Tobramycin (Tobi)

Trade Name : TOBI

Novartis Pharmaceuticals Corporation

SOLUTION

Strength 300 mg/5mL

TOBRAMYCIN Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tobramycin (Tobi) which is also known as TOBI and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 300 mg/5mL per ml. Read more

Tobramycin (Tobi) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Warnings and Precautions, Ototoxicity ()u00a0u00a0u00a0u00a0u00a010/2018

TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with .
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV) < 25% or > 75% predicted, or patients colonized with u00a0
TOBI is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with .
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV) < 25% or > 75% predicted, or patients colonized with .

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TOBI is supplied as a sterile inhalational solution for nebulization in single-dose 5 mL ampoules. Each 5 mL ampoule contains 300 mg of tobramycin.

u2022
3

TOBI is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
Known hypersensitivity to any aminoglycoside ()

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Bronchospasm:
Ototoxicity:
Nephrotoxicity:
Neuromuscular Disorders:
Embryo-fetal Toxicity:

The following serious adverse reactions are described below and elsewhere in the labeling:
Most common adverse reactions (incidence > 5%) are increased cough, pharyngitis, increased sputum, dyspnea, hemoptysis, decreased lung function, voice alteration, taste perversion and rash. ()
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .

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Signs and symptoms of acute toxicity from overdosage of intravenous (IV) tobramycin might include dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. Administration by inhalation results in low systemic bioavailability of tobramycin. Tobramycin is not significantly absorbed following oral administration. Tobramycin serum concentrations may be helpful in monitoring overdosage.
Acute toxicity should be treated with immediate withdrawal of TOBI, and baseline tests of renal function should be undertaken.
In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.
Hemodialysis may be helpful in removing tobramycin from the body.

TOBIu00a0is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic,u00a0aqueous solution with the pH and salinity adjusted specifically for administration by a compressed airu00a0driven reusable nebulizer. The chemical formula for tobramycin is CHNO and the molecular weightu00a0is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-u03b1-D-glucopyranosyl-(1u21924)-O-[2,6-diamino-2,3,6-u00a0trideoxy-u03b1-D-ribo-hexopyranosyl-(1u21926)]-2-deoxy-L-streptamine. The structural formula foru00a0tobramycin is:
Each single-dose 5 mL ampoule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.

No data

A two-year rat inhalation toxicology study to assess carcinogenic potential of TOBI has been completed. Rats were exposed to TOBI for up to 1.5 hours per day for 95 weeks. The clinical formulation of the drug was used for this carcinogenicity study. Serum levels of tobramycin of up to 35 mcg/mL were measured in rats, in contrast to the average 1 mcg/mL levels observed in cystic fibrosis patients in clinical trials. There was no drug-related increase in the incidence of any variety of tumor.
Additionally, tobramycin has been evaluated for genotoxicity in a battery of and tests. The Ames bacterial reversion test, conducted with 5 tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains. Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test.
Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.

Two identically designed, double-blind, randomized, placebo-controlled, parallel group, 24-weeku00a0clinical studies (Study 1 and Study 2) at a total of 69 cystic fibrosis centers in the United States wereu00a0conducted in cystic fibrosis patients with . Subjects who were less than 6 years of age, hadu00a0a baseline creatinine of > 2 mg/dL, or had isolated from sputum were excluded.u00a0
All subjects had baseline FEV% predicted between 25% and 75%. In these clinical studies, 258u00a0patients received TOBI therapy on an outpatient basis (see Table 2) using a hand-held PARI LC PLUSu00a0Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor.
All patients received either TOBI or placebo (saline with 1.25 mg quinine for flavoring) in addition to standard treatment recommended for cystic fibrosis patients, which included oral and parenteral antipseudomonal therapy, u03b22-agonists, cromolyn, inhaled steroids, and airway clearance techniques. In addition, approximately 77% of patients were concurrently treated with dornase alfa (PULMOZYME, Genentech).
In each study, TOBI-treated patients experienced significant improvement in pulmonary function. Improvement was demonstrated in the TOBI group in Study 1 by an average increase in FEV% predicted of about 11% relative to baseline (Week 0) during 24 weeks compared to no average change in placebo patients. In Study 2, TOBI-treated patients had an average increase of about 7% compared to an average decrease of about 1% in placebo patients. Figure 1 shows the average relative change in FEV% predicted over 24 weeks for both studies.
In each study, TOBI therapy resulted in a significant reduction in the number of colonyu00a0forming units (CFUs) in sputum during the on-drug periods. Sputum bacterial density returned tou00a0baseline during the off-drug periods. Reductions in sputum bacterial density were smaller in eachu00a0successive cycle (see Figure 2).
Patients treated with TOBI were hospitalized for an average of 5.1 days compared to 8.1 days for placebo patients. Patients treated with TOBI required an average of 9.6 days of parenteral antipseudomonal, antibacterial treatment compared to 14.1 days for placebo patients. During the 6 months of treatment, 40% of TOBI patients and 53% of placebo patients were treated with parenteral antipseudomonal antibacterials.
The relationship between susceptibility test results and clinical outcome with TOBI therapy isu00a0not clear. However, four TOBI patients who began the clinical trial with isolates having MICu00a0values u2265 128 mcg/mL did not experience an improvement in FEVor a decrease in sputum bacterialu00a0density.
Treatment with TOBI did not affect the susceptibility of the majority of isolates duringu00a0the 6-month studies. However, some isolates did exhibit increased tobramycin MICs. Theu00a0percentage of patients with isolates with tobramycin MICs u2265 16 mcg/mL was 13% at theu00a0beginning, and 23% at the end of 6 months of the TOBI regimen.

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Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Difficulty Breathing:
Advise patients to inform their physicians if they experience shortness of breath or wheezing after administration of tobramycin inhalation solution. Tobramycin inhalation solution can cause a narrowing of the airway [].
Hearing Loss:
Advise patients to inform their physician if they experience ringing in the ears, dizziness, or any changes in hearing because tobramycin inhalation solution has been associated with hearing loss [].
Kidney Damage:
Advise patients to inform their physician if they have any history of kidney problems because tobramycin inhalation solution is in a class of drugs that have caused kidney damage [].
Embryo-fetal Toxicity:
Advise pregnant women that aminoglycosides can cause irreversible congenital deafness when administered to a pregnant woman [].
Lactation:
Advise a woman to monitor their breastfed infants for diarrhea and/or bloody stools [].
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
u00a9 Novartis
T2018-120

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 10/2018
u00a9 NovartisT2018-121
Instructions for Use
TOBI (TOH-bee) (tobramycin inhalation solution) for oral inhalation use
Read this Instructions for Use before you start using TOBI inhalation solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.n
TOBI is made for inhalation using a PARI LC PLUSu2122 Reusable Nebulizer and a DeVilbissu00ae Pulmo-Aideu00ae air compressor. TOBI can be taken at home, school, or at work. The following instructions tell you how to use the DeVilbiss Pulmo-Aide air compressor and PARI LC PLUS Reusable Nebulizer to administer TOBI.
You will need the following supplies (See Figure A)
It is important that your nebulizer and compressor function properly before starting your TOBI therapy.
Note: Read the manufacturer care and use instructions for important information.
Prepare Your TOBI for Inhalation Therapy
Step 1:
Stepn- 2:
Step 3:n- (See Figure B)
Step 4: n- (See Figure C)n- Do not
Step 5:
Step 6:n- (See Figure D)
Step 7:n- (See Figure E).
Step 8:n- (See Figure F).
Step 9:n- (See Figure G).
Step 10:n- (See Figure H)
Step 11:n- (See Figure I).
Step 12n- (See Figure J)
Step 13:n- (See Figure K).
Step 14:n- (See Figure L)
Step 15:n- (See Figure M).
Step 16:n- (See Figure N).n- Make sure to keep the Nebulizer Cup upright.
Giving your TOBI Inhalation Therapy
Step 17:n- (See Figure O)
Step 18:n- (See Figure P).
Step 19:n- (See Figure Q).n- Do not
Step 20
If you are interrupted, need to cough or rest during your TOBI treatment, turn off the compressor to save your medicine. Turn the compressor back on when you are ready to restart your treatment.
Follow the nebulizer cleaning and disinfecting instructions after completing your therapy.
After your TOBI Inhalation Therapy
Cleaning Your Nebulizer
To reduce the risk of infection, illness or injury from contamination, you must thoroughly clean all parts of the nebulizer as instructed after each treatment. Never use a nebulizer with a clogged nozzle. If the nozzle is clogged, no aerosol mist is made, and your therapy will not be as effective. Replace the nebulizer if clogging occurs.
You can also wash all parts of the nebulizer in a dishwasher (except tubing).
Disinfecting Your Nebulizer
Your nebulizer is for your use only. share your nebulizer with other people. You must disinfect the nebulizer every other treatment day. Failure to disinfect the nebulizer every other treatment day could lead to serious or fatal illness.
Clean the nebulizer as described above. Every other treatment day, disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes. Dry parts on a clean, lint-free cloth.
Care and Use of Your Pulmo-Aide Compressor
Follow the manufacturer instructions for care and use of your compressor.
Filter Change:
Compressor Cleaning:
Caution: submerge in water because this will damage the compressor.
How should I store TOBI?
Keep TOBI and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Additional Information
Nebulizer: 1-800-327-8632
Compressor: 1-800-338-1988
TOBI: 1-888-NOW-NOVA (1-888-669-6682)
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
u00a9 Novartis
IFU:TOBRIS:RX12/2018

NDC 0078-0494-71
TOBIn Tobramycin Inhalation Solution, USP
300 mg / 5 mL Ampules56 Single-Use Ampules (28-Day Supply)
Store In Refrigerator
Contents:
Dosage and Administration:
Storage:
U.S. Patent 5,508,269; other patents pending.
Store In Refrigerator
For more information, call1-888-NOW-NOVA (1-888-669-6682)
Manufactured by:Catalent Pharma Solution, LLCWoodstock, Illinois 60098
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
PCR-700-11544 US

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Tobramycin (Tobi)

Trade Name : TOBI

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Tobramycin (Tobi)

Trade Name : TOBI

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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