Table 2.
Excipients identified as known to be harmful and potentially harmful and the prescribing prevalence of medications containing them in studied neonates
| Excipient§ | No of medications containing / Total Number of prescriptions | Medications containing excipients (number of prescriptions† ) |
|---|---|---|
|
Known to be harmful to neonates | ||
| Parabens (methyl- and propyl parahydroxybenzoate) |
6 / 343 |
Gentamicin inj (200), heparin inj (86), iron oral solution (32), heparin sodium ointment (12), prednisolone inj (7), cetirizine oral solution (6) |
| Saccharin sodium |
6 / 173 |
Simeticone oral suspension (108), iron oral solution (32), zidovudine oral solution (17), cetirizine oral solution (6), miconazole ointment (6), sultamicilline powder for suspension (4) |
| Sodium benzoate |
4 / 156 |
Simeticone oral suspension (108), caffeine solution (29), zidovudine oral solution (17), fludrocortisone inj (2) |
| Benzyl alcohol |
6 / 125 |
Heparin inj (86), hydrocortisone inj (23), phenobarbital inj (13), clotrimazole ointment (1), diazepam rectal suspension (1), diclofenac inj (1) |
| Benzalkonium chloride |
6 / 104 |
Salbutamol nebulisation solution (54), chloramphenicol ophthalmic solution (29), fusidic acid opthalmic solution (16), troxerutin gel (3), ipratropium bromide nebulisation solution (1), dexamethasone + neomycin + polymyxin B opthalmic solution (1) |
| Propylene glycol |
7 / 79 |
Salbutamol nebulisation solution (54), phenobarbital inj (13), cetirizine oral solution (6), diazepam oral solution (3), ibuprofen tablet (1), diclofenac inj (1), diazepam rectal solution (1) |
| Polysorbate 80 |
4 / 70 |
Budesonide nebulisation solution (31), chloramphenicol ophalmic solution (29), miconazole ointment (6), tobramycin opthalmic ointment (4) |
| Ethanol |
7 / 31 |
Heparin sodium ointment (12), miconazole ointment (6), dinoprostone inj (5), Lipase + amylase + protease tablet (3), diazepam oral solution (3), diosmectide powder for oral suspension (1), alprostadil inj (1) |
|
Potentially harmful excipients | ||
| Sodium metabisulphite |
6 / 297 |
Gentamicin inj (200), dobutamine inj (45), epinephrine inj (36), morphine inj (14), diclofenac inj (1), norepinephrine inj (1) |
| Silica, colloidal anhydrous |
10 / 195 |
Simeticone oral suspension (108), phenobarbital tablet (29), hyoscine butylbromide tablet (20), spironolactone tablet (18), furosemide tablet (6), ursodeoxycholic acid tablet (5), sotalol tablet (4), propranolol tablet (3), diosmectide powder for oral suspension (1), ibuprofen tablet (1) |
| Sorbic acid |
2 / 168 |
Simeticone oral suspension (108), laurilsulphate + sorbitol + sodium citrate rectal solution (60) |
| Anhydrous sodium hydrogen phosphate (monobasic, dibasic) |
10 / 122 |
Paracetamol suppository (29), paracetamol infusion solution (24), hydrocortisone powder for infusion solution (23), epoetin beta inj (22), dexamethazone inj (8), oxacillin powder for infusion solution (7), sultamicillin powder for infusion solution (4), ranitidine inj (2), pentoxifylline inj (2), ipratropium bromide nebulisation solution (1) |
| Sodium cyclamate |
1 / 108 |
Simeticone oral suspension (108) |
| Disodium edetate |
10 / 106 |
Budesonide nebulisation solution (31), piperacillin + tazobactam inj (25), fusidic acid ophthalmic solution (16), metoclopramide inj (10), dexamethazone inj (8), sulphametizole opthalmic solution (6), aminophylline inj (4), troxerutin ointment (3), esomeprazole inj (2), acetylcysteine inj (1) |
| Gelatin |
5 / 51 |
Phenobarbital tablet (29), hydrochlorothiazide tablet (10), ursodeoxycholic acid tablet (5), digoxin tablet (4), lipase + amylase + protease tablet (3) |
| Sodium bicarbonate |
4 / 44 |
Meropenem inj (32), povidone-iodine ointment (8), ceftazidime powder for infusion solution (3), enalapril tablet (1) |
| Boric acid |
2 / 33 |
Chloramphenicol opthalmic solution (29), tobramycin opthalmic solution (4) |
| Borax |
1 / 29 |
Chloramphenicol opthalmic solution (29) |
| Macrogols - polyethylene glycol |
5 / 25 |
Povidone-iodine ointment (8), pentoxifylline tablet (7), Hydrocortisone + chlorhexidine ointment (4), lipase + amylase + protease tablet (3), propranolol tablet (3) |
| Trometamol |
2 / 25 |
Ibuprofen inj (21), tobramycin ophthalmic ointment (4) |
| Glycine |
1 / 22 |
Epoetin beta inj (22) |
| Calcium chloride dihydrate |
1 / 22 |
Epoetin beta inj (22) |
| Leucine |
1 / 22 |
Epoetin beta inj (22) |
| Titanium dioxide |
5 / 21 |
Pentoxifylline tablet (7), ursodeoxycholic acid tablet (5), lipase + amylase + protease tablet (3), propranolol tablet (3), sildenafil tablet (3) |
| Povidone |
4 / 19 |
Pentoxifylline tablet (7), furosemide tablet (6), drotaverine tablet (5), teophylline tablet (1) |
| Trolamine |
2 / 15 |
Heparin sodium ointment (12), troxerutin ointment (3) |
| Cresol |
1 / 11 |
Diosmectide powder for oral suspension (1) |
| Maltose |
2 / 7 |
Tobramycin ophthalmic ointment (4), immunoglobuline inj (3) |
| Erythrosine |
1 / 7 |
Pentoxifylline tablet (7) |
| Benzethonium chloride |
1 / 7 |
Ketamine inj (7) |
| Sodium acetate trihydrates |
2 / 7 |
Cetirizine oral solution (6), flecainide inj (1) |
| Cetostearyl alcohol |
2 / 5 |
Hydrocortisone + chlorhexidine ointment (4), clotrimazole ointment (1) |
| Ethylendiamine |
1 / 4 |
Aminophylline inj (4) |
| Macrogol cetostearyl ether |
1 / 4 |
Hydrocortisone + chlorhexidine ointment (4) |
| Sodium laurilsulfate |
1 / 3 |
Lipase + amylase + protease tablet (3) |
| Lactic acid |
1 / 3 |
Milrinone inj (3) |
| Copovidone |
1 / 3 |
Propranolol tablet (3) |
| Sodium formaldehyde sulfoxylate |
2 / 2 |
Diazepam rectal solution (1), diclofenac inj (1) |
| Castor oil |
1 / 1 |
Teophylline tablet (1) |
| Sorbitan stearate |
1 / 1 |
Clotrimazole ointment (1) |
| Acacia | 1 / 1 | Diosmectide powder for oral suspension (1) |
§European Pharmacopoeia names were used for excipients.
† Pooled data from Tartu University Hospital (February - August 2008) and Tallinn Children’s Hospital (February - August 2009).