Solu Cortef - Consumer Medicine Information
|Condition:||Addison's Disease, Adrenocortical Insufficiency, Asthma, acute, Inflammatory Conditions, Inflammatory Bowel Disease, Shock|
|Form:||Liquid solution, Intramuscular (IM), Intravenous (IV)|
|Ingredients:||hydrocortisone sodium succinate, dibasic sodium phosphate dried, monobasic sodium phosphate anhydrous, sterile water for injection|
(hydrocortisone sodium succinate for injection)
About this Medication
What the Medication is Msed For
SOLU-CORTEF (hydrocortisone sodium succinate for injection) is used in the treatment of various conditions such as allergy or inflammation; it is used to replace corticosteroid hormone when the body does not produce enough due to problems with the adrenal glands (e.g. adrenal insufficiency).
SOLU-CORTEF is also used in emergencies, for the treatment of certain conditions of shock or severe allergic reactions, where high blood levels of hydrocortisone are required rapidly.
What it Does
SOLU-CORTEF is a corticosteroid hormone (glucocorticoid). It decreases the body’s immune response to certain diseases and reduces symptoms such as swelling and redness
When it Should not be Used
Do not use SOLU-CORTEF if you have:
- had an allergic reaction to hydrocortisone or any other steroid medicine or any of the ingredients found in SOLU-CORTEF; or
- a fungal infection or any untreated infection. herpes simplex of the eye
- chickenpox or smallpox
- received a type of vaccine called a live or live / attenuated vaccine
- low platelet count
What the Medicinal Ingredient Is
Hydrocortisone sodium succinate.
What the Nonmedicinal Ingredients Are
SOLU-CORTEF contains dibasic sodium phosphate dried and monobasic sodium phosphate anhydrous.
Act-O-Vials contains Sterile Water for Injection.
What Dosage Forms it Comes In
SOLU-CORTEF comes in a two-compartment vial (Act-O-Vial) containing sterile white powder in the lower compartment and sterile water in the upper compartment. It is available in 4 strengths:
100 mg / 2mL water Act-O-Vials
250 mg / 2mL water Act-O-Vials
500 mg / 4mL water Act-O-Vials
1000 mg / 8mL water Act-O-Vials
Warnings and Precautions
Before taking SOLU-CORTEF, talk to your doctor or pharmacist if:
- you have or have had an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm); Ifyou or your child is exposed to measles or chickenpox during treatment with SOLU-CORTEF, contact you doctor immediately.
- you have bleeding problem; blood clotting problem
- you have brittle bone (osteoporosis)
- you have high blood pressure
- you have heart problems such as heart failure you have kidney disease
- you have diabetes
- you have or have had seizures (convulsions) or other neurological problems
- you have thyroid problem
- you have muscle pain or weakness (such as myasthenia gravis)
- you have skin cancer (Kaposi’s sarcoma), or a tumor of the adrenal glands (Pheochromocytoma)
- you have certain eye disease such as glaucoma, cataracts, herpes infection or any problems with the retina
- you have liver disease such as cirrhosis
- you have certain mental or mood conditions (such as depression)
- you have or have had stomach or gut problems (ulcer, ulcerative colitis)
- you have low potassium or calcium you have a weak immune response
- you have Cushing’s disease (caused by an excess of cortisol hormone)
- you are pregnant or trying to become pregnant you are breast-feeding or planning to breast-feed
Before you have any operation, tell your doctor, dentist or anesthetist that you are taking SOLU-CORTEF.
Children: Corticosteroids can affect growth in children.
Interactions With This Medication
Before taking SOLU -CORTEF, please talk to your doctor or pharmacist about all your other medications including those you bought without prescription, herbal or natural product and especially if are taking the following:
- drugs to treat glaucoma and epilepsy such as acetazolamide
- drugs to ‘thin’ the blood (anticoagulant such as warfarin, coumadin)
- drugs to treat myasthenia gravis ( a muscle condition) such as distigmine and neostigmine
- antibiotics (erythromycin, clarithromycin and troleandomycin, Rifampicin and rifabutin)
- aspirin and non steroidal anti-inflammatory drugs (such as ibuprofen)
- drugs to treat inflammatory conditions (such as methylprednisolone)
- drugs to treat epilepsy (such as barbiturates and phenytoin)
- drugs for antifungal infections (such as ketoconazole) cyclosporine
- drugs for heart problems or high blood pressure as diltiazem and digoxin
- drugs to treat high cholesterol (cholestyramine) water pills (diuretics)
- drugs to treat HIV infections such as indinavir or ritonavir
- vaccines – tell your doctor if you have recently had or are about to have any vaccination.
- Hormones, such as estrogen and somatropin. Drugs to treat diabetes.
- Drugs to treat tuberculosis.
Proper Use of This Medication
DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM
- Press down on plastic activator to force sterile water into the lower compartment.
- Gently agitate to effect solution.
- Remove plastic tab covering center of stopper.
- Sterilize top of stopper with a suitable germicide.
- Insert needle straight through center of stopper until tip is just visible. Invert vial upside-down and withdraw dose.
The initial dose of SOLU-CORTEF depends on the severity of the condition. Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity.
SOLU-CORTEF can affect growth in children so your doctor will prescribe the lowest dose that will be effective for your child.
When your condition has improved, your dose will be reduced gradually.
SOLU -CORTEF should not be stopped abruptly. Do not stop taking SOLU-CORTEF without talking to your doctor.
|In case of drug overdose, contact your doctor, or a poison control centre, or go to emergency room of the hospital near you immediately, even if there are no symptoms|
If you are concerned that you may have missed a dose, talk to you doctor or nurse immediately.
Side Effects and What to do About Them
The following is a list of side effects that may occur with SOLU-CORTEF. This is not a complete list. Therefore, check with your doctor immediately if you notice or are bothered by any unusual symptoms.
SOLU-CORTEF may hide symptoms of infections, may cause latent infections to become active, and may induce infections by normally inoffensive organisms due to lowered body resistance.
Potential Side Effects of SOLU-CORTEF Include
- anaphylaxis (a severe, life-threatening allergic reaction)
- cardiac arrest
- bronchospasm (narrowing of the airway)
- heart failure heart attack
- arrhythmia (irregular heartbeat)
- high and low blood pressure
- blood clots
- thrombophlebitis (vein inflammation)
- thrombosis (blood clot within a blood vessel)
- thin fragile skin
- impaired wound healing
- ecchymosis (spots caused by ruptured blood vessels)
- petechiae (reddish spot containing blood that appears in skin)
- stretch marks
- dry, scaly skin
- lightening or darkening of an area of skin
- suppressed reactions to skin tests
- thinning hair
Endocrine and Metabolism
- development of Cushingoid state (abnormal bodily condition caused by excess corticosteroids)
- moon face (enlargement of chin and forehead)
- weight gain
- abnormal fat deposits
- suppression of pituitary-adrenal axis (a condition that could lead to disabling the body’s responses to physiological stress such as severe infections or trauma)
- suppression of growth in children
- abnormal hair growth
- new symptoms of diabetes
- stomach ulcer
- stomach bleeding
- inflammation of the pancreas and esophagus
- perforation of the bowel
- vomiting or altered sense of taste (with rapid administration of large doses)
- abdominal pain bloating
- bowl/bladder dysfunction
- increased appetite
- enlarged liver
- Pancreatitis (inflammation of the pancreas)
- loss of muscle mass
- muscle weakness
- muscle pain
- malaise (feeling of general discomfort or uneasiness)
- pathological fractures
- vertebral compression fractures
- tendon rupture, (particularly of the Achilles tendon)
- Charcot joint disease (neuropathic arthropathy)
- joint pain
- pain and tenderness
- impaired sensation, strength, and reflexes
- sensation of tingling, tickling, prickling, or burning of a person's skin
- increased intraocular pressure
- emotional instability
- euphoria (intense feelings of well-being, elation, happiness, excitement and joy)
- mood swings
- personality changes
- suicidal ideation
- menstrual irregularities
- increased or decreased motility and number of sperm
- Above normal white blood cell count
- Abnormal blood tests
- fatigue, hiccups
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Congestive heart failure||✓|
|Fluid retention, swelling||✓|
|High blood pressure (symptoms of which are headaches or feeling unwell)||✓|
|Stomach ulcers (burst or bleeding ulcers; symptoms of which are stomach pain, blood in stools and/or vomiting blood)||✓|
|Wounds that are slow to heal||✓|
|Psychological disorders (feeling depressed including thinking about suicide, feeling anxious, insomnia)||✓|
|Irregular menstrual periods||✓|
|Diabetes (symptoms of which can be frequent urination and thirst)||✓|
|Cramps and spasms||✓|
|Visual problems, failing eyesight||✓|
|Reactivation of tuberculosis (symptoms of which could be coughing blood or pain in the chest)||✓|
|Infections (symptoms might include a raised temperature and feeling unwell)||✓|
|Allergic reactions in the form of angioedema (a severe skin reaction with swelling, itching and large welts).||✓|
This is not a complete list of side effects. For any unexpected effects while taking SOLU-CORTEF contact your doctor or pharmacist.
How to Store It
Before Reconstitution: store SOLU-CORTEF Act-O-Vial at room temperature (15oC to 30oC). Protect from light. Keep out of the reach of children.
After Reconstitution: store reconstituted solution of SOLU-CORTEF at room temperature (15oC to 30oC). Protect from light. Keep out of the reach of children. Single use only. Discard unused solutions after 3 days.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals, can be found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.