TOBRAMYCIN INHALATION SOLUTION PAK- tobramycin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tobramycin (UNII: VZ8RRZ51VK) (Tobramycin - UNII:VZ8RRZ51VK)

Available from:

Genericus, Inc.

INN (International Name):

Tobramycin

Composition:

Tobramycin 300 mg in 5 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)]. Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [Warnings and Precautions (5.5)] . Although there are no available data on TOBRAMYCIN INHALATION SOLUTION PAK use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3)] . There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data ). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproductive toxicity studies have been conducted with tobramycin inhalation solution. However, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes. Subcutaneous doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. Ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin. Risk Summary There are no data on the presence of tobramycin inhalation solution in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3)] . Tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TOBRAMYCIN INHALATION SOLUTION PAK and any potential adverse effects on the breastfed infant from TOBRAMYCIN INHALATION SOLUTION PAK or from the underlying maternal condition. Clinical Considerations Tobramycin may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). The safety and efficacy of tobramycin inhalation solution have not been studied in pediatric patients under 6 years of age. Clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.3)]. INSTRUCTIONS FOR USE TOBRAMYCIN INHALATION SOLUTION PAK (tobramycin inhalation solution), for oral inhalation Follow the instructions below for using TOBRAMYCIN INHALATION SOLUTION PAK which contains tobramycin inhalation solution and the PARI LC PLUS Reusable Nebulizer (PARI LC PLUS). If you have any questions, ask your healthcare provider or pharmacist. Each TOBRAMYCIN INHALATION SOLUTION PAK carton (28-day supply) contains 56 tobramycin inhalation solution ampules packed in 14 foil pouches that each contain 4 single- use tobramycin inhalation solution ampules. You will need the following supplies (See Figure A): - 1 tobramycin inhalation solution ampule - PARI LC PLUS Reusable Nebulizer - DeVilbiss Pulmo-Aide (Pulmo-Aide) air compressor - tubing to connect the nebulizer and compressor - clean, lint-free towel - nose clip (optional, not pictured) Note: Read the Instructions for Use that come with your PARI LC PLUS Reusable Nebulizer and DeVilbiss Pulmo-Aide air compressor for detailed instructions on how to use and care for your nebulizer and air compressor before you use it. Do not mix the medicine in TOBRAMYCIN INHALATION SOLUTION PAK with other medicines in your nebulizer. The medicine in TOBRAMYCIN INHALATION SOLUTION PAK (tobramycin inhalation solution) comes in a sealed foil pouch. Do not open a sealed pouch until you are ready to use a dose. After opening the pouch, unopened ampules should be returned to and stored in the pouch. Getting ready: - Open the PARI LC PLUS package. Place the PARI LC PLUS parts including Top and Bottom (Nebulizer Cup) Assembly, Inspiratory Valve Cap, Mouthpiece with Valve, and Tubing on a clean, dry surface or towel (See Figure B). Preparing your TOBRAMYCIN INHALATION SOLUTION PAK dose: Step 1: Wash your hands with soap and water (See Figure C). Step 2: Open the foil pouch (See Figure D). Step 3: Separate 1 ampule by gently pulling apart starting at the top of the ampules and continue down to the bottom tabs (See Figure E) and use it right away. Step 4: Hold the bottom tab on the TOBRAMYCIN INHALATION SOLUTION PAK ampule with 1 hand (See Figure F). With your other hand, hold the top of the ampule and twist off the top of the ampule (See Figure F). - Do not squeeze the ampule until you are ready to squeeze all of the medicine into the Nebulizer Cup. Step 5: Hold the Nebulizer Cup and twist off the Nebulizer Insert or Top in a counter-clockwise direction (See Figure G). Set the Top aside on a clean, dry, surface. Step 6: Squeeze all the medicine from the ampule into the Nebulizer Cup (See Figure H). Step 7: Replace the Nebulizer Insert. Line up the semi-circle on the Nebulizer Insert with the Nebulizer Outlet and twist on the Nebulizer Insert in a clockwise direction until it is tight and the alignment rings are lined up (See Figure I). Step 8: Push the Mouthpiece straight onto the Nebulizer Cup (See Figure J). Step 9: Firmly push the Inspiratory Valve Cap straight down onto the Nebulizer Cup Top (See Figure K). The Inspiratory Valve Cap should fit tightly. Step 10: Connect 1 end of the tubing to the compressor air outlet (See Figure L). The tubing should fit tightly. Step 11: Plug your compressor into an electrical outlet (See Figure M). Step 12: Hold the Nebulizer Cup upright and firmly push the free end of the tubing straight up onto the Air Intake on the bottom of the Nebulizer Cup (See Figure N). Make sure to keep the Nebulizer Cup upright. Giving your TOBRAMYCIN INHALATION SOLUTION PAK dose: Step 13: Turn on the compressor (See Figure O). You should see a steady mist coming from the Mouthpiece (See Figure P). Step 14: Sit or stand in a comfortable, upright position that will allow you to breathe normally. Place the Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (See Figure Q). - Nose clips may help you breathe only through your mouth and not through your nose. Step 15: Keep breathing in your TOBRAMYCIN INHALATION SOLUTION PAK dose for at least 15 minutes. You will know that you have received your full dose of medicine when you hear a “sputtering noise” coming from the Mouthpiece for at least 1 minute and the Nebulizer Cup is empty. After your TOBRAMYCIN INHALATION SOLUTION PAK dose: Step 16: Clean and disinfect your nebulizer (see manufacturer's Instructions for Use). Care and Use of your DeVilbiss Pulmo-Aide compressor: Follow the manufacturer's instructions for care and use of your compressor. How should I store TOBRAMYCIN INHALATION SOLUTION PAK? - Store tobramycin inhalation solution in the refrigerator between 36°F to 46°F (2°C to 8°C) until needed. - You may store the tobramycin inhalation solution in the foil pouches (opened or unopened) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days. - Do not use tobramycin inhalation solution after the expiration date stamped on the ampule. - Keep tobramycin inhalation solution in the foil pouch and out of the light. - Tobramycin inhalation solution is normally slightly yellow, but may get darker with age if unrefrigerated. The color change does not change how the medicine works. - Do not use tobramycin inhalation solution if it is cloudy, has particles in the solution, or if it has been stored at room temperature for more than 28 days. Throw the applicable ampule(s) away in your household trash and get a new ampule. Keep TOBRAMYCIN INHALATION SOLUTION PAK and all medicines out of the reach of children. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.         Revised: DATE Additional Information PARI LC PLUS® Reusable Nebulizer: 1-800-327-8632 DeVilbiss® Pulmo-Aide® Air Compressor: 1-800-338-1988 TOBRAMYCIN INHALATION SOLUTION PAK: 1-877-236-7239 Manufactured by: Catalent Pharma Solutions, LLC Woodstock, IL 60098 Distributed by: Genericus, Inc., Glen Allen, 23060 VA 899D9999 Rev. B 11/2019 © 2016-2019 PulmoFlow, Inc. All rights reserved.

Product summary:

TOBRAMYCIN INHALATION SOLUTION PAK co-packaged kit (NDC 70644-899-99) is available in cartons containing one reusable PARI LC PLUS nebulizer (Model No.: 022B81-TA) and 14 tobramycin inhalation solution pouches. Each pouch contains four 300 mg/5 ml ampules of tobramycin inhalation solution for a total of 56 ampules in each carton. Each carton constitutes a 28 day supply.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TOBRAMYCIN INHALATION SOLUTION PAK - TOBRAMYCIN SOLUTION
GENERICUS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOBRAMYCIN INHALATION
SOLUTION PAK SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR TOBRAMYCIN
INHALATION SOLUTION PAK.
TOBRAMYCIN INHALATION SOLUTION PAK (TOBRAMYCIN INHALATION SOLUTION),
FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
TOBRAMYCIN INHALATION SOLUTION PAK contains tobramycin, an
aminoglycoside antibacterial drug
indicated for the management of cystic fibrosis _in adults and
pediatric_ patients _6 years of age and older_
with _Pseudomonas aeruginosa_ (1).
DOSAGE AND ADMINISTRATION
TOBRAMYCIN INHALATION SOLUTION PAK is a co-packaging of tobramycin
inhalation solution with a
PARI LC PLUS
Reusable Nebulizer (2.1).
Administer tobramycin inhalation solution as one single–use ampule
(300 mg/5 mL) twice a day by oral
inhalation in alternating periods of 28 days on drug, followed by 28
days off drug (2.1).
Dosage is not adjusted by weight (2.1).
Take doses as close to 12 hours apart as possible; but not less than 6
hours apart (2.1).
Administer each 300 mg dose using the PARI LC PLUS Reusable Nebulizer
and DeVilbiss
Pulmo-Aide
compressor (2.2).
DOSAGE FORMS AND STRENGTHS
Inhalation Solution: 300 mg in a single-use 5 mL ampule (3).
CONTRAINDICATIONS
Known hypersensitivity to any aminoglycoside (4).
WARNINGS AND PRECAUTIONS
_Bronchospasm:_ Can occur with inhalation of tobramycin inhalation
solution. Treat as medically
appropriate, if it occurs (5.1).
_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 (5.2).
_Nephrotoxicity:_ Has been associated with aminoglycosides as a class.
If nephrotoxicity develops,
manage the patient as medically appropriate, including potentially
discontinuing tobramycin inhalation
solution