Prixina

Prixina may be available in the countries listed below.

Ingredient matches for Prixina

Prulifloxacin

Prulifloxacin is reported as an ingredient of Prixina in the following countries:

• Poland

International Drug Name Search

Gen-Zopiclone

Gen-Zopiclone may be available in the countries listed below.

Ingredient matches for Gen-Zopiclone

Eszopiclone

Zopiclone is reported as an ingredient of Gen-Zopiclone in the following countries:

• Canada

International Drug Name Search

Fluoxetina Winthrop

Fluoxetina Winthrop may be available in the countries listed below.

Ingredient matches for Fluoxetina Winthrop

Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Winthrop in the following countries:

• Portugal

International Drug Name Search

Cefapirin

In some countries, this medicine may only be approved for veterinary use.

Scheme

Prop.INN

ATC (Anatomical Therapeutic Chemical Classification)

J01DB08

CAS registry number (Chemical Abstracts Service)

0021593-23-7

Chemical Formula

C17-H17-N3-O6-S2

Molecular Weight

423

Therapeutic Category

Antibacterial: Cephalosporin, cephalosporinase-sensitive

Chemical Name

5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[(acetyloxy)methyl]-8-oxo-7-[[(4-pyridinylthio)acetyl]amino]-, (6R-trans)-

Foreign Names

• Cefapirinum (Latin)
• Cefapirin (German)
• Céfapirine (French)
• Cefapirina (Spanish)

Generic Names

• Cefapirin (OS: BAN)
• Cefapirina (OS: DCIT)
• Céfaprin (OS: DCF)
• Cefapirin (PH: BP 2003, Ph. Eur. 5)
• Cefapirine, comp. with N,N'-dibenzylethylenediamine (IS)
• Cephapirin Benzathine (PH: USP 32)
• Cefapirin Sodium (OS: BANM)
• Cephapirin Sodium (OS: USAN)
• Sodium Cefapirin (OS: JAN)
• BL-P 1322 (IS: Bristol)
• Cefapirin Sodium (PH: BP 2010, JP XV, Ph. Eur. 6)
• Cefapirina sodica (PH: F.U. IX)
• Cefapirinum natricum (PH: Ph. Eur. 6)
• Cephapirin Sodium (PH: USP 32)

Brand Names

• Cefa Safe (veterinary use)
  Intervet, Poland



• Cefa-Safe (veterinary use)
  Intervet, Netherlands



• Metricure (veterinary use)
  Intervet / Schering-Plough Animal Health, New Zealand; Intervet/Schering-Plough Animal Health, Australia



• Cefa Dri (veterinary use)
  Fort Dodge Animale Health, United States



• Cefa Safe (veterinary use)
  Intervet / Schering-Plough Animal Health, New Zealand



• Cefatron Asciutta (veterinary use)
  Ati, Italy; Fatro, Italy



• Cephudder (veterinary use)
  Intervet, South Africa



• Masti-Safe (veterinary use)
  Intervet, Germany



• Metricure (veterinary use)
  Intervet, Belgium; Intervet, Germany; Intervet, France; Intervet, United Kingdom; Intervet, Ireland; Intervet, Italy; Intervet, Netherlands; Veterinaria, Switzerland



• Tomorrow (veterinary use)
  Fort Dodge Animale Health, United States



• Cefa Lak (veterinary use)
  Fort Dodge Animale Health, United States



• Céfaloject
  Bristol-Myers Squibb, Burkina Faso; Bristol-Myers Squibb, Benin; Bristol-Myers Squibb, Central African Republic; Bristol-Myers Squibb, Congo; Bristol-Myers Squibb, Cote D'ivoire; Bristol-Myers Squibb, Cameroon; Bristol-Myers Squibb, Gabon; Bristol-Myers Squibb, Guinea; Bristol-Myers Squibb, Madagascar; Bristol-Myers Squibb, Mali; Bristol-Myers Squibb, Mauritania; Bristol-Myers Squibb, Niger; Bristol-Myers Squibb, Senegal; Bristol-Myers Squibb, Chad; Bristol-Myers Squibb, Togo; Bristol-Myers Squibb, Zaire



• Cefatrex
  Bristol-Myers Squibb, Greece



• Cefatrexyl
  Latina, Bulgaria



• Cefatron Lattazione (veterinary use)
  Ati, Italy; Fatro, Italy



• Cefratrexyl
  Bristol-Myers Squibb, Oman



• Cephazer
  Purzer, Taiwan



• Mastiplan (Cefapirin and Prednisolon (veterinary use))
  Veterinaria, Switzerland



• Today (veterinary use)
  Fort Dodge Animale Health, United States

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Prop.INN	Proposed International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Prodrox

In the US, Prodrox (hydroxyprogesterone systemic) is a member of the drug class progestins.

US matches:

• Prodrox

Ingredient matches for Prodrox

Hydroxyprogesterone

Hydroxyprogesterone caproate (a derivative of Hydroxyprogesterone) is reported as an ingredient of Prodrox in the following countries:

• United States

International Drug Name Search

Pro-Cure

Pro-Cure may be available in the countries listed below.

Ingredient matches for Pro-Cure

Finasteride

Finasteride is reported as an ingredient of Pro-Cure in the following countries:

• Israel

International Drug Name Search

Pamipro

Pamipro may be available in the countries listed below.

Ingredient matches for Pamipro

Pamidronic Acid

Pamidronic Acid disodium salt (a derivative of Pamidronic Acid) is reported as an ingredient of Pamipro in the following countries:

• Netherlands

International Drug Name Search

Adormix

Adormix may be available in the countries listed below.

Ingredient matches for Adormix

Zolpidem

Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Adormix in the following countries:

• Chile

International Drug Name Search

Pangel

Pangel may be available in the countries listed below.

Ingredient matches for Pangel

Benzoyl Peroxide

Benzoyl Peroxide is reported as an ingredient of Pangel in the following countries:

• Belgium

International Drug Name Search

DiltaHexal

DiltaHexal may be available in the countries listed below.

Ingredient matches for DiltaHexal

Diltiazem

Diltiazem is reported as an ingredient of DiltaHexal in the following countries:

• Luxembourg

Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of DiltaHexal in the following countries:

• Australia


• Germany

International Drug Name Search

Pro Pen G

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Pro Pen G

Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Pro Pen G in the following countries:

• United States

International Drug Name Search

Dexa-Gentamicin

Dexa-Gentamicin may be available in the countries listed below.

Ingredient matches for Dexa-Gentamicin

Dexamethasone

Dexamethasone is reported as an ingredient of Dexa-Gentamicin in the following countries:

• Germany


• Slovakia

Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Dexa-Gentamicin in the following countries:

• Germany

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Dexa-Gentamicin in the following countries:

• Germany


• Slovakia

International Drug Name Search

Tisacid

Tisacid may be available in the countries listed below.

Ingredient matches for Tisacid

Hydrotalcite

Hydrotalcite is reported as an ingredient of Tisacid in the following countries:

• Hungary

International Drug Name Search

Probenecid

In the US, Probenecid (probenecid systemic) is a member of the drug class antigout agents and is used to treat Adjunct to Antibiotic Therapy and Gout.

US matches:

• Probenecid


• Probenecid and colchicine


• Probenecid Colchicine


• Probenecid Tablets


• Probenecid/Colchicine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

M04AB01

CAS registry number (Chemical Abstracts Service)

0000057-66-9

Chemical Formula

C13-H19-N-O4-S

Molecular Weight

285

Therapeutic Category

Uricosuric agent

Chemical Name

Benzoic acid, 4-[(dipropylamino)sulfonyl]-

Foreign Names

• Probenecidum (Latin)
• Probenecid (German)
• Probénécide (French)
• Probenecida (Spanish)

Generic Names

• Probenecid (OS: DCIT, JAN, BAN)
• Probénécide (OS: DCF)
• Probenecid (PH: BP 2010, Ph. Eur. 6, Ph. Int. 4, USP 32, JP XIV)
• Probénécide (PH: Ph. Eur. 6)
• Probenecidum (PH: Ph. Int. 4, Ph. Eur. 6)

Brand Names

• Bencid
  Geno, India



• Benecid
  Kaken Seiyaku, Japan; Valdecasas, Mexico



• Benemid
  Merck Sharp & Dohme, Ethiopia



• Benemide
  Bouchara, France



• Benuryl
  Teva, Israel; Valeant, Canada



• Mydrox (Probenecid and Cefadroxil)
  Solitaire, India



• Probalan
  Lannett, United States



• Probecid
  BioPhausia, Norway; BioPhausia, Sweden



• Proben
  Aspen Pharmacare, South Africa



• Probenecid Medic
  Medic, Denmark



• Probenecid Synco
  Synco, Hong Kong



• Probenecid Weimer
  Biokanol, Germany



• Probenecid
  AFT, New Zealand; Mylan, United States; Watson, United States; Watson, United States



• Procid
  Johnson, Taiwan



• Pro-Cid
  Phebra, Australia



• Santuril
  Lipomed, Switzerland

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Trinovum

Trinovum may be available in the countries listed below.

UK matches:

• Trinovum (SPC)

Ingredient matches for Trinovum

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Trinovum in the following countries:

• Austria


• Belgium


• Colombia


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Germany


• Luxembourg


• Netherlands


• Slovakia


• Slovenia


• South Africa


• Sweden


• Switzerland


• United Kingdom

Norethisterone

Norethisterone is reported as an ingredient of Trinovum in the following countries:

• Austria


• Belgium


• Colombia


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Germany


• Luxembourg


• Netherlands


• Slovakia


• Slovenia


• South Africa


• Sweden


• Switzerland


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Alfamedin

Alfamedin may be available in the countries listed below.

Ingredient matches for Alfamedin

Doxazosin

Doxazosin is reported as an ingredient of Alfamedin in the following countries:

• Poland

International Drug Name Search

ProctoCream HC

Ingredient matches for ProctoCream HC

Hydrocortisone

Hydrocortisone is reported as an ingredient of ProctoCream HC in the following countries:

• United States

International Drug Name Search

Compound W One-Step Wart Remover Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

• Akurza


• Aliclen


• Avosil


• Betasal


• Compound W


• Corn Removing


• Dermarest Psoriasis


• DHS Sal


• Drytex


• Duofilm


• Duoplant


• Durasal


• Freezone


• Fung-O


• Gets-It Corn/Callus Remover


• Gordofilm


• Hydrisalic


• Ionil


• Ionil Plus


• Keralyt


• Keralyt Scalp


• Lupicare


• Mediplast


• Mg217 Sal-Acid


• Mosco Corn & Callus Remover


• Neutrogena


• Occlusal-HP


• Off-Ezy


• Oxy Balance


• P & S


• Palmer's Skin Success Acne Cleanser


• Propa pH


• Salac


• Sal-Acid Plaster


• Salactic Film


• Salex


• Salitop


• Salkera


• Sal-Plant Gel


• Salvax


• Seba-Clear


• Stri-Dex


• Thera-Sal


• Therasoft Anti-Acne


• Tinamed


• Ti-Seb


• Virasal


• Wart-Off Maximum Strength


• Zapzyt

In Canada

• Acnex


• Acnomel Acne Mask


• Clear Away Wart Removal System


• Compound W One-Step Wart Remover


• Compound W Plus


• Dr. Scholl's Clear Away One Step Plantar Wart Remover


• Dr. Scholl's Cushlin Ultra Slim Callus Removers


• Dr. Scholl's Cushlin Ultra Slim Corn Removers


• Duoforte 27


• Freezone - One Step Callus Remover Pad


• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap


• Lotion


• Liquid


• Foam


• Ointment


• Gel/Jelly


• Solution


• Cream


• Pad


• Paste


• Shampoo


• Dressing


• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Compound W One-Step Wart Remover

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Compound W One-Step Wart Remover

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Argatroban


• Bivalirudin


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Dipyridamole


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lepirudin


• Nefazodone


• Paroxetine


• Protein C


• Rivaroxaban


• Sertraline


• Sibutramine


• Ticlopidine


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Ardeparin


• Azilsartan Medoxomil


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Certoparin


• Chlorothiazide


• Chlorthalidone


• Clopamide


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Eprosartan


• Ethacrynic Acid


• Furosemide


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Irbesartan


• Losartan


• Methyclothiazide


• Metolazone


• Nadroparin


• Olmesartan Medoxomil


• Parnaparin


• Phenindione


• Phenprocoumon


• Piretanide


• Polythiazide


• Probenecid


• Reviparin


• Tamarind


• Tasosartan


• Telmisartan


• Tinzaparin


• Torsemide


• Trichlormethiazide


• Valsartan


• Warfarin


• Xipamide

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or


• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or


• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Compound W One-Step Wart Remover. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.


• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.


• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Cut the plaster to fit the wart, corn, or callus and apply.


• For corns and calluses:
  
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  
  
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
  
  


• For warts:
  
  • Depending on the product, either:
    
    • Apply plaster and repeat every 48 hours as needed, or
      
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
      
      
    
    
  
  
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
  
  


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.


• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.


• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• This medicine is flammable. Do not use it near heat or open flame or while smoking.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Avoid breathing in the vapors from the medicine.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.


• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.


• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.


• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing

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

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

• For cream dosage form:
  
  • For corns and calluses:
    
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
    
    
  
  


• For gel dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 5% gel one time a day.
    
    
  
  
  • For psoriasis:
    
    • Adults and children—Use the 5% gel one time a day.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 5 to 26% gel one time a day.
    
    
  
  


• For lotion dosage form:
  
  • For acne:
    
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
    
    
  
  
  • For dandruff and antiseborrhic dermatitis of the scalp:
    
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    
    
  
  


• For ointment dosage form:
  
  • For acne:
    
    • Adults and children—Use the 3 to 6% ointment as needed.
    
    
  
  
  • For psoriasis and seborrheic dermatitis:
    
    • Adults and children—Use the 3 to 10% ointment as needed.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
    
    
  
  


• For pads dosage form:
  
  • For acne:
    
    • Adults and children—Use one to three times a day.
    
    
  
  


• For plaster dosage form:
  
  • For corns, calluses, common warts, or plantar warts:
    
    • Adults and children—Use one time a day or one time every other day.
    
    
  
  


• For shampoo dosage form:
  
  • For dandruff or seborrheic dermatitis of the scalp:
    
    • Adults and children—Use on the scalp one or two times a week.
    
    
  
  


• For soap dosage form:
  
  • For acne:
    
    • Adults and children—Use as needed.
    
    
  
  


• For topical solution dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
    
    
  
  
  • For common warts and plantar warts:
    
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
    
    
  
  
  • For corns and calluses:
    
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Compound W One-Step Wart Remover

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Compound W One-Step Wart Remover Side Effects

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

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

Less common or rare

• Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

• Dryness and peeling of skin


• flushing


• redness of skin


• unusually warm skin

Symptoms of salicylic acid poisoning

• Confusion


• diarrhea


• dizziness


• fast or deep breathing


• headache (severe or continuing)


• hearing loss


• lightheadedness


• nausea


• rapid breathing


• ringing or buzzing in ears (continuing)


• severe drowsiness


• stomach pain


• vomiting

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

More common

• Skin irritation not present before use of this medicine (mild)


• stinging

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

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

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Vecuronium

Dosage Form: injection, powder, lyophilized, for solution
Vecuronium Bromide for Injection

Rx only

THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.

Vecuronium Description

Vecuronium bromide for injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as piperidinium, 1-[(2β, 3α, 5α, 16β, 17β)-3, 17-bis(acetyloxy)-2-(1-piperidinyl) androstan-16-yl]-1-methyl-, bromide. The structural formula is:

Its chemical formula is C34H57BrN2O4 with molecular weight 637.74.

Vecuronium bromide for injection is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each 10 mL vial contains 10 mg Vecuronium bromide, 20.75 mg citric acid anhydrous, 16.25 mg sodium phosphate dibasic anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4. Each 20 mL vial contains 20 mg of Vecuronium bromide, 41.5 mg citric acid anhydrous, 32.5 mg sodium phosphate dibasic anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4. When reconstituted with bacteriostatic water for injection, USP, contains 0.9% w/v BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS.

Vecuronium - Clinical Pharmacology

Vecuronium is a nondepolarizing neuromuscular blocking agent possessing all of the characteristic pharmacological actions of this class of drugs (curariform). It acts by competing for cholinergic receptors at the motor end-plate. The antagonism to acetylcholine is inhibited and neuromuscular block is reversed by acetylcholinesterase inhibitors such as neostigmine, edrophonium, and pyridostigmine. Vecuronium is about 1/3 more potent than pancuronium; the duration of neuromuscular blockade produced by Vecuronium is shorter than that of pancuronium at initially equipotent doses. The time to onset of paralysis decreases and the duration of maximum effect increases with increasing Vecuronium doses. The use of a peripheral nerve stimulator is recommended in assessing the degree of muscular relaxation with all neuromuscular blocking drugs. The ED90 (dose required to produce 90% suppression of the muscle twitch response with balanced anesthesia) has averaged 0.057 mg/kg (0.049 to 0.062 mg/kg in various studies). An initial Vecuronium bromide dose of 0.08 to 0.1 mg/kg generally produces first depression of twitch in approximately 1 minute, good or excellent intubation conditions within 2.5 to 3 minutes, and maximum neuromuscular blockade within 3 to 5 minutes of injection in most patients.

Under balanced anesthesia, the time to recovery to 25% of control (clinical duration) is approximately 25 to 40 minutes after injection and recovery is usually 95% complete approximately 45 to 65 minutes after injection of intubating dose. The neuromuscular blocking action of Vecuronium is slightly enhanced in the presence of potent inhalation anesthetics. If Vecuronium is first administered more than 5 minutes after the start of the inhalation of enflurane, isoflurane, or halothane, or when steady-state has been achieved, the intubating dose of Vecuronium may be decreased by approximately 15% (see DOSAGE AND ADMINISTRATION). Prior administration of succinylcholine may enhance the neuromuscular blocking effect of Vecuronium and its duration of action. With succinylcholine as the intubating agent, initial doses of 0.04 to 0.06 mg/kg of Vecuronium bromide will produce complete neuromuscular block with clinical duration of action of 25 to 30 minutes. If succinylcholine is used prior to Vecuronium, the administration of Vecuronium should be delayed until the patient starts recovering from succinylcholine induced neuromuscular blockade. The effect of prior use of other nondepolarizing neuromuscular blocking agents on the activity of Vecuronium has not been studied (see PRECAUTIONS-Drug Interactions).

Repeated administration of maintenance doses of Vecuronium has little or no cumulative effect on the duration of neuromuscular blockade. Therefore, repeat doses can be administered at relatively regular intervals with predictable results. After an initial dose of 0.08 to 0.1 mg/kg under balanced anesthesia, the first maintenance dose (suggested maintenance dose is 0.01 to 0.015 mg/kg) is generally required within 25 to 40 minutes; subsequent maintenance doses, if required, may be administered at approximately 12 to 15 minute intervals. Halothane anesthesia increases the clinical duration of the maintenance dose only slightly. Under enflurane a maintenance dose of 0.01 mg/kg is approximately equal to 0.015 mg/kg dose under balanced anesthesia.

The recovery index (time from 25 to 75% recovery) is approximately 15 to 25 minutes under balanced or halothane anesthesia. When recovery from Vecuronium neuromuscular blocking effect begins, it proceeds more rapidly than recovery from pancuronium. Once spontaneous recovery has started, the neuromuscular block produced by Vecuronium is readily reversed with various anticholinesterase agents, e.g., pyridostigmine, neostigmine, or edrophonium in conjunction with an anticholinergic agent such as atropine or glycopyrrolate. Rapid recovery is a finding consistent with Vecuronium short elimination half-life, although there have been occasional reports of prolonged neuromuscular blockade in patients in the intensive care unit (see PRECAUTIONS- Long-Term Use in ICU).

The administration of clinical doses of Vecuronium is not characterized by laboratory or clinical signs of chemically mediated histamine release. This does not preclude the possibility of rare hypersensitivity reactions (see ADVERSE REACTIONS).

Pharmacokinetics

At clinical doses of 0.04 to 0.1 mg/kg, 60 to 80% of Vecuronium bromide is usually bound to plasma protein. The distribution half-life following a single intravenous dose (range 0.025 to 0.28 mg/kg) is approximately 4 minutes. Elimination half-life over this sample dosage range is approximately 65 to 75 minutes in healthy surgical patients and in renal failure patients undergoing transplant surgery.

In late pregnancy, elimination half-life may be shortened to approximately 35 to 40 minutes. The volume of distribution at steady state is approximately 300 to 400 mL/kg; systemic rate of clearance is approximately 3 to 4.5 mL/kg/minute. In man, urine recovery of Vecuronium varies from 3 to 35% within 24 hours. Data derived from patients requiring insertion of a T-tube in the common bile duct suggests that 25 to 50% of a total intravenous dose of Vecuronium may be excreted in bile within 42 hours. Only unchanged Vecuronium has been detected in human plasma following use during surgery. In addition, one metabolite 3-desacetyl Vecuronium has been rarely detected in human plasma following prolonged clinical use in the ICU (see PRECAUTIONS-Long-Term Use in ICU). The 3-desacetyl Vecuronium metabolite has been recovered in the urine of some patients in quantities that account for up to 10% of injected dose; 3-desacetyl Vecuronium has also been recovered by T-tube in some patients, accounting for up to 25% of the injected dose.

This metabolite has been judged by animal screening (dogs and cats) to have 50% or more of the potency of Vecuronium; equipotent doses are of approximately the same duration as Vecuronium in dogs and cats. Biliary excretion accounts for about half the dose of Vecuronium within 7 hours in the anesthetized rat. Circulatory bypass of the liver (cat preparation) prolongs recovery from Vecuronium. Limited data derived from patients with cirrhosis or cholestasis suggests that some measurements of recovery may be doubled in such patients. In patients with renal failure, measurements of recovery do not differ significantly from similar measurements in healthy patients.

Studies involving routine hemodynamic monitoring in good risk surgical patients reveal that the administration of Vecuronium, in doses up to three times that needed to produce clinical relaxation (0.15 mg/kg), did not produce clinically significant changes in systolic, diastolic, or mean arterial pressure. The heart rate, under similar monitoring, remained unchanged in some studies and was lowered by a mean of up to 8% in other studies. A large dose of 0.28 mg/kg administered during a period of no stimulation, while patients were being prepared for coronary artery bypass grafting, was not associated with alterations in rate-pressure-product or pulmonary capillary wedge pressure. Systemic vascular resistance was lowered slightly and cardiac output was increased insignificantly. (The drug has not been studied in patients with hemodynamic dysfunction secondary to cardiac valvular disease.) Limited clinical experience with use of Vecuronium bromide during the surgery for pheochromocytoma has shown that administration of this drug is not associated with changes in blood pressure or heart rate.

Unlike other nondepolarizing skeletal muscle relaxants, Vecuronium has no clinically significant effects on hemodynamic parameters. Vecuronium will not counteract those hemodynamic changes or known side effects produced by or associated with anesthetic agents, other drugs, or various other factors known to alter hemodynamics.

Indications and Usage for Vecuronium

Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Contraindications

Vecuronium bromide is contraindicated in patients known to have a hypersensitivity to it.

Warnings

Vecuronium SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND THE POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS FACILITIES FOR INTUBATION, ARTIFICIAL RESPIRATION, OXYGEN THERAPY, AND REVERSAL AGENTS ARE IMMEDIATELY AVAILABLE. THE CLINICIAN MUST BE PREPARED TO ASSIST OR CONTROL RESPIRATION. TO REDUCE THE POSSIBILITY OF PROLONGED NEUROMUSCULAR BLOCKADE AND OTHER POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING LONG-TERM USE IN THE ICU, Vecuronium OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSES BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND WHO ARE FAMILIAR WITH APPROPRIATE PERIPHERAL NERVE STIMULATOR MUSCLE MONITORING TECHNIQUES (see PRECAUTIONS Long-Term Use in ICU).

In patients who are known to have myasthenia gravis or the myasthenic (Eaton-Lambert) syndrome, small doses of Vecuronium may have profound effects. In such patients, a peripheral nerve stimulator and use of a small test dose may be of value in monitoring the response to administration of muscle relaxants.

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including Vecuronium bromide, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs.

Precautions

Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents. In addition, inform your patients that severe anaphylactic reactions to neuromuscular blocking agents, including Vecuronium bromide have been reported.

Renal Failure

Vecuronium is well tolerated without clinically significant prolongation of neuromuscular blocking effect in patients with renal failure who have been optimally prepared for surgery by dialysis. Under emergency conditions in anephric patients, some prolongation of neuromuscular blockade may occur; therefore, if anephric patients cannot be prepared for non-elective surgery, a lower initial dose of Vecuronium should be considered.

Altered Circulation Time

Conditions associated with slower circulation time in cardiovascular disease, old age, edematous states resulting in increased volume of distribution may contribute to delay in onset time; therefore, dosage should not be increased.

Hepatic Disease

Experience in patients with cirrhosis or cholestasis has revealed prolonged recovery time in keeping with the role the liver plays in Vecuronium metabolism and excretion (see CLINICAL PHARMACOLOGY- Pharmacokinetics). Data currently available do not permit dosage recommendations in patients with impaired liver function.

Long-Term Use in ICU

In the intensive care unit, long-term use of neuromuscular blocking drugs to facilitate mechanical ventilation may be associated with prolonged paralysis and/or skeletal muscle weakness, that may be first noted during attempts to wean such patients from the ventilator. Typically, such patients receive other drugs such as broad spectrum antibiotics, narcotics and/or steroids and may have electrolyte imbalance and diseases which lead to electrolyte imbalance, hypoxic episodes of varying duration, acid-base imbalance and extreme debilitation, any of which may enhance the actions of a neuromuscular blocking agent. Additionally, patients immobilized for extended periods frequently develop symptoms consistent with disuse muscle atrophy. The recovery picture may vary from regaining movement and strength in all muscles to initial recovery of movement of the facial and small muscles of the extremities then to the remaining muscles. In rare cases recovery may be over an extended period of time and may even, on occasion, involve rehabilitation. Therefore, when there is a need for long term mechanical ventilation, the benefits-to-risk ratio of neuromuscular blockade must be considered.

Continuous infusion or intermittent bolus dosing to support mechanical ventilation has not been studied sufficiently to support dosage recommendations. IN THE INTENSIVE CARE UNIT, APPROPRIATE MONITORING, WITH THE USE OF A PERIPHERAL NERVE STIMULATOR TO ASSESS THE DEGREE OF NEUROMUSCULAR BLOCKADE IS RECOMMENDED TO HELP PRECLUDE POSSIBLE PROLONGATION OF THE BLOCKADE. WHENEVER THE USE OF Vecuronium OR ANY NEUROMUSCULAR BLOCKING AGENT IS CONTEMPLATED IN THE ICU, IT IS RECOMMENDED THAT NEUROMUSCULAR TRANSMISSION BE MONITORED CONTINUOUSLY DURING ADMINISTRATION AND RECOVERY WITH THE HELP OF A NERVE STIMULATOR. ADDITIONAL DOSES OF Vecuronium OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD NOT BE GIVEN BEFORE THERE IS A DEFINITE RESPONSE TO T1 OR TO THE FIRST TWITCH. IF NO RESPONSE IS ELICITED, INFUSION ADMINISTRATION SHOULD BE DISCONTINUED UNTIL A RESPONSE RETURNS.

Severe Obesity or Neuromuscular Disease

Patients with severe obesity or neuromuscular disease may pose airway and/or ventilatory problems requiring special care before, during and after the use of neuromuscular blocking agents such as Vecuronium.

Malignant Hyperthermia

Many drugs used in anesthetic practice are suspected of being capable of triggering a potentially fatal hypermetabolism of skeletal muscle known as malignant hyperthermia. There are insufficient data derived from screening in susceptible animals (swine) to establish whether or not Vecuronium is capable of triggering hyperthermia.

CNS

Vecuronium has no known effect on consciousness, the pain threshold or cerebration. Administration must be accompanied by adequate anesthesia or sedation.

Drug Interactions

Prior administration of succinylcholine may enhance the neuromuscular blocking effect of Vecuronium and its duration of action. If succinylcholine is used before Vecuronium, the administration of Vecuronium should be delayed until the succinylcholine effect shows signs of wearing off. With succinylcholine as the intubating agent, initial doses of 0.04 to 0.06 mg/kg of Vecuronium may be administered to produce complete neuromuscular block with clinical duration of action of 25 to 30 minutes (see CLINICAL PHARMACOLOGY).

The use of Vecuronium before succinylcholine, in order to attenuate some of the side effects of succinylcholine, has not been sufficiently studied.

Other nondepolarizing neuromuscular blocking agents (pancuronium, d-tubocurarine, metocurine, and gallamine) act in the same fashion as does Vecuronium; therefore, these drugs and Vecuronium, may manifest an additive effect when used together. There are insufficient data to support concomitant use of Vecuronium and other competitive muscle relaxants in the same patient.

Inhalational Anesthetics

Use of volatile inhalational anesthetics such as enflurane, isoflurane, and halothane with Vecuronium will enhance neuromuscular blockade. Potentiation is most prominent with use of enflurane and isoflurane. With the above agents the initial dose of Vecuronium may be the same as the balanced anesthesia unless the inhalational anesthetic has been administered for a sufficient time at a sufficient dose to have reached clinical equilibrium (see CLINICAL PHARMACOLOGY).

Antibiotics

Parenteral/intraperitoneal administration of high doses of certain antibiotics may intensify or produce neuromuscular block on their own. The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. If these or other newly introduced antibiotics are used in conjunction with Vecuronium, unexpected prolongation of neuromuscular block should be considered a possibility.

Thiopental

Reconstituted Vecuronium, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions such as thiopental) in the same syringe or administered simultaneously during intravenous infusion through the same needle or same intravenous line (see DOSAGE AND ADMINISTRATION– COMPATIBILITY).

Other

Experience concerning injection of quinidine during recovery from use of other muscle relaxants suggests that recurrent paralysis may occur. This possibility must also be considered for Vecuronium. Vecuronium-induced neuromuscular blockade has been counteracted by alkalosis and enhanced by acidosis in experimental animals (cat). Electrolyte imbalance and diseases which lead to electrolyte imbalance, such as adrenal cortical insufficiency, have been shown to alter neuromuscular blockade. Depending on the nature of the imbalance, either enhancement or inhibition may be expected. Magnesium salts, administered for the management of toxemia of pregnancy, may enhance the neuromuscular blockade.

Drug/Laboratory Test Interactions

None known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Vecuronium. It is also not known whether Vecuronium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vecuronium should be given to a pregnant woman only if clearly needed.

Labor and Delivery

The use of Vecuronium in patients undergoing cesarean section has been reported in the literature. Following tracheal intubation with succinylcholine, Vecuronium dosages of 0.04 mg/kg (n=11) and 0.06 to 0.08 mg/kg (n=20) were administered. The umbilical venous plasma concentrations were 11% of maternal concentrations at delivery and mean neonate APGAR scores at 5 minutes were ≥ 9 in both reports. The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of toxemia of pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Vecuronium is administered to a nursing woman.

Pediatric Use

Infants under 1 year of age but older than 7 weeks, also tested under halothane anesthesia, are moderately more sensitive to Vecuronium on a mg/kg basis than adults and take about 1.5 times as long to recover. See DOSAGE AND ADMINISTRATION-Use in Pediatrics subsection for recommendations for use in pediatric patients 7 weeks to 16 years of age. The safety and effectiveness of Vecuronium in pediatric patients less than 7 weeks of age have not been established.

Geriatric Use

Clinical studies of Vecuronium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. There are some reports in the peer reviewed literature of increased effect and longer duration of action of Vecuronium in the elderly compared to younger patients. However, other reports have found no significant differences between healthy elderly and younger adults. Advanced age or other conditions associated with slower circulation time, may be associated with a delay in onset time (see PRECAUTIONS– Altered Circulation Time). Nevertheless, recommended doses of Vecuronium should not be increased in these patients to reduce onset time, as higher doses produce a longer duration of action (see CLINICAL PHARMACOLOGY). Dose selections for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Close monitoring of neuromuscular function is recommended.

Adverse Reactions

The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the drug's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiration insufficiency or apnea.

Inadequate reversal of the neuromuscular blockade is possible with Vecuronium bromide as with all curariform drugs. These adverse reactions are managed by manual or mechanical ventilation until recovery is judged adequate. Little or no increase in intensity of blockade or duration of action with Vecuronium bromide is noted from the use of thiobarbiturates, narcotic analgesics, nitrous oxide, or droperidol. See OVERDOSAGE for discussion of other drugs used in anesthetic practice which also cause respiratory depression.

Prolonged to profound extensions of paralysis and/or muscle weakness as well as muscle atrophy have been reported after long-term use to support mechanical ventilation in the intensive care unit (see PRECAUTIONS- Long-Term Use in ICU). The administration of Vecuronium bromide has been associated with rare instances of hypersensitivity reactions (bronchospasm, hypotension and/or tachycardia, sometimes associated with acute urticaria or erythema); (see CLINICAL PHARMACOLOGY).

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including Vecuronium bromide. These reactions, in some cases, have been life-threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS).

Overdosage

The possibility of iatrogenic overdosage can be minimized by carefully monitoring muscle twitch response to peripheral nerve stimulation.

Excessive doses of Vecuronium produce enhanced pharmacological effects. Residual neuromuscular blockade beyond the time period needed may occur with Vecuronium as with other neuromuscular blockers. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. A peripheral nerve stimulator may be used to assess the degree of residual neuromuscular blockade from other causes of decreased respiratory reserve.

Respiratory depression may be due either wholly or in part to other drugs used during the conduct of general anesthesia such as narcotics, thiobarbiturates and other central nervous system depressants.

Under such circumstances, the primary treatment is maintenance of a patent airway and manual or mechanical ventilation until complete recovery of normal respiration is assured. Pyridostigmine, neostigmine, or edrophonium, in conjunction with atropine or glycopyrrolate, will usually antagonize the skeletal muscle relaxant action of Vecuronium. Satisfactory reversal can be judged by adequacy of skeletal muscle tone and by adequacy of respiration. A peripheral nerve stimulator may also be used to monitor restoration of twitch height. Failure of prompt reversal (within 30 minutes) may occur in the presence of extreme debilitation, carcinomatosis, and with concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular blockade or cause respiratory depression of their own. Under such circumstances, the management is the same as that of prolonged neuromuscular blockade. Ventilation must be supported by artificial means until the patient has resumed control of his respiration. Prior to the use of reversal agents, reference should be made to the specific package insert of the reversal agent.

The effects of hemodialysis and peritoneal dialysis on plasma levels of Vecuronium and its metabolite are unknown.

Vecuronium Dosage and Administration

Vecuronium bromide for injection is for intravenous use only.

This drug should be administered by or under the supervision of experienced clinicians familiar with the use of neuromuscular blocking agents. Dosage must be individualized in each case. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only, especially regarding enhancement of neuromuscular blockade of Vecuronium bromide by volatile anesthetics and by prior use of succinylcholine (see PRECAUTIONS Drug Interactions).

To obtain maximum clinical benefits of Vecuronium bromide and to minimize the possibility of overdosage, the monitoring of muscle twitch response to peripheral nerve stimulation is advised.

The recommended initial dose of Vecuronium bromide is 0.08 to 0.1 mg/kg (1.4 to 1.75 times the ED90) given as an intravenous bolus injection. This dose can be expected to produce good or excellent non-emergency intubation conditions in 2.5 to 3 minutes after injection. Under balanced anesthesia, clinically required neuromuscular blockade lasts approximately 25 to 30 minutes, with recovery to 25% of control achieved approximately 25 to 40 minutes after injection and recovery to 95% of control achieved approximately 45 to 65 minutes after injection. In the presence of potent inhalation anesthetics, the neuromuscular blocking effect of Vecuronium bromide is enhanced. If Vecuronium bromide is first administered more than 5 minutes after the start of inhalation agent or when steady-state has been achieved, the initial Vecuronium bromide dose may be reduced by approximately 15%, i.e., 0.06 to 0.085 mg/kg.

Prior administration of succinylcholine may enhance the neuromuscular blocking effect and duration of action of Vecuronium bromide. If intubation is performed using succinylcholine, a reduction of initial dose of Vecuronium bromide to 0.04 to 0.06 mg/kg with inhalation anesthesia and 0.05 to 0.06 mg/kg with balanced anesthesia may be required.

During prolonged surgical procedures, maintenance doses of 0.01 to 0.015 mg/kg of Vecuronium bromide are recommended; after the initial Vecuronium bromide injection, the first maintenance dose will generally be required within 25 to 40 minutes. However, clinical criteria should be used to determine the need for maintenance doses.

Since Vecuronium bromide lacks clinically important cumulative effects, subsequent maintenance doses, if required, may be administered at relatively regular intervals for each patient, ranging approximately from 12 to 15 minutes under balanced anesthesia, slightly longer under inhalation agents. (If less frequent administration is desired, higher maintenance doses may be administered.)

Should there be reason for the selection of larger doses in individual patients, initial doses ranging from 0.15 mg/kg up to 0.28 mg/kg have been administered during surgery under halothane anesthesia without ill effects to the cardiovascular system being noted as long as ventilation is properly maintained (see CLINICAL PHARMACOLOGY-Pharmacokinetics).

Use by Continuous Infusion

After an intubating dose of 0.08 to 0.1 mg/kg, a continuous infusion of 1 mcg/kg/min can be initiated approximately 20 to 40 min later. Infusion of Vecuronium bromide should be initiated only after early evidence of spontaneous recovery from the bolus dose. Long-term intravenous infusion to support mechanical ventilation in the intensive care unit has not been studied sufficiently to support dosage recommendations. (See PRECAUTIONS-Long-Term Use in ICU.)

The infusion of Vecuronium bromide should be individualized for each patient. The rate of administration should be adjusted according to the patient's twitch response as determined by peripheral nerve stimulation. An initial rate of 1 mcg/kg/min is recommended, with the rate of the infusion adjusted thereafter to maintain a 90% suppression of twitch response. Average infusion rates may range from 0.8 to 1.2 mcg/kg/min.

Inhalation anesthetics, particularly enflurane and isoflurane may enhance the neuromuscular blocking action of nondepolarizing muscle relaxants. In the presence of steady state concentrations of enflurane or isoflurane, it may be necessary to reduce the rate of infusion 25 to 60%, 45 to 60 minutes after the intubating dose. Under halothane anesthesia it may not be necessary to reduce the rate of infusion.

Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of Vecuronium bromide infusion may be expected to proceed at rates comparable to that following a single bolus dose (see CLINICAL PHARMACOLOGY).

Infusion solutions of Vecuronium bromide can be prepared by adding Vecuronium bromide with an appropriate infusion solution such as Dextrose 5% Injection, Sodium Chloride 0.9% Injection, Dextrose 5% and Sodium Chloride 0.9% Injection, or Lactated Ringer's Injection.

Unused portions of infusion solutions should be discarded.

Infusion rates of Vecuronium bromide can be individualized for each patient using the following table:

Drug Delivery Rate	Infusion Delivery Rate
(mcg/kg/min)	(mL/kg/min)
	0.1 mg/mL*	0.2 mg/mL†
* 10 mg of Vecuronium bromide in 100 mL solution † 20 mg of Vecuronium bromide in 100 mL solution
0.7	0.007	0.0035
0.8	0.008	0.0040
0.9	0.009	0.0045
1.0	0.010	0.0050
1.1	0.011	0.0055
1.2	0.012	0.0060
1.3	0.013	0.0065

The following table is a guideline for mL/min delivery for a solution of 0.1 mg/mL (10 mg in 100 mL) with an infusion pump.

Vecuronium BROMIDE INFUSION RATE - mL/min

Amount of Drug mcg/kg/min	Patient Weight - kg
	40	50	60	70	80	90	100
0.7	0.28	0.35	0.42	0.49	0.56	0.63	0.70
0.8	0.32	0.40	0.48	0.56	0.64	0.72	0.80
0.9	0.36	0.45	0.54	0.63	0.72	0.81	0.90
1.0	0.40	0.50	0.60	0.70	0.80	0.90	1.00
1.1	0.44	0.55	0.66	0.77	0.88	0.99	1.10
1.2	0.48	0.60	0.72	0.84	0.96	1.08	1.20
1.3	0.52	0.65	0.78	0.91	1.04	1.17	1.30

NOTE: If a concentration of 0.2 mg/mL is used (20 mg in 100 mL), the rate should be decreased by one-half.

Use in Pediatrics

Pediatric patients (10 to 16 years of age) have approximately the same dosage requirements (mg/kg) as adults and may be managed the same way. Younger pediatric patients (1 to 10 years of age) may require a slightly higher initial dose and may also require supplementation slightly more often than adults.

Infants under 1 year of age but older than 7 weeks are moderately more sensitive to Vecuronium bromide on a mg/kg basis than adults and take about 1½ times as long to recover. (See PRECAUTIONS - Pediatric Use.) Information presently available does not permit recommendation on usage in pediatric patients less than 7 weeks of age (see PRECAUTIONS-Pediatric Use). There are insufficient data concerning continuous infusion of Vecuronium in pediatric patients, therefore, no dosing recommendations can be made.

COMPATIBILITY

Vecuronium bromide is compatible in solution with:

 

Sodium Chloride 0.9% Injection

 

Dextrose 5% Injection

 

Sterile Water for Injection

 

Dextrose 5% in Sodium Chloride 0.9% Injection

 

Lactated Ringer's Injection

Use within 24 hours of mixing with the above solutions.

Vecuronium bromide is also compatible in solution with: bacteriostatic water for injection (NOT FOR USE IN NEWBORNS)

Use within 5 days of mixing with the above solution.

Reconstituted Vecuronium bromide, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions such as thiopental) in the same syringe or administered simultaneously during intravenous infusion through the same needle or through the same intravenous line.

After Reconstitution

See DOSAGE AND ADMINISTRATION – Compatibility for diluents compatible with Vecuronium Bromide for Injection.

• When reconstituted with bacteriostatic water for injection: CONTAINS BENZYL ALCOHOL, WHICH IS NOT INTENDED FOR USE IN NEWBORNS. Use within 5 days. May be stored at room temperature or refrigerated.


• When reconstituted with sterile water for injection or other compatible IV solutions: Refrigerate vial. Use within 24 hours. Single use only. Discard unused portion.

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

How is Vecuronium Supplied

Vecuronium Bromide for Injection is supplied as follows:

NDC Number	Packaging Configuration	Vial Size
0703-2914-03	Vecuronium Bromide for Injection 10 mg (diluent not supplied) Shelf pack carton of 10 individual vials.	10 mL
0703-2925-03	Vecuronium Bromide for Injection 20 mg (diluent not supplied) Shelf pack carton of 10 individual vials.	20 mL

STORAGE

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use.

Rev. A 10/2011

Teva Parenteral Medicines, Inc.

Irvine, CA 92618

PRINCIPAL DISPLAY PANEL

Vecuronium Bromide for Injection 10 mg Tray Label Text

NDC 0703-2914-03

Rx only

Vecuronium

Bromide for Injection

10 mg*

*1 mg/mL when reconstituted to 10 mL

For IV Use Only

Sterile

10 x 10 mL Vials

TEVA

PRINCIPAL DISPLAY PANEL

Vecuronium Bromide for Injection 20 mg Tray Label Text

NDC 0703-2925-03

Rx only

Vecuronium

Bromide for Injection

20 mg*

*1 mg/mL when reconstituted to 20 mL

For IV Use Only

Sterile

10 x 20 mL Vials

TEVA

Vecuronium BROMIDE  Vecuronium bromide  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0703-2914 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vecuronium BROMIDE (Vecuronium) Vecuronium BROMIDE 10 mg  in 10 mL

Inactive Ingredients I

Prodeine

Prodeine may be available in the countries listed below.

Ingredient matches for Prodeine

Codeine

Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Prodeine in the following countries:

• Australia

Paracetamol

Paracetamol is reported as an ingredient of Prodeine in the following countries:

• Australia

International Drug Name Search

Panthenol-CT

Panthenol-CT may be available in the countries listed below.

Ingredient matches for Panthenol-CT

Dexpanthenol

Dexpanthenol is reported as an ingredient of Panthenol-CT in the following countries:

• Germany

International Drug Name Search