Timentin

Before using ticarcillin/clavulanate, tell your doctor or pharmacist if you are allergic to either of the drugs; or to penicillin, cephalosporin, or beta-lactam antibiotics; or to other beta-lactamase inhibitors such as sulbactam; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, cystic fibrosis, kidney disease, seizures, severe loss of body water/minerals (dehydration).This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (e.g., congestive heart failure, high blood pressure).Before having surgery, tell your doctor or dentist that you are using this medication.Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug, especially salt retention.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Consult the package instructions or your pharmacist for other storage details. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Reviewed on 4/16/2014 References

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ticarcillin and clavulanate potassium and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Other drugs may interact with ticarcillin and clavulanate potassium, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Absorption

Bioavailability

Ticarcillin not appreciably absorbed from GI tract2 4 7 and must be administered parenterally.1

Concomitant administration of clavulanate potassium does not affect the pharmacokinetics of ticarcillin;1 not known whether ticarcillin affects the pharmacokinetics of clavulanate potassium.67

Distribution

Extent

Both ticarcillin and clavulanate are distributed into blister fluid, peritoneal fluid,3 and bone.3

Only low ticarcillin concentrations attained in CSF.3 4 7 26 29

Like other penicillins, ticarcillin probably crosses the placenta and is distributed into milk in low concentrations.7 Clavulanic acid readily crosses the placenta138 and is distributed into milk in low concentrations.63

Plasma Protein Binding

Ticarcillin is 45–65% bound to serum proteins.1 2 4 7 27 1 Clavulanate is 22–30% bound to serum proteins.19 56 83

Elimination

Metabolism

Metabolic fate of clavulanate has not been fully elucidated; the drug appears to be extensively metabolized.139 60

Elimination Route

Clavulanic acid is eliminated in urine principally by glomerular filtration.56 59 60 1

Approximately 60–70% of a ticarcillin dose and 35–45% of a clavulanate dose is eliminated unchanged in urine within 6 hours.1

Half-life

In adults with normal renal function, ticarcillin has a distribution half-life of 0.27 hours67 and an elimination half-life of 1.1–1.2 hours1 67 and clavulanic acid has a distribution half-life of 0.42 hours67 and an elimination half-life of 1.1–1.5 hours.1 67

Special Populations

Serum concentrations of ticarcillin and of clavulanic acid are higher and the serum half-lives prolonged in patients with renal impairment.1 In patients with impaired renal function, the elimination half-life of ticarcillin and of clavulanic acid averaged 4.9 and 2.3 hours, respectively, in those with Clcr 11–37 mL/minute and averaged 8.5 and 2.9 hours, respectively, in those with Clcr <8 mL/minute.a

• Advise patients that antibacterials (including ticarcillin and clavulanate) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).b

• Importance of completing full course of therapy, even if feeling better after a few days.b

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ticarcillin and clavulanate or other antibacterials in the future.b

• Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information. (See Cautions.)

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 or nurse immediately if any of the following side effects occur:

Rare

• Blood in the urine
• frequent urination
• lower abdominal or stomach cramping
• painful urination

Incidence not known

• Abdominal or stomach cramps, pain, or tenderness
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• convulsions
• cough
• dark urine
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• dizziness
• fast heartbeat
• fever
• general tiredness and weakness
• headache
• increased thirst
• irritability
• itching
• joint or muscle pain
• loss of appetite
• lower back or side pain
• muscle twitching
• nausea or vomiting
• pain, tenderness, or swelling of the foot or leg
• pinpoint red spots on the skin
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• restlessness
• seizures
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling or inflammation of the mouth
• swollen glands
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• upper right abdominal or stomach pain
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• change in taste or bad unusual or unpleasant (after) taste
• difficulty with moving
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• muscle aching, cramping, or stiffness
• passing gas
• swollen joints

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.

• It is used to treat bacterial infections.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Any unexplained bruising or bleeding.
• Redness or swelling where the shot is given.
• Seizures.
• It is common to have diarrhea when taking Timentin. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.