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Tobramycin

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Overview

What is TOBI Podhaler?

TOBI Podhaler consists of a dry powder formulation of tobramycin for oral inhalation only with the Podhaler device. The inhalation powder is filled into clear, colorless hypromellose capsules.

Each clear, colorless hypromellose capsule contains a spray dried powder of 28 mg of tobramycin active ingredient with 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment).

The active component of TOBI Podhaler is tobramycin. Tobramycin is an aminoglycoside antibiotic. Its chemical name is -3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)--[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine; its structural formula is:

Tobramycin has a molecular weight of 467.52, and its empirical formula is CHNO. Tobramycin is a white to almost white powder; visually free from any foreign contaminants. Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether.

The Podhaler device is a plastic device used to inhale the dry powder contained in the TOBI Podhaler capsule. Under standardized testing at a fixed flow rate of 60 L/min and volume of 2 L for 2 seconds, the Podhaler device has a target delivered dose of 102 mg of tobramycin from the mouthpiece (4 capsules per dose). Peak inspiratory flow rate and inhaled volumes were explored in 96 cystic fibrosis patients aged 6 years and older. Older patients with significant disease progression and associated decreases in forced expiratory volume (FEV) and younger patients with inhaled volumes <1 L were able to generate inspiratory flow rates and volumes required to receive their medication when following the instructions for use. However, no pediatric patients aged 6 to 10 years with FEV less than 40% predicted were evaluated.



What does TOBI Podhaler look like?



What are the available doses of TOBI Podhaler?

Inhalation powder: 28 mg in a capsule ()

What should I talk to my health care provider before I take TOBI Podhaler?

     

How should I use TOBI Podhaler?

TOBI Podhaler is indicated for the management of cystic fibrosis patients 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 >80% predicted, or patients colonized with .

DO NOT SWALLOW TOBI PODHALER CAPSULES

FOR USE WITH THE PODHALER DEVICE ONLY

FOR ORAL INHALATION ONLY 

TOBI Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained. The contents of TOBI Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device.

The recommended dosage of TOBI Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg TOBI Podhaler capsules twice-daily for 28 days using the Podhaler device.

Refer to the Instructions For Use (IFU) for full administration information.

Dosage is not adjusted by weight. Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.

TOBI Podhaler is administered twice-daily in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.

TOBI Podhaler capsules should always be stored in the blister and each capsule should only be removed IMMEDIATELY BEFORE USE.

For patients taking several different inhaled medications and/or performing chest physiotherapy, the order of therapies should follow the physician’s recommendation. It is recommended that TOBI Podhaler is taken last.


What interacts with TOBI Podhaler?

Sorry No Records found


What are the warnings of TOBI Podhaler?

Sorry No Records found


What are the precautions of TOBI Podhaler?

Sorry No Records found


What are the side effects of TOBI Podhaler?

Sorry No records found


What should I look out for while using TOBI Podhaler?

TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside.


What might happen if I take too much TOBI Podhaler?

The maximum tolerated daily dose of TOBI Podhaler has not been established.

In the event of accidental oral ingestion of TOBI Podhaler capsules, systemic toxicity is unlikely as tobramycin is poorly absorbed. Tobramycin serum concentrations may be helpful in monitoring overdosage.

Acute toxicity should be treated with immediate withdrawal of TOBI Podhaler, and baseline tests of renal function should be undertaken.

Hemodialysis may be helpful in removing tobramycin from the body.

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 TOBI Podhaler?

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)Protect TOBI Podhaler from moisture.Keep this and all drugs out of the reach of children.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)Protect TOBI Podhaler from moisture.Keep this and all drugs out of the reach of children.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)Protect TOBI Podhaler from moisture.Keep this and all drugs out of the reach of children.Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Tobramycin is an aminoglycoside antibiotic .

Non-Clinical Toxicology
TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Drug Interactions:

Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition

Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, doetilide) have not been performed, but caution is advised (see ).

Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction.

Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies . Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.

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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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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