البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
hydrocortisone, Quantity: 4 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone
Oral
bulk tablets, 50
Medicine Registered
(S4) Prescription Only Medicine
INDICATIONS AS AT 6 May 1992: Hydrocortisone is indicated for replacement therapy in Addison's disease or chronic adrenocortical insufficiency secondary to hypopituitarism.
Visual Identification: Round, biconvex, white tablet marked "H/4" on one side, "G" on reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-21
HYSONE ® 4; HYSONE ® 20 H y s o n e CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING HYSONE? HYSONE contains the active ingredient hydrocortisone. HYSONE is used to replace the hydrocortisone in patients whose adrenal glands do not produce enough naturally. This occurs in conditions such as Addison's disease or when the adrenal glands are damaged or not working properly. For more information, see Section 1. Why am I using HYSONE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE HYSONE? Do not use if you have ever had an allergic reaction to hydrocortisone or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use HYSONE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with HYSONE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE HYSONE? • The dose varies from patient to patient. Your doctor will tell you how many tablets you need to take each day and when to take them. This depends on your condition and whether or not you are taking any other medicines. • Swallow the tablets with a glass of milk, or take HYSONE with food. More instructions can be found in Section 4. How do I use HYSONE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING HYSONE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using HYSONE • If you become pregnant while taking HYSONE, tell your doctor. • Discuss with your doctor situations in which it may be appropriate for you to make short-term changes of dose during illness, or at a time of medical or dental procedures. • Visit your doctor regularly so they can اقرأ الوثيقة كاملة
AUSTRALIAN PRODUCT INFORMATION HYSONE ® 4 HYSONE ® 20 _Hydrocortisone tablets _ 1 NAME OF THE MEDICINE Hydrocortisone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone, also known as cortisol, is a white or almost white, odourless crystalline powder. It is practically insoluble in water; sparingly soluble in ethanol (96%) and in acetone; slightly soluble in chloroform; very slightly soluble in ether. It melts at about 214 C, with decomposition. Each HYSONE 4 tablet contains 4 mg of hydrocortisone. Each HYSONE 20 tablet contains 20 mg of hydrocortisone. Excipients with known effect: sulfites and sugars as lactose For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM HYSONE 4 mg tablet: white, scored, marked H/4 on one side, G on reverse HYSONE 20 mg tablet: white, scored, marked H/20 on one side, G on reverse 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hydrocortisone is indicated for replacement therapy in Addison's disease or chronic adrenocortical insufficiency secondary to hypopituitarism. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage requirements are variable and must be individualised on the basis of the disease and the response of the patient. A typical dose in adults is hydrocortisone 30 mg daily in divided doses. Dosage may be increased if clinically necessary. Patients should be advised to take their hydrocortisone replacement therapy with meals or a glass of milk or antacid because the drug may increase gastric acidity. Approximately 2/3 of the dose should be taken in the morning and 1/3 at about 4pm. Some individuals may exhibit irritability or insomnia after initiation of therapy; in these the dosage should be reduced. Smaller doses may also be necessary in patients with hypertension, diabetes mellitus, or active tuberculosis. Supplementary administration of fludrocortisone, 0.05 to 0.1 mg daily by mouth, is required to replace mineralocorticoid deficiency. Blood pressure and serum electrolyte measurements will give an indication of adequacy of m اقرأ الوثيقة كاملة