Timentin ADD-Vantage

Timentin is a prescription medication used to treat bacterial infections of the stomach, skin, lungs, bone, joint, and urinary tract. It is also used to treat gynecological infections. It contains 2 medications, ticarcillin and clavulanic acid.

Ticarcillin belongs to a group of drugs called penicillin antibiotics, which help stop the growth of bacteria. Clavulanic acid belongs to a group of drugs called beta lactamase inhibitors, which work by preventing bacteria from destroying ticarcillin.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Timentin include rash, nausea, diarrhea, and irritation at the site of injection.

Timentin is a prescription medication used to treat bacterial infections of the stomach, skin, lungs, bone, joint, and urinary tract. It is also used to treat gynecological infections.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Glaxo SmithKline Pharmaceuticals

• GlaxoSmithKline LLC

Serious side effects have been reported with Timentin. See the “Drug Precautions” section.

Common side effects of Timentin include rash, nausea, diarrhea, and irritation at thE site of injection.

This is not a complete list of Timentin side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), and tobramycin (Nebcin)
• probenecid (Benemid, Probalan)
• birth control pills
• methotrexate (Rheumatrex, Trexall)

This is not a complete list of Timentin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Timentin including:

• hypersensitivity (severe allergic reaction). This type of reaction may be serious and possibly fatal. These reactions are more likely to occur in those with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Tell your healthcare provider right away if you start to develop signs or symptoms of a hypersensitivity reaction, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • fainting
  • rash
• diarrhea. Diarrhea is a common problem caused by antibiotics, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, contact your doctor, as this may be a sign of an infection of the bowels.
• superinfection. Timentin should not be used for extended periods. Prolonged use can lead to the growth of dangerous organisms that are resistant or unaffected by Timentin. Take this medication for the duration prescribed by your doctor.
• bleeding abnormalities. Your health care provider may want to monitor lab tests that show how well your blood is able to clot or that measure your tendency to bleed. Any abnormalities or irregularities that may occur may be more common in those with kidney dysfunction.
• seizures. Some may experience a seizure when the dose of Timentin exceeds the recommended dose, especially for those with kidney dysfunction.

Do not take Timentin if you are allergic to ticarcillin/clavulanic acid or any of its ingredients, or if you are allergic to other beta lactam antibiotics (cephalosporins, penicillins).

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Timentin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Timentin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Timentin or any of its ingredients
• are allergic to similar antibiotics (penicillins, cephalosporins)
• have other types of allergies
• have cystic fibrosis
• have a history of seizures
• have kidney problems
• are on a sodium restricted diet
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Timentin falls into category B. There are no well-done studies that have been done in humans with Timentin. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Timentin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Timentin.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

The Timentin dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function
• your age
• your weight

Adults

• The recommended dose for systemic and urinary tract infections in adults is 3.1 grams of Timentin (3 grams ticarcillin and 100 mg clavulanic acid) given every 4 to 6 hours.
• The recommended dose for gynecologic infections in adults is as follows (based on ticarcillin content):
  • Moderate infections – 200 mg/kg/day in divided doses every 6 hours
  • Severe infections – 300 mg/kg/day in divided doses every 4 hours
  • For patients weighing less than 60 kg, the recommended dosage is 200 to 300 mg/kg/day given in divided doses every 4 to 6 hours

Children less than 60 kg

• Mild to moderate infections – 200 mg/kg/day based on the ticarcillin content in divided doses every 6 hours
• Severe infections – 300 mg/kg/day based on the ticarcillin content in divided doses every 4 hours

Children greater than or equal to 60 kg

• Mild to moderate infections – 3.1 grams every 6 hours
• Severe infections – 3.1 grams every 4 hours

If Timentin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.