药品名称
【别名】阿莫西林、阿莫灵、阿莫仙、阿莫新、新达贝宁、阿摩西林、安福喜、奥纳欣、弗莱莫星、酚塔西林、广林、奈他美、羟氨苄青霉素、强必林、强力阿莫仙、特力士、益萨林、氧他西林、再林、再灵。
【外文名】Amoxicillin、Amolin、Amolin Bristamox、Amoxa、Amoxicilline、Amoxicillinum、Amoxicllin、Amoxil、Amoxipen、Amoxycillin、BRL-2333、Bristamox、Clamoxil、Clamoxyl、Daxipen、Flemoxin、Larocin、Natamox、Oxetacillin

药理作用
阿莫西林为半合成广谱青霉素类药，抗菌谱及抗菌活性与氨苄西林基本相同，但其耐酸性较氨苄西林强，其杀菌作用优于氨苄西林，但不能用于脑膜炎的治疗。半衰期约为61.3分钟。
阿莫西林杀菌作用强，穿透细胞壁的能力也强。口服后药物分子中的内酰胺基立即水解生成肽键，迅速和菌体内的转肽酶结合使之失活，切断了菌体依靠转肽酶合成糖肽用来建造细胞壁的唯一途径，使细菌细胞迅速成为球形体而破裂溶解，菌体终于因细胞壁损水份不断渗透而胀裂死亡。对大多数致病的G+菌和G-菌(包括球菌和杆菌)均有强大的抑菌和杀菌作用。其中对溶血性链球菌，布氏杆菌，沙门氏菌和肠球菌等中度或轻度敏感。血液透析能清除部分药物，但腹膜透析无清除本品的作用。
敏感菌：链球菌A、B、C、F、G和非分组型、单核细胞增多性李斯特菌、白喉杆菌、奈瑟脑膜炎双球菌、百日咳杆菌、产气荚膜杆菌属、丙酸杆菌、消化链球菌、牛链球菌、沙门菌、真细菌属、放线菌、钩端螺旋体、梅毒螺旋体。
不稳定性敏感菌：青霉素敏感性或耐药性肺炎球菌、肠粪链球菌、大肠杆菌、奇异变形杆菌、志贺菌、霍乱弧菌、流感嗜血菌、淋病奈瑟球菌、梭状杆菌。
耐药菌：葡萄球菌、卡他菌属、产酸克雷白杆菌、肺炎克雷白杆菌、普通变形杆菌、假单孢菌属、不动杆菌、弯曲杆菌、韦荣球菌、支原体、立克次体、军团菌属、分歧杆菌、脆弱杆菌。

适应症
用以治疗伤寒、其他沙门菌感染和伤寒带菌者，敏感细菌所致的尿路感染及肺炎球菌、不产青霉素酶金葡菌、溶血性链球菌和流感杆菌所致的耳、鼻、喉感染和软组织感染等。

禁忌
青霉素过敏及青霉素皮肤试验阳性患者禁用。

不良反应
临床应用阿莫西林的不良反应发生率约为5-6%，因反应而停药者约2%。其主要不良反应有：
1.过敏反应症状
可出现药物热、荨麻疹、皮疹等，尤易发生于传染性单核细胞增多症者。少见过敏性休克。
2.消化系统症状
多见腹泻、恶心、呕吐等症状，偶见假膜性结肠炎。
3.血液系统症状
偶见嗜酸粒细胞增多、白细胞减少、血小板减少、贫血等。
4.皮肤粘膜反应
偶见斑丘疹、渗出性多形性红斑、Lyell综合征、剥脱性皮炎。
5.肝、肾功能紊乱
少数患者用药后偶见血清转氨酶升高、急性间质性肾炎。
6.其它
长期使用本药可出现由念珠菌或耐药菌引起的二重感染。
7.静脉注射量大时可见惊厥、嗜酸性粒细胞增多。

注意事项
1.对一种青霉素过敏者可能对其它青霉素过敏，也可能对青霉胺或头孢菌素过敏，用药前必须做青霉素皮肤试验，阳性者禁用。
2.对此药或其它青霉素类药物过敏的患者；传染性单核细胞增多症、淋巴细胞性白血病、巨细胞病毒感染、淋巴瘤等患者禁用。
3.对头孢菌素类药过敏者；本品可经乳汁排出，乳母使用本品后可使婴儿致敏，哺乳期妇女；哮喘、湿疹、枯草热、荨麻疹等过敏性疾病史者；疱疹病毒感染者，尤其是传染性单核细胞增多症患者(可增强皮肤不良反应的危险性)；应慎用。晚期妊娠孕妇应用后，可使血浆中结合的雌激素浓度减少，但对游离的雌激素和孕激素无影响。
4.用含硫酸铜的片状试剂(R)、费林溶液测定尿糖时可能会导致假阳性反应 ；少数患者用药后可出现血清转氨酶升高、嗜酸粒细胞增多和白细胞减少。

药物相互作用
1.丙磺舒可延缓阿莫西林经肾排泄，延长其血清半衰期，因而使本品的血药浓度升高。
2.阿莫西林与氨基糖苷类药合用时，在亚抑菌浓度时可增强阿莫西林对粪链球菌体外杀菌作用。
3.阿莫西林与β-内酰胺酶抑制剂如克拉维酸合用时，抗菌作用明显增强。克拉维酸不仅可以不同程度地增强产β-内酰胺酶菌株对阿莫西林的敏感性，还可增强阿莫西林对某些非敏感菌株的作用，这些菌株包括拟杆菌、军团菌、诺卡菌和假鼻疽杆菌。
4.阿莫西林与避孕药合用时，可干扰避孕药的肠肝循环，从而降低其药效。
5.别嘌呤类尿酸合成抑制剂可增加阿莫西林发生皮肤不良反应的危险性。
6.阿莫西林与氨甲蝶呤合用时，本品可使氨甲蝶呤肾廓清率降低，从而增加氨甲蝶呤毒性。
7.食物可延迟阿莫西林的吸收，但食物并不明显降低药物吸收的总量。
【原产地英文商品名】:AMOXIL TABLET CHEW 400mg/tablet 20tablets/bottle
【原产地英文药品名】:AMOXICILLIN TRIHYDRATE
【中文参考商品译名】:阿莫西林咀嚼片 400毫克/片 20片/瓶
【中文参考药品译名】:阿莫西林三水物
【生产厂家中文参考译名】:葛兰素史克
【生产厂家英文名】:GLAXOSMITHKLINE

AMOXIL®
(amoxicillin) Capsules, Tablets, Chewable Tablets, and Powder for Oral Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL (amoxicillin) and other antibacterial drugs, AMOXIL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION
Formulations of AMOXIL contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p­hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:

The amoxicillin molecular formula is C16H19N3O5S• 3H2O, and the molecular weight is 419.45.

Capsules, tablets, and powder for oral suspension of AMOXIL are intended for oral administration.

Capsules: Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the 500-mg capsule are imprinted with AMOXIL and 500. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.

Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Chewable Tablets: Each cherry-banana-peppermint-flavored tablet contains 200 mg or 400 mg amoxicillin as the trihydrate.

Each 200-mg chewable tablet contains 0.0005 mEq (0.0107 mg) of sodium; the 400-mg chewable tablet contains 0.0009 mEq (0.0215 mg) of sodium. The 200-mg and 400-mg pale pink round tablets are imprinted with the product name AMOXIL and 200 or 400 along the edge of 1 side. Inactive ingredients: Aspartame®, crospovidone NF, FD&C Red No. 40 aluminum lake, flavorings, magnesium stearate, and mannitol.

*See PRECAUTIONS.

Powder for Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg, or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium; each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium.

Pediatric Drops for Oral Suspension: Each mL of reconstituted suspension contains 50 mg amoxicillin as the trihydrate and 0.03 mEq (0.69 mg) of sodium.

Amoxicillin trihydrate for oral suspension 200 mg/5 mL, 250 mg/5 mL (or 50 mg/mL), and 400 mg/5 mL are bubble-gum-flavored pink suspensions. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.

INDICATIONS
AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase- negative) strains of the designated microorganisms in the conditions listed below:

Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae , Staphylococcus spp., or H. influenzae.

Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis.

Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli.

Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due toN. gonorrhoeae (males and females).

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple Therapy: AMOXIL/clarithromycin/lansoprazole

AMOXIL, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See Clinical Studies and DOSAGE AND ADMINISTRATION.)

Dual Therapy: AMOXIL/lansoprazole

AMOXIL, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See Clinical Studies and DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL and other antibacterial drugs, AMOXIL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Indicated surgical procedures should be performed.

DOSAGE AND ADMINISTRATION
Capsules, chewable tablets, and oral suspensions of AMOXIL may be given without regard to meals. The 400-mg suspension, 400-mg chewable tablet, and the 875-mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXIL is 30 mg/kg/day divided q12h.

After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.

General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple Therapy: AMOXIL/clarithromycin/lansoprazole

The recommended adult oral dose is 1 gram AMOXIL, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

Dual Therapy: AMOXIL/lansoprazole

The recommended adult oral dose is 1 gram AMOXIL and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

Directions for Mixing Oral Suspension: Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

HOW SUPPLIED
Capsules of AMOXIL: Each capsule contains 500 mg amoxicillin as the trihydrate.
500-mg Capsule
NDC 0029-6007-32 Bottles of 500

Tablets of AMOXIL: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.
500-mg Tablet
NDC 0029-6046-20 Bottles of 100

875-mg Tablet
NDC 0029-6047-20 Bottles of 100

Chewable Tablets of AMOXIL: Each cherry-banana-peppermint-flavored tablet contains 200 mg or 400 mg amoxicillin as the trihydrate.

200-mg Tablet
NDC 0029-6044-12 Bottles of 20

400-mg Tablet
NDC 0029-6045-12 Bottles of 20

AMOXIL for Oral Suspension: Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200, 250, or 400 mg amoxicillin as the trihydrate.

200 mg/5 mL
NDC 0029-6048-54 50-mL bottle
NDC 0029-6048-55 75-mL bottle
NDC 0029-6048-59 100-mL bottle
NDC 0029-6048-18 5-mL unit dose bottle

250 mg/5 mL
NDC 0029-6009-23 100-mL bottle
NDC 0029-6009-22 150-mL bottle

400 mg/5 mL
NDC 0029-6049-54 50-mL bottle
NDC 0029-6049-55 75-mL bottle
NDC 0029-6049-59 100-mL bottle
NDC 0029-6049-18 5-mL unit dose bottle

Pediatric Drops of AMOXIL for Oral Suspension: Each mL of bubble-gum-flavored reconstituted suspension contains 50 mg amoxicillin as the trihydrate.
NDC 0029-6038-39 30-mL bottle

Store at or below 20°C
•500-mg capsules
•250-mg unreconstituted powder

Store at or below 25°C
•200-mg and 400-mg unreconstituted powder
•200-mg and 400-mg chewable tablets
•500-mg and 875-mg tablets Dispense in a tight container

SIDE EFFECTS
As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:

Infections and Infestations: Mucocutaneous candidiasis.

Gastrointestinal: Nausea, vomiting, diarrhea, black hairy tongue, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Hypersensitivity Reactions: Anaphylaxis (See WARNINGS)

Serum sickness-like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.

Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.

Renal: Crystalluria has also been reported (see OVERDOSAGE).

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Combination Therapy with Clarithromycin and Lansoprazole: In clinical trials using combination therapy with amoxicillin plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with amoxicillin, clarithromycin, or lansoprazole.

Triple Therapy: Amoxicillin/Clarithromycin/Lansoprazole: The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Amoxicillin/Lansoprazole: The most frequently reported adverse events for patients who received amoxicillin three times daily plus lansoprazole three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin three times daily plus lansoprazole three times daily dual therapy than with lansoprazole alone.

For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.

DRUG INTERACTIONS
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

In common with other antibiotics, AMOXIL may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Drug/Laboratory Test Interactions: High urine concentrations of ampicillin may result in falsepositive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict's Solution, or Fehling's Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX®) be used.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin

WARNINGS
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXIL, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXIL SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.”

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.

PRECAUTIONS
General: The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.

Prescribing AMOXIL in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Phenylketonurics: Each 200-mg chewable tablet of AMOXIL contains 1.82 mg phenylalanine; each 400-mg chewable tablet contains 3.64 mg phenylalanine. The suspensions of AMOXIL do not contain phenylalanine and can be used by phenylketonurics.

Laboratory Tests: As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m²).

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery: Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers: Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

Pediatric Use: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of AMOXIL should be modified in pediatric patients 12 weeks or younger ( ≤ 3 months). (See DOSAGE AND ADMINISTRATION: Neonates and Infants.)

Geriatric Use: An analysis of clinical studies of AMOXIL was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 1,811 subjects treated with capsules of AMOXIL, 85% were < 60 years old, 15% were ≥ 61 years old and 7% were ≥ 71 years old. This analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

OVERDOSE
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.3

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.

Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.

CONTRAINDICATIONS
A history of allergic reaction to any of the penicillins is a contraindication