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Tice Bcg Generic Name & Formulations
Legal Class
Rx
General Description
Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis live, attenuated culture preparation; 50mg per vial; pwd for intravesical administration after reconstitution and dilution; preservative-free.
Pharmacological Class
BCG Live.
How Supplied
Vial—1
Manufacturer
Mechanism of Action
Tice BCG induces a granulomatous reaction at the local site of administration. The precise mechanism of action is unknown.
Tice Bcg Indications
Indications
Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. Prophylaxis of stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
Tice Bcg Dosage and Administration
Adult
1 vial in 50mL preservative-free saline intravesically once per week for 6 weeks (may repeat this regimen once if remission not achieved); then monthly for 6–12 months if needed. Avoid fluid at least 4hrs before treatment and void immediately before administration. Retain in bladder for 2hrs.
Children
Not recommended.
Tice Bcg Contraindications
Contraindications
Immunosuppressed. Active TB. Febrile illness. UTI. Gross hematuria. Do not give within 7 days after bladder biopsy, TUR, or traumatic catheterization.
Tice Bcg Boxed Warnings
Boxed Warning
Prepare, handle, and dispose of as a biohazard material. BCG infections. Nosocomial infections.
Tice Bcg Warnings/Precautions
Warnings/Precautions
Not a vaccine for prevention of cancer or TB. Not for IV or SC inj use. Determine PPD status prior to therapy; rule out active TB if (+). Monitor for signs of systemic BCG infection: flu-like symptoms >72 hrs, fever ≥103°F, persistent LFT abnormalities; prostatitis, epididymitis, orchitis >2 days; treat with at least 2 antimycobacterial drugs (except pyrazinamide). High risk for HIV infection. Local irritative toxicities: do not treat with antimycobacterials. Bleeding bladder mucosa, small bladder. Disinfect fluid voided after therapy with bleach. PPD seroconversion may occur with treatment. Pregnancy, nursing mothers: not recommended.
Tice Bcg Pharmacokinetics
See Literature
Tice Bcg Interactions
Interactions
Immunosuppressants, myelosuppressants, radiation, antimicrobial therapy may reduce efficacy.
Tice Bcg Adverse Reactions
Adverse Reactions
Dysuria, urinary frequency, urgency, flu-like syndrome, hematuria, fever, malaise/fatigue, cystitis, bladder irritation, inflammation (begins after 4 hrs and last up to 72 hrs), chills, systemic BCG infection, nocturia, cramps, pain, incontinence, rigors, arthralgia.
Tice Bcg Clinical Trials
See Literature
Tice Bcg Note
Not Applicable
Tice Bcg Patient Counseling
See Literature
