Mysimba is not designed to be used as a stand alone treatments but should be part of a regime which includes a calorie controlled diet and sufficient exercise.
The exact mechanism of action is not yet fully understood. Both drugs are designed to work on different areas of the brain. When taken together they have an additive effect which results in your body utilising more energy and reducing the amount of food you eat by controlling any cravings you may have.
Although Mysimba has shown to be effective as a weight loss treatment and was approved for use in Europe in 2015, it does not have a license for this use on the NHS in the UK.
How is Mysimba Presented?
Mysimba is a prolonged release tablet which is blue in colour. The tablets are round and have NB-890 embossed on one side.
What are the Active Ingredients in Mysimba?
7.2mg of Naltrexone (equivalent to 8mg of Naltrexone Hydrochloride)
78mg of Bupropion (equivalent to 90mg to Bupropion Hydrochloride)
Who can use Mysimba?
Where weight management has not succeeded using a calorie controlled diet and an increased level of physical activity, Mysimba can be used as an adjunct to therapy.
Treatment is indicated for those individuals with a Body Mass Index (BMI) of
>27kg/m2 but <30kg/m2 (overweight) – must be accompanied by at least one other risk factor which can be related to the patients weight e.g. High blood pressure, diabetes or hyperlipidaemia.
BMI = Weight (kg) / (Height (m) x Height (m))
Patients can expect to lose a minimum of 5% of their initial body weight after completing 16 weeks of treatment. If this has not occurred then treatment may need to be discontinued at this stage.
What is the dosage of Mysimba to be used?
The dose for Mysimba is gradually increased to the maintenance dose over a four week period as follows –
- Week 1 – ONE tablet to be taken in the MORNING
- Week 2 – ONE tablet to be taken in the MORNING & in the EVENING
- Week 3 – TWO tablets to be taken in the MORNING & ONE to be taken in the EVENING
- Week 4 – TWO tablets to be taken in the MORNING & in the EVENING
- Maintenance DOSE – Same as week 4
The maximum recommended dosage of Mysimba on a daily basis is two tablets twice a day. If the desired weight loss (minimum 5% body weight) has not been achieved after 16 weeks of treatment then the need for treatment should be re-assessed by your clinician.
Always take this medication exactly how your prescriber has told you. Check with your doctor or pharmacist if you are unsure.
Mysimba is intended for oral use only. Tablets should be swallowed whole with plenty of water. Do not cut, chew or crush the tablets before taking them.
Mysimba should be taken with or immediately after food.
Full details are contained within the patient information leaflet. Patients are advised to read this before taking any medication and to follow the instructions carefully.
Additional information and guidance on Mysimba can be found at www.mysimba.co.uk
Special Considerations, Cautions and Contra-indications for Treatment with Mysimba
Elderly – Used with caution in patients aged 65-74. Not recommended for those over the age of 75.
Renal impairment – in patients with mild to moderate renal impairment then the maximum dose of Mysimba should be reduced from four tablets daily to two tablets daily. Mysimba should not be used in patients with severe or end stage renal impairment. A thorough risk assessment needs to be carried out before treatment can be commenced.
Hepatic impairment – Mysimba should be avoided in all patients with any level of hepatic impairment.
Under 18 years of age – drug effectiveness and safety profile has not been established therefore Mysimba should not be used in this group of patients.
Mysimba should not be used in patients who suffer from uncontrolled blood pressure and disorders which have resulted in a recent or past seizure. It should also not be used by patients who have suffered from a CNS tumour, Alcohol or substance withdrawal, sensitivity to any of the excipients, bipolar disorder, taking medication which already contain naltrexone or bupropion, anorexia, bulimia, opioid dependence or withdrawal and any patient taking a monoamine oxidase inhibitor (MOI) at the same time (in which case at least a 14 day window should be left between the two drugs).
Studies have not been conducted in females who may be trying to get pregnant, are pregnant or are breast-feeding. Treatment should therefore be avoided in these patients.
What are the Side Effects Associated with Mysimba?
As with all medication, Mysimba can be associated with unwanted side effects. Although generally mild in nature some of these can be more severe which can result in the treatment being discontinued.
- Anxiety and Insomnia
- Feeling restless
- Abdominal pain and constipation
- Nausea and vomiting
- Joint and muscular pain
- Hypersensitivity reactions (e.g. rash, itch)
- Reduction in lymphocyte cells count
- Depression, anxiety & irritability
- Dizziness, vertigo & tinnitus
- Tiredness, difficulty concentrating and paying attention
- Taste disturbances
- Increased tear production
- Palpitations & hot flushes
- Chest pain
- Dry mouth & toothache
- Excess sweating
- Delayed ejaculation
- Herpes (oral)
- Infection of the foot (soles & intra-digit space)
- Abnormal dreams & mood changes such as feeling nervous or agitated or tense etc.
- Eye disorders – blurred vision, swellings, irritation
- Tachycardia (increased heart rate)
- Blood pressure changes
- Hernia, excess wind, piles
- Lip swelling
- Liver abnormalities
- Irregular menstruation
- Erectile dysfunction
- Urea and electrolyte changes
- Idiopathic thrombocytopenic purpura (platelet reduction necessary for blood clotting)
- Severe hypersensitivity reactions such as angioedema
- Blood glucose disturbances
- Suicidal thoughts
- Postural hypotension
- Urinary frequency/retention
List compiled from data taken from www.medicines.org.uk – Please visit their website for a more complete and comprehensive list. Medicines.org is a stand alone entity and is in no way associated with this site.