348e 00006000 (cache) Bcg Dosage Guide with Precautions - Drugs.com
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Bcg Dosage

Applies to the following strength(s): vaccine 50 mg ; 50 mg ; 81 mg ; 27 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Tuberculosis - Prophylaxis

BCG vaccine for use in tuberculosis prophylaxis:

BCG vaccine is reserved for persons who have a reaction of <5 mm induration after skin testing with 5 TU of PPD tuberculin. It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculosis infection.

The immunizing dose of 0.2 to 0.3 mL of BCG vaccine is dropped from the syringe and needle onto the cleansed surface of the skin and spread over a 1" by 2" area using the edge of the multiple puncture device. The vaccine is administered percutaneously using a sterile multiple puncture device. The preferred site is the deltoid region. The multiple puncture device is centered over the vaccine and firm downward pressure is applied such that the device points are buried into the skin. Pressure should be maintained for five seconds. (The device should not be rocked.) Pressure underneath the arm is then released and the device is removed.

If the procedure is successful, the points will have punctured the skin. If the points only indent the skin, then the procedure must be repeated.

After a successful procedure, the vaccine should be spread as evenly as possible over the puncture area with the edge of the device. An additional 1 to 2 drops of BCG vaccine may be added to ensure a very wet vaccination site.

The patient should be tuberculin skin tested two to three months after BCG administration. BCG vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after two to three months.

Usual Adult Dose for Urinary Tumor

Intravesical BCG for use in the treatment of urinary tumors:

Do not inject subcutaneously or intravenously.

The initial dosage of BCG for intravesical use recommended for this patient is one vial administered by intravesical installation into the urinary bladder.

TICE BCG (for intravesical use): The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of one vial of BCG suspended in 50 mL preservative-free saline.

A standard TICE BCG treatment schedule consists of one intravesical instillation per week for six weeks. This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Intravesical TICE BCG administration should then continue at approximately monthly intervals for at least six to twelve months.

TheraCys (for intravesical use): One dose of TheraCys BCG Live consists of the intravesical instillation of 81 mg (dry weight) BCG. This dose is prepared by reconstituting the vial containing freeze-dried BCG with the contents of the vial containing diluent. The vial of reconstituted BCG is further diluted in 50 mL of sterile, preservative-free saline, for a total of 53 mL instillation volume.

A standard TheraCys BCG treatment schedule also consists of one intravesical instillation per week for six weeks. However, the TheraCys therapy then continues on to one dose administered at 3, 6, 12, 18, and 24 months following the initial dose.

Usual Pediatric Dose for Tuberculosis - Prophylaxis

Safety and effectiveness of intravesical BCG for the treatment of superficial bladder cancer in pediatric patients have not been established.

BCG vaccine for use in tuberculosis prophylaxis:

BCG vaccine is reserved for persons who have a reaction of <5 mm induration after skin testing with 5 TU of PPD tuberculin. It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculosis infection.

The vaccine is administered percutaneously using a sterile multiple puncture device. The preferred site is the deltoid region.

Generally, 1 mL of sterile water for injection is added to one vial of vaccine. However, in infants less than one month old, the dosage of BCG vaccine should be reduced by one half by using 2 mL of sterile water for injection when reconstituting the vial.

The immunizing dose of 0.2 to 0.3 mL of BCG vaccine is dropped from the syringe and needle onto the cleansed surface of the skin and spread over a 1" by 2" area using the edge of the multiple puncture device. The multiple puncture device is centered over the vaccine and firm downward pressure is applied such that the device points are buried into the skin. Pressure should be maintained for five seconds. (The device should not be rocked.) Pressure underneath the arm is then released and the device is removed.

If the procedure is successful, the points will have punctured the skin. If the points only indent the skin, then the procedure must be repeated.

After a successful procedure, the vaccine should be spread as evenly as possible over the puncture area with the edge of the device. An additional 1 to 2 drops of BCG vaccine may be added to ensure a very wet vaccination site.

The patient should be tuberculin skin tested two to three months after BCG administration. BCG vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after two to three months. For infants vaccinated at less than one month of age, if the vaccinated infant remains tuberculin negative for 5 TU on skin testing, and if indications for vaccination persist, the infant should receive a full dose after one year of age..

Precautions

BCG should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation) or immunosuppressive therapy (e.g. corticosteroids).

Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization.

BCG should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with BCG.

Other Comments

BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material.

BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG.

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