tobramycin inhaled (Rx)

Brand and Other Names:TOBI, Bethkis, more...TOBI Podhaler, Kitabis Pak
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for nebulization

  • 300mg/4mL ampule (Bethkis)
  • 300mg/5mL ampule (TOBI, Kitabis Pak)
  • NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)

powder for inhalation

  • 28mg/capsule
more...

Pseudomonas aeruginosa Infection

Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis

Nebulizer: 300 mg inhaled orally via nebulizer BID

Powder for inhalation: 4 capsules (28 mg/capsule) inhaled PO BID

Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on drug, followed by 28 days off drug, then resume therapy with the next 28 day on/28 day off cycle

Dosing Considerations

Safety and efficacy not established in the following patients

  • Age <6 years
  • FEV1 <25% or >80% predicted
  • Colonized with Burkholderia cepacia

Administration

For oral inhalation only

Bethkis: Administer using a hand-held PARI LC Plus reusable nebulizer with a APRI Vios Air compressor over ~15 minutes

TOBI: Administer using a hand-held PARI LC Plus reusable nebulizer with a DeVilbiss Pulmo-Aide compressor over ~15 minutes

Kitabis: Administer using PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor over ~15 minutes

TOBI Podhaler: For use with Podhaler device for oral inhalation; do not swallow capsules

Doses should be taken as close to 12 hr apart as possible; and, not less than 6 hr apart

Do not dilute or mix with dornase alfa in nebulizer; patients taking multiple therapies should take other nebulized therapies first, followed by tobramycin inhaled

Storage

  • Store ampules refrigerated (2-8°C [36-46°F])
  • Avoid exposure to intense light
  • May store the ampules foil pouches (opened or unopened) at room temperature (up to 25°C [77°F]) for up to 28 days
  • Unrefrigerated solution may slightly darken beyond its normally light yellow color; however the quality/potency of the solution is maintained for up to 28 days

Bronchiectasis (Orphan)

TOBI: Orphan designation for treatment of bronchiectasis patients infected with Pseudomonas aeruginosa

Orphan sponsor

  • Novartis Pharmaceuticals Corp; Drug Regulatory Affairs; One Health Plaza; East Hanover, NJ 07936-1080

Dosage Forms & Strengths

solution for nebulization

  • 300mg/4mL ampule (Bethkis)
  • 300mg/5mL ampule (TOBI, Kitabis Pak)
  • NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)

powder for inhalation

  • 28mg/capsule
more...

Pseudomonas aeruginosa Infection

Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis

<6 years: Safety and efficacy not established

≥6 years

  • Nebulizer: 300 mg inhaled orally via nebulizer BID
  • Powder for inhalation: 4 capsules (28 mg/capsule) inhaled PO BID
  • Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on drug, followed by 28 days off drug, then resume therapy with the next 28 day on/28 day off cycle

Dosing Considerations

Safety and efficacy not established in the following patients

  • Age <6 years
  • FEV1 <25% or >80% predicted
  • Colonized with Burkholderia cepacia

Administration

For oral inhalation only

Bethkis: Administer using a hand-held PARI LC Plus reusable nebulizer with a APRI Vios Air compressor over ~15 minutes

TOBI: Administer using a hand-held PARI LC Plus reusable nebulizer with a DeVilbiss Pulmo-Aide compressor over ~15 minutes

Kitabis: Administer using PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor over ~15 minutes

TOBI Podhaler: For use with Podhaler device for oral inhalation; do not swallow capsules

Doses should be taken as close to 12 hr apart as possible; and, not less than 6 hr apart

For patients taking several different inhaled medications and/or performing chest physiotherapy, it is recommended that TOBI Podhaler is taken last

Storage

  • Store ampules refrigerated (2-8°C [36-46°F])
  • Avoid exposure to intense light
  • May store the ampules foil pouches (opened or unopened) at room temperature (up to 25°C [77°F]) for up to 28 days
  • Unrefrigerated solution may slightly darken beyond its normally light yellow color; however the quality/potency of the solution is maintained for up to 28 days
Next:

Interactions

Interaction Checker

and tobramycin inhaled

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Voice alteration (12.8%)

            1-10%

            Myalgia (4.7%)

            Laryngitis (4.3%)

            Tinnitus (3%)

            Epistaxis (3%)

            Postmarketing Reports

            General disorders: Malaise

            Ear and labyrinth disorders: Hearing loss

            Skin and subcutaneous tissue disorders: Hypersensitivity, pruritus, urticaria, rash

            Nervous system disorders: Aphonia, dysgeusia

            Respiratory, thoracic, and mediastinal disorders: Bronchospasm, oropharyngeal pain, sputum discolored

            Decreased appetite

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Known or suspected renal, auditory, vestibular, or neuromuscular dysfunction

            Carefully monitor if on concomitant parenteral aminoglycosides

            Tinnitus occurred in clinical trials of inhaled tobramycin; however, ototoxicity did not occur (postmarketing experience reported hearing loss, see Adverse Effects)

            Nephrotoxicity not observed in clinical trials, but has been associated with aminoglycosides as a class

            May exacerbate muscular disorders (eg, myasthenia gravis, Parkinson disease); aminoglycosides aggravate muscle weakness because of a curare-like effect

            Bronchospasm can occur

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Unknown whether inhaled tobramycin will reach sufficient concentration to be distributed in breast milk; because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate breastfeeding or discontinue inhaled tobramycin

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Aminoglycoside that acts by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death

            In vitro activity against wide range of gram-negative organisms including Pseudomonas aeruginosa

            Absorption

            Sputum Concentration (10 min post dose): 1154 mcg/g (range: 39-8085 mcg/g)

            Serum Concentration (1 hr post dose): 0.95 mcg/mL (single dose); 1.05 mcg/mL (after 20 weeks of therapy)

            Elimination

            Half-life: 2 hr (IV)

            Excretion: Unabsorbed drug eliminated primarily in expectorated sputum

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous