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Vantobra (Tobramycin Sulfate)
Vantobra (generic name: Tobramycin Sulfate) is a tobramycin Small molecule drug developed by Pfizer. It is currently FDA-approved (first approved 1974) for Allergic conjunctivitis, Anterior uveitis, Bacterial conjunctivitis.
Vantobra is a medication that contains the active ingredient tobramycin, used to treat Cystic Fibrosis. It is a bioequivalent alternative to TOBI, another tobramycin-containing medication, as demonstrated in a clinical study.
At a glance
| Generic name | Tobramycin Sulfate |
|---|---|
| Sponsor | Pfizer |
| Drug class | tobramycin |
| Target | Taste receptor type 2 member 20 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1974 |
Approved indications
- Allergic conjunctivitis
- Anterior uveitis
- Bacterial conjunctivitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial infection due to Serratia
- Bacterial meningitis
- Bacterial peritonitis
- Bacterial septicemia
- Bacterial urinary infection
- Blepharoconjunctivitis
- Citrobacter Complicated UTI
- Complicated Proteus UTI
- Complicated UTI with Pseudomonas Aeruginosa
- Complicated Urinary Tract Infections
- Corneal abrasion
- Dacryocystitis
- E. Coli Osteomyelitis
- E. Coli Peritonitis
- Enterobacter Osteomyelitis
- Enterobacter Pneumonia
Boxed warnings
- WARNINGS Patients treated with tobramycin injection and other aminoglycosides should be under close clinical observation, because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity. Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. Eighth-nerve impairment and nephrotoxicity may develop, primarily in patients having preexisting renal damage and in those with normal renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued. Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible. Renal and eighth-nerve function should be closely monitored in patients with known or suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Peak and trough serum concentrations of aminoglycosides should be monitored periodically during therapy to assure adequate levels and to avoid potentially toxic levels. Prolonged serum concentrations above 12 mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, excessive peak concentrations, advanced age, and cumulative dose may contribute to ototoxicity and nephrotoxicity (see PRECAUTIONS ). Urine should be examined for decreased specific gravity and increased excretion of protein, cells, and casts. Blood urea nitrogen, serum creatinine, and creatinine clearance should be measured periodically. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of impairment of renal, vestibular, or auditory function requires discontinuation of the drug or dosage adjustment. Tobramycin injection should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug. Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics, particularly other aminoglycosides (e.g., amikacin, streptomycin, neomycin, kanamycin, gentamicin, and paromomycin), cephaloridine, viomycin, polymyxin B, colistin, cisplatin, and vancomycin, should be avoided. Other factors that may increase patient risk are advanced age and dehydration. Aminoglycosides should not be given concurrently with potent diuretics, such as ethacrynic acid and furosemide. Some diuretics themselves cause ototoxicity, and intravenously administered diuretics enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Aminoglycosides can cause fetal harm when administered to a pregnant woman (see PRECAUTIONS ).
Common side effects
- Dizziness
- Vertigo
- Tinnitus
- Roaring in the ears
- Hearing loss
- Nephrotoxicity
- Anemia
- Granulocytopenia
- Thrombocytopenia
- Fever
- Rash
- Exfoliative dermatitis
Drug interactions
- carbamide
- mannitol
- tubocurarine
- vancomycin
- vecuronium
Key clinical trials
- Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection (NA)
- Microbiome-guided Prophylaxis to Reduce Ventilator-Associated Pneumonia in Intensive Care Units: A Pilot Randomized Controlled Trial (PHASE2)
- Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy (PHASE3)
- Acute Application of Antibiotic Powder in Open Fracture Wounds (PHASE4)
- Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA (PHASE3)
- Fluorometholone Study (PHASE2)
- Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction (NA)
- Tobradex as Intracanal Medicament (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vantobra CI brief — competitive landscape report
- Vantobra updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Vantobra
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What does Vantobra target?
Related
- Drug class: All tobramycin drugs
- Target: All drugs targeting Taste receptor type 2 member 20
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Allergic conjunctivitis
- Indication: Drugs for Anterior uveitis
- Indication: Drugs for Bacterial conjunctivitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing