Ticarcillin / Clavulanate Potassium

Trade Names:
Timentin
- Powder for injection 3 g ticarcillin (as disodium) and 0.1 g clavulanic acid (as potassium) (contains 4.75 mEq sodium and 0.15 mEq potassium/g)
- Injection solution 3 g ticarcillin (as disodium) and 0.1 g clavulanic acid (as potassium) per 100 mL (contains 18.7 mEq sodium and 0.5 mEq potassium per 100 mL)

Pharmacology

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Ticarcillin inhibits bacterial cell wall mucopeptide synthesis. Clavulanate lactamase enzymes commonly found in microorganisms resistant to ticarcillin.

Pharmacokinetics

Absorption

T _max is achieved immediately after completion of the infusion. C _max is 330 mcg/mL (ticarcillin) and 8 to 16 mcg/mL (clavulanic acid). AUC is about 485 mcg•h/mL and about 8.2 mcg•h/mL for ticarcillin and clavulanic acid, respectively.

Distribution

The drugs are not highly protein bound (approximately 45% and 9% for ticarcillin and clavulanic acid, respectively). Ticarcillin/Clavulanate is detected in tissues and interstitial fluid following IV administration. Penetration into bile and pleural fluid has been demonstrated.

Elimination

Serum t _½ is about 1.1 h. Approximately 60% to 70% of ticarcillin and approximately 35% to 45% of clavulanic acid are excreted unchanged in urine during the first 6 h after a single dose.

Special Populations

The dosage of ticarcillin need only be adjusted in severe renal function impairment. The drugs may be removed from patients undergoing dialysis; the actual amount removed depends on the duration and type of dialysis.

Indications and Usage

Treatment of bacterial septicemia, skin and skin structure infections, lower respiratory tract infections, bone and joint infections, GU and gynecologic infections, and intra-abdominal infections caused by susceptible strains of bacteria.

Contraindications

Hypersensitivity to penicillin.

Dosage and Administration

IV 3.1 g every 4 to 6 h.

IV 200 to 300 mg/kg/day (based on ticarcillin component) in divided doses every 4 to 6 h.

IV 200 to 300 mg/kg/day (based on ticarcillin component) in divided doses every 4 to 6 h.

General Advice

• If using regular vial with powder for injection, reconstitute with 13 mL sterile water for injection or sodium chloride injection. Shake well to dissolve powder. Resulting solution contains approximately 200 mg ticarcillin/mL and 6.7 mg clavulanate/mL (each 5 mL of reconstituted solution contains 1 g ticarcillin and 33 mg clavulanate). Further dilute reconstituted solution to final concentration of 10 to 100 mg ticarcillin/mL with sodium chloride injection, dextrose 5% injection, or lactated Ringer's injection.
• Inspect solution visually before administration. Do not administer if solution is cloudy, discolored, or contains particulate matter. The normal color of reconstituted solution is light to dark yellow.
• Administer prescribed dose over 30 min by direct infusion or through a Y-type IV infusion set already in place. If using Y-type IV infusion set, temporarily discontinue administration of any other solution during infusion of ticarcillin and clavulanate potassium.

Storage/Stability

Store powder for injection at or below 75°F. Reconstituted solution is stable for up to 6 h if stored at room temperature (70° to 75°F) or up to 72 h if refrigerated (40°F). IV solution diluted (10 to 100 mg/mL) with lactated Ringer's injection or sodium chloride injection may be stored for up to 24 h at room temperature, up to 4 days if refrigerated, or 30 days if frozen (0°F). IV solution diluted (10 to 100 mg/mL) with dextrose 5% injection may be stored for up to 24 h at room temperature, up to 3 days if refrigerated, or 7 days if frozen. Frozen diluted IV solutions must be used within 8 h of thawing. Do not refreeze thawed solutions. Store premixed, frozen solutions at or below 4°F. Thaw at room temperature (72°F) or in refrigerator (39°F). Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solution is stable for 24 h at room temperature or 7 days if refrigerated. Do not refreeze thawed solutions.

Drug Interactions

May increase bleeding risks of anticoagulant by prolonging bleeding time.

Synergism or antagonism may develop.

May reduce efficacy of oral contraceptives. Use additional form of contraception during ticarcillin/clavulanate therapy.

Synergism or antagonism may develop.

May increase bleeding risks of heparin by prolonging bleeding time.

Serum methotrexate concentrations may be elevated, increasing the risk of toxicity.

May increase ticarcillin levels.

May impair bactericidal effects of ticarcillin/clavulanate.

Incompatibility

May inactivate parenteral aminoglycosides in vitro; do not mix in same IV solution. May be used in combination for synergy. Ticarcillin/clavulanate is incompatible with sodium bicarbonate; not recommended as diluent.

Laboratory Test Interactions

May cause false-positive urine glucose test results with Benedict Solution, Fehling Solution, or Clinitest tablets but not with enzyme-based tests (eg, Clinistix , Tes-tape ); false-positive direct Coombs test in certain patient groups; positive direct antiglobulin tests (DAT); false-positive protein reactions with sulfosalicylic acid and boiling test, acetic acid test, biuret reaction, and nitric acid test but not with bromphenol blue test ( Multi-Stix ).

Adverse Reactions

CNS

Convulsive seizures; giddiness; headache; neuromuscular hyperirritability.

EENT

Disturbed smell.

GI

Diarrhea; disturbed taste; epigastric pain; flatulence; nausea; pseudomembranous colitis; stomatitis; vomiting.

Hematologic-Lymphatic

Eosinophilia; leukopenia; neutropenia; prolonged bleeding or PT; reduced hematocrit or hemoglobin; thrombocytopenia.

Hepatic

Cholestatic jaundice and transient hepatitis.

Hypersensitivity

Hypersensitivity reactions including anaphylactic reactions, chest discomfort, chills, drug fever, erythema multiforme, myalgia, pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria.

Lab Tests

Elevated ALT and AST, serum alkaline phosphatase, serum bilirubin, serum creatinine and or BUN, serum LDH; decreased serum potassium and uric acid; hypernatremia.

Local

Burning; induration at injection site; pain; swelling; thrombophlebitis.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Hypersensitivity

Reactions range from mild to life-threatening. Administer cautiously to cephalosporin-sensitive patients because of possible cross-reactivity.

Renal Function

Dosage and interval adjustments necessary in renal insufficiency.

Superinfection

May result in bacterial or fungal overgrowth of nonsusceptible organisms.

Bleeding abnormalities

Hemorrhagic manifestations associated with abnormalities of coagulation tests (bleeding time, prothrombin time, platelet aggregation) may occur. Abnormalities should revert to normal once drug is discontinued.

Hypokalemia

Ticarcillin has rarely decreased potassium levels.

Pseudomembranous colitis

May occur because of overgrowth of clostridia. Consider possibility in patients with diarrhea.

Sodium content

Powder for injection contains 4.75 mEq Na/g of ticarcillin.

Overdosage

Symptoms

Neuromuscular hyperexcitability, seizures.

Patient Information

• Advise patient or caregiver that medication will be prepared by a health care provider and administered in a health care setting.
• Review dosing schedule and prescribed length of therapy with patient. Advise patient that dose, dosing frequency, and duration of therapy are dependent on site of infection, severity of infection, and response to treatment.
• Advise patient or caregiver to immediately inform health care provider if injection site pain or redness, skin rash, hives, itching, or shortness of breath occur during treatment.
• Advise patient or caregiver to report signs of superinfection to health care provider: black “furry” tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
• Warn patient or caregiver that diarrhea containing blood or pus may be a sign of a serious disorder and, if noted after discharge, to seek medical care if noted and not treat at home.

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