Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1400
Predicate | Object |
---|---|
rdf:type | |
rdfs:label |
TIMENTIN (Injection, Powder, For Solution)
|
dailymed-instance:dosage |
TIMENTIN should be
administered by intravenous infusion (30 min.).<br/>Adults: The usual recommended dosage for systemic and urinary tract
infections for average (60 kg) adults is 3.1 grams of TIMENTIN (3.1-gram
vial containing 3 grams ticarcillin and 100 mg clavulanic acid)
given every 4 to 6 hours. For gynecologic infections, TIMENTINshould be administered as follows: Moderate
infections 200 mg/kg/day in divided doses every 6 hours and for
severe infections 300 mg/kg/day in divided doses every 4 hours. For patients
weighing less than 60 kg, the recommended dosage is 200 to 300 mg/kg/day,
based on ticarcillin content, given in divided doses every 4 to 6 hours.<br/>Pediatric Patients���(3 months):<br/>For patients<60 kg: In patients<60 kg, TIMENTINis dosed at 50 mg/kg/dose based on the ticarcillin component.
TIMENTINshould be administered as follows:
Mild to moderate infections, 200 mg/kg/day in divided doses every 6 hours;
for severe infections, 300 mg/kg/day in divided doses every 4 hours.<br/>For patients���60 kg: For mild to moderate infections, 3.1 grams of TIMENTIN
(3 grams of ticarcillin and 100 mg of clavulanic acid) administered
every 6 hours; for severe infections, 3.1 grams every 4 hours.<br/>Renal Impairment: For infections complicated by renal insufficiency,
an initial loading dose of 3.1 grams should be followed by doses based
on creatinine clearance and type of dialysis as indicated below: NOTE: TIMENTIN in
the ADD-VANTAGE system should only be administered for 3.1-gram
dosing. The
half-life of ticarcillin in patients with renal failure is approximately 13 hours. Dosage
for any individual patient must take into consideration the site and severity
of infection, the susceptibility of the organisms causing infection, and the
status of the patient's host defense mechanisms. The
duration of therapy depends upon the severity of infection. Generally, TIMENTIN
should be continued for at least 2 days after the signs and symptoms
of infection have disappeared. The usual duration is 10 to 14 days; however,
in difficult and complicated infections, more prolonged therapy may be required. Frequent
bacteriologic and clinical appraisals are necessary during therapy of chronic
urinary tract infection and may be required for several months after therapy
has been completed. Persistent infections may require treatment for several
weeks, and doses smaller than those indicated above should not be used. In
certain infections, involving abscess formation, appropriate surgical drainage
should be performed in conjunction with antimicrobial therapy. INSTRUCTIONS FOR USE<br/>To Open Diluent Container: Peel overwrap at corner and remove
solution container. Some opacity of the plastic due to moisture absorption
during the sterilization process may be observed. This
is normal and does not affect the solution quality or safety. The opacity
will diminish gradually.<br/>To Assemble Vial and Flexible Diluent Container: (Use
Aseptic Technique): NOTE: Do not access
vial with syringe. NOTE: Once vial is sealed,
do not attempt to remove (see Figure 4). To Reconstitute the Drug: Preparation for Administration: (Use Aseptic
Technique): WARNING: Do not use
flexible container in series connections.
|
dailymed-instance:descripti... |
TIMENTIN is a sterile
injectable antibacterial combination consisting of the semisynthetic antibiotic
ticarcillin disodium, and the��-lactamase inhibitor clavulanate potassium
(the potassium salt of clavulanic acid) for intravenous administration. Ticarcillin
is derived from the basic penicillin nucleus, 6-amino-penicillanic acid. Chemically,
ticarcillin disodium is N-(2-Carboxy-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-6-yl)-3-thiophenemalonamic
acid disodium salt and may be represented as: Clavulanic
acid is produced by the fermentation of Streptomyces
clavuligerus. It is a��-lactam structurally related to the
penicillins and possesses the ability to inactivate a wide variety of��-lactamases
by blocking the active sites of these enzymes. Clavulanic acid is particularly
active against the clinically important plasmid-mediated��-lactamases
frequently responsible for transferred drug resistance to penicillins and
cephalosporins. 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: TIMENTIN is supplied as a white to pale yellow
powder for reconstitution. TIMENTIN is very soluble in water, its solubility
being greater than 600 mg/mL. The reconstituted solution is clear, colorless
or pale yellow, having a pH of 5.5 to 7.5. For the
3.1-gram dosage of TIMENTIN, the theoretical sodium content is 4.51 mEq
(103.6 mg) per gram of TIMENTIN. The theoretical potassium content is
0.15 mEq (6 mg) per gram of TIMENTIN.
|
dailymed-instance:clinicalP... |
After an intravenous infusion (30 min.) of 3.1 grams
of TIMENTIN, peak serum concentrations of both ticarcillin and clavulanic
acid are attained immediately after completion of infusion. Ticarcillin serum
levels are similar to those produced by the administration of equivalent amounts
of ticarcillin alone with a mean peak serum level of 330 mcg/mL. The
corresponding mean peak serum level for clavulanic acid was 8 mcg/mL.
(See following table.) SERUM LEVELS IN ADULTS AFTER
A 30-MINUTE IV INFUSION OF TIMENTIN TICARCILLIN
SERUM LEVELS (mcg/mL) CLAVULANIC ACID SERUM LEVELS (mcg/mL) The mean area under the serum concentration curve was
485 mcg���hr/mL for ticarcillin and 8.2 mcg���hr/mL for
clavulanic acid. The mean serum half-lives of ticarcillin
and clavulanic acid in healthy volunteers are 1.1 hours and 1.1 hours,
respectively. In pediatric patients receiving approximately
50 mg/kg of TIMENTIN (30:1 ratio ticarcillin to clavulanate), mean ticarcillin
serum half-lives were 4.4 hours in neonates (n = 18) and 1.0 hour
in infants and children (n = 41). The corresponding clavulanate
serum half-lives averaged 1.9 hours in neonates (n = 14) and
0.9 hour in infants and children (n = 40). Area under the serum
concentration time curves averaged 339 mcg���hr/mL in infants and
children (n = 41), whereas the corresponding mean clavulanate area
under the serum concentration time curves was approximately 7 mcg���hr/mL
in the same population (n = 40). Approximately
60% to 70% of ticarcillin and approximately 35% to 45% of clavulanic acid
are excreted unchanged in urine during the first 6 hours after administration
of a single dose of TIMENTIN to normal volunteers with normal renal function.
Two hours after an intravenous injection of 3.1 grams of TIMENTIN, concentrations
of ticarcillin in urine generally exceed 1,500 mcg/mL. The corresponding
concentrations of clavulanic acid in urine generally exceed 40 mcg/mL.
By 4 to 6 hours after injection, the urine concentrations of ticarcillin
and clavulanic acid usually decline to approximately 190 mcg/mL and 2 mcg/mL,
respectively. Neither component of TIMENTIN is highly protein bound; ticarcillin
has been found to be approximately 45% bound to human serum protein and clavulanic
acid approximately 25% bound. Somewhat higher and more
prolonged serum levels of ticarcillin can be achieved with the concurrent
administration of probenecid; however, probenecid does not enhance the serum
levels of clavulanic acid. Ticarcillin can be detected
in tissues and interstitial fluid following parenteral administration. Penetration
of ticarcillin into bile and pleural fluid has been demonstrated. The results
of experiments involving the administration of clavulanic acid to animals
suggest that this compound, like ticarcillin, is well distributed in body
tissues. An inverse relationship exists between the
serum half-life of ticarcillin and creatinine clearance. The dosage of TIMENTIN
need only be adjusted in cases of severe renal impairment. (See DOSAGE AND
ADMINISTRATION.) Ticarcillin may be removed from patients
undergoing dialysis; the actual amount removed depends on the duration and
type of dialysis.<br/>Microbiology: Ticarcillin is a semisynthetic antibiotic with a broad spectrum
of bactericidal activity against many gram-positive and gram-negative aerobic
and anaerobic bacteria. Ticarcillin is, however, susceptible
to degradation by��-lactamases, and therefore, the spectrum of activity
does not normally include organisms which produce these enzymes. Clavulanic
acid is a��-lactam, structurally related to the penicillins, which possesses
the ability to inactivate a wide range of��-lactamase enzymes commonly
found in microorganisms resistant to penicillins and cephalosporins. In particular,
it has good activity against the clinically important plasmid-mediated��-lactamases
frequently responsible for transferred drug resistance. The
formulation of ticarcillin with clavulanic acid in TIMENTIN protects ticarcillin
from degradation by��-lactamase enzymes and effectively extends the
antibiotic spectrum of ticarcillin to include many bacteria normally resistant
to ticarcillin and other��-lactam antibiotics. Thus, TIMENTIN possesses
the distinctive properties of a broad-spectrum antibiotic and a��-lactamase
inhibitor. Ticarcillin/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 the INDICATIONS AND USAGE section.<br/>Gram-Positive Aerobes: Staphylococcus
aureus (��-lactamase and non�����-lactamase���producing) Staphylococcus epidermidis (��-lactamase
and non�����-lactamase���producing) *Staphylococci
that are resistant to methicillin/oxacillin must be considered resistant to
ticarcillin/clavulanic acid.<br/>Gram-Negative Aerobes: Citrobacter species (��-lactamase and non�����-lactamase���producing) Enterobacter species including E.
cloacae (��-lactamase and non�����-lactamase���producing) (Although
most strains of Enterobacter species
are resistant in vitro, clinical efficacy has been demonstrated with TIMENTIN
in urinary tract infections and gynecologic infections caused by these organisms.) Escherichia coli (��-lactamase and non�����-lactamase���producing) Haemophilus influenzae (��-lactamase and
non�����-lactamase���producing) Klebsiella species including K.
pneumoniae (��-lactamase and non�����-lactamase���producing) Pseudomonas species including P.
aeruginosa (��-lactamase and non�����-lactamase���producing) Serratia marcescens (��-lactamase and non�����-lactamase���producing) ��-lactamase���negative,
ampicillin-resistant (BLNAR) strains of H. influenzae must be considered resistant to ticarcillin/clavulanic acid.<br/>Anaerobic Bacteria: Bacteroides
fragilis group (��-lactamase and non�����-lactamase���producing) Prevotella (formerly Bacteroides) melaninogenicus (��-lactamase
and non�����-lactamase���producing) The
following in vitro data are available, but
their clinical significance is unknown. The
following strains exhibit an in vitro minimum inhibitory concentration (MIC)
less than or equal to the susceptible breakpoint for ticarcillin/clavulanic
acid. However, with the exception of organisms shown to respond to ticarcillin
alone, the safety and effectiveness of ticarcillin/clavulanic acid in treating
infections due to these microorganisms have not been established in adequate
and well-controlled clinical trials.<br/>Gram-Positive Aerobes: Staphylococcus
saprophyticus (��-lactamase and non�����-lactamase���producing) Streptococcus
agalactiae(Group B) Streptococcus bovis Streptococcus pneumoniae(penicillin-susceptible
strains only) Streptococcus pyogenes Viridans
group streptococci<br/>Gram-Negative Aerobes: Acinetobacter
baumannii (��-lactamase and non�����-lactamase���producing) Acinetobacter calcoaceticus (��-lactamase
and non�����-lactamase���producing) Acinetobacter haemolyticus (��-lactamase
and non�����-lactamase���producing) Acinetobacter lwoffi (��-lactamase and
non�����-lactamase���producing) Moraxella catarrhalis (��-lactamase and
non�����-lactamase���producing) Morganella morganii (��-lactamase and non�����-lactamase���producing) Neisseria gonorrhoeae (��-lactamase and
non�����-lactamase���producing) Pasteurella multocida (��-lactamase and
non�����-lactamase���producing) Proteus mirabilis (��-lactamase and non�����-lactamase���producing) Proteus penneri (��-lactamase and non�����-lactamase���producing) Proteus vulgaris (��-lactamase and non�����-lactamase���producing) Providencia rettgeri (��-lactamase and
non�����-lactamase���producing) Providencia stuartii (��-lactamase and
non�����-lactamase���producing) Stenotrophomonas maltophilia (��-lactamase
and non�����-lactamase���producing)<br/>Anaerobic Bacteria: Clostridium species including C. perfringens, C. difficile, C. sporogenes, C.
ramosum, and C. bifermentans (��-lactamase
and non�����-lactamase���producing) Eubacterium species Fusobacterium species including F.
nucleatum and F. necrophorum (��-lactamase
and non�����-lactamase���producing) Peptostreptococcus species Veillonella species These
are non�����-lactamase���producing strains, and therefore,
are susceptible to ticarcillin. In vitrosynergism between
TIMENTIN and gentamicin, tobramycin, or amikacin against multiresistant strains
of Pseudomonas aeruginosa has been
demonstrated.<br/>Susceptibility Testing:<br/>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 method(broth or agar) or equivalent with
standardized inoculum concentrations and standardized concentrations of ticarcillin/clavulanate
potassium powder. The recommended dilution pattern
utilizes a constant level of 2 mcg/mL clavulanic acid in all tubes with
varying amounts of ticarcillin. MICs are expressed in terms of the ticarcillin
concentration in the presence of clavulanic acid at a constant 2 mcg/mL.
The MIC values should be interpreted according to the following criteria: RECOMMENDED
RANGES FOR TICARCILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING For Pseudomonas aeruginosa: For Enterobacteriaceae: For Staphylococci: Expressed as concentration
of ticarcillin in the presence of clavulanic acid at a constant 2 mcg/mL. Staphylococci that are susceptible
to ticarcillin/clavulanic acid but resistant to methicillin/oxacillin must
be considered as resistant. A report of���Susceptible���indicates that the pathogen is likely to be inhibited if the antimicrobial
compound in the blood reaches the concentrations 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 fromcausing 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 ticarcillin/clavulanate
potassium powder should provide the following MIC values: Expressed as concentration
of ticarcillin in the presence of clavulanic acid at a constant 2 mcg/mL.<br/>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 procedurerequires the use
of standardized inoculum concentrations. This procedure uses paper disks impregnated
with 85 mcg of ticarcillin/clavulanate potassium (75 mcg ticarcillin
plus 10 mcg clavulanate potassium) to test the susceptibility of microorganisms
to ticarcillin/clavulanic acid. Reports from the laboratory
providing results of the standard single-disk susceptibility test with an
85 mcg of ticarcillin/clavulanate potassium (75 mcg ticarcillin
plus 10 mcg clavulanate potassium) disk should be interpreted according
to the following criteria: RECOMMENDED RANGES FOR TICARCILLIN/CLAVULANIC
ACID SUSCEPTIBILITY TESTING For Pseudomonas
aeruginosa: For Enterobacteriaceae: For Staphylococci: Staphylococci that are resistant to methicillin/oxacillin must be
considered as resistant to ticarcillin/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 ticarcillin/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 85 mcg of ticarcillin/clavulanate
potassium (75 mcg ticarcillin plus 10 mcg clavulanate potassium)
disk should provide the following zone diameters in these laboratory test
quality control strains:<br/>Anaerobic Techniques: For anaerobic
bacteria, the susceptibility to ticarcillin/clavulanic acid can be determined
by standardized test methods.The MIC values obtained should
be interpreted according to the following criteria: RECOMMENDED
RANGES FOR TICARCILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING Expressed as concentration
of ticarcillin in the presence of clavulanic acid at a constant 2 mcg/mL. Interpretation
is identical to that stated above for results using dilution techniques. As
with other susceptibility techniques, the use of laboratory control microorganisms
is required to control the technical aspects of the laboratory standardized
procedures. Standardized ticarcillin/clavulanate potassium powder should provide
the following MIC values: Expressed as concentration
of ticarcillin in the presence of clavulanic acid at a constant 2 mcg/mL.
|
dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
TIMENTIN is contraindicated
in patients with a history of hypersensitivity reactions to any of the penicillins.
|
dailymed-instance:supply |
Each 3.1-gram vial of TIMENTIN contains sterile ticarcillin
disodium equivalent to 3 grams ticarcillin and sterile clavulanate potassium
equivalent to 0.1 gram clavulanic acid. NDC 0029-6571-40
3.1-gram ADD-VANTAGEAntibiotic Vial TIMENTIN
is also supplied as: NDC 0029-6571-26 3.1-gram Vial Each
31-gram Pharmacy Bulk Package contains sterile ticarcillin disodium equivalent
to 30 grams ticarcillin and sterile clavulanate potassium equivalent
to 1 gram clavulanic acid. NDC 0029-6579-21 31-gram
Pharmacy Bulk Package TIMENTIN should be stored at or below 24��C (75��F). NDC
0029-6571-31 TIMENTINas an iso-osmotic,
sterile, nonpyrogenic, frozen solution in GALAXY(PL 2040)
Plastic Containers���supplied in 100-mL single-dose containers equivalent
to 3 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram
clavulanic acid.
|
dailymed-instance:activeMoi... | |
dailymed-instance:precautio... |
General: While TIMENTINpossesses
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. Bleeding
manifestations have occurred in some patients receiving��-lactam antibiotics.
These reactions have been associated with abnormalities of coagulation tests
such as clotting time, platelet aggregation, and prothrombin time and are
more likely to occur in patients with renal impairment. If bleeding manifestations
appear, treatment with TIMENTIN should be discontinued and appropriate therapy
instituted. TIMENTIN
has only rarely been reported to cause hypokalemia; however, the possibility
of this occurring should be kept in mind particularly when treating patients
with fluid and electrolyte imbalance. Periodic monitoring of serum potassium
may be advisable in patients receiving prolonged therapy. The
theoretical sodium content is 4.51 mEq (103.6 mg) per gram of TIMENTIN.
This should be considered when treating patients requiring restricted salt
intake. As with any penicillin, an allergic reaction,
including anaphylaxis, may occur during administration of TIMENTIN, particularly
in a hypersensitive individual. The possibility of
superinfections with mycotic or bacterial pathogens should be kept in mind,
particularly during prolonged treatment. If superinfections occur, appropriate
measures should be taken. Prescribing TIMENTIN 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.<br/>Information for Patients: Patients should be counseled
that antibacterial drugs, including TIMENTIN, should only be used to treat
bacterial infections. They do not treat viral infections (e.g., the common
cold). When TIMENTIN 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 TIMENTIN or other antibacterial
drugs in the future.<br/>Drug/Laboratory Test Interactions: As with other penicillins, the mixing of TIMENTIN with an
aminoglycoside in solutions for parenteral administration can result in substantial
inactivation of the aminoglycoside. Probenecid interferes
with the renal tubular secretion of ticarcillin, thereby increasing serum
concentrations and prolonging serum half-life of the antibiotic. High
urine concentrations of ticarcillin may produce false-positive protein reactions
(pseudoproteinuria) with the following methods: Sulfosalicylic acid and boiling
test, acetic acid test, biuret reaction and nitric acid test. The bromphenol
blue (MULTI-STIX) reagent strip test has been reported to
be reliable. The presence of clavulanic acid in TIMENTIN
may cause a nonspecific binding of IgG and albumin by red cell membranes,
leading to a false-positive Coombs test.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to
evaluate carcinogenic potential. However, results from assays for gene mutation
in vitro using bacteria (Ames tests) and yeast, and for chromosomal effects
in vitroin human lymphocytes, and in
vivo in mouse bone marrow (micronucleus test) indicate that TIMENTIN is without
any mutagenic potential.<br/>Pregnancy (Category B): Reproduction studies have been performed in rats given doses
up to 1,050 mg/kg/day and have revealed no evidence of impaired fertility
or harm to the fetus due to TIMENTIN. 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.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when TIMENTIN is administered to a nursing woman.<br/>Pediatric Use: The safety and effectiveness of TIMENTIN have been established
in the age group of 3 months to 16 years. Use of TIMENTIN in these
age groups is supported by evidence from adequate and well-controlled studies
of TIMENTIN in adults with additional efficacy, safety, and pharmacokinetic
data from both comparative and non-comparative studies in pediatric patients.
There are insufficient data to support the use of TIMENTIN in pediatric patients
under 3 months of age or for the treatment of septicemia and/or infections
in the pediatric population where the suspected or proven pathogen is H. influenzae type b. In those patients in whom meningeal seeding from a distant
infection site or in whom meningitis is suspected or documented, or in patients
who require prophylaxis against central nervous system infection, an alternate
agent with demonstrated clinical efficacy in this setting should be used.
|
dailymed-instance:overdosag... |
As with other penicillins, neurotoxic reactions may arise
when very high doses of TIMENTIN are administered, especially in patients
with impaired renal function. (See WARNINGS and ADVERSE REACTIONS-Central
Nervous System.) In case of overdosage, discontinue
TIMENTIN, treat symptomatically, and institute supportive measures as required.
Ticarcillin may be removed from circulation by hemodialysis. The molecularweight, degree of protein binding, and pharmacokinetic profile of clavulanic
acid, together with information from a single patient with renal insufficiency
all suggest that this compound may also be removed by hemodialysis.
|
dailymed-instance:genericMe... |
ticarcillin disodium and clavulanate potassium
|
dailymed-instance:fullName |
TIMENTIN (Injection, Powder, For Solution)
|
dailymed-instance:adverseRe... |
As with other penicillins, the following adverse reactions
may occur:<br/>Hypersensitivity Reactions: Skin rash, pruritus, urticaria, arthralgia, myalgia, drug
fever, chills, chest discomfort, erythema multiforme, toxic epidermal necrolysis,
Stevens-Johnson syndrome, and anaphylactic reactions.<br/>Central Nervous System: Headache, giddiness, neuromuscular hyperirritability, or
convulsive seizures.<br/>Gastrointestinal Disturbances: Disturbances of taste and smell, stomatitis, flatulence,
nausea, vomiting and diarrhea, epigastric pain, and pseudomembranous colitis
have been reported. Onset of pseudomembranous colitis symptoms may occur during
or after antibiotic treatment. (See WARNINGS.)<br/>Hemic and Lymphatic Systems: Thrombocytopenia, leukopenia, neutropenia, eosinophilia,
reduction of hemoglobin or hematocrit, and prolongation of prothrombin time
and bleeding time.<br/>Abnormalities of Hepatic and Renal Function Tests: Elevation of serum aspartate aminotransferase (SGOT), serum
alanine aminotransferase (SGPT), serum alkaline phosphatase, serum LDH, serum
bilirubin. There have been reports of transient hepatitis and cholestatic
jaundice���as with some other penicillins and some cephalosporins. Elevation
of serum creatinine and/or BUN, hypernatremia, reduction in serum potassium
and uric acid.<br/>Local Reactions: Pain, burning, swelling, and induration at the injection
site and thrombophlebitis with intravenous administration. Available
safety data for pediatric patients treated with TIMENTIN demonstrate a similar
adverse event profile to that observed in adult patients.
|
dailymed-instance:warning |
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 TIMENTIN CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC
REACTION OCCURS, TIMENTIN 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 PROVIDED AS INDICATED. Pseudomembranous
colitis has been reported with nearly all antibacterial agents, including
TIMENTIN, and may range in severity from mild to life-threatening. Therefore,
it is important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents. Treatment
with antibacterial agents alters the normal flora of the colon and may permit
overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of���antibiotic-associated colitis.��� After
the diagnosis of pseudomembranous colitis has been established, appropriate
therapeutic measures should be initiated. Mild cases of pseudomembranous colitis
usually respond to drug discontinuation alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against C. difficile colitis. When
very high doses of TIMENTINare administered,
especially in the presence of impaired renal function, patients may experience
convulsions. (See ADVERSE REACTIONS and OVERDOSAGE.)
|
dailymed-instance:indicatio... |
TIMENTIN is indicated in the treatment of infections caused
by susceptible strains of the designated microorganisms in the conditions
listed below: Septicemia(including bacteremia) caused by��-lactamase���producing
strains of Klebsiella spp., E. coli, S.
aureus, or P. aeruginosa(or other Pseudomonas species) Lower
Respiratory Infections caused by��-lactamase���producing
strains of S. aureus, H. influenzae, or Klebsiella spp. Bone and Joint Infections caused by��-lactamase���producing
strains of S. aureus Skin and Skin Structure Infections caused by��-lactamase���producing
strains of S. aureus, Klebsiella spp., or E. coli Urinary Tract Infections (complicated and uncomplicated)
caused by��-lactamase���producing strains of E. coli, Klebsiella spp., P. aeruginosa(or other Pseudomonas spp.), Citrobacter spp., Enterobacter cloacae, S. marcescens,
or S. aureus Gynecologic Infections endometritis caused by��-lactamase���producing
strains of P. melaninogenicus, Enterobacter spp. (including E.
cloacae), E. coli, K. pneumoniae, S. aureus, or S. epidermidis Intra-abdominal Infections peritonitis caused by��-lactamase���producing strains of E.
coli, K. pneumoniae, or B. fragilisgroup Efficacy
for this organism in this organ system was studied in fewer than 10 infections. NOTE: For information on use in pediatric patients (���3 months
of age) see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. There
are insufficient data to support the use of TIMENTIN in pediatric patients
under 3 months of age or for the treatment of septicemia and/or infections
in the pediatric population where the suspected or proven pathogen is H. influenzae type
b. While TIMENTIN is indicated only for the
conditions listed above, infections caused by ticarcillin-susceptible organisms
are also amenable to treatment with TIMENTIN due to its ticarcillin content.
Therefore, mixed infections caused by ticarcillin-susceptible organisms and��-lactamase���producing organisms susceptible to ticarcillin/clavulanic
acid should not require the addition of another antibiotic. Appropriate
culture and susceptibility tests should be performed before treatment in order
to isolate and identify organisms causing infection and to determine their
susceptibility to ticarcillin/clavulanic acid. Because of its broad spectrum
of bactericidal activity against gram-positive and gram-negative bacteria,
TIMENTIN is particularly useful for the treatment of mixed infections and
for presumptive therapy prior to the identification of the causative organisms.
TIMENTIN has been shown to be effective as single drug therapy in the treatment
of some serious infections where normally combination antibiotic therapy might
be employed. Therapy with TIMENTIN may be initiated before results of such
tests are known when there is reason to believe the infection may involve
any of the��-lactamase���producing organisms listed above. Based
on the in vitro synergism between ticarcillin/clavulanic acid and aminoglycosides
against certain strains of P. aeruginosa,
combined therapy has been successful, especially in patients with impaired
host defenses. Both drugs should be used in full therapeutic doses. To
reduce the development of drug-resistant bacteria and maintain the effectiveness
of TIMENTIN and other antibacterial drugs, TIMENTIN 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 theempiric selection of therapy.
|
dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
TIMENTIN
|