Pronunciation:

tye-kar-SIL-in dye-SOE-dee-um, KLAV-ue-la-nate poe-TAS-ee-um

Brand Names:

• Timentin
• Timentin Novaplus

Classifications:

Pharmacologic—

Ticarcillin

Uses of This Medicine:

Ticarcillin and clavulanate combination is used to treat bacterial infections in many different parts of the body.

Ticarcillin and clavulanate combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine was to be given only by or under the direct supervision of a doctor.

The ticarcillin/clavulanate combination was withdrawn from the United States market on February 9, 2015.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ticarcillin and clavulanate combination in children. However, safety and efficacy have not been established in infants younger than 3 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ticarcillin and clavulanate combination in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, which may require an adjustment in the dose for patients receiving ticarcillin and clavulanate combination.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other 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 receiving this medicine, 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 this medicine 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.

• Amifampridine
• Bupropion
• Desogestrel
• Dienogest
• Donepezil
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levonorgestrel
• Mestranol
• Methotrexate
• Mycophenolate Mofetil
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Warfarin

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to cephalosporin or penicillin antibiotics, history of— Should not be used in patients with this condition.

• Bleeding problems or
• Congestive heart failure or
• Diarrhea or
• Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

Tell your doctor if you are on a low-salt diet.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Call your doctor if your symptoms do not improve or if they get worse.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, shortness of breath, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat after you receive this medicine.

Ticarcillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Ticarcillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g. condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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.