What is Tobravisc?
Tobravisc is an aminoglycoside (ah-meen-oh-GLY-ko-side) antibiotic. Tobravisc fights infections that are caused by bacteria.
Tobravisc inhalation is inhaled into the lungs using a nebulizer. Tobravisc inhalation is used to treat lung infections in patients with cystic fibrosis.
Tobravisc inhalation is for use in adults and children who are at least 6 years old.
Tobravisc inhalation may also be used for purposes not listed in this medication guide.
Tobravisc indications
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobravisc injection and other antibacterial drugs, Tobravisc injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Tobravisc injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli, and Klebsiella sp.
Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains).
Serious central nervous system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp.
Skin, bone and skin-structure infections caused by P. aeruginosa, Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus.
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp.
Aminoglycosides, including Tobravisc, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobravisc may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to Tobravisc. If susceptibility tests show that the causative organisms are resistant to Tobravisc, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with Tobravisc sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with Tobravisc should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGS box above.
How should I use Tobravisc?
Use Tobravisc ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Remove contact lenses before you use Tobravisc ointment.
- Do not wear contact lenses while you are using Tobravisc ointment. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
- Tobravisc ointment may be used around the eye or in the eye. To use Tobravisc ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Tobravisc ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- To clear up your infection completely, take/use Tobravisc ointment for the full course of treatment. Keep taking/using it even if you feel better in a few days.
- Tobravisc ointment works best if it is used at the same time each day.
- Do not miss any doses. If you miss a dose of Tobravisc ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Ask your health care provider any questions you may have about how to use Tobravisc ointment.
Uses of Tobravisc in details
Use: Labeled Indications
Cystic fibrosis: Management of cystic fibrosis in adults and pediatric patients ≥6 years of age with Pseudomonas aeruginosa.
Limitations of use: Safety and efficacy have not been demonstrated in patients with FEV <25% or >75% predicted (Tobravisc; Tobravisc), or in patients colonized with Burkholderia cepacia.
Off Label Uses
Non-cystic fibrosis bronchiectasis
According to a national consensus summary and international guidelines, aerosolized Tobravisc should not be used for the treatment and prevention of non-cystic fibrosis bronchiectasis. Aerosolized antibiotics may be considered in patients who have experienced 3 or more exacerbations requiring antibiotic therapy per year; organism sensitivity should be considered when choosing an antibiotic. The risk of adverse events, cost of therapy, and patient status should be considered prior to initiating aerosolized Tobravisc because the efficacy of aerosolized Tobravisc in the treatment of non-cystic fibrosis bronchiectasis has not been well documented.
Tobravisc description
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the pseudomonas species. It is a 10% component of the antibiotic complex, nebramycin, produced by the same species. [PubChem]
Tobravisc dosage
Tobravisc Dosage
Generic name: Tobravisc 300mg in 5mL
Dosage form: inhalation solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Dosing Information
- Tobravisc is a co-packaging of Tobravisc inhalation solution ampules with a PARI LC PLUS Reusable Nebulizer. Administer as follows: One single-use ampule (300 mg /5 mL) of Tobravisc inhalation solution twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug.
- The 300 mg/5mL dose of Tobravisc inhalation solution is the same for all patients regardless of age or weight.
- The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
Administration of Tobravisc Inhalation Solution
Each dose of Tobravisc inhalation solution is administered by oral inhalation using only the co-packaged PARI LC PLUS Reusable Nebulizer (Model No. 022B81-T) included in the Tobravisc, along with a DeVilbiss Pulmo-Aide air compressor (Model No. 5650D).
Tobravisc inhalation solution is not for subcutaneous, intravenous or intrathecal administration.
Prior to administration, read the Patient Information/Instructions for Use for Tobravisc for detailed information on how to use Tobravisc and follow the manufacturer's instructions for use and care of the DeVilbiss Pulmo-Aide air compressor.
The entire Tobravisc inhalation solution treatment should take approximately 15 minutes to complete. Continue treatment until all the Tobravisc inhalation solution has been delivered, and there is no longer any mist being produced.
Tobravisc inhalation solution should not be diluted or mixed with other drugs including dornase alfa (Pulmozyme®) in the nebulizer. Instruct patients on multiple therapies to take their medications prior to inhaling the Tobravisc inhalation solution, or as directed by their physician.
Tobravisc inhalation solution should not be used if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days.
More about Tobravisc (Tobravisc)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- 0 Reviews - Add your own review/rating
- Generic Availability
Consumer resources
- Tobravisc (Advanced Reading)
- Other brands: Tobravisc, Bethkis, Tobravisc, Nebcin
Professional resources
- Tobravisc (FDA)
- Tobravisc Sulfate (AHFS Monograph)
Related treatment guides
- Cystic Fibrosis
Tobravisc interactions
See also:
What other drugs will affect Tobravisc?
No clinical drug interaction studies have been performed with Tobravisc. In clinical studies, patients receiving Tobravisc continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides. No clinical signs of drug interactions with these medicines were identified.
Concurrent and/or sequential use of Tobravisc with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.
Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Tobravisc should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and Tobravisc has not been evaluated.
Tobravisc side effects
See also:
What are the possible side effects of Tobravisc?
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tobravisc has been evaluated for safety in 425 cystic fibrosis patients exposed to at least one dose of Tobravisc, including 273 patients who were exposed across three cycles (6 months) of treatment. Each cycle consisted of 28 days on-treatment (with 112 mg administered twice-daily) and 28 days off-treatment. Patients with serum creatinine ≥2 mg/dL and blood urea nitrogen (BUN) ≥40 mg/dL were excluded from clinical studies. There were 218 males and 207 females in this population, and reflecting the cystic fibrosis population in the U.S., the vast majority of patients were Caucasian. There were 221 patients ≥20 years old, 121 patients ≥13 to <20 years old, and 83 patients ≥6 to <13 years old. There were 239 patients with screening FEV1 % predicted ≥50%, 156 patients with screening FEV1 % predicted <50%, and 30 patients with missing FEV1 % predicted.
The primary safety population reflects patients from Study 1, an open-label study comparing Tobravisc with Tobravisc (Tobravisc inhalation solution, USP) over three cycles of 4 weeks on treatment followed by 4 weeks off treatment. Randomization, in a planned 3:2 ratio, resulted in 308 patients treated with Tobravisc and 209 patients treated with Tobravisc. For both the Tobravisc and Tobravisc groups, mean exposure to medication for each cycle was 28 to 29 days. The mean age for both arms was between 25 and 26 years old. The mean baseline FEV1 % predicted for both arms was 53%.
Table 1 displays adverse drug reactions reported by at least 2% of Tobravisc patients in Study 1, inclusive of all cycles (on and off treatment). Adverse drug reactions are listed according to MedDRA system organ class and sorted within system organ class group in descending order of frequency.
| 1This includes adverse events of pulmonary or cystic fibrosis exacerbations | ||
| Primary System Organ Class Preferred Term | Tobravisc N=308 % | Tobravisc N=209 % |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 48.4 | 31.1 |
| Lung disorder1 | 33.8 | 30.1 |
| Productive cough | 18.2 | 19.6 |
| Dyspnea | 15.6 | 12.4 |
| Oropharyngeal pain | 14.0 | 10.5 |
| Dysphonia | 13.6 | 3.8 |
| Hemoptysis | 13.0 | 12.4 |
| Nasal congestion | 8.1 | 7.2 |
| Rales | 7.1 | 6.2 |
| Wheezing | 6.8 | 6.2 |
| Chest discomfort | 6.5 | 2.9 |
| Throat irritation | 4.5 | 1.9 |
| Gastrointestinal disorders | ||
| Nausea | 7.5 | 9.6 |
| Vomiting | 6.2 | 5.7 |
| Diarrhea | 4.2 | 1.9 |
| Dysgeusia | 3.9 | 0.5 |
| Infections and infestations | ||
| Upper respiratory tract infection | 6.8 | 8.6 |
| Investigations | ||
| Pulmonary function test decreased | 6.8 | 8.1 |
| Forced expiratory volume decreased | 3.9 | 1.0 |
| Blood glucose increased | 2.9 | 0.5 |
| Vascular disorders | ||
| Epistaxis | 2.6 | 1.9 |
| Nervous system disorders | ||
| Headache | 11.4 | 12.0 |
| General disorders and administration site conditions | ||
| Pyrexia | 15.6 | 12.4 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal chest pain | 4.5 | 4.8 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 2.3 | 2.4 |
Adverse drug reactions that occurred in <2% of patients treated with Tobravisc in Study 1 were: bronchospasm (Tobravisc 1.6%, Tobravisc 0.5%); deafness including deafness unilateral (reported as mild to moderate hearing loss or increased hearing loss) (Tobravisc 1.0%, Tobravisc 0.5%); and tinnitus (Tobravisc 1.9%, Tobravisc 2.4%).
Discontinuations in Study 1 were higher in the Tobravisc arm compared to Tobravisc (27% Tobravisc versus 18% Tobravisc). This was driven primarily by discontinuations due to adverse events (14% Tobravisc versus 8% Tobravisc). Higher rates of discontinuation were seen in subjects ≥20 years old and those with baseline FEV1 % predicted <50%.
Respiratory related hospitalizations occurred in 24% of the patients in the Tobravisc arm and 22% of the patients in the Tobravisc arm. There was an increased new usage of antipseudomonal medication in the Tobravisc arm (65% Tobravisc versus 55% Tobravisc). This included oral antibiotics in 55% of Tobravisc patients and 40% of Tobravisc patients and intravenous antibiotics in 35% of Tobravisc patients and 33% of Tobravisc patients. Median time to first antipseudomonal usage was 89 days in the Tobravisc arm and 112 days in the Tobravisc arm.
The supportive safety population reflects patients from two studies: Study 2, a double-blind, placebo-controlled design for the first treatment cycle, followed by all patients receiving Tobravisc (replaced placebo) for two additional cycles, and Study 3, a double-blind, placebo-controlled trial for one treatment cycle only. Placebo in these studies was inhaled powder without the active ingredient, Tobravisc. The patient population for these studies was much younger than in Study 1 (mean age 13 years old).
Adverse drug reactions reported more frequently by Tobravisc patients in the placebo-controlled cycle (Cycle 1) of Study 2, which included 46 Tobravisc and 49 placebo patients, were:
Respiratory, thoracic, and mediastinal disorders
Pharyngolaryngeal pain (Tobravisc 10.9%, placebo 0%); dysphonia (Tobravisc 4.3%, placebo 0%)
Gastrointestinal disorders
Dysgeusia (Tobravisc 6.5%, placebo 2.0%)
Adverse drug reactions reported more frequently by Tobravisc patients in Study 3, which included 30 Tobravisc and 32 placebo patients, were:
Respiratory, thoracic, and mediastinal disorders
Cough (Tobravisc 10%, placebo 0%)
Ear and labyrinth disorders
Hypoacusis (Tobravisc 10%, placebo 6.3%)
Audiometric Assessment
In Study 1, audiology testing was performed in a subset of approximately 25% of Tobravisc (n=78) and Tobravisc (n=45) patients. Using the criteria for either ear of ≥10 dB loss at two consecutive frequencies, ≥20 dB loss at any frequency, or loss of response at three consecutive frequencies where responses were previously obtained, five Tobravisc patients and three Tobravisc patients were judged to have ototoxicity, a ratio similar to the planned 3:2 randomization for this study.
Audiology testing was also performed in a subset of patients in both Study 2 (n=13 from the Tobravisc group and n=9 from the placebo group) and Study 3 (n=14 from the Tobravisc group and n=11 from the placebo group). In Study 2, no patients reported hearing complaints but two Tobravisc patients met the criteria for ototoxicity. In Study 3, three Tobravisc and two placebo patients had reports of ‘hypoacusis.’ One Tobravisc and two placebo patients met the criteria for ototoxicity. In some patients, ototoxicity was transient or may have been related to a conductive defect.
Cough
Cough is a common symptom in cystic fibrosis, reported in 42% of the patients in Study 1 at baseline. Cough was the most frequently reported adverse event in Study 1 and was more common in the Tobravisc arm (48% Tobravisc versus 31 % Tobravisc). There was a higher rate of cough adverse event reporting during the first week of active treatment with Tobravisc (i.e., the first week of Cycle 1). The time to first cough event in the Tobravisc and Tobravisc groups were similar thereafter. In some patients, cough resulted in discontinuation of Tobravisc treatment. Sixteen patients (5%) receiving treatment with Tobravisc discontinued study treatment due to cough events compared with 2 (1%) in the Tobravisc treatment group. Children and adolescents coughed more than adults when treated with Tobravisc, yet the adults were more likely to discontinue: of the 16 patients on Tobravisc in Study 1 who discontinued treatment due to cough events, 14 were ≥20 years of age, one patient was between the ages of 13 and <20, and one was between the ages of 6 and <13. The rates of bronchospasm (as measured by ≥20% decrease in FEV1 % predicted post-dose) were approximately 5% in both treatment groups, and none of these patients experienced concomitant cough.
In Study 2, cough was the most commonly reported adverse event during the first cycle of treatment (the double blind period of treatment) and occurred more frequently in placebo-treated patients (26.5%) than patients treated with Tobravisc (13%). Similar percentages of patients in both treatment groups reported cough as a baseline symptom. In Study 3, cough events were reported by three patients in the Tobravisc group (10%) and none in the placebo group (0%).
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Tobravisc. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Respiratory, thoracic, and mediastinal disorders
Aphonia, Sputum discolored
General disorders and administration site conditions
Malaise
Tobravisc contraindications
See also:
What is the most important information I should know about Tobravisc?
A hypersensitivity to any aminoglycoside is a contraindication to the use of Tobravisc. A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.
Active ingredient matches for Tobravisc:
Tobramycin in Belgium, Luxembourg, United Kingdom.
List of Tobravisc substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Tobravis (Bosnia & Herzegowina) | |
| Tobravisc 0.3% (Slovakia) | |
| Tobravision (Colombia) | |
| Tobrawal | |
| Tobrawal E/E 5 ml Drop (Radicura Pharmaceutical Pvt. Ltd.) | $ 0.26 |
| TOBRAZID (Germany) | |
| TOBRAZID 40 mg/ml (Germany) | |
| Tobrazol (Peru) | |
| TOBREAGE DPS (India) | |
| 0.3 % x 5ml (P & B) | $ 0.34 |
| Tobreage DPS 0.3% EYE-DPS / 5ml (P & B) | $ 0.34 |
| TOBREAGE DPS eye drops 0.3 % x 5ml (P & B) | $ 0.34 |
| Tobreage DPS 0.3% EYE-DPS / 5ml (P & B) | $ 0.34 |
| TOBREB (India) | |
| TOBREB Injection / 80mg / 2ml units (Taurus Laboratories Pvt. Ltd.) | $ 0.42 |
| 80 mg x 2ml (Taurus Laboratories Pvt. Ltd.) | $ 0.42 |
| Tobreb Eye 5 ml Drop (Taurus Laboratories Pvt. Ltd.) | $ 0.25 |
| Tobreb 80 mg Injection (Taurus Laboratories Pvt. Ltd.) | $ 0.42 |
| Tobreb 80mg VIAL / 2ml (Taurus Laboratories Pvt. Ltd.) | $ 0.42 |
| TOBREB inj 80 mg x 2ml (Taurus Laboratories Pvt. Ltd.) | $ 0.42 |
| Tobreb 80mg VIAL / 2ml (Taurus Laboratories Pvt. Ltd.) | $ 0.42 |
| TOBREB DPS (India) | |
| 0.3 % x 5ml (Taurus Labs) | $ 0.25 |
| Tobreb DPS 0.3% EYE-DPS / 5ml (Taurus Labs) | $ 0.25 |
| TOBREB DPS eye drops 0.3 % x 5ml (Taurus Labs) | $ 0.25 |
| Tobreb DPS 0.3% EYE-DPS / 5ml (Taurus Labs) | $ 0.25 |
| Tobrel (Bangladesh) | |
| Tobrex 0.3% (Egypt) | |
| Tobrex 0.3% Eye Drop (Alcon Laboratories) | $ 1.12 |
| Tobrex 2 x (Romania) | |
| Tobrex 2X (Israel, Russian Federation) | |
| Drops; Ophthalmic; Tobramycin 0.3% | |
| Tobrex 3mg/g (Hungary, Luxembourg) | |
| Tobrex 3mg/ml (Hungary, Luxembourg) | |
| Tobrex Depot (Denmark, Finland, Sweden) | |
| Tobrex LA (Czech Republic) | |
| Tobrex Ophthalmic Ointment | |
| Tobrexan (Poland) | |
| Tobrexan solution 0.3 % (Alcon) | |
| Tobridavi (Portugal) | |
| Tobrimed (Georgia) | |
| Tobrin (Bahrain, Bulgaria, Chile, Egypt, Georgia, Iraq, Jordan, Kuwait, Lebanon, Libya, Lithuania, Oman, Qatar, Romania, Saudi Arabia, Sudan, United Arab Emirates, Yemen) | |
| Ointment; Ophthalmic; Tobramycin 0.3% (Talson Pharmaceuticals) | |
| Solution; Ophthalmic; Tobramycin 0.3% (Talson Pharmaceuticals) | |
| Tobrin 1 Bottle 5 mL (Talson Pharmaceuticals) | |
| 0.3 % x 5ml (Talson Pharmaceuticals) | $ 0.30 |
| Tobrin Eye 5 ml Drop (Talson Pharmaceuticals) | $ 0.30 |
| Tobrin 0.3% EYE-DPS / 5ml (Talson Pharmaceuticals) | $ 0.30 |
| TOBRIN eye drops 0.3 % x 5ml (Talson Pharmaceuticals) | $ 0.30 |
| Tobrin 0.3% (Egypt) | |
See 947 substitutes for Tobravisc | |
References
- DailyMed. "TOBRAMYCIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "tobramycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "tobramycin". http://www.drugbank.ca/drugs/DB00684 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Tobravisc are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tobravisc. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
