Timentin Injection
Name: Timentin Injection
- Timentin Injection drug
- Timentin Injection injection
- Timentin Injection dosage
- Timentin Injection 100 mg
- Timentin Injection used to treat
Warnings and Precautions
Anaphylactic Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with TIMENTIN, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue TIMENTIN and institute appropriate therapy.
Clostridium difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TIMENTIN, 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 antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Convulsions
Patients may experience convulsions when the dose of TIMENTIN exceeds the recommended dose, especially in the presence of impaired renal function [see Adverse Reactions (6.2), Overdosage (10)].
Risk of Bleeding
Some patients receiving β-lactam antibacterials have experienced bleeding associated with abnormalities in coagulation tests. These adverse reactions are more likely to occur in patients with renal impairment. If bleeding manifestations appear, treatment with TIMENTIN should be discontinued and appropriate therapy instituted.
Potential for Microbial Overgrowth or Bacterial Resistance
The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfections occur, appropriate measures should be taken.
Development of Drug-Resistant Bacteria
Prescribing TIMENTIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug‑resistant bacteria.
Interference with Laboratory Tests
High urine concentrations of ticarcillin may produce false-positive protein reactions (pseudoproteinuria) [see Drug Interactions (7.4)].
Clavulanic acid may cause a nonspecific binding of IgG and albumin by red cell membranes, leading to a false-positive Coombs test [see Drug Interactions (7.4)].
Electrolyte Imbalance
Hypokalemia has been reported during treatment with TIMENTIN. Serum potassium should be monitored in patients with fluid and electrolyte imbalance and 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.
Adverse Reactions
The following are discussed in more detail in other sections of the labeling:
• Anaphylactic Reactions [see Warnings and Precautions (5.1)] • Clostridium difficile Associated Diarrhea [see Warnings and Precautions (5.2)]Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring in ≥1% of 867 patients receiving TIMENTIN 3.1 grams in clinical studies included rash, nausea, diarrhea, and phlebitis at the injection site. The most common laboratory abnormalities (≥3%) were elevations in eosinophils, serum aspartate aminotransferase (AST), and serum alanine aminotransferase (ALT).
Available safety data for pediatric patients treated with TIMENTIN demonstrate a similar adverse event profile to that observed in adult patients.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use of TIMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These adverse reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to TIMENTIN.
Hypersensitivity Reactions: Skin rash, pruritus, urticaria, arthralgia, myalgia, drug fever, chills, chest discomfort, anaphylactic reactions, and bullous reactions (including erythema multiforme, toxic epidermal necrolysis, and Stevens‑Johnson syndrome).
Central Nervous System: Headache, giddiness, neuromuscular hyperirritability, or convulsive seizures.
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 antibacterial treatment [see Warnings and Precautions (5.2)].
Hemic and Lymphatic Systems: Thrombocytopenia, leukopenia, neutropenia, eosinophilia, reduction of hemoglobin or hematocrit, and prolongation of prothrombin time and bleeding time.
Abnormalities of Hepatic Function Tests: Elevation of AST, ALT, serum alkaline phosphatase, serum LDH, and serum bilirubin. There have been reports of transient hepatitis and cholestatic jaundice, as with some other penicillins and some cephalosporins.
Renal and Urinary Effects: Hemorrhagic cystitis, elevation of serum creatinine and/or BUN, hypernatremia, reduction in serum potassium, and uric acid.
Local Reactions: Pain, burning, swelling, and induration at the injection site and thrombophlebitis with intravenous administration.
Drug Interactions
Aminoglycosides
The mixing of TIMENTIN with an aminoglycoside in solutions for parenteral administration can result in substantial inactivation of the aminoglycoside.
Probenecid
Probenecid interferes with the renal tubular secretion of ticarcillin, thereby increasing serum concentrations and prolonging serum half‑life of ticarcillin. Probenecid does not affect the serum levels of clavulanic acid.
Oral Contraceptives
Ticarcillin disodium/clavulanate potassium may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Effects on Laboratory Tests
High urine concentrations of ticarcillin may produce false‑positive protein reactions (pseudoproteinuria) with certain methods. The bromphenol blue reagent strip test has been reported to be a reliable method for testing protein reactions [see Warnings and Precautions (5.7)].
Clavulanic acid in TIMENTIN may cause a nonspecific binding of IgG and albumin by red cell membranes, leading to a false‑positive Coombs test. A positive Coombs test should be interpreted with caution during treatment with TIMENTIN [see Warnings and Precautions (5.7)].
Use in specific populations
Pregnancy
Pregnancy Category B.
Reproduction studies have been performed in rats given doses up to 1,050 mg/kg/day (approximately half of the recommended human dose based on body surface area) and have revealed no evidence of 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.
Nursing Mothers
It is not known whether ticarcillin or clavulanic acid 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.
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.
If meningitis is suspected or documented, an alternative agent with demonstrated clinical efficacy in this setting should be used.
Geriatric Use
An analysis of clinical studies of TIMENTIN was conducted to determine whether subjects aged 65 and older respond differently from younger subjects. Of the 1,078 subjects treated with at least one dose of TIMENTIN, 67.5% were <65 years old, and 32.5% were ≥65 years old. No overall differences in safety or efficacy were observed between older and younger subjects, and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.3)].
TIMENTIN contains 103.6 mg (4.51 mEq) of sodium per gram of TIMENTIN. At the usual recommended doses, patients would receive between 1,285 and 1,927 mg/day (56 and 84 mEq) of sodium. The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically important with regard to such diseases as congestive heart failure.
Renal Impairment
Ticarcillin is predominantly excreted by the kidney [see Clinical Pharmacology (12.3)]. Dosage adjustments should be made for patients with renal impairment [see Dosage and Administration (2.3)].
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long‑term studies in animals have not been performed to evaluate carcinogenic potential. Results from in vitro assays in bacteria (Ames tests), yeast, and human lymphocytes, and in vivo in mouse bone marrow (micronucleus test) indicate TIMENTIN is without genotoxic potential.
Reproduction studies have been performed in rats given doses up to 1,050 mg/kg/day (approximately half of the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility due to TIMENTIN.
References
How Supplied/Storage and Handling
Each 3.1‑gram vial of TIMENTIN for Injection contains sterile ticarcillin disodium equivalent to 3 grams ticarcillin and sterile clavulanate potassium equivalent to 0.1 gram clavulanic acid.
| NDC 0029-6571-26 | 3.1‑gram Vial |
Each 31‑gram Pharmacy Bulk Package of TIMENTIN for Injection 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 |
Each 100‑mL single-dose GALAXY Container (PL 2040 Plastic) of Timentin Injection contains ticarcillin disodium equivalent to 3.0 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram clavulanic acid.
| NDC 0029-6575-31 | 100 mL GALAXY Container (PL 2040 Plastic) |
3.1-gram Vials and 31-gram Pharmacy Bulk Packages of TIMENTIN for Injection should be stored at or below 25°C (77°F).
GALAXY Containers (PL 2040 Plastic) of Timentin Injection should be stored at or below -20°C (-4°F). Avoid unnecessary handling of containers.
Thawing of Plastic Containers: Thaw frozen container at room temperature 22°C (72°F) or in a refrigerator 4°C (39°F). [Do not force thaw by immersion in water baths or by microwave irradiation.] Check for minute leaks by squeezing container firmly. If leaks are detected discard solution as sterility may be impaired. Do not add supplementary medication.
The container should be visually inspected. Thawed solutions should not be used unless clear; solutions will be light to dark yellow in color. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. If, after visual inspection, the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.
The thawed solution is stable for 24 hours at room temperature 22°C (72°F) or for 7 days under refrigeration 4°C (39°F).
Do not refreeze.
Patient Counseling Information
Drug Resistance: Inform patients 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, inform patients 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.
Clostridium difficile Associated Diarrhea: Inform patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, 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 their last dose of the antibacterial. If this occurs, advise patients to contact their physician as soon as possible.
Allergic Reactions: Inform patients that TIMENTIN contains a penicillin that can cause allergic reactions in some individuals [see Warnings and Precautions (5.1)].
TIMENTIN is a registered trademark of the GSK group of companies.
GALAXY is a registered trademark of Baxter International Inc.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2014, the GSK group of companies. All rights reserved.
TMN:25PI
Principal Display Panel
NDC 0029-6571-26
TIMENTIN®
STERILE TICARCILLIN DISODIUM AND CLAVULANATE POTASSIUM
3.1 grams
Equivalent to TICARCILLIN, 3 GRAMS, CLAVULANIC ACID, 100 MG INJECTION
Rx only
Intravenous Infusion
Store dry powder at room temperature 21o to 25oC (70o – 77oF) or below.
Vial contains sterile ticarcillin disodium equivalent to 3 grams ticarcillin, and sterile clavulanate potassium equivalent to 100 mg clavulanic acid.
Dosage: See accompanying folder for complete prescribing information.
Directions for use: Reconstitute with approximately 13 mL Sterile Water for Injection, USP. Each mL of solution contains approximately 200 mg ticarcillin and 6.7 mg of clavulanic acid. Store solution for no more than 6 hours at room temperature (70o – 77oF) or 72 hours under refrigeration (40oF). This aqueous solution may be further diluted to 100 mL. Select diluent from I.V. solutions listed in prescribing information. Do not exceed specified storage times.
GlaxoSmithKline
RTP, NC 27709
Made in England. Rev. 10/13
10000000121260
Principal Display Panel
NDC 0029-6579-21
TIMENTIN®
STERILE TICARCILLIN DISODIUM AND CLAVULANATE POTASSIUM
31 grams
Equivalent to TICARCILLIN, 30 GRAMS, CLAVULANIC ACID, 1 GRAM INJECTION
Rx only
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
Intravenous Infusion
Store dry powder at room temperature 21o to 25oC (70o to 77oF) or below.
Store reconstituted stock solution refrigerated 4oC (40oF).
Vial contains sterile ticarcillin disodium equivalent to 30 grams ticarcillin, and sterile clavulanate potassium equivalent to 1 gram clavulanic acid.
Dosage: See accompanying folder for complete prescribing information.
Directions for use: Add 76 mL of a recommended I.V. solution (see prescribing information) and shake well. The solution will contain approximately 300 mg/mL ticarcillin and 10 mg/mL clavulanic acid. Transfer recommended dosage and further dilute to a desired concentration between 10 mg/mL and 100 mg/mL. Aliquoting operations must be completed within four hours of reconstitution. Discard the reconstituted stock solution four hours after initial entry.
GlaxoSmithKline
RTP, NC 27709
Made in England.
Rev. 10/13
10000000121292
Principal Display Panel
NDC 0029-6571-31
TIMENTIN®
TICARCILLIN DISODIUM AND CLAVULANATE POTASSIUM INJECTION
3.1 grams
Rx only
Galaxy
Single-Dose Container
100 mL
Iso-osmotic
Code 2G3545
Sterile, Nonpyrogenic
Each 100 mL contains: ticarcillin disodium equivalent to 3 grams ticarcillin, clavulanate potassium equivalent to 0.1 gram clavulanic acid and 0.3 gram sodium citrate hydrous, USP, added as a buffer. pH adjusted with sodium hydroxide and may have been adjusted with hydrochloric acid. pH 5.5 to 7.5.
Dosage: Intravenously as directed by a physician. See package insert.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Store at or below -20oC (-4oF). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thaw at room temperature 22oC (72oF) or under refrigeration 4oC (39oF). The thawed solution is stable for 24 hours at room temperature or for 7 days under refrigeration. Do not refreeze.
TIMENTIN is a registered trademark of GlaxoSmithKline.
GALAXY is a registered trademark of Baxter International Inc.
Manufactured for GlaxoSmithKline
Research Triangle Park, NC 27709
by Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in England
PL 2040 Plastic
07-34-71-853
Rev. 6/13
10000000117823
| TIMENTIN ticarcillin disodium and clavulanate potassium injection, powder, for solution | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| TIMENTIN ticarcillin disodium and clavulanate potassium injection, powder, for solution | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| TIMENTIN ticarcillin disodium and clavulanate potassium injection, solution | ||||||||||||
| ||||||||||||
| ||||||||||||
| ||||||||||||
| ||||||||||||
| ||||||||||||
| Labeler - GlaxoSmithKline LLC (167380711) |