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Militian Inessa Mesropovna 、薬局による医学的評価、 最終更新日:13.05.2022
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PRIMAXIN I.M.深刻な感染症の治療に使用されます(リストされています。 以下)筋肉内療法が適切な軽度から中等度の重症度。. PRIMAXIN I.M.は、重度または生命にかかわる治療を目的としていません。 細菌性敗血症または心内膜炎を含む感染症、または主要な場合。 ショックなどの生理学的障害。.
PRIMAXIN I.M.感受性によって引き起こされる感染症の治療に適応されます。 以下にリストされた条件における指定された微生物の株:
- 下気道感染症。 肺炎と気管支炎を含みます。 COPD(慢性閉塞性肺疾患)の悪化として引き起こされた。 沿って。 Streptococcus pneumoniae。 と。 Haemophilus influenzae。.
- 腹腔内感染症。 急性壊 ⁇ または穴あきを含む。 グループD連鎖球菌によって引き起こされる虫垂炎および腹膜炎を伴う虫垂炎。 含む。 Enterococcus faecalis *; Streptococcus viridans。 グループ*;。 エシェリヒア。 コリ; Klebsiella pneumoniae *;緑 ⁇ 菌*;バクテロイデス。 種。 含む。 B. fragilis、B。distasonis *、B。intermedius *およびB. thetaiotaomicron *;。 フソバクテリウム。 種;そして。 ペプトストレプトコッカス*。 種。.
- 皮膚および皮膚構造の感染症。 ⁇ 瘍、蜂巣炎を含む。 感染した皮膚 ⁇ 瘍および原因による創傷感染。 黄色ブドウ球菌。 ペニシリナーゼ産生株を含む;。 Streptococcus pyogenes *;。 グループD streptococcusを含む。 Enterococcus faecalis;アシネトバクター種*。 Aを含む calcoaceticus *;シトロバクター種*;大腸菌;腸内細菌。 クロアカエ; Klebsiella pneumoniae *;緑 ⁇ 菌*;。 と。 バクテロイデス。 種*。 B. fragilis *を含む。.
- 婦人科感染症、。 産後子宮内膜炎を含む。 グループDによる。 連鎖球菌。 含む。 Enterococcus faecalis *;エシェリヒア。 コリ; Klebsiella pneumoniae *;バクテロイデス中間体*;。 と。 ペプトストレプトコッカス。 種*。.
他のベータラクタム抗生物質と同様に、緑 ⁇ 菌のいくつかの株。 PRIMAXIN I.M.による治療中、かなり急速に耐性を発現する可能性があります。中。 緑 ⁇ 菌感染症の治療、定期的な感受性試験。 臨床的に適切なときに行われるべきです。.
薬剤耐性菌の発生を減らし、効果を維持する。 PRIMAXIN I.M.のその他の抗菌薬、PRIMAXIN I.M.使用する必要があります。 証明された、または強く疑われる感染症を治療または予防するためだけに。 感受性細菌によって引き起こされる。. 文化と感受性情報。 利用可能であり、抗菌剤の選択または変更において検討する必要があります。 治療。. そのようなデータがない場合、地域の疫学と感受性。 パターンは、治療の経験的選択に寄与する可能性があります。.
*この臓器系におけるこの生物の有効性は、以下で研究されました。 10感染。.
PRIMAXIN I.M.筋肉内使用のみです。.
PRIMAXIN I.M.の推奨投与量イミペネムの量を表します。 投与される。. 同等の量のシラスタチンも存在します。.
下気道感染症、皮膚および皮膚構造感染症の患者。 軽度から中等度の重症度の婦人科感染症は治療されることがあります。 重症度に応じて、12時間ごとに500 mgまたは750 mgを投与します。 感染。.
腹腔内感染は、12時間ごとに750 mgで治療できます。.
投与量ガイドライン。
タイプ。††/感染の場所。 | 重大度。 | 投与計画。 |
下気道皮膚および皮膚構造婦人科。 | 穏やか/中程度。 | 感染の重症度に応じて500または750 mg q 12時間。 |
腹腔内。 | 穏やか/中程度。 | 750 mg q 12時間。 |
†† |
1日あたり1500 mgを超える1日の総IM投与量は推奨されません。.
特定の患者の投与量は、の場所とに基づいている必要があります。 感染の重症度、感染性病原体の感受性、 および腎機能。.
治療期間は、感染の種類と重症度によって異なります。. 一般に、PRIMAXIN I.M.その後少なくとも2日間は継続する必要があります。 感染の兆候と症状は解決しました。. 治療の安全性と有効性。 14日を超えて確立されていません。.
PRIMAXIN I.M. aへの深い筋肉内注射によって投与されるべきです。 大きな筋肉量( ⁇ 筋や大 ⁇ の外側など)。 21ゲージの2インチ針。. 不注意を避けるために願望が必要です。 血管への注射。.
腎機能障害のある成人。
PRIMAXIN I.M.の安全性と有効性患者では研究されていません。 クレアチニンクリアランスが20 mL / min / 1.73 m未満。2 血清クレアチニン。. 腎機能の十分に正確な測定ではないかもしれません。. クレアチニン。 クリアランス(Tcc)は、次の式から推定できます。
Tcc(女性)= 0.85×上記の値。
管理の準備。
PRIMAXIN I.M. 1.0%リドカインHCl溶液で使用できるように準備する必要があります。 ⁇ 。 (エピネフリンなし)。. PRIMAXIN I.M. 500は2 mLとPRIMAXIN I.M. 750、3 mLのリドカインHCl。. ⁇ して懸 ⁇ 液を形成し、バイアル全体を筋肉内に引き出して注入します。. PRIMAXIN I.M.のサスペンションリドカインHClは、準備後1時間以内に使用する必要があります。. 注:IM製剤はIV使用ではありません。.
互換性と安定性。
再構成前:。
乾燥粉末は25°C(77°F)未満の温度で保管する必要があります。.
IM管理の一時停止。
PRIMAXIN I.M.のサスペンション白から淡黄 ⁇ 色です。. のバリエーション。 この範囲内の色は、製品の効力に影響を与えません。.
PRIMAXIN I.M.のサスペンションリドカインではHClを1つで使用する必要があります。 準備の1時間後。. PRIMAXIN I.M.と混合したり、物理的に混合したりしないでください。 他の抗生物質に追加されました。. ただし、PRIMAXIN I.M.同時に投与することができます。 しかし、アミノグリコシドなどの他の抗生物質を含む別の場所で。.
⁇ 。パッケージの通達を参照してください。 に関する詳細情報については、リドカインHClについて。 禁 ⁇ 、。 警告、注意、。 と。 悪影響.
WARNINGS
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH 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 ANOTHER BETA-LACTAM. BEFORE INITIATING THERAPY WITH PRIMAXIN® I.M. (imipenem and cilastatin) , CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER BETA-LACTAMS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PRIMAXIN® SHOULD BE DISCONTINUED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, MAY ALSO BE ADMINISTERED AS INDICATED.
Seizure Potential
Seizures and other CNS adverse experiences, such as myoclonic activity, have been reported during treatment with PRIMAXIN I.M.
Carbapenems, including imipenem, may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop below the therapeutic range or a seizure occurs .
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including PRIMAXIN I.M., and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Lidocaine HCl - Refer to the package circular for lidocaine HCl.
PRECAUTIONS
General
CNS adverse experiences such as myoclonic activity or seizures have been reported with PRIMAXIN I.M. These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) who also have compromised renal function. However, there were reports in which there was no recognized or documented underlying CNS disorder. Anticonvulsant therapy should be continued in patients with a known seizure disorder.
As with other antibiotics, prolonged use of PRIMAXIN I.M. may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient"s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Prescribing PRIMAXIN I.M. 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.
Caution should be taken to avoid inadvertent injection into a blood vessel. For additional precautions, refer to the package circular for lidocaine HCl.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals have not been performed to evaluate carcinogenic potential of imipenem-cilastatin. Genetic toxicity studies were performed in a variety of bacterial and mammalian tests in vivo and in vitro. The tests used were: V79 mammalian cell mutagenesis assay (imipenem-cilastatin sodium alone and imipenem alone), Ames test (cilastatin sodium alone and imipenem alone), unscheduled DNA synthesis assay (imipenem-cilastatin sodium) and in vivo mouse cytogenetics test (imipenem-cilastatin sodium). None of these tests showed any evidence of genetic alterations.
Reproductive tests in male and female rats were performed with imipenem-cilastatin sodium at intravenous doses up to 80 mg/kg/day and at a subcutaneous dose of 320 mg/kg/day, 2.1 times*** the maximum recommended daily human dose of the intramuscular formulation (on a mg/m2 body surface area basis). Slight decreases in live fetal body weight were restricted to the highest dosage level. No other adverse effects were observed on fertility, reproductive performance, fetal viability, growth, or postnatal development of pups.
Pregnancy: Teratogenic Effects
Pregnancy Category C: Teratology studies with cilastatin sodium at doses of 30, 100, and 300 mg/kg/day administered intravenously to rabbits and 40, 200, and 1000 mg/kg/day administered subcutaneously to rats, up to approximately 3.9 and 6.5 times*** the maximum recommended daily human dose (on a mg/m2 body surface area basis) of the intramuscular formulation of PRIMAXIN (25 mg/kg/day) in the two species, respectively, showed no evidence of adverse effects on the fetus. No evidence of teratogenicity was observed in rabbits given imipenem at intravenous doses of 15, 30, or 60 mg/kg/day and rats given imipenem at intravenous doses of 225, 450, or 900 mg/kg/day, up to approximately 0.8 and 5.8 times*** the maximum recommended daily human dose (on a mg/m2 body surface area basis) in the two species, respectively.
Teratology studies with imipenem-cilastatin sodium at intravenous doses of 20 and 80 and a subcutaneous dose of 320 mg/kg/day, approximately equal to (mice) and up to 2.1 times*** (rats) the maximum recommended daily intramuscular human dose (on a mg/m2 body surface area basis) in pregnant rodents during the period of major organogenesis, revealed no evidence of teratogenicity.
Imipenem-cilastatin sodium, when administered to pregnant rabbits subcutaneously at dosages above the usual human dose of the intramuscular formulation (1000-1500 mg/day), caused body weight loss, diarrhea, and maternal deaths. When comparable doses of imipenem-cilastatin sodium were given to non-pregnant rabbits, body weight loss, diarrhea, and deaths were also observed. This intolerance is not unlike that seen with other beta-lactam antibiotics in this species and is probably due to alteration of gut flora.
A teratology study in pregnant cynomolgus monkeys given imipenem-cilastatin sodium at doses of 40 mg/kg/day (bolus intravenous injection) or 160 mg/kg/day (subcutaneous injection) resulted in maternal toxicity including emesis, inappetence, body weight loss, diarrhea, abortion and death in some cases. In contrast, no significant toxicity was observed when non-pregnant cynomolgus monkeys were given doses of imipenem-cilastatin sodium up to 180 mg/kg/day (subcutaneous injection). When doses of imipenem-cilastatin sodium (approximately 100 mg/kg/day or approximately 1.3 times*** the maximum recommended daily human dose of the intramuscular formulation) were administered to pregnant cynomolgus monkeys at an intravenous infusion rate which mimics human clinical use, there was minimal maternal intolerance (occasional emesis), no maternal deaths, no evidence of teratogenicity, but an increase in embryonic loss relative to the control groups.
No adverse effects on the fetus or on lactation were observed when imipenem-cilastatin sodium was administered subcutaneously to rats late in gestation at dosages up to 320 mg/kg/day, 2.1 times the maximum recommended daily human dose (on a mg/m2 body surface area basis).
There are, however, no adequate and well-controlled studies in pregnant women. PRIMAXIN I.M. should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Nursing Mothers
It is not known whether imipenem-cilastatin sodium or lidocaine HCl (diluent) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PRIMAXIN I.M. is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Geriatric Use
Clinical studies of PRIMAXIN I.M. did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects; however, clinical studies of PRIMAXIN I.V. in a sufficient number of subjects aged 65 and over have not revealed overall differences in safety or effectiveness between these subjects and younger subjects (refer to the package circular for PRIMAXIN I.V.). Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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. Dosage adjustment in the case of renal impairment is necessary .
***Based on patient body surface area of 1.6 m2 (weight of 60 kg).
PRIMAXIN I.M .
PRIMAXIN I.M.の複数回投与臨床試験の686人の患者では、以下の副作用が報告されました。
局所的な副作用。
PRIMAXIN I.M.による治療に潜在的、おそらく、または確実に関連すると報告された最も頻繁な局所臨床反応注射部位の痛みでした(1.2%)。.
全身副作用。
PRIMAXIN I.M.に潜在的、おそらく、または確実に関連すると報告された最も頻繁に報告された全身性副作用吐き気(0.6%)、下 ⁇ (0.6%)、 ⁇ 吐(0.3%)および発疹(0.4%)でした。.
有害検査の変化。
報告された薬物関係に関係なく、研究室での有害な変化。 臨床試験中:
ヘミック:。 ヘモグロビンとヘマトクリットの減少、好酸球増加症が増加しました。 WBCの減少、血小板の増加と減少、赤血球の減少。 そしてプロトロンビン時間の増加。.
肝臓:。 AST、ALT、アルカリホスファターゼ、ビリルビンの増加。.
腎臓:。 BUNとクレアチニンの増加。.
尿検査:。 赤血球、白血球、ギプスなどの存在。 尿中の細菌。.
潜在的な悪影響:。
さらに、PRIMAXIN I.M.を使用した臨床試験では観察されなかったさまざまな副作用が、PRIMAXIN I.V.の静脈内投与で報告されています。 (注射用イミペネムとシラスタチン)。. 以下にリストされているものは、医師への警告情報として機能します。.
全身副作用。
最も頻繁に報告された全身性副臨床反応。 PRIMAXIN I.V.に潜在的、おそらく、または確実に関連していると報告されています。 (イミペネム。 注射用シラスタチン)は、発熱、低血圧、発作でした。 めまい、そう ⁇ 、じんま疹、傾眠。.
おそらく、おそらく、追加の全身性臨床反応が報告されました。 または、薬物が販売されてから薬物関連または報告されたものがリストされています。 重症度が低下する順に、各ボディシステム内:。 消化管:。 偽膜性大腸炎(偽膜性大腸炎の症状の発症はあるかもしれません。 抗生物質治療中または治療後に発生します。
有害検査の変化。
報告された薬物関係に関係なく、研究室での有害な変化。 臨床試験中、または薬剤が販売されてから報告されたものは次のとおりです。
肝臓:。 LDHの増加;。 ヘミック:。 正のクームス。 試験、好中球の減少、無 ⁇ 粒球症、単球の増加、異常。 プロトロンビン時間、リンパ球の増加、好塩基球の増加; 電解質:。 血清ナトリウムの減少、カリウムの増加、塩化物の増加; 尿検査:。 尿タンパク質、尿ビリルビン、尿ウロビリノーゲンの存在。.
リドカインHCl。 -リドカインHClについては、パッケージの円形を参照してください。.
Following intramuscular administrations of 500 or 750 mg doses of imipenem-cilastatin sodium in a 1:1 ratio with 1% lidocaine, peak plasma levels of imipenem antimicrobial activity occur within 2 hours and average 10 and 12 µg/mL, respectively. For cilastatin, peak plasma levels average 24 and 33 g/mL, respectively, and occur within 1 hour. When compared to intravenous administration of imipenem-cilastatin sodium, imipenem is approximately 75% bioavailable following intramuscular administration while cilastatin is approximately 95% bioavailable. The absorption of imipenem from the IM injection site continues for 6 to 8 hours while that for cilastatin is essentially complete within 4 hours. This prolonged absorption of imipenem following the administration of the intramuscular formulation of imipenem-cilastatin sodium results in an effective plasma half- life of imipenem of approximately 2 to 3 hours and plasma levels of the antibiotic which remain above 2 g/mL for at least 6 or 8 hours, following a 500 mg or 750 mg dose, respectively. This plasma profile for imipenem permits IM administration of the intramuscular formulation of imipenem-cilastatin sodium every 12 hours with no accumulation of cilastatin and only slight accumulation of imipenem.
A comparison of plasma levels of imipenem after a single dose of 500 mg or 750 mg of imipenem-cilastatin sodium (intravenous formulation) administered intravenously or of imipenem-cilastatin sodium (intramuscular formulation) diluted with 1% lidocaine and administered intramuscularly is as follows:
PLASMA CONCENTRATIONS OF IMIPENEM (µg/mL)
TIME | 500 MG | 750 MG | ||
I.V. | I.M. | I.V. | I.M. | |
25 min | 45.1 | 6.0 | 57.0 | 6.7 |
1 hr | 21.6 | 9.4 | 28.1 | 10.0 |
2 hr | 10.0 | 9.9 | 12.0 | 11.4 |
4 hr | 2.6 | 5.6 | 3.4 | 7.3 |
6 hr | 0.6 | 2.5 | 1.1 | 3.8 |
12 hr | ND** | 0.5 | ND** | 0.8 |
** ND: Not Detectable (<0.3 µg/mL) |
Imipenem urine levels remain above 10 µg/mL for the 12-hour dosing interval following the administration of 500 mg or 750 mg doses of the intramuscular formulation of imipenem-cilastatin sodium. Total urinary excretion of imipenem averages 50% while that for cilastatin averages 75% following either dose of the intramuscular formulation of imipenem-cilastatin sodium.
Imipenem, when administered alone, is metabolized in the kidneys by dehydropeptidase I resulting in relatively low levels in urine. Cilastatin sodium, an inhibitor of this enzyme, effectively prevents renal metabolism of imipenem so that when imipenem and cilastatin sodium are given concomitantly, increased levels of imipenem are achieved in the urine. The binding of imipenem to human serum proteins is approximately 20% and that of cilastatin is approximately 40%.
In a clinical study in which a 500-mg dose of the intramuscular formulation of imipenem-cilastatin sodium was administered to healthy subjects, the average peak level of imipenem in interstitial fluid (skin blister fluid) was approximately 5.0 µg/mL within 3.5 hours after administration.
Imipenem-cilastatin sodium is hemodialyzable. However, usefulness of this procedure in the overdosage setting is questionable.
Microbiology
The bactericidal activity of imipenem results from the inhibition of cell wall synthesis. Its greatest affinity is for penicillin-binding proteins (PBPs) 1A, 1B, 2, 4, 5 and 6 of Escherichia coli, and 1A, 1B, 2, 4 and 5 of Pseudomonas aeruginosa. The lethal effect is related to binding to PBP 2 and PBP 1B.
Imipenem has a high degree of stability in the presence of beta-lactamases, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria. It is a potent inhibitor of beta-lactamases from certain gram-negative bacteria which are inherently resistant to many beta-lactam antibiotics, e.g., Pseudomonas aeruginosa, Serratia spp. and Enterobacter spp.
Imipenem has in vitro activity against a wide range of gram-positive and gram-negative organisms. Imipenem has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections treated with the intramuscular formulation of imipenem-cilastatin sodium as described in the INDICATIONS section.
Gram-positive aerobes:
Staphylococcus aureus including penicillinase-producing strains
(NOTE: Methicillin-resistant staphylococci should be reported as resistant to
imipenem.)
Group D streptococcus including Enterococcus faecalis (formerly S.
faecalis)
(NOTE: Imipenem is inactive in vitro against Enterococcus faecium
(formerly S. faecium).)
Streptococcus pneumoniae
Streptococcus pyogenes (Group A streptococci)
Streptococcus viridans group
Gram-negative aerobes:
Acinetobacter spp., including A. calcoaceticus
Citrobacter spp.
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Klebsiella pneumoniae
Pseudomonas aeruginosa
(NOTE: Imipenem is inactive in vitro against Xanthomonas (Pseudomonas)
maltophilia and P. cepacia.)
Gram-positive anaerobes:
Peptostreptococcus spp.
Gram-negative anaerobes:
Bacteroides spp., including
Bacteroides distasonis
Bacteroides intermedius (formerly B. melaninogenicus intermedius)
Bacteroides fragilis
Bacteroides thetaiotaomicron
Fusobacterium spp.
Imipenem exhibits in vitro minimal inhibitory concentrations (MICs) of 4 µg/mL or less against most ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of imipenem in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Gram-positive aerobes:
Bacillus spp.
Listeria monocytogenes
Nocardia spp.
Group C streptococci
Group G streptococci
Gram-negative aerobes:
Aeromonas hydrophila
Alcaligenes spp.
Capnocytophaga spp.
Enterobacter agglomerans
Haemophilus ducreyi
Klebsiella oxytoca
Neisseria gonorrhoeae including penicillinase-producing strains
Pasteurella spp.
Proteus mirabilis
Providencia stuartii
Gram-positive anaerobes:
Clostridium perfringens
Gram-negative anaerobes:
Prevotella bivia
Prevotella disiens
Prevotella melaninogenica
Veillonella spp.
In vitro tests show imipenem to act synergistically with aminoglycoside antibiotics against some isolates of Pseudomonas aeruginosa.
Susceptibility Tests
Dilution techniques:
Use a standardized dilution method1 (broth, agar, microdilution) or equivalent with imipenem powder. The MIC values obtained should be interpreted according to the following criteria:
MIC (µg/mL) | Interpretation |
≤ 4 | Susceptible |
8 | Moderately Susceptible |
≥ 16 | Resistant |
A report of "susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of "moderately susceptible" suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissues and fluids in which high antibiotic levels are attained. A report of "resistant" indicates that achievable concentrations are unlikely to be inhibitory and other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control organisms. Standard imipenem powder should provide the following MIC values:
Organism | MIC (µg/mL) |
E. coli ATCC 25922 | 0.06-0.25 |
S. aureus ATCC 29213 | 0.015-0.06 |
E. faecalis ATCC 29212 | 0.5-2.0 |
P. aeruginosa ATCC 27853 | 1.0-4.0 |
Diffusion techniques:
Quantitative methods that require measurement of zone diameters give the most precise estimate of antibiotic susceptibility. One such standard procedure2, which has been recommended for use with disks to test susceptibility of organisms to imipenem, uses the 10-µg imipenem disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for imipenem.
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 10-µg imipenem disk should be interpreted according to the following criteria:
Zone Diameter (mm) | Interpretation |
≥ 16 | Susceptible |
14-15 | Moderately Susceptible |
≤ 13 | Resistant |
Standardized procedures require the use of laboratory control organisms. The 10- g imipenem disk should give the following zone diameters:
Organism | Zone Diameter (mm) |
E. coli ATCC 25922 | 26-32 |
P. aeruginosa ATCC 27853 | 20-28 |
For anaerobic bacteria, the MIC of imipenem can be determined by agar or broth dilution (including microdilution) techniques3.
The MIC values obtained should be interpreted according to the following criteria:
MIC (µg/mL) | Interpretation |
≥ 4 | Susceptible |
8 | Moderately Susceptible |
≤ 16 | Resistant |
REFERENCES
1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2 NCCLS, Villanova, PA, 1997.
2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1 NCCLS, Villanova, PA, 1997.
3. National Committee for Clinical Laboratory Standards, Method for Antimicrobial Susceptibility Testing of Anaerobic Bacteria - Third Edition. Approved Standard NCCLS Document M11-A3, Vol. 13, No. 26 NCCLS, Villanova, PA, 1993.