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|Clavulin-250F

PENICILLINS AND BETA-LACTAMASE INHIBITORS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Augmentin ¹
• Timentin ⁴
• Unasyn ²
• Zosyn ³

In Canada—

• Clavulin-250 ¹
• Clavulin-125F ¹
• Clavulin-250F ¹
• Clavulin-500F ¹
• Tazocin ³
• Timentin ⁴

Category

• Antibacterial, systemic—Amoxicillin and Clavulanate; Ampicillin and Sulbactam; Piperacillin and Tazobactam; Ticarcillin and Clavulanate

Description

Penicillins and beta-lactamase inhibitors are used to treat infections caused by bacteria. They work by killing the bacteria or preventing their growth. The beta-lactamase inhibitor is added to the penicillin to protect the penicillin from certain substances (enzymes) that will destroy the penicillin before it can kill the bacteria.

There are several different kinds of penicillins. Each is used to treat different kinds of infections. One kind of penicillin usually may not be used in place of another. In addition, penicillins are used to treat bacterial infections in many different parts of the body. They are sometimes given with other antibacterial medicines. Some of the penicillins may also be used for other problems as determined by your doctor. However, none of the penicillins will work for colds, flu, or other virus infections.

Penicillins are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Amoxicillin and Clavulanate
  • Oral suspension (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S.)

• Parenteral
• Ampicillin and Sulbactam
  • Injection (U.S.)
• Piperacillin and Tazobactam
  • Injection (U.S. and Canada)
• Ticarcillin and Clavulanate
  • Injection (U.S. and Canada)

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 penicillins, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Tell your doctor if you are on a low-sodium (low-salt) diet. Some of these medicines contain enough sodium to cause problems in some people.

Pregnancy—Penicillins and beta-lactamase inhibitors have not been studied in pregnant women. However, penicillins have not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—Penicillins and sulbactam, a beta-lactamase inhibitor, pass into the breast milk. Even though only small amounts may pass into breast milk, allergic reactions, diarrhea, fungus infections, and skin rash may occur in nursing babies.

Children—Penicillins and beta-lactamase inhibitors have been used in children and, in effective doses, are not expected to cause different side effects or problems in children than they do in adults.

Some strengths of the chewable tablets and oral suspensions of amoxicillin and clavulanate combination contain aspartame, which is changed by the body to phenylalanine, a substance that is harmful to patients with phenylketonuria.

Older adults—Penicillins and beta-lactamase inhibitors have been used in the elderly and have not been shown to cause different side effects or problems in older people than they do in younger adults.

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 taking a penicillin and beta-lactamase inhibitor combination, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Heparin (e.g., Panheprin) or
• Inflammation or pain medicine (except narcotics) or
• Pentoxifylline (e.g., Trental) or
• Plicamycin (e.g., Mithracin) or
• Sulfinpyrazone (e.g., Anturane) or
• Valproic acid (e.g., Depakene)—Use of these medicines with piperacillin and tazobactam combination or with ticarcillin and clavulanate combination may increase the chance of bleeding

• Oral contraceptives (birth control pills)—Use of penicillins and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance for pregnancy

• Probenecid (e.g., Benemid)—Probenecid causes penicillins, sulbactam, and tazobactam to build up in the blood. This may increase the chance of side effects. However, your doctor may want to give you probenecid with a penicillin and beta-lactamase inhibitor combination to treat some infections

Other medical problems—The presence of other medical problems may affect the use of penicillin and beta-lactamase inhibitor combinations. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergies or a history of allergies, such as asthma, eczema, hay fever, or hives—Patients with a history of allergies may be more likely to have a severe allergic reaction to a penicillin and beta-lactamase inhibitor combination

• Bleeding problems, history of—Patients with a history of bleeding problems may be more likely to have bleeding when receiving piperacillin and tazobactam combination or ticarcillin and clavulanate combination

• Congestive heart failure (CHF) or
• High blood pressure—Large doses of ticarcillin and clavulanate combination may make these conditions worse, because this medicine contains a large amount of salt

• Cystic fibrosis—Patients with cystic fibrosis may have an increased chance of fever and skin rash when receiving piperacillin and tazobactam combination

• Kidney disease—Patients with kidney disease may have an increased chance of side effects

• Liver disease (active or a history of)—Penicillins and beta-lactamase inhibitor combinations may cause this condition to recur or become worse

• Mononucleosis (“mono”)—Patients with mononucleosis may have an increased chance of skin rash when receiving ampicillin and sulbactam combination

• Phenylketonuria—Some strengths of the amoxicillin and clavulanate combination chewable tablets and oral suspension contain aspartame, which is changed by the body to phenylalanine.

• Stomach or intestinal disease, history of (especially colitis, including colitis caused by antibiotics)—Patients with a history of stomach or intestinal disease may be more likely to develop colitis while taking penicillins and beta-lactamase inhibitors

Proper Use of This Medicine

Amoxicillin and clavulanate combination may be taken on a full or empty stomach. Taking amoxicillin and clavulanate combination with food may decrease the chance of diarrhea, nausea, and vomiting.

For patients taking the oral liquid form of amoxicillin and clavulanate combination :

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
• Do not use after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

For patients taking the chewable tablet form of amoxicillin and clavulanate combination :

• Tablets should be chewed or crushed before they are swallowed.

To help clear up your infection completely, keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking a penicillin and beta-lactamase inhibitor combination .

• For amoxicillin and clavulanate combination
• For bacterial infections:
  • For oral dosage forms (chewable tablets and suspension):
    • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) of amoxicillin, in combination with 125 mg of clavulanate, every eight hours or 500 to 875 mg of amoxicillin, in combination with 125 mg of clavulanate, every twelve hours.
    • Neonates and infants up to 12 weeks (3 months) of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg of amoxicillin per kg (6.8 mg per pound) of body weight every twelve hours.
    • Infants 3 months of age and older and children weighing up to 40 kg (88 pounds)—6.7 to 22.5 mg of amoxicillin per kg (3 to 10.2 mg per pound) of body weight, in combination with 1.7 to 3.2 mg of clavulanate per kg (0.8 to 1.5 mg per pound) of body weight, every eight or twelve hours.
  • For oral dosage form (tablets):
    • Adults, teenagers, and children weighing more than 40 kg (88 pounds)—250 to 500 mg of amoxicillin, in combination with 125 mg of clavulanate, every eight hours or 500 to 875 mg of amoxicillin, in combination with 125 mg of clavulanate, every twelve hours.
    • Infants and children weighing up to 40 kg (88 pounds)—The amoxicillin and clavulanate combination tablets are too strong for children weighing less than 40 kg (88 pounds). The chewable tablets or oral suspension are used in these children.

• For ampicillin and sulbactam combination
• For bacterial infections:
  • For injection dosage form:
    • Adults and teenagers—1 to 2 grams of ampicillin, in combination with 500 milligrams (mg) to 1 gram of sulbactam, injected into a vein or a muscle every six hours.
    • Children 1 to 12 years of age—Dose must be determined by your doctor.
    • Children up to 1 year of age—Use and dose must be determined by your doctor.

• For piperacillin and tazobactam combination
• For bacterial infections:
  • For injection dosage form:
    • Adults and teenagers—3 to 4 grams of piperacillin, in combination with 0.375 to 0.5 grams of tazobactam, injected into a vein every six to eight hours for seven to ten days.
    • Children up to 12 years of age—Dose must be determined by your doctor.

• For ticarcillin and clavulanate combination
• For bacterial infections:
  • For injection dosage form:
    • Adults and teenagers weighing 60 kilograms (kg) (132 pounds) or more—3 grams of ticarcillin, in combination with 100 milligrams (mg) of clavulanate, injected into a vein every four to six hours.
    • Adults and teenagers weighing less than 60 kg (132 pounds)—50 mg of ticarcillin per kg (22.7 mg per pound) of body weight, in combination with 1.7 mg of clavulanate per kg (0.8 mg per pound) of body weight, injected into a vein every four to six hours.
    • Infants and children 1 month to 12 years of age—50 mg of ticarcillin per kg (22.7 mg per pound) of body weight, in combination with 1.7 mg of clavulanate per kg (0.8 mg per pound) of body weight, injected into a vein every four to six hours.
    • Infants up to 1 month of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood or urine. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store tablets in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store the oral liquid form of penicillins in the refrigerator because heat will cause this medicine to break down. However, keep the medicine from freezing. Follow the directions on the label.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Penicillins may cause diarrhea in some patients.

• Check with your doctor if severe diarrhea occurs . Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine . Diarrhea medicines may make your diarrhea worse or make it last longer.
• For mild diarrhea, diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.
• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

For patients with diabetes :

• Penicillin and beta-lactamase inhibitor combinations may cause false test results with some urine sugar tests . Check with your doctor before changing your diet or the dosage of your diabetes medicine.

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

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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, penicillins and beta-lactamase inhibitor combinations are used in certain patients with the following medical conditions:

• Amoxicillin and clavulanate combination
• Bronchitis
• Chancroid

• Ampicillin and sulbactam combination
• Gonorrhea

• Ticarcillin and clavulanate combination
• Certain surgeries, such as colorectal surgery, abdominal hysterectomy, and high-risk cesarean section: This medicine is sometimes used to prevent infection from these surgical procedures.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 12/12/2000

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