Patient Medication Information: uses, side effects, how to take - Florinef
What is FLORINEF used for?
FLORINEF is used to treat:
- addison’s disease (also called adrenal insufficiency). This is a condition caused by the adrenal glands in the body not being able to make enough of certain hormones such as cortisol and aldosterone.
- a condition called ‘salt losing adrenogenital syndrome’. This occurs when the body is not able to retain enough salt.
How does FLORINEF work?
FLORINEF belongs to a group of medicines called steroids. Steroids occur naturally in the body and help control the balance of water and salt in the body. FLORINEF acts by boosting the body with steroids that retain water and salt in the body.
What are the ingredients in FLORINEF?
Medicinal ingredients: fludrocortisone acetate
Non-medicinal ingredients: corn starch, dicalcium phosphate, lactose anhydrous, lactose monohydrate, magnesium stearate, sodium benzoate, talc
FLORINEF comes in the following dosage forms:
Tablets: 0.1 mg
Do not use FLORINEF if:
- you are allergic to fludrocortisone acetate, or any other steroid medicine, or any other ingredients in FLORINEF.
- you have a fungal infection or any other untreated infection.
- you have herpes simplex of the eye.
- you have chickenpox or smallpox.
- you have recently received a type of vaccine called a live or live / attenuated vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLORINEF. Talk about any health conditions or problems you may have, including if you:
- are lactose intolerant because FLORINEF contains lactose.
- have a rare hereditary problem of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- have used other steroid medicines in the past.
- have or have had an infection, such as herpes simplex, chicken pox, tuberculosis.
- have a weak immune response.
- have a cancer that has spread from where it started to another part of your body (metastatic cancer).
- have a tumor in the adrenal glands (pheochromocytoma).
- have a high blood pressure.
- have heart problems, such as heart failure.
- have edema (water retention).
- have bleeding problems or blood clotting problems.
- have Cushing’s disease (caused by an excess of cortisol hormone).
- have or have had seizures (convulsions) or other neurological problems.
- have myasthenia gravis, a condition that causes progressive muscle pain and weakness.
- have certain eye problem, such as glaucoma, cataract, herpes infection or any problems with the retina.
- have mental health problems, such as depression.
- have diabetes.
- have thyroid problems.
- have liver problems.
- have kidney problems.
- have or have had stomach or gut problems, such as ulcers, ulcerative colitis.
- have low level of potassium or calcium in your blood.
- have brittle bones (osteoporosis).
- have skin rash (exanthema).
- have recently had or are about to have any vaccination.
are pregnant or trying to become pregnant.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
Infections:
- FLORINEF can make it hard for your body to respond to stress and illness. It can make you more likely to get infections and it can make infections that might be hidden in your body active again.
- You should avoid coming into contact with people who have measles or chicken pox while taking FLORINEF. If you are exposed, tell your healthcare professional right away.
- Surgery: Before you have any operation, tell your healthcare professional that you are taking FLORINEF.
Blood Tests:
- You may need to take blood tests while on FLORINEF. Your healthcare professional will determine when to perform blood tests and how to interpret the results.
- Based on the results of your blood tests, your healthcare professional will decide if you should take any dietary supplements or if you need to adjust your diet.
Driving and using machines: FLORINEF may cause dizziness, vision changes and fatigue. Do not drive, use machinery, or do activities that require you to be alert until you know how FLORINEF affects you.
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 FLORINEF:
- medicines used to treat glaucoma (caused by increased pressure in the eye)
- medicines used to relax you during surgery
- medicines used to treat inflammatory conditions such as methylprednisolone
- medicines used to treat myasthenia gravis (a muscle condition) such as neostigmine
- medicines used to ‘thin’ the blood (anticoagulants such as warfarin)
- medicines used to treat diabetes
- medicines used to treat high blood pressure
- medicines used for heart problems or high blood pressure such as digoxin and diltiazem
- medicines used to help prevent organ rejection such as cyclosporine and tacrolimus
- medicines used to treat epilepsy such as barbiturates, carbamazepine, phenobarbital, phenytoin
- medicines used to treat fungal infections such as itraconazole, ketoconazole
- antibiotics, used to treat bacterial infections, such as erythromycin, clarithromycin, rifabutin
- medicines used to treat tuberculosis such as isoniazid and rifampin
- medicines used to treat HIV infections such as ritonavir, cobicistat
- medicines used to prevent nausea and vomiting caused by cancer chemotherapy treatment such as aprepitant and fosaprepitant
- hormones, such as estrogen and somatropin
- nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation, such as ibuprofen, acetylsalicylic acid
- medicines that can lower potassium levels such as amphotericin-B (used to treat fungal infections) and “water pills” (also called diuretics, used to lower high blood pressure)
- medicines used to treat thyroid conditions
- vaccines
grapefruit and grapefruit juice
How to take FLORINEF:
- Take FLORINEF exactly as your healthcare professional tells you to.
- Do not stop taking FLORINEF or change your dose without talking to your healthcare professional. Your healthcare professional will tell you how to reduce your dose gradually when you no longer need to take FLORINEF.
Usual dose:
Your healthcare professional will decide on the dose that is right for you based on your health condition and the progression of the disease.
Overdose:
If you think you, or a person you are caring for, have taken too much FLORINEF, 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.
What are possible side effects from using FLORINEF?
These are not all the possible side effects you may have when taking FLORINEF. If you experience any side effects not listed here, tell your healthcare professional. nausea
- insomnia
- headache
- spinning sensation (vertigo)
- weight gain
- fainting (syncope)
- slow healing
- darkening of skin or nails
- muscle cramps, spasms and pains
- irregular menstruation
- abnormal hair growth
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| UNKNOWN FREQUENCY | |||
| Adrenal suppression: dizziness, nausea, vomiting, abdominal pain, weakness, fatigue, generally feeling unwell, headache | |||
| Allergic reaction, including serious reactions (anaphylaxis): rash, hives, | |||
| itching, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, skin rash with swelling, itching and large welts, chest pain or tightness | |||
| Blood clots, in the leg or arm: pain, redness and swelling, skin is warm to the touch | |||
| Congestive heart failure: shortness of breath with activity or when lying down, fatigue, swelling in the legs, ankles and feet, rapid or irregular heartbeat, cough or wheezing | |||
| Cushing’s Syndrome (excess 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 | |||
| Diabetes: frequent urination, thirst | |||
| Edema: fluid retention, swelling of the hands, legs or feet | |||
Eye problems: Cataracts: blurry vision, eye pain Glaucoma: increased pressure in your eyes, eye pain, halos around lights or coloured images, red eyes Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision Exophthalmos (bulging of the eye) | |||
| High blood pressure: headaches, feeling unwell, shortness of breath | |||
| Infections: fever, chills, feeling unwell, sore throat, body aches, fatigue | |||
| Mental health problems: feeling depressed including thinking about suicide, feeling anxious, insomnia, confusion, hallucinations (seeing or hearing things that are not really there), euphoria (intense feelings of well-being, elation, happiness, excitement and joy), mood swings, personality changes, memory problems, irritability | |||
| Muscle weakness/loss | |||
| Osteonecrosis (degradation of bone tissue): progressive or persistent pain or limited range of motion in a joint or limb | |||
| Osteoporosis (bone / joint pain, broken bone or weakening of the bones): In situations where healthy people would not normally break a bone you may have sudden pain in any location and especially in the wrist, spine or hip. This may be a broken bone. | |||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, tenderness when touching the abdomen | |||
| Seizures: convulsions or fits, with or without loss of consciousness | |||
| Skin problems: bruising (red or purplish mark on the skin) | |||
| Stomach ulcers: stomach pain, blood in stools and/or vomiting blood | |||
| Slowing of growth in children | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Keep refrigerated between 2°C and 8°C.
- Keep out of reach and sight of children.
If you want more information about FLORINEF:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com or by calling 1-844-483-5636.