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Drug overview for MOXATAG (amoxicillin):
Generic name: AMOXICILLIN (a-MOX-i-SIL-in)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
Amoxicillin is an aminopenicillin antibiotic that is structurally related to ampicillin.
Amoxicillin shares the uses of other aminopenicillins and is used principally for the treatment of infections caused by susceptible gram-negative bacteria (e.g., Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella). Amoxicillin also is used for the treatment of infections caused by susceptible gram-positive bacteria (e.g., Streptococcus pneumoniae, enterococci, nonpenicillinase-producing staphylococci, Listeria); however, like other aminopenicillins, amoxicillin generally should not be used for the treatment of streptococcal or staphylococcal infections when a natural penicillin would be effective.
Generic name: AMOXICILLIN (a-MOX-i-SIL-in)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
Amoxicillin is an aminopenicillin antibiotic that is structurally related to ampicillin.
Amoxicillin shares the uses of other aminopenicillins and is used principally for the treatment of infections caused by susceptible gram-negative bacteria (e.g., Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella). Amoxicillin also is used for the treatment of infections caused by susceptible gram-positive bacteria (e.g., Streptococcus pneumoniae, enterococci, nonpenicillinase-producing staphylococci, Listeria); however, like other aminopenicillins, amoxicillin generally should not be used for the treatment of streptococcal or staphylococcal infections when a natural penicillin would be effective.
DRUG IMAGES
MOXATAG ER 775 MG TABLET
The following indications for MOXATAG (amoxicillin) have been approved by the FDA:
Indications:
Pharyngitis due to Streptococcus pyogenes
Tonsillitis due to Streptococcus pyogenes
Upper respiratory infection
Professional Synonyms:
Acute upper respiratory tract infection
Acute URI
Epidemic sore throat
Pharyngitis due to group A beta-hemolytic streptococci
Pharyngitis due to Streptococcus epidemicus
Septic sore throat
Streptococcal pharyngitis
Streptococcus pyogenes tonsillitis
Indications:
Pharyngitis due to Streptococcus pyogenes
Tonsillitis due to Streptococcus pyogenes
Upper respiratory infection
Professional Synonyms:
Acute upper respiratory tract infection
Acute URI
Epidemic sore throat
Pharyngitis due to group A beta-hemolytic streptococci
Pharyngitis due to Streptococcus epidemicus
Septic sore throat
Streptococcal pharyngitis
Streptococcus pyogenes tonsillitis
The following dosing information is available for MOXATAG (amoxicillin):
Dosage of amoxicillin, which is available for oral use as the trihydrate, is expressed in terms of anhydrous amoxicillin.
The usual adult dosage of amoxicillin for the treatment of mild to moderate infections of the ear, nose, or throat; skin and skin structure; or genitourinary tract is 500 mg every 12 hours or 250 mg every 8 hours. A dosage of 875 mg every 12 hours or 500 mg every 8 hours should be used for the treatment of severe infections of the ear, nose, or throat; skin and skin structure; or genitourinary tract in adults. The usual adult dosage of amoxicillin for the treatment of mild, moderate, or severe lower respiratory tract infections is 875 mg every 12 hours or 500 mg every 8 hours.
A single 3-g oral dose of amoxicillin has been used effectively for the initial treatment of acute, uncomplicated urinary tract infections in nonpregnant women+.
When oral amoxicillin is used in neonates and infants 12 weeks of age or younger, the manufacturer states that a dosage up to 30 mg/kg daily can be given in divided doses every 12 hours.
The usual dosage of oral amoxicillin for pediatric patients 3 months of age or older for the treatment of mild to moderate infections of the ear, nose, throat, skin and skin structure, or genitourinary tract is 20 mg/kg daily in divided doses every 8 hours or 25 mg/kg daily in divided doses every 12 hours. The usual dosage of oral amoxicillin for pediatric patients 3 months of age or older for the treatment of mild, moderate, or severe lower respiratory tract infections or for the treatment of severe infections of the ear, nose, throat, skin and skin structure, or genitourinary tract is 40 mg/kg daily in divided doses every 8 hours or 45 mg/kg daily in divided doses every 12 hours.
When oral amoxicillin is used for the treatment of mild to moderate infections in children beyond the neonatal period, the American Academy of Pediatrics (AAP) recommends a dosage of 25-50 mg/kg daily given in 3 divided doses.
When oral amoxicillin is used for step-down therapy in the treatment of severe infections in children beyond the neonatal period, AAP recommends a dosage of 80-100 mg/kg daily given in 3 divided doses. For highly susceptible pathogens, AAP states that a dosage of 90 mg/kg daily given in 2 divided doses can be used.
In patients with renal impairment, doses and/or frequency of administration of amoxicillin should be modified in response to the degree of renal impairment, severity of the infection, and susceptibility of the causative organisms. The manufacturer states that adults with severe renal impairment and creatinine clearances less than 30 mL/minute should not receive the commercially available film-coated tablets containing 875 mg of amoxicillin. The recommended dosage of amoxicillin for adults with creatinine clearances of 10-30 mL/minute is 250 or 500 mg every 12 hours, depending on the severity of the infection, and the recommended dosage for adults with creatinine clearances less than 10 mL/minute is 250 or 500 mg every 24 hours, depending on the severity of the infection.
Patients undergoing hemodialysis should receive 250 or 500 mg of amoxicillin every 24 hours, depending on the severity of the infection, and should receive an additional dose of the drug during and after each dialysis period.
The manufacturer states that data are insufficient to recommend dosage for pediatric patients with renal impairment.
The usual adult dosage of amoxicillin for the treatment of mild to moderate infections of the ear, nose, or throat; skin and skin structure; or genitourinary tract is 500 mg every 12 hours or 250 mg every 8 hours. A dosage of 875 mg every 12 hours or 500 mg every 8 hours should be used for the treatment of severe infections of the ear, nose, or throat; skin and skin structure; or genitourinary tract in adults. The usual adult dosage of amoxicillin for the treatment of mild, moderate, or severe lower respiratory tract infections is 875 mg every 12 hours or 500 mg every 8 hours.
A single 3-g oral dose of amoxicillin has been used effectively for the initial treatment of acute, uncomplicated urinary tract infections in nonpregnant women+.
When oral amoxicillin is used in neonates and infants 12 weeks of age or younger, the manufacturer states that a dosage up to 30 mg/kg daily can be given in divided doses every 12 hours.
The usual dosage of oral amoxicillin for pediatric patients 3 months of age or older for the treatment of mild to moderate infections of the ear, nose, throat, skin and skin structure, or genitourinary tract is 20 mg/kg daily in divided doses every 8 hours or 25 mg/kg daily in divided doses every 12 hours. The usual dosage of oral amoxicillin for pediatric patients 3 months of age or older for the treatment of mild, moderate, or severe lower respiratory tract infections or for the treatment of severe infections of the ear, nose, throat, skin and skin structure, or genitourinary tract is 40 mg/kg daily in divided doses every 8 hours or 45 mg/kg daily in divided doses every 12 hours.
When oral amoxicillin is used for the treatment of mild to moderate infections in children beyond the neonatal period, the American Academy of Pediatrics (AAP) recommends a dosage of 25-50 mg/kg daily given in 3 divided doses.
When oral amoxicillin is used for step-down therapy in the treatment of severe infections in children beyond the neonatal period, AAP recommends a dosage of 80-100 mg/kg daily given in 3 divided doses. For highly susceptible pathogens, AAP states that a dosage of 90 mg/kg daily given in 2 divided doses can be used.
In patients with renal impairment, doses and/or frequency of administration of amoxicillin should be modified in response to the degree of renal impairment, severity of the infection, and susceptibility of the causative organisms. The manufacturer states that adults with severe renal impairment and creatinine clearances less than 30 mL/minute should not receive the commercially available film-coated tablets containing 875 mg of amoxicillin. The recommended dosage of amoxicillin for adults with creatinine clearances of 10-30 mL/minute is 250 or 500 mg every 12 hours, depending on the severity of the infection, and the recommended dosage for adults with creatinine clearances less than 10 mL/minute is 250 or 500 mg every 24 hours, depending on the severity of the infection.
Patients undergoing hemodialysis should receive 250 or 500 mg of amoxicillin every 24 hours, depending on the severity of the infection, and should receive an additional dose of the drug during and after each dialysis period.
The manufacturer states that data are insufficient to recommend dosage for pediatric patients with renal impairment.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MOXATAG ER 775 MG TABLET | Maintenance | Adults take 1 tablet (775 mg) by oral route once daily for 10 days |
No generic dosing information available.
The following drug interaction information is available for MOXATAG (amoxicillin):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Methotrexate/Penicillins SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Penicillins may compete with the renal tubular secretion of methotrexate. CLINICAL EFFECTS: The concurrent use of methotrexate and penicillins may result in elevated levels of methotrexate and methotrexate toxicity, leading to increased risk of severe neurotoxicity, stomatitis, and myelosuppression. PREDISPOSING FACTORS: Risk factors for methotrexate toxicity include: - High-dose oncology regimens - Impaired renal function, ascites, or pleural effusions PATIENT MANAGEMENT: Patients receiving concurrent therapy with methotrexate and penicillins should be monitored closely for elevated methotrexate levels and methotrexate toxicity. The dose and duration of leucovorin rescue therapy may need to be increased. DISCUSSION: Elevated methotrexate levels, signs of methotrexate toxicity, and death have been reported following the concurrent use of methotrexate (both low dose and high dose) and penicillin derivatives. In a patient being treated with high-dose methotrexate (8 G/m2), the concurrent use of amoxicillin resulted in a 56% decrease in the clearance of methotrexate and signs of methotrexate toxicity.(1) There are two cases of methotrexate toxicity following the addition of amoxicillin to low-dose methotrexate therapy (7.5 mg-10 mg weekly) for psoriasis. In another case, a patient was found to have a toxic methotrexate level 12 days after her last dose of weekly methotrexate (7.5 mg). The patient had been treated with amoxicillin followed by flucloxacillin.(2) In a case report, dicloxacillin decreased methotrexate clearance 93%.(4) Flucloxacillin was shown to increase the area-under-curve (AUC) of methotrexate by 7.3% in a study in 10 subjects.(5) In a case report, a patient on low-dose methotrexate (5 mg) developed methotrexate pneumonia following the addition of flucloxacillin to his regimen.(5) In a patient being treated with high-dose methotrexate (12 G/m2), the concurrent use of mezlocillin increased the half-life of methotrexate from 10.1 to 27.2 hours.(6) In a case report, a patient developed methotrexate toxicity following the addition of penicillin V potassium to his methotrexate (50 mg weekly).(7) In a case report, penicillin decreased methotrexate clearance 36%.(4) In one report, leucovorin rescue therapy had to be continued for 192 hours following the concurrent use of methotrexate (3 G/m2) and piperacillin. During cycles without concurrent piperacillin, leucovorin rescue therapy was only required for 72 hours.(8) There are two reports of neutropenia and death following the concurrent use of piperacillin and low-dose methotrexate (2.5 mg three times weekly in one patient, 5 mg weekly in another) for psoriasis. One of these patients also received flucloxacillin. (3) In another case report, the concurrent use of piperacillin decreased methotrexate clearance by 67%.(4) In a case report, ticarcillin decreased methotrexate clearance by 60%.(4) |
JYLAMVO, METHOTREXATE, METHOTREXATE SODIUM, OTREXUP, RASUVO, TREXALL, XATMEP |
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
There are 4 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Oral Contraceptives/Penicillins SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Estrogens and progesterones are extensively excreted in bile, principally as glycuronide conjugates. Subsequently, they undergo enterohepatic circulation where bacterial hydrolysis occurs, allowing for reabsorption of the oral contraceptives through the bowel wall and eventual urinary excretion. Treatment with antibiotics destroys the gut flora and prevents steroid reabsorption, resulting in lower than normal concentrations of the contraceptive and excretion via the feces rather than the urine. CLINICAL EFFECTS: May observe reduced pharmacologic effects of oral contraceptives with resultant breakthrough bleeding and pregnancy. Reduced effects may be seen for several days after discontinuation of antibiotic therapy. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Current guidelines suggest that additional precautions are not necessary when non-enzyme inducing antibiotics are used concurrently with hormonal contraceptives; however, some patients may still prefer to use an additional method of contraception. DISCUSSION: Evidence for this interaction is limited and conflicting; however, the CDC and the Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit no longer recommend use of a backup contraceptive method during use of a non-enzyme inducing antibiotic. Reports of breakthrough bleeding and loss of contraceptive protection leading to unwanted pregnancies have occurred in women taking oral contraceptive agents who received concurrent ampicillin, amoxicillin, penicillin G, or oxacillin. Several studies have shown that the administration of ampicillin or penicillin to pregnant and nonpregnant women resulted in lowered urinary estrogen excretion, in some women as soon as three days after ampicillin therapy began. However in one small prospective study, plasma ethinyl estradiol concentrations showed a tendency to decrease during ampicillin administration on the third, fourth, and fifth morning of ampicillin administration, but were never lower than pretreatment values. In another small prospective study of women taking low dose combination contraceptives, concurrent ampicillin therapy neither altered the plasma levels nor the AUC of norethisterone and ethinyl estradiol. In addition, progesterone levels were in an anovulatory range. In another prospective study of 13 women taking long term oral contraceptive steroids, concurrent ampicillin was not associated with any significant changes in plasma concentrations of ethinyl estradiol, levonorgestrel, follicle stimulating hormone or progesterone, although lower concentrations of ethinyl estradiol were noted in two women. |
2-METHOXYESTRADIOL, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMILA, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DEBLITANE, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DOLISHALE, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, ELINEST, ELLA, EMZAHH, ENPRESSE, ENSKYCE, ERRIN, ESTARYLLA, ESTRADIOL, ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRIOL, ESTRIOL MICRONIZED, ESTRONE, ETHINYL ESTRADIOL, ETHYNODIOL-ETHINYL ESTRADIOL, FALMINA, FEIRZA, FEMLYV, FINZALA, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, HEATHER, ICLEVIA, INCASSIA, ISIBLOOM, JAIMIESS, JASMIEL, JENCYCLA, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KELNOR 1-50, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEENA, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD ETH ESTRAD, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LEVORA-28, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUTERA, LYLEQ, LYZA, MARLISSA, MERZEE, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MINZOYA, MONO-LINYAH, NATAZIA, NECON, NEXTSTELLIS, NIKKI, NORA-BE, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NYLIA, OCELLA, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, RECLIPSEN, RIVELSA, SAFYRAL, SETLAKIN, SHAROBEL, SIMLIYA, SIMPESSE, SLYND, SPRINTEC, SRONYX, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TRIVORA-28, TULANA, TURQOZ, TYBLUME, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, YASMIN 28, YAZ, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
| Selected Anticoagulants (Vit K antag)/Selected Penicillins SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Unknown. CLINICAL EFFECTS: Large doses of parenterally administered penicillins and oral amoxicillin appear to increase the risk of bleeding during concurrent administration of anticoagulants. PREDISPOSING FACTORS: Renal failure may predispose patients to penicillin-induced coagulation abnormalities. A study suggests that various inflammatory syndromes or the nature of the infection can affect INR levels. The risk for bleeding episodes may be greater in patients with additional disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: Monitor patient INR for an increase in the hypoprothrombinemic response to anticoagulants during concomitant administration of penicillins. Adjust the dose of warfarin accordingly. When concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin and/or hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: High dose parenteral administration of penicillins and oral amoxicillin have been reported to cause an increase in the hypoprothrombinemic effects of warfarin producing bleeding. Significant clinical effects have been reported with combined administration of warfarin and either carbenicillin or penicillin G. There have been several case reports and retrospective reviews documenting increased acenocoumarol and warfarin effects, including bleeding, following the addition of amoxicillin, with and without clavulanic acid, to therapy. In a randomized controlled trial, adult ambulatory patients that had no recent and ongoing infectious or inflammatory conditions received warfarin to a target INR between 2 and 3 with amoxicillin-clavulanic acid (1 gram twice daily for seven days) or placebo. The results showed the mean maximum INR increase from baseline to day 10 did not differ between amoxicillin/clavulanic acid (0.22 +/- 0.3) and the placebo period (0.24 +/- 0.6, p = 0.94). No patient experienced an INR of greater than 3.5. No bleeding events were reported during the entire study. A prospective cross-sectional observational study in 120 patients evaluated warfarin drug interactions, particularly with high-dose amoxicillin/clavulanate. The study found that patients on amoxicillin/clavulanate had a relative risk of having an INR >=4 of 4.8 compared to patients not on amoxicillin/clavulanate (95% CI 2.1-11.3, p < 0.001). This risk was primarily driven by patients on high-dose amoxicillin/clavulanate, who were 5.8 times more likely to have INR >=4 (95% CI 3.5-9.6, p<0.001). Significantly more patients on high-dose than normal dose amoxicillin/clavulanate had an INR value >= 4 (87.5% v. 28.9%, respectively). Nine out of ten patients who experienced bleeding during hospitalization were prescribed amoxicillin/clavulanate. A large systematic review was performed on 72 warfarin drug-drug interactions studies that reported on bleeding, thromboembolic events, or death. Most studies were retrospective cohorts. A meta-analysis of 11 of those studies found a higher rate of clinically significant bleeding in patients on warfarin and antimicrobials (OR=1.63; 95% CI 1.45-1.83). Increased bleeding risk was also seen in subgroup analyses with penicillins (OR=1.59; 95% CI 1.14-2.20) and amoxicillin (OR=1.78; 95% CI 1.14-2.79). A case-control nested cohort study of Medicare beneficiaries with warfarin prescriptions was evaluated for antibiotic use and warfarin toxicity in older adults. An increased risk of bleeding was associated with penicillins with an adjusted odds ratio of 1.92. Parenteral penicillins linked to this monograph include: almecillin, amdinocillin, amoxicillin, ampicillin, azlocillin, bacampicillin, carbenicillin, cyclacillin, hetacillin, mezlocillin, penicillin, penicillin G, penicillin V, phenethicillin, piperacillin, and ticarcillin. Oral penicillins linked to this monograph include: amoxicillin and penicillin. |
ANISINDIONE, DICUMAROL, JANTOVEN, WARFARIN SODIUM |
| Selected Cephalosporins & Penicillins/Probenecid SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Probenecid impairs the clearance of some cephalosporins and penicillins via inhibition of renal anion transporters in the proximal tubule.(49) It has also been hypothesized that probenecid may affect tissue distribution of cephalosporins.(1-5) CLINICAL EFFECTS: The concurrent administration of probenecid may result in increased maximum concentration (Cmax), area-under-curve (AUC), and half-life of the cephalosporin or penicillin.(49) While this may improve antibiotic efficacy,(46-48) increased levels may also increase the risk for antibiotic-associated nephrotoxicity.(4) PREDISPOSING FACTORS: Underlying renal dysfunction may increase the risk for nephrotoxicity. PATIENT MANAGEMENT: In patients receiving the combination to improve antibiotic efficacy, monitor for antibiotic adverse effects and consider monitoring renal function. In patients receiving probenecid therapy to prevent or treat hyperuricemia, exposure to the antibiotic will be increased. A decrease in antibiotic dose or frequency may be required. The US manufacturer of piperacillin-tazobactam states probenecid should not be coadministered with piperacillin-tazobactam unless the benefit outweighs the risk.(50) DISCUSSION: Concurrent use of probenecid with a cephalosporin or penicillin may cause an increase in the Cmax, AUC, and an increased elimination half life of the antibiotic.(6-8,49) This may be beneficial or necessary in difficult to treat infections,(46-48) but an increased risk for adverse effects should be expected. Antibiotics not dose adjusted for concurrent use with probenecid may be associated with an increased risk for adverse effects, such as nephrotoxicity. Probenecid administered concurrently with piperacillin-tazobactam prolongs the half-life of piperacillin by 21% and tazobactam by 71%. In a study in 8 healthy males, concurrent administration of probenecid (1 g) with piperacillin (1 g IM) increased piperacillin's Cmax and AUC by 30% and 60%. Renal clearance was reduced by 40%.(51) The cephalosporins affected by probenecid include cefazolin,(9-11) cephacetrile,(12,13) cephaloglycin,(14,15) cephalexin,(16-21) cephradine, (22-23) cefoxitin,(24-28) cefadroxil(29), cefaclor,(23) cefamandole,(30) ceftizoxime,(31,32) cefuroxime,(33,34) cefprozil,(35) cefonicid,(36) cefmetazole,(37) cefmenoxime,(38) and cefditoren.(39) Probenecid has been shown not to affect moxalactam,(4,40,41) ceforanide, (4,42), cefoperazone, ceftazidime(4,34,43) or ceftriaxone.(4) |
PROBENECID, PROBENECID-COLCHICINE |
| Allopurinol/Amoxicillin, Ampicillin, Bendamustine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. Allopurinol, amoxicillin, ampicillin, and bendamustine have been documented to cause cases of Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), and Drug reaction with eosinophilia and systemic symptoms (DRESS).(1) CLINICAL EFFECTS: Concurrent administration of allopurinol with amoxicillin, ampicillin or bendamustine may result in an increased incidence of rash which may be severe. PREDISPOSING FACTORS: Patients who are HLA-B*58:01 positive may be at increased risk. PATIENT MANAGEMENT: Consider an alternative to amoxicillin, ampicillin, or bendamustine in patients with a history of serious skin rashes, such as SJS, TEN, or DRESS. Discontinue allopurinol at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction when used with amoxicillin or ampicillin or bendamustine. Instruct patients to seek medical attention for any peeling skin rash or blisters.(1) DISCUSSION: In the Boston Collaborative Drug Surveillance Program, drug rash was seen in 22.4% of 67 hospitalized patients (relative risk 3.0) receiving concurrent allopurinol and ampicillin compared to 7.5% of 1257 patients receiving only ampicillin and 2.1% of 283 patients rceiving only allopurinol.(4) A hospital drug monitoring program found the observed risk of developing an exanthema with concurrent use is as follows: aminopenicillin without allopurinol 10.1%, aminopenicillin combined with allopurinol 7.2%, allopurinol without aminopenicillin 3.0%, or neither of the two drugs 1.5%.(6) A case-control study did not find a statistically significant increased risk of SJS with concurrent use of allopurinol and amoxicillin or ampicillin (allopurinol alone 4.4% vs. with amoxicillin 6.8%; allopurinol alone 0.1% vs. with ampicillin 2.7% at 1 month)(allopurinol alone 4.4% vs. with amoxicillin 5.7% or allopurinol alone 0.2% vs. with ampicillin 2.9% at 3 months).(8) In a retrospective study looking at mortality data, records were screened for administration of high risk drugs associated with SJS. Allopurinol and ampicillin was one of the drug combinations listed as contributing to mortality in patients (p = 0.049).(9) |
ALLOPURINOL, ALLOPURINOL SODIUM, ALOPRIM, DUZALLO, ZYLOPRIM |
The following contraindication information is available for MOXATAG (amoxicillin):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Clostridioides difficile infection |
| Infectious mononucleosis |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for MOXATAG (amoxicillin):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 27 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Anaphylaxis Exfoliative dermatitis Urticaria |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute generalized exanthematous pustulosis Agranulocytosis Autoimmune hemolytic anemia Clostridioides difficile infection Crystalluria DRESS syndrome Drug-induced hepatitis Enterocolitis Eosinophilia Erythema multiforme Furred tongue Hypersensitivity angiitis Idiopathic thrombocytopenic purpura Interstitial nephritis Laryngeal edema Leukopenia Maculopapular rash Obstructive hyperbilirubinemia Seizure disorder Serum sickness Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Nausea Skin rash Vomiting Vulvovaginal candidiasis |
Abdominal pain with cramps Pruritus of skin |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Agitation Anemia Behavioral disorders Dental discoloration Dizziness Insomnia Mucocutaneous candidiasis Symptoms of anxiety |
The following precautions are available for MOXATAG (amoxicillin):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Safe use of amoxicillin during pregnancy has not been definitely established. There are no adequate or controlled studies using aminopenicillins in pregnant women, and amoxicillin should be used during pregnancy only when clearly needed. However, amoxicillin has been administered to pregnant women without evidence of adverse effects to the fetus. In addition, amoxicillin is included in the US Centers For Disease Control and Prevention (CDC) recommendations for the treatment of chlamydial infections+ during pregnancy and included in CDC recommendations for the treatment of cutaneous anthrax+ or for postexposure prophylaxis+ following exposure to Bacillus anthracis spores.
Because amoxicillin is distributed into milk and may lead to sensitization of infants, the drug should be used with caution in nursing women. Because of its general safety in infants, CDC states that amoxicillin is an option for anti-infective prophylaxis in breast-feeding women when B. anthracis is known to be penicillin susceptible and there is no contraindication to maternal amoxicillin use.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for MOXATAG (amoxicillin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MOXATAG (amoxicillin)'s list of indications:
| Pharyngitis due to streptococcus pyogenes | |
| J02.0 | Streptococcal pharyngitis |
| Tonsillitis due to streptococcus pyogenes | |
| J03.0 | Streptococcal tonsillitis |
| J03.00 | Acute streptococcal tonsillitis, unspecified |
| J03.01 | Acute recurrent streptococcal tonsillitis |
| Upper respiratory infection | |
| J00 | Acute nasopharyngitis [common cold] |
| J01 | Acute sinusitis |
| J01.0 | Acute maxillary sinusitis |
| J01.00 | Acute maxillary sinusitis, unspecified |
| J01.01 | Acute recurrent maxillary sinusitis |
| J01.1 | Acute frontal sinusitis |
| J01.10 | Acute frontal sinusitis, unspecified |
| J01.11 | Acute recurrent frontal sinusitis |
| J01.2 | Acute ethmoidal sinusitis |
| J01.20 | Acute ethmoidal sinusitis, unspecified |
| J01.21 | Acute recurrent ethmoidal sinusitis |
| J01.3 | Acute sphenoidal sinusitis |
| J01.30 | Acute sphenoidal sinusitis, unspecified |
| J01.31 | Acute recurrent sphenoidal sinusitis |
| J01.4 | Acute pansinusitis |
| J01.40 | Acute pansinusitis, unspecified |
| J01.41 | Acute recurrent pansinusitis |
| J01.8 | Other acute sinusitis |
| J01.80 | Other acute sinusitis |
| J01.81 | Other acute recurrent sinusitis |
| J01.9 | Acute sinusitis, unspecified |
| J01.90 | Acute sinusitis, unspecified |
| J01.91 | Acute recurrent sinusitis, unspecified |
| J02 | Acute pharyngitis |
| J02.0 | Streptococcal pharyngitis |
| J02.8 | Acute pharyngitis due to other specified organisms |
| J02.9 | Acute pharyngitis, unspecified |
| J03 | Acute tonsillitis |
| J03.0 | Streptococcal tonsillitis |
| J03.00 | Acute streptococcal tonsillitis, unspecified |
| J03.01 | Acute recurrent streptococcal tonsillitis |
| J03.8 | Acute tonsillitis due to other specified organisms |
| J03.80 | Acute tonsillitis due to other specified organisms |
| J03.81 | Acute recurrent tonsillitis due to other specified organisms |
| J03.9 | Acute tonsillitis, unspecified |
| J03.90 | Acute tonsillitis, unspecified |
| J03.91 | Acute recurrent tonsillitis, unspecified |
| J04 | Acute laryngitis and tracheitis |
| J04.0 | Acute laryngitis |
| J04.1 | Acute tracheitis |
| J04.10 | Acute tracheitis without obstruction |
| J04.11 | Acute tracheitis with obstruction |
| J04.2 | Acute laryngotracheitis |
| J04.3 | Supraglottitis, unspecified |
| J04.30 | Supraglottitis, unspecified, without obstruction |
| J04.31 | Supraglottitis, unspecified, with obstruction |
| J05 | Acute obstructive laryngitis [croup] and epiglottitis |
| J05.0 | Acute obstructive laryngitis [croup] |
| J05.1 | Acute epiglottitis |
| J05.10 | Acute epiglottitis without obstruction |
| J05.11 | Acute epiglottitis with obstruction |
| J06 | Acute upper respiratory infections of multiple and unspecified sites |
| J06.0 | Acute laryngopharyngitis |
| J06.9 | Acute upper respiratory infection, unspecified |
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