Patient Medication Information: uses, side effects, how to take - Apo Prednisone Tab 5mg
What is APO-PREDNISONE used for?
APO-PREDNISONE is used in adults and children 6 years of age and older to treat many different conditions. These include allergy and inflammation.
How does APO-PREDNISONE work?
APO-PREDNISONE is a corticosteroid. It decreases the body’s reaction to some diseases and reduces inflammation. It is only able to prevent or reduce symptoms of your condition, it does not cure it.
Serious Warnings and Precautions
APO-PREDNISONE can cause serious side effects, including:
- Pheochromocytoma crisis: Pheochromocytoma crisis (rare tumor of the adrenal gland), a fatal condition, has been reported in patients taking APO-PREDNISONE. Talk to your healthcare professional if you have a tumor of the adrenal glands.
- Viral infections: Taking APO-PREDNISONE with other medicines that weaken your immune system may increase your risk of infections. Viral infections, including chickenpox and measles, can have a more severe or even fatal course if you are not immune and are taking other medicines that weaken your immune system.
- Scleroderma Kidney Crisis: Your risk of developing scleroderma kidney crisis is higher if you have systemic sclerosis (chronic immune system disease) and are taking a daily dose of 15 mg or more of APO-PREDNISONE. This may be life threatening. This disease hardens and tightens skin, increases your blood pressure and causes you to make less urine.
- Strongyloides (threadworm) infestation: Talk to your healthcare professional if you have or had a threadworm (Strongyloides) infection. Taking APO-PREDNISONE if you have a threadworm infection, can lead to the rapid growth and spread of the parasite. This can result in serious side effects, such as, inflammation of the intestines (enterocolitis) and a potentially life-threatening bloodstream infection.
What are the ingredients in APO-PREDNISONE?
Medicinal ingredients: prednisone
Non-medicinal ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose.
APO-PREDNISONE comes in the following dosage forms:
Tablets: 1 mg, 5 mg and 50 mg
Do not use APO-PREDNISONE if you:
- are allergic to prednisone, any other corticosteroid medicine or any of the ingredients in the APO-PREDNISONE tablet.
- have a systemic fungal infection (a fungal infection that has spread throughout your body).
- have a viral infection, such as measles, chickenpox or herpes simplex of the eye.
- have recently received, or will receive, a type of vaccine called a live, or live/attenuated vaccine.
- have stomach or gut problems, such as an ulcer, ulcerative colitis or diverticulitis.
- have a bacterial or viral infection that is not being treated.
- have pancreatitis. Except pancreatitis caused by sarcoidosis (an inflammatory disease).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-PREDNISONE. Talk about any health conditions or problems you may have, including if you:
- have an infection, such as tuberculosis.
- have a bleeding or blood clotting problem.
- have osteoporosis (thin, fragile bones).
- have high blood pressure.
- have seizures (convulsions) or other neurological problems.
- have a thyroid problem (hypothyroidism).
- have a condition called myasthenia gravis that causes muscle pain, stiffness or weakness.
- have skin cancer (Kaposi’s sarcoma).
- have heart problems such as heart failure or have had a heart attack.
- have eye problems, such as ocular herpes simplex, glaucoma, cataracts, or any problems with the retina.
- have kidney disease.
- have received vaccines for smallpox, measles or chickenpox in the past.
- have liver problems such as cirrhosis.
- have mental health problems, such as feeling high (euphoria), depression, trouble sleeping, mood swings.
- have low levels of potassium or calcium in your blood.
- have stomach or gut problems.
- have Cushing’s disease, a condition where your body produces too much cortisol.
- have a weak immune response.
- have high blood sugar or are experiencing high levels of stress or have recently had surgery, an infection or experienced trauma.
- have a family history of diabetes.
- have muscle weakness and wasting caused by Duchenne’s muscular dystrophy or long term use of corticosteroids.
- have skin problems.
- are 65 years of age or older.
Other warnings you should know about:
You should tell any other healthcare professional that you see that you are being, or have been treated, with APO-PREDNISONE.
Driving and Using Machines: APO-PREDNISONE is likely to affect your ability to drive or use machines. Do not drive, operate machinery, or participate in any dangerous activities where alertness is required, until you know how APO-PREDNISONE affects you.
Surgery: Before you have any type of surgery, including dental procedures, tell your healthcare professional or dentist that you are taking APO-PREDNISONE.
Stopping treatment: Stopping treatment with APO-PREDNISONE should be gradual. Your healthcare professional will determine how to stop your treatment. If you suddenly stop taking APO-PREDNISONE, you may experience:
- Adrenal insufficiency, a condition where your body does not make enough of the cortisol hormone. This includes symptoms such as fainting, weakness, restlessness, nausea, vomiting, headache, dizziness, muscle weakness or joint pain.
- Withdrawal syndrome. This includes symptoms such as nausea, fatigue, decreased appetite, anorexia, shortness of breath, low blood pressure, low blood sugar levels, muscle pain, mood changes, fever, dehydration, general discomfort, joint pain, dizziness, peeling of skin and fainting.
- Tell your healthcare professional right away if you experience any of these symptoms after changing or stopping your treatment. Some of these symptoms can last for months after you stop taking APO-PREDNISONE.
Infections: Treatment with APO-PREDNISONE may reduce your body’s ability to fight infections. This can sometimes lead to infections caused by germs that rarely cause infection under normal situations.
- Taking APO-PREDNISONE with other medicines that weaken your immune system may increase your risk of infections.
- During treatment, avoid contact with anyone who has chickenpox, shingles or measles. If you were in contact with any of these infections, talk to your healthcare professional right away, even if there are no symptoms.
- The signs and symptoms of infections such as fever or inflammation may be hidden by the anti-inflammatory action of APO-PREDNISONE. You should talk to your healthcare professional if you have any symptoms of an infection.
- Do not have any immunizations (particularly with "live" vaccines such as measles, oral polio or yellow fever) without talking to your healthcare professional while you are being treated with APO-PREDNISONE.
Pregnancy and breastfeeding:
- If you are pregnant or planning on becoming pregnant while taking APO-PREDNISONE, there are specific risks that you should discuss with your healthcare professional.
- This medicine can cross the placenta and harm your baby.
- Tell your healthcare professional right away if you become pregnant while taking APO-PREDNISONE.
- APO-PREDNISONE can pass into your breast milk and harm your baby. Before taking this medicine, talk to your healthcare professional about the best way to feed your baby during treatment.
Fertility: APO-PREDNISONE may reduce fertility in both male in female patients. It can cause irregular periods in women and abnormal sperm in men.
Children: Corticosteroids can affect growth in children. Your healthcare professional will regularly monitor growth and development in growing children.
Lab tests and monitoring:
- If you are going to have a skin test for allergies or test for bacterial infection, tell your healthcare professional as APO-PREDNISONE may interfere with the results.
- You should monitor you fluid retention by recording your weight daily, observing your fluid intake and output.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-PREDNISONE:
alcohol
- grapefruit or grapefruit juice.
- medicines used to treat glaucoma, such as acetazolamide.
- medicines used to “thin” the blood and prevent blood clots, such as warfarin, coumadin.
- medicines used to treat myasthenia gravis, such as distigmine, neostigmine.
- antibiotics used to treat bacterial infections, such as isoniazid, erythromycin, clarithromycin, troleandomycin, rifampicin, rifabutin.
acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), used to treat
- fever and inflammation, such as ibuprofen.
- antacids used to treat stomach upset and heart burn such as calcium carbonate, magnesium hydroxide, or aluminum hydroxide.
- medicines used during surgery, such as pancuronium, vecuronium.
- medicines that treat skeletal muscle weakness, such as anticholinesterases.
- medicines used to prevent or alleviate nausea and vomiting, such as aprepitant.
- medicines used to treat inflammatory conditions, such as methylprednisolone.
- medicines used to treat epilepsy, such as barbiturates, carbamazepine, primidone, phenytoin, phenobarbital.
- medicines used to treat fungal infections, such as ketoconazole, itraconazole, amphotericin-B.
- medicines used to treat auto-immune disorders, such as cyclosporine, tacrolimus, cyclophosphamide.
- Mifepristone, the medicine used in aborting a pregnancy
- medicines used to treat breathing problems like asthma and COPD.
- medicines used to treat heart problems or high blood pressure, such as digoxin, diltiazem, salbutamol, salmeterol, terbutaline, formoterol.
- medicines used to treat high cholesterol, such as cholestyramine.
- medicines used to treat high blood pressure called “water pills” or diuretics.
- medicines used to treat HIV infections, such as indinavir, ritonavir.
- hormones, such as estrogen, oral birth control pills, growth hormone (somatropin).
- medicines used to treat diabetes.
- medicines used to treat tuberculosis.
- medicines used to treat various types of cancer, such as methotrexate, aminoglutethimide.
- vaccines.
How to take APO-PREDNISONE:
- Take APO-PREDNISONE exactly as directed by your healthcare professional.
- How often you take APO-PREDNISONE may vary depending on the condition being treated. It can be taken once daily, several times a day or on alternate days (every other day). Your healthcare professional will decide on the schedule that is best for you.
- Your healthcare professional may need to change your dose temporarily during treatment depending on your response, other conditions that you have and any side-effects you might experience.
- APO-PREDNISONE should not be stopped abruptly. Do not stop taking APO-PREDNISONE without talking to your healthcare professional.
- APO-PREDNISONE tables should be taken orally, with water.
Usual dose:
Adults and Children 6 years of age and older: Your healthcare professional will decide on the dose that is right for you based on the condition being treated and your response to the treatment. They will prescribe the smallest possible dose.
Your healthcare professional might adjust your initial dose until you have a satisfactory response. When your condition has improved, your healthcare professional will reduce your dose gradually.
Overdose:
If you think you, or a person you are caring for, have taken too much APO-PREDNISONE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What are possible side effects from using APO-PREDNISONE?
These are not all the possible side effects you may have when taking APO-PREDNISONE. If you experience any side effects not listed here, talk to your healthcare professional.
Side effects may include:
- abdominal pain, nausea, vomiting, diarrhea
- blurred vision
- constipation, bloating, indigestion, change in taste
- increased appetite, weight gain
- hiccups
- change in strength and reflexes, loss of muscle mass
- muscle pain and weakness
- confusion, forgetfulness
- dizziness, vertigo
- headache
- feeling of general discomfort or uneasiness
- increased sweating
- Increased physical movement
- loss of appetite
- restlessness
- wasting or shrinkage of tissues, organs, or muscles
- thinning hair, unusual hair growth, excessive hair growth in women
- slow wound healing, thin, fragile skin
- feeling tired
APO-PREDNISONE can cause abnormal lab tests including high fats in your blood and sugar in your urine. Your healthcare professional will decide when to perform lab tests and interpret the results.
Serious side effects and what to do about them:
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| UNKNOWN FREQUENCY | |||
| Adrenal insufficiency (low levels of cortisol produced by the adrenal glands): fainting, weakness, restlessness, nausea, vomiting, headache, dizziness, muscle weakness, joint pain | √ | ||
| Hypothyroidism (low level of parathyroid hormone): low calcium level, muscle spasm, twitching, brittle nails, tingling sensation in hands, feet, mouth, memory problems, depression. | √ | ||
| Slowed growth in children | √ | ||
| Scleroderma kidney crisis in patients already suffering from scleroderma (an autoimmune disease): sudden increase in blood pressure, kidney failure, hardened and tightened skin. | √ | ||
| Allergic reaction and Angioedema (swelling of the tissue under the skin): swelling of the hands, feet, ankles, genitals, face, lips, tongue, or throat, difficulty swallowing or breathing, itching, hives, rash, swelling of the digestive tract | √ | ||
| causing diarrhea, nausea, vomiting | |||
| Bradycardia (slow heart rate): fainting, dizziness, shortness of breath, fatigue, or chest pain | √ | ||
| Congestive heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, cough, rapid or irregular heartbeat | √ | ||
| Cushing’s syndrome (high blood cortisol): round “moon” face, rapid weight gain especially around the body, excess sweating, thinning of the skin, easy bruising, dry skin, stretch marks, muscle weakness, fat deposits between the shoulder blades (buffalo hump), wounds that are slow to heal | √ | ||
| Deep vein thrombosis (blood clot in the arm or leg): pain, tenderness, or swelling in your arm or leg, difficulty standing or walking, feeling of warmth in the arm or leg, red or discolored skin | √ | ||
| Edema: fluid retention, swelling of the hands, legs, or feet, muscle pain or cramps | √ | ||
Eye problems:
| √ | ||
| |||
| Gastrointestinal perforation (a hole in the wall of your stomach or bowels): severe abdominal pain and tenderness, nausea, vomiting, chills or fever, diarrhoea, gastric irritation, constipation, esophageal thrush (fungal infection of the esophagus caused by Candida), larger liver | √ | ||
| Heart attack: pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, irregular heartbeat | √ | ||
| Infections: fever, chills, feeling unwell, sore throat, body aches, fatigue | √ | ||
| Intracranial hypertension (increased pressure inside the skull and around the brain that can cause brain injury): severe headache, burning or prickling sensation in hands, arms and legs, weakness or paralysis of the legs, vision changes, sudden loss of vision, nausea, vomiting, dizziness | √ | ||
| Latent (delayed) Diabetes / High blood sugar: increased thirst, frequent urination, dry skin, headache, blurred vision, fatigue, tingling or numbness in the hands or feet | √ | ||
| Mental health problems: feeling depressed including thinking about suicide, feeling anxious, difficulty sleeping (insomnia), having delusions and/or hallucinations, mood swings, personality changes, memory problems, confusion, irritability, nervousness, euphoria (intense feelings of well-being, elation, happiness, excitement, and joy), drug dependence, paranoid state, altered perception and thinking | √ | ||
| Seizures or worsened episodes of seizures: convulsions or fits with or without loss of consciousness | √ | ||
| Bone problems: | √ | ||
| |||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Pulmonary embolism (blood clot in the lung): sharp pain in the chest, coughing blood or sudden shortness of breath | √ | ||
| Reactivation of Tuberculosis: coughing blood, pain in the chest, loss of appetite, unexplained weight loss, fever, chills, night sweats | √ | ||
| Irregular menstrual periods or missing of periods | √ | ||
| Skin problems: bruises or contusions, itching, spider veins, facial redness, swelling, puffiness, red or purple discolored spots , acne | √ | ||
| Stomach ulcer: severe, long-lasting stomach pain, black | √ | ||
| tarry stools or blood in stools, vomiting blood, heartburn, loss of appetite, weight loss | |||
| Stroke (blood clot in the brain): sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech, weakness or numbness in the face, arm or leg | √ | ||
| Thromboembolism (blood clot forms in a blood vessel and travels to another part of the body to block blood flow): shortness of breath, chest pain, rapid heartbeat, and swelling or pain in a limb | √ | ||
| High blood pressure: headache, shortness of breath, feeling unwell, swelling in your ankles and legs, heart palpitations | √ | ||
| Withdrawal symptoms: nausea, fatigue, decreased appetite, anorexia, shortness of breath, low blood pressure, low blood sugar levels, muscle pain, fever, general discomfort, joint pain, dizziness, peeling of skin, fainting | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature 15◦C to 30◦C.
Keep out of reach and sight of children.
If you want more information about APO-PREDNISONE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.