Amoxicillin/Clavulanate Potassium

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Overview

What is Amoxicillin/Clavulanate Potassium?

PRESCRIBING

INFORMATION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets, USP and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Amoxicillin and Clavulanate Potassium Tablet USP is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is CHNOS·3HO and the molecular weight is 419.46. Chemically, amoxicillin is -6-[()-(-)-2-Amino-2-(-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.

Clavulanic acid is produced by the fermentation of . It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is CHKNO and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ()-(25 )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.

Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium.

Inactive Ingredients:

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How should I use Amoxicillin/Clavulanate Potassium?

Amoxicillin and Clavulanate Potassium Tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: - caused by β-lactamase-producing strains of and . - caused by β-lactamase-producing strains of and . - caused by β-lactamase-producing strains of and . - caused by β-lactamase-producing strains of , , and . - caused by β-lactamase-producing strains of , ., and .

While Amoxicillin and Clavulanate Potassium Tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Amoxicillin and Clavulanate Potassium Tablets due to their amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to Amoxicillin and Clavulanate Potassium Tablets should not require the addition of another antibiotic. Because amoxicillin has greater activity against than does ampicillin or penicillin, the majority of strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and Amoxicillin and Clavulanate Potassium Tablets. (See )

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets 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.

Bacteriological studies, to determine the causative organisms and their susceptibility to Amoxicillin and Clavulanate Potassium Tablets, should be performed together with any indicated surgical procedures.

Since both the 250 mg/125 mg and 500 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium are not equivalent to one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium; therefore, two 250 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium.

Dosage

Adults:

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 LT 30 mL/min. should not receive the 875 mg/125 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg/125 mg or 250 mg/125 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/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See )

Pediatric Patients

Due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5), the 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the pediatric patient weighs at least 40 kg or more.

Administration

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What should I look out for while using Amoxicillin/Clavulanate Potassium?

Amoxicillin and Clavulanate Potassium Tablets are contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium Tablets.

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. 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 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED.

Clostridium difficile

associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium Tablets, 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

C. difficile

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

Amoxicillin and Clavulanate Potassium Tablets should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of Amoxicillin and Clavulanate Potassium Tablets is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications. (See and )

What might happen if I take too much Amoxicillin/Clavulanate Potassium?

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.

In the case of overdosage, discontinue Amoxicillin and Clavulanate Potassium Tablets, 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 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.

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 both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis. (See for recommended dosing for patients with impaired renal function)

How should I store and handle Amoxicillin/Clavulanate Potassium?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Amoxicillin and Clavulanate Potassium Tablets, USP 500/125 mg They are supplied in plastic bottles of 20, 30 and 100 (with desiccant).Amoxicillin and Clavulanate Potassium Tablets, USP 875/125 mg They are supplied in plastic bottles of 20 and 100 (with desiccant).Store tablets at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.Amoxicillin and Clavulanate Potassium Tablets, USP 500/125 mg They are supplied in plastic bottles of 20, 30 and 100 (with desiccant).Amoxicillin and Clavulanate Potassium Tablets, USP 875/125 mg They are supplied in plastic bottles of 20 and 100 (with desiccant).Store tablets at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.Amoxicillin and Clavulanate Potassium Tablets, USP 500/125 mg They are supplied in plastic bottles of 20, 30 and 100 (with desiccant).Amoxicillin and Clavulanate Potassium Tablets, USP 875/125 mg They are supplied in plastic bottles of 20 and 100 (with desiccant).Store tablets at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.Amoxicillin and Clavulanate Potassium Tablets, USP 500/125 mg They are supplied in plastic bottles of 20, 30 and 100 (with desiccant).Amoxicillin and Clavulanate Potassium Tablets, USP 875/125 mg They are supplied in plastic bottles of 20 and 100 (with desiccant).Store tablets at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.Amoxicillin and Clavulanate Potassium Tablets, USP 500/125 mg They are supplied in plastic bottles of 20, 30 and 100 (with desiccant).Amoxicillin and Clavulanate Potassium Tablets, USP 875/125 mg They are supplied in plastic bottles of 20 and 100 (with desiccant).Store tablets at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Amoxicillin and Clavulanate Potassium Tablets. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While Amoxicillin and Clavulanate Potassium Tablets can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In 1 study, the relative bioavailability of clavulanate was reduced when Amoxicillin and Clavulanate Potassium Tablets were dosed at 30 and 150 minutes after the start of a high-fat breakfast. The safety and efficacy of Amoxicillin and Clavulanate Potassium Tablets have been established in clinical trials where Amoxicillin and Clavulanate Potassium Tablets were taken without regard to meals.

Mean* amoxicillin and clavulanate potassium pharmacokinetic parameters are shown in the table below:

*Mean values of 14 normal volunteers (n = 15 for clavulanate potassium in the low-dose regimens). Peak concentrations occurred approximately 1.5 hours after the dose. Administered at the start of a light meal.

Amoxicillin serum concentrations achieved with Amoxicillin and Clavulanate Potassium Tablets are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after the oral administration of Amoxicillin and Clavulanate Potassium Tablets is 1.3 hours and that of clavulanic acid is 1.0 hour.

Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single Amoxicillin and Clavulanate Potassium tablet 250 mg/125 mg or 500 mg/125 mg.

Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.

Neither component in Amoxicillin and Clavulanate Potassium Tablets is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.

Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.

Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by β-lactamases, and therefore, the spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a β-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of β-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance.

The formulation of amoxicillin and clavulanic acid in Amoxicillin and Clavulanate Potassium Tablets protects amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other β-lactam antibiotics. Thus, Amoxicillin and Clavulanate Potassium Tablets possess the properties of a broad-spectrum antibiotic and a β-lactamase inhibitor.

Amoxicillin/clavulanic acid has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in .

Gram-Positive Aerobes

Staphylococcus aureus

Gram-Negative Aerobes

Enterobacter

Enterobacter

Escherichia coli

Haemophilus influenzae

Klebsiella

Moraxella catarrhalis

The following in vitro data are available, .

Amoxicillin/clavulanic acid exhibits in vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less against most (≥90%) strains of ; MICs of 0.06 mcg/mL or less against most (≥90%) strains of ; MICs of 4 mcg/mL or less against most (≥90%) strains of staphylococci and anaerobic bacteria; and MICs of 8 mcg/mL or less against most (≥90%) strains of other listed organisms. However, with the exception of organisms shown to respond to amoxicillin alone, the safety and effectiveness of amoxicillin/clavulanic acid in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Because amoxicillin has greater in vitro activity against than does ampicillin or penicillin, the majority of strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin.

Gram-Positive Aerobes

Enterococcus faecalis

Staphylococcus epidermidis

Staphylococcus saprophyticus

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococcus

Gram-Negative Aerobes

Eikenella corrodens

Neisseria gonorrhoeae

Proteus mirabilis

Anaerobic Bacteria

Bacteroides

Bacteroides fragilis

Fusobacterium

Peptostreptococcus

Dilution Techniques

The recommended dilution pattern utilizes a constant amoxicillin/clavulanate potassium ratio of 2 to 1 in all tubes with varying amounts of amoxicillin. MICs are expressed in terms of the amoxicillin concentration in the presence of clavulanic acid at a constant 2 parts amoxicillin to 1 part clavulanic acid. The MIC values should be interpreted according to the following criteria:

RECOMMENDED RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING

For Gram-Negative Enteric Aerobes

For

Staphylococcus

and

Haemophilus

species

** Staphylococci which are susceptible to amoxicillin/clavulanic acid but resistant to methicillin/oxacillin must be considered as resistant.

For

S. pneumoniae

from

non

meningitis

sources

Note

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard amoxicillin/clavulanate potassium powder should provide the following MIC values:

††

Diffusion Techniques

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-mcg amoxicillin/clavulanate acid (20 mcg amoxicillin plus 10 mcg clavulanate potassium) disk should be interpreted according to the following criteria:

RECOMMENDED RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING

For Staphylococcus

species and H. influenzae

For

Other

Organisms

Except

S. pneumoniae

and

N. gonorrhoeae

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for amoxicillin/clavulanic acid.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30 mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) disk should provide the following zone diameters in these laboratory quality control strains:

Non-Clinical Toxicology

Amoxicillin and Clavulanate Potassium Tablets are contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium Tablets.

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. 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 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED.

Clostridium difficile

associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium Tablets, 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

C. difficile

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

Amoxicillin and Clavulanate Potassium Tablets should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of Amoxicillin and Clavulanate Potassium Tablets is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications. (See and )

Combined use of haloperidol and lithium. An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

The possibility of similar adverse interactions with other antipsychotic medication exists.

Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.

Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDS): Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteriodal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone.

General

While Amoxicillin and Clavulanate Potassium Tablets possess the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy.

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.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving or ), the drug should be discontinued and/or appropriate therapy instituted.

Prescribing Amoxicillin and Clavulanate Potassium Tablets 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.

Drug Interaction

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxicillin and Clavulanate Potassium Tablets may result in increased and prolonged blood levels of amoxicillin. Coadministration of probenecid cannot be recommended.

The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Amoxicillin and Clavulanate Potassium Tablets and allopurinol administered concurrently.

In common with other broad-spectrum antibiotics, Amoxicillin and Clavulanate Potassium Tablets may reduce the efficacy of oral contraceptives.

Drug/Laboratory Test Interaction

Oral administration of Amoxicillin and Clavulanate Potassium Tablets will result in high urine concentrations of amoxicillin. High urine concentrations of ampicillin may result in false-positive 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 and therefore Amoxicillin and Clavulanate Potassium Tablets, 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 and therefore Amoxicillin and Clavulanate Potassium Tablets.

Information for patients

Patients should be counseled that antibacterial drugs including Amoxicillin and Clavulanate Potassium Tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Amoxicillin and Clavulanate Potassium Tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Amoxicillin and Clavulanate Potassium Tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Labor and Delivery

Oral ampicillin-class antibiotics are generally poorly absorbed during labor. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions; however, it is not known whether the use of Amoxicillin and Clavulanate Potassium Tablets 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. In a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with Amoxicillin and Clavulanate Potassium Tablets may be associated with an increased risk of necrotizing enterocolitis in neonates.

Nursing Mothers

Ampicillin-class antibiotics are excreted in the milk; therefore, caution should be exercised when Amoxicillin and Clavulanate Potassium Tablets are administered to a nursing woman.

Pediatric Use

Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations (see ). Safety and effectiveness of Amoxicillin and Clavulanate Potassium Tablets in pediatric patients weighing less than 40 kg have not been established.

Geriatric use

An analysis of clinical studies of Amoxicillin and Clavulanate Potassium Tablets was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 3,119 patients in this analysis, 68% were LT 65 years old, 32% were GE 65 years old and 14% were LE 75 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 dose dependant 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.

Amoxicillin and Clavulanate Potassium Tablets are generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects. The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache.

The following adverse reactions have been reported for ampicillin-class antibiotics:

Gastrointestinal:

WARNINGS

Hypersensitivity Reactions:

WARNINGS

Liver:

CONTRAINDICATIONS

Renal:

OVERDOSAGE

Hemic and Lymphatic Systems:

Central Nervous System:

Miscellaneous:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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