–30°C.a Flammable; keep away from heat and open flame.a d e


Gel

Tightly closed containers at 15–30°C.a p


Gel in flexible collodion: Tightly closed containers at 15–30°C.a Flammable, keep away from heat and open flame.a d e


Shampoo

Salicylic acid 3%: Tightly closed containers; avoid excessive heat or cold.m


Plaster

Well-closed containers at 15–30°C.a


ActionsActions



  • Exact mechanism(s) of action not elucidated; appears to soften and destroy the stratum corneum by increasing endogenous hydration that causes the cornified epithelium (horny layer) of the skin to swell, soften, and desquamate.a j l o




  • In low concentrations, has keratoplastic activity (correction of abnormal keratinization); at concentrations ≥1%, has keratolytic activity (causes peeling of skin); and at concentrations ≥20%, has a caustic effect.a




  • Has weak antifungal and antibacterial activity.a




  • May promote the penetration of other active ingredients and have a comedolytic effect.a




  • Requires moisture to exert its action on the skin and for maceration and desquamation of epidermal tissue.a



Advice to Patients



  • Importance of keeping salicylic acid preparations out of reach of children.g m o




  • Importance of avoiding heat or flames during use of certain salicylic acid collodion formulations.n o




  • For external use only.o Importance of avoiding contact with eyes.k n q r




  • Importance of rinsing hands thoroughly after topical application, unless hands are being treated.l o p




  • Advise patients that salicylic acid topical preparations used concurrently with other topical medications may increase skin dryness or irritation.c




  • Importance of not using for prolonged periods of time for self-medication of dandruff, seborrheic dermatitis, or psoriasis; importance of consulting a clinician if the condition worsens or does not improve after regular use.f




  • Advise patients that, when salicylic acid preparations are used for wart removal, visible improvement generally occurs during the first several days of treatment and complete removal may require 3–12 weeks of use.j




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.l o p




  • Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.l o




  • Importance of informing patients of other important precautionary information. (See Cautions.) o



Preparations


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


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name










































































































































































































































































































































Salicylic Acid

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Powder*



Topical



Cake



0.5%



Aveeno Clear Complexion Cleansing Bar



Johnson & Johnson



Oxy Bar Soap



Mentholatum



2%



Salicylic Acid Cleansing Bar



Stiefel



Cleansing Cream



2%



Clearasil Oil Control Cream Cleanser



Reckitt Benckiser



Clearasil StayClear Skin Perfecting Wash



Reckitt Benckiser



Cleansing Pledgets (saturated with solution)



0.5%



Oxy Daily Cleansing Pad (with alcohol 34%)



Mentholatum



Stridex Sensitive Skin Pads (with SD alcohol 28% and aloe)



Blistex



1%



Stridex Essential Care Pads



Blistex



2%



Clearasil StayClear Acne Fighting Cleansing Wipes



Reckitt Benckiser



Clearasil StayClear Daily Pore Cleansing Pads



Reckitt Benckiser



Clearasil Ultra Deep Pore Cleansing Pads (with propylene glycol and parabens)



Reckitt Benckiser



Noxzema Triple Clean Pads (with SD-alcohol 40)



Procter & Gamble



Oxy Blackhead Pads (with alcohol 46%)



Mentholatum



Oxy Daily Cleansing Pads (with alcohol 46%)



Mentholatum



Oxy Maximum Cleansing Pads (with alcohol 46%)



Mentholatum



Stridex Pads Maximum Strength (with SD alcohol 40 44%)



Blistex



Cleansing Solution



2%



Noxzema Triple Clean Blackhead Cleanser



Proctor & Gamble



Oxy Body Wash (with parabens and propylene glycol)



Mentholatum



Oxy Face Wash



Mentholatum



Cleansing Suspension



2%



Clearasil StayClear Daily Facial Scrub



Reckitt Benckiser



Oxy Maximum Face Scrub (with parabens and propylene glycol)



Mentholatum



Cream



6%



Salex (with parabens)



Coria



Gel



1%



Clearasil Blackhead Control



Reckitt Benckiser



2%



Neutrogena Rapid Clear Acne Eliminating (with propylene glycol)



Neutrogena



Stridex Clear Gel Maximum Strength (with SD alcohol 9.3%)



Blistex



3%



Dermarest Psoriasis Medicated Scalp Treatment (with SD alcohol 40, propylene glycol, and parabens)



Del



Dermarest Psoriasis Medicated Skin Treatment (with parabens and propylene glycol)



Del



Keralyt (with SD-40 alcohol 21% and propylene glycol)



Summers



6%



Hydrisalic (with SD alcohol 40B and propylene glycol)



Pedinol



Keralyt (with SD-40 alcohol 21% and propylene glycol)



Summers



17%



Sal-Plant Gel (with isopropyl alcohol 2.5% in flexible collodion)



Pedinol



17.6%



Compound W Gel (with alcohol 67.5% in flexible collodion)



Prestige



Lotion



2%



Dermarest Psoriasis Medication Moisturizer (with parabens)



Del



Sebasorb (with attapulgite activated, acetyl alcohol, and propylene glycol)



Summers



6%



Salex (with parabens)



Coria



Ointment



3%



MG 217 Sal-Acid



Triton



Plaster



15%



Trans-Ver-Sal (with karaya and propylene glycol)



Doak



40%



Compound W One Step Invisible Strips



Prestige



Compound W One Step Pads



Prestige



Curad Mediplast



Beiersdorf



Dr Scholl’s Callus Remover



Schering-Plough



Dr Scholl’s Clear Away Medicated Disk



Schering-Plough



Dr Scholl’s Clear Away One-Step Invisible Strips



Schering-Plough



Dr Scholl’s Clear Away Plantar for Feet



Schering-Plough



Sal-Acid



Pedinol



Shampoo



2%



Ionil Plus (with SD alcohol 40 12%)



Healthpoint



P&S (with methylparaben and propylparaben)



Aero



3%



Denorex Extra Strength Shampoo (with propylene glycol)



Prestige



DHS Sal Shampoo



Person & Covey



Neutrogena T/Sal Maximum Strength



Neutrogena



Psoriasin Therapeutic Shampoo & Body Wash



Alva-Amco Pharmacal



Solution



2%



Noxzema 2-in-1 Astringent (with SD-alcohol 40)



Procter & Gamble



Noxzema Continuous Clean Clarifying Toner



Procter & Gamble



3%



Dermarest Psoriasis Medicated Overnight Treatment



Del



16.7%



Gordofilm (in flexible collodion)



Gordon



17%



Dr Scholl’s Clear Away Fast Acting Liquid (with SD alcohol 32 17% and ether 52% in flexible collodion)



Schering-Plough



Dr Scholl’s Liquid Corn/Callus Remover (with alcohol SD 32 18% and ether 53% in flexible collodion)



Schering-Plough



DuoFilm (with alcohol SD 32 17% and ether 52% in flexible collodion)



Schering-Plough



Occlusal-HP (with isopropyl alcohol 63% in polyacrylic vehicle)



Bioglan



Salactic Film (with isopropyl alcohol 2.7% in flexible collodion)



Pedinol



Wart-Off (with alcohol 26.35% in flexible collodion)



Pfizer



17.6%



Compound W Liquid (with alcohol 21.2% and ether 63.6% in flexible collodion)



Prestige



Freezone (with alcohol 33% and ether 65.5% in flexible collodion)



Prestige




























Salicylic Acid Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Lotion



1% with Sodium Thiosulfate 25%



Versiclear (with propylene glycol)



Hope



Ointment



5% with Urea 10%



Kerasal Foot Ointment



Alterna



Shampoo



3% with Coal Tar Solution 10% (equivalent to 2% coal tar)



Tarsum



Summers



3% with Colloidal Sulfur 5%



Meted



DUSA


Comparative Pricin