Clomipramine

[Emma143]

Hi, is anyone else on Clomipramine?

I have been told that they are discontinuing it. I have been on it for 20 years and i’m finding it hard to find one that suits me. I tried another one, but it made me so sleepy and I can’t have it as I need to go to work.

I had to stop it, and go back to Clomipramine. I’ve only got a few left now and am panicking. I’ve only got 10’s left, and it’s not high enough as I feel so I’ll. my body needs them.

I don’t know what to do. Please help.

Emma.

[Donna67honey]

Iv been on clomipramine for nearly 4 years also and I’m worried they are discontinuing it, I know they discontinued the 10mg but not the 25mg and 50mg as I’m on 50mg, these are the only ones that work for me also.

[Donna67honey]

I found this online it seems the shortage is just for 10mg at the moment so I wouldn’t worry too much. Shortage of Clomipramine 10mg Capsules

Date: 22ndFebruary2019

Description of products affected

Clomipramine is licensed for the treatment of:

 The symptoms of depressive illness especially where sedation is required

 Phobic and obsessional states

 Adjunctive treatment of cataplexy associated with narcolepsy.

 Cambridgeshire and Peterborough CCG also support clomipramine as an alternative to SSRIs in obsessive-compulsive disorder (OCD) (off-label use).1,2,3

Background

 There have been ongoing supply problems with all strengths of clomipramine capsule.

 The 10mg capsule strength is currently temporarily unavailable, supplies pending for the end of March.

 Assurance has been provided that the 25mg and 50mg capsule strengths still remain available from some manufacturers (Sigma and Teva).

 It is unclear when this supply issue will resolve.

 Anafranil SR 75mg tablets (clomipramine modified release) was discontinued

in 2015.

 The availability of clomipramine is being monitored closely by the Medicines Optimisation Team. If the 25mg and 50mg strengths become unavailable, further guidance will be issued about potential alternative treatment options and switch strategies4.

Suggested management options for patients on clomipramine 10mg capsules

 We recommend that each patient currently taking clomipramine 10mg capsules is reviewed and the indication for its use established.

 Different indications have different recommended initial doses, dosing ranges and maximum doses as per BNF1.

 The decision about what to do will need to be individualised to each patient4.

 Preferred option is to change to an equivalent or nearest equivalent dose of clomipramine capsules using the 25mg and/or 50mg strength that are currently available.

 The patient should be encouraged to try several pharmacies in order to fulfil the prescription as different pharmacies use a range of wholesalers and distributors. The patient may wish to ring pharmacies in advance of attending to ascertain availability.

 It is important to involve any patients (and their carers, as appropriate) in the discussion regarding any planned change to their medication BEFORE making the change5.

 Clomipramine has a prolonged half-life, therefore instead of divided doses, once-daily dosage regimens are also suitable, usually given at night6. This may be an option to consider when changing to the equivalent or nearest equivalent daily dose.

Preferred: maintain patient on clomipramine using 25mg or 50mg capsules5

Total daily dose

Recommendation

Considerations

Total daily dose is divisible by 25 or 50.

 Change to equivalent daily dose using the 25mg and/or 50mg capsules.

 Patient remains on clomipramine.

 Prescriber review will be required if dosing frequency is to change i.e. to once daily dosing.

 Dosing regimen required may be different and extra patient counselling will be required to support.

Total daily dose is not divisible by 25 or 50.

 Review patient’s dose and round to the nearest 25mg. Whether the dose is rounded up or down will be a clinical decision based on the patient’s history, relapse risk and current tolerability of clomipramine.

 Patient remains on clomipramine.

 Prescriber review will be required.

 Dose and dosing regimen will be different and extra patient counselling will be required to support.

 Additional monitoring to check for efficacy or tolerability due to dose change will be needed.

Total daily dose less than 25mg

 Review the on-going need for treatment potentially withdraw clomipramine or increase dose to 25mg.

 NB: Please see guidance below regarding stopping clomipramine.

 Review by prescriber to withdraw clomipramine and monitoring of patient condition and withdrawal symptoms will be required.

 Review and additional monitoring required to check for tolerability due to increase in dose.

 If the above recommendations are not clinically acceptable or there is any uncertainty about what to do or how to do it then management options should be discussed with the responsible consultant specialist depending on indication5.

Reducing dose or stopping clomipramine

 It is important that, wherever possible, clomipramine treatment should not be stopped abruptly.

 If the decision is made to discontinue treatment, this ideally should be a tapered approach over at least 4 weeks however, this may not be feasible due to the unavailability of the 10mg strength7.

 Discontinuation symptoms usually onset within 5 days of stopping treatment and the following symptoms commonly occur after abrupt withdrawal or reduction of the dose of clomipramine: nausea, vomiting, abdominal pain, diarrhoea, insomnia, headache, nervousness and anxiety2,7.

References

1. Joint Formulary Committee (2019) British National Formulary. Available at: bnf.nice.org.uk (Accessed: 19 February 2019)

2. SPCs for Clomipramine preparations acccessed via electronic Medicines Compendium. Available at: medicines.org.uk/emc/produc... (Accessed: 19 February 2019)

3. NHS Cambridgeshire and Peterborough Formulary. Available at:

cambridgeshireandpeterborou... bDetails.asp?FormularySectionID=4&SubSectionRef=04.03.01&SubSectio nID=B100&drugmatch=1102#1102 (Accessed: 19 February 2019)

4. MedicinesShortageBulletinShortageofclomipraminecapsules–Oxford Health NHS Foundation Trust: November 2018. Available at: oxfordhealthformulary.nhs.u... s%20shortage%20memo%20Nov%202018.pdf?UNLID=34247222920181 1875823 (Accessed 19 February 2019)

5. McAllister-Williams H and Ahuja N Dr. Guidance on clomipramine supply problems and therapeutic alternatives – Northumberland, Tyne and Wear NHS Foundation Trust: May 2014. Available at: northoftyneapc.nhs.uk/wp- content/uploads/sites/6/2014/05/NTW-advice-on-clomipramine- shortages-and-therapeutic-alternatives-May-2014.pdf (Accessed: 19 February 2019)

6. Martindale. Clomipramine monograph, updated November 2018. Available at: medicinescomplete.com/#/con... e?hspl=clomipramine (Accessed 20 February 2019)

7. The Maudsley Prescribing Guidelines. 10th edition. Informa Healthcare: 2009.

Prepared by and for all correspondence please contact:

Cambridgeshire and Peterborough Clinical Commission Group, Medicines Optimisation Team. 20 February 2019; email: [e-mail]

Disclaimer: The content of this alert may not reflect national guidance. Some of this alert is based on clinical opinion from practitioners. Users should bear this in mind. Any decision to prescribe off- label must take into account the relevant GMC guidance and governance procedures for unlicensed medicines. Prescribers are advised to pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label. As with all prescribing, the prescriber is medically and legally responsible for the prescriptions they sign and for their decisions and actions when they supply and administer medicines or authorise or instruct others to do so.

[Emma143]

Hi Donna. That’s really good news. I was going to ask my doctor to increase my dose anyway, as I haven’t been feeling too good, so it doesn’t matter about the 10’s now.

Thanks for that.

Hope they don’t stop then, it’s so hard to get one to suit.x