Timentin (Intravenous)

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 bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

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

Your doctor will monitor your progress closely while you or your child are taking this medicine. This will help your doctor determine if the medicine is effective and if you should keep using it.

Call your doctor if your symptoms do not improve or if they worsen.

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

Ticarcillin and clavulanate combination may cause diarrhea, and in some cases, it can be severe. This may happen 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without checking with your doctor first. If you have questions, or if mild diarrhea persists or worsens, consult your doctor.

Before undergoing any medical tests, inform the doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

Ticarcillin and clavulanate combination may reduce the effectiveness of some oral contraceptives (birth control pills). To prevent an unwanted pregnancy, it is advisable to use additional contraceptive methods along with your pills (e.g., condoms, a diaphragm, or a contraceptive foam or jelly) while taking this medicine.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies conducted so far have not shown any specific problems in children that would limit the usefulness of the ticarcillin and clavulanate combination. However, safety and effectiveness have not been established in infants younger than 3 months of age.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the usefulness of the ticarcillin and clavulanate combination. However, older adults are more likely to have age-related kidney or heart problems, which may require a dose adjustment for patients receiving the ticarcillin and clavulanate combination.

Breast Feeding

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

Interactions with Medicines

While some medicines should never be used together, in other cases, two different medicines may be used together even if an interaction could happen. 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 knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, 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 worsen these conditions.

• Kidney disease—Use with caution. Effects may be increased due to slower removal of the medicine from the body.

Along with its benefits, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if you experience any of the following side effects:

Rare

• Blood in the urine
• Frequent urination
• Cramping in the lower abdomen or stomach
• 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
• Severe, watery diarrhea, 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
• Pain in the lower back or side
• Muscle twitching
• Nausea or vomiting
• Pain, tenderness, or swelling in 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
• Pain in the upper right abdomen or stomach
• Vomiting blood
• Yellowing of the eyes or skin

Some side effects might occur that usually do not need medical attention. These side effects might go away as your body gets used to the medicine. Your healthcare professional may also have suggestions to prevent or reduce some of these side effects. Talk to your healthcare professional if any of the following side effects continue, are bothersome, or if you have 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 an unusual bad taste
• Difficulty moving
• Excess air or gas in the stomach or intestines
• Feeling overly full
• Heartburn
• Muscle aches, cramps, or stiffness
• Passing gas
• Swollen joints

Other side effects not listed may also happen in some patients. If you notice any other effects, consult with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Timentin
• Timentin Novaplus

Pharmacologic Class: Ticarcillin

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.