국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
dutasteride, Quantity: 500 microgram; tamsulosin hydrochloride, Quantity: 400 microgram
GlaxoSmithKline Australia Pty Ltd
Capsule, modified release
Excipient Ingredients: maize starch; carrageenan; Gelatin; purified talc; butylated hydroxytoluene; iron oxide yellow; titanium dioxide; iron oxide red; glycerol; medium chain triglycerides; potassium chloride; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); purified water; triethyl citrate; lecithin; glyceryl caprylate/caprate; sunset yellow FCF; Carnauba Wax; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide
Oral
7 capsule (40 mL bottle), 90 capsule (200 mL bottle), 30 capsule (100 mL bottle)
(S4) Prescription Only Medicine
DOUBLUTS is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (BPH).
Visual Identification: Oblong, hard-shell capsules with a brown body and an orange cap imprinted with GS 7CZ in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-03-04
DOUBLUTS _500 MICROGRAMS / 400 MICROGRAMS_ _Dutasteride 500 micrograms and tamsulosin HCl 400 micrograms_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you take DOUBLUTS. This leaflet answers some common questions about DOUBLUTS. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking DOUBLUTS against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS DOUBLUTS USED FOR? DOUBLUTS is a combination of two medicine; dutasteride and tamsulosin hydrochloride. Dutasteride belongs to a group of medicines called 5-alpha reductase enzyme inhibitors and tamsulosin hydrochloride belongs to a group of medicines called alpha- blockers. These medicines can be used either alone or in combination in men who have a condition known as benign prostatic hyperplasia (BPH). BPH is a non-cancerous enlargement of the prostate gland which is located at the lower portion of the urinary bladder surrounding the urethra (urine carrying tube). In men with BPH, the prostate gland becomes large enough to squeeze the urine tube running through it. If the urine tube is squeezed it narrows, making it more difficult for you to pass urine normally and you may have some or all of the following symptoms: • difficulty in starting to urinate • an interrupted, weak urinary stream • more frequent urination, especially at night • feeling that you need to urinate right away • leaking or dribbling • a feeling that you cannot empty your bladder completely. As the disease progresses, untreated BPH can lead to an increased risk of complete blockage of urine flow (acute urinary retention) and/or the need for surgery. Prostate growth is caused by a hormone in the blood called dihydrotestost 전체 문서 읽기
1 AUSTRALIAN PI – DOUBLUTS (DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE) CAPSULE 1 NAME OF THE MEDICINE Dutasteride/tamsulosin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 micrograms of dutasteride and 400 micrograms of tamsulosin hydrochloride. _Dutasteride_ - Dutasteride is a white to pale yellow powder. It is practically insoluble in water, and soluble in organic solvents, dimethyl sulfoxide, acetone, methanol, ethanol and ispropanol. _Tamsulosin Hydrochloride -_ White or almost white crystalline powder. It is sparingly soluble in water, and slightly soluble in the following solvents; Acetone, Ethanol, Ethyl acetate and Methanol. The pKa values for tamsulosin are as follows: pKa1 = 8.4 (secondary amine) and pKa2 = 10.7 (sulphonamide). The partition coefficient is clogP = 2.2 (calculated using Property Calculator 4.7) EXCIPIENTS WITH KNOWN EFFECT Lecithin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DOUBLUTS capsules (dutasteride 500 micrograms / tamsulosin hydrochloride 400 micrograms): oblong, hard-shell capsules with a brown body and an orange cap imprinted with GS 7CZ in black ink [each containing one oblong, opaque, dull-yellow dutasteride soft gelatin capsule (containing 500 micrograms of dutasteride) and white to off-white tamsulosin hydrochloride pellets (containing 400 micrograms of tamsulosin hydrochloride)]. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DOUBLUTS is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (BPH). 4.2 DOSE AND METHOD OF ADMINISTRATION DOUBLUTS must be taken approximately 30 minutes after the same meal each day. Patients should be advised that DOUBLUTS should not be taken on an empty stomach as this may increase the potential for cardiovascular related adverse events such as orthostatic hypotension. 2 For advice on switching from tamsulosin monotherapy to DOUBLUTS combination therapy, please read the information under Section 5.1 PHARMACODYNAMIC PROPERT 전체 문서 읽기