Thursday 12 June 2014

MEPACRINE











 



MEPACRINE


What are the aims of this leaflet?


This leaflet has been written to help you understand more about mepacrine. It tells you what it is, how it works, how it is used to treat skin conditions, and where you can find out more about it.

What is mepacrine and how does it work?


Mepacrine (an unlicensed drug in the UK) was introduced as a treatment for malaria and for certain other tropical infections. It is one of several antimalarial drugs that have been found also to have anti-inflammatory properties, which can help some skin conditions.

What does “unlicensed” mean in relation to a drug?


An unlicensed drug is one that has not been awarded a Market Authorisation from the UK Medicines Healthcare Products Regulatory Agency (MHRA). A drug may be licensed in other countries, but not in the UK. Drug licenses in the UK are awarded following a rigorous process of evaluation by the MHRA following an application by a pharmaceutical company. Once awarded, the licensed drug can then be marketed and sold in the UK.

In the absence of a license, the drug may still be prescribed in the UK, provided there is funding available locally to pay for it. Additionally, there must be a clear body of evidence to confirm that the drug is effective for the condition in question and that safety concerns have been adequately addressed. Even after such evidence has been supplied it is still a matter for the local formulary group (a multidisciplinary group who make decisions on the prescribing of medicinal drugs at a local level) to make a final decision on a case-by-case basis.

Mepacrine is widely used for lupus in many countries including the UK and North America but remains unlicensed and has to be obtained from a

TAJ PHARMA INDIA, Taj Pharma Group (India), P.O. Box No. 12002, Azad Nagar Post office,
Andheri (w), Mumbai - 400 053. India. (+91) -22-2637 4592 (IST) (+91) -22-2637 4593 Fax: (+91) - (0)22-2634-1274


‘Specials’ pharmaceutical manufacturer. It is listed as a treatment for discoid lupus erythematosus in the British National Formulary.

Which skin conditions are treated with mepacrine?


Mepacrine is used particularly to treat  discoid lupus erythematosus and for  subacute cutaneous lupus erythematosus. Mepacrine has also been used in the treatment of  erythema multiforme,  sarcoidosis and dermatomyositis (please see the relevant BAD Patient Information Leaflets).

What dose of mepacrine should I take?


Your doctor will advise you about this. For skin conditions, the dose may be as small as 50 mg (half a 100 mg tablet) taken three times a week. A maximum dose would be 100 mg, taken three times a day. The dose for children is 2 mg per kg bodyweight, given as a split dosage three times a day (to a maximum of 300 mg daily). It may take several weeks to reach its full effect.

What are the possible side effects of mepacrine?


Mepacrine is well tolerated at the low doses used in dermatology. However, it can have some undesirable side effects:

Yellow discoloration of the skin and urine may occur during long-term treatment or with large doses. This is common but quite harmless, and should not be a cause for concern as it goes away when you stop the drug. Similarly, the palate, nails and eyes may be discoloured blue or black, which also resolve when you stop taking the drug.
Mepacrine can cause dizziness, particularly when you get up from sitting or lying down. Getting up slowly should help to reduce this side effect.
Other possible side effects include stomach upsets, headaches, nausea and vomiting, rashes (occasionally severe), and changes in mood or behaviour. Fits may occur with overdosing. Liver inflammation and alterations in the blood count can occur but are rare.

Mepacrine should be used with caution in:

patients with porphyria elderly patients
the presence of liver disease



TAJ PHARMA INDIA, Taj Pharma Group (India), P.O. Box No. 12002, Azad Nagar Post office,
Andheri (w), Mumbai - 400 053. India. (+91) -22-2637 4592 (IST) (+91) -22-2637 4593 Fax: (+91) - (0)22-2634-1274


Mepacrine is best avoided by patients with psoriasis as it can make this condition worse. It should also be avoided in myasthenia gravis and by patients with a history of the severe forms of mental illness called psychoses.

How will I be monitored for the side effects of mepacrine treatment?


Blood tests are usually performed twice a year to check your blood count and liver function.

Can I have vaccinations while I am on mepacrine?


Yes. This should not be a problem. If you are travelling to a place where malaria occurs, mepacrine alone will not provide adequate protection against it and you must see your GP to be prescribed additional antimalarial treatment which may be taken at the same time as mepacrine.

Does mepacrine affect fertility or pregnancy?

There are no data on the use of this drug in pregnancy and breastfeeding.


Consequently, it is recommended that you should avoid taking it if you are pregnant or planning a pregnancy, or if you are breast feeding.

May I drink alcohol while I am taking mepacrine?


Mepacrine has been reported to produce a mild flushing reaction when taken with alcohol. There may be symptoms such as a racing heartbeat, dizziness, headache, shortness of breath, and sickness. If you experience these symptoms it is advisable to avoid alcohol.

Can I take other medicines at the same time as mepacrine?


Mepacrine is often used in conjunction with  hydroxychloroquine for additional benefits. This is safe, however, some drugs do interact with mepacrine. For example, mepacrine may increase the blood level of primaquine (a medication used in the treatment of malaria), resulting in a higher risk of toxicity, and it has been recommended that these two drugs should not be used together

You should always let any doctors who are treating you know that you are taking mepacrine.






TAJ PHARMA INDIA, Taj Pharma Group (India), P.O. Box No. 12002, Azad Nagar Post office,
Andheri (w), Mumbai - 400 053. India. (+91) -22-2637 4592 (IST) (+91) -22-2637 4593 Fax: (+91) - (0)22-2634-1274

Where can I find out more about mepacrine?


If you want to know more about mepacrine, or if you are worried about your treatment, you should speak to your doctor or pharmacist. This information sheet does not list all of the side effects of mepacrine. For fuller details, look at the medicine information sheet which comes as an insert with your prescription for mepacrine.

Web links to detailed leaflets:

Taj Pharma India's business can be contacted by common group
e-mail: tajgroup@tajpharma.com, and query --will be forwarded to the relevant departments; additionally, telephone lines +91 - (0)22 - 26374592 / 93 can be utilised if -you have an enquiry about the company, our healthcare business, or one of our medicines at India Standard Time (IST)


TAJ PHARMA INDIA
Taj Pharma India Correspondence
Taj Pharma Group (India)
P.O. Box No. 12002,
Azad Nagar Post office,
Andheri (w), Mumbai - 400 053.
India.
(+91) -22-2637 4592 (IST)
        (+91) -22-2637 4593
Fax: (+91) - (0)22-2634-1274

















TAJ PHARMA INDIA, Taj Pharma Group (India), P.O. Box No. 12002, Azad Nagar Post office,
Andheri (w), Mumbai - 400 053. India. (+91) -22-2637 4592 (IST) (+91) -22-2637 4593 Fax: (+91) - (0)22-2634-127