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Articles

Safety in Lactation: Diuretics

21 October 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Thiazides and related diuretics (includes bendroflumethiazide,…
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Medicine Compliance Aid Stability

InspraPfizer Ltd

Pfizer Ltd
Inspra
Tablets 25mg, 50mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special precautions for storage
9 November 2015

Lactation Safety Information

Spironolactone
Aldosterone antagonist
No published evidence of safety
24 February 2017

New Medicines

InspraMyocardial infarction (MI) post-MI

Information

Inspra
Licence extension / variation
Pfizer
Pfizer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
None
Jan 18: No recent reports of development identified, and not listed in Pfizer product pipeline

Jan 16: No recent reports of development identified, and not listed in Pfizer product pipeline [4]

Category

Selective aldosterone inhibitor
About 146,000 people in the UK have an MI every year. Most occur in people aged over 50 and it becomes more common with increasing age. Sometimes younger people are affected [2].
Myocardial infarction (MI) post-MI
Oral

Trial or other data

01. Mar 13: PIII REMINDER trial (NCT01176968) is a randomized, double-blind trial, involving 1,012 pts investigating the impact of eplerenone (25-50 mg OD) on cardiovascular outcomes within 24-hours of myocardial infarction in patients without heart failure. The trial is being conducted at sites in Canada, the Czech Republic, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Spain and the UK. Results from the REMINDER trial showing statistically significant risk reductions in the primary composite efficacy endpoint. The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) =40% after 1 month, or an elevation of BNP/ NT-proBNP after 1 month. The REMINDER trial demonstrated a statistically significant 42.9% relative risk reduction in the primary endpoint with p
02. Apr 14: Results of the REMINDER trial published in the European Heart Journal [3].