部分中文TORADOL处方资料(仅供参考) 【药物名称】 中文通用名称:酮洛酸氨丁三醇 英文通用名称:Ketorolac Tromethamine 其它名称:安贺拉、酮酪酸氨丁三醇、酮洛来克、酮洛酸、酮洛酸氨基丁三醇、痛力克、痛立消、Acula、Acular、Droal、Ketanov、Ketorol、Ketorolac、Ketorolac Trometamol、Ketorolac Tromethamin、Ketorolacum、Ketorolacum Tromethaminum、Tonum、Toradol、Torolac 【功效】 1.用于中、重度疼痛(如术后、骨折、扭伤疼痛、牙痛及癌性疼痛等)的止痛。 2.本药滴眼液用于治疗眼科手术后的炎症、季节变应性结膜炎等(国外资料)。 【药理】 1.药效学 本药为吡咯酸的衍生物,属非甾体类抗炎药,其结构与托美丁(Tolmtin)和吲哚美辛等药物类似。通过抑制前列腺素环氧酶(不与脑中的阿片受体μ、δ、κ等作用)而抑制前列腺素的生物合成,从而产生镇痛、解热和抗炎作用。镇痛作用与阿司匹林近似,肌内注射后镇痛作用与中等量吗啡近似。本药还可抑制由花生四烯酸和胶原诱导的血小板聚集作用,但不抑制二磷酸腺苷(ADP)的诱导作用。 2.药动学 本药肌内注射吸收迅速完全,注射30mg在50分钟后平均血药浓度峰值为2.2μg/ml;口服吸收完全,给药后24小时可达稳态血药浓度。关节腔内药物浓度为血中浓度50%以上。口服给药或肌内注射时镇痛作用可持续6-8小时。药物可通过胎盘。口服生物利用度为80%-100%。本药血浆蛋白结合率达99%。原形药及其代谢产物主要经肾脏排泄,少量随粪便排出。青壮年的半衰期为5.3小时;老年人(平均72岁)的半衰期延长至7小时;肾功能不全者的半衰期延长至9.62-9.91小时。 【注意事项】 1.禁忌症 (1)对本药、阿司匹林或其它非甾体类抗炎药过敏者。 (2)鼻息肉综合征患者(国外资料)。 (3)血管性水肿患者(国外资料)。 (4)有高危出血倾向者(国外资料)。 (5)活动性消化性溃疡患者。 (6)肝肾疾病、心脏病、高血压患者。 (7)孕妇。 (8)儿童。 2.慎用 尚不明确。 3.药物对妊娠的影响 本药不宜用于分娩镇痛。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为C级。 4.药物对哺乳的影响 尚不明确。 【不良反应】 1.常见精神神经系统不良反应(如嗜睡、头晕、头痛、思维异常、抑郁、欣快、失眠)及消化道不良反应(如恶心、呕吐、腹痛、消化不良)。 2.偶见注射部位疼痛、出汗增多、皮肤瘙痒、皮下出血及紫绀。 3.其它不良反应有口干、肌肉痛、心悸、血管扩张等。 4.长期使用可引起皮疹、支气管痉挛、休克等过敏反应和肾功能不全。 5.现已有因消化道出血、术后出血、急性肾功能不全和过敏反应而致死的报道。 【国外不良反应参考】 1.血液 有一例接受本药治疗关节痛复发时,引起溶血性尿毒症的报道。 2.心血管系统 临床试验中,有受试者出现水肿和高血压。尚有发生心悸、晕厥、低血压和皮肤潮红的报道。 3.中枢神经系统 临床试验中,有引起头痛、头晕、嗜睡、神经过敏和感觉异常的报道。但因许多患者的用药时间为大手术后的恢复期,故这些反应与本药的关系尚不明确。 4.代谢/内分泌系统 有使用本药后引起高血钾和体重增加的报道。 5.消化系统 本药可能引起溃疡形成、出血和穿孔,老年人大剂量使用时更易出现。也可引起恶心、消化不良、腹痛、腹泻、肝功能检测值升高等。很少引起胰腺炎。 6.泌尿生殖系统 临床试验中,本药引起血尿、蛋白尿、少尿、尿潴留、多尿和尿频的发生率大于1%。肾炎、急性肾衰竭和溶血性尿毒症也有报道。 7.眼 使用本药眼用制剂后,可引起一过性刺痛和烧灼感。其它眼部不良反应还有过敏反应、浅表性角膜炎、眼部刺激、角膜水肿或虹膜炎等。 8.呼吸系统 本药在临床试验中有引起支气管痉挛和过敏反应的报道,出现这些症状的很多患者曾有阿司匹林过敏、哮喘和鼻息肉三联征病史。 9.其它 有用药后出现听力丧失、耳鸣、头痛及引起血管性水肿的报道。还可出现注射部位疼痛。肌注后有皮肤瘙痒、烧灼感、出汗和寒战的报道,但少见。 【药物相互作用】 ·药物-药物相互作用 1.本药与其它非甾体类抗炎药合用,不良反应增加,应避免合用。 2.合用利尿药可使本药不良反应增加。 3.本药与吗啡或盐酸哌替啶合用治疗术后疼痛,无明显不良相互作用。 4.与某些抗感染药如β-内酰胺类的青霉素、头孢菌素及氨基糖苷类抗生素、止吐药、泻药、支气管扩张药等合用,无药物相互作用。 ·药物-食物相互作用 食物可降低本药的吸收速度,但不影响吸收率。 【给药说明】 1.本药可延长出血时间,故不作为预防性镇痛药用于大手术前和术中。 2.本药若与吗啡或哌替啶合用,可减少后两者用量。 3.本药不宜长期口服用于治疗慢性疼痛。 【用法与用量】 成人: ·常规剂量 ·口服给药 一次10mg,一日2次。剧痛时可增至一次20mg。用药时间不宜超过2日。 ·肌内注射 一次30-60mg,一日极量为90mg。首次注射后,可每6小时注射20-30mg。用药不宜超过3日。 ·静脉注射 用于重度疼痛,一次10-30mg。 ·经眼给药 一次1-2滴,一日3次。 ·肾功能不全时剂量:推荐用低剂量。 ·老年人剂量:65岁以上老人推荐用低剂量。 【国外用法用量参考】 成人: ·常规剂量 ·口服给药 在英国,推荐一次10mg,每4-6小时1次,一日极量为40mg;在美国,建议给药持续时间不超过5日。 ·肌内注射 术后疼痛:初量为一次10mg,每2小时1次。必要时可将剂量调整为一次10-30mg,每4-6小时1次。一日极量为90mg;体重小于50kg者,一日极量为60mg。建议给药持续时间不超过2日,且应尽早改为口服给药。 ·静脉注射 术后疼痛:一次给药时间不应小于15秒,其余同肌内注射项。 ·经眼给药 季节变应性结膜炎所致的眼瘙痒、囊斑样水肿的局部治疗和眼科手术引起炎症的防治:使用0.5%的本药溶液。 ·肾功能不全时剂量:轻度肾功能不全时,肌内注射或静脉给药的极量为一日60mg。 ·老年人剂量:肌注或静脉给药的极量为一日60mg。 【制剂与规格】 酮洛酸氨丁三醇片 10mg。 酮洛酸氨丁三醇注射液 (1)1ml:10mg。(2)1ml:30mg。 酮洛酸氨丁三醇滴眼液 8ml:8mg。 【禁忌】 (1)对本药、阿司匹林或其它非甾体类抗炎药过敏者。 (2)鼻息肉综合征患者(国外资料)。 (3)血管性水肿患者(国外资料)。 (4)有高危出血倾向者(国外资料)。 (5)活动性消化性溃疡患者。 (6)肝肾疾病、心脏病、高血压患者。 (7)孕妇。(8)儿童。 Generic Name: ketorolac (Oral route, Intravenous route, Injection route, Intramuscular route) kee-toe-ROLE-ak Oral routeTablet Warning Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral and injectable ketorolac tromethamine should not exceed 5 days. Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of oral ketorolac tromethamine beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. Gastrointestinal risk Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events. Cardiovascular risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ketorolac tromethamine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Renal risk Ketorolac tromethamine is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. Risk of bleeding Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding. Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery Risk during labor and delivery The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. The use of ketorolac tromethamine is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates. Concomitant use with NSAIDs Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or because of the cumulative risk of inducing serious NSAID-related side effects. Special populations Dosage should be adjusted for patients 65 years or older, for patients under 50 kilograms (110 pounds) of body weight and for patients with moderately elevated serum creatinine For short term use only (up to 5 days in adults). Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors . Intravenous routeSolution Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level. It is not indicated for minor or chronic painful conditions. Ketorolac tromethamine is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events. Gastrointestinal effects Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation. Therefore, ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Renal effects Ketorolac tromethamine is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. Risk of bleeding Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding. Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery and is contraindicated intraoperatively when hemostasis is critical because of the increased risk of bleeding. Hypersensitivity Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection. Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Intrathecal or epidural administration Ketorolac tromethamine is contraindicated for intrathecal or epidural administration due to its alcohol content. Labor, delivery and nursing The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. The use of ketorolac tromethamine is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates. Concomitant use with NSAIDs Ketorolac tromethamine is contraindicated in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects. Dosage and administration Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine IV/IM, and the combined duration of use of ketorolac tromethamine IV/IM and ketorolac tromethamine tablets is not to exceed 5 days, because of the increased risk of serious adverse events. The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine IV/IM (maximum 120 mg). Special populations Dosage should be adjusted for patients 65 years or older, for patients under 50 kilograms (110 pounds) of body weight and for patients with moderately elevated serum creatinine. IV/IM doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients. Ketorolac tromethamine injection is indicated as a single dose therapy in pediatric patients; not to exceed 30 mg for IM administration and 15 mg for IV administration . For short term use only (up to 5 days in adults). Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, intra-operatively when hemostasis is critical, intrathecal/epidural use, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors . Intramuscular routeSolution Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level. It is not indicated for minor or chronic painful conditions. Ketorolac tromethamine is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events. Gastrointestinal effects Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation. Therefore, ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Renal effects Ketorolac tromethamine is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. Risk of bleeding Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding. Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery and is contraindicated intraoperatively when hemostasis is critical because of the increased risk of bleeding. Hypersensitivity Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection. Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Intrathecal or epidural administration Ketorolac tromethamine is contraindicated for intrathecal or epidural administration due to its alcohol content. Labor, delivery and nursing The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. The use of ketorolac tromethamine is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates. Concomitant use with NSAIDs Ketorolac tromethamine is contraindicated in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects. Dosage and administration Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine IV/IM, and the combined duration of use of ketorolac tromethamine IV/IM and ketorolac tromethamine tablets is not to exceed 5 days, because of the increased risk of serious adverse events. The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine IV/IM (maximum 120 mg). Special populations Dosage should be adjusted for patients 65 years or older, for patients under 50 kilograms (110 pounds) of body weight and for patients with moderately elevated serum creatinine. IV/IM doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients. Ketorolac tromethamine injection is indicated as a single dose therapy in pediatric patients; not to exceed 30 mg for IM administration and 15 mg for IV administration . For short term use only (up to 5 days in adults). Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, intra-operatively when hemostasis is critical, intrathecal/epidural use, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors . Commonly used brand name(s): In the U.S. Toradol Toradol IV/IM Available Dosage Forms: Solution Tablet Injectable Therapeutic Class: Analgesic Pharmacologic Class: NSAID Chemical Class: Acetic Acid (class) Uses For Toradol Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac is not a narcotic and is not habit-forming. It will not cause physical or mental dependence, as narcotics can. However, ketorolac is sometimes used together with a narcotic to provide better pain relief than either medicine used alone.
Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with the length of treatment. Therefore, ketorolac should not be used for more than 5 days. Before using this medicine, you should discuss with your doctor the good that this medicine can do as well as the risks of using it. Ketorolac is available only with your doctor's prescription. Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ketorolac is used in certain patients with the following medical conditions: Pain after surgery in children Before Using Toradol In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ketorolac in children up to 16 years of age with use in other age groups. Geriatric Stomach or intestinal problems, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of ketorolac. Also, elderly people are more likely than younger adults to get very sick if the medicine causes stomach problems. Studies in older adults have shown that ketorolac stays in the body longer than it does in younger people. Your doctor will consider this when deciding on how much ketorolac should be given for each dose and how often it should be given. Interactions with Medicines Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Aceclofenac Acemetacin Alclofenac Apazone Aspirin Benoxaprofen Bufexamac Carprofen Clometacin Clonixin Dexketoprofen Diclofenac Diflunisal Dipyrone Droxicam Etodolac Etofenamate Felbinac Fenbufen Fenoprofen Fentiazac Floctafenine Flufenamic Acid Flurbiprofen Ibuprofen Indomethacin Indoprofen Isoxicam Ketoprofen Lornoxicam Meclofenamate Mefenamic Acid Meloxicam Nabumetone Naproxen Niflumic Acid Nimesulide Oxaprozin Oxyphenbutazone Phenylbutazone Pirazolac Piroxicam Pirprofen Propyphenazone Proquazone Sulindac Suprofen Tenidap Tenoxicam Tiaprofenic Acid Tolmetin Zomepirac Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Ardeparin Beta Glucan Certoparin Dalteparin Danaparoid Enoxaparin Ginkgo Methotrexate Nadroparin Parnaparin Pemetrexed Reviparin Tacrolimus Tinzaparin Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Acetohexamide Alacepril Amiloride Azosemide Bemetizide Benazepril Bendroflumethiazide Benzthiazide Bumetanide Buthiazide Candesartan Cilexetil Canrenoate Captopril Chlorothiazide Chlorpropamide Chlorthalidone Cilazapril Citalopram Clopamide Clopidogrel Clovoxamine Cyclopenthiazide Cyclosporine Cyclothiazide Delapril Desvenlafaxine Duloxetine Enalaprilat Enalapril Maleate Eprosartan Escitalopram Ethacrynic Acid Femoxetine Flesinoxan Fluoxetine Fluvoxamine Fosinopril Furosemide Gliclazide Glimepiride Glipizide Gliquidone Glyburide Hydrochlorothiazide Hydroflumethiazide Imidapril Indapamide Irbesartan Lisinopril Lithium Losartan Methyclothiazide Metolazone Milnacipran Moexipril Nefazodone Olmesartan Medoxomil Paroxetine Pentopril Perindopril Piretanide Polythiazide Probenecid Quinapril Quinethazone Ramipril Sertraline Spirapril Spironolactone Tasosartan Telmisartan Temocapril Tolazamide Tolbutamide Torsemide Trandolapril Triamterene Trichlormethiazide Valsartan Venlafaxine Xipamide Zimeldine Zofenopril Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Alcohol abuse or Diabetes mellitus (sugar diabetes) or Edema (swelling of face, fingers, feet or lower legs caused by too much fluid in the body) or Kidney disease or Liver disease (severe) or Systemic lupus erythematosus (SLE)—The chance of serious side effects may be increased Asthma or Heart disease or High blood pressure—Ketorolac may make your condition worse. Bleeding in the brain (history of) or Hemophilia or other bleeding problems—Ketorolac may increase the chance of serious bleeding Bleeding from the stomach or intestines (history of) or Colitis, stomach ulcer, or other stomach or intestinal problems (or history of)—Ketorolac may make stomach or intestinal problems worse. Also, bleeding from the stomach or intestines is more likely to occur during ketorolac treatment in people with these conditions Proper Use of ketorolac This section provides information on the proper use of a number of products that contain ketorolac. It may not be specific to Toradol. Please read with care. For patients taking ketorolac tablets: To lessen stomach upset, ketorolac tablets should be taken with food (a meal or a snack) or with an antacid. Take this medicine with a full glass of water. Also, do not lie down for about 15 to 30 minutes after taking it. This helps to prevent irritation that may lead to trouble in swallowing. For patients using ketorolac injection: Medicines given by injection are sometimes used at home. If you will be using ketorolac at home, your health care professional will teach you how the injections are to be given. You will also have a chance to practice giving injections. Be certain that you understand exactly how the medicine is to be injected. For safe and effective use of this medicine, do not use more of it, do not use it more often, and do not use it for more than 5 days. Using too much of this medicine increases the chance of unwanted effects, especially in elderly patients. Ketorolac should be used only when it is ordered by your doctor for treating certain kinds of pain. Because of the risk of serious side effects, do not save any leftover ketorolac for use in the future, and do not share it with other people. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets): For pain: Adults (patients 16 years of age and older)—One 10-milligram (mg) tablet four times a day, four to six hours apart. Some people may be directed to take two tablets for the first dose only. Children up to 16 years of age—Use and dose must be determined by your doctor. For injection dosage form: For pain: Adults (patients 16 years of age and older)—15 or 30 mg, injected into a muscle or a vein four times a day, at least 6 hours apart. This amount of medicine may be contained in 1 mL or in one-half (0.5) mL of the injection, depending on the strength. Some people who do not need more than one injection may receive one dose of 60 mg, injected into a muscle. Children up to 16 years of age—Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Precautions While Using Toradol Taking certain other medicines together with ketorolac may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. Therefore, do not take acetaminophen (e.g., Tylenol) together with ketorolac for more than a few days, unless otherwise directed by your medical doctor or dentist. Also, do not take any of the following medicines together with ketorolac, unless your medical doctor or dentist has directed you to do so and is following your progress: Aspirin or other salicylates Diclofenac (e.g., Voltaren) Diflunisal (e.g., Dolobid) Etodolac (e.g., Lodine) Fenoprofen (e.g., Nalfon) Floctafenine (e.g., Idarac) Flurbiprofen (e.g., Ansaid) Ibuprofen (e.g., Motrin) Indomethacin (e.g., Indocin) Ketoprofen (e.g., Orudis) Meclofenamate (e.g., Meclomen) Mefenamic acid (e.g., Ponstel) Nabumetone (e.g., Relafen) Naproxen (e.g., Naprosyn) Oxaprozin (e.g., Daypro) Phenylbutazone (e.g., Butazolidin) Piroxicam (e.g., Feldene) Sulindac (e.g., Clinoril) Tenoxicam (e.g., Mobiflex) Tiaprofenic acid (e.g., Surgam) Tolmetin (e.g., Tolectin) Zomepirac (e.g., Zomax) Ketorolac may cause some people to become dizzy or drowsy. If either of these side effects occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert. Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs. Toradol Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Stop taking this medicine and get emergency help immediately if any of the following effects occur: Rare Bleeding from the rectum or bloody or black, tarry stools bleeding or crusting sores on lips blue lips and fingernails chest pain convulsions fainting shortness of breath, fast, irregular, noisy, or troubled breathing, tightness in chest, and/or wheezing vomiting of blood or material that looks like coffee grounds Check with your doctor as soon as possible if any of the following side effects occur:
More common Swelling of face, fingers, lower legs, ankles, and/or feet weight gain (unusual) Less common Bruising (not at place of injection) high blood pressure skin rash or itching small, red spots on skin sores, ulcers, or white spots on lips or in mouth Rare Abdominal or stomach pain, cramping, or burning (severe) bloody or cloudy urine blurred vision of other vision change burning, red, tender, thick, scaly, or peeling skin cough or hoarseness dark urine decrease in amount of urine (sudden) fever with severe headache, drowsiness, confusion, and stiff neck or back fever with or without chills or sore throat general feeling of illness hallucinations (seeing, hearing, or feeling things that are not there) hearing loss hives increase in amount of urine or urinating often light-colored stools loss of appetite low blood pressure mood changes or unusual behavior muscle cramps or pain nausea, heartburn, and/or indigestion (severe and continuing) nosebleeds pain in lower back and/or side pain, tenderness, and/or swelling in the upper abdominal area painful or difficult urination pale skin puffiness or swelling of the eyelids or around the eyes ringing or buzzing in ears runny nose severe restlessness swollen and/or painful glands swollen tongue thirst (continuing) unusual tiredness or weakness yellow eyes or skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common Abdominal or stomach pain (mild or moderate) bruising at place of injection diarrhea dizziness drowsiness headache indigestion nausea Less common or rare Bloating or gas burning or pain at place of injection constipation feeling of fullness in abdominal or stomach area increased sweating vomiting Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 附件:
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--------------------------------------------------------------- 产地国家: 英国 原产地英文商品名: TORADOL IM Injection 10mg/ml/vial 5vials/box 原产地英文药品名: KETOROLAC TROMETHAMINE 中文参考商品译名: TORADOL IM注射剂 10毫克/毫升/瓶 5瓶/盒 中文参考药品译名: 酮洛酸氨丁三醇 生产厂家中文参考译名: 罗氏 生产厂家英文名: ROCHE PALO 该药品相关信息网址1: http://www.roche.com/ 该药品相关信息网址2: http://www.rxlist.com/toradol-drug.htm 该药品相关信息网址3: http://www.medbroadcast.com/drug_info_details.asp?brand_name_id=1009
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