Adverse drug reactions formulation effects

The adverse effects of iron formulations have resulted in trials to optimize dose regimens. A large database of clinical variance reports from Fresenius Medical Care North America (FMCNA) has been analysed to determine the incidence of suspected adverse drug reactions of iron dextran and the associated patient characteristics, dialysis practice patterns, and outcomes (8). A case-cohort design was used, comparing individuals who had suspected adverse drug reactions with the overall population. Out of 841 252 intravenous iron dextran administrations over 6 months, there were 165 reported suspected adverse drug... 

Amphotericin B is the mainstay of treatment of patients with severe endemic fungal infections. The conventional deoxycholate formulation of the drug can be associated with substantial infusion-related adverse effects (e.g., chills, fever, nausea, rigors, and in rare cases hypotension, flushing, respiratory difficulty, and arrhythmias). Pre-medication with low doses of hydrocortisone, acetaminophen, nonsteroidal anti-inflammatory agents, and meperidine is common to reduce acute infusion-related reactions. Venous irritation associated with the drug can also lead to thrombophlebitis, hence central venous catheters are the preferred route of administration in patients receiving more than a week of therapy. 

Many re-challenges occur accidentally and do not fulfil the full criteria mentioned above. Rechallenge should only be undertaken when the patient has recovered completely from the first reaction. Re-challenge means that precisely the same drug, in the same formulation, at the same dose is given to the patient again, for as long as is reasonable to re-produce the adverse effect. The aim is to see if the same effect is produced under controlled conditions. It is important to differentiate this from re-exposure. Re-exposure is an accidental event in... 

Nasal formulations of modern sympathicomimet-ics like oxymetazoline and xylometazoline are effective. Rebound nasal congestion after withdrawal of sympathicomimetic-containing nose sprays or drops is a common phenomenon and patients should be advised to use these medicaments no longer than 3-5 days. Older per oral drugs like ephedrine and pseudo-ephedrine have no place in the therapy of rhinitis due to the risk of serious adverse reactions which are not in proportion to the indication. 

Weiner, M. Bernstein, I.L., Eds. Adverse effects bulk materials. In Adverse Reactions to Drug Formulation Agents Marcel Dekker, Inc. New York, 1989 89-113, Ch. 6. 

Reports on adverse reactions to lower doses of medroxyprogesterone acetate are not entirely consistent, probably because of differences in pharmaceutical formulation which markedly affect the drug s systemic availability. However, high doses of medroxyprogesterone acetate are extensively used for the treatment of hormone-depen-dent carcinomas (notably of the breast) and marked adverse effects occur consistently under these conditions (SEDA-12, 343). Such doses are likely to bring out the... 

Adverse CNS effects occur when the procaine portion of the procaine benzylpenicillin (procaine penicillin) formulation is given intravascularly. The signs of toxicity include hyperexcitability, muscle tremors, ataxia, apnea and cardiac arrest. There is no specific treatment for procaine toxicity one can only attempt to prevent the horse from injuring itself and others imtil the effects of the procaine wear off. The CNS reaction can be prevented by pretreatment with diazepam. The solubility of the procaine fraction of procaine benzylpenicillin (procaine penicillin) formulations increases with increasing ambient temperature, so these products should be stored in a cool place to reduce the risk of reactions. Procaine is a common cause of positive drug tests in racehorses and other performance horses. Procaine benzylpenicillin (procaine penicillin) should be avoided in these animals. 

Many excipients have been associated with adverse reactions in those ingesting drugs and vitamin/mineral formulations containing these compoundsJ78 79 Antioxidants (e.g., sodium sulfite, sodium and potassium bisulfites, and metabisulfites), bacterial preservatives (e.g., benzyl alcohol and benzalkonium chloride), artificial sweeteners (e.g., aspartame and saccharine), coloring agents (e.g., FD C yellow 5, blue 2, and red 40), and propylene glycol. A few examples of the toxic effects of these follow. 

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