Actions of Tobramycin Stada Pymepharco in details
Tobramycin Stada Pymepharco binds irreversibly to one of two aminoglycoside binding sites on the 30 S ribosomal subunit, inhibiting bacterial protein synthesis. Tobramycin Stada Pymepharco may also destabilize bacterial memebrane by binding to 16 S 16 S r-RNA. An active transport mechanism for aminoglycoside uptake is necessary in the bacteria in order to attain a significant intracellular concentration of Tobramycin Stada Pymepharco.
How should I take Tobramycin Stada Pymepharco?
Use Tobramycin Stada Pymepharco only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
Keep using Tobramycin Stada Pymepharco for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Tobramycin Stada Pymepharco usually comes with patient instructions. Read them carefully before using Tobramycin Stada Pymepharco. Ask your doctor if you have any questions.
If you are using the inhalation solution:
- Tobramycin Stada Pymepharco inhalation solution is packaged in small plastic containers called ampules. Each ampule contains one full dose of Tobramycin Stada Pymepharco. Do not use an ampule that has already been opened. Also, do not use an ampule of Tobramycin Stada Pymepharco after the expiration date printed on the package.
- Tobramycin Stada Pymepharco is especially formulated to be used with a PARI LC PLUS™ nebulizer. Tobramycin Stada Pymepharco® is used together with a DeVilbiss® Pulmo-Aide® compressor, while Bethkis® is used together with a PARI Vios air compressor. An air compressor is used with a nebulizer to turn the medicine into a fine spray. You will breathe the spray in through your mouth and to your lungs.
- Use the mouthpiece of the nebulizer to breathe in Bethkis®.
- You will need to use the nebulizer for about 10 to 15 minutes, or until the medicine in the nebulizer cup is gone. You may hear a sputtering sound when the cup is empty.
- Clean all the parts of the nebulizer after each use.
- You may want to rinse your mouth or suck on hard candy if Tobramycin Stada Pymepharco® inhalation solution leaves a bad taste in your mouth.
If you are using the inhalation capsule:
- Do not swallow the inhalation capsules.
- Tobramycin Stada Pymepharco is especially formulated to be used with the Podhaler™ device.
- Store the capsules in the blister pack until you are ready to use them.
- Always use a new Podhaler™ device every 7 days.
- To inhale Tobramycin Stada Pymepharco, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece in your mouth with the device upright.
- Breathe in slowly and deeply.
- Hold your breath for about 5 seconds, then breathe out slowly.
- Check if the capsule is empty after inhaling. If some powder remains in the capsule, repeat inhalation until the capsule is empty.
- Wipe the mouthpiece with a clean, dry cloth. Make sure that the Podhaler™ stays dry at all times to work the right way.
If you are taking any other medicines for cystic fibrosis, keep taking them as you did before you started using Tobramycin Stada Pymepharco, unless otherwise directed by your doctor. However, do not put any other inhaled medicine in the nebulizer at the same time that you use Tobramycin Stada Pymepharco. Other inhaled medicines may be used in a clean nebulizer before or after your treatment with Tobramycin Stada Pymepharco. It is recommended that Tobramycin Stada Pymepharco® Podhaler™ is taken last.
Dosing
The dose of Tobramycin Stada Pymepharco will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Tobramycin Stada Pymepharco. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For Pseudomonas lung infections:
- For inhalation dosage form (solution):
- Adults, teenagers, and children 6 years of age and older—One ampule or container with 300 milligrams (mg) of Tobramycin Stada Pymepharco two times a day for 28 days in the nebulizer. Then, stop using Tobramycin Stada Pymepharco and wait 28 days, and repeat the cycle (28-day on, 28-day off cycle). You should space the doses at least 6 hours apart.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For inhalation dosage form (capsule):
- Adults, teenagers, and children 6 years of age and older—Four capsules with 28 milligrams (mg) of Tobramycin Stada Pymepharco two times a day for 28 days in the Podhaler™ device. Then, stop using Tobramycin Stada Pymepharco and wait 28 days, and repeat the cycle (28-day on, 28-day off cycle). You should space the doses at least 6 hours apart.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For inhalation dosage form (solution):
Missed Dose
If you miss a dose of Tobramycin Stada Pymepharco, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
If you can't keep the Tobramycin Stada Pymepharco inhalation solution in the refrigerator, store the medicine in the foil pouch at room temperature away from heat or direct light. Do not use the unrefrigerated medicine after 28 days.
Store the Tobramycin Stada Pymepharco® Podhaler™ capsules at room temperature, away from heat and direct light. Keep the capsules and Podhaler™ device in a dry place.
Tobramycin Stada Pymepharco administration
Use Tobramycin Stada Pymepharco exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Tobramycin Stada Pymepharco is inhaled into the lungs with the use of a nebulizer. Do not swallow the solution by mouth.
Wash your hands with soap and water before preparing each treatment.
To use Tobramycin Stada Pymepharco inhalation:
- Set up the nebulizer as directed.
- Open one ampule of Tobramycin Stada Pymepharco solution for inhalation and squeeze the contents of the ampule into the nebulizer cup. Replace the nebulizer top.
- Turn on the compressor. Check for a steady mist from the mouthpiece. If there is no mist, check all tubing connections and make sure the compressor is working.
- Sit or stand in a position that will allow you to breathe normally. Place the mouthpiece of the nebulizer between your teeth and above your tongue and breathe normally only through your mouth. A noseclip may help you to breathe only through your mouth during a treatment. Continue breathing through the mouthpiece until all of the medicine is gone and no more mist is being produced. You may hear a sputtering sound when the nebulizer cup is empty. The entire treatment should take approximately 15 minutes to complete.
- If you are interrupted or need to cough or rest during a treatment, turn the compressor off to save the medication. Turn the compressor back on when you are ready to resume treatment.
To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.
If you are using several respiratory medications, the recommended order is bronchodilator first, followed by chest physiotherapy, then other inhaled medications, followed by Tobramycin Stada Pymepharco.
Do not use Tobramycin Stada Pymepharco that is cloudy or that has particles in it. Tobramycin Stada Pymepharco stored at room temperature may become a darker color of yellow. This does not indicate any change in quality of the medication.
Do not mix Tobramycin Stada Pymepharco with dornase alfa (Pulmozyme) or any other medications in the nebulizer.
Do not use Tobramycin Stada Pymepharco in bigger doses or more often than prescribed.
Use all of the Tobramycin Stada Pymepharco that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.
Store Tobramycin Stada Pymepharco in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius). If refrigeration is not available (e.g., when traveling), Tobramycin Stada Pymepharco may be stored at room temperature (77 degrees Fahrenheit/25 degrees Celsius) for up to 28 days. Avoid exposing ampules of Tobramycin Stada Pymepharco to direct light. Do not use Tobramycin Stada Pymepharco beyond the expiration date printed on the ampule.
Tobramycin Stada Pymepharco pharmacology
Tobramycin Stada Pymepharco is specifically formulated for administration by inhalation. When inhaled, Tobramycin Stada Pymepharco is concentrated in the airways.
Pharmacokinetics
Tobramycin Stada Pymepharco contains Tobramycin, a cationic polar molecule that does not readily cross epithelial membranes.(1) The bioavailability of Tobramycin Stada Pymepharco may vary because of individual differences in nebulizer performance and airway pathology.(2) Following administration of Tobramycin Stada Pymepharco, Tobramycin Stada Pymepharco remains concentrated primarily in the airways.
Sputum Concentrations: Ten minutes after inhalation of the first 300-mg dose of Tobramycin Stada Pymepharco, the average concentration of Tobramycin Stada Pymepharco was 1237 mcg/g (ranging from 35 to 7417 mcg/g) in sputum. Tobramycin Stada Pymepharco does not accumulate in sputum; after 20 weeks of therapy with the Tobramycin Stada Pymepharco regimen, the average concentration of Tobramycin Stada Pymepharco at ten minutes after inhalation was 1154 mcg/g (ranging from 39 to 8085 mcg/g) in sputum. High variability of Tobramycin Stada Pymepharco concentration in sputum was observed. Two hours after inhalation, sputum concentrations declined to approximately 14% of Tobramycin Stada Pymepharco levels at ten minutes after inhalation.
Serum Concentrations: The average serum concentration of Tobramycin Stada Pymepharco one hour after inhalation of a single 300-mg dose of Tobramycin Stada Pymepharco by cystic fibrosis patients was 0.95 mcg/mL. After 20 weeks of therapy on the Tobramycin Stada Pymepharco regimen, the average serum Tobramycin Stada Pymepharco concentration one hour after dosing was 1.05 mcg/mL.
Elimination: The elimination half-life of Tobramycin Stada Pymepharco from serum is approximately 2 hours after intravenous (IV) administration. Assuming Tobramycin Stada Pymepharco absorbed following inhalation behaves similarly to Tobramycin Stada Pymepharco following IV administration, systemically absorbed Tobramycin Stada Pymepharco is eliminated principally by glomerular filtration. Unabsorbed Tobramycin Stada Pymepharco, following Tobramycin Stada Pymepharco administration, is probably eliminated primarily in expectorated sputum.
Microbiology
Tobramycin Stada Pymepharco is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.(1) It acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death.(3)
Tobramycin Stada Pymepharco has in vitro activity against a wide range of gram-negative organisms including Pseudomonas aeruginosa. It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Susceptibility Testing
A single sputum sample from a cystic fibrosis patient may contain multiple morphotypes of Pseudomonas aeruginosa and each morphotype may have a different level of in vitro susceptibility to Tobramycin Stada Pymepharco. Treatment for 6 months with Tobramycin Stada Pymepharco in two clinical studies did not affect the susceptibility of the majority of P. aeruginosa isolates tested; however, increased minimum inhibitory concentrations (MICs) were noted in some patients. The clinical significance of this information has not been clearly established in the treatment of P. aeruginosa in cystic fibrosis patients. For additional information regarding the effects of Tobramycin Stada Pymepharco on P. aeruginosa MIC values and bacterial sputum density, please refer to the CLINICAL STUDIES section.
The in vitro antimicrobial susceptibility test methods used for parenteral Tobramycin Stada Pymepharco therapy can be used to monitor the susceptibility of P. aeruginosa isolated from cystic fibrosis patients. If decreased susceptibility is noted, the results should be reported to the clinician.
Susceptibility breakpoints established for parenteral administration of Tobramycin Stada Pymepharco do not apply to aerosolized administration of Tobramycin Stada Pymepharco. The relationship between in vitro susceptibility test results and clinical outcome with Tobramycin Stada Pymepharco therapy is not clear.
References
- DailyMed. "TOBRAMYCIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Tobramycin: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- EPA DSStox. "Tobramycin: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
