How does it work? Ofloxacin belongs to a group of broad spectrum antibiotics called the quinolones. It works by entering the bacterial cell and inhibiting a chemical called DNA-gyrase which is involved in the production of genetic material (DNA). This therefore prevents the bacteria from reproducing and their growth is stopped Ofloxacin is effective against several types of bacteria that tend to be resistant to other commonly used antibiotics. It is used to treat a wide range of infections, including inf ections of the chest, urinary tract. It is also used as a single dose treatment for gonorrhoea )What is it used for? Gonorrhoea[ na rI Infection of the bladder or tubes that pass urine(urinary tract infection Infection of the blood(septicaemia or blood poisoning) Infection of the lungs and airways(chest or lower respiratory tract infection) Infections of the sex organs and organs associated with urination (genito-urinary Skin or soft tissue infections sensitivity of your skin. If exposure to sunlight cannot be avoided use protective measures such as sun-creams or protective clothing The effects of alcohol are enhanced by this medicine. This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won' t affect your perfomance At the first sign of pain or inf lammation of the joints, patients taking quinolone antibiotics should stop taking the drug, rest the affected limb(s)and consult a doctor immediatel )Use with caution in Decreased kidney function History of convulsions, eg epilepsy History of disorders of the Central Nervous System(CNS) Psychiatric disorders P Not to be used in
How does it work? Ofloxacin belongs to a group of broad spectrum antibiotics called the quinolones. It works by entering the bacterial cell and inhibiting a chemical called DNA-gyrase which is involved in the production of genetic material (DNA). This therefore prevents the bacteria from reproducing and their growth is stopped. Ofloxacin is effective against several types of bacteria that tend to be resistant to other commonly used antibiotics. It is used to treat a wide range of infections, including inf ections of the chest, urinary tract. It is also used as a single dose treatment for gonorrhoea. What is it used for? ▪ Gonorrhoea [ ] ▪ Infection of the bladder or tubes that pass urine (urinary tract infection) ▪ Infection of the blood (septicaemia or blood poisoning) ▪ Infection of the lungs and airways (chest or lower respiratory tract infection) ▪ Infections of the sex organs and organs associated with urination (genito -urinary infections) ▪ Skin or soft tissue infections Warning! ▪ Avoid exposure to sunlight or sunlamps while using this medicine, as it increases the sensitivity of your skin. If exposure to sunlight cannot be avoided, use protective measures such as sun-creams or protective clothing. ▪ The effects of alcohol are enhanced by this medicine. ▪ This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance. ▪ At the first sign of pain or inflammation of the joints, patients taking quinolone antibiotics should stop taking the drug, rest the affected limb(s) and consult a doctor immediately. Use with caution in ▪ Decreased kidney function ▪ Decreased liver function ▪ History of convulsions, eg epilepsy ▪ History of disorders of the Central Nervous System (CNS) ▪ Psychiatric disorders Not to be used in ▪ Epilepsy
Lack of the enzyme G6PD in the blood(G6PD deficiency) Not generally recommended for use in children and growing adolescents This medicine should not be used if you are allergic to one or any of its ingredients. Please inf orm your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately >Pregnancy and Breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benef its to the mother outweigh the risks to the unborn baby Always inf orm your doctor if you are pregnant or planning a pregnancy, before using any medicine This medicine should not be used in pregnancy. Seek medical advice from your doctor This medicine passes into breast milk. It is recommended that mothers should avoid using this medicine while breastfeeding Seek medical advice from your doctor )Label war id exposure of skin to direct sunlight or Do not take iron preparations or indigestion remedies at the same time of day as this Take at regular intervals. Complete the prescribed course unless otherwise directed Medicines and their possible side effects can affect individual people in different ways. The to be asse Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect Rash itching(pruritus) Abdominal pain Diarrhoea Disturbed sleep Restlessness Loss of contact with reality(psychosis) Nausea and vomiting
▪ Lack of the enzyme G6PD in the blood (G6PD deficiency) ▪ Not generally recommended for use in children and growing adolescents. This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and Breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby.Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. ▪ This medicine should not be used in pregnancy. Seek medical advice from your doctor. ▪ This medicine passes into breast milk. It is recommended that mothers should avoid using this medicine while breastfeeding. Seek medical advice from your doctor. Label warnings ▪ Avoid exposure of skin to direct sunlight or sun lamps. ▪ Do not take iron preparations or indigestion remedies at the same time of day as this medication. ▪ Take at regular intervals. Complete the prescribed course unless otherwise directed. Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. ▪ Headache ▪ Rash ▪ Itching (pruritus) ▪ Abdominal pain ▪ Diarrhoea ▪ Disturbed sleep ▪ Restlessness ▪ Loss of contact with reality (psychosis) ▪ Dizziness ▪ Nausea and vomiting
Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching rigidity(extrapyramidal effects) Numbness The side effects listed above may not include all of the side effects reported by the drug,s manuf acturer For more information about any other possible risks associated with this medicine, please read the inf ormation provided with the medicine or consult your doctor or pharmacist )How can this medicine affect other medicines When used with ofloxacin the following medications increase the risk of convul sions Non-steriodal anti-inf lammatory drugs(NSAID's) Theophylline The blood thinning effects of warf arn and nicoumalone are enhanced with ofloxacin Ofloxacin increases the risk of kidney damage when used with cyclosporin. Sucralfate reduces the absorption of of loxacin -do not take within two hours of takin ofloxacin 药理: 药效学 本品是国内常用氟喹诺酮类中的较好品种,其抗菌谱、抗菌活性与环丙沙星基本相同,对革 兰阴性杆菌(包括肠杆菌科细菌、绿脓杆菌等)的体外活性较环丙沙星略弱,但氧氟沙星口服 吸收好,生物利用度高,每日用量少,不良反应少等,优于环丙沙星 近年来由于喹诺酮类的广泛应用,细菌对本类药物的耐药性有所增长,细菌耐药性与DNA 螺旋酶A亚单位的结构突变(高度耐药)和细菌细胞膜通透性改变(低度耐药)有关 药动学 口服后吸收完全,血药峰浓度于1小时左右到达,口服200~300和400mg的峰浓度分别为 247、437和585μg/ml。食物对本品的吸收影响很少。多次给药稳态血药浓度在给药后第 3日达到。T1/2β为5小时左右,蛋白结合率为20~25%。氧氟沙星吸收后在体内的分布 广泛,在全身组织和体液中均可达有效抗菌浓度。胆汁中药物浓度可达血药浓度的5倍以上, 在肺、肾组织中也可达3倍以上。骨、前列腺、皮肤软组织或体液中均可超过血药浓度而达 有效水平。本品尚可穿过胎盘进入胎儿体内,也可通过乳汁分泌 氧氟沙星主要以原形自肾排泄,少量在肝内代谢。口服后24小时内尿中回收给药量的75~ 90%。尿中代谢物很少。本品以原形自粪便中排出少量,给药后24和48小时内累积排出量 分别为给药量的1.6%和3.9%。[药理作用]氧氟沙星属氟喹诺酮抗菌药,其抗菌谱与诺氟 沙星相仿。对需氧革兰阴性杄菌的抗菌活性高于诺氟沙星、依诺沙星和培氟沙星,较环丙沙 星略差:对需氧革兰阳性球菌,如葡萄球菌属、肺炎球菌和链球菌的抗菌活性与环丙沙星相 仿,高于其他氟喹诺酮类;对厌氧菌的作用差。本品尚对结核杆菌、其他分枝杆菌、沙眼衣
▪ Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects) ▪ Numbness The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. How can this medicine affect other medicines? When used with ofloxacin the following medications increase the risk of convulsions: - Non-steriodal anti-inflammatory drugs (NSAID's) - Theophylline The blood thinning effects of warfarin and nicoumalone are enhanced with ofloxacin. Ofloxacin increases the risk of kidney damage when used with cyclosporin. Sucralfate reduces the absorption of ofloxacin - do not take within two hours of taking ofloxacin. 药理： 药效学 本品是国内常用氟喹诺酮类中的较好品种，其抗菌谱、抗菌活性与环丙沙星基本相同，对革 兰阴性杆菌(包括肠杆菌科细菌、绿脓杆菌等)的体外活性较环丙沙星略弱，但氧氟沙星口服 吸收好，生物利用度高，每日用量少，不良反应少等，优于环丙沙星。 近年来由于喹诺酮类的广泛应用，细菌对本类药物的耐药性有所增长，细菌耐药性与 DNA 螺旋酶 A 亚单位的结构突变(高度耐药)和细菌细胞膜通透性改变(低度耐药)有关。 药动学 口服后吸收完全，血药峰浓度于 1 小时左右到达，口服 200～300 和 400mg 的峰浓度分别为 2.47、4.37 和 5.85μg/ml。食物对本品的吸收影响很少。多次给药稳态血药浓度在给药后第 3 日达到。Ｔ1/2β为 5 小时左右，蛋白结合率为 20～25％。氧氟沙星吸收后在体内的分布 广泛，在全身组织和体液中均可达有效抗菌浓度。胆汁中药物浓度可达血药浓度的 5 倍以上， 在肺、肾组织中也可达 3 倍以上。骨、前列腺、皮肤软组织或体液中均可超过血药浓度而达 有效水平。本品尚可穿过胎盘进入胎儿体内，也可通过乳汁分泌。 氧氟沙星主要以原形自肾排泄，少量在肝内代谢。口服后 24 小时内尿中回收给药量的 75～ 90％。尿中代谢物很少。本品以原形自粪便中排出少量，给药后 24 和 48 小时内累积排出量 分别为给药量的 1.6％和 3.9％。[药理作用]氧氟沙星属氟喹诺酮抗菌药，其抗菌谱与诺氟 沙星相仿。对需氧革兰阴性杆菌的抗菌活性高于诺氟沙星、依诺沙星和培氟沙星，较环丙沙 星略差；对需氧革兰阳性球菌，如葡萄球菌属、肺炎球菌和链球菌的抗菌活性与环丙沙星相 仿，高于其他氟喹诺酮类；对厌氧菌的作用差。本品尚对结核杆菌、其他分枝杆菌、沙眼衣
原体、肺炎支原体、溶脲脲原体和人型支原体等均有作用。本品的作用杋制与诺氟沙星同 细菌耐药情况参见诺氟沙星。 药动学 口服后吸收迅速而完全.口服制剂的生物利用度达90%以上。单剂空腹口服和静滴200mg 后的血药峰浓度分别为247hmg/L和5.lmg/L,但两种给药途径的药时曲线下最大面积相仿 药物在体内广泛分布,在前列腺、痰液、肺组织、骨、耳鼻喉组织、水泡液中均可达有效药 物浓度。血清消除半减期5~7h,主要经肾排泄,24h内自尿中排出给药量的70%~80%, 主要为药物的原形。胆汁中药物浓度约为血药浓度的7倍左右 适应症 适用于各种敏感菌(主要为革兰阴性菌)所致的骨、关节感染,皮肤软组织感染,肺炎,尿路 感染,肠道感染等;对伤寒、副伤寒包括多重耐药株所致者的疗效肯定。氧氟沙星对淋病 前列腺炎、衣原体属和支原体属所致的感染(包括非淋病性尿道炎)也有效。本品也可试用于 布鲁菌病、军团菌病、立克次体病、多重耐药株所致的难治性结核、麻风、败血症等。 临床应用适应证与诺氟沙星大致相仿,但由于本品口服吸收完全,血药浓度高,在大多感染 病灶内可达有效浓度,因此氧氟沙星可用于下呼吸道感染、多重耐药菌所致伤寒、淋球菌与 衣原体或支原体混合泌尿生殖系感染、胆系、腹腔感染以及耳、鼻、喉等部位感染的治疗, 疗效良好。用于眼睑炎、麦粒肿、泪囊炎、睑板腺炎、结膜炎、角膜炎、角膜溃疡、术后感 染等 用法用量: 1)成人的每日量为200-60mg,分1-2次服用,疗程7-14日。 (2)单纯下尿路感染每日200mg,分1一2次服用。单纯性淋病单剂400mg即可。 (3)本品对伤寒的疗效确定,每日600mg,分2次服用,疗程不少于10日 (4)国外以每日口服量400mg一次给予治疗各种感染,获得满意效果。可试用于轻、中度感 染病例。一次量不宜超过400mg。 制剂与规格]氧氟沙星片(1)0.1g(2)0.2g 口服,一日0.2-0.6g分1-3次用控制伤寒反复感染,一日50mg连服3-6个月抗结核每日0.3g, 顿服 用法及用量]用于治疗下呼吸道感染、复杂性尿路感染时每日600mg,分2次服;治疗较 重感染时可增至每日800mg,分2次:急性单纯性尿路感染每日200~400ng,顿服或分2 次;急性单纯性淋病单剂40Omg服用,如有衣原体或支原体混合感染时需给予每次200mg, 每日2次,10日为一疗程;其他各种感染的疗程视病情、病种而定。本品静滴液可用于重 症感染的治疗,一般剂量为每日400mg,分2次缓慢静滴(每200mg滴注时间不少于 3Umin),病情需要时或病原菌为绿脓杆菌等敏感性略差者,剂量可增至每日600~-8σ0mg, 分2次缓慢静滴。亦可在治程初期静脉滴注本品,病情显著缓解后改为口服给药 「剂型与规格]片剂;0.1g/片,0.2/片。注射剂:200mg/瓶。滴耳剂:0.3%,5ml/支 用法及用量]滴眼,每次1滴,每日3~5次。涂眼,适量,每日3次或临睡前用。不宜长 期使用。 剂型与规格]滴眼剂:0.3%,5m支。眼膏剂:0.3%,3.5g/支 可进入乳汁哺乳妇女、孕妇及可能受孕的妇女禁用动物实验对骨发育有障碍幼儿禁用.严重 肾功能障碍、癫痫或曾患过癫痫等痉挛性疾病者慎用.对本品过敏者禁用 老年患者亦需减量应用
原体、肺炎支原体、溶脲脲原体和人型支原体等均有作用。本品的作用机制与诺氟沙星同。 细菌耐药情况参见诺氟沙星。 药动学 口服后吸收迅速而完全．口服制剂的生物利用度达 90％以上。单剂空腹口服和静滴 200mg 后的血药峰浓度分别为 2.47mg/L 和 5.1mg/L，但两种给药途径的药时曲线下最大面积相仿。 药物在体内广泛分布，在前列腺、痰液、肺组织、骨、耳鼻喉组织、水泡液中均可达有效药 物浓度。血清消除半减期 5～7h，主要经肾排泄，24h 内自尿中排出给药量的 70％～80％， 主要为药物的原形。胆汁中药物浓度约为血药浓度的 7 倍左右。 适应症： 适用于各种敏感菌(主要为革兰阴性菌)所致的骨、关节感染，皮肤软组织感染，肺炎，尿路 感染，肠道感染等；对伤寒、副伤寒包括多重耐药株所致者的疗效肯定。氧氟沙星对淋病、 前列腺炎、衣原体属和支原体属所致的感染(包括非淋病性尿道炎)也有效。本品也可试用于 布鲁菌病、军团菌病、立克次体病、多重耐药株所致的难治性结核、麻风、败血症等。 临床应用适应证与诺氟沙星大致相仿，但由于本品口服吸收完全，血药浓度高，在大多感染 病灶内可达有效浓度，因此氧氟沙星可用于下呼吸道感染、多重耐药菌所致伤寒、淋球菌与 衣原体或支原体混合泌尿生殖系感染、胆系、腹腔感染以及耳、鼻、喉等部位感染的治疗， 疗效良好。用于眼睑炎、麦粒肿、泪囊炎、睑板腺炎、结膜炎、角膜炎、角膜溃疡、术后感 染等。 用法用量： 1)成人的每日量为 200— 600mg，分 1 一 2 次服用，疗程 7 一 14 日。 (2)单纯下尿路感染每日 200mg，分 1 一 2 次服用。单纯性淋病单剂 400mg 即可。 (3)本品对伤寒的疗效确定，每日 600mg，分 2 次服用，疗程不少于 10 日。 (4)国外以每日口服量 400mg 一次给予治疗各种感染，获得满意效果。可试用于轻、中度感 染病例。一次量不宜超过 400mg。 [制剂与规格]氧氟沙星片(1) 0.1g(2) 0.2g 口服,一日 0.2-0.6g,分 1-3 次用.控制伤寒反复感染,一日 50mg,连服 3-6 个月.抗结核,每日 0.3g, 顿服. [用法及用量] 用于治疗下呼吸道感染、复杂性尿路感染时每日 600mg，分 2 次服；治疗较 重感染时可增至每日 800mg，分 2 次；急性单纯性尿路感染每日 200～400mg，顿服或分 2 次；急性单纯性淋病单剂 40Omg 服用，如有衣原体或支原体混合感染时需给予每次 200mg， 每日 2 次，10 日为一疗程；其他各种感染的疗程视病情、病种而定。本品静滴液可用于重 症感染的治疗，一般剂量为每日 400mg，分 2 次缓慢静滴(每 200mg 滴注时间不少于 30min)，病情需要时或病原菌为绿脓杆菌等敏感性略差者，剂量可增至每日 600～800mg， 分 2 次缓慢静滴。亦可在治程初期静脉滴注本品，病情显著缓解后改为口服给药。 [剂型与规格]片剂；0.1g/片，0.2/片。注射剂：200mg/瓶。滴耳剂：0.3％，5ml/支。 [用法及用量]滴眼，每次 1 滴，每日 3～5 次。涂眼，适量，每日 3 次或临睡前用。不宜长 期使用。 [剂型与规格]滴眼剂：0.3％，5ml/支。眼膏剂：0.3％，3.5g／支。 可进入乳汁,哺乳妇女、孕妇及可能受孕的妇女禁用.动物实验对骨发育有障碍,幼儿禁用.严重 肾功能障碍、癫痫或曾患过癫痫等痉挛性疾病者慎用.对本品过敏者禁用. 老年患者亦需减量应用
给药说明: 参考盐酸环丙沙星 (1)本品宜空腹服用,食物虽可延迟其吸收,但生物利用度未见减少,故也可考虑于餐后服 用,以减少胃肠道反应。 (2)肾功能减退(cr10-5oml/min)时需减量或延长给药间期,有条件时进行血药浓度监测 老年患者宜根据肌酐清除率降低程度减量用药。 (3)患者的尿pH在7以上时易发生结晶尿,故应避免同用碱化剂。成人的每日进水量宜保 持在1200m以上 不良反应 ①实验室异常发生率一般为6一10%,大多为可以耐受的胃肠道反应;②神经系反应如头 昏、失眠等,严重反应如抽搐、严重眩晕等少见,或仅发生于高剂量时:③过敏反应如皮疹、 皮肤瘙痒等。本品的不良反应发生率在常用同类药物中相对较低。 偶有休克症状出现当出现不适,发汗,呼吸困难,血压下降等症状时,停止投药,并作适当处理 出现皮疹,搔痒等过敏症状应即停药可引起肾损害,时有血中氮(BUN)及肌酐升高肝损害,肝 酶升高血象改变如白细胞、红细胞、血红蛋白、血细胞比容、血小板减少和嗜酸细胞增加 等现象可见中枢神经症状,如失眠,头晕头痛偶有痉挛,麻木等时有恶心、呕吐,胃腹部不适、 疼痛、腹泻、烧心,且偶有口干、口炎等. 同诺氟沙星,口服本品后的消化道反应较培氟沙星和环丙沙星为少见,其不良反应发生率约 3%~8%,其中半数以上为消化道反应。 偶见局部辛辣、疼痛感 相互作用 参阅盐酸环丙沙星[药物相互作用]1)(4) (1)在常用品种如诺氟沙星、依诺沙星、环丙沙星等中,氧氟沙星对茶碱类和咖啡因的代谢 影响最小,因此,当发生呼吸系感染而需同时用氨茶碱和氟喹诺酮类时,以采用氧氟沙星为 宜,但仍需勤加观察。 (2)氧氟沙星与抗凝剂之间的相互作用不明显,本品与头孢噻肟、甲硝唑、克林霉素、环孢 菌素等同用后,各药物的药动学过程均无明显改变。 本品对荼碱类、咖啡因等在体内代谢的影响不明显 本品与茶碱联合应用,可使后者血浓度升高,应加强监测
给药说明： 参考盐酸环丙沙星。 (1)本品宜空腹服用，食物虽可延迟其吸收，但生物利用度未见减少，故也可考虑于餐后服 用，以减少胃肠道反应。 (2)肾功能减退(Ccr10— 5Oml/min)时需减量或延长给药间期，有条件时进行血药浓度监测。 老年患者宜根据肌酐清除率降低程度减量用药。 (3)患者的尿 pH 在 7 以上时易发生结晶尿，故应避免同用碱化剂。成人的每日进水量宜保 持在 1200ml 以上。 不良反应： ①实验室异常发生率一般为 6 一 10％，大多为可以耐受的胃肠道反应；②神经系反应如头 昏、失眠等，严重反应如抽搐、严重眩晕等少见，或仅发生于高剂量时；③过敏反应如皮疹、 皮肤瘙痒等。本品的不良反应发生率在常用同类药物中相对较低。 偶有休克症状出现.当出现不适,发汗,呼吸困难,血压下降等症状时,停止投药,并作适当处理. 出现皮疹,搔痒等过敏症状应即停药.可引起肾损害,时有血中氮(BUN)及肌酐升高.肝损害,肝 酶升高.血象改变,如白细胞、红细胞、血红蛋白、血细胞比容、血小板减少和嗜酸细胞增加 等现象.可见中枢神经症状,如失眠,头晕头痛,偶有痉挛,麻木等.时有恶心、呕吐，胃腹部不适、 疼痛、腹泻、烧心，且偶有口干、口炎等. 同诺氟沙星，口服本品后的消化道反应较培氟沙星和环丙沙星为少见，其不良反应发生率约 3％～8％，其中半数以上为消化道反应。 偶见局部辛辣、疼痛感。 相互作用： 参阅盐酸环丙沙星[药物相互作用](1)一(4)。 (1)在常用品种如诺氟沙星、依诺沙星、环丙沙星等中，氧氟沙星对茶碱类和咖啡因的代谢 影响最小，因此，当发生呼吸系感染而需同时用氨茶碱和氟喹诺酮类时，以采用氧氟沙星为 宜，但仍需勤加观察。 (2)氧氟沙星与抗凝剂之间的相互作用不明显，本品与头孢噻肟、甲硝唑、克林霉素、环孢 菌素等同用后，各药物的药动学过程均无明显改变。 本品对茶碱类、咖啡因等在体内代谢的影响不明显。 本品与茶碱联合应用，可使后者血浓度升高，应加强监测
