Bramitob Nebulization
Tobramycin Sulphate
300mg/4ml
Chiesi Farmaceutici S.p.A.
| Pack size | [56 's Single Dose Container (Strip x 4, each of 4 ml)] |
|---|---|
| Dispensing mode | POM |
| Source | ITALY |
| Agent | New Country Healthcare L.L.C. |
| Retail Price | 9837.50 AED |
Indications
Bramitob Nebulization is used for:
Cystic fibrosis
Adult Dose
Inhalation
Cystic fibrosis
Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis
Adult: One single-use ampoule (300 mg) 12 hrly, inhaled from a suitable nebuliser for 28 days, then stop for 28 days and repeat in cycles of 28 days as needed.
Child Dose
Inhalation
Cystic fibrosis
Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis
Child: >6 yr : 300 mg 12 hrly, inhaled from a suitable nebuliser for 28 days, then stop for 28 days and repeat in cycles of 28 days as needed.
Renal Dose
Renal impairment: Dosage adjustment needed.
Administration
Contra Indications
Hypersensitivity to aminoglycosides; pregnancy.
Precautions
Preexisting renal and auditory or vestibular impairment; dehydration; neuromuscular blockade, muscular disorders (e.g. myasthenia gravis, parkinsonism); neonates; elderly; lactation.
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-Lactation
Pregnancy
Aminoglycosides can cause fetal harm; aminoglycosides cross the placenta; published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman; although there are no available data on ophthalmic use of tobramycin 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
There are risks to mother associated with cystic fibrosis in pregnancy; 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; advise pregnant women of potential risk to a fetus
Cystic fibrosis may increase risk for preterm delivery
Lactation
There are no data on presence of drug in either human or animal milk, the effects on breastfed infant, or 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; therapy may cause alteration in intestinal flora of breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Therapy may cause intestinal flora alteration; advise a woman to monitor breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash)
Interactions
Increased nephrotoxicity or ototoxicity with etacrynic acid, furosemide, other aminoglycosides, cefalotin, cisplatin, vancomycin, piperacillin, ciclosporin, amphotericin B. Decrease serum tobramycin levels with miconazole.
Potentially Fatal: Increased neuromuscular-blocking activity with magnesium and other neuromuscular-blocking agents.
Adverse Effects
Side effects of Tobramycin Sulphate :
>10%
Voice alteration (12.8%)
1-10%
Myalgia (4.7%), Laryngitis (4.3%), Tinnitus (3%), Epistaxis (3%)
Mechanism of Action
Tobramycin acts by binding to 30S ribosomal subunits thus interfering with bacterial protein synthesis. It is active against many aerobic gram-negative bacteria and some aerobic gram-positive bacteria but inactive against Chlamydia, fungi, viruses, and most anaerobic bacteria.
Note
Bramitob 300mg/4ml Nebulization manufactured by Chiesi Farmaceutici S.p.A.. Its generic name is Tobramycin Sulphate. Bramitob is availble in United Arab Emirates.
Farmaco UAE drug index information on Bramitob Nebulization is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.