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tobramycin
Overview
What is BETHKIS?
BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is CHNO and the molecular weight is 467.52. Tobramycin is O‑3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine.
The structural formula for tobramycin is:
Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used to adjust the pH, as needed, to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives.
What does BETHKIS look like?
What are the available doses of BETHKIS?
A clear, colorless to pale yellow solution for oral inhalation in a single-use ampule containing 300 mg tobramycin. ()
What should I talk to my health care provider before I take BETHKIS?
How should I use BETHKIS?
BETHKIS is indicated for the management of cystic fibrosis patients with . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV less than 40% or greater than 80% predicted, or patients colonized with
.
The recommended dosage for patients six years of age and older is to administer one single-use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart.
The 300 mg/4 mL dose of BETHKIS is the same for patients regardless of age or weight. BETHKIS has not been studied in patients less than six years old.
What interacts with BETHKIS?
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What are the warnings of BETHKIS?
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What are the precautions of BETHKIS?
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What are the side effects of BETHKIS?
Sorry No records found
What should I look out for while using BETHKIS?
BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
What might happen if I take too much BETHKIS?
No overdoses have been reported with BETHKIS in clinical trials. Signs and symptoms of acute toxicity from overdosage of intravenous 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.
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.
How should I store and handle BETHKIS?
Storage and HandlingStore at room temperature; 20°C to 25°C (68°F to 77°F).Storage and HandlingStore at room temperature; 20°C to 25°C (68°F to 77°F).BETHKIS 300 mg/4 mL is a clear, colorless to pale yellow solution and is available as follows: StorageBETHKIS should be stored under refrigeration at 36‑46 °F/2‑8 °C. Upon removal from the refrigerator, or if refrigeration is unavailable, BETHKIS pouches (opened or unopened) may be stored at room temperature (up to 77 °F/25 °C) for up to 28 days. BETHKIS should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (36‑46 °F/2‑8 °C) or beyond 28 days when stored at room temperature (77 °F/25 °C). BETHKIS ampules should not be exposed to intense light. BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.BETHKIS 300 mg/4 mL is a clear, colorless to pale yellow solution and is available as follows: StorageBETHKIS should be stored under refrigeration at 36‑46 °F/2‑8 °C. Upon removal from the refrigerator, or if refrigeration is unavailable, BETHKIS pouches (opened or unopened) may be stored at room temperature (up to 77 °F/25 °C) for up to 28 days. BETHKIS should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (36‑46 °F/2‑8 °C) or beyond 28 days when stored at room temperature (77 °F/25 °C). BETHKIS ampules should not be exposed to intense light. BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.BETHKIS 300 mg/4 mL is a clear, colorless to pale yellow solution and is available as follows: StorageBETHKIS should be stored under refrigeration at 36‑46 °F/2‑8 °C. Upon removal from the refrigerator, or if refrigeration is unavailable, BETHKIS pouches (opened or unopened) may be stored at room temperature (up to 77 °F/25 °C) for up to 28 days. BETHKIS should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (36‑46 °F/2‑8 °C) or beyond 28 days when stored at room temperature (77 °F/25 °C). BETHKIS ampules should not be exposed to intense light. BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.BETHKIS 300 mg/4 mL is a clear, colorless to pale yellow solution and is available as follows: StorageBETHKIS should be stored under refrigeration at 36‑46 °F/2‑8 °C. Upon removal from the refrigerator, or if refrigeration is unavailable, BETHKIS pouches (opened or unopened) may be stored at room temperature (up to 77 °F/25 °C) for up to 28 days. BETHKIS should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (36‑46 °F/2‑8 °C) or beyond 28 days when stored at room temperature (77 °F/25 °C). BETHKIS ampules should not be exposed to intense light. BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
BETHKIS is an antibacterial drug .
Non-Clinical Toxicology
BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside.Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a "stimulating" effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs and sympathomimetic drugs.
Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.
A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).
Caution should be exercised when prescribing BETHKIS to patients with known or suspected auditory or vestibular dysfunction.
Findings related to ototoxicity as measured by audiometric evaluations and auditory adverse event reports were similar between BETHKIS and placebo in controlled clinical trials. Hearing loss was reported in two (1.1%) BETHKIS-treated patients and in one (0.9%) placebo-treated patient during clinical studies. Additionally, dizziness and vertigo, both of which may be manifestations of vestibular forms of ototoxicity, were observed in similar numbers of BETHKIS- and placebo-treated patients. Dizziness occurred in two (1.1%) BETHKIS-treated patients and one (0.9%) placebo-treated patient and vertigo occurred in two (1.1%) BETHKIS‑treated patients versus no placebo patients in clinical studies. None of the BETHKIS patients discontinued their therapy due to hearing loss, dizziness or vertigo.
Tinnitus may be a sentinel symptom of ototoxicity. No reports of tinnitus occurred in patients during clinical studies with BETHKIS, but because it has been observed with inhaled tobramycin solutions , onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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