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 详细处方信息以本药内容附件PDF文件（201052521595920.pdf）的“原文Priscribing Information”为准
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部分中文Periostat处方资料（仅供参考）

英文药名: Periostat (Doxycyline Hyclate)

中文药名: 盐酸强力霉素

别名: 多西环素（Doxycycline），脱氧土霉素，长效土霉素，Doxitard，Doxy，Liviatin，Doryx，Medomycin，Monodoxin，Servidoxyne，Vibramycin，Wanmycin，Zadorin，Vibrodox，Hydramycin等。

规格:20mg。

适应症
    主要用于治疗敏感菌引起的呼吸道、泌尿道及胆道感染。抗菌谱与四环素、土霉素基本相同，体内、外抗菌力均较四环素为强。微生物对本品与四环素、土霉素等有密切的交叉耐药性。口服吸收良好。主要用于敏感的革兰阳性菌和革兰阴性杆菌所致的上呼吸道感染、扁条体炎、胆道感染、淋巴结炎、蜂窝组炎、老年慢性支气管炎等，也用于治疗斑疹伤寒、羌虫病、支原体肺炎等。尚可用于治疗霍乱，也可用于预防恶性疟疾和钩端螺旋体感染。主要用于敏感的革兰阳性球菌和革兰阴性桿菌所致的上呼吸道感染、扁桃体炎、胆道感染、淋巴结炎、蜂窝组织炎、老年慢性支气管炎等，也用于斑疹伤寒、恙虫病、支原体肺炎等。抗菌谱与四环素、土霉素基本相同，体内、外抗菌力均较四环素为强。微生物对本品与四环素、土霉素等有密切的交叉耐药性。口服吸收良好。
    在长期的治疗实践中人们发现，强力霉素是一个较好的抗菌药，它是由土霉素加工制成的一种长效广谱的半合成四环素旋抗生素，强力霉素用于治疗慢性支气管炎效果较好的原因是由于：
⑴抗菌谱广，抗菌作用强。除对革兰氏阳性菌和阴性菌有作用外，还可抑制立克次体、肺炎支原体、砂眼支原体、阿米巴原虫等。特别是慢性去气管炎病人的呼吸道常见细菌对强力霉素都比较敏感。
⑵作用维持时间长，口服后吸收较快，3小时后就可发挥最大效应，主要由肾脏缓慢排泄，成人一次口服200毫克，24小时内排出32%，48小时内排出41%，有效血药浓度比四环素、士霉素长，更适合治疗慢性炎症。口服药量第1天0.2克，以后每天服1次，每次0.1克(100毫克)。
⑶强力霉素具有一定的镇咳、祛痰和平喘作用，这些作用都已经过动物实验证实，更进一步说明强力霉素治疗慢性支气管炎疗效较好的原因。

用法用量
口服：1次0.1g，1日2次。必要时首剂可加倍。8岁以上儿童：首剂每千克体重4mg；以后，每次每千克体重2mg，1日2次。一般疗程为3～7日。预防恶性疟：每周0.1g；预防勾端螺旋体病：每周2次，每次0.1g。谨遵医嘱！

不良反应
主要为光敏反应，其它不良反应均比四环素轻。
1.胃肠道反应多见（约20％），如恶心、呕吐、腹泻等，饭后服药可减轻。
2.其它不良反应参见四环素。
3.用法应为１日2次，如每日应用0.1g1次，不足以维持有效血药浓度。
4.在肝、肾功能轻度不全者，本药的半衰期与在正常者无显著区别，但对肝、肾功能重度不全者则应注意慎用。
5.二重感染（长期使用广谱抗生素后，敏感菌株的生长受到抑制，不敏感菌株乘机大量繁殖，从而引起新的感染，此称为二重感染．）
6.影响牙齿和骨骼的发育；主要是对胎儿和婴幼儿的影响，四环素类抗生素能在胚胎和幼儿的骨骼和牙齿中沉积，并与钙结合，从而可引起牙齿釉质变黄（俗称四环素牙）和发育不全．
7.肝毒性；
8.光毒性；
9.肾毒性；
10.脑假瘤；
11.前庭反应；
12.过敏反应。
13.对８岁以下小儿及孕妇、哺乳妇女一般应禁用。 

PERIOSTAT®
(doxycycline hyclate) 20 mg Tablets

DRUG DESCRIPTION
Periostat® is available as a 20 mg tablet formulation of doxycycline for oral administration.

Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.

Inert ingredients in the formulation are: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. Each tablet contains 23 mg of doxycycline hyclate equivalent to 20 mg of doxycycline.

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INDICATIONS
Periostat® is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

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DOSAGE AND ADMINISTRATION
THE DOSAGE OF PERIOSTAT® DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS.

Periostat® 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months.

Periostat® should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Periostat® is taken close to meal times, allow at least one hour prior to or two hours after meals. Safety beyond 12 months and efficacy beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the tablets is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS Section).

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HOW SUPPLIED
Periostat® (white tablet imprinted with a PS20) containing doxycycline hyclate equivalent to 20 mg doxycycline. Bottle of 60 (NDC 64682-008-01), Bottle of 100 (NDC 64682-008-02) and Bottle of 1000 (NDC 64682-008-03).

Storage: All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP).

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SIDE EFFECTS
Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines:Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class.

Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION Section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS Section).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS Section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

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DRUG INTERACTIONS
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacterial antibiotics, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of members of the -lactam (e.g. penicillin) class of antibiotics, it is not advisable to administer these antibiotics concomitantly.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and ironcontaining preparations, and by bismuth subsalicylate.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines may render oral contraceptives less effective.

Drug/Laboratory Test Interactions: False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

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WARNINGS
THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAYBROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP AND IN PREGNANT OR NURSING MOTHERS UNLESS THE POTENTIAL BENEFITS MAY BE ACCEPTABLE DESPITE THE POTENTIAL RISKS.

All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracyclines in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Doxycycline can cause fetal harm when administered to a pregnant woman. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

If any tetracyclines are 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.

The catabolic action of the tetracyclines may cause an increase in BUN. Previous studies have not observed an increase in BUN with the use of doxycycline in patients with impaired renal function.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.

Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

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PRECAUTIONS
While no overgrowth by opportunistic microorganisms such as yeast were noted during clinical studies, as with other antimicrobials, Periostat® therapy may result in overgrowth of nonsusceptible microorganisms including fungi.

The use of tetracyclines may increase the incidence of vaginal candidiasis.

Periostat® should be used with caution in patients with a history or predisposition to oral candidiasis. The safety and effectiveness of Periostat® has not been establishedfor the treatment of periodontitis in patients with coexistant oral candidiasis.

If superinfection is suspected, appropriate measures should be taken.

Laboratory Tests
In long term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Doxycycline hyclate was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately nine times that observed in female humans that used Periostat (exposure comparison based upon AUC values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in either gender at the other dosages studied.

Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).

Doxycycline hyclate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline hyclate is a weak clastogen.

Oral administration of doxycycline hyclate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline hyclate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10 times the amount of doxycycline hyclate contained in the recommended daily dose of Periostat® for a 60 kg human when compared on the basis of body surface area estimates (mg/m²). Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of Periostat® on human fertility is unknown.

Pregnancy
Teratogenic Effects
Pregnancy Category D. (See WARNINGS Section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

Nonteratogenic effects
(See WARNINGS Section).

Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from doxycycline, the use of Periostat® in nursing mothers is contraindicated. (See WARNINGS Section).

Pediatric Use
The use of Periostat® in infancy and childhood is contraindicated. (See WARNINGS section.)

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OVERDOSE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

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CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

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 详细处方信息以本药内容附件PDF文件（201052521595920.pdf）的“原文Priscribing Information”为准
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