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Generic Name: phenobarbital |
通用名：苯巴比妥 | |
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Brand Name: Luminal® |
商標(biāo)名：魯米那® | |
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Drug Category: barbiturate, nonselective central nervous system depressant |
類別：巴比妥類藥，非選擇性中樞神經(jīng)系統(tǒng)抑制藥 | |
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Dosage Form: Tablet, Elixir |
劑型：片劑、酏劑 | |
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Indication |
適用癥 | |
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a. Sedatives. b. Hypnotics, for the short-term treatment of insomnia c. Preanesthetics. d. Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. |
a. 鎮(zhèn)靜 b. 催眠，短期治療失眠癥 c. 前驅(qū)麻醉 | |
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Inactive Ingredients |
輔助成份 | |
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Oral Tablets - corn starch, lactose, magnesium stearate and sodium starch glycolate Oral Elixir - ethyl alcohol, glycerin, oil of orange, sucrose, water |
口服片劑－玉米淀粉、乳糖、硬脂酸鎂和羥甲基淀粉鈉 | |
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Mechanism of Action |
作用原理 | |
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Phenobarbital acts on GABA receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal. |
苯巴比妥作用于γ-氨基丁酸受體，增加突觸后神經(jīng)抑制，提高發(fā)作閾值，減少發(fā)作病灶效能的擴(kuò)散。苯巴比妥還對(duì)鈣通道起抑制作用，減少興奮性遞質(zhì)的釋放。苯巴比妥的鎮(zhèn)靜催眠效果很可能是其對(duì)多突觸中腦網(wǎng)狀結(jié)構(gòu)作用的結(jié)果，它控制CNS覺醒。 | |
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Toxicity |
毒性作用 | |
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CNS and respiratory depression which may progress to Cheyne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may show paralytic dilation), oliguria, tachycardia, hypotension, lowered body temperature, and coma. Typical shock syndrome (apnea, circulatory collapse, respiratory arrest, and death) may occur. |
CNS和呼吸抑制可導(dǎo)致潮式呼吸、反射消失、瞳孔微縮（中毒嚴(yán)重時(shí)可表現(xiàn)為無力性擴(kuò)張)、少尿、心動(dòng)過速、低血壓、低溫和昏迷。也可能出現(xiàn)典型的休克綜合癥（呼吸暫停、循環(huán)衰竭、呼吸停止、死亡)。 | |
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Half Life: 53 to 118 hours (mean 79 hours) |
半衰期：53至118小時(shí)（平均79小時(shí))。 | |
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Pharmacology |
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Phenobarbital is capable of producing all levels of CNS mood alteration, from excitation to mild sedation to hypnosis, and deep coma. Over-dosage can produce death. In high enough therapeutic doses, Phenobarbital induces anesthesia. Phenobarbital depresses the sensory cortex, decreases motor activity, alters cerebellar function, and produces drowsiness, sedation, and hypnosis. Phenobarbital-induced sleep differs from physiological sleep. Sleep laboratory studies have demonstrated that Phenobarbital reduces the amount of time spent in the rapid eye movement (REM) phase of sleep or the dreaming stage. Also Stages III and IV sleep are decreased. Following abrupt cessation of Phenobarbital used regularly, patients may experience markedly increased dreaming, nightmares and/or insomnia. Therefore, withdrawal of a single therapeutic dose over 5 or 6 days has been recommended to lessen the REM rebound and disturbed sleep which contribute to drug withdrawal syndrome (for example, decrease the dose from 3 to 2 doses a day for 1 week). |
苯巴比妥可導(dǎo)致CNS狀 態(tài)改變，由興奮至輕度鎮(zhèn)靜至催眠，直至深度昏迷。用藥過量可致死。足夠的治療劑量可誘發(fā)麻醉。苯巴比妥抑制感覺皮層，減弱運(yùn)動(dòng)活力，改變小腦功能，引起困 倦、鎮(zhèn)靜和催眠。苯巴比妥誘導(dǎo)的睡眠與生理睡眠不同。睡眠實(shí)驗(yàn)證明，苯巴比妥縮短睡眠眼速動(dòng)期或睡夢(mèng)期時(shí)間，睡眠第三期和第四期也被縮短。若在定期使用苯 巴比妥一段時(shí)間后突然停藥，病人睡夢(mèng)、夢(mèng)魘和/或失眠明顯增加，因此，有人建議用5－6天時(shí)間逐漸停止單次治療劑量以減少快速眼動(dòng)睡眠反跳和睡眠混亂，避免戒斷綜合癥（如將一周劑量由一天三次減為一天兩次)。 | |
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Phenobarbital has little analgesic action at subanesthetic doses. Rather, in sub anesthetic doses, this drug may increase the reaction to painful stimuli. All barbiturates exhibit anticonvulsant activity in anesthetic doses. However, of the drugs in this class, only phenobarbital, mephobarbital, and metharbital are effective as oral anticonvulsants in sub hypnotic doses. |
苯巴比妥亞麻醉劑量時(shí)幾無鎮(zhèn)痛作用，反倒會(huì)增加對(duì)疼痛刺激的反應(yīng)。所有麻醉劑量的巴比妥類藥都有抗驚厥作用，不過，在此類藥物中，只有苯巴比妥、甲苯比妥和美沙比妥的亞催眠劑量效果和口服抗驚厥劑相同。 | |
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Phenobarbital is a respiratory depressant. The degree of respiratory depression is dependent upon the dose. With hypnotic doses, respiratory depression produced by Phenobarbital is similar to that which occurs during physiologic sleep with slight decrease in blood pressure and heart rate. Studies in laboratory animals have shown that Phenobarbital causes reduction in the tone and contractility of the uterus, ureters, and urinary bladder. However, concentrations of the drug required to produce this effect in humans are not reached with sedative-hypnotic doses. Phenobarbital does not impair normal hepatic function but has been shown to induce liver microsomal enzymes, thus increasing and/or altering the metabolism of barbiturates and other drugs. |
苯巴比妥為呼吸抑制劑，呼吸抑制程度取決于劑量。催眠劑量苯巴比妥產(chǎn)生的呼吸抑制效果類似于生理睡眠狀態(tài)，血壓、心率略有降低。動(dòng)物實(shí)驗(yàn)表明，苯巴比妥導(dǎo)致子宮、輸尿管、膀胱張力和收縮力降低。然而，鎮(zhèn)靜-催眠劑量無法達(dá)到人體產(chǎn)生這種效果所需的藥物濃度。 苯巴比妥不損害肝臟的功能，但可誘導(dǎo)肝微粒體酶，從而增加或改變巴比妥類和其他藥物的代謝。 | |
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Drug Abuse and Dependence |
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Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of phenobarbital. As tolerance to phenobarbital develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxicating dosage and fatal dosage becomes smaller. |
苯巴比妥可導(dǎo)致耐受性、精神性和身體性依賴，尤其是長期大劑量服用。隨著苯巴比妥耐藥性的增強(qiáng)，保持相同宿醉狀態(tài)所需的藥量也隨之增加，但是，對(duì)致死劑量耐受性的增加卻不會(huì)超過兩倍。此時(shí)，中毒劑量和致死劑量之間的差距縮短。 | |
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Symptoms of acute intoxication with phenobarbital include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints. |
苯巴比妥急性中毒癥狀包括步態(tài)不穩(wěn)、言語不清和持續(xù)眼震。慢性中毒心理癥狀包括意識(shí)混亂、判斷力差、易怒、失眠及軀體不適。 | |
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Symptoms of phenobarbital dependence are similar to those of chronic alcoholism. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood, the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested. The symptoms of phenobarbital withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of phenobarbital. These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of this drug. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Individuals susceptible to phenobarbital abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers. |
苯巴比妥依賴癥狀與慢性酒精中毒癥狀相似。如果病人出現(xiàn)酒精中毒癥狀，血液酒精濃度異常，就應(yīng)懷疑使用苯巴比妥。飲酒者的苯巴比妥致死量更小。苯巴比妥戒斷癥狀會(huì)很嚴(yán)重，可能引起死亡，輕微的戒斷癥狀可能在末次劑量8－12小時(shí)后出現(xiàn)，癥狀出現(xiàn)順序通常為：焦慮、肌肉顫搐、手及手指發(fā)顫、進(jìn)行性無力、頭昏、視覺失真、惡心、嘔吐、失眠和體位性低血壓。16小時(shí)內(nèi)出現(xiàn)重大戒斷癥狀（抽搐和譫妄)，從突然停藥起可持續(xù)5天。在大約15天左右的時(shí)間里，戒斷癥狀強(qiáng)度逐漸減弱。苯巴比妥濫用和依賴易感個(gè)體包括濫用酒精和鴉片及其他鎮(zhèn)靜-催眠、苯丙胺藥物者。 | |
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Drug dependence on phenobarbital arises from repeated administration of the barbiturate or an agent with barbiturate-like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence on phenobarbital include: (a) a strong desire or need to continue taking the drug, (b) a tendency to increase the dose, (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation of those effects, and (d) a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn. |
苯巴比妥藥物依賴緣于巴比妥類或具有巴比妥樣效用的制劑的連續(xù)重復(fù)使用，其劑量通常都超出治療量。苯巴比妥藥物依賴特征：1、有繼續(xù)服用的強(qiáng)烈愿望或需要；2、增加劑量趨勢(shì)明顯；3、對(duì)藥物效果的精神性依賴與個(gè)體對(duì)這些效果的主觀認(rèn)識(shí)有關(guān)；和4、對(duì)藥物效果的軀體依賴要求通過藥物來保持體內(nèi)穩(wěn)定，一旦停藥，就會(huì)導(dǎo)致明顯、特異和自限性戒斷綜合癥。 | |
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Treatment of phenobarbital dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of phenobarbital for each 100 to 200 mg dose that the patient has been taking. The total daily amount of phenobarbital is then administered in 3 to 4 divided doses, not to exceed 600 mg daily. Should signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of phenobarbital may be administered IM in addition to the oral dose. After stabilization on phenobarbital, the total daily dose is decreased by 30 mg a day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patient's regular dosage level and decreasing the daily dosage by 10 percent if tolerated by the patient. |
治療苯巴比妥依賴應(yīng)采取謹(jǐn)慎和漸進(jìn)的戒斷方式。方法之一是用30 mg劑量苯巴比妥替代病人服用的100－200 mg苯巴比妥，將病人一天的苯巴比妥總量按3－4次分劑量服用，每天不超過600 mg。治療第一天若出現(xiàn)戒斷癥狀，可在口服劑量之外，靜脈加注100－200 mg的負(fù)荷劑量。穩(wěn)定后，只要戒斷正常，就可按每天30 mg標(biāo)準(zhǔn)逐日減少藥量。也可以對(duì)此方法加以變通，按病人正常劑量開始治療，若病人耐受，即可按每天10%的劑量逐日遞減。 | |
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Infants physically dependent on phenobarbital may be given a lower dose of phenobarbital at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of phenobarbital should be gradually decreased and completely withdrawn over a 2-week period. |
產(chǎn)生軀體依賴的嬰兒可以給服更小劑量的苯巴比妥，即3－10 mg/kg/day。在戒斷癥狀（活動(dòng)過度、睡眠混亂、顫抖、反射亢進(jìn))減輕后，應(yīng)逐漸減少劑量，并在2周內(nèi)完全戒除。 | |
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Contraindications |
禁忌癥 | |
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Phenobarbital is contraindicated in patients with known phenobarbital sensitivity or a history of manifest or latent porphyria. |
苯巴比妥過敏、有征候性或潛伏性卟啉病史者禁用苯巴比妥。 | |
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Administration |
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用法 |
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Suggested doses of phenobarbital for specific indications are as follows: a. Pediatric Oral Dosage: preoperative: 1 to 3 mg/kg. b. Adult Oral Dosage: 1. Daytime sedative: 30 to 120 mg daily in 2 to 3 divided doses. 2. Bedtime hypnotic: 100 to 320 mg. 3. Anticonvulsant: 50 to 100 mg 2 to 3 times daily. |
具體適應(yīng)癥的建議劑量如下： 1、兒科口服劑量：1－3 mg/kg； 2、成人口服劑量： 1)日間鎮(zhèn)靜：每日39－120 mg，2－3次分服； 2)睡前催眠：100－200 mg； 3)抗驚厥：50－100 mg，一天2－3次。 | |
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Dosages of phenobarbital must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical. |
苯巴比妥劑量因人而異，應(yīng)充分了解病人特點(diǎn)及推薦的給藥頻度，考慮病人的年齡、體重和身體狀況。只在無法口服情況下采用非腸道給藥。 | |
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Anticonvulsant use: A therapeutic anticonvulsant level of phenobarbital in serum is 10 to 25 µg/mL. To achieve the blood levels considered therapeutic in children, higher per-kilogram dosages are generally necessary for phenobarbital and most other anticonvulsants. In children and infants, phenobarbital at loading dose of 15 to 20 mg/kg produces blood levels of about 20 µg/mL shortly after administration. |
抗驚厥治療所需的血藥濃度為10－25µg/mL。為獲得兒童治療所需的血藥濃度，苯巴比妥及其他多數(shù)抗驚厥藥物一般都應(yīng)提高每公斤體重劑量。兒童及嬰兒15-20 mg/kg的負(fù)荷劑量可使血藥濃度很快達(dá)到20µg/mL。 | |
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In status epilepticus, it is imperative to achieve therapeutic blood levels of phenobarbital as rapidly as possible. Because a barbiturate-induced depression may occur along with a postictal depression once the seizures are controlled, it is important, therefore, to use the minimal amount required, and to wait for the anticonvulsant effect to develop before administering a second dose. 醫(yī)學(xué) 全在.線提供www.med126.com |
癲癇持續(xù)狀態(tài)時(shí)必須盡快達(dá)到血液苯巴比妥治療濃度，因?yàn)橐坏┌l(fā)作得到控制，巴比妥類藥物引起的抑制就會(huì)與發(fā)作后抑制一起發(fā)生，所以，很重要的一點(diǎn)就是使用最小劑量，在抗驚厥作用出現(xiàn)后再跟服第二劑。 | |
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Phenobarbital has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy. |
苯巴比妥已被用于熱性癲癇發(fā)作的治療和預(yù)防。但是，并不能確定熱性癲癇發(fā)作的預(yù)防是否影響癲癇的后續(xù)發(fā)展。 | |
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Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to phenobarbital. Dosage should be reduced for patients with impaired renal function or hepatic disease. |
特殊病人：老人或體弱病人應(yīng)減少劑量，因?yàn)檫@些病人對(duì)苯巴比妥更敏感。腎功能受損或肝病病人的劑量也應(yīng)減少。 | |
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Drug Interactions |
藥物相互作用 | |
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Doctors or pharmacist should be aware of and monitor for any possible drug interactions. Do not start, stop, or change the dosage of any medicine before checking with the doctor or pharmacist first. |
醫(yī)生或藥劑師應(yīng)知道并監(jiān)測(cè)可能的藥物相互作用。在向醫(yī)生或藥劑師核實(shí)前，不得開始、停止或改變用藥劑量。 | |
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This drug should not be used with the following medications because very serious interactions may occur: delavirdine, sodium oxybate, voriconazole. |
鑒于可能出現(xiàn)嚴(yán)重的藥物相互作用，本品不能與下列藥物一起服用：地拉韋啶、羥丁酸鈉、伏立康唑。 | |
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Some other drowsiness-causing medications may cause serious (possibly fatal) slowed breathing when taken with higher doses of phenobarbital. The patient should tell the doctors or pharmacists, before starting phenobarbital, if he or she also takes other drugs that cause drowsiness such as: medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). |
其 他一些致睡藥物與大劑量苯巴比妥一起服用時(shí)可能導(dǎo)致嚴(yán)重的（可能致命的)呼吸減慢，病人 應(yīng)在開始服用前告知醫(yī)生或藥劑師是否服用其他致睡藥物，如睡眠或 焦慮藥（阿普唑倉、地西泮、唑吡坦)、肌松藥、麻醉性止痛藥（可待因)、精神病藥（氯丙嗪、利培酮、阿米替林、曲唑酮)。 | |
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Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: warfarin, estrogens, corticosteroids (e.g., prednisone, dexamethasone), quinidine, felodipine, metronidazole, doxycycline, griseofulvin, phenytoin, valproic acid, theophylline, MAO inhibitors (e.g., phenelzine, selegiline). |
用藥前，病人應(yīng)告知醫(yī)生或藥劑師本人可能使用的所有處方、非處方及草藥等，特別是華法林、雌激素、皮質(zhì)激素（如潑尼松、地塞米松)、奎尼丁、非洛地平、甲硝噠唑、多西環(huán)素、灰黃霉素、苯妥英、丙戊酸、茶堿、單胺氧化酶抑制藥（苯乙肼、司來吉蘭)。 | |
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Before using this medication, tell your doctor or pharmacist if you use any other prescription and nonprescription products that cause drowsiness such as certain antihistamines (e.g., diphenhydramine) and anti-seizure drugs (e.g., carbamazepine). |
用藥前，應(yīng)告知醫(yī)生或藥劑師是否使用任何其他可致睡的處方及非處方藥品，如一些抗組胺類（苯海拉明)及抗癲癇藥物（如卡馬西平) | |
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Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. |
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This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details. |
本品可能減弱組合型避孕藥片效果，導(dǎo)致懷孕。因此，在使用本品時(shí)，病人可能需要另外采取可靠的避孕措施。詳細(xì)情況可咨詢醫(yī)生或藥劑師。 | |
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Precautions |
注意事項(xiàng) | |
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Tolerance and psychological and physical dependence may occur with continuing use. Phenobarbital should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. Elderly or debilitated patients may react to Phenobarbital with marked excitement, depression, and confusion. |
連續(xù)用藥可產(chǎn)生耐藥性、精神依賴性和軀體依賴性。精神壓抑、有自殺傾向或藥物濫用史者，確需服用時(shí)應(yīng)格外謹(jǐn)慎。老年或體弱病人服用苯巴比妥可出現(xiàn)明顯的興奮、抑郁、意識(shí)混亂等反應(yīng)， | |
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In patients with hepatic damage, phenobarbital should be administered with caution and initially reduced doses. Phenobarbital should not be administered to patients showing the premonitory signs of hepatic coma. |
肝損病人應(yīng)謹(jǐn)慎使用苯巴比妥，并應(yīng)減少初始劑量。有肝昏迷先兆病人不能使用苯巴比妥。 | |
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Prolonged therapy with phenobarbital should be accompanied by periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic systems. |
長期服用苯巴比妥病人應(yīng)對(duì)器官系統(tǒng)作定期評(píng)估檢查，這些包括造血、腎臟、肝臟等系統(tǒng)。 | |
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Human-data: A retrospective study of 84 children with brain tumors matched to 73 normal controls and 78 cancer controls (malignant disease other than brain tumors) suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumors. |
84名腦瘤兒童與73名正常對(duì)照組和78名癌癥對(duì)照組病人（腦瘤除外的惡性病例)回顧性研究提示，產(chǎn)前接觸巴比妥類藥物與腦瘤發(fā)病率有關(guān)。 | |
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Warning |
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告誡事項(xiàng) |
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1. Habit forming: To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal symptoms. Phenobarbital should be withdrawn gradually. |
1、習(xí)慣問題：為減少藥物過量機(jī)會(huì)，減少藥物依賴，應(yīng)限制鎮(zhèn)靜-催眠用巴比妥類藥物，只開、配下次就診時(shí)為止的數(shù)量。藥品依賴病人在長期用藥后突然停止時(shí)可出現(xiàn)戒斷癥狀。苯巴比妥戒斷應(yīng)逐步進(jìn)行。 | |
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2. Acute or chronic pain: Caution should be exercised when Phenobarbital is administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of phenobarbital as a sedative in the postoperative surgical period and as an adjunct to cancer chemotherapy is well established. |
2、急性或慢性疼痛：急性或慢性疼痛病人給用苯巴比妥時(shí)就謹(jǐn)慎，因?yàn)樗赡芤甬惓Ｅd奮，或掩蓋某些重要癥狀。但是，術(shù)后鎮(zhèn)靜或作為癌癥化療輔助藥物作用時(shí)則無此顧慮。 | |
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3. Use in pregnancy: Phenobarbital can cause fetal damage when administered to a pregnant woman. Retrospective case-controlled studies have suggested a connection between the maternal consumption of phenobarbital and higher than expected incidence of fetal abnormalities. Following oral administration, Phenobarbital readily crosses the placental barrier and is distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain. Withdrawal symptoms occur in infants born to mothers who receive phenobarbital throughout the last trimester of pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. |
3、 妊娠使用：妊娠婦女使用苯巴比妥可致胎兒損傷，回顧性對(duì)照研究提示，母體服用苯巴比妥與胎兒發(fā)育異常比例高于預(yù)期有關(guān)。服藥后，苯巴比妥迅速透過胎盤屏 障，遍及胎兒組織，胎盤、胎兒肝臟和大腦的藥物濃度極高。妊娠后三個(gè)月服用苯巴比妥母親所生嬰兒出現(xiàn)戒斷癥狀，如懷孕期間服用本品，或病人服藥期間懷孕， 應(yīng)將胎兒潛在危險(xiǎn)通知病人。 | |
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4. Synergistic effects: The concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects. |
4、協(xié)同效應(yīng)：同步飲用酒精或其他CNS抑制藥物可增強(qiáng)CNS抑制作用。 | |
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Side Effects |
副作用 | |
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The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients. |
經(jīng)對(duì)成千上萬例住院病人監(jiān)護(hù)發(fā)現(xiàn)，本品具有下列不良反應(yīng)： | |
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More than 1 in 100 patients: The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 100 is somnolence. |
1%以上病人： 據(jù)估計(jì)，每100位病人中，1－3位病人最常見的不良反應(yīng)為嗜眠 | |
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Less than 1 in 100 patients: Adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are: |
1%以下病人： 據(jù)估計(jì)，不到1%的病人出現(xiàn)下列不良反應(yīng)（按器官排列，發(fā)生最多者排列在前)： | |
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l Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality. l Respiratory system: Hypoventilation, apnea. l Cardiovascular system: Bradycardia, hypotension, syncope. l Digestive system: Nausea, vomiting, constipation. l Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following. |
神經(jīng)系統(tǒng)：激動(dòng)、意識(shí)混亂、運(yùn)動(dòng)機(jī)能亢進(jìn)、共濟(jì)失調(diào)、CNS抑制、夢(mèng)魘、神經(jīng)過敏、精神障礙、幻覺、失眠、焦慮、頭昏、思維異常。 呼吸系統(tǒng)：換氣不足、呼吸暫停。 心血管系統(tǒng)：心搏徐緩、低血壓、暈厥。 消化系統(tǒng)：惡心、嘔吐、便秘。 其他反應(yīng)：頭痛、注射部位反應(yīng)、超敏反應(yīng)（血管性水腫、皮疹、剝脫性皮炎)、發(fā)熱、肝損傷、巨幼細(xì)胞貧血。 | |
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Overdose/Missed Dose |
過量/漏服 | |
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If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: dizziness, fainting, inability to wake up (coma), slowed breathing, bluish/cold skin. |
如疑有藥物過量，請(qǐng)即與當(dāng)?shù)刂卸究刂浦行幕蚣痹\室聯(lián)系。藥物過量癥狀：頭昏、昏暈、無法醒來（昏迷)、呼吸減慢、皮膚發(fā)青發(fā)冷。 | |
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If you are taking this medication to prevent seizures and miss a dose, take it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. |
用本品預(yù)防癲癇發(fā)作者漏服時(shí)，記起時(shí)請(qǐng)盡快服用，除非已接近下次服藥時(shí)間。若已接近下次服藥時(shí)間，請(qǐng)直接按服藥計(jì)劃服用下次劑量，不要加倍劑量以彌補(bǔ)前次漏服。 | |
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Pregnancy |
妊娠 | |
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Pregnancy Category D. （See Warning 3. Use in pregnancy) |
妊娠類別D。 （參見告誡事項(xiàng)3：妊娠使用) | |
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Storage |
貯藏 | |
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Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Keep all medicines away from children and pets. Properly discard this product when it is expired or no longer needed. |
68－77OF（20－25OC)室溫保存，避光避潮。遠(yuǎn)離兒童和寵物。正確處理過期或不再使用的藥物。 | |
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Presentation |
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包裝 |
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Oral Tablets 15 mg - Each white round tablet imprinted Þ 026 contains 15 mg of Phenobarbital. Tablets are supplied in bottles of 1000. 30 mg - Each white, round, scored tablet imprinted Þ 028 contains 30 mg of Phenobarbital. Tablets are supplied in bottles of 1000. 100 mg - Each white, round, scored tablet imprinted Þ 030 contains 100 mg of Phenobarbital. Tablets are supplied in bottles of 1000. |
口服片劑 15 mg－白色，圓形片劑，Þ 026字印，含15 mg苯巴比妥，，1000片瓶裝。 30 mg－白色、圓形、刻痕片劑，Þ 028字印，含30 mg苯巴比妥，1000片瓶裝。 100 mg－白色、圓形、刻痕片劑，Þ 030字印，含100 mg苯巴比妥。1000片瓶裝。 | |
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Oral Elixir Red, clear elixir contains 20 mg of Phenobarbital per teaspoon (5 ml). Alcohol 13% by volume. Elixir is supplied in pints. Preserve and dispense in tight, light- resistant containers as defined in the USP. Store at controlled room temperature 15º- 30ºC (59º- 86º F). |
口服酏劑 紅色、透明酏劑，每茶匙（5 ml)含20 mg苯巴比妥，酒精13%(按體積計(jì)算)。單位品脫。 遵照美國藥典，密閉、避光容器保存、配藥。15－30C（59－86)室溫儲(chǔ)藏。 | |
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Rx only. |
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憑處方。 |
