Tobramycin Premix Choongwae Uses

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What is Tobramycin Premix Choongwae?

Tobramycin Premix Choongwae is an aminoglycoside (ah-meen-oh-GLY-ko-side) antibiotic. Tobramycin Premix Choongwae fights infections that are caused by bacteria.

Tobramycin Premix Choongwae inhalation is inhaled into the lungs using a nebulizer. Tobramycin Premix Choongwae inhalation is used to treat lung infections in patients with cystic fibrosis.

Tobramycin Premix Choongwae inhalation is for use in adults and children who are at least 6 years old.

Tobramycin Premix Choongwae inhalation may also be used for purposes not listed in this medication guide.

Tobramycin Premix Choongwae indications

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin Premix Choongwae injection and other antibacterial drugs, Tobramycin Premix Choongwae 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.

Tobramycin Premix Choongwae 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 Tobramycin Premix Choongwae, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin Premix Choongwae 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 Tobramycin Premix Choongwae. If susceptibility tests show that the causative organisms are resistant to Tobramycin Premix Choongwae, 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 Tobramycin Premix Choongwae sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with Tobramycin Premix Choongwae 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 Tobramycin Premix Choongwae?

Use Tobramycin Premix Choongwae ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Tobramycin Premix Choongwae ointment.

Uses of Tobramycin Premix Choongwae in details

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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 (Tobramycin Premix Choongwae; Tobramycin Premix Choongwae), or in patients colonized with Burkholderia cepacia.

Off Label Uses

Non-cystic fibrosis bronchiectasis

According to a national consensus summary and international guidelines, aerosolized Tobramycin Premix Choongwae 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 Tobramycin Premix Choongwae because the efficacy of aerosolized Tobramycin Premix Choongwae in the treatment of non-cystic fibrosis bronchiectasis has not been well documented.

Tobramycin Premix Choongwae description

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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]

Tobramycin Premix Choongwae dosage

Tobramycin Premix Choongwae Dosage

Generic name: Tobramycin Premix Choongwae 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

Administration of Tobramycin Premix Choongwae Inhalation Solution

Each dose of Tobramycin Premix Choongwae inhalation solution is administered by oral inhalation using only the co-packaged PARI LC PLUS Reusable Nebulizer (Model No. 022B81-T) included in the Tobramycin Premix Choongwae, along with a DeVilbiss Pulmo-Aide air compressor (Model No. 5650D).

Tobramycin Premix Choongwae inhalation solution is not for subcutaneous, intravenous or intrathecal administration.

Prior to administration, read the Patient Information/Instructions for Use for Tobramycin Premix Choongwae for detailed information on how to use Tobramycin Premix Choongwae and follow the manufacturer's instructions for use and care of the DeVilbiss Pulmo-Aide air compressor.

The entire Tobramycin Premix Choongwae inhalation solution treatment should take approximately 15 minutes to complete. Continue treatment until all the Tobramycin Premix Choongwae inhalation solution has been delivered, and there is no longer any mist being produced.

Tobramycin Premix Choongwae 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 Tobramycin Premix Choongwae inhalation solution, or as directed by their physician.

Tobramycin Premix Choongwae 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.

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Tobramycin Premix Choongwae interactions

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What other drugs will affect Tobramycin Premix Choongwae?

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No clinical drug interaction studies have been performed with Tobramycin Premix Choongwae. In clinical studies, patients receiving Tobramycin Premix Choongwae 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 Tobramycin Premix Choongwae 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. Tobramycin Premix Choongwae should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and Tobramycin Premix Choongwae has not been evaluated.

Tobramycin Premix Choongwae side effects

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What are the possible side effects of Tobramycin Premix Choongwae?

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 Premix Choongwae has been evaluated for safety in 425 cystic fibrosis patients exposed to at least one dose of Tobramycin Premix Choongwae, 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 Premix Choongwae with Tobramycin Premix Choongwae (Tobramycin Premix Choongwae 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 Premix Choongwae and 209 patients treated with Tobramycin Premix Choongwae. For both the Tobramycin Premix Choongwae and Tobramycin Premix Choongwae 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 Premix Choongwae 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.

Table 1: Adverse Reactions Reported in Study 1 (Occurring in ≥2% of Tobramycin Premix Choongwae Patients)
1This includes adverse events of pulmonary or cystic fibrosis exacerbations
Primary System Organ Class

Preferred Term

Tobramycin Premix Choongwae

N=308

%

Tobramycin Premix Choongwae

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 Premix Choongwae in Study 1 were: bronchospasm (Tobramycin Premix Choongwae 1.6%, Tobramycin Premix Choongwae 0.5%); deafness including deafness unilateral (reported as mild to moderate hearing loss or increased hearing loss) (Tobramycin Premix Choongwae 1.0%, Tobramycin Premix Choongwae 0.5%); and tinnitus (Tobramycin Premix Choongwae 1.9%, Tobramycin Premix Choongwae 2.4%).

Discontinuations in Study 1 were higher in the Tobramycin Premix Choongwae arm compared to Tobramycin Premix Choongwae (27% Tobramycin Premix Choongwae versus 18% Tobramycin Premix Choongwae). This was driven primarily by discontinuations due to adverse events (14% Tobramycin Premix Choongwae versus 8% Tobramycin Premix Choongwae). 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 Premix Choongwae arm and 22% of the patients in the Tobramycin Premix Choongwae arm. There was an increased new usage of antipseudomonal medication in the Tobramycin Premix Choongwae arm (65% Tobramycin Premix Choongwae versus 55% Tobramycin Premix Choongwae). This included oral antibiotics in 55% of Tobramycin Premix Choongwae patients and 40% of Tobramycin Premix Choongwae patients and intravenous antibiotics in 35% of Tobramycin Premix Choongwae patients and 33% of Tobramycin Premix Choongwae patients. Median time to first antipseudomonal usage was 89 days in the Tobramycin Premix Choongwae arm and 112 days in the Tobramycin Premix Choongwae 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 Premix Choongwae (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 Premix Choongwae. 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 Premix Choongwae patients in the placebo-controlled cycle (Cycle 1) of Study 2, which included 46 Tobramycin Premix Choongwae and 49 placebo patients, were:

Respiratory, thoracic, and mediastinal disorders

Pharyngolaryngeal pain (Tobramycin Premix Choongwae 10.9%, placebo 0%); dysphonia (Tobramycin Premix Choongwae 4.3%, placebo 0%)

Gastrointestinal disorders

Dysgeusia (Tobramycin Premix Choongwae 6.5%, placebo 2.0%)

Adverse drug reactions reported more frequently by Tobramycin Premix Choongwae patients in Study 3, which included 30 Tobramycin Premix Choongwae and 32 placebo patients, were:

Respiratory, thoracic, and mediastinal disorders

Cough (Tobramycin Premix Choongwae 10%, placebo 0%)

Ear and labyrinth disorders

Hypoacusis (Tobramycin Premix Choongwae 10%, placebo 6.3%)

Audiometric Assessment

In Study 1, audiology testing was performed in a subset of approximately 25% of Tobramycin Premix Choongwae (n=78) and Tobramycin Premix Choongwae (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 Premix Choongwae patients and three Tobramycin Premix Choongwae 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 Premix Choongwae group and n=9 from the placebo group) and Study 3 (n=14 from the Tobramycin Premix Choongwae group and n=11 from the placebo group). In Study 2, no patients reported hearing complaints but two Tobramycin Premix Choongwae patients met the criteria for ototoxicity. In Study 3, three Tobramycin Premix Choongwae and two placebo patients had reports of ‘hypoacusis.’ One Tobramycin Premix Choongwae 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 Premix Choongwae arm (48% Tobramycin Premix Choongwae versus 31 % Tobramycin Premix Choongwae). There was a higher rate of cough adverse event reporting during the first week of active treatment with Tobramycin Premix Choongwae (i.e., the first week of Cycle 1). The time to first cough event in the Tobramycin Premix Choongwae and Tobramycin Premix Choongwae groups were similar thereafter. In some patients, cough resulted in discontinuation of Tobramycin Premix Choongwae treatment. Sixteen patients (5%) receiving treatment with Tobramycin Premix Choongwae discontinued study treatment due to cough events compared with 2 (1%) in the Tobramycin Premix Choongwae treatment group. Children and adolescents coughed more than adults when treated with Tobramycin Premix Choongwae, yet the adults were more likely to discontinue: of the 16 patients on Tobramycin Premix Choongwae 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 Premix Choongwae (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 Premix Choongwae group (10%) and none in the placebo group (0%).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Tobramycin Premix Choongwae. 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

Tobramycin Premix Choongwae contraindications

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What is the most important information I should know about Tobramycin Premix Choongwae?

A hypersensitivity to any aminoglycoside is a contraindication to the use of Tobramycin Premix Choongwae. 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 Tobramycin Premix Choongwae:

Tobramycin in South Korea.


List of Tobramycin Premix Choongwae substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tobran 40 mg Injection (Redson Pharmaceuticals)$ 0.53
TOBRANEG Injection / 80mg / 2ml units (Elder Pharmaceuticals Pvt Ltd)$ 0.72
TOBRANEG Injection / 20ml / 2ml units (Elder Pharmaceuticals Pvt Ltd)$ 0.34
TOBRANEG Injection / 60mg / 1.5ml units (Elder Pharmaceuticals Pvt Ltd)$ 0.60
Tobraneg 20mg/2mL VIAL / 1 (Elder Pharmaceuticals Pvt Ltd)$ 0.48
Tobraneg 60mg/1.5mL VIAL / 1 (Elder Pharmaceuticals Pvt Ltd)$ 0.66
Tobraneg 80mg/2mL VIAL / 1 (Elder Pharmaceuticals Pvt Ltd)$ 0.80
20 mg x 2 mL x 1's (Elder Pharmaceuticals Pvt Ltd)$ 0.48
60 mg x 1.5 mL x 1's (Elder Pharmaceuticals Pvt Ltd)$ 0.66
80 mg x 2 mL x 1's (Elder Pharmaceuticals Pvt Ltd)$ 0.80
Tobraneg 80 mg Injection (Elder Pharmaceuticals Pvt Ltd)$ 0.84
Tobraneg 20 mg Injection (Elder Pharmaceuticals Pvt Ltd)$ 0.28
Tobraneg 60 mg Injection (Elder Pharmaceuticals Pvt Ltd)$ 0.60
TOBRANEG 20MG INJECTION 1 vial / 2 ML injection each (Elder Pharmaceuticals Pvt Ltd)$ 0.49
TOBRANEG 20MG INJECTION 1 vial / 2 ML injection each (Elder Pharmaceuticals Pvt Ltd)$ 0.49
TOBRANEG 60MG INJECTION 1 vial / 1 ML injection each (Elder Pharmaceuticals Pvt Ltd)$ 0.69
TOBRANEG 80MG INJECTION 1 vial / 2 ML injection each (Elder Pharmaceuticals Pvt Ltd)$ 0.87
TOBRANEG inj 20 mg x 2 mL x 2ml (Elder Pharmaceuticals Pvt Ltd)$ 0.48
TOBRANEG inj 60 mg x 1.5 mL x 1.5ml (Elder Pharmaceuticals Pvt Ltd)$ 0.72
TOBRANEG inj 80 mg x 2 mL x 2ml (Elder Pharmaceuticals Pvt Ltd)$ 0.87
Tobraneg 20mg Injection (Elder Pharmaceuticals Pvt Ltd)$ 0.25
Tobraneg 60mg Injection (Elder Pharmaceuticals Pvt Ltd)$ 0.69
Tobraneg 80mg Injection (Elder Pharmaceuticals Pvt Ltd)$ 0.41
TOBRANEG 10MG INJECTION 1 vial / 2 ML injection each (Eli Lilly and Company India Pvt Ltd)$ 0.69
TOBRANEG 60MG INJECTION 1 vial / 1 ML injection each (Eli Lilly and Company India Pvt Ltd)$ 0.48
TOBRANEG 60MG INJECTION 1 vial / 2 ML injection each (Eli Lilly and Company India Pvt Ltd)$ 0.52
TOBRANEG 80MG INJECTION 1 vial / 2 ML injection each (Eli Lilly and Company India Pvt Ltd)$ 0.83
TOBRAPIC EYE DROP 1 packet / 10 ML eye drop each (PCI Pharmaceuticals)$ 0.12

References

  1. 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).
  2. PubChem. "tobramycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "tobramycin". http://www.drugbank.ca/drugs/DB00684 (accessed September 17, 2018).

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