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Carefully read the instruction before use.
Ifnecessary, ask your plzysician forfurther information.
This drug should be used under prescriplion only.
RUMACERIN Cap
COMPOSITION:
Each capsule contains:
Diaccrhein ........................... 50 mg
Excigients: Lactose Hydrate, Povidone, Magnesium Stearate.
PHARMACODYNAMICS:
The mcchanism of action differs from the nonsteroidal antiìnflammatory drugs sínce it is
not related to the inhibition of the synthesis of the prostaglandins. Anti-osteoarthxitic and
cartỉlage-stimulating properties have been demonstrated in vilro and in animal modcls.
Diacerhein and rhein have been shown to inhibit the production of ìnterleukin-l beta by
human monocytes and the effects of the cytokine on chondrocytes in vivo. They exert
chondroprotectivc cffects ìn culturcd articular cartilage and reduce severity of cartỉlage,
bonc, and synovial membrane damage in osteoarthritis. There appear to be some ínhibitory
effects on leukocyte migration and activation, conlrìbuting to the weak antỉ-infiammatory
activity of the drug. Studies indicate that Diacerhein does not block the synthesis of
prostaglandins, thromboxanes, or leukotrienes but may actually stimulate prostaglandin
synthesis, especially PGF-2 alpha, a prostaglandin with cytoprotectìve effect on the gastric
mucosa. Diacerhein does not alter renal or platclct cyclo—oxygcnase activity and may
thereforc bo tolcratcd by patients with prostaglandin-dependent renal function. [Z
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PHARMACOKINETICS: '/
Absorption: Oral bioavailability of Diacerhein is 35% to 56%. Concurrent intakc of food
delays the time to peak conccntration from 2.4 hours to 52 hours (p less than 0.05), but is
associated with a 25% ỉncrease in absorption. Therefore, diacerhein is best gìven with
food.
Distribution: T otal protein bìndíng of rhein ỉs about 99% to plasma albumin and in a lesser
percentage to lipoproteins and gamma-immunoglobulins. It achievcs synovial íluid
concentration of 0.3 to 3.0 milligrams/litcr.
Membolism: Diaccrhein is mctabolized extensively (100%) in liver following oral dosing, \
to the deacetylated active mctabolỉtc rhein, prior to entering systemic circulation. Major '
active metabolites ínclude Rhein glucuronide and Rhein sulfate with half-lỉfe being 7 to 8
hours. ,
Excretion: Urinary cxcrctìon of diacerhein in the form of its metabolites has ranged I
between 35% and 60%, with approximately 20% as free rheìn and 80% as conjugatcs of
rhein.
INDICATIONS:
Symptomatic treatmem of Osteoarthritis; Anhmpathy and Degenerative joint disease
DOSAGE AND ADMINISTRATION :
It ìs to be administered orally.
lnitially l capsule once daily at nỉght for the first 2 to 4 weeks followed by l capsule twice
daily from the 4th wcek onwards.
Usual dose: ] capsule twice daily.
Oral absorption ìs greatest when administcred wỉth food.
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CONTRAINDICATIONS:
Hypersensitívity to diacerhein or any of the components.
lnfiammatory intestinal disease (ulcerative colitis, Crohn Disc '
PRECAUTIONS AND WARNINGS:
General
~ It is recommended to ìnìtiate therapy With one capsule at night for lhc first 2 to 4 wceks as
use of the drug can produce an acceleration of the intestinal transit time initially.
' Il ỉs recommended to continue treatment for at least 6 months: the clinical studies have
demonstrated that the drug can be used for 2 years wilhout serious adverse effects.
. As with any other long tcrrn thcrapy, it is recommended to monitor laboratory parameters,
ỉncluding hepatic enzymes, every 6 months.
= Avoìd concomitam use with laxatives.
Renal lmpairment
ln paticnts with mild-to-scvcre renal impainncnt, there was a significant increase in the
arca-undcr—the-curve and a decrease in the total apparent clearance compared to the healthy
adults. Severe renal failure (creatinine clearance 10 to 27 millilitcrs/minutc) showcd a
significantly decreased renal clearance of rhcin, thcrcforc, a 50% reduction ìn the dose of
diacerheỉn should be made in patients with severe renal ìnsufficiency.
Hepatic lmpairment
No significant difference in pharmacokinetic parameters of rhein between patients with
liver impairment and healthy volunteers was observed either in plasma or in urine
assessmcnts. However, sìnce cirrhosis may ỉnfiuence drug accumulatìon after multiple
doses, close clinical monitoring ìs advísed for patients with hepatic ỉnsufficiency
Geriatric Use _,
Daily doses exceeding 100 milligrams may warram close clinìcal monitoring ìn geriatric /ếẶ
patiems. ' Z
Pediatric Use /
Pharmacokinetics of diacerhein has not bccn studicd ìn pedìatric population and its
administration is not recommende in pcdiatrìc popuìation.
IJNDESIRABLE EFFECTS:
Generally, the drug has bccn well tolcrated. The commonest reported adverse reaction was
acceleration of the time of intestinal transit (diarrhoea 37% of patients). Few cases of
abdominal pains have been described .The modificatỉon of the dose ìn the initial periods of
the treatment (2 to 4 weeks) has allowed to surpass or to diminísh these adverse events.
Other advcrsc cvents reported are urỉne discoloration in 14.4% cases and single cases of
hypokalemìa, hepatotoxicity resulting into acute hepatilỉs and falal toxỉc epidermal
necrolysis (Lycll's syndromc).
Inform your doctor of any adverse effect related to drug use.
USE IN PREGNANCY AND LACTATION:
Use in pregnancy: Use of diacerheìn is not recommended in women attempting to
conceive. No clinical data on exposed pregnancies are available for diacerhein. The
potential for human risk in pregnancy is unknown.
Use in lactation: Pharmacokinetics of diacerhcin has not been studied in lactating women
and ìts administration is not recommended.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: None.
INTERACTIONS:
The clinical studies have demonstratcd the abscncc of interactíon with the drugs such as:
warfarin, tolbutamide, aspirin (acetylsalicylic acid), chlorpromazine, indomethacin.
OVERDOSAGE & TREATMENT:
ln cases of overdose it can produce a profuse diarrhea. The treatment must be symplomatic
with correction of any electrolyle imbalance, which may be necessary.
STORAGE:
Store below 30°C, protecting from light.
K eep out ofthe reach of children.
QUALITY SPECIFICATION: In house standard.
SHELF-LIFE: 36 months from manufacturỉng date.
PACKAGE: Box of 100 capsules (10 blisters x 10 capsules); Box of 30 capsulcs (3 blisters x
10 capsules).
Manufactured by:
SAMCHUNDANG PHARM. CO., LTD.
904-L Sangshin-RL Hyangnam—Myun, Hwaseong—City, Gyeonggi-Do, Korea
Tel: 82—2—2046-1100 Fax: 82-2-2046-1102
Đọc kỹ hưởng dẫn sử dụng trước khi dùng.
Nêu cân thêm thông Iin, xỉn hỏi ý kỉên thây lhuôc.
Chỉ dùng lhuôc nãy theo sự kẽ đỉn_của t_hầy thụôc.
Viên nang RUMACERIN
THÀNH PHẨN:
Môi viên nang cứng chứa:
Diacerhein ................................. 50 mg
Tá dươc: Lactose Hydrate, Povidone, Magnesium Stearate.
DƯỢC LỰC HỌC:
Khác với các ~thuôc kháng viêm không steroid, cơ chế tảc động cùa Diacerhein không liên
quan đến sự tông hợp prostaglandỉn. Dặc tinh chông viêm xương khởp và kích thích sụn đă
được chứng minh trên in vitro vả trên mô hình động vật Diacerhein vả rhein ức chế sự sản
xuất interleukin- [ bêta bới cảc bạch cầu đơn nhân to ở người vả ức chế tảc dụng cùa
cytokine trên tế bảo sụn in vitr o. Thuốc thể hìện tảo dụng bảo vệ sụn trên sun nhân tạo nuôi
cây và giảm mức độ tổn thương mảng hoạt dịch, xương và sụn trong bệnh viêm xương
khớp. Chủng cũng có vải tác dụng ức chế trên sự hoạt hóa và di chuyền cùa bạch cằu, diều
nảy góp phần vảo tác dụng kháng viêm yếu cùa thuốc. Cảo nghiên cứu đã chi ra rằng
Diacerhein không ức chế sự tông hợp prostagiandin, thxomboxane, hoặc leukotriene nhưng
thực tế có thể kích thích sự tông hợp prostaglandin, dặc biệt là PGF— 2 alpha, một
prostaglandin có tảo dụng bảo vệ tế bảo niêm mạc dạ dảy. Diacerhein không lảm thay đồi
hoạt tính cyclooxygenase tiểu cầu hoặc thận vả do đó có thế được dung nạp ở những bệnh
nhân có chức năng thận phụ thuộc vảo prostaglandin
\f>ẵì~
DƯỢC ĐỘNG HỌC:
Hấp thu: Sình khả dụng dường uống cùa Diacerhein khoảng 35% dến 56%. Uống thuốc
cùng với thức ăn lảm chậm thời gian dạt nồng dộ đinh từ 2 4 giờ đến 5 ,2 giờ (p
+ "Lưu ý những sản phẩm đăng trên website thuộc loại thực phẩm chức năng: những sản phẩm này không phải là thuốc và không có tác dụng thay thế thuốc chữa bệnh"
+ Dùng thuốc theo chỉ định của Bác sĩ
+ Đọc kỹ hướng dẫn sử dụng trước khi dùng