【药品名称】精氨洛芬
【英文名称】Arginine and Ibuprofen
【其他名称】精氨洛芬颗粒, 精氨酸布洛芬颗粒, 快速平, 司百得, 儿快平, 快平
【功能与主治】
1.口服或局部给药用于缓解类风湿关节炎、骨性关节炎、脊柱关节病、痛风性关节炎、风湿性关节炎等各种慢性关节炎的急性发作期或持续性的关节肿痛症状。
2.口服或局部给药用于非关节性的各种软组织风湿性疼痛或炎症，如肌腱及腱鞘炎、滑囊炎、肩痛、肌痛及运动后损伤性疼痛等。
3.口服给药用于急性轻、中度疼痛，如手术、创伤、劳损后疼痛、原发性痛经、继发性痛经(放置宫内节育器引起)、下腰疼痛、牙痛、头痛等。
4.口服或直肠给药可用于感冒、急性上呼吸道感染、急性咽喉炎等疾病引起的发热。
【注意事项】
1.交叉过敏对阿司匹林或其它非甾体类抗炎药过敏者，也可能对本药过敏。
2.禁忌症
(1)对本药过敏者。
(2)对阿司匹林或其它非甾体类抗炎药过敏者。
(3)活动性消化性溃疡或溃疡合并出血(或穿孔)者。
(4)有失血倾向者。
(5)孕妇。
(6)哺乳期妇女。
(7)脱水小儿禁用本药滴剂。
(8)对丙二醇及对羟基苯甲酸甲酯钠过敏者禁用本药乳膏。
3.慎用
(1)支气管哮喘患者或有此病史者(可能引起支气管痉挛)。
(2)心功能不全、高血压患者。
(3)血友病或其它出血性疾病(包括凝血障碍及血小板功能异常)患者。
(4)有消化性溃疡史者。
(5)肠胃疾病患者。
(6)严重肝功能不全者。
(7)肾功能不全者。
(8)红斑狼疮或其它免疫疾病患者。
(9)6个月以下小儿。
4.药物对妊娠的影响妊娠晚期用药可使孕期延长，引起难产及产程延长。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为B级，妊娠晚期为D级。
5.药物对检验值或诊断的影响
(1)可抑制血小板聚集，使出血时间延长(停药24小时后该作用即可消失)。
(2)血尿素氮及血清肌酸酐含量升高，肌酐清除率下降。
(3)氨基转移酶升高。
6.用药前后及用药时应当检查或监测用药期间应定期检查血常规及肝、肾功能。
【不良反应】
1.消化系统可出现消化不良(约16%)，也较多见胃烧灼感、胃痛、恶心、呕吐等，但症状较轻，停药后即消失，不停药也可耐受。偶见消化性溃疡和消化道出血(发生率均低于1%)，亦有因溃疡而致穿孔的报道。
2.神经系统偶可出现头痛、嗜睡、晕眩、耳鸣等，发生率约为1%-3%。抑郁或其它精神症状、视物模糊及中毒性弱视少见。
3.肝脏肝毒性反应轻微，可见肝功能异常，主要表现为氨基转移酶升高。
4.肾脏少数患者用药后可出现下肢浮肿。对一些有潜在性肾病的易感者可出现肾乳头坏死的急性肾功能不全。
5.血液系统大剂量用药可出现出血时间延长、白细胞减少、粒细胞减少甚至粒细胞缺乏、血小板缺乏及全血细胞减少。个别病例可因胃肠道隐血而致贫血。
6.皮肤过敏性皮肤反应不常见，多为短暂性荨麻疹、紫癜性或红斑性改变，常伴有瘙痒。
7.呼吸系统易感者可出现支气管哮喘发作。
【用法与用量】
成人
·常规剂量
·口服给药
1.抗风湿：一次0.4-0.8g，一日3-4次。类风湿关节炎比骨性关节炎用量大。一日最大用药量不超过2.4g。
2.轻、中度疼痛：
(1)一次0.2-0.4g，每4-6小时1次。一日最大用药量不宜超过2.4g。
(2)分散片：推荐剂量为一次0.2-0.4g，一日3次。
(3)缓释片：一次0.3-0.6g，早、晚各一次。
(4)缓释胶囊：一次0.3g，早、晚各一次。
(5)缓释混悬剂：推荐剂量为一次0.3-0.6g，一日2次。
3.发热：(1)一次0.2g，一日3-4次。
(2)分散片：推荐剂量为一次0.2-0.4g，一日3次。
(3)缓释混悬剂：推荐剂量为一次0.3-0.6g，一日2次。
4.抗炎：
(1)缓释片：一次0.3-0.6g，早、晚各一次。
(2)缓释胶囊：一次0.3g，早、晚各一次。
(3)缓释混悬剂：推荐剂量为一次0.3-0.6g，一日2次。
·局部给药乳膏：依患处面积大小，取适量轻揉患处，一日3-4次。搽剂：涂患处，一次2-4ml，一日3次。
·直肠给药一次100mg，如需再次用药应间隔4小时以上。
儿童
·常规剂量
·口服给药12岁以上儿童用法用量同成人(除风湿性疾病)。1-12岁儿童用法用量如下：
1.发热：
(1)分散片、混悬液：推荐剂量为一日20mg/kg，分3次服用。
(2)缓释混悬剂：推荐剂量为一日20mg/kg，分2次服用。
(3)混悬滴剂具体用法如下：一次5-10mg/kg，需要时每6-8小时重复使用，每24小时不超过4次。或参照下表，用滴管量取。使用前请摇匀使用后请清洗滴管。
年龄、体重剂量表
年龄体重(kg)剂量(次)
6-11月5.5-8.01滴管(1.25ml)
12-23月8.1-12.01.5滴管(1.875ml)
2-3岁12.1-15.92滴管(2.5ml)
2.疼痛：
(1)分散片、混悬液：推荐剂量为一日30mg/kg，分3次服用。
(2)缓释混悬剂:推荐剂量为一日30mg/kg，分2次服用。
(3)混悬滴剂用法用量同发热项。
3.风湿性疾病：用于12岁以上儿童，混悬液推荐剂量为一次0.3-0.4g，一日3-4次。
·局部给药参见成人用法与用量。
·直肠给药1-3岁患儿：一次50mg，塞肛门内。如症状无缓解，每4-6小时可重复给药1次，24小时不超过200mg。3岁以上患儿：一次100mg。
【禁忌】
(1)对本药过敏者。
(2)对阿司匹林或其它非甾体类抗炎药过敏者。
(3)活动性消化性溃疡或溃疡合并出血(或穿孔)者。
(4)有失血倾向者。
(5)孕妇。
(6)哺乳期妇女。
(7)脱水小儿禁用本药滴剂。
(8)对丙二醇及对羟基苯甲酸甲酯钠过敏者禁用本药乳膏。
Therapeutic Indications:
Spidifen 400 mg can be used for the symptomatic relief of mild to moderate pain in the following situations: - toothache -- headache - fever - primary dysmenorrhoea.
Qualitative and quantitative composition:
One film-coated tablet contains 400 mg of ibuprofen (in situ formation of L-arginine salt).
For excipients, see section 'List of excipients '.
Pharmaceutical form:
Film-coated tablet.
White, film coated tablets, in the form of a capsule, with a score line on one side.
Posology and method of administration:
For adults and children over 12 years, the starting dose is 400 mg, followed if necessary by 400 mg a time every 4 to 6 hours up to 1,200 mg per day.
The product is not intended for use in children younger than 12 years as an ibuprofen tablet contains more than is recommended for this group of patients .
Method and duration of administration.
for oral use.
Take the tablet with a glass of water (200 ml).
This product should not exceed 7 days or at higher doses administered without a doctor.
If symptoms persist or worsen, patients should be advised to consult a physician.
For patients with a sensitive stomach it is recommended that Spidifen 400 mg is taken together with food.
patients with kidney problems, liver or heart, the dose reduced.
This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.
Contraindications:
Hypersensitivity to active ingredient 'ibuprofen' or any of the ingredients of this medicine.
Hypersensitivity Reactions in the history (eg bronchospasm, asthma, rhinitis or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
A history of, or existing gastrointestinal ulceration, gastrointestinal bleeding or other active bleeding or cerebrovascular bleeding such as ulcerative colitis.
Severe renal and / or hepatic insufficiency, severe uncontrolled heart failure.
Haemorrhagic diathesis.
third trimester of pregnancy (see section 'Pregnancy and lactation').
Special warnings and precautions for use:
The intervention of gastrointestinal bleeding with ibuprofen therapy should be discontinued (see section 'Contraindications').
Caution should be exercised and in elderly patients with coagulation disorders and liver, cardiac or renal insufficiency.
by a potential fluid retention and edema with caution in patients with hypertension or heart disease.
Ibuprofen, the objective and subjective symptoms which accompany infection mask. In isolated cases, an exacerbation of infectious inflammations described (eg development of fasciitis necroticans) in a temporary connection with the use of NSAIDs. A therapy with ibuprofen in patients with an infection should therefore be done with caution.
Bronchospasm may occur more rapidly in patients suffering from bronchial asthma or allergic disease or that have a history.
Caution is advised in patients with systemic lupus erythematosus or other collagen diseases.
The adverse effects may be reduced to a minimum by using the minimum effective dose and shortest possible duration. Risks of prolonged use of analgesics habit headache and analgesic nephropathy.
The use of ibuprofen may reduce female fertility and is not recommended for pregnant women who try to be. In women who become pregnant may be difficult or a infertiliteitsonderzoek undergoing a cessation of the 400 mg dose Spidifen be considered.
This medicine contains sucrose 16.7 mg per tablet respectively. per dose when the intake is done using the recommended dose. Not suitable for hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Patients who experience disturbances of vision during ibuprofen therapy should stop the treatment and an ophthalmologic examination.
NSAIDs may an increase in liver function test results of the cause.
Pregnancy and lactation:
On the use of ibuprofen in pregnancy in humans are insufficient data to assess the potential damage. On effects in animals are also insufficient data to assess the potential damage.
During the last trimester of pregnancy were described as effects prostaglandinesynthetase inhibitors: inhibition of uterine contractions and delay / extension of confinement, cardiopulmonary (premature closure of the ductus arteriosus arteriosus, pulmonary hypertension) and renal (oliguria, oligohydramnios), fetal toxicity and prolongation of bleeding time with mother and child.
Because of insufficient data in humans, ibuprofen should not be used during the first two trimesters of pregnancy unless really necessary. Because of potential adverse effects on the fetus and the pregnancy should not use ibuprofen during the third trimester of pregnancy (see section 'Contraindications').
Ibuprofen appears in a very low concentration in breast milk and is unlikely adverse impact on the nursing infant. It is not necessary to interrupt breastfeeding for a short-term treatment with the recommended dose.
Undesirable effects:
Adverse effects are mainly due to the pharmacological effect of ibuprofen on prostaglandin synthesis. The most common are diarrhea and dyspepsia.
Gastrointestinal: Abdominal pain, nausea, dyspepsia, diarrhea, anorexia, constipation. Occasionally peptic ulcer and gastro-intestinal haemorrhage.
Skin and hypersensitivity reactions: Hypersensitivity reactions were reported in treatment with NSAIDs. These may include: - (a) non-specific allergic reactions and anaphylaxis - (b) reactivity of the respiratory tract including asthma, aggravated asthma, bronchospasm or dyspnoea, - (c) Several skin conditions, including different types of skin rash, pruritus, urticaria, purpura, angioedema and, less common, with blistering dermatosis (including epidermal necrolysis, erythema multiforme and exfoliative dermatitis).
Central nervous system: Headache, dizziness.
Hematology: Thrombocytopenia, agranulocytosis, aplastic anemia.
Kidney: Haematuria, interstitial nephritis, papillary necrosis which can lead to renal failure.
Other: In rare cases, liver disorders, hearing disorders.
Effects on ability to drive and use machines:
Dizziness and headache are possible adverse effects after taking NSAIDs, and can affect the ability of the patient to a vehicle to drive or operate machinery influence.
Overdose:
after overdose the following symptoms: nausea, stomach pain, vomiting (blood) and diarrhea (blood), dizziness, spasms, nystagmus and diplopia, headache and tinnitus. In severe intoxication also renal dysfunction, hypotension, reduction of consciousness and coma (it is not clear whether the impairment is a result of intoxication or of hypotension).
The stomach should be emptied as soon as possible. If possible the patient to vomit. If the patient is unconscious, a gastric lavage and correction of severe electrolyte abnormalities should be considered.
List of excipients
tablet core.
L-arginine - Sodium - Crospovidone - Magnesium.
Film coating.
Hypromellose - Sucrose - Titanium dioxide (E171) - Polishing (shiny surface): Macrogol 4000.
Interaction with other medicinal products and other forms of interaction:
The efficacy of furosemide and thiazide diuretics may be reduced, probably by a prostaglandinesyntheseremming in the kidney associated sodium retention.
There it is possible that the effect of ibuprofen oral anticoagulants increased, a concomitant use of Spidifen 400 mg with oral anticoagulants is not recommended without medical advice.
Ibuprofen, the effect of antihypertensive drugs. Consequently, concomitant use of NSAIDs and ACE inhibitors or beta blockers are associated with risk of acute renal failure.
The ulcerogenic effect can be enhanced by concomitant treatment with corticosteroids.
In the literature are individual cases described by ibuprofen elevated plasma levels of digoxin, phenytoin and lithium.
As with other NSAIDs is, the combination of ibuprofen with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids with appropriate safeguards happen: it will risk on undesirable effects on the gastro-intestinal system increase.
Ibuprofen may increase plasma levels of methotrexate.
Concomitant treatment with zidovudine and ibuprofen, the risk of haemarthroses and hematoma in HIV (+) hemophiliacs increase.
Concomitant use of ibuprofen and tacrolimus may increase the risk of nephrotoxicity because of the reduction of renal prostaglandin synthesis.
Ibuprofen increases the effect of oral hypoglycemic drugs and insulin hypoglykemiërende. You may need to adjust the dose.
Interactions with diagnostic test results: - Bleeding time (may prolong bleeding time up to 1 days after discontinuation of therapy) - Serum glucose concentrations (may cut) - Creatinine clearance (may fall).
Hematocrit or Hemoglobin (may decrease); - BUN (Blood Urea Nitrogen), creatinine concentrations and kaliemie (may increase) - Liver function tests (elevation of transaminases can occur).
A simultaneous administration of ibuprofen low-dose aspirin may reduce the inhibition of COX-1 and platelet aggregation by low-dose aspirin.
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【原产地英文商品名】SPIDIFEN 400mg/tab 30tabs/box
【原产地英文药品名】ARGININE AND IBUPROFEN
【中文参考商品译名】SPIDIFEN 400毫克/片 30片/盒