Bactocill

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• diarrhea that is watery or bloody;
• fever, chills, body aches, flu symptoms;
• easy bruising or bleeding, unusual weakness;
• urinating less than usual or not at all;
• severe skin rash, itching, or peeling;
• agitation, confusion, unusual thoughts or behavior; or
• seizure (black-out or convulsions).

Less serious side effects may include:

• nausea, vomiting, stomach pain;
• vaginal itching or discharge;
• headache;
• swollen, black, or "hairy" tongue; or
• thrush (white patches or inside your mouth or throat).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Absorption

Bioavailability

Rapidly absorbed from IM injection sites;1 14 29 30 31 peak serum concentrations generally attained within 30 minutes.1 14 31

Distribution

Extent

Distributed into synovial,5 24 pleural,1 5 pericardial,10 and ascitic fluids.10 Also distributed into bone,10 16 17 24 55 lungs,62 sputum,5 and bile.1 5 31

Only low concentrations attained in CSF.1 10 31

Crosses the placenta5 31 and is distributed into milk.1 5 31

Plasma Protein Binding

89–94% bound to serum proteins.4 15 19 20 70

Elimination

Metabolism

Partially metabolized to active and inactive metabolites.10 23 27

Approximately 49% of a dose is hydrolyzed to penicilloic acids which are microbiologically inactive;23 also hydroxylated to a small extent to a microbiologically active metabolite which appears to be slightly less active than oxacillin.27

Elimination Route

Oxacillin and its metabolites rapidly eliminated in urine principally by tubular secretion and glomerular filtration.1 5 10 27 70

Following IM administration, 40–70% of the dose is excreted in urine as unchanged drug and active metabolites within 6 hours.31

Half-life

Adults with normal renal function: 0.3–0.8 hours.1 7 10 15 21 22 45

Children 1 week to 2 years of age: 0.9–1.8 hours.26

Neonates: 1.6 hours in those 8–15 days of age and 1.2 hours in those 20–21 days of age.70

Special Populations

Patients with renal impairment: serum half-life slightly prolonged.7 15 18 28 45 Serum half-life may be 0.5–2 hours in patients with Clcr <10 mL/minute per 1.73 m2.7 15 18 45

This section provides information on the proper use of a number of products that contain penicillin. It may not be specific to Bactocill. Please read with care.

Penicillins (except bacampicillin tablets, amoxicillin, penicillin V, pivampicillin, and pivmecillinam) are best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

For patients taking amoxicillin, penicillin V, pivampicillin, and pivmecillinam:

• Amoxicillin, penicillin V, pivampicillin, and pivmecillinam may be taken on a full or empty stomach.
• The liquid form of amoxicillin may also be taken by itself or mixed with formulas, milk, fruit juice, water, ginger ale, or other cold drinks. If mixed with other liquids, take immediately after mixing. Be sure to drink all the liquid to get the full dose of medicine.

For patients taking bacampicillin:

• The liquid form of this medicine is best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.
• The tablet form of this medicine may be taken on a full or empty stomach.

For patients taking penicillin G by mouth:

• Do not drink acidic fruit juices (for example, orange or grapefruit juice) or other acidic beverages within 1 hour of taking penicillin G since this may keep the medicine from working properly.

For patients taking the oral liquid form of penicillins:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, 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:

• 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. If you have a ”strep” infection, you should keep taking this medicine for at least 10 days. This is especially important in ”strep” infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

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.

Make certain your health care professional knows if you are on a low-sodium (low-salt) diet. Some of these medicines contain enough sodium to cause problems in some people.

Dosing

The dose medicines in this class 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 amount of medicine 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 using the medicine.

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.

• For amoxicillin:
  • For bacterial infections:
    • For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
      • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours, depending on the type and severity of the infection.
      • Neonates and infants up to 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight or less every twelve hours.
      • Infants 3 months of age and older and children weighing up to 40 kg (88 lbs.)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.7 to 13.3 mg per kg (3 to 6 mg per pound) of body weight every eight hours or 12.5 to 22.5 mg per kg (5.7 to 10.2 mg per pound) of body weight every twelve hours.
        • For duodenal ulcers (associated with Helicobacter pylori bacterial infection):
          • For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
            • Adults: 1000 mg twice a day every twelve hours for fourteen days, along with the two other medicines, clarithromycin and lansoprazole, as directed by your doctor.
            • Teenagers and children: Use and dose must be determined by your doctor.
              • For dual medicine therapy—
                • Adults: 1000 mg three times a day every eight hours for fourteen days, along with the other medicine, lansoprazole, as directed by your doctor.
                • Teenagers and children: Use and dose must be determined by your doctor.

• For ampicillin:
  • For bacterial infections:
    • For oral dosage forms (capsules and oral suspension):
      • Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
      • Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours; or 16.7 to 33.3 mg per kg (7.6 to 15 mg per pound) of body weight every eight hours.
        • For injection dosage form:
          • Adults, teenagers, and children weighing more than 20 kg (44 pounds)—250 to 500 mg, injected into a vein or muscle every three to six hours.
          • Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight, injected into a vein or muscle every six hours.

• For bacampicillin:
  • For bacterial infections:
    • For oral dosage forms (oral suspension and tablets):
      • Adults, teenagers, and children weighing more than 25 kilograms (kg) (55 pounds)—400 to 800 milligrams (mg) every twelve hours.
      • Children weighing up to 25 kg (55 pounds)—Bacampicillin tablets are not recommended for use in children weighing up to 25 kg (55 pounds). The dose of the oral suspension is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every twelve hours.

• For carbenicillin:
  • For bacterial infections:
    • For oral dosage form (tablets):
      • Adults and teenagers—500 milligrams (mg) to 1 gram every six hours.
      • Children—Dose must be determined by your doctor.
        • For injection dosage form:
          • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 to 83.3 mg per kilogram (kg) (22.8 to 37.9 mg per pound) of body weight, injected into a vein or muscle every four hours.
          • Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 16.7 to 75 mg per kg (7.6 to 34 mg per pound) of body weight, injected into a vein or muscle every four to six hours.

• For cloxacillin:
  • For bacterial infections:
    • For oral dosage form (capsules and oral solution):
      • Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
      • Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
        • For injection dosage form:
          • Adults, teenagers, and children weighing more than 20 kg—250 to 500 mg, injected into a vein every six hours.
          • Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight, injected into a vein every six hours.

• For dicloxacillin:
  • For bacterial infections:
    • For oral dosage form (capsules and oral suspension):
      • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—125 to 250 milligrams (mg) every six hours.
      • Infants and children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 3.1 to 6.2 mg per kg (1.4 to 2.8 mg per pound) of body weight every six hours.

• For flucloxacillin:
  • For bacterial infections:
    • For oral dosage form (capsules and oral suspension):
      • Adults, teenagers, and children more than 12 years of age and weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every six hours.
      • Children less than 12 years of age and weighing up to 40 kg (88 pounds)—125 to 250 mg every six hours; or 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
      • Infants up to 6 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight every six hours.

• For methicillin:
  • For bacterial infections:
    • For injection dosage form:
      • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—1 gram injected into a muscle every four to six hours; or 1 gram injected into a vein every six hours.
      • Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 25 milligrams (mg) per kg (11.4 mg per pound) of body weight, injected into a vein or muscle every six hours.

• For mezlocillin:
  • For bacterial infections:
    • For injection dosage form:
      • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 87.5 milligrams (mg) per kilogram (kg) (15.1 to 39.8 mg per pound) of body weight, injected into a vein or muscle every four to six hours; or 3 to 4 grams every four to six hours.
      • Infants over 1 month of age and children up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 mg per kg (22.7 mg per pound) of body weight, injected into a vein or muscle every four hours.

• For nafcillin:
  • For bacterial infections:
    • For oral dosage form (capsules and tablets):
      • Adults and teenagers—250 milligrams (mg) to 1 gram every four to six hours.
      • Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kilogram (kg) (2.8 to 5.7 mg per pound) of body weight every six hours.
      • Newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight every six to eight hours.
        • For injection dosage form:
          • Adults and teenagers—500 mg to 2 grams injected into a vein or muscle every four to six hours.
          • Infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 25 mg per kg (4.5 to 11.4 mg per pound) of body weight, injected into a muscle every twelve hours; or 10 to 40 mg per kg (4.5 to 18.2 mg per pound) of body weight, injected into a vein every four to eight hours.

• For oxacillin:
  • For bacterial infections:
    • For oral dosage form (capsules and oral solution):
      • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—500 milligrams (mg) to 1 gram every four to six hours.
      • Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours.
        • For injection dosage form:
          • Adults, teenagers, and children weighing more than 40 kg (88 pounds)—250 mg to 1 gram injected into a vein or muscle every four to six hours.
          • Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight, injected into a vein or muscle every four to six hours.
          • Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight, injected into a vein or muscle every six hours.

• For penicillin G:
  • For bacterial infections:
    • For oral dosage form (oral solution, oral suspension, and tablets):
      • Adults and teenagers—200,000 to 500,000 Units (125 to 312 milligrams [mg]) every four to six hours.
      • Infants and children less than 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 4167 to 30,000 Units per kilogram (kg) (189 to 13,636 Units per pound) of body weight every four to eight hours.
        • For benzathine injection dosage form:
          • Adults and teenagers—1,200,000 to 2,400,000 Units injected into a muscle as a single dose.
          • Infants and children—300,000 to 1,200,000 Units injected into a muscle as a single dose; or 50,000 Units per kg (22,727 Units per pound) of body weight injected into a muscle as a single dose.
            • For injection dosage forms (potassium and sodium salts):
              • Adults and teenagers—1,000,000 to 5,000,000 Units, injected into a vein or muscle every four to six hours.
              • Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 8333 to 25,000 Units per kg (3788 to 11,363 Units per pound) of body weight, injected into a vein or muscle every four to six hours.
              • Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 30,000 Units per kg (13,636 Units per pound) of body weight, injected into a vein or muscle every twelve hours.
                • For procaine injection dosage form:
                  • Adults and teenagers—600,000 to 1,200,000 Units injected into a muscle once a day.
                  • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 50,000 Units per kg (22,727 Units per pound) of body weight, injected into a muscle once a day.

• For penicillin V:
  • For bacterial infections:
    • For the benzathine salt oral dosage form (oral solution):
      • Adults and teenagers—200,000 to 500,000 Units every six to eight hours.
      • Children—100,000 to 250,000 Units every six to eight hours.
        • For the potassium salt oral dosage forms (oral solution, oral suspension, and tablets):
          • Adults and teenagers—125 to 500 milligrams (mg) every six to eight hours.
          • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 to 16.7 mg per kilogram (kg) (1.1 to 7.6 mg per pound) of body weight every four to eight hours.

• For piperacillin:
  • For bacterial infections:
    • For injection dosage form:
      • Adults and teenagers—3 to 4 grams, injected into a vein or muscle every four to six hours.
      • Infants and children—Dose must be determined by your doctor.

• For pivampicillin:
  • For bacterial infections:
    • For oral dosage form (oral suspension):
      • Adults, teenagers, and children 10 years of age and older—525 to 1050 milligrams (mg) two times a day.
      • Children 7 to 10 years of age—350 mg two times a day.
      • Children 4 to 6 years of age—262.5 mg two times a day.
      • Children 1 to 3 years of age—175 mg two times a day.
      • Infants 3 to 12 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 30 mg per kilogram (kg) (9.1 to 13.6 mg per pound) of body weight two times a day.
        • For oral dosage form (tablets):
          • Adults, teenagers, and children 10 years of age and older—500 mg to 1 gram two times a day.
          • Children up to 10 years of age—Dose must be determined by your doctor.

• For pivmecillinam:
  • For bacterial infections:
    • For oral dosage form (tablets):
      • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—200 milligrams (mg) two to four times a day for three days.
      • Children up to 40 kg (88 pounds)—Dose must be determined by your doctor.

• For ticarcillin:
  • For bacterial infections:
    • For injection dosage form:
      • Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—3 grams injected into a vein every four hours; or 4 grams injected into a vein every six hours.
      • Children up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 75 milligrams (mg) per kg (15 to 34 mg per pound) of body weight, injected into a vein every four to six hours.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

• Fast or irregular breathing
• fever
• joint pain
• lightheadedness or fainting (sudden)
• puffiness or swelling around the face
• red, scaly skin
• shortness of breath
• skin rash, hives, itching

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach cramps and pain (severe)
• abdominal tenderness
• convulsions (seizures)
• decreased amount of urine
• diarrhea (watery and severe), which may also be bloody
• mental depression
• nausea and vomiting
• pain at place of injection
• sore throat and fever
• unusual bleeding or bruising
• yellow eyes or skin

• Agitation or combativeness
• anxiety
• confusion
• fear of impending death
• feeling, hearing, or seeing things that are not real

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:

• Diarrhea (mild)
• headache
• sore mouth or tongue
• vaginal itching and discharge
• white patches in the mouth and/or on the tongue

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.

Manufacturer Recommendations:
Mild to moderate infections: 250 to 500 mg IV or IM every 4 to 6 hours
Severe infections: 1 g IV or IM every 4 to 6 hours

Duration of therapy: Therapy should continue for at least 14 days in severe staphylococcal infections. Therapy should continue for at least 48 hours after patient is afebrile, asymptomatic, and has negative cultures. Endocarditis and osteomyelitis may require a longer duration of therapy.

Approved indication: Treatment of infections caused by susceptible penicillinase-producing staphylococci

Manufacturer Recommendations: See Usual Adult Dose (Bacterial Infection)

Some experts recommend: 2 g IV or IM every 4 to 6 hours
Duration of therapy: 3 to 4 weeks, depending on the nature and severity of the infection. Longer therapy, for 6 weeks or longer, may be required for prosthetic joint infections.
Comments: A third-generation cephalosporin, ciprofloxacin, and/or rifampin should be added, depending on the results of the Gram stain.

Manufacturer Recommendations: See Usual Adult Dose (Bacterial Infection)

Some experts recommend: 1.5 to 2 g IV every 4 hours
Duration of therapy: In general, treatment of acute or chronic osteomyelitis should continue for 3 to 8 weeks followed by treatment with an oral penicillinase-resistant penicillin. Parenteral penicillinase-resistant therapy for 5 to 28 days followed by oral penicillinase-resistant penicillin for 3 to 6 weeks has also been effective for acute osteomyelitis.

Data not available

General:
-Bacteriologic studies recommended to verify causative organisms and susceptibility.
-Parenteral therapy should be used initially in severe infections. Oral therapy may be used as follow-up therapy as soon as the clinical condition warrants.

Monitoring:
-General: Clinical and laboratory signs of toxic or adverse effects (pediatric patients); blood cultures (prior to and at least weekly during therapy); blood levels (renally impaired patients).
-Hematologic: White blood cell and differential cell counts (prior to and at least weekly during therapy); hematopoietic function (during prolonged therapy).
-Hepatic: AST and ALT periodically (during therapy); hepatic function (during prolonged therapy).
-Renal: Periodic urinalysis, blood urea nitrogen, and creatinine (during therapy); renal function (geriatric patients; during prolonged therapy).