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 详细处方信息以本药内容附件PDF文件（201262618443836.PDF,201262618443212.PDF）的“原文Priscribing Information”为准
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 部分中文异烟肼处方资料（仅供参考）

异烟肼
【英文名称】 Isoniazid 

【其他名称】 雷米封，异烟酰肼，异烟脲，INH，INAH，Rimifon，Mybasan，Nicotihine 
 
【适应证】异烟肼单用适用于各型结核病的预防：
1.与新确诊为传染性肺结核病人有密切接触的结核分枝杆菌素试验(PPD)阳性幼儿和青少年。
2.结核分枝杆菌素试验强阳性者。
3.正在接受免疫抑制剂或长期激素治疗的患者，某些血液病或网状内皮系统疾病(如白血病、霍奇金氏病)、糖尿病、尿毒症、矽肺等患者，其结核分枝杆菌素试验呈阳性反应者。
4.未接种卡介苗5岁以下儿童结核分枝杆菌素试验阳性者。
5.已知或疑为HIV感染者，其结核分枝杆菌素试验呈阳性反应者，或与活动性肺结核患者有密切接触的结核分枝杆菌素试验呈阴性反应者。异烟肼与其他抗结核药联合，适用于各型结核病的治疗，包括结核性脑膜炎以及其他分枝杆菌感染。
 
【不良反应】发生率较多者有步态不稳或麻木针刺感、烧灼感或手脚疼痛(周围神经炎)、深色尿、眼或皮肤黄染(肝毒性，35岁以上患者中发生的可能性增加)、食欲不佳、异常乏力或软弱、恶心或呕吐(肝毒性的前驱症状)。发生率极少者有视力模糊或视力减退，合并或不合并眼痛(视神经炎)；发热、皮疹、血细胞减少及男性乳房发育等。本品偶可因神经毒性引起抽搐。

【注意事项】
1.交叉过敏反应，对乙硫异烟胺、吡嗪酰胺、烟酸或其他化学结构有关药物过敏者也可能对本品过敏。
2.本品可穿过胎盘，导致胎儿血药浓度高于母血药浓度。本品属妊娠用药C类。大鼠和家兔实验证实异烟肼可引起死胎，在人类中虽未证实有问题，但孕妇应用时必须充分权衡利弊。此外，新生儿肝脏乙酰化能力较差，本品的消除半衰期可能延长，新生儿用药时应密切观察不良反应。
3.在乳汁中浓度可达12mg/L，与血药浓度相近；虽然在人类尚未证实有问题，哺乳期间用仍应充分权衡利弊后决定是否用药，如用药则宜停止哺乳。   
4.对诊断的干扰：用硫酸铜法进行尿糖测定可呈假阳性反应，但不影响酶法测定的结果。异烟肼可使血清胆红素、丙氨酸氨基转移酶及门冬氨酸氨基转移酶的测定值增高。
5.避免应用于有精神病、癫痫病史者、肝功能损害、严重肾功能损害者应慎用。50岁以上患者用本品引起肝炎的发生率较高。
6.如疗程中出现视神经炎症状，需立即进行眼部检查，并定期复查。
7.肝功能减退者异烟肼的剂量应酌减。
8.用药前、疗程中应定期检查肝功能，包括血清胆红素、AST、ALT，疗程中密切注意有无肝炎的前驱症状，一旦出现肝毒性的症状及体征时应即停药，必须待肝炎的症状、体征完全消失后方可重新应用异烟肼，此时必须从小剂量开始，逐步增加剂量，如有任何肝毒性表现应即停药。
9.逾量的处理：①保持呼吸道通畅；②采用短效巴比妥制剂和维生素B6静脉内给药，维生素B6剂量为每1mg异烟肼用1mg，如服用异烟肼的剂量不明，可给予5g每30分钟1次，直至抽搐停止，患者恢复清醒。继以洗胃，洗胃应在服用异烟肼后的2～3小时内进行；③立即抽血测定血气、电解质、尿素氮、血糖等；④立即静脉给予碳酸氢钠，纠正代谢性酸中毒，需要时重复给予；⑤采用渗透性利尿剂，并在临床症状已改善后继续应用，促进异烟肼排泄，预防中毒症状复发；⑥严重中毒患者应及早配血，做好血液透析的准备，不能进行血液透析时，可进行腹膜透析，同时合用利尿剂；⑦采取有效措施，防止出现缺氧、低血压及吸入性肺炎。

【药物相互作用】
1.服用异烟肼时每日饮酒，易引起异烟肼诱发的肝脏毒性反应，并加速异烟肼的代谢，因此须调整异烟肼的剂量，并密切观察肝毒性征象。应劝告患者服药期间避免酒精饮料。
2.含铝制酸药可延缓并减少异烟肼口服后的吸收，使血药浓度减低，故应避免两者同时服用，或在口服制酸剂前至少1小时服用异烟肼。
3.抗凝药(如香豆素或茚满双酮衍生物)与异烟肼同时应用时，由于本品抑制了抗凝药的代谢，使抗凝作用增强。
4.与环丝氨酸合用时可增加中枢神经系统不良反应(如头昏或嗜睡)，需调整剂量，密切观察，尤其对于从事需要灵敏度较高的工作的患者。
5.利福平与异烟肼合用时可增加肝毒性的危险性，尤其是已有肝功能损害者或为异烟肼快乙酰化者，因此在疗程的头3个月应密切随访有无肝毒性征象出现。
6.异烟肼为维生素B6的拮抗剂，可能导致周围神经炎，两者合用时维生素B6的需要量增加。   
7.与肾上腺皮质激素(尤其泼尼松龙)合用时，可增加异烟肼在肝内的代谢及排泄，导致后者血浓度减低而影响疗效，在快乙酰化者更为显著，应适当调整剂量。
8.与阿芬太尼(alfentanil)合用时，由于异烟肼为肝药酶抑制剂，可延长阿芬太尼的作用；与双硫仑(disulfiram)合用可增强其中枢神经系统作用，产生眩晕、动作不协调、易激惹、失眠等；与安氟醚合用可增加具有肾毒性的无机氟代谢物的形成。
9.与乙硫异烟胺或其他抗结核药合用，可加重后二者的不良反应。与其他肝毒性药合用可增加本品的肝毒性，因此宜尽量避免。
10.异烟肼与酮康唑或咪康唑合用，可使后两者的血浓度降低，不宜合用。
11.与苯妥英钠或氨茶碱合用时可抑制二者在肝脏中的代谢，而导致苯妥英钠或氨茶碱血浓度增高，故异烟肼与两者先后应用或合用时，苯妥英钠或氨茶碱的剂量应适当调整。
12.与对乙酰氨基酚合用时，由于异烟肼可诱导肝细胞色素P-450，使乙酰氨基酚形成毒性代谢物的量增加，可增加肝毒性及肾毒。
13.与卡马西平同时应用时，异烟肼可抑制其代谢，使卡马西平的血浓度增高，引起不良反应；卡马西平可诱导肝药酶而加快异烟肼的代谢，具有肝毒性的中间代谢物增加。
14.本品不宜与其他可引起神经系统不良反应的药物合用，以免增加神经毒性。

【给药说明】
1.慢乙酰化患者较易产生不良反应，如周围神经炎等，故宜用较低剂量。一般在爱斯基摩人、东方人和美洲印第安人中慢乙酰化者较少；埃及人、以色列人、斯堪的那维亚、高加索等地居民和黑人中慢乙酰化者所占比例最高。异烟肼可每日用药1次。
2.除预防性用药外，治疗必须与其他抗结核药物联合，避免单一用药。间歇疗法时，成人异烟肼剂量为500～600mg，每周给药2次或3次。
3.肾功能减退者其血肌酐值低于6mg/100ml者，异烟肼的用量不需减少。如肾功能减退更为严重或患者系慢乙酰化者则可能需减量，以异烟肼服用后24小时的血药浓度不超过1mg/L。为宜。在无尿患者中异烟肼的剂量可减为常用量之半。
4.大剂量使用异烟肼时，应适当补充维生素B6，有助于防止或减轻周围神经炎及(或)维生素 B6缺乏症状。
5.如出现胃肠道刺激症状，异烟肼可与食物同服；亦可服用制酸剂，但异烟肼应在口服制酸剂前至少1小时服用。与食物或制酸剂同服可能减少异烟肼的吸收。

【用法与用量】
1.口服：①预防，成人每日0.3g，顿服；小儿每日按体重10mg/kg，每日总量不超过0.3g，顿服。②治疗，成人与其他抗结核药合用，按体重每日口服5mg/kg，每日0.3～0.4g，顿服；或每日15mg/kg，最高900mg，一周2～3次。小儿按体重每日10～20mg/kg，每日不超过0.3g，顿服。某些严重结核病患儿(如结核性脑膜炎)，每日按体重可高达30mg/kg(每日量不超过600mg)。
2.肌内注射：治疗剂量同上。
3.静脉滴注：用于重症病例，用氯化钠注射液或5%葡萄糖注射液溶解并稀释后静滴，每日0.3～0.6g(注射多用于不能口服的患者)。

【制剂与规格】
1.异烟肼片：①50mg；②100mg；③300mg。
2. 注射用异烟肼：0.1g。

Isoniazid
Main use：Tuberculosis
Active ingredient：Isoniazid
 
How does it work?
Isoniazid is an antibiotic that is used to treat tuberculosis (TB). It works by killing the bacteria that cause the disease.

The exact mechanism of action of isoniazid is unknown, but it is thought to prevent the tuberculosis bacteria from making substances called mycolic acids, which are needed to form the cell walls of the bacteria. It also seems to combine with an enzyme that interferes with the cell metabolism of the bacteria. As a result of the disruption in it's metabolism and without a cell wall, the bacteria die.

There are two stages in the treatment for tuberculosis. In the first two months treatment is aimed at killing as many bacteria as possible. Therefore several anti-TB drugs with different mechanisms of action are used at the same time (usually rifampicin, pyrazinamide, isoniazid and ethambutol). After this time some of the medicines are stopped and the others (usually rifampicin and isoniazid) are continued for a further four months to kill any remaining bacteria. Isoniazid is used in both stages of treatment.

The bacteria that cause TB are difficult to treat. By using several medicines at the same time, the bacteria can be targeted in different ways and hence treatment is more likely to be effective than using a single medicine. In addition, using different medicines together makes it less likely that bacteria will develop resistance to the treatment.

What is it used for?
Treatment of tuberculosis (in combination with other anti-tuberculosis medicines).

Warning!
Each dose of this medicine should be taken at least 30 minutes before a meal or two hours after a meal to ensure it is fully absorbed from the gut.
It is important that you take each dose of this antibiotic regularly, as prescribed by your doctor. Unless your doctor tells you otherwise, it is also important that you finish the prescribed course of this antibiotic medicine, even if you feel better or it seems the infection has cleared up. Stopping the course early increases the chance that the infection will come back and that the bacteria will grow resistant to the antibiotic.
You will need to have a blood test to check your liver function before you start treatment with this medicine. If this test shows any existing problems with your liver, you will need to have regular blood tests to monitor your liver function throughout treatment with this medicine. All people taking this medicine should consult their doctor immediately if they experience any symptoms that may suggest a liver problem. These may include the development of jaundice (a yellow colouring to the skin and the whites of the eyes), persistent nausea and vomiting, abdominal pain, or feeling generally unwell.
You should avoid drinking large amounts of alcohol while you are taking this medicine, as this may increase the risk of side effects on the liver.

Use with caution in
Elderly people.
Decreased kidney function.
Decreased liver function.
Slow liver metabolism (slow acetylator status).
Alcoholism.
Malnutrition.
Hereditary blood disorders called porphyrias.
Diabetes.
Epilepsy.
History of psychotic illness.
HIV infection.

Not to be used in
Liver disease caused by medication.

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.

The safety of this medicine for use during pregnancy has not been established. It should only be during pregnancy if considered essential by your doctor, and if the potential benefits to the mother outweigh any risks to the developing baby. Seek medical advice from your doctor.
This medicine passes into breast milk and may have adverse effects on a nursing infant. As a result this medicine should be used with caution in breastfeeding mothers, and only if the expected benefit to the mother is greater than any possible risk to the baby. Seek medical advice from your doctor. If you do breastfeed during treatment with this medicine, your doctor may prescribe pyridoxine (vitamin B6) supplements for you and the baby, to reduce the risk of side effects on the nerves.

Label warnings
Take this medication half to one hour before food.
Do not stop taking this medication except on your doctor's advice.

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. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Nausea and vomiting.
Constipation.
Dry mouth.
Fever.
Difficulty urinating.
Dizziness or spinning sensation (vertigo).
Inflammation of the nerves (neuritis), which may cause pins and needles sensations, muscle weakness or blurred vision. Your doctor may prescribe you pyridoxine (vitamin B6) supplements to help prevent this side effect. Tell your doctor straight away if you experience symptoms like these.
Inflammation of the liver (hepatitis).
Seizures (convulsions).
Loss of contact with reality (psychosis).
Blood disorders.
Skin reactions.
Raised blood sugar levels (hyperglycaemia).

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?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Antacids (used to treat indigestion and heartburn) may reduce the absorption of this medicine from the gut. You should not take antacids at the same time of day as this medicine.

Isoniazid may prevent the breakdown by the liver of the medicines listed below, which may increase the amount of these medicines in the blood and hence the risk of their side effects.
Benzodiazepines, eg diazepam, triazolam.
Carbamazepine.
Ethosuximide.
Phenytoin.
Theophylline.

Isoniazid may reduce the blood level of the antifungal medicine ketoconazole, and so may make it less effective.

Other medicines containing the same active ingredient
Rifinah contains isoniazid in combination with rifampicin.

Rifater contains isoniazid in combination with rifampicin and pyrazinamide.

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 详细处方信息以本药内容附件PDF文件（201262618443836.PDF,201262618443212.PDF）的“原文Priscribing Information”为准
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