Sacomni 100 for Doctors, Pharmacists and Distributors

EMK Omni Pharma markets the product; manufacturing is carried out at GMP certified contract units on the company's behalf.

Sacomni 100 carries the standard Schedule H caution that it is not to be sold by retail without the prescription of a registered medical practitioner.

At the counter, verify that the prescription is legible and current, that the prescriber's registration details are present, and that the strength written matches the strength dispensed, since Sacomni 50 and Sacomni 100 differ only by number on a fast moving shelf. Record the sale in the prescription register as required under the Drugs and Cosmetics Rules and retain records for the prescribed period.

Flag for the prescriber where the patient is also carrying an ACE inhibitor, another angiotensin receptor blocker, aliskiren, a potassium supplement or a potassium sparing diuretic without documented monitoring. Also check for anti inflammatory painkillers bought over the counter, which are common in this population.

Do not split blisters in a way that separates the batch number and expiry from the tablets supplied.

Keep cartons below 25 degrees Celsius in a cool, dry and dark section of the store, away from direct sunlight, display windows and lighting that generates heat. In humid coastal and monsoon conditions, keep stock off the floor, away from external walls, and consider dehumidification for the storage area.

Rotate stock strictly on a first expiry, first out basis and check the shelf periodically for cartons nearing expiry. Inspect returns and damaged consignments for breached foil, moisture marks or discolouration, and quarantine anything doubtful rather than returning it to the saleable shelf.

Maintain the cold chain rules that apply to other products separately; this product does not require refrigeration and should not be stored in a fridge.

Blood pressure, serum potassium and renal function are the routine parameters after initiation and after each change in strength, and periodically thereafter. Caution applies in volume depletion, bilateral renal artery stenosis, moderate hepatic impairment and in the elderly, and the combination is generally avoided in severe hepatic impairment and in a history of angioedema with an ACE inhibitor or angiotensin receptor blocker.

One laboratory point is worth repeating to prescribers and patients alike. Because sacubitril inhibits neprilysin, BNP is not a reliable marker of heart strain during treatment, whereas NT-proBNP is not a neprilysin substrate and remains usable.

The label also carries the fetal toxicity warning: when pregnancy is detected, discontinue as soon as possible, since medicines acting directly on the renin angiotensin system can cause injury and death to the developing foetus.

Pharmacies, hospitals, clinics, stockists and distributors can reach EMK Omni Pharma for supply of Sacomni 100 and other products in the Cardiac Care range, including Sacomni 50 and Toromni Plus 10/50.

Distribution enquiries, franchise and stockist discussions, and questions about pack availability can be raised through the same channels. Suspected quality concerns about a specific batch should be reported with the batch number and expiry date printed on the carton so the matter can be traced.

This article is for general information only and is not a substitute for advice from a registered medical practitioner.