Augmentin Oral Suspension

Generic Name: amoxicillin and clavulanate potassium

Dosage Form: powder, for oral suspension
AUGMENTIN®

(amoxicillin/clavulanate potassium)

Powder for Oral Suspension and Chewable Tablets

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

Augmentin Oral Suspension Description

AUGMENTIN 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 C16H19N3O5S•3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R ) - 6 - [(R) - ( - ) - 2 - Amino - 2 - (p - hydroxyphenyl)acetamido] - 3,3 - dimethyl - 7 - oxo - 4 - thia - 1 - azabicyclo[3.2.0]heptane - 2 - carboxylic acid trihydrate and may be represented structurally as:

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . 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 C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:

Inactive Ingredients

Powder for Oral Suspension—Colloidal silicon dioxide, flavorings (see HOW SUPPLIED), xanthan gum, and 1 or more of the following: Aspartamea, hypromellose, mannitol, silica gel, silicon dioxide, and sodium saccharin. Chewable Tablets—Colloidal silicon dioxide, flavorings (see HOW SUPPLIED), magnesium stearate, mannitol, and 1 or more of the following: Aspartamea, D&C Yellow No. 10, FD&C Red No. 40, glycine, sodium saccharin and succinic acid.

a  See PRECAUTIONS—Information for the Patient.

Each 125-mg chewable tablet and each 5 mL of reconstituted 125 mg/5 mL oral suspension of AUGMENTIN contains 0.16 mEq potassium. Each 250-mg chewable tablet and each 5 mL of reconstituted 250 mg/5 mL oral suspension of AUGMENTIN contains 0.32 mEq potassium. Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of AUGMENTIN contains 0.14 mEq potassium. Each 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of AUGMENTIN contains 0.29 mEq of potassium.

Augmentin Oral Suspension - Clinical Pharmacology

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of AUGMENTIN. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While AUGMENTIN 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 AUGMENTIN was dosed at 30 and 150 minutes after the start of a high-fat breakfast. The safety and efficacy of AUGMENTIN have been established in clinical trials where AUGMENTIN was taken without regard to meals.

Oral administration of single doses of 400-mg chewable tablets of AUGMENTIN and 400 mg/5 mL suspension to 28 adult volunteers yielded comparable pharmacokinetic data:

Dosea	AUC0-∞ (mcg.hr/mL)		Cmax (mcg/mL)b
(amoxicillin/clavulanate potassium)	amoxicillin (±S.D.)	clavulanate potassium (±S.D.)	amoxicillin (±S.D.)	clavulanate potassium (±S.D.)
400/57 mg (5 mL of suspension)	17.29 ± 2.28	2.34 ± 0.94	6.94 ± 1.24	1.10 ±  0.42
400/57 mg (1 chewable tablet)	17.24 ± 2.64	2.17 ± 0.73	6.67 ± 1.37	1.03 ±  0.33

a  Administered at the start of a light meal.

b  Mean values of 28 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.

Oral administration of 5 mL of 250 mg/5 mL suspension of AUGMENTIN or the equivalent dose of 10 mL of 125 mg/5 mL suspension of AUGMENTIN provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg.hr/mL for amoxicillin and 2.9 mcg.hr/mL for clavulanic acid when 5 mL of 250 mg/5 mL suspension of AUGMENTIN or equivalent dose of 10 mL of 125 mg/5 mL suspension of AUGMENTIN was administered to adult volunteers. One 250-mg chewable tablet of AUGMENTIN or two 125-mg chewable tablets of AUGMENTIN are equivalent to 5 mL of 250 mg/5 mL suspension of AUGMENTIN and provide similar serum levels of amoxicillin and clavulanic acid.

Amoxicillin serum concentrations achieved with AUGMENTIN 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 AUGMENTIN is 1.3 hours and that of clavulanic acid is 1.0 hour. Time above the minimum inhibitory concentration of 1.0 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hours and every 8 hours dosing regimens of AUGMENTIN in adults and children.

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 10 mL of 250 mg/5 mL suspension of AUGMENTIN.

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

Neither component in AUGMENTIN 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.

Two hours after oral administration of a single 35 mg/kg dose of suspension of AUGMENTIN to fasting children, average concentrations of 3.0 mcg/mL of amoxicillin and 0.5 mcg/mL of clavulanic acid were detected in middle ear effusions.

Microbiology

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 AUGMENTIN 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, AUGMENTIN possesses the distinctive 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 INDICATIONS AND USAGE.

Gram-Positive Aerobes

Staphylococcus aureus (β-lactamase and non−β-lactamase−producing)c

c  Staphylococci which are resistant to methicillin/oxacillin must be considered resistant to amoxicillin/clavulanic acid.

Gram-Negative Aerobes

Enterobacter species (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with AUGMENTIN in urinary tract infections caused by these organisms.)

Escherichia coli (β-lactamase and non−β-lactamase−producing)

Haemophilus influenzae (β-lactamase and non−β-lactamase−producing)

Klebsiella species (All known strains are β-lactamase−producing.)

Moraxella catarrhalis (β-lactamase and non−β-lactamase−producing)

The following in vitro data are available, but their clinical significance is unknown.

Amoxicillin/clavulanic acid exhibits in vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less against most (≥ 90%) strains of Streptococcus pneumoniaed; MICs of 0.06 mcg/mL or less against most (≥ 90%) strains of Neisseria gonorrhoeae; MICs of 4 mcg/mL or less against most (≥ 90%) strains of staphylococci and anaerobic bacteria; 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.

d  Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin.

Gram-Positive Aerobes

Enterococcus faecalise

Staphylococcus epidermidis (β-lactamase and non−β-lactamase−producing)

Staphylococcus saprophyticus (β-lactamase and non−β-lactamase−producing)

Streptococcus pneumoniaee, f

Streptococcus pyogenese, f

viridans group Streptococcuse, f

Gram-Negative Aerobes

Eikenella corrodens (β-lactamase and non−β-lactamase−producing)

Neisseria gonorrhoeaee (β-lactamase and non−β-lactamase−producing)

Proteus mirabilise (β-lactamase and non−β-lactamase−producing)

Anaerobic Bacteria

Bacteroides species, including Bacteroides fragilis (β-lactamase and non−β-lactamase−producing)

Fusobacterium species (β-lactamase and non−β-lactamase−producing)

Peptostreptococcus speciesf

e  Adequate and well-controlled clinical trials have established the effectiveness of amoxicillin alone in treating certain clinical infections due to these organisms.

f  These are non−β-lactamase−producing organisms, and therefore, are susceptible to amoxicillin alone.

Susceptibility Testing

Dilution Techniques

Quantitative methods are used to determine antimicrobial MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of amoxicillin/clavulanate potassium powder.

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: INTERPRETIVE CRITERIA FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING

For Gram-Negative Enteric Aerobes:

MIC (mcg/mL)	Interpretation
≤ 8/4	Susceptible (S)
16/8	Intermediate (I)
≥ 32/16	Resistant (R)

For Staphylococcus aureusg and Haemophilus influenzae:

MIC (mcg/mL)	Interpretation
≤ 4/2	Susceptible (S)
≥ 8/4	Resistant (R)

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

For S. pneumoniae from non-meningitis sources:

Isolates should be tested using amoxicillin/clavulanic acid and the following criteria should be used:

MIC (mcg/mL)	Interpretation
≤ 2/1	Susceptible (S)
4/2	Intermediate (I)
≥ 8/4	Resistant (R)

Note: These interpretive criteria are based on the recommended doses for respiratory tract infections.

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 that 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:

Microorganism	MIC Range (mcg/mL)h
E. coli ATCC 25922	2 to 8
E. coli ATCC 35218	4 to 16
H. influenzae ATCC 49247	2 to 16
S. aureus ATCC 29213	0.12 to 0.5
S. pneumoniae ATCC 49619	0.03 to 0.12

h  Expressed as concentration of amoxicillin in the presence of clavulanic acid at a constant 2 parts amoxicillin to 1 part clavulanic acid.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg of amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) to test the susceptibility of microorganisms to amoxicillin/clavulanic acid.

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

INTERPRETIVE CRITERIA FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING

For Gram-Negative Enteric Aerobes:

Zone Diameter (mm)	Interpretation
≥ 18	Susceptible (S)
14 to 17	Intermediate (I)
≤ 13	Resistant (R)

For Staphylococcus aureusi and Haemophilus influenzaej:

Zone Diameter (mm)	Interpretation
≥ 20	Susceptible (S)
≤ 19	Resistant (R)

i  Staphylococcus aureus which are resistant to methicillin or oxacillin must be considered as resistant to amoxicillin/clavulanic acid.

j  A broth microdilution method should be used for testing Haemophilus influenzae. Beta-lactamase−negative, ampicillin-resistant strains must be considered resistant to amoxicillin/clavulanic acid.

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:

Microorganism	Zone Diameter (mm)
E. coli ATCC 25922	18 to 24 mm
E. coli ATCC 35218	17 to 22 mm
S. aureus ATCC 25923	28 to 36 mm
H. influenza ATCC 49247	15 to 23 mm

Indications and Usage for Augmentin Oral Suspension

AUGMENTIN is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis.

Otitis Media − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis.

Sinusitis − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections − caused by β-lactamase−producing strains of S. aureus, E. coli, and Klebsiella spp.

Urinary Tract Infections − caused by β-lactamase−producing strains of E. coli, Klebsiella spp. and Enterobacter spp.

While AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase−producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and AUGMENTIN. (See Microbiology.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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 AUGMENTIN, should be performed together with any indicated surgical procedures.

Contraindications

AUGMENTIN is 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 AUGMENTIN.

Warnings

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 AUGMENTIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AUGMENTIN SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AUGMENTIN, 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.

AUGMENTIN should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of AUGMENTIN 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 CONTRAINDICATIONS and ADVERSE REACTIONS—Liver.)

Precautions

General

While AUGMENTIN possesses 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 Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.

Prescribing AUGMENTIN 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.

Information for the Patient

AUGMENTIN may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset. Many antibiotics can cause diarrhea. If diarrhea is severe or lasts more than 2 or 3 days, call your doctor.

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 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of AUGMENTIN, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of AUGMENTIN may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.

Patients should be counseled that antibacterial drugs including AUGMENTIN, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When AUGMENTIN is 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 AUGMENTIN or other antibacterial drugs in the future.

Phenylketonurics

Each 200-mg chewable tablet of AUGMENTIN contains 2.1 mg phenylalanine; each 400-mg chewable tablet contains 4.2 mg phenylalanine; each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine. The other products of AUGMENTIN do not contain phenylalanine and can be used by phenylketonurics. Contact your physician or pharmacist.

Drug Interactions

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

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

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 AUGMENTIN and allopurinol administered concurrently.

In common with other broad-spectrum antibiotics, AUGMENTIN may reduce the efficacy of oral contraceptives.

Drug/Laboratory Test Interactions

Oral administration of AUGMENTIN 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 AUGMENTIN, 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 AUGMENTIN.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenesis

The mutagenic potential of AUGMENTIN was investigated in vitro with an Ames test, a human lymphocyte cytogenetic assay, a yeast test and a mouse lymphoma forward mutation assay, and in vivo with mouse micronucleus tests and a dominant lethal test. All were negative apart from the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations.

Impairment of Fertility

AUGMENTIN at oral doses of up to 1,200 mg/kg/day (5.7 times the maximum human dose, 1,480 mg/m2/day, based on body surface area) was found to have no effect on fertility and reproductive performance in rats, dosed with a 2:1 ratio formulation of amoxicillin:clavulanate.

Pregnancy

Teratogenic Effects

Pregnancy (Category B). Reproduction studies performed in pregnant rats and mice given AUGMENTIN at oral dosages up to 1,200 mg/kg/day, equivalent to 7,200 and 4,080 mg/m2/day, respectively (4.9 and 2.8 times the maximum human oral dose based on body surface area), revealed no evidence of harm to the fetus due to AUGMENTIN. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Oral ampicillin-class antibiotics are 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 AUGMENTIN 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 AUGMENTIN 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 AUGMENTIN is administered to a nursing woman.

Pediatric Use

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of AUGMENTIN should be modified in pediatric patients younger than 12 weeks (3 months). (See DOSAGE AND ADMINISTRATION—Pediatric.)

Adverse Reactions

AUGMENTIN is 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. From the original premarketing studies, where both pediatric and adult patients were enrolled, 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.

In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse event profile seen was comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes. (See CLINICAL STUDIES.)

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

Gastrointestinal

Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Hypersensitivity Reactions

Skin rashes, pruritus, urticaria, angioedema, serum sickness−like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. (See WARNINGS.)

Liver

A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibiotics, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice, (See CONTRAINDICATIONS.) increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with AUGMENTIN. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, 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.

Renal

Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported (see OVERDOSAGE).

Hemic and Lymphatic Systems

Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly.

Central Nervous System

Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.

Miscellaneous

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

Overdosage

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 AUGMENTIN, 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.3

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

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

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

Augmentin Oral Suspension Dosage and Administration

Dosage

Pediatric Patients

Based on the amoxicillin component, AUGMENTIN should be dosed as follows:

Neonates and infants aged < 12 weeks (3 months)

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of AUGMENTIN is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended.

Patients aged 12 weeks (3 months) and older

INFECTIONS	DOSING REGIMEN
	q12ha	q8h
	200 mg/5 mL or 400 mg/5 mL oral suspensionb	125 mg/5 mL or 250 mg/5 mL oral suspension
Otitis mediac, sinusitis, lower respiratory tract infections, and more severe infections	45 mg/kg/day q12h	40 mg/kg/day q8h
Less severe infections	25 mg/kg/day q12h	20 mg/kg/day q8h

a  The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.

b  Each strength of suspension of AUGMENTIN is available as a chewable tablet for use by older children.

c  Duration of therapy studied and recommended for acute otitis media is 10 days.

Pediatric Patients Weighing 40 kg and More

Should be dosed according to the following adult recommendations: The usual adult dose is one 500-mg tablet of AUGMENTIN every 12 hours or one 250-mg tablet of AUGMENTIN every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of AUGMENTIN every 12 hours or one 500-mg tablet of AUGMENTIN every 8 hours. Among adults treated with 875 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for tablets of AUGMENTIN.

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

Adults

Adults who have difficulty swallowing may be given the 125 m

Zacare

Generic Name: benzoyl peroxide and sodium hyaluronate topical kit (BEN zoe il per OX ide and SOE dee um HYE al ure ON ate)

Brand Names: Zacare

What is benzoyl peroxide and sodium hyaluronate topical?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Sodium hyaluronate is a lubricant that restores moisture to the skin.

Benzoyl peroxide and sodium hyaluronate topical are used together to treat severe acne along with dry or scaly skin.

Benzoyl peroxide and sodium hyaluronate topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about benzoyl peroxide and sodium hyaluronate topical?

This medication comes as a kit containing benzoyl peroxide lotion and sodium hyaluronate gel.

You should not use this medication if you are allergic to benzoyl peroxide or sodium hyaluronate. Do not use this medication on a child younger than 12 years old without the advice of a doctor. Avoid getting this medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take up to 3 weeks of using this medicine before your symptoms improve. Talk with your doctor if your symptoms do not improve. The best results may be seen after 8 to 12 weeks of use. Do not use other medicated skin products unless your doctor has told you to.

Stop using benzoyl peroxide and sodium hyaluronate and call your doctor at once if you have severe stinging or burning of your skin.

What should I discuss with my healthcare provider before using benzoyl peroxide and sodium hyaluronate topical?

You should not use this medication if you are allergic to benzoyl peroxide or sodium hyaluronate. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether benzoyl peroxide and sodium hyaluronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child younger than 12 years old without the advice of a doctor.

How should I use benzoyl peroxide and sodium hyaluronate topical?

This medication comes as a kit containing benzoyl peroxide lotion and sodium hyaluronate gel.

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Shake the benzoyl peroxide lotion well just before each use. Wet the skin before applying the benzoyl peroxide cleansing lotion. Work the lotion into a lather and rinse thoroughly. Gently the skin dry.

During your first week of treatment, wash the affected skin with the benzoyl peroxide lotion once daily. After the first week, wash the skin twice daily.

The sodium hyaluronate gel may be applied 2 or 3 times daily. Follow your doctor's instructions. Apply a liberal amount of the gel and rub it in thoroughly.

Do not cover the treated skin area unless your doctor has told you to.

It may take up to 3 weeks of using this medicine before your symptoms improve. Talk with your doctor if your symptoms do not improve. The best results may be seen after 8 to 12 weeks of use. Do not use other medicated skin products unless your doctor has told you to.

Store benzoyl peroxide and sodium hyaluronate at room temperature away from moisture and heat. Keep the lotion bottle and ointment tube tightly closed when not in use.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of benzoyl peroxide and sodium hyaluronate applied to the skin is not likely to cause life-threatening symptoms.

What should I avoid while using benzoyl peroxide and sodium hyaluronate topical?

Avoid getting this medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water.

Avoid using benzoyl peroxide and sodium hyaluronate topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

Do not use other medicated skin products unless your doctor has told you to.

Benzoyl peroxide and sodium hyaluronate topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzoyl peroxide and sodium hyaluronate and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

• 
  

  redness or peeling of treated skin;

  
  


• 
  

  mild burning or stinging; or

  
  


• 
  

  dry skin.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect benzoyl peroxide and sodium hyaluronate topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide and sodium hyaluronate. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Zacare resources

• Zacare Side Effects (in more detail)
• Zacare Use in Pregnancy & Breastfeeding
• Zacare Drug Interactions
• Zacare Support Group
• 0 Reviews for Zacare - Add your own review/rating

Compare Zacare with other medications

• Acne

Where can I get more information?

• Your pharmacist can provide more information about benzoyl peroxide and sodium hyaluronate topical.

See also: Zacare side effects (in more detail)

Procaine Hydrochloride

Class: Local Anesthetics
ATC Class: N01BA52
VA Class: CN204
Chemical Name: 4-amino-, 2-(diethylamino) ethyl ester monohydrochloride
CAS Number: 51-05-8

Introduction

Short-acting local anesthetic (ester type).^a

Uses for Procaine Hydrochloride

Local or Regional Anesthesia

Local or regional analgesia or anesthesia^{c d} in surgical, dental, and diagnostic procedures.^{a b}

Procaine Hydrochloride Dosage and Administration

General

• 
  

  Determine dosage based on anesthetic procedure, area to be anesthetized, vascularity of tissues, number of neuronal segments to be blocked, depth and duration of anesthesia, degree of muscular relaxation, individual tolerance, and physical condition of the patient.^{c d} Use smallest dose and concentration required to produce the desired effect.^{a c d}

  
  

Administration

Injection

For solution and drug compatibility information, see Compatibility under Stability.

Administer by local infiltration, peripheral nerve block, or subarachnoid (spinal) block.^{a c d} Has been administered by continuous intra-articular infusion† (e.g., for control of postoperative pain); however, such use associated with chondrolysis.^{200 201 202 203 204 205 206 207 208 209} (See Risk of Chondrolysis Associated with Intra-articular Infusions of Local Anesthetics under Cautions.)

Consult specialized references for specific techniques and procedures for administering local anesthetics.^a

For local infiltration or peripheral nerve block, inject slowly and avoid rapid injection of large volumes; when feasible, administer in fractional (incremental) doses.^d

For subarachnoid (spinal) block, use 2-mL single-dose ampuls containing procaine hydrochloride 10% only.^{c d} Position patient properly prior to spinal anesthesia.^{a b}

For disinfection of container surface, autoclave once at 15 PSI and 121°C for 15 minutes^a (diluent dextrose may show some brown discoloration due to caramelization); immersion in antiseptic solution not recommended.^c Reautoclaving not recommended because it increases likelihood of crystal formation.^a

Dilution

For local infiltration, dilute appropriate dose of 1% procaine hydrochloride injection with 0.9% sodium chloride to obtain final concentration of 0.25 or 0.5%.^{a d} May add 0.5–1 mL of epinephrine 0.1% to each 100 mL of anesthetic solution (to provide final epinephrine concentration of 1:200,000 to 1:100,000) for vasoconstrictive effect.^a

For peripheral nerve block, dilute appropriate dose of 1% procaine hydrochloride injection with 0.9% sodium chloride to obtain final concentration of 0.5%.^{a d} Alternatively, may use 1% procaine hydrochloride injection without diluting.^d May add 0.5–1 mL of epinephrine 0.1% to each 100 mL of anesthetic solution (to provide a final epinephrine concentration of 1:200,000 to 1:100,000) for vasoconstrictive effect.^a

For subarachnoid (spinal) block, dilute appropriate dose of 10% procaine hydrochloride injection with sterile 0.9% sodium chloride injection, sterile water for injection, CSF, or, for hyperbaric technique, sterile dextrose injection.^{a c} For anesthesia of the perineum, dilute 0.5 mL of the 10% procaine hydrochloride injection (50 mg) with an equal volume of diluent.^a For anesthesia of the perineum and lower extremities, dilute 1 mL of the 10% injection (100 mg) with an equal volume of diluent.^a For anesthesia extending up to the costal margin, dilute 2 mL of the 10% injection (200 mg) with 1 mL of diluent.^a

Rate of Administration

For subarachnoid (spinal) block, usual rate of injection is 1 mL/5 seconds.^a

Dosage

Available as procaine hydrochloride; dosage expressed in terms of the salt.^{c d}

Pediatric Patients

Local or Regional Anesthesia

Local Infiltration

Up to 15 mg/kg as a 0.5% solution.^d

Adults

Local or Regional Anesthesia

Local Infiltration

Usually, 350–600 mg, administered as diluted solution (i.e., 140–240 mL of a 0.25% solution or 70–120 mL of a 0.5% solution).^{a d}

Peripheral Nerve Block

Up to 1 g, administered undiluted (i.e., 100 mL of a 1% injection) or as diluted solution (i.e., 200 mL of a 0.5% solution).^{a d}

Subarachnoid (Spinal) Block

Recommended Dosage for Spinal Anesthesia in Adultsac

Extent of Anesthesia	Total Dose of Procaine Hydrochloride (mg) (as 10% Injection)	Site of Injection (Lumbar Interspace)
Perineum	50	4th
Perineum and lower extremities	100	3rd or 4th
Up to costal margin	200	2nd, 3rd, or 4th

Prescribing Limits

Pediatric Patients

Local or Regional Anesthesia

Local Infiltration

Maximum 15 mg/kg as a 0.5% solution.^d

Adults

Local or Regional Anesthesia

Local Infiltration, Peripheral Nerve Block

Maximum 1 g per injection.^a

Special Populations

Hepatic Impairment

Reduce dosage in patients with hepatic disease.^a

Geriatric Patients

Reduce dosage based on age, weight, and physical status.^{c d}

Other Populations

Reduce dosage in patients with cardiac disease, debilitated patients, and acutely ill patients.^{a d}

Reduce dosage in obstetric patients and patients with increased intra-abdominal pressure.^a

Cautions for Procaine Hydrochloride

Contraindications

• 
  

  Contraindications to spinal anesthesia: generalized septicemia, sepsis at proposed injection site, and certain diseases of the cerebrospinal system (e.g., meningitis, syphilis, spinal fluid block, cranial or spinal hemorrhage, tumors, poliomyelitis, metastatic lesions of the spinal cord).^{b c}

  
  


• 
  

  Known hypersensitivity to procaine, drugs of a similar chemical configuration, aminobenzoic acid or its derivatives, or any ingredient in the formulation.^{c d}

  
  

Warnings/Precautions

Warnings

Experience of Supervising Clinician

Should be used only by clinicians who are sufficiently knowledgeable in the diagnosis and management of dose-related toxicity and other acute emergencies that might arise.^{b c d} Oxygen, resuscitative equipment, and drugs must be available for immediate use.^{a b} Delay in appropriate management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may result in acidosis, cardiac arrest, and, possibly, death.^{b d}

Risk of Chondrolysis Associated with Intra-articular Infusions of Local Anesthetics

Chondrolysis (necrosis and destruction of articular cartilage) reported in patients receiving continuous intra-articular infusions of local anesthetics, administered for 48–72 hours via elastomeric infusion devices, for treatment of postoperative pain.^{200 201 202 203 204 205 206 207 208 209} Primarily observed in the shoulder joint following arthroscopic or other shoulder surgery.²⁰⁰ May result in long-term disability; often requires intervention (e.g., debridement, arthroplasty).^{200 202 203 204 205 206 209} Not known whether the drug, infusion device, and/or other factors contributed to the development of chondrolysis.^{200 201} Neither local anesthetics nor elastomeric infusion devices are approved for use for continuous intra-articular infusion therapy.^{200 201}

Accidental Intravascular Injection

Accidental intravascular injection of local anesthetics may result in seizures, CNS or cardiorespiratory depression, coma, and/or respiratory arrest.^b

Aspirate prior to and during administration to guard against intravascular injection.^{b d}

Sensitivity Reactions

Hypersensitivity Reactions and Cross-sensitivity

Allergic reactions are rare.^{b d}

Possible urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and anaphylactoid reactions (including severe hypotension).^{c d}

Cross-sensitivity between ester-type local anesthetics reported.^{b d}

Use with caution in patients with known drug allergies and hypersensitivities.^{c d}

Sulfite Sensitivity

Some procaine hydrochloride preparations contain acetone sodium bisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^{a b}

General Precautions

CNS Effects

Toxic plasma concentrations of local anesthetics (resulting from systemic absorption) associated with adverse CNS effects (e.g., anxiety, apprehension, restlessness, nervousness, disorientation, incoherent speech, confusion, dizziness, lightheadedness, blurred vision, tremors, twitching, shivering, numbness and tingling of the mouth and lips, metallic taste, tinnitus, seizures, depression, drowsiness, unconsciousness, respiratory arrest).^{b c d}

Carefully monitor level of consciousness after each local anesthetic administration.^{c d}

Cardiovascular Effects

Toxic plasma concentrations of local anesthetics (resulting from systemic absorption) associated with adverse cardiovascular effects (e.g., myocardial depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, cardiovascular collapse, cardiac arrest).^{b c d} Carefully monitor cardiovascular (e.g., BP) and respiratory vital signs after each local anesthetic injection.^{a c d}

Use with caution in patients with severe disturbances of cardiac rhythm, shock, heart block, or hypotension.^{c d}

Avoid use of large doses in patients with heart block.^{c d}

For solutions containing a vasoconstrictor (e.g., epinephrine), consider risk of exaggerated vasoconstrictor response in patients with peripheral or hypertensive vascular disease.^d Use with caution and in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply (e.g., digits, nose, external ear, penis).^d

Vasoconstrictor Administration

Concomitant use with a vasoconstrictor such as epinephrine may cause ischemic injury or necrosis.^d

Familial Malignant Hyperthermia

Many drugs used during the conduct of anesthesia may trigger familial malignant hyperthermia; not known whether ester-type local anesthetics trigger this reaction.^d However, standard protocol for management should be available.^d Early unexplained signs of tachycardia, tachypnea, labile BP, and metabolic acidosis may precede temperature elevation.^d If familial malignant hyperthermia is confirmed, discontinue triggering agent and initiate appropriate therapy (e.g., oxygen, dantrolene) and other supportive measures.^d

Preexisting Conditions

Employ anesthetic procedures with caution when there is inflammation and/or sepsis in the region of the proposed injection.^{c d} (See Contraindications under Cautions.)

Conditions that may preclude the use of spinal anesthesia (depending on the clinician’s evaluation of the situation and ability to manage potential complications) include cardiovascular disease (e.g., shock, hypertension, hypotension, arteriosclerosis, occlusive arterial disease); pulmonary disease; renal impairment; metabolic or endocrine disorders; GI disorder (e.g., intestinal obstruction, peritonitis); complicated obstetrical deliveries; spinal deformities that make spinal puncture inadvisable or difficult; bleeding resulting from traumatic lumbar puncture; severe anemia, cachexia, or moribund condition; chronic backache; preoperative headache or history of migraine; extremes of age; and emotional instability, hysteria, or nervous tension.^{b c} (See Contraindications under Cautions.)

Specific Populations

Pregnancy

Category C.^d

Labor and Delivery

Maternal hypotension reported.^b To prevent decreases in BP, elevate patient’s legs and position patient on her left side.^b Monitor fetal heart rate continuously; electronic fetal monitoring highly advisable.^b

Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts; may increase need for forceps assistance.^b

Possible diminished muscle strength and tone on neonate’s first or second day of life.^d

Lactation

Not known whether procaine is distributed into milk.^d Caution if used in nursing women.^d

Pediatric Use

Some manufacturers recommend reducing dosage of local anesthetics in proportion to age, weight, and physical condition.^b (See Pediatric Patients under Dosage and Administration.)

Geriatric Use

Reduce dosage based on age, weight, and physical status.^{c d}

Hepatic Impairment

Use with caution; patients with severe hepatic disease are at greater risk of developing toxic plasma concentrations.^d Dosage reduction recommended.^a

Renal Impairment

Weigh benefits against risks of spinal anesthesia in patients with renal impairment.^c

Common Adverse Effects

Adverse CNS and cardiovascular effects, underventilation, apnea.^d (See CNS Effects and also Cardiovascular Effects, under Cautions.)

Spinal anesthesia: Possible postspinal headache, meningismus, arachnoiditis, palsies, spinal nerve paralysis, hypotension, respiratory impairment or paralysis, nausea, vomiting.^c

Interactions for Procaine Hydrochloride

When used with epinephrine, consider usual drug interactions associated with epinephrine administration.^{c d}

Specific Drugs

Drug	Interaction	Comments
Aminosalicylic acid	Possible antagonism of aminosalicylic acid activitya	Consider avoiding concomitant usea b
Antidepressants, tricyclics	Possible severe, prolonged hypertension or disturbances of cardiac rhythm due to epinephrine componentd	Avoid concomitant use with epinephrine; if must be used concomitantly, careful monitoring is requiredd
Butyrophenones	Possible reduction or reversal of pressor effect of epinephrined
Ergot alkaloid oxytocics (ergonovine, methylergonovine)	Possible severe, persistent hypertension or cerebrovascular accidents (e.g., rupture of cerebral blood vessel) due to epinephrine componentc d	Avoid concomitant use with epinephrined
MAO inhibitors	Possible severe, prolonged hypertension or disturbances of cardiac rhythm due to epinephrine componentd	Avoid concomitant use with epinephrine; if must be used concomitantly, careful monitoring is requiredd
Phenothiazines	Possible reduction or reversal of pressor effect of epinephrine;d severe sustained hypertension or hypotension also may occurc	Use concomitantly with epinephrine with extreme cautionc
Succinylcholine	Possible increase in neuromuscular blocking effect with high IV doses of procaineb
Sulfonamides	Possible antagonism of sulfonamide activityb	Avoid concomitant usea b

Procaine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Readily absorbed following parenteral administration.^c

Rate of systemic absorption dependent upon total dose and concentration administered, route of administration, vascularity of administration site, and presence or absence of epinephrine in solution.^d

Onset

2–5 minutes.^a

Duration

1–1.5 hours.^{a c d}

Distribution

Extent

Local anesthetics are distributed to some extent to all body tissues, with high concentrations found in highly perfused organs (e.g., liver, lungs, heart, brain).^d

Local anesthetics generally cross blood-brain and placental barriers.^{b d}

Elimination

Metabolism

Rapidly and almost completely hydrolyzed by plasma cholinesterase to p-aminobenzoic acid and diethylaminoethanol.^{a c d}

Elimination Route

Approximately 90% of p-aminobenzoic acid and its conjugates and 33% of diethylaminoethanol are excreted in urine; <2% of administered dose is excreted in urine as unchanged drug.^d

Special Populations

Possible delayed metabolism in neonates, adults with liver disease, and adults with impaired renal function.^a

Stability

Storage

Parenteral

Injection

20–25°C.^c Protect from light.^{c d} Discard unused portion of solutions not containing preservatives.^d

Do not use if crystal formation, cloudiness, or discoloration is observed.^a

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose-Ringer's injection combinations
Dextrose-Ringer’s injection, lactated, combinations
Dextrose-saline combinations
Dextrose 2½, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer's injection
Ringer's injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M

Drug Compatibility

Do not mix with other local anesthetics (insufficient clinical data).^d

Admixture CompatibilityHID

Compatible
Ascorbic acid injection
Hydrocortisone sodium succinate
Penicillin G potassium
Penicillin G sodium
Vitamin B complex with C
Incompatible
Amobarbital sodium
Chlorothiazide sodium
Magnesium sulfate
Phenobarbital sodium
Phenytoin sodium
Sodium bicarbonate
Variable
Aminophylline

ActionsActions

• 
  

  Local anesthetics block the generation and conduction of nerve impulses by increasing the threshold for electrical excitation, slowing the propagation of the nerve impulse, and reducing the rate of rise of the action potential.^{b c d}

  
  


• 
  

  Produces vasodilation; may add a vasoconstrictor (e.g., epinephrine) to solutions of procaine to retard procaine’s absorption, prolong its duration of action, and maintain hemostasis.^{a d}

  
  


• 
  

  Has short duration of action.^a

  
  


• 
  

  Has little topical activity.^a

  
  

Advice to Patients

• 
  

  Prior to administration, advise patients of the possibility of temporary loss of sensation and motor activity following local or regional anesthesia.^d

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular or liver disease).^{c d}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{c d}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{c d} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Procaine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

200. Food and Drug Administration. Information for healthcare professionals: Chondrolysis reported with continuously infused local anesthetics (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, and ropivacaine). Rockville, MD; Updated 2010 Feb 16. From FDA website ().

201. Todd JF. Chondrolysis linked to intra-articular infusions. Medical Devices Alerts and Notices. Silver Spring, MD: Food and Drug Administration; 2010 June. From FDA website ().

202. Hansen BP, Beck CL, Beck EP et al. Postarthroscopic glenohumeral chondrolysis. Am J Sports Med. 2007; 35:1628-34. [PubMed 17609526]

203. Bailie DS, Ellenbecker TS. Severe chondrolysis after shoulder arthroscopy: a case series. J Shoulder Elbow Surg. 2009 Sep-Oct; 18:742-7.

204. Anakwenze OA, Hosalkar H, Huffman GR. Case Reports: Two Cases of Glenohumeral Chondrolysis after Intraarticular Pain Pumps. Clin Orthop Relat Res. 2010; :.

205. Anderson SL, Buchko JZ, Taillon MR et al. Chondrolysis of the glenohumeral joint after infusion of bupivacaine through an intra-articular pain pump catheter: a report of 18 cases. Arthroscopy. 2010; 26:451-61. [PubMed 20362823]

206. Rapley JH, Beavis RC, Barber FA. Glenohumeral chondrolysis after shoulder arthroscopy associated with continuous bupivacaine infusion. Arthroscopy. 2009; 25:1367-73. [PubMed 19962061]

207. Scheffel PT, Clinton J, Lynch JR et al. Glenohumeral chondrolysis: A systematic review of 100 cases from the English language literature. J Shoulder Elbow Surg. 2010; :. [PubMed 20421168]

208. Ballieul RJ, Jacobs TF, Herregods S et al. The peri-operative use of intra-articular local anesthetics: a review. Acta Anaesthesiol Belg. 2009; 60:101-8. [PubMed 19594092]

209. Busfield BT, Romero DM. Pain pump use after shoulder arthroscopy as a cause of glenohumeral chondrolysis. Arthroscopy. 2009; 25:647-52. [PubMed 19501296]

a. AHFS drug information 2011. McEvoy GK, ed. Procaine Hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; e-pub ahead of print.

b. AHFS drug information 2011. McEvoy GK, ed. Local Anesthetics, Parenteral, General Statement. Bethesda, MD: American Society of Health-Systems Pharmacists; e-pub ahead of print.

c. Hospira, Inc. Novocain (procaine hydrochloride) injection 10% solution for spinal anesthesia prescribing information. Lake Forest, IL; 2005 Jul.

d. Hospira, Inc. Novocain (procaine hydrochloride) injection prescribing information. Lake Forest, IL; 2005 Jun.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1395-7.

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neomycin and polymyxin b Topical

nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate

Commonly used brand name(s)

In the U.S.

• Antibiotic Cream

Available Dosage Forms:

• Powder


• Cream

Therapeutic Class: Antibacterial Combination

Chemical Class: Neomycin

Uses For neomycin and polymyxin b

Neomycin and polymyxin B combination is used to prevent bacterial infections. It works by killing bacteria.

Neomycin and polymyxin B cream is applied to the skin to prevent minor bacterial skin infections. It may also be used for other problems as determined by your doctor.

neomycin and polymyxin b is available without a prescription.

Before Using neomycin and polymyxin b

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For neomycin and polymyxin b, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to neomycin and polymyxin b or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of neomycin and polymyxin B combination in children with use in other age groups, neomycin and polymyxin b is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of neomycin and polymyxin B combination in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking neomycin and polymyxin b, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using neomycin and polymyxin b with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium


• Atracurium


• Cidofovir


• Cisatracurium


• Colistimethate Sodium


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Fazadinium


• Furosemide


• Gallamine


• Hexafluorenium


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Sorafenib


• Tacrolimus


• Tubocurarine


• Vecuronium

Using neomycin and polymyxin b with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium


• Atracurium


• Bumetanide


• Cisatracurium


• Doxacurium


• Fazadinium


• Gallamine


• Hexafluorenium


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Tubocurarine


• Vecuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of neomycin and polymyxin b

If you are using neomycin and polymyxin b without a prescription, do not use it to treat deep wounds, puncture wounds, animal bites, serious burns, or raw areas without first checking with your health care professional.

Do not use neomycin and polymyxin b in the eyes.

To use:

• Before applying neomycin and polymyxin b, wash the affected area(s) with soap and water, and dry thoroughly.


• Apply a small amount of neomycin and polymyxin b to the affected area(s) and rub in gently.


• After applying neomycin and polymyxin b, the treated area(s) may be covered with a gauze dressing if desired.

Do not use neomycin and polymyxin b for longer than 1 week or on large areas of the skin, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

To help clear up your skin infection completely, keep using neomycin and polymyxin b for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of neomycin and polymyxin b will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of neomycin and polymyxin b. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  
  • For prevention of minor bacterial infections:
    
    • Adults and children 2 years of age and older—Apply to the affected area(s) of the skin one to three times a day.
    
    
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of neomycin and polymyxin b, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using neomycin and polymyxin b

If your skin infection does not improve within 1 week, or if it becomes worse, check with your health care professional.

neomycin and polymyxin b Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Itching, pain, skin rash, swelling, redness, or other sign of skin irritation not present before use of neomycin and polymyxin b

Rare

• Loss of hearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More neomycin and polymyxin b Topical resources

• Neomycin and polymyxin b Topical Use in Pregnancy & Breastfeeding
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• 0 Reviews · Be the first to review/rate this drug

Pergolide Mesylate

Generic Name: Pergolide Mesylate (PER-go-lide)
Brand Name: Permax

Pergolide Mesylate is used for:

Treating Parkinson disease when used with levodopa/carbidopa.

Pergolide Mesylate is dopamine agonist. It works by stimulating dopamine receptors in the brain.

Do NOT use Pergolide Mesylate if:

• you are allergic to any ingredient in Pergolide Mesylate


• you are allergic to ergot-type medicines (eg, ergotamine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pergolide Mesylate:

Some medical conditions may interact with Pergolide Mesylate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of heart or kidney problems, irregular heartbeat, lung problems, low blood pressure, or hallucinations

Some MEDICINES MAY INTERACT with Pergolide Mesylate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, thioridazine), or thioxanthenes (eg, thiothixene) because the effectiveness of Pergolide Mesylate may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pergolide Mesylate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pergolide Mesylate:

Use Pergolide Mesylate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pergolide Mesylate may be taken with or without food.


• If Pergolide Mesylate needs to be stopped or if a different medicine is added to therapy by your doctor, this will be done gradually. The risk of side effects may be increased if Pergolide Mesylate is suddenly stopped.


• If you miss a dose of Pergolide Mesylate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pergolide Mesylate.

Important safety information:

• Pergolide Mesylate may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pergolide Mesylate. Using Pergolide Mesylate alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Pergolide Mesylate may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Pergolide Mesylate. Pergolide Mesylate will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Pergolide Mesylate if you suddenly stop taking it or if your dose is lowered too quickly. Symptoms may include increased body heat; rigid muscles; altered mental abilities, including lack of response to your surroundings; fast or irregular heartbeat; sweating. Contact your doctor at once if any of these symptoms occur. Do not stop taking Pergolide Mesylate without first talking with your doctor.


• Use Pergolide Mesylate with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion.


• Pergolide Mesylate is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Pergolide Mesylate can cause harm to the fetus. If you become pregnant while taking Pergolide Mesylate, discuss with your doctor the benefits and risks of using Pergolide Mesylate during pregnancy. It is unknown if Pergolide Mesylate is excreted in breast milk. Do not breast-feed while taking Pergolide Mesylate.

If you suddenly stop taking Pergolide Mesylate, you may experience WITHDRAWAL symptoms, including anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Pergolide Mesylate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; dry mouth; lightheadedness; loss of appetite; nausea; pain; runny nose; stomach pain; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; increased jerking movements; leg or foot swelling; seeing or hearing strange things (hallucinations); severe dizziness or lightheadedness; trouble breathing; unusual weakness; unusually slow, fast, or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Pergolide Mesylate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include agitation; fast or irregular heartbeat; hallucinations; nausea; seizures; tingling or uncontrolled movement of the arms and legs; unusual dizziness or fainting; vomiting

Proper storage of Pergolide Mesylate:

Store Pergolide Mesylate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pergolide Mesylate out of the reach of children and away from pets.

General information:

• If you have any questions about Pergolide Mesylate, please talk with your doctor, pharmacist, or other health care provider.


• Pergolide Mesylate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pergolide Mesylate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• Pergolide Mesylate Side Effects (in more detail)
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• 0 Reviews for Pergolide Mesylate - Add your own review/rating

• Pergolide Mesylate Monograph (AHFS DI)


• Pergolide Prescribing Information (FDA)


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• pergolide Advanced Consumer (Micromedex) - Includes Dosage Information


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