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Tobramycin (Tobramycin)

Trade Name : Tobramycin

Teva Pharmaceuticals USA, Inc.

SOLUTION

Strength 300 mg/5mL

TOBRAMYCIN Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]

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

Tobramycin (Tobramycin) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Tobramycin inhalation solution 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 (FEV1) <25% or >75% predicted, or patients colonized with n
  • Tobramycin inhalation solution 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 (FEV1) <25% or >75% predicted, or patients colonized with ()
  • No data
  • For oral inhalation only. ()
  • The recommended dosage for adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) twice daily by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug. ()
  • Dosage is not adjusted by weight. ()
  • Take doses as close to 12 hours apart as possible; but not less than 6 hours apart. ()
  • Administer each 300 mg dose by inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. ()
  • Tobramycin Inhalation Solution USP is supplied as a sterile inhalational solution for nebulization in single-dose 5 mL ampules. Each 5 mL ampule contains 300 mg of tobramycin.
  • Inhalation Solution: 300 mg per 5 mL solution in a single-dose ampule ()
  • Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
  • Known hypersensitivity to any aminoglycoside ()
  • No data
  • Bronchospasm: Can occur with inhalation of tobramycin inhalation solution. Treat as medically appropriate, if it occurs. ()
  • Ototoxicity: Tinnitus and hearing loss have been reported in patients receiving tobramycin inhalation solution. If noted, manage as medically appropriate, including potentially discontinuing tobramycin inhalation solution. ()
  • Nephrotoxicity: Has been associated with aminoglycosides as a class. If nephrotoxicity develops, manage the patient as medically appropriate, including potentially discontinuing tobramycin inhalation solution. ()
  • Neuromuscular Disorders: Aminoglycosides may aggravate muscle weakness because of a potential curareu2010like effect on neuromuscular function. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary. ()
  • Embryo-fetal Toxicity: Aminoglycosides can cause fetal harm (, )
  • 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 Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided ()
  • Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity ().
  • No data
  • 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 tobramycin inhalation solution, and baseline tests of renal function should be undertaken.n
  • 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.n
  • Hemodialysis may be helpful in removing tobramycin from the body.n
  • Tobramycin Inhalation Solution USP is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin, USP is CHNO and the molecular weight is 467.52. Tobramycin, USP is -3-amino-3-deoxy-u03b1-D-glucopyranosyl-(1u21924)--[2,6-diamino-2,3,6-trideoxy-u03b1-D--hexopyranosyl-(1u21926)]-2-deoxy-L-streptamine. The structural formula for tobramycin, USP is:
  • Each single-dose 5 mL ampule contains 300 mg tobramycin, USP 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 tobramycin inhalation solution has been completed. Rats were exposed to tobramycin inhalation solution 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 n 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.n
  • 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.n
  • Two identically designed, double-blind, randomized, placebo-controlled, parallel group, 24-week clinical studies (Study 1 and Study 2) at a total of 69 cystic fibrosis centers in the United States were conducted in cystic fibrosis patients with . Subjects who were less than 6 years of age, had a baseline creatinine of >2 mg/dL, or had isolated from sputum were excluded.
  • All subjects had baseline FEV % predicted between 25% and 75%. In these clinical studies, 258 patients received tobramycin inhalation solution therapy on an outpatient basis (see Table 2) using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor.
  • Table 2: Dosing Regimens in Clinical Studies
  • All patients received either tobramycin inhalation solution 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, tobramycin inhalation solution -treated patients experienced significant improvement in pulmonary function. Improvement was demonstrated in the tobramycin inhalation solution 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, tobramycin inhalation solution-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.
  • Figure 1: Relative Change From Baseline in FEV% Predicted
  • Arrayn- Array
  • In each study, tobramycin inhalation solution therapy resulted in a significant reduction in the number of colony forming units (CFUs) in sputum during the on-drug periods. Sputum bacterial density returned to baseline during the off-drug periods. Reductions in sputum bacterial density were smaller in each successive cycle (see Figure 2).
  • Figure 2: Absolute Change From Baseline in Log CFUs
  • Arrayn- Array
  • Patients treated with tobramycin inhalation solution were hospitalized for an average of 5.1 days compared to 8.1 days for placebo patients. Patients treated with tobramycin inhalation solution 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 tobramycin inhalation solution patients and 53% of placebo patients were treated with parenteral antipseudomonal antibacterials.
  • The relationship between susceptibility test results and clinical outcome with tobramycin inhalation solution therapy is not clear. However, 4 tobramycin inhalation solution patients who began the clinical trial with isolates having MIC values u2265128 mcg/mL did not experience an improvement in FEV or a decrease in sputum bacterial density.
  • Treatment with tobramycin inhalation solution did not affect the susceptibility of the majority of isolates during the 6-month studies. However, some isolates did exhibit increased tobramycin MICs. The percentage of patients with isolates with tobramycin MICs u226516 mcg/mL was 13% at the beginning, and 23% at the end of 6 months of the tobramycin inhalation solution regimen.
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Difficultyu00a0n- 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 n n n n
  • 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 n n n
  • 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 [see Warnings and Precautions ()].n
  • Embryofetal Toxicity:
  • Advise pregnant women that aminoglycosides can cause irreversible congenital deafness when administered to a pregnant woman n n
  • Lactation:
  • Advise a woman to monitor their breastfed infants for diarrhea and/or bloody stools n n n
  • Manufactured In England By:n Runcorn, Cheshire WA7 3FA England
  • Manufactured For:n North Wales, PA 19454
  • Rev. H 1/2019n
  • No data
  • Instructions for Use
  • Tobramycin (toeu2033 bra myeu2032 sin) Inhalation Solution
  • for oral inhalation use
  • Rx only
  • Read this Instructions for Use before you start using tobramycin 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.
  • Tobramycin inhalation solution is made for inhalation using a PARI LC PLUSu2122 Reusable Nebulizer (manufactured by PARI International) and a DeVilbiss Pulmo-Aide air compressor (manufactured by DeVilbiss International). Tobramycin inhalation solution 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 PLUSu2122 Reusable Nebulizer to administer tobramycin inhalation solution.n
  • You will need the following supplies (See Figure A):
  • (Figure A)
  • Arrayn- Array
  • It is important that your nebulizer and compressor function properly before starting your tobramycin inhalation solution therapy.n
  • Note: Read the manufacturer care and use instructions for important information.n
  • Prepare Your Tobramycin Inhalation Solution for Inhalation Therapy
  • Step 1:
  • Step 2:
  • Step 3:n- See Figure B
  • (Figure B)
  • Step 4:n- See Figure Cn- Do not
  • (Figure C)
  • Arrayn- Array
  • Step 5:
  • Step 6:n- See Figure D
  • (Figure D)
  • Arrayn- Array
  • Step 7:n- See Figure E
  • (Figure E)
  • Arrayn- Array
  • Step 8:n- See Figure F
  • (Figure F)
  • Arrayn- Array
  • Step 9:n- See Figure G
  • (Figure G)
  • Arrayn- Array
  • u00a0
  • Step 10:n- See Figure H
  • (Figure H)
  • Arrayn- Array
  • Step 11:n- See Figure I
  • Arrayn- (Figure I)
  • Arrayn- Array
  • Step 12:n- See Figure J
  • (Figure J)
  • Arrayn- Array
  • Step 13:n- See Figure K
  • (Figure K)
  • Arrayn- Array
  • Step 14:n- See Figure L
  • (Figure L)
  • Arrayn- Array
  • Step 15: n- See Figure M
  • Arrayn- (Figure M)
  • Arrayn- Array
  • Step 16: n- See Figure Nn- Make sure to keep the Nebulizer Cup upright.
  • Arrayn- (Figure N)
  • Arrayn- Array
  • Giving Yourn- Tobramycin Inhalation Solution Inhalation Therapy
  • Step 17:n- See Figure O
  • (Figure O)
  • Step 18:n- See Figure P
  • (Figure P)
  • Arrayn- Array
  • Step 19:n- See Figure Qn- Do not
  • (Figure Q)
  • Arrayn- Array
  • Step 20:
  • If you are interrupted, need to cough or rest during your tobramycin inhalation solution treatment, turn off the compressor to save your medicine. Turn the compressor back on when you are ready to restart your treatment.n
  • Follow the nebulizer cleaning and disinfecting instructions after completing your therapy.n
  • After Your Tobramycin Inhalation Solution Inhalation Therapy
  • u00a0n- 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.
  • 1) Remove tubing from nebulizer and disassemble nebulizer parts.n
  • 2) Wash all parts (except tubing) with warm water and liquid dish soap.
  • 3) Rinse thoroughly with warm water and shake out water.
  • 4) Air dry or hand dry nebulizer parts on a clean, lint-free cloth. Reassemble nebulizer when dry, and store.
  • You can also wash all parts of the nebulizer in a dishwasher (except tubing).
  • 1) Place the nebulizer parts in a dishwasher basket.
  • 2) Place the dishwasher basket on the top rack of the dishwasher.
  • 3) Remove and dry the parts when the cycle is complete.
  • 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 Tobramycin Inhalation Solution?
  • Keep tobramycin inhalation solution and all medicines out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
  • Additional Information
  • Nebulizer: 1-800-327-8632
  • Compressor: 1-800-338-1988
  • Tobramycin Inhalation Solution (Teva Pharmaceuticals): 1-888-838-2872.
  • Manufactured In England By:n Runcorn, Cheshire WA7 3FA England
  • Manufactured For:n North Wales, PA 19454
  • Rev. F 1/2019
  • Arrayn- Array
  • Arrayn- Array
  • NDCn- 4085
  • Tobramycinn- Inhalation Solution USPn- 300 mg/5 mL Ampules
  • PHARMACIST: Dispense the enclosed Patient Information Leaflet to each patient.Contents of the carton should not be subdivided.Retain ampules in the pouch until time of use.For more information, call 1-888-838-2872.n n
  • Rx only
  • 56 Single-Use Ampules (28-Day Supply) (4 Single-Use Ampules per pouch, 14 pouches per carton)
  • TEVA

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