Dexium SP Injection

Generic Name: dexamethasone sodium phosphate injection

Dosage Form: FOR ANIMAL USE ONLY

DESCRIPTION:

Dexamethasone sodium phosphate (a synthetic adrenocortical steroid), is a white or slightly yellow crystalline powder.  It is freely soluble in water and is exceedingly hygroscopic.  Each mL of sterile aqueous solution contains Dexamethasone Sodium Phosphate 4 mg (equivalent to dexamethasone 3 mg).  Sodium Citrate 10 mg, Sodium Bisulfite 2 mg, Benzyl Alcohol 1.5% as preservative, in Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid to adjust pH to between 7.0 and 8.5.

CLINICAL PHARMACOLOGY

Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity.  Dexamethasone sodium phosphate is a salt of dexamethasone that is particularly suitable for intravenous administration because it is highly water soluble, permitting administration of relatively large doses in a small volume of diluent.  Dexamethasone, as a steroid, is equivalent in potency to some established steroids while being considerably more potent that others.  In the case of the dog, dexamethasone is found to be about equivalent in dosage to prednisone but about 30 to 40 times more potent than prednisolone.

INDICATIONS AND USAGE

Dexamethasone Sodium Phosphate Injection is indicated as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.

CONTRAINDICATIONS

Do not use in viral infections.  Except when used for emergency therapy, dexamethasone sodium phosphate is contraindicated in animals with tuberculosis and chronic nephritis.  Existence of congestive heart failure, osteoporosis and diabetes are relative contraindications.  In the presence of infection appropriate antibacterial agents should also be administered and should be continued for at least 3 days after discontinuance of the hormone and disappearance of all signs of infection.

WARNINGS

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis.  Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate.  Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

PRECAUTIONS

Because of the anti-inflammatory action of corticosteroids, signs of infection may be hidden and it may be necessary to stop treatment until diagnosis is made.  Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss and weight gains.

In infections characterized by overwhelming toxicity, dexamethasone sodium phosphate therapy, in conjunction with indicated antibacterial therapy, is effective in reducing mortality.  It is essential that the causative organism be known and an effective antibacterial agent be administered concurrently.  The injudicious use of adrenal hormones in animals with infections can be hazardous.

Use of corticosteroids, depending on dose, duration and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal.  In patients presently receiving or recently withdrawn from systemic corticosteroid should be considered in unusually stressful situations.

Use of corticosteroids, depending on dose, duration and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal.  In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in unusually stressful situations.

ADVERSE REACTIONS

The therapeutic use of dexamethasone sodium phosphate injection is unlikely to cause undesired accentuation of metabolic effects.  However, if continued corticosteroid therapy is anticipated, a high protein intake should be provided to keep the animal in positive nitrogen balance.  A retardant effect on wound healing should be considered when it is used in conjunction with surgery.  Euphoria or an improvement of attitude, and increased appetite are the usual manifestations.  Side effects such as glycosuria, hyperglycemia, diarrhea, polydipsia and polyuria have been observed in some species.

Side effects such as SAP and SGPT enzyme elevations, eosinopenia, and vomiting have occurred following use of synthetic corticosteroids in dogs.  Cushing's Syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Corticosteroids reportedly cause laminitis in horses.

DOSAGE AND ADMINISTRATION

For Intravenous Use Only.

Horses:  The usual intravenous dosage is 2.5 mg to 5 mg (based on 3 mg per mL of dexamethasone content).  If permanent corticosteroid effect is required, oral therapy with dexamethasone may be substituted.  When therapy is to be withdrawn after prolonged corticosteroid administration, the daily dose should be reduced gradually over a number of days, in stepwise fashion.

HOW SUPPLIED

Dexium-SP, dexamethasone sodium phosphate injection 4 mg/mL (equivalent to 3 mg/mL dexamethasone) is available in 100 mL multiple dose vials.

Store between 15 degrees and 30 degrees C (56 degrees and 86 degrees F).  Do not freeze.

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexium-SP  Multiple Dose Vial


DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP


4 mg per mL


Sterile


Equivalent to dexamethasone 3 mg/mL


FOR INTRAVENOUS USE IN HORSES ONLY


CAUTION:  Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.


ANADA #200-317 Approved by FDA


Net Contents:  100mL

DEXIUM-SP  dexamethasone sodium phosphate  injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 61133-0892 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexamethasone Sodium Phosphate (Dexamethasone) Dexamethasone 4 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Sodium Citrate   Sodium Bisulfite   Benzyl Alcohol   Water   Sodium Hydroxide   Hydrochloric Acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61133-0892-9 100 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200317	04/04/2009

Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)

Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)

Establishment
Name	Address	ID/FEI	Operations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group		256232216	manufacture

Revised: 02/2011Bimeda, Inc. Division of Cross Vetpharm Group

Belladonna and opium rectal

Generic Name: belladonna and opium (rectal) (BEL a DON a and OH pee um)

Brand names: B & O Supprettes 15-A, B & O Supprettes 16-A, B & O Supprettes 15-A, B & O Supprettes 16-A

What is belladonna and opium?

Belladonna is a natural substance made from a toxic plant. The medicinal form of belladonna has many effects in the body, such as decreasing muscle activity.

Opium is also a natural substance made from the seeds of a plant. The medicinal form of opium is a narcotic pain reliever.

The combination of belladonna and opium is used to treat moderate to severe pain caused by muscle spasms in the tubes that connect the kidneys to the bladder.

Belladonna and opium may also be used for purposes not listed in this medication guide.

What is the most important information I should know about belladonna and opium?

Do not take belladonna and opium rectal by mouth. It is for use only in your rectum. You should not use belladonna and opium if you have glaucoma, a muscle disorder, severe breathing problems, diarrhea caused by infection, severe liver or kidney disease, seizures, severe bleeding, a history of head injury, if you are debilitated, or if you have recently used drugs or alcohol. There are many other drugs that should not be used together with belladonna and opium rectal. Tell your doctor about all other medicines you use.

Before using belladonna and opium, tell your doctor about all of your medical conditions.

Opium may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my health care provider before using belladonna and opium rectal?

Do not use belladonna and opium if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) within the past 14 days.

Do not use belladonna and opium if you are also using linezolid (Zyvox), pramlintide (Symlin), procarbazine (Matulane), naltrexone (ReVia), or potassium supplement tablets or capsules.

You should not use this medication if you are allergic to belladonna or opium, or if you have:

• 
  

  glaucoma;

  
  


• 
  

  urination problems or an enlarged prostate;

  
  


• 
  

  severe liver or kidney disease;

  
  


• 
  

  a blockage in your stomach or intestines;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  diarrhea caused by infection;

  
  


• 
  

  severe bleeding;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  asthma or severe breathing disorder;

  
  


• 
  

  if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications; or

  
  


• 
  

  if you are bed-ridden or otherwise debilitated.

  
  

To make sure you can safely use belladonna and opium, tell your doctor if you have any of these other conditions:

• 
  

  liver or kidney disease;

  
  


• 
  

  heart disease, high or low blood pressure;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  chronic obstructive pulmonary disease (COPD) or other breathing problems;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  drug or alcohol addiction; or

  
  


• 
  

  an allergy to atropine or any narcotic pain medicine such as hydrocodone (Lortab, Vicodin), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), and others.

  
  

FDA pregnancy category C. It is not known whether belladonna and opium will harm an unborn baby. Opium may cause addiction or withdrawal symptoms in a newborn if the mother uses the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether belladonna and opium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Opium may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

How should I use belladonna and opium rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take a belladonna and opium rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the rectal suppository.

Try to empty your bowel and bladder just before using the belladonna and opium suppository.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom for at least an hour after using the suppository.

Drink plenty of water to prevent constipation while using belladonna and opium.

Belladonna and opium rectal is most often used 1 or 2 times per day. Do not use the suppositories more than 4 times per day. Follow your doctor's instructions. Call your doctor if your symptoms do not improve, or if they get worse while using this medication.

Do not stop using the medication suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using belladonna and opium rectal. Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze the suppositories. Ask your pharmacist how to properly dispose of any unused suppositories that are no longer needed. Keep track of the amount of medicine used from each new supply of this medication. Opium is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since belladonna and opium is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or excited, confusion or unusual behavior, muscle weakness, weak or shallow breathing, fainting, or coma.

What should I avoid while using belladonna and opium?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid becoming overheated or dehydrated during exercise and in hot weather. This medication can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol can increase certain side effects of belladonna and opium.

Belladonna and opium side effects

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

• 
  

  painful or difficult urination;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  weak, shallow breathing;

  
  


• 
  

  extreme weakness, feeling like you might pass out;

  
  


• 
  

  headache, confusion; or

  
  


• 
  

  severe constipation and stomach pain.

  
  

Less serious side effects may include:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  nausea, vomiting, constipation;

  
  


• 
  

  dry mouth, dry eyes;

  
  


• 
  

  decreased sense of taste; or

  
  


• 
  

  impotence, loss of interest in sex, or trouble having an orgasm.

  
  

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 belladonna and opium?

Many drugs can interact with belladonna and opium. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate);

  
  


• 
  

  cold or allergy medicines;

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Etrafon), nortriptyline (Pamelor), trazodone (Desyrel), and others;

  
  


• 
  

  medicine to treat a mental illness, such as clozapine (Clozaril, FazaClo), chlorpromazine (Thorazine), and others;

  
  


• 
  

  diazepam (Valium) or similar medicines such as alprazolam (Xanax), clorazepate (Tranxene), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), triazolam (Halcion), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others; or

  
  


• 
  

  narcotic medicine such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin, Vicoprofen), methadone (Dolophine, Methadose), morphine (Avinza, Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Percocet, Combunox), and others.

  
  

This list is not complete and other drugs may interact with belladonna and opium. 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 belladonna and opium resources

• Belladonna and opium Use in Pregnancy & Breastfeeding
• Belladonna and opium Drug Interactions
• Belladonna and opium Support Group
• 2 Reviews for Belladonna and opium - Add your own review/rating

Compare belladonna and opium with other medications

• Overactive Bladder

Where can I get more information?

• Your pharmacist can provide more information about belladonna and opium rectal.

Bayer Low Adult Strength Controlled-Release Tablets

Pronunciation: AS-pir-in
Generic Name: Aspirin
Brand Name: Examples include Bayer Low Adult Strength and ZORprin

Bayer Low Adult Strength Controlled-Release Tablets are used for:

Relieving arthritis symptoms. It may also be used for other conditions as determined by your doctor.

Bayer Low Adult Strength Controlled-Release Tablets are a salicylate. It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Do NOT use Bayer Low Adult Strength Controlled-Release Tablets if:

• you are allergic to any ingredient in Bayer Low Adult Strength Controlled-Release Tablets


• you are a child or teenager with influenza (flu) or chicken pox


• you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets


• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness), to aspirin, tartrazine, or an NSAID (eg, ibuprofen, naproxen, celecoxib)


• you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

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

Before using Bayer Low Adult Strength Controlled-Release Tablets:

Some medical conditions may interact with Bayer Low Adult Strength Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines or other substances


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chicken pox, or vitamin K deficiency


• if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Bayer Low Adult Strength Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Bayer Low Adult Strength Controlled-Release Tablets's effectiveness


• Anticoagulants (eg, heparin, warfarin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of their side effects, including risk of bleeding, may be increased by Bayer Low Adult Strength Controlled-Release Tablets


• Insulin and oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Bayer Low Adult Strength Controlled-Release Tablets


• Methotrexate or valproic acid because the risk of their actions and side effects may be increased by Bayer Low Adult Strength Controlled-Release Tablets


• Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Bayer Low Adult Strength Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bayer Low Adult Strength Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bayer Low Adult Strength Controlled-Release Tablets:

Use Bayer Low Adult Strength Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Bayer Low Adult Strength Controlled-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Bayer Low Adult Strength Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing unless directed by your health care provider.


• Take Bayer Low Adult Strength Controlled-Release Tablets with a full glass of water (8 oz/240 mL).


• Use Bayer Low Adult Strength Controlled-Release Tablets exactly as directed on the package, unless instructed differently by your doctor. If you are taking Bayer Low Adult Strength Controlled-Release Tablets without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of Bayer Low Adult Strength Controlled-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bayer Low Adult Strength Controlled-Release Tablets.

Important safety information:

• Bayer Low Adult Strength Controlled-Release Tablets has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Talk to your doctor before you take Bayer Low Adult Strength Controlled-Release Tablets or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Bayer Low Adult Strength Controlled-Release Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Bayer Low Adult Strength Controlled-Release Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


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


• Aspirin has been linked to a serious illness called Reye syndrome. Do not give Bayer Low Adult Strength Controlled-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• If Bayer Low Adult Strength Controlled-Release Tablets has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.


• Tell your doctor or dentist that you take Bayer Low Adult Strength Controlled-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Do not take Bayer Low Adult Strength Controlled-Release Tablets for at least 7 days after any surgery unless directed by your health care provider.


• Do not take Bayer Low Adult Strength Controlled-Release Tablets for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.


• Diabetes patients-Bayer Low Adult Strength Controlled-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use Bayer Low Adult Strength Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially those with a blood coagulation disorder.


• Different brands of Bayer Low Adult Strength Controlled-Release Tablets may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bayer Low Adult Strength Controlled-Release Tablets while you are pregnant. Bayer Low Adult Strength Controlled-Release Tablets are not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Bayer Low Adult Strength Controlled-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Bayer Low Adult Strength Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Bayer Low Adult Strength Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Heartburn; nausea; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Bayer Low Adult Strength side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Proper storage of Bayer Low Adult Strength Controlled-Release Tablets:

Store Bayer Low Adult Strength Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bayer Low Adult Strength Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Bayer Low Adult Strength Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Bayer Low Adult Strength Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Bayer Low Adult Strength Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bayer Low Adult Strength resources

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

Compare Bayer Low Adult Strength with other medications

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Dermovate

Generic Name: clobetasol (Topical application route)

kloe-BAY-ta-sol PROE-pee-oh-nate

Commonly used brand name(s)

In the U.S.

• Clobevate


• Clobex


• Cormax


• Embeline


• Embeline E


• Embeline Scalp Application


• Olux


• Olux/Olux-E Complete Pack


• Olux-E


• Temovate


• Temovate E

In Canada

• Clobetasol Propionate


• Dermovate


• Dermovate Scalp Application


• Med Clobetasol Scalp Application


• Ratio-Clobetasol

Available Dosage Forms:

• Cream


• Ointment


• Gel/Jelly


• Spray


• Solution


• Foam


• Emollient Cream


• Lotion


• Shampoo

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Clobetasol

Uses For Dermovate

Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution and foam are used for scalp problems, the lotion and spray are used for moderate to severe plaque psoriasis, and the shampoo is used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Dermovate

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical gel, foam, cream, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical gel, foam, cream, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical spray, lotion, or shampoo have not been established in children and use is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobetasol topical in the elderly.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

• Perioral dermatitis (skin problem) or


• Rosacea (skin problem)—Should not be used in patients with these conditions.

Proper Use of clobetasol

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

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

To use the cream, foam, gel, lotion, ointment, or spray:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

To use the foam, scalp solution, or shampoo:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.


• Do not cover the scalp (e.g., shower cap, bathing cap) while it is being treated.


• Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream, gel, or ointment):
    
    • Adults—Apply to the affected area of the skin two times per day.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two times per day.
    
    
    • Children—Use is not recommended.
    
    
  
  


• For plaque psoriasis:
  
  • For topical dosage form (foam):
    
    • Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (spray):
    
    • Adults—Spray to the affected area of the skin two times per day.
    
    
    • Children—Use is not recommended.
    
    
  
  


• For scalp problems:
  
  • For topical dosage form (foam or scalp solution):
    
    • Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (shampoo):
    
    • Adults—Apply to the affected area of the scalp once a day.
    
    
    • Children—Use is not recommended.
    
    
  
  

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

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.

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

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

Precautions While Using Dermovate

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Make sure your doctor knows that you are using clobetasol gel. You may need to stop using this medicine several days before having surgery.

Do not use cosmetics or other skin care products on the treated areas.

Dermovate 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

• Burning or stinging at the application site

Less common

• Burning sensation of the skin


• dry skin


• flushing or redness of the skin


• itching, scaling, severe redness, soreness, or swelling of the skin


• skin irritation


• skin rash, encrusted, scaly and oozing


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

Incidence not known

• Burning, itching, and pain in hairy areas, or pus at the root of the hair


• hair loss


• redness and scaling around the mouth


• thinning of the hair


• thinning, weakness, or wasting away of the skin

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

• Cough


• sore throat

Less common

• Burning, itching, and pain in hairy areas, or pus at the root of the hair


• changes in skin coloring


• body aches or pain


• congestion


• cough


• dryness or soreness of the throat


• fever


• headache


• hoarseness


• raised, dark red, wart-like spots on the skin, especially when used on the face


• skin discomfort


• stuffy or runny nose


• tender, swollen glands in the neck


• trouble with swallowing


• unusual tiredness or weakness


• voice changes

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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: Dermovate 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 Dermovate resources

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

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Dritho-Scalp Cream

Pronunciation: AN-thrah-lin
Generic Name: Anthralin
Brand Name: Examples include Dritho-Scalp and Zithronal RR

Dritho-Scalp Cream is used for:

Treating psoriasis.

Dritho-Scalp Cream is a topical antimitotic. It works by slowing the reproduction of skin cells.

Do NOT use Dritho-Scalp Cream if:

• you are allergic to any ingredient in Dritho-Scalp Cream


• you have active inflamed psoriatic eruptions

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

Before using Dritho-Scalp Cream:

Some medical conditions may interact with Dritho-Scalp Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have inflamed psoriatic eruptions, folliculitis, other skin problems, or kidney disease

Some MEDICINES MAY INTERACT with Dritho-Scalp Cream. Because little, if any, of Dritho-Scalp Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dritho-Scalp Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dritho-Scalp Cream:

Use Dritho-Scalp Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dritho-Scalp Cream is for external use only. Avoid contact with the eyes, nose, and mouth. Do not apply to folds or creases of the skin.


• Wash and completely dry the affected area. Apply a small amount onto the lesions and rub it in gently and carefully.


• At the end of each skin treatment period, rinse the skin completely with cool to lukewarm water before washing it with soap. The margins of lesions may gradually become stained (purple/brown) as you continue to use Dritho-Scalp Cream, but the staining will disappear after your treatment is finished.


• For scalp treatment, wash your hair before applying Dritho-Scalp Cream. Rinse your hair with water, and comb it to remove scaling. Apply Dritho-Scalp Cream while your scalp is still damp. Rub the medicine into the lesions well. Do not apply Dritho-Scalp Cream to areas where there are no lesions.


• Remove any medicine that may be behind the ears.


• At the end of each scalp treatment period, rinse your hair and scalp completely with cool to lukewarm water. Shampoo your hair and scalp to remove any additional cream (which may have become red/brown).


• Wash your hands immediately after using Dritho-Scalp Cream, unless your hands are part of the treated area.


• If excessive soreness or spreading of lesions occurs after using Dritho-Scalp Cream, contact your health care provider.


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

Ask your health care provider any questions you may have about how to use Dritho-Scalp Cream.

Important safety information:

• Dritho-Scalp Cream may be harmful if swallowed. If you may have taken Dritho-Scalp Cream by mouth, contact your local poison control center or emergency room immediately.


• Dritho-Scalp Cream may stain skin or hair. Temporary discoloration of hair and fingernails may occur while using Dritho-Scalp Cream, but can be minimized by carefully applying the medicine.


• To prevent discoloration of the tub or shower, always rinse the tub or shower with lukewarm water right after washing or showering. Use a cleanser to remove any deposit on the surface of the tub or shower.


• Use protective dressings while using Dritho-Scalp Cream to prevent staining of clothing and bed sheets unless instructed otherwise by your doctor. Staining of fabric may be permanent.


• Contact with plastics and other materials may cause staining and should be avoided.


• Use Dritho-Scalp Cream with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Dritho-Scalp Cream, discuss with your doctor the benefits and risks of using Dritho-Scalp Cream during pregnancy. It is unknown if Dritho-Scalp Cream is excreted in breast milk. Do not breast-feed while taking Dritho-Scalp Cream.

Possible side effects of Dritho-Scalp Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Irritation; staining of treated areas.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe skin soreness; spreading of lesions.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dritho-Scalp side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Dritho-Scalp Cream:

Store Dritho-Scalp Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dritho-Scalp Cream out of the reach of children and away from pets.

General information:

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


• Dritho-Scalp Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dritho-Scalp Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dritho-Scalp resources

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

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