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Articles

How should medicines be dosed in children who are obese?

28 May 2021Review on how to calculate medicine doses in children who are obese which includes a table on commonly prescribed medicines.

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,…

What medicines should be avoided by patients suffering from "sulfa allergy"?

12 June 2020This updated Medicines Q&A evaluates the limited evidence available on cross-sensitivity between sulfonamide-containing medicines and lists classes of medication that contain a sulfonamide in their…

How should ankle oedema caused by calcium channel blockers be treated?

1 June 2020Ankle oedema is a common, often troublesome adverse effect for patients who are receiving calcium channel blocker (CCB) therapy, and may affect compliance. It is…
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Medicine Compliance Aid Stability

genericAmdipharm Mercury Co Ltd

Amdipharm Mercury Co Ltd
generic
Tablets 20mg, 40mg, 500mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Exposure of furosemide tablets to light may cause discoloration. Should be stored and dispensed in well-closed, light-resistant containers.
9 November 2015

Lactation Safety Information

-
No published evidence of safety
Low levels anticipated in milk due to high (>98%) plasma protein binding
Used in full-term neonates from birth
24 February 2017

New Medicines

FuroscixChronic heart failure in patients with oedema - micropump patch formulation

Information

Furoscix
New formulation
scPharmaceuticals
scPharmaceuticals

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Not approved
Nov 22scPharmaceuticals intends to resubmit NDA application to the US FDA in Q1 22, with an anticipated launch in Q4 22 [10].
Jul 20scPharmaceuticals receives Complete Response Letter (CRL) from FDA citing the need to conduct pre-approval inspections at third-party manufacturing facilities, and questions related to testing, labelling, and features of the combination product unrelated to the drug constituent. The CRL did not identify clinical deficiencies [9].
Jul 20scPharmaceuticals resubmit NDA to US FDA for treatment of congestion in patients with heart failure [8].
Dec 19scPharmaceuticals announced it had completed both human factor studies as mandated by the FDA for resubmission of the NDA for Oedema in CHF. The device validation and drug stability testing studies are ongoing [7].
Oct 18scPharmaceuticals, announced that following the Complete Response Letter, the FDA has asked the company to conduct additional human factors studies and a dose delivery validation study. The FDA has not requested any additional clinical trialsi, and the company intends to re-submit NDA for Oedema (with chronic heart failure) by the end of 2019 [6].
Aug 17Filed in US for Chronic heart failure, the submission is for the furosemide controlled release formulation in combination with a wearable minipump, called sc2Wear [5].
Nov 15scPharmaceuticals plans to submit furosemide controlled release formulation (drug-device combination) to the FDA in mid 2016, while international regulatory filings are anticipated for H2 2016 [2].

Category

A controlled-release formulation of the loop diuretic furosemide. The drug is delivered subcutaneously via a wearable micro-pump patch; a rotation of the pump shaft results in a very precise, small volume (10µL) release of the drug, via a needle.
Heart failure is a common condition; more than 401,729 patients registered with general practitioners in England were diagnosed with this condition in 2013-2014, a prevalence of 0.7% of all patients registered [1].
Chronic heart failure in patients with oedema - micropump patch formulation
Subcutaneous injection

Further information

Yes

Trial or other data

Nov 15: scPharmaceuticals announce top-line pharmacokinetics and pharmacodynamics results from a pivotal registrational PII/III. scPharmaceuticals initiated the randomised pivotal trial in April 2015 to assess the pharmacokinetics and bioavailability of single doses of its subcutaneous furosemide product, compared to intravenous bolus doses of furosemide USP, in patients with chronic heart failure (NCT02329834; scP-01-002). The trial enrolled 16 patients in the US, and was completed in October 2015. The company had received inputs from the US FDA, through in-person meetings and correspondence, for conduct of the trial [2].


Oct 14: scPharmaceuticals complete a PII study that assessed the pharmacodynamics and pharmacokinetics of subcutaneously administered formulation of furosemide compared with an orally administered formulation, in patients with heart failure having chronic fluid overload (NCT02350725; EudraCT2014-002546-49; SCP01-001). This randomised, open-label study enrolled 10 patients in the Netherlands [2].

Evidence based evaluations