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Powder for inhalation in capsules containing tobramycin
Chronic pulmonary infection caused by P.aeruginosa in cystic fibrosis
The dose of tobramycin inhalation is the same for all patients within the approved age range, regardless of age or weight.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended dose of inhaled tobramycin is 112mg (4 x 28mg capsules), administered twice daily for 28 days.
The two doses (of 4 capsules each) should be inhaled as close to 12 hours apart but not less than 6 hours apart.
Inhaled tobramycin is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Treatment with inhaled tobramycin should be continued on cyclical basis for as long as the doctor considers the patient is gaining benefit from the treatment taking into account that long term safety data are not available.
There are insufficient data in the patient population over 65 years of age to support a recommendation for or against dose adjustment.
Children aged 6 and older: see Adult dose.
Patients with Renal Impairment
Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment.
Additional Dosage Information
In case of missed dose with at least 6 hours until the next scheduled dose, the patient should take the dose as soon as possible. Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose.
Children under 6 years
Precautions and Warnings
Administer other inhaled drugs first
Correct dehydration before commencing therapy
Treatment to be initiated and supervised by a specialist
Any concomitant bronchodilator should be used first
Baseline assessment of lung function advised
Evaluate renal function before and during treatment
Monitor auditory and vestibular function
Monitor peak and trough serum levels
Monitor periodically for overgrowth of non-susceptible organisms
Monitor urea and creatinine levels every 12 months
Advise patient to report hearing loss or tinnitus
Advise patient to report persistent cough
Bronchospasm(lowered FEV)in presence of bronchodilator may indicate allergy
May cause bronchospasm
Potentially ototoxic and nephrotoxic
Discontinue if allergic reaction occurs
Discontinue or interrupt therapy if nephrotoxicity occurs
Children below the age of 13 years may be more likely to cough when treated with these inhalation powder capsules.
If cough persists with this medication, the physician should consider whether an approved tobramycin nebuliser solution should be used as an alternative treatment.
Pregnancy and Lactation
There are little data on the use of inhaled tobramycin during human pregnancy. Tobramycin crosses the placenta into foetal circulation and amniotic fluid. Ototoxicity has not been reported as an effect of tobramycin during therapy. However, eighth cranial nerve toxicity in the foetus is well known with other aminoglycosides and should not be ruled out with tobramycin. There have been no reports linking tobramycin to congenital defects. One study concluded that there was no detectable teratogenic risk for structural defects for tobramycin and that the risk of deafness after in utero aminoglycoside exposure was small.
Animal data have not shown evidence of teratogenicity in rats and rabbits. However, renal toxicity has been observed in pregnant rats after high doses of tobramycin.
The use of aminoglycosides is not recommended during pregnancy unless the benefits to the mother outweigh the potential risks to the foetus. If tobramycin is used during pregnancy, carefully monitor maternal serum levels and adjust dose if necessary. Treatment during pregnancy is not cause for termination or invasive diagnostic procedures. Inform patients of the potential risks to the foetus.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Tobramycin is poorly excreted in human breast milk and oral absorption in the infant is poor. Serum levels with typical dosage are considered to be below those attained when treating newborn infections and systemic effects are considered unlikely. However, serum levels with respect to inhaled tobramycin are unknown. Accumulation of tobramycin by the infant is possible and the potential for ototoxicity and nephrotoxicity in infants should not be ruled out.
If tobramycin is strongly indicated during breastfeeding, the infant should be monitored for possible effects on gastrointestinal flora (diarrhoea, nappy rash etc.).
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Vestibular and auditory damage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2013.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013.
Summary of Product Characteristics: TOBI Podhaler 28mg inhalation powder, hard capsules. Novartis Pharmaceuticals UK Ltd. Revised October 2015.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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