Radepur

Radepur may be available in the countries listed below.

Ingredient matches for Radepur

Chlordiazepoxide

Chlordiazepoxide is reported as an ingredient of Radepur in the following countries:

• Germany

International Drug Name Search

Felicipin

Felicipin may be available in the countries listed below.

Ingredient matches for Felicipin

Felodipine

Felodipine is reported as an ingredient of Felicipin in the following countries:

• Bulgaria

International Drug Name Search

TriamCreme Lichtenstein

TriamCreme Lichtenstein may be available in the countries listed below.

Ingredient matches for TriamCreme Lichtenstein

Triamcinolone

Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of TriamCreme Lichtenstein in the following countries:

• Germany

International Drug Name Search

Debax

Debax may be available in the countries listed below.

Ingredient matches for Debax

Captopril

Captopril is reported as an ingredient of Debax in the following countries:

• Austria

International Drug Name Search

Indomen

Indomen may be available in the countries listed below.

Ingredient matches for Indomen

Indometacin

Indometacin is reported as an ingredient of Indomen in the following countries:

• Singapore

International Drug Name Search

Opidol

Opidol may be available in the countries listed below.

Ingredient matches for Opidol

Tramadol

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

• Bangladesh

International Drug Name Search

Oxaliplatin Mayne

Oxaliplatin Mayne may be available in the countries listed below.

Ingredient matches for Oxaliplatin Mayne

Oxaliplatin

Oxaliplatin is reported as an ingredient of Oxaliplatin Mayne in the following countries:

• Denmark


• Estonia


• Ireland


• Latvia


• Lithuania


• Luxembourg

International Drug Name Search

Zibramax

Zibramax may be available in the countries listed below.

Ingredient matches for Zibramax

Azithromycin

Azithromycin is reported as an ingredient of Zibramax in the following countries:

• Indonesia

International Drug Name Search

Ritemed Ampicillin

Ritemed Ampicillin may be available in the countries listed below.

Ingredient matches for Ritemed Ampicillin

Ampicillin

Ampicillin trihydrate (a derivative of Ampicillin) is reported as an ingredient of Ritemed Ampicillin in the following countries:

• Philippines

International Drug Name Search

Meclozine

Scheme

Prop.INN

ATC (Anatomical Therapeutic Chemical Classification)

R06AE05

CAS registry number (Chemical Abstracts Service)

0000569-65-3

Chemical Formula

C25-H27-Cl-N2

Molecular Weight

390

Therapeutic Categories

Antiemetic

Histamine, H₁-receptor antagonist

Chemical Names

1-(4-Chlorbenzhydryl)-4-(3-methylbenzyl)piperazine (WHO)

1-[(4-Chlorophenyl)phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine

Foreign Names

• Meclozinum (Latin)
• Meclozin (German)
• Méclozine (French)
• Meclozina (Spanish)

Generic Names

• Meclozina (OS: DCIT)
• Meclozine (OS: BAN)
• Méclozine (OS: DCF)
• Histaméthizine (IS: DCF vieille)
• Meclizine (IS)
• UCB 5062 (IS: UCB)
• Meclizine Hydrochloride (OS: JAN)
• Meclozine Hydrochloride (OS: BANM)
• Meclizine Hydrochloride (PH: USP 32)
• Meclozindihydrochlorid (PH: Ph. Eur. 6)
• Méclozine (chlorhydrate de) (PH: Ph. Eur. 6)
• Meclozine Hydrochloride (PH: BP 2010, Ph. Eur. 6)
• Meclozini hydrochloridum (PH: Ph. Int. 2, Ph. Eur. 6)

Brand Names

• Agyrax
  UCB, France; Vedim, Tunisia



• Emesafene (Meclozine and Pyridoxine)
  ACE, Netherlands



• Meclizine HCl Amide
  Amide, Hong Kong



• Navidoxine
  Alfa, Peru



• Acliz
  Aristopharma, Bangladesh



• Agyrax
  Pierre Fabre, Belgium; UCB, Luxembourg; Vedim, Algeria



• Antivert
  Pfizer, United States



• Antivery
  Chemist, Bangladesh



• Avert Radi
  Bio-Pharma, Bangladesh



• Avert
  Bio-Pharma, Bangladesh



• Bonadoxina
  Pfizer, Belize; Pfizer, Costa Rica; Pfizer, Guatemala; Pfizer, Honduras; Pfizer, Nicaragua; Pfizer, El Salvador



• Bonamina
  Pfizer, Chile



• Bonamine
  McNeil Consumer Healthcare, Canada; Pfizer, Philippines



• Bonine
  Insight, United States; Pfizer, Russian Federation



• Chiclida
  Andromaco, Mexico; Torrents, Spain



• Clizine
  VPP, Taiwan



• Dramamine
  Pfizer, United States



• Dramine
  Uriach, Spain



• Emenil
  Incepta, Bangladesh



• Emetostop
  Specifar, Greece; Specifar, Romania



• Emezin
  Eskayef, Bangladesh



• Hipermex
  Ethical, Dominican Republic



• Itinerol B6 (Meclozine and Pyridoxine)
  Vifor, Switzerland



• Meclin
  Apsen, Brazil



• Meclizine HCl
  Par, United States; Sandoz, United States; Watson, United States



• Navicalm
  Arafarma, Spain; Confar, Portugal



• Navidoxine
  UCB Pharma, Malta



• Navidoxine (Meclozine and Pyridoxine)
  UCB, Oman



• Nomosic
  Drug International, Bangladesh



• Postadoxine
  UCB, Philippines



• Postafen
  UCB, Denmark; UCB, Finland; UCB, Iceland; UCB, Norway; UCB, Sweden



• Postafene
  Pierre Fabre, Belgium; UCB, Luxembourg



• Sea-Legs
  GlaxoSmithKline, Ethiopia; Reckitt Benckiser, New Zealand; SSL International, United Kingdom



• Suprimal
  Alfaco, Netherlands



• Vertina
  Square, Bangladesh



• Vomec
  Beximco, Bangladesh



• Vomiseda
  Souriree, Taiwan

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)
WHO	World Health Organization

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

Micotenk

Micotenk may be available in the countries listed below.

Ingredient matches for Micotenk

Itraconazole

Itraconazole is reported as an ingredient of Micotenk in the following countries:

• Argentina

International Drug Name Search

Bronchotussine

Bronchotussine may be available in the countries listed below.

Ingredient matches for Bronchotussine

Bromhexine

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

• Greece


• Malta

International Drug Name Search

Tamsumedin

Tamsumedin may be available in the countries listed below.

Ingredient matches for Tamsumedin

Tamsulosin

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

• Germany

International Drug Name Search

Nicorette Chewing Gum

Nicorette Chewing Gum may be available in the countries listed below.

Ingredient matches for Nicorette Chewing Gum

Nicotine

Nicotine is reported as an ingredient of Nicorette Chewing Gum in the following countries:

• Slovakia

Nicotine resinate (a derivative of Nicotine) is reported as an ingredient of Nicorette Chewing Gum in the following countries:

• Australia


• Austria


• Belgium


• Brazil


• Chile


• Croatia (Hrvatska)


• Estonia


• Finland


• Germany


• Hungary


• Iceland


• Ireland


• Israel


• Italy


• Latvia


• Lithuania


• Malta


• Mexico


• New Zealand


• Portugal


• Russian Federation


• Singapore


• Slovakia


• Slovenia


• South Africa


• Spain


• Thailand


• United Kingdom


• Venezuela

International Drug Name Search

Benzilum

Benzilum may be available in the countries listed below.

Ingredient matches for Benzilum

Domperidone

Domperidone is reported as an ingredient of Benzilum in the following countries:

• Vietnam

International Drug Name Search

Azibact

Azibact may be available in the countries listed below.

Ingredient matches for Azibact

Azithromycin

Azithromycin monohydrate (a derivative of Azithromycin) is reported as an ingredient of Azibact in the following countries:

• Germany

International Drug Name Search

Venofusin Bicarb Sodico

Venofusin Bicarb Sodico may be available in the countries listed below.

Ingredient matches for Venofusin Bicarb Sodico

Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Venofusin Bicarb Sodico in the following countries:

• Spain

International Drug Name Search

Budesoderm

Budesoderm may be available in the countries listed below.

Ingredient matches for Budesoderm

Budesonide

Budesonide is reported as an ingredient of Budesoderm in the following countries:

• Greece

International Drug Name Search

Norcal

Norcal may be available in the countries listed below.

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

Ingredient matches for Norcal

Calcium Borogluconate

Calcium Borogluconate is reported as an ingredient of Norcal in the following countries:

• South Africa

Magnesium

Magnesium is reported as an ingredient of Norcal in the following countries:

• South Africa

International Drug Name Search

Kurepane

Kurepane may be available in the countries listed below.

Ingredient matches for Kurepane

Domperidone

Domperidone is reported as an ingredient of Kurepane in the following countries:

• India

Pantoprazole

Pantoprazole is reported as an ingredient of Kurepane in the following countries:

• India

International Drug Name Search

Dilt-XR

Generic Name: diltiazem (Oral route)

dil-TYE-a-zem

Commonly used brand name(s)

In the U.S.

• Cardizem


• Cardizem CD


• Cardizem LA


• Cartia XT


• Dilacor XR


• Dilt-CD


• Diltia XT


• Dilt-XR


• Diltzac


• Matzim LA


• Taztia XT


• Tiazac

Available Dosage Forms:

• Capsule, Extended Release


• Tablet, Extended Release


• Tablet


• Capsule, Extended Release, 24 HR


• Capsule, Extended Release, 12 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Benzothiazepine

Uses For Dilt-XR

Diltiazem is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Diltiazem is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, diltiazem relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload .

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

Before Using Dilt-XR

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 have not been performed on the relationship of age to the effects of diltiazem in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of diltiazem in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving diltiazem .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride

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


• Amiodarone


• Aprepitant


• Atazanavir


• Atenolol


• Atorvastatin


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clonidine


• Clozapine


• Colchicine


• Crizotinib


• Dantrolene


• Dilevalol


• Dronedarone


• Droperidol


• Erythromycin


• Esmolol


• Everolimus


• Fentanyl


• Labetalol


• Levobunolol


• Lurasidone


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Ranolazine


• Simvastatin


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Tolvaptan

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.

• Alfentanil


• Alfuzosin


• Amlodipine


• Aspirin


• Buspirone


• Carbamazepine


• Celecoxib


• Cilostazol


• Cimetidine


• Clopidogrel


• Colestipol


• Cyclosporine


• Dalfopristin


• Digitoxin


• Digoxin


• Dutasteride


• Efavirenz


• Enflurane


• Fosaprepitant


• Fosphenytoin


• Guggul


• Indinavir


• Lithium


• Lovastatin


• Methylprednisolone


• Midazolam


• Moricizine


• Nevirapine


• Nifedipine


• Phenytoin


• Quinupristin


• Rifampin


• Rifapentine


• Ritonavir


• Sirolimus


• St John's Wort


• Tacrolimus


• Triazolam

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Bowel blockage, severe or


• Congestive heart failure—Use with caution. May make this condition worse .

• Heart attack or


• Heart block (type of abnormal heart rhythm, can use if have a pacemaker that works properly) or


• Hypotension (low blood pressure), severe or


• Lung problem (e.g., pulmonary congestion) or


• Sick sinus syndrome (type of abnormal heart rhythm, can use if have a pacemaker that works properly)—Should not be used in patients with these conditions .

• Kidney disease or


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

Proper Use of diltiazem

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

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Swallow the extended-release tablet or extended-release capsule whole. Do not open, crush, or chew it. It is best to take the extended-release capsule on an empty stomach .

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 chest pain:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 30 milligrams (mg) four times a day before meals and at bedtime. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 180 mg once a day either in the evening or in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—At first, 120 mg once a day in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

• For high blood pressure:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 180 to 240 milligrams (mg) once a day either in the morning or at bedtime. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—At first, 180 to 240 mg once a day in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your 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 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 Dilt-XR

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem .

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness .

Dilt-XR 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

• Body aches or pain


• congestion


• cough


• dryness or soreness of throat


• fever


• hoarseness


• runny nose


• tender or swollen glands in neck


• trouble in swallowing


• voice changes

Less common

• Chest pain or discomfort


• chills


• diarrhea


• difficult or labored breathing


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• flushing or redness of skin, especially on face and neck


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• shivering


• shortness of breath


• slow or irregular heartbeat


• sore throat


• sweating


• swelling of hands, ankles, feet, or lower legs


• tightness in chest


• trouble sleeping


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Blistering, peeling, or loosening of skin


• itching


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


• no heart beat


• red irritated eyes


• red skin lesions, often with a purple center


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

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

• Sneezing


• stuffy nose

Less common

• Acid or sour stomach


• belching


• constipation


• continuing ringing or buzzing or other unexplained noise in ears


• degenerative disease of the joint


• difficulty in moving


• hearing loss


• heartburn


• indigestion


• lack or loss of strength


• muscle aching or cramping


• muscle pains or stiffness


• pain or tenderness around eyes and cheekbones


• rash


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep

Incidence not known

• Hair loss or thinning of hair

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: Dilt-XR 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.

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More Dilt-XR resources

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

• Dilt-XR Prescribing Information (FDA)


• Dilt-XR 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Diltiazem Prescribing Information (FDA)


• Cardizem Consumer Overview


• Cardizem MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem Prescribing Information (FDA)


• Cardizem CD Prescribing Information (FDA)


• Cardizem CD 24-Hour Sustained-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem LA Prescribing Information (FDA)


• Cardizem LA 24-Hour Extended-Release Beads Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cartia XT Prescribing Information (FDA)


• DILT-CD Prescribing Information (FDA)


• Dilacor XR Prescribing Information (FDA)


• Diltia XT Prescribing Information (FDA)


• Diltiazem Hydrochloride Monograph (AHFS DI)


• Matzim LA Prescribing Information (FDA)


• Taztia XT Prescribing Information (FDA)


• Taztia XT 24-Hour Extended-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Tiazac Prescribing Information (FDA)


• Tiazac Consumer Overview

Compare Dilt-XR with other medications

• Angina Pectoris Prophylaxis
• Atrial Fibrillation
• Atrial Flutter
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome
• Supraventricular Tachycardia

Rhophylac

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)

Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:

• 
  

  heart disease or a history of coronary artery disease (hardened arteries);

  
  


• 
  

  high triglycerides (a type of fat in the blood);

  
  


• 
  

  a bleeding disorder (such as hemophilia); or

  
  


• 
  

  immune globulin A (IgA) deficiency.

  
  

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

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

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  fever, chills, shaking, back pain, dark colored urine;

  
  


• 
  

  rapid breathing, feeling short of breath.

  
  


• 
  

  urinating less than usual or not at all, swelling, rapid weight gain; or

  
  


• 
  

  pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

  
  

Less serious side effects may include:

• 
  

  joint or muscle pain;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  feeling weak or tired;

  
  


• 
  

  mild itching or skin rash;

  
  


• 
  

  nausea, diarrhea, vomiting, stomach pain; or

  
  


• 
  

  pain or tenderness where the medicine was injected.

  
  

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 RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. 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 Rhophylac resources

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

• Rhophylac Prescribing Information (FDA)


• Rhophylac Consumer Overview


• Rhophylac Advanced Consumer (Micromedex) - Includes Dosage Information


• Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayrho-D full dose


• HyperRHO S/D Full Dose Prescribing Information (FDA)


• MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)


• RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)


• WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Rhophylac with other medications

• Idiopathic Thrombocytopenic Purpura
• Rh-Isoimmunization

Where can I get more information?

• Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

See also: Rhophylac side effects (in more detail)

Oxsoralen-Ultra

Generic Name: methoxsalen (Oral route)

meth-OX-a-len

Oral route(Capsule)

Methoxsalen with UV radiation should be used only by physicians who have special competence in diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. Photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy. Risks of therapy include ocular damage, aging of the skin, and skin cancer (including melanoma). The soft gelatin capsules should not be used interchangeably with regular methoxsalen hard gelatin capsules due to greater bioavailability and earlier photosensitization onset time .

Commonly used brand name(s)

In the U.S.

• 8-Mop


• Oxsoralen-Ultra

Available Dosage Forms:

• Capsule

Therapeutic Class: Antipsoriatic

Chemical Class: Psoralen

Uses For Oxsoralen-Ultra

Methoxsalen belongs to the group of medicines called psoralens. It is used along with ultraviolet light (found in sunlight and some special lamps) in a treatment called PUVA to treat vitiligo, a disease in which skin color is lost, and psoriasis, a skin condition associated with red and scaly patches.

Methoxsalen is also used with ultraviolet light in the treatment of white blood cells. This treatment is called photopheresis and is used to treat the skin problems associated with mycosis fungoides, which is a type of lymphoma.

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

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 the product labeling, methoxsalen is used in certain patients with the following medical conditions:

• Alopecia areata


• Atopic dermatitis


• Eczema


• Lichen planus


• Skin that is abnormally sensitive to sunlight

Before Using Oxsoralen-Ultra

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:

Methoxsalen is a very strong medicine that increases the skin's sensitivity to sunlight. In addition to causing serious sunburns if not properly used, it has been reported to increase the chance of skin cancer and cataracts. Also, like too much sunlight, PUVA can cause premature aging of the skin. Therefore, methoxsalen should be used only as directed and it should not be used simply for suntanning. Before using this medicine, be sure that you have discussed its use with your doctor.

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

Some of the side effects are more likely to occur in children up to 12 years of age, since these children may be more sensitive to the effects of methoxsalen.

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 methoxsalen in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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 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.

• Phenytoin

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:

• Allergy to sunlight (or family history of) or


• Infection or


• Lupus erythematosus or


• Porphyria or


• Skin cancer (history of) or


• Skin conditions (other) or


• Stomach problems—Use of PUVA may make the condition worse

• Eye problems, such as cataracts or loss of the lens of the eye—The light treatment may make the condition worse or may cause damage to the eye

• Heart or blood vessel disease (severe)—The heat or prolonged standing associated with each light treatment may make the condition worse

• Liver disease—Condition may cause increased blood levels of the medicine and cause an increase in side effects

Proper Use of methoxsalen

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

Eating certain foods while you are taking methoxsalen may increase your skin's sensitivity to sunlight. To help prevent this, avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while you are being treated with this medicine.

Methoxsalen usually comes with patient directions. Read them carefully before using this medicine.

This medicine may take 6 to 8 weeks to really help your condition. Do not increase the amount of methoxsalen you are taking or spend extra time in the sunlight or under an ultraviolet lamp. This will not make the medicine act any more quickly and may result in a serious burn.

If this medicine upsets your stomach:

• Patients taking the hard gelatin capsules may take them with food or milk.


• Patients taking the soft gelatin capsules may take them with low-fat food or low-fat milk.

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 oral dosage form (hard gelatin capsule):
  
  • For treating mycosis fungoides and psoriasis:
    
    • Adults and children 12 years of age and over—Dose is based on body weight and must be determined by your doctor. However, the usual dose is 0.6 mg per kilogram (kg) (0.27 mg per pound) of body weight taken two hours before UVA exposure. This treatment (methoxsalen and UVA) is given two or three times a week with the treatment spaced at least forty-eight hours apart.
    
    
    • Children up to 12 years of age—Dose must be determined by your doctor.
    
    
  
  
  • For vitiligo:
    
    • Adults and children 12 years of age and over—20 milligrams (mg) per day taken two to four hours before ultraviolet light A (UVA) exposure. This treatment (methoxsalen and UVA) is given two or three times a week with the treatment spaced at least forty-eight hours apart.
    
    
    • Children up to 12 years of age—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (soft gelatin capsule):
  
  • For psoriasis:
    
    • Adults and children 12 years of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.4 mg per kg (0.18 mg per pound) of body weight taken one and one-half to two hours before UVA exposure. This treatment (methoxsalen and UVA) is given two or three times a week, with the treatment spaced at least forty-eight hours apart.
    
    
    • Children up to 12 years of age—Dose must be determined by your doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

If you are late in taking, or miss taking, a dose of this medicine, notify your doctor so your light treatment can be rescheduled. Remember that exposure to sunlight or ultraviolet light must take place a certain number of hours after you take the medicine or it will not work. For patients taking the hard gelatin capsules, this is 2 to 4 hours. For patients taking the soft gelatin capsules, this is 1½ to 2 hours. If you have any questions about this, check with your doctor.

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 Oxsoralen-Ultra

Your doctor should check your progress at regular visits to make sure this medicine is working and that it does not cause unwanted effects. Eye examinations should be included.

This medicine increases the sensitivity of your skin and lips to sunlight. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn. If you must go out during the daylight hours:

• Before each treatment, cover your skin for at least 24 hours by wearing protective clothing, such as long-sleeved shirts, full-length slacks, wide-brimmed hat, and gloves. In addition, protect your lips with a special sun block lipstick that has a skin protection factor (SPF) of at least 15. Check with your doctor before using sun block products on other parts of your body before a treatment, since sun block products should not be used on the areas of your skin that are to be treated.


• After each treatment, cover your skin for at least 8 hours by wearing protective clothing. In addition, use a sun block product that has a skin protection factor (SPF) of at least 15 on your lips and on those areas of your body that cannot be covered.

If you have any questions about this, check with your health care professional.

Your skin may continue to be sensitive to sunlight for some time after treatment with this medicine. Use extra caution for at least 48 hours following each treatment if you plan to spend any time in the sun. In addition, do not sunbathe anytime during your course of treatment with methoxsalen.

For 24 hours after you take each dose of methoxsalen, your eyes should be protected during daylight hours with special wraparound sunglasses that totally block or absorb ultraviolet light (ordinary sunglasses are not adequate). This is to prevent cataracts. Your doctor will tell you what kind of sunglasses to use. These glasses should be worn even in indirect light, such as light coming through window glass or on a cloudy day.

This medicine may cause your skin to become dry or itchy. However, check with your doctor before applying anything to your skin to treat this problem.

Oxsoralen-Ultra 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:

• Blistering and peeling of skin


• reddened, sore skin


• swelling (especially of feet or lower legs)

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

• Itching of skin


• nausea

Less common

• Dizziness


• headache


• mental depression


• nervousness


• trouble in sleeping

Treatment with this medicine usually causes a slight reddening of your skin 24 to 48 hours after the treatment. This is an expected effect and is no cause for concern. However, check with your doctor right away if your skin becomes sore and red or blistered.

There is an increased risk of developing skin cancer after use of methoxsalen. You should check your body regularly and show your doctor any skin sores that do not heal, new skin growths, and skin growths that have changed in the way they look or feel.

Premature aging of the skin may occur as a result of prolonged methoxsalen therapy. This effect is permanent and is similar to what happens when a person sunbathes for long periods of time.

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: Oxsoralen-Ultra 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 Oxsoralen-Ultra resources

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

• Oxsoralen-Ultra Concise Consumer Information (Cerner Multum)


• Oxsoralen-Ultra Soft-Gelatin Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Oxsoralen-Ultra Prescribing Information (FDA)


• Methoxsalen Professional Patient Advice (Wolters Kluwer)


• 8-MOP Prescribing Information (FDA)


• 8-MOP Hard-Gelatin Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Uvadex Prescribing Information (FDA)

Compare Oxsoralen-Ultra with other medications

• Psoriasis

Telbans DS

Telbans DS may be available in the countries listed below.

Ingredient matches for Telbans DS

Theophylline

Theophylline is reported as an ingredient of Telbans DS in the following countries:

• Japan

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Prednisolone Sodium Succinate

Prednisolone Sodium Succinate may be available in the countries listed below.

Ingredient matches for Prednisolone Sodium Succinate

Prednisolone

Prednisolone Sodium Succinate (USAN) is known as Prednisolone in the US.

International Drug Name Search

Glossary

USAN	United States Adopted Name

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

Balgin

Balgin may be available in the countries listed below.

Ingredient matches for Balgin

Dimeticone

Dimeticone is reported as an ingredient of Balgin in the following countries:

• Japan

Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Balgin in the following countries:

• Japan

International Drug Name Search

Rani 2

Rani 2 may be available in the countries listed below.

Ingredient matches for Rani 2

Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Rani 2 in the following countries:

• Australia

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Bacsul Balsámico

Bacsul Balsámico may be available in the countries listed below.

Ingredient matches for Bacsul Balsámico

Guaifenesin

Guaifenesin is reported as an ingredient of Bacsul Balsámico in the following countries:

• Peru

Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Bacsul Balsámico in the following countries:

• Peru

Trimethoprim

Trimethoprim is reported as an ingredient of Bacsul Balsámico in the following countries:

• Peru

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Aminofilina Ariston

Aminofilina Ariston may be available in the countries listed below.

Ingredient matches for Aminofilina Ariston

Aminophylline

Aminophylline is reported as an ingredient of Aminofilina Ariston in the following countries:

• Ecuador

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Cefgam

Cefgam may be available in the countries listed below.

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Cefprozil

Cefprozil monohydrate (a derivative of Cefprozil) is reported as an ingredient of Cefgam in the following countries:

• Greece

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Fepradinol

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0063075-47-8

Chemical Formula

C12-H19-N-O2

Molecular Weight

209

Therapeutic Categories

Analgesic, antipyretic and anti-inflammatory agent

Non-steroidal anti-inflammatory drug, NSAID

Chemical Name

(±)-α-[[(2-Hydroxy-1,1-dimethylethyl)amino]methyl]benzyl alcohol

Foreign Names

• Fepradinolum (Latin)
• Fepradinol (German)
• Fepradinol (French)
• Fepradinol (Spanish)

Generic Name

• EL 608 (IS)

Brand Names

• Sinalgia
  Hormona, Mexico



• Dalgen
  Recordati, Spain



• Sinalgia
  Hormona, Mexico

International Drug Name Search

Glossary

IS	Inofficial Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Desowen

desonide

Dosage Form: cream, ointment and lotion
Desowen®

(desonide cream, ointment and lotion)

cream 0.05%

ointment 0.05%

and lotion 0.05%

For Dermatologic Use Only –

Not for Ophthalmic Use –

Rx Only

Desowen Description

Desowen® Cream 0.05%, Ointment 0.05%, and Lotion 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 [(1methylethylidene) bis(oxy)]-,(11β,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Chemically, desonide is C24H32O6. It has the following structural formula:

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water.

Each gram of Desowen® Cream contains 0.5 mg of desonide in a base of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid, and synthetic beeswax.

Each gram of Desowen® Ointment contains 0.5 mg of desonide in a base of mineral oil and polyethylene.

Each gram of Desowen® Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.

Desowen - Clinical Pharmacology

Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Desowen® (desonide cream, ointment and lotion) Cream, Ointment, and Lotion indicate that they are in the low to medium range of potency as compared with other topical cortico-steroids.

Indications and Usage for Desowen

Desowen® Cream, Ointment and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Contraindications

Desowen® Cream, Ointment and Lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Precautions

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS - Pediatric use).

If irritation develops, Desowen® Cream, Ointment or Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desowen® (desonide cream, ointment and lotion) Cream, Ointment or Lotion should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1. 
   

   This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

   
   


2. 
   

   This medication should not be used for any disorder other than that for which it was prescribed.

   
   


3. 
   

   The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.

   
   


4. 
   

   Patients should report to their physician any signs of local adverse reactions.

   
   

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of Desowen® Cream, Ointment, and Lotion.

Pregnancy

Teratogenic Effects

Pregnancy category C:

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with Desowen® Cream, Ointment or Lotion. It is also not known whether Desowen® Cream, Ointment or Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Desowen® Cream, Ointment and Lotion should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desowen® Cream, Ointment or Lotion is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%, irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.

The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Overdosage

Topically applied Desowen® (desonide cream, ointment and lotion) Cream, Ointment and Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Desowen Dosage and Administration

Desowen® Cream, Ointment or Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Desowen® Cream, Ointment and Lotion should not be used with occlusive dressings.

How is Desowen Supplied

Desowen® (desonide cream) Cream 0.05% is supplied in tubes containing:

60 g NDC 0299-5770-60

Desowen® (desonide ointment) Ointment 0.05% is supplied in tubes containing:

60 g NDC 0299-5775-60

Desowen® (desonide lotion) Lotion 0.05% is supplied in bottles containing:

2 fl oz NDC 0299-5765-02

4 fl oz NDC 0299-5765-04

Storage Conditions: Store between 2° and 30°C (36° and 86°F).

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177, USA

Mfd. by: DPT Laboratories, Ltd.

San Antonio, Texas 78215, USA

GALDERMA is a registered trademark.

325007-0203

Revised: April 2007

PACKAGE LABEL

NDC 0299-5770-60

Rx Only

Desowen®

(desonide cream)

Cream 0.05% NET WT. 60 g

GALDERMA

For External Use Only. Not for Ophthalmic Use. Store between 2° and 30°C (35° and 86°F).

Usual dosage: Apply a small amount to affected areas 2 or 3 times daily. See package insert for complete prescribing information.

Each gram contains: desonide 0.5 mg in a cream base consisting of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid and synthetic beeswax.

Lot no. and exp. date on crimp.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

303017-0402

Desowen®

(desonide ointment)

NDC 0299-5775-60

Rx Only

Ointment 0.05% NET WT. 60 g

GALDERMA

For External Use Only. Not for Ophthalmic Use.

Store between 2° and 30°C (35° and 86°F).

Usual dosage: Apply a small amount to affected areas two or three times daily. See package insert for complete prescribing information.

Each gram contains: deconide 0.5 mg in an ointment base consisting of mineral oil and polyethylene.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth Texas, 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

310020-1102

Rx only NDC 0299-5765-04

Desowen®

(desonide lotion)

LOTION 0.05%

4 FL OZ

(118 mL)

GALDERMA

FOR EXTERNAL USE ONLY.  NOT FOR OPHTHALMIC USE. STORE BETWEEN 2° AND 30°C (36° AND 86°F). SHAKE WELL BEFORE USING.

Usual dosage: Apply a small amount to affected areas 2 or 3 times daily.

See package insert for complete prescribing information.

Contains: Active: desonide 0.05% w/w (0.5 mg/g). Inactive: cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment. Lot number and expiration date on bottom of bottle.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas

76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas

78215 USA

GALDERMA is a registered trademark.

326074-0702

Desowen   desonide  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0299-5770 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desonide (Desonide) Desonide 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Citric acid   Isopropyl palmitate   Polysorbate 60   Potassium sorbate   Propyl gallate   Propylene glycol   Water   Sodium hydroxide   Sorbic Acid   Stearic Acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0299-5770-60 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019048	12/14/1984

Desowen   desonide  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0299-5775 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desonide (Desonide) Desonide 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Mineral Oil

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0299-5775-60 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071425	01/24/1992	03/31/2011

Desowen   desonide  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0299-5765 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desonide (Desonide) Desonide 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Cetyl alcohol   Edetate sodium   Glyceryl Monostearate   Light Mineral Oil   Methylparaben   Propylene glycol   Propylparaben   Water   Sodium lauryl sulfate   Sorbitan monostearate   Stearyl alcohol   Citric acid   Sodium hydroxide

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0299-5765-02 59 g In 1 BOTTLE None 2 0299-5765-04 118 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072354	07/15/1988

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Operations
DPT Laboratories, Ltd.		832224526	MANUFACTURE

Revised: 02/2010Galderma Laboratories, L.P.

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