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SCITEK INTERNATIONAL (H.K.) LIMITED
Email: sciteck.hongkong@gmail.com
 

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  药店国别: 美国药房
产地国家: 美国
所属类别: 眼科药物->治疗青光眼药物
处方药:处方药
包装规格: 10毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
Aton International, Inc.
生产厂家英文名:
Aton International, Inc.
该药品相关信息网址1:
http://www.aton.com/
该药品相关信息网址2:
http://www.rxlist.com/timoptic-drug.htm
原产地英文商品名:
TIMOPTIC 0.5% EYE DROPS 10ml/bottle
原产地英文药品名:
TIMOLOL MALEATE
中文参考商品译名:
TIMOPTIC 0.5%滴眼液 10毫升/瓶
中文参考药品译名:
马来酸噻吗洛尔
原产地国家批准上市年份:
1978/08/17
英文适应病症1:
Anti-IOP
英文适应病症2:
Treatment of glaucoma
临床试验期:
完成
中文适应病症参考翻译1:
抗眼压
中文适应病症参考翻译2:
治疗青光眼
药品信息:

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 详细处方信息以本药内容附件PDF文件(201041222295922.pdf)的“原文Priscribing Information”为准
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部分中文TIMOPTIC处方资料(仅供参考)

TIMOLOL MALEATE(马来酸噻吗洛尔)
  本品主要成分及其化学名称为:主要成分是马来酸噻吗洛尔,其化学名为:(一)-1-(叔丁氨基)-3-[(4-吗啉基-1,2,5-噻二唑-3-基)氧]-2-丙醇顺丁稀二酸盐。
  C13H24N4O3S·C4H4O4,
  分子量:432.49
  性状:本品为无色的澄明液体。
  适应症:对原发性开角型青光眼具有良好的降低眼内压疗效。对于某些继发性青光眼,高眼压症,部分原发性闭角型青光眼以及其他药物及手术无效的青光眼,加用本品滴眼可进一—步增强降眼压效果。
  用法用量:滴眼,一次1滴,一日1—2次,如眼压已控制,可改为一日1次。如原用其他药物,住改用本品治疗时.原药物不宜突然停用,应自滴用本品的第二天起逐渐停用
  禁忌:
  1.支气管哮喘者或有支气管哮喘史者,严重慢性阻塞性肺部疾病。2.窦性心动过缓,II或III度房室传导阻滞,明显心衰,心源性休克。3.对本品过敏者。
  注意事项:
  1.当出现呼吸急促、脉搏明显减慢、过敏等症状时,请立即停止使用本品。2.使用中若出现脑供血不足症状时应立即停药,3.心功能损害者,使用本品时应避免服用钙离子拮抗剂.4.对无心衰史的患者,如出现心衰症状应立即停药。5.正在服用儿茶酚胺耗竭药(如利血平)者,使用本品时应严密观察。6.冠状动脉疾患、糖尿病、甲状腺功能亢进和重症肌无力患者,用本品滴眼时需遵医嘱。7.本品慎用于自发性低血糖患者及接受胰岛素或口服降糖药治疗的患者,因p受体阻滞剂可掩盖低血糖症状。8.本品不宜单独用于治疗闭角型青光眼。9.与其他滴眼液联合使用时,请间隔lO分钟以上。10.定期复查眼压,根据眼压变化调整用药方案11.用前应摇匀,避免容器尖端接触眼睛,防止滴眼液污染。[孕妇及哺乳期妇女用药]本品对于孕妇的安全性尚未确定。滴眼后可在哺乳期妇女乳汁中测到本品,因对授乳婴儿具有多种潜在不良反应.需根据滴用本品对母亲的重要性决定终止哺乳或终止用药,[儿童用药]本品对于儿童的安全性和疗效尚未确定。
  药物相互作用:
  1.与肾上腺素合用可引起瞳孔扩大。2.不主张两种局部p受体阻断剂同时应用。3.本品与钙通道拮抗剂合用应慎重,囚可引起房室传导阻滞,左心室衰竭及低血压。肘心功能受损的患者,应避免两种药合并使用4.正在服用儿茶酚胺耗竭药(如利血平)者,使用本品时应严密观察,因可引起低血压和明显的心动过缓。5.本品与洋地黄类和钙通道拮抗剂合用可进一步延长房室传导时间。 6,本品与奎宁丁合用能引起心率减慢等全身p受休阻断的副作用。可能的原因是奎宁丁可抑制P450酶和CYPZD6对噻吗洛尔的代谢作用。
  药理作用:
  药理作用:马来酸噻吗洛尔是一种非选择性p—肾上腺能受体阻滞剂,没有明显的内源性拟交感活性和局麻作用,对心肌无直接抑制作用。本品为马来酸噻吗洛尔滴眼液.对高眼压患者和正常人均有降低眼内压作用、其降低眼内压的确切机理尚不清楚,眼压描记和房水荧光光度研究提示本品的降眼压作用与减少房水生成有关非临床毒理研究:致癌性:动物实验显示长期大量口服马来酸噻吗洛尔可使雄性大鼠肾卜腺嗜铬细胞瘤,雌性小鼠良性及恶性肺部肿瘤,良性子宫息肉及乳腺痛的发生率明显增高。生殖毒性:动物实验显示大剂量门服马来酸噻吗洛尔,对雄、雌性小鼠的生殖功能均无影响。
    孕妇及哺乳期妇女用药:本品对于孕妇的安全性尚未确定。滴眼后可在哺乳期妇女乳汁中测到本品,因对授乳婴儿具有多种潜在不良反应,需根据滴用本品对母亲的重要性决定终止哺乳或终止用药。
  儿童用药:本品对于儿童的安全性和疗效尚未确定。
  药物相互作用:1.与肾上腺素合用可引起瞳孔扩大。2.不主张两种局部β受体阻断剂同时应用。3.本品与钙通道拮抗剂合用应慎重,因可引起房室传导阻滞,左心室衰竭及低血压。对心功能受损的患者,应避免两种药合并使用。4.正在服用儿茶酚胺耗竭药(如利血平)者,使用本品时应严密观察,因可引起低血压和明显的心动过缓。5.本品与洋地黄类和钙通道拮抗剂合用可进一步延长房室传导时间。6.本品与奎宁丁合用能引起心率减慢等全身β受体阻断的副作用。可能的原因是奎宁丁可抑制P450酶和CYPZD6对噻吗洛尔的代谢作用。
  药物过量:过量应用本品可引起类似全身应用β受体阻断剂的副作用,如头晕,头痛,气短,心动过缓,支气管痉挛及心搏停止。
  包装:聚乙烯塑料眼药瓶。
  贮藏:遮光,密闭保存。
  药物毒理:药理作用: 马来酸噻吗洛尔是一种非选择性β-肾上腺能受体阻滞剂,没有明显的内源性拟交感活性和局麻作用。对心肌无直接抑制作用。本品为马来酸噻码洛尔滴眼液,对高眼压患者和正常人均有降低眼内压作用。其降低眼内压的确切机理尚不清楚,眼压描记和房水荧光光度研 究提示本品的降眼压作用与减少房水生成有关。 非临床毒理研究: 致癌性:动物实验显示长期大量口服马来酸噻吗洛尔可使雄性大鼠肾上腺嗜铬细胞瘤,雌牲小鼠良性及恶性肺部肿瘤,良性子宫息肉及乳腺癌的发生率明显增高。 生殖毒性:动物实验显示大剂量口服马来酸噻吗洛尔,对雄、雌性小鼠的生殖功能均无影响。 
  药代动力学:动物实验显示,用0.5本品对家兔单剂量滴眼,房水和血中的药物峰浓度出现在用药后30分钟,半衰期为1.5小时。全身吸收的马来酸噻吗洛尔在肝内代谢,70%的药物原型随尿排出。对6个接受治疗者的血浆药物浓度测定显示,每日用0.5%本品滴眼2次,早晨滴药后的平均血浆峰浓度为0.46ng/ml,下午滴眼后约为0.35ng/ml.


TIMOPTIC®
(timolol maleate) Ophthalmic Solution 0.25% AND 0.5%

DRUG DESCRIPTION
TIMOPTIC* (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer.

Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol.

TIMOPTIC is stable at room temperature. TIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of TIMOPTIC 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 274-328 mOsm. Each mL of TIMOPTIC 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.

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INDICATIONS
TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

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DOSAGE AND ADMINISTRATION
TIMOPTIC Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent TIMOPTIC in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) twice a day.

Since in some patients the pressure-lowering response to TIMOPTIC may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTIC.

If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

Dosages above one drop of 0.5 percent TIMOPTIC twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS: DRUG INTERACTIONS, Beta-adrenergic blocking agents.)

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HOW SUPPLIED
Sterile Ophthalmic Solution TIMOPTIC is a clear, colorless to light yellow solution.

No. 8895 — TIMOPTIC Ophthalmic Solution, 0.25% timolol equivalent, is supplied in an OCUMETER®* PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with yellow label as follows:NDC 0006-8895-35, 5 mL in a 7.5 mL capacity bottle

No. 8896 — TIMOPTIC Ophthalmic Solution, 0.5% timolol equivalent, is supplied in an OCUMETER® PLUS container, a white translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with yellow label as follows:NDC 0006-8896-35, 5 mL in a 7.5 mL capacity bottle NDC 0006-8896-36, 10 mL in an 18 mL capacity bottle.

Storage
Store at room temperature, 15-30°C (59-86°F). Protect from freezing. Protect from light.

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SIDE EFFECTS
The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations:

Body As A Whole
Headache, asthenia/fatigue, and chest pain.

Cardiovascular
Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet.

Digestive
Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.

Immunologic
Systemic lupus erythematosus.

Nervous System/Psychiatric
Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.

Skin
Alopecia and psoriasiform rash or exacerbation of psoriasis.

Hypersensitivity
Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and localized and generalized rash.

Respiratory
Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.

Endocrine
Masked symptoms of hypoglycemia in diabetic patients (see WARNINGS).

Special Senses
Signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery (see PRECAUTIONS, General); and tinnitus.

Urogenital
Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease.

The following additional adverse effects have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole: Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular: Worsening of arterial insufficiency, vasodilatation; Digestive:Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic: Nonthrombocytopenic purpura; thrombocytopenic purpura, agranulocytosis; Endocrine: Hyperglycemia, hypoglycemia; Skin: Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory:Rales, bronchial obstruction; Urogenital: Urination difficulties.

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DRUG INTERACTIONS
Although TIMOPTIC used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with TIMOPTIC and epinephrine has been reported occasionally.

Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and TIMOPTIC should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.

Calcium antagonists: Caution should be used in the coadministration of beta-adrenergic blocking agents, such as TIMOPTIC, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided.

Catecholamine-depleting drugs: Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

Digitalis and calcium antagonists: The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

CYP2D6 inhibitors: Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, SSRIs) and timolol.

Clonidine: Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. There have been no reports of exacerbation of rebound hypertension with ophthalmic timolol maleate.

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WARNINGS
As with many topically applied ophthalmic drugs, this drug is absorbed systemically.

The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate (see CONTRAINDICATIONS).

Cardiac Failure
Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition of beta-adrenergic receptor blockade may precipitate more severe failure.

In Patients Without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, TIMOPTIC should be discontinued.

Obstructive Pulmonary Disease
Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which TIMOPTIC is contraindicated [see CONTRAINDICATIONS]) should, in general, not receive beta-blockers, including TIMOPTIC.

Major Surgery
The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents.

If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.

Diabetes Mellitus
Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis
Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.

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PRECAUTIONS
General
Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with TIMOPTIC, alternative therapy should be considered.

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. (See PRECAUTIONS: Information for Patients.)

Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g. timolol).

Angle-closure glaucoma: In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil. Timolol maleate has little or no effect on the pupil. TIMOPTIC should not be used alone in the treatment of angle-closure glaucoma.

Anaphylaxis: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Muscle Weakness: Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.

Information for Patients
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

Patients should also be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. (See PRECAUTIONS, General.)

Patients should also be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.

Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product. (See CONTRAINDICATIONS.)

Patients should be advised that TIMOPTIC contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following TIMOPTIC administration.

Carcinogenesis, Mutagenesis, Impairment of Fertility
In a two-year study of timolol maleate administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day (approximately 42,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Similar differences were not observed in rats administered oral doses equivalent to approximately 14,000 times the maximum recommended human ophthalmic dose.

In a lifetime oral study in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose), but not at 5 or 50 mg/kg/day (approximately 700 or 7,000, respectively, times the systemic exposure following the maximum recommended human ophthalmic dose). In a subsequent study in female mice, in which post-mortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumors was again observed at 500 mg/kg/day.

The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumors has been established in humans. Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.

Timolol maleate was devoid of mutagenic potential when tested in vivo (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg/kg) and in vitro in a neoplastic cell transformation assay (up to 100 mcg/mL). In Ames tests the highest concentrations of timolol employed, 5,000 or 10,000 mcg/plate, were associated with statistically significant elevations of revertants observed with tester strain TA100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2. A ratio of 2 is usually considered the criterion for a positive Ames test.

Reproduction and fertility studies in rats demonstrated no adverse effect on male or female fertility at doses up to 21,000 times the systemic exposure following the maximum recommended human ophthalmic dose.

Pregnancy
Teratogenic Effects — Pregnancy Category C. Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity.

There are no adequate and well-controlled studies in pregnant women. TIMOPTIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers
Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from TIMOPTIC in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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OVERDOSE
There have been reports of inadvertent overdosage with TIMOPTIC Ophthalmic Solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest (see also ADVERSE REACTIONS).

Overdosage has been reported with Tablets BLOCADREN* (timolol maleate tablets). A 30-year-old female ingested 650 mg of BLOCADREN (maximum recommended oral daily dose is 60 mg) and experienced second and third degree heart block. She recovered without treatment but approximately two months later developed irregular heartbeat, hypertension, dizziness, tinnitus, faintness, increased pulse rate, and borderline first degree heart block.

An in vitro hemodialysis study, using 14C timolol added to human plasma or whole blood, showed that timolol was readily dialyzed from these fluids; however, a study of patients with renal failure showed that timolol did not dialyze readily.

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CONTRAINDICATIONS
TIMOPTIC is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.


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 详细处方信息以本药内容附件PDF文件(201041222295922.pdf)的“原文Priscribing Information”为准
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于2010年4月13日更新

更新日期: 2010-4-13
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