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Safety in Lactation: Drugs for hypertension

23 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Many of the drugs covered by…

What are the reported incidences of ankle oedema with different calcium channel blockers?

1 June 2020The potential to cause ankle oedema appears to exist for all calcium channel blocking agents, and is caused by increasing capillary pressure leading to leakage…

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…

Adalat (nifedipine) products: discontinuations and shortages

23 August 2018There are ongoing supply issues with some preparations and long-term discontinuations: Alternative nifedipine presentations continue to remain available from generic suppliers. Supplies of nifedipine 5mg…
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Medicine Compliance Aid Stability

Coracten SRUCB Pharma Ltd

UCB Pharma Ltd
Coracten SR
Capsules m/r 10mg, 20mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Valni XLZentiva

Zentiva
Valni XL
Tablets m/r 30mg, 60mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Fortipine LAAmdipharm Mercury Co Ltd

Amdipharm Mercury Co Ltd
Fortipine LA
Tablets m/r 40mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Nifedipress MRDexcel Pharma Ltd

Dexcel Pharma Ltd
Nifedipress MR
Tablets m/r 10mg, 20mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Coracten XLUCB Pharma Ltd

UCB Pharma Ltd
Coracten XL
Capsules 30mg, 60mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Protect from light.
9 November 2015

Adipine MRChiesi Ltd

Chiesi Ltd
Adipine MR
Tablets m/r 10mg, 20mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Tensipine MRGenus Pharmaceuticals

Genus Pharmaceuticals
Tensipine MR
Tablets m/r 10mg, 20mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Adalat RetardBayer plc

Bayer plc
Adalat Retard
Tablets m/r 10mg, 20mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Adalat LABayer plc

Bayer plc
Adalat LA
Tablets m/r 20mg, 30mg, 60mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

AdalatBayer plc

Bayer plc
Adalat
Capsules 5mg, 10mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Adipine XLChiesi Ltd

Chiesi Ltd
Adipine XL
Tablets m/r 30mg, 60mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nifedipine is very light sensitive
9 November 2015

Lactation Safety Information

Yes
-
Moderate published evidence of safety
Extensive experience of safe use in breastfeeding
Small amounts in breast milk
No adverse effects reported in breastfed infants
Used in infants >1 month
Preferred choice during breastfeeding for treating Raynaud’s syndrome
16 January 2017

New Medicines

Chronic anal fissure - in conjunction with standard therapy

Information

New formulation
9 Meters Biopharma
9 Meters Biopharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase II Clinical Trials
May 20No apparent development since completion of PII/III trial in 2018, and not listed in 9 Meters Biopharma pipeline [11,12].

Category

Calcium channel blocker
There are no recent data on prevalence of anal fissure, however it is believed to have a lifetime incidence of around 11%. It is most common between the second and fourth decades, but may occur at any age; acute fissures are more common than chronic fissures, which are those present for six weeks or more [4].
Chronic anal fissure - in conjunction with standard therapy
Rectal

Trial or other data

Dec 18Aug 18. Phase II/III trial (NCT02527109) completed [7]