Timentin Novaplus (Intravenous)

Ticarcillin and clavulanate combination is used to treat bacterial infections in various 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The ticarcillin/clavulanate combination was withdrawn from the United States market on February 9, 2015.

Your doctor will closely monitor your progress while you or your child are taking this medicine. This will help your doctor determine if the medicine is effective and decide whether to continue treatment.

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 require immediate medical attention. Call your doctor right away if you experience itching, hives, hoarseness, shortness of breath, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

The combination of ticarcillin and clavulanate may cause diarrhea, which in some cases can be severe. This may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first consulting your doctor. If you have any questions or if mild diarrhea persists or worsens, check with your doctor.

Before undergoing any medical tests, inform the doctor in charge that you are using this medicine. Some test results may be affected by this medicine.

The combination of ticarcillin and clavulanate 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it will provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any pediatric-specific issues that would limit the use of ticarcillin and clavulanate combination in children. However, safety and effectiveness have not been confirmed in infants younger than 3 months of age.

Geriatric

Studies conducted so far have not shown any geriatric-specific issues that would limit the use of ticarcillin and clavulanate combination in older adults. However, elderly patients are more likely to have age-related kidney or heart problems, which may mean that the dose needs to be adjusted for those receiving ticarcillin and clavulanate combination.

Breast Feeding

Research suggests that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor might change the dose, or other precautions may be needed. It is very important that your healthcare professional knows if you are taking any of the following medicines while receiving this medicine. The interactions listed below are chosen based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both 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

Some medicines should not be taken at or around the time of eating food or certain types of food because interactions might occur. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to 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. These conditions may worsen.

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

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

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
• Watery and severe 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
• 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 gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects persist 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 aftertaste
• 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, consult 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.