Sterapred DS

Prednisone is a prescription medication used to treat:

• low corticosteroid levels. Corticosteroids are steroids naturally produced by the body that are required for normal body function.
• arthritis
• allergic reactions
• asthma
• multiple sclerosis. Multiple sclerosis is a disease in which nerves do not function properly due to inflammation.
• lupus. Lupus is a disease in which the body’s immune system attacks itself.
• severe psoriasis. Psoriasis is a disease in which the skin becomes red, irritated, and flaky.
• certain conditions affecting the lungs, skin, eyes, kidneys, blood, thyroid, stomach, and intestines. Prednisone frequently treats diseases of these organs by reducing inflammation.
• some types of cancer such as leukemia (cancer in bone marrow) and lymphoma (cancer of white blood cells)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Sterapred DS is part of the drug classes:

• Corticosteroids acting locally

• Glucocorticoids

Serious side effects have been reported with prednisone. See “Drug Precautions” section.

Common side effects of prednisone include:

• dizziness
• hypertension
• slow healing
• retention of fluid resulting in swelling
• acne
• electrolyte imbalances
• decreased immune system function
• decreased bone density
• depression
• inappropriate happiness
• nausea
• joint and muscle pain
• blurred vision
• headache
• abnormal distribution of body fat

This is not a complete list of prednisone side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amphotericin B (Ambisome and Amphotec)
• potassium depleting diuretics such as acetazolamide (Diamox) and methazolamide (Neptazane)
• anticholinesterases such as neostigmine (Prostigmin) and pyridostigmine (Mestinon)
• warfarin (Coumadin)
• medications to treat diabetes
• isoniazid
• bupropion (Zyban and Wellbutrin)
• cholestyramine (Prevalite)
• cyclosporine (Neoral, Sandimmune, Gengraf)
• digoxin (Lanoxin)
• estrogens and oral contraceptives
• fluoroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin)
• barbituates such as phenobarbital (Donnatal)
• phenytoin (Dilantin)
• carbamazepine (Tegretol, Carbatrol, Equetro, Teril, Epitol)
• rifampin (Rifadin, Rimactane)
• ritonavir (Norvir)
• indinavir (Crixivan)
• macrolide antibiotics such as erythromycin and azithromycin (Zithromax)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• quetiapine (Seroquel)
• thalidomide (Thalomid)
• vaccines

This is not a complete list of prednisone drug interactions. Ask your doctor or pharmacist for more information.

Before taking prednisone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have thyroid, liver, kidney, or heart disease
• have recently experienced an infection (bacterial, viral, or fungal)
• have recently had or will have a surgical procedure
• have an autoimmune disease like HIV/AIDS
• have had an allergic reaction to prednisone
• have had tuberculosis
• have osteoporosis
• plan to receive a vaccination
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store prednisone at room temperature.
• Keep this and all medicines out of the reach of children.

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 prednisone in children. However, pediatric patients are more likely to have slower growth and bone problems if prednisone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

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

Pregnancy

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.

• Desmopressin
• Rotavirus Vaccine, Live

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.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Asparaginase
• Bemiparin
• Bosutinib
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Daclatasvir
• Darunavir
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dipyrone
• Drospirenone
• Droxicam
• Elvitegravir
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etonogestrel
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Gestodene
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Levonorgestrel
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mestranol
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Nifedipine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norethindrone
• Norgestimate
• Norgestrel
• Olaparib
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piperaquine
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tacrolimus
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Ulipristal
• Valdecoxib

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.

• Alcuronium
• Alfalfa
• Amobarbital
• Aprobarbital
• Aspirin
• Atracurium
• Butabarbital
• Butalbital
• Clarithromycin
• Fluconazole
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Ketoconazole
• Licorice
• Mephobarbital
• Metocurine
• Montelukast
• Ospemifene
• Pancuronium
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rifapentine
• Saiboku-To
• Secobarbital
• Vecuronium
• Warfarin

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:

• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Eye infection or
• Glaucoma or
• Heart attack, recent or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Infection (eg, bacterial, virus, fungus, or parasite) or
• Mood changes, including depression or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Peptic ulcer, active or history of or
• Personality changes or
• Stomach or intestinal problems (eg, diverticulitis, ulcerative colitis) or
• Thyroid problems or
• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Fungal infections or
• Herpes simplex eye infection—Should not be used in patients with these conditions.

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

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you 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.

This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are being treated with prednisone, do not have any immunizations (vaccines) without your doctor's approval. Prednisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while taking this medicine.

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

• Aggression
• agitation
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mood changes
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Abdominal or stomach cramping or burning (severe)
• abdominal or stomach pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of the skin
• decrease in height
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in the back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

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

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp 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.

Applies to prednisone: compounding powder, oral delayed release tablet, oral solution, oral tablet

General

The most commonly reported adverse effects associated with corticosteroid use include fluid retention, alteration in glucose tolerance, high blood pressure, behavior and mood changes, increased appetite and weight gain. Occurrence is often associated with dose and duration of therapy; long-term effects include HPA suppression, Cushingoid appearance, cataracts and increased intraocular pressure/glaucoma, osteoporosis and vertebral compression fractures.[Ref]

Metabolic

Frequency not reported: Decreased carbohydrate and glucose tolerance, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipid abnormal, negative nitrogen balance caused by protein catabolism, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, potassium loss, sodium retention with resulting edema, increased appetite and weight gain, anorexia and weight loss, hypertriglyceridemia, hypercholesterolemia[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypotension, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, necrotizing angiitis, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis[Ref]

Endocrine

Frequency not reported: Adrenal insufficiency associated symptoms including arthralgias, buffalo hump, amenorrhea, postmenopausal bleeding or menstrual irregularities, development of cushingoid state, hyperthyroidism, hypothyroidism, moon face, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress as in trauma, surgery, or illness), increased or decreased motility and number of spermatozoa[Ref]

Ocular

Frequency not reported: Blurred vision, cataracts (including posterior subcapsular cataracts) central serous chorioretinopathy, secondary bacterial, fungal, and viral infections, exophthalmos, glaucoma, increased intraocular pressure[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, abdominal pain, constipation, diarrhea, gastric irritation, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting[Ref]

Immunologic

Frequency not reported: Immunosuppression, aggravation/masking of infections, decreased resistance to infection[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, aseptic necrosis of femoral and humeral heads, increased risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures, suppression of growth in pediatric patients[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, allergic reactions[Ref]

Nervous system

Frequency not reported: Arachnoiditis, benign intracranial hypertension, convulsions, dementia, dizziness, EEG abnormalities, impaired cognition, increased intracranial pressure with papilledema, increased motor activity, ischemic neuropathy, severe tiredness or weakness, meningitis, neuritis, neuropathy, paraparesis/paraplegia, sensory disturbances[Ref]

Psychiatric

Frequency not reported: Amnesia, anxiety, delirium, depression, emotional instability and irritability, euphoria, hallucinations, severe psychiatric symptoms, insomnia, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of preexisting psychiatric conditions, restlessness, schizophrenia, verbal memory loss, withdrawn behavior[Ref]

Hematologic

Frequency not reported: Anemia, neutropenia, febrile neutropenia, moderate leukocytosis, lymphopenia, eosinopenia, polycythemia[Ref]

Dermatologic

Frequency not reported: Acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymosis and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, telangiectasis, thin fragile skin, thinning scalp hair, urticaria, hypertrichosis[Ref]

Hepatic

Frequency not reported: ALT, AST and alkaline phosphatase elevations (usually reversible upon discontinuation), hepatomegaly[Ref]

Respiratory

Frequency not reported: Hiccups, pulmonary edema[Ref]

Oncologic

Frequency not reported: Kaposi's sarcoma[Ref]

Other

Frequency not reported: Vertigo, pyrexia, abnormal fat deposits, malaise[Ref]

Some side effects of Sterapred DS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.