Background and Importance Peripheral tissue ischemia (PTI) is a complication of vascular catheterisation in newborns. Conservative measures are often insufficient. Topical nitroglycerin has been used off-label as salvage therapy. We were requested 2% topical nitroglycerin ointment (TNO) as a compounding formula for PTI in two prematures. Due to the shortage of raw material, an effective and safe alternative had to be sought out.

Aim and Objectives To identify an alternative for 2% TNO as therapy for PTI, and thus, to describe the effectiveness and security of applying 0,4% rectal nitroglycerin ointment (RNO) in the affected areas.

Material and Methods Prospective study between January-June 2022, of 2 newborns with PTI. Patient 1: female, 31+5; 2 days, 1500g, ecchymosis in 4 fingers. Patient 2: female, 24+6; 5days , 595g, marked necrosis in the pads of 5 fingers.

The manufacturing laboratory and other hospitals were contacted to find out the availability of the raw material. We also consulted the Spanish Pharmacy Preparations and Compounding Group, and the Spanish Agency for Medicines and Medical Products (AEMPS) database for alternatives. We systematically searched MEDLINE, PubMed, Embase, Google Scholar. A close follow-up was carried out in coordination with paediatricians, and electronic prescription and computerised medical records were consulted daily, to evaluate effectiveness and security.

Results Due to the lack of raw material and alternatives in its preparation, other marketed pharmaceutical forms of nitroglycerin were evaluated (intravenous solution, transdermal patches, sublingual tablets, rectal ointment and sublingual spray). Application of 0.4% RNO in the affected areas was considered the most effective, safest, easy to dose, and quickest to acquire alternative.

Patient 1: ecchymosis completely disappeared in 48 hours of treatment. No adverse events, normal control of methaemoglobin. Good perfusion without vasoactives. Patient 2: 10 days to remit the marked necrosis. Well tolerated, initial slight drop in blood pressure, needing an increase of dopamine. Loss of the phalanges was avoided in both patients.

Conclusion and Relevance Commercialised 0.4% RNO in PTI was effective and safe in low birth weight premature newborns. However, it is necessary to be studied in more patients.

Pharmacist’s role in the preparation, control and dispensing of medicines is essential, and its integration in the multidisciplinary team is crucial to ensure a quick response in emergency situations.

Conflict of Interest No conflict of interest