What are the possible side effects of Tobramycin 80mg/2mL Faulding?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tobramycin 80mg/2mL Faulding can damage nerves and may cause hearing loss that may be permanent. Tell your doctor right away if you have:
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numbness, tingling, muscle stiffness or uncontrolled twitching;
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dizziness, spinning sensation, seizure (convulsions); or
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hearing loss, or a ringing or roaring sound in your ears (even after you have stopped using Tobramycin 80mg/2mL Faulding injection).
Call your doctor at once if you have:
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swelling, rapid weight gain, little or no urinating;
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confusion, loss of appetite, vomiting, pain in your side or lower back;
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fever; or
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severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
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headache;
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lack of energy;
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mild rash or itching;
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nausea, vomiting, diarrhea; or
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pain where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Tobramycin 80mg/2mL Faulding in details
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.
Tobramycin 80mg/2mL Faulding has been evaluated for safety in 425 cystic fibrosis patients exposed to at least one dose of Tobramycin 80mg/2mL Faulding, 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 Tobramycin 80mg/2mL Faulding with TOBI (Tobramycin 80mg/2mL Faulding 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 Tobramycin 80mg/2mL Faulding and 209 patients treated with TOBI. For both the Tobramycin 80mg/2mL Faulding and TOBI 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 Tobramycin 80mg/2mL Faulding 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 | Tobramycin 80mg/2mL Faulding N=308 % | TOBI 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 Tobramycin 80mg/2mL Faulding in Study 1 were: bronchospasm (Tobramycin 80mg/2mL Faulding 1.6%, TOBI 0.5%); deafness including deafness unilateral (reported as mild to moderate hearing loss or increased hearing loss) (Tobramycin 80mg/2mL Faulding 1.0%, TOBI 0.5%); and tinnitus (Tobramycin 80mg/2mL Faulding 1.9%, TOBI 2.4%).
Discontinuations in Study 1 were higher in the Tobramycin 80mg/2mL Faulding arm compared to TOBI (27% Tobramycin 80mg/2mL Faulding versus 18% TOBI). This was driven primarily by discontinuations due to adverse events (14% Tobramycin 80mg/2mL Faulding versus 8% TOBI). 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 Tobramycin 80mg/2mL Faulding arm and 22% of the patients in the TOBI arm. There was an increased new usage of antipseudomonal medication in the Tobramycin 80mg/2mL Faulding arm (65% Tobramycin 80mg/2mL Faulding versus 55% TOBI). This included oral antibiotics in 55% of Tobramycin 80mg/2mL Faulding patients and 40% of TOBI patients and intravenous antibiotics in 35% of Tobramycin 80mg/2mL Faulding patients and 33% of TOBI patients. Median time to first antipseudomonal usage was 89 days in the Tobramycin 80mg/2mL Faulding arm and 112 days in the TOBI 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 Tobramycin 80mg/2mL Faulding (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, Tobramycin 80mg/2mL Faulding. 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 Tobramycin 80mg/2mL Faulding patients in the placebo-controlled cycle (Cycle 1) of Study 2, which included 46 Tobramycin 80mg/2mL Faulding and 49 placebo patients, were:
Respiratory, thoracic, and mediastinal disorders
Pharyngolaryngeal pain (Tobramycin 80mg/2mL Faulding 10.9%, placebo 0%); dysphonia (Tobramycin 80mg/2mL Faulding 4.3%, placebo 0%)
Gastrointestinal disorders
Dysgeusia (Tobramycin 80mg/2mL Faulding 6.5%, placebo 2.0%)
Adverse drug reactions reported more frequently by Tobramycin 80mg/2mL Faulding patients in Study 3, which included 30 Tobramycin 80mg/2mL Faulding and 32 placebo patients, were:
Respiratory, thoracic, and mediastinal disorders
Cough (Tobramycin 80mg/2mL Faulding 10%, placebo 0%)
Ear and labyrinth disorders
Hypoacusis (Tobramycin 80mg/2mL Faulding 10%, placebo 6.3%)
Audiometric Assessment
In Study 1, audiology testing was performed in a subset of approximately 25% of Tobramycin 80mg/2mL Faulding (n=78) and TOBI (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 Tobramycin 80mg/2mL Faulding patients and three TOBI 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 Tobramycin 80mg/2mL Faulding group and n=9 from the placebo group) and Study 3 (n=14 from the Tobramycin 80mg/2mL Faulding group and n=11 from the placebo group). In Study 2, no patients reported hearing complaints but two Tobramycin 80mg/2mL Faulding patients met the criteria for ototoxicity. In Study 3, three Tobramycin 80mg/2mL Faulding and two placebo patients had reports of ‘hypoacusis.’ One Tobramycin 80mg/2mL Faulding 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 Tobramycin 80mg/2mL Faulding arm (48% Tobramycin 80mg/2mL Faulding versus 31 % TOBI). There was a higher rate of cough adverse event reporting during the first week of active treatment with Tobramycin 80mg/2mL Faulding (i.e., the first week of Cycle 1). The time to first cough event in the Tobramycin 80mg/2mL Faulding and TOBI groups were similar thereafter. In some patients, cough resulted in discontinuation of Tobramycin 80mg/2mL Faulding treatment. Sixteen patients (5%) receiving treatment with Tobramycin 80mg/2mL Faulding discontinued study treatment due to cough events compared with 2 (1%) in the TOBI treatment group. Children and adolescents coughed more than adults when treated with Tobramycin 80mg/2mL Faulding, yet the adults were more likely to discontinue: of the 16 patients on Tobramycin 80mg/2mL Faulding 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 Tobramycin 80mg/2mL Faulding (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 Tobramycin 80mg/2mL Faulding group (10%) and none in the placebo group (0%).
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Tobramycin 80mg/2mL Faulding. 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
What is the most important information I should know about Tobramycin 80mg/2mL Faulding?
- Tobramycin 80mg/2mL Faulding solution only works against bacteria; it does not treat viral infections (eg, the common cold).
- Drinking extra fluids while you are using Tobramycin 80mg/2mL Faulding solution is recommended. Check with your doctor for instructions.
- If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Tobramycin 80mg/2mL Faulding solution, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.
- Be sure to use Tobramycin 80mg/2mL Faulding solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Tobramycin 80mg/2mL Faulding solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Tell your doctor or dentist that you take Tobramycin 80mg/2mL Faulding solution before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including kidney function, hearing tests, and Tobramycin 80mg/2mL Faulding levels, may be performed while you use Tobramycin 80mg/2mL Faulding solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Tobramycin 80mg/2mL Faulding solution should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Tobramycin 80mg/2mL Faulding solution has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tobramycin 80mg/2mL Faulding solution while you are pregnant. It is not known if Tobramycin 80mg/2mL Faulding solution is found in breast milk after inhalation. Do not breast-feed while taking Tobramycin 80mg/2mL Faulding solution.
Tobramycin 80mg/2mL Faulding contraindications
A hypersensitivity to any aminoglycoside is a contraindication to the use of Tobramycin 80mg/2mL Faulding. 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.
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).
- DTP/NCI. "tobramycin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Tobramycin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Tobramycin 80mg/2mL Faulding 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 Tobramycin 80mg/2mL Faulding. 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 side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
