MIRTAZAPINE TABLET – Is it safe? Uses, Side Effects, Dosage
WHAT IS MIRTAZAPINE TABLET?
These tablets have Mirtazapine as the active ingredient. It belongs to the antidepressants category. Pharmacologically it is classified under atypical antidepressants.
It is marketed by Actavis, Barnstaple, EX32, UK
The major indications are:
- Major Depressive Disorder
- Panic disorders including anxiety
- Chronic tension-type headache
- Post Traumatic Stress Disorder (PTSD)
- Obsessive Compulsion Disorder (OCD).
It should be stored at 25°c and to be protected from light and moisture.
Oral Disintegrating Tablets should be consumed immediately after opening the blister.
MIRTAZAPINE TABLET – Is it safe? Uses, Side Effects, Dosage
What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
How effective is this medicine?
Is it addictive?
What is the dosage?
What if I miss a dose?
What to do in case of overdosage?
What to do in case of allergic reactions?
What are the side effects?
Does this medicine have any drug interactions?
Precautions
Is it safe to use if I am pregnant?
Is it safe to use if I am breastfeeding?
CAN THIS MEDICINE BE GIVEN TO CHILDREN AND INFANTS?
IS THIS MEDICINE AVAILABLE AS OVER THE COUNTER (OTC) PRODUCT?
FREQUENTLY ASKED QUESTIONS
Reference
WHAT ARE GENERIC NAME(s)?
These tablets have Mirtazapine[1] as the main active ingredient.
WHAT IS IT’S COMPOSITION?
These tablets include:
Active content
- Mirtazapine( as film-coated tablets)
Inactive contents
- Lactose monohydrate[2]
- Pregelatinised maize starch[3] anhydrous colloidal silica
- Croscarmellose sodium[4]
- Magnesium stearate
Tablet coating contents
AVAILABLE STRENGTHS
- 2 mg
- 7.5 mg
- 15 mg
- 30 mg
- 45 mg
HOW DOES IT WORK?
It blocks Alpha-2 receptors[8] and thereby promoting the Noradrenaline[9] and Serotonin[10] release. The enhanced Noradrenaline increases firing of serotonin neurons[11] through Alpha-1 receptors.
The drug also blocks the action of Serotonin sub-receptors 2 and 3 which are held responsible for the depression[12] pathophysiology.
WHAT ARE IT’S USES?
The major indication for which it is prescribed as a first line agent includes Unipolar Major Depressive Disorder[13] (MDD).
Indications for which it is prescribed as a second line agent include:
- Panic Disorders[14]
- Anxiety[15]
- Post Traumatic Stress Disorder (PTSD)
- Obsessive Compulsive Disorder (OCD)
It is also indicated for the prophylaxis of Chronic type headache.
HOW EFFECTIVE IS THIS MEDICINE?
It shows rapid and complete absorption when given orally. Its bioavailability is approximately 50% and the elimination half-life is 20-40 hours; studies say that women show an increased elimination half-life than men. Antidepressant effects are visible by 1st week of drug administration itself.
It shows a beneficial effect when administered in depression patients with insomnia. It is also known to show a delayed onset of action when compared to other antidepressants.
A comprehensive clinical trial from the US and Europe demonstrated that it has sustained antidepressant efficacy action.
Few studies and experts consider it as an extremely useful drug in geriatric patients with depression for stimulating appetite and hence weight loss.
IS IT ADDICTIVE?
It is not always the abuse which leads to addiction like heroin but its the long term usage for the indicated disease which causes addiction. Though it is used to treat addiction in a clinical setting and at the same time, chances are there for it to cause addiction as well.
There is another problem associated with it; which is, it causing withdrawal symptoms which normally include the following:
- nausea
- vomiting
- a headache
- diarrhoea
- dizziness
- anorexia
- sweating
- chill
- tremor
- sleep disturbances
WHAT IS THE DOSAGE?
ADULT DOSAGE
- MAJOR DEPRESSIVE DISORDER: Initially begin with 15 mg at night time (once daily only), an increment of 15mg at an interval not less than 2 weeks to be followed with a maximum dose of 45mg/day only.
- PANIC DISORDER: Used as a second line agent in patients who are unresponsive to first-line agent drugs. Initially begin with 15 mg at night time (once daily only), an increment of 15 mg at an interval, not less than 1 weeks to be followed with a maximum dose of 45mg/day only. The increment should be based on response and tolerance.
- A CHRONIC HEADACHE: Initially begin with 15 mg at bedtime, increase to 30mg on next week.
GERIATRIC DOSAGE
- MAJOR DEPRESSIVE DISORDER: The initial dose to be administered is 7.5mg once daily at bedtime. The drug should always be used with caution because renal clearance and hepatic clearance are reduced in geriatric patients.
DOSAGE ADJUSTMENTS
RENAL FAILURE: The drug/medicine label does not mention any need for dosage adjustments but its well understood that the drug clearance will be reduced because of renal impairment.
HEPATIC FAILURE: Same like Renal failure; drug/medicine label does not mention any need for dosage adjustments even though the drug clearance will be reduced in hepatic impairment as well.
WHAT IF I MISS A DOSE?
It is always advisable that you take your medication on time to get the best desirable action.
In the case of mirtazapine, if you have missed a dose under any unforeseen situations, note the below steps:
MISSED A ONCE DAILY DOSE
- Take the missed dose soon after you remember of it.
- In case you are near to the next dosing time, please skip the missed dose and take the regular dose only.
- Avert yourself from taking a double dose, if you think it is going to give you higher efficacy.
MISSED A TWICE DAILY DOSE
- If you missed your morning dose, you can take the missed dose along with your evening dose.
- If you have missed your evening dose, skip it. Continue the regular dosing from next day.
- If you have missed both the doses, skip them and continue regular dosing.
WHAT TO DO IN CASE OF OVERDOSAGE?
In any case that you suspect an overdosage, act quickly.
- Call to the nearest hospital or physician available.
- Carry the suspected medicine with you. This will make the physician confirm the drug and treat you with no delay.
- Be ready to give all the information asked by the physician related to the event. These would be the number of tablets taken, the time and duration, conditions and symptoms.
WHAT TO DO IF THERE IS AN ALLERGIC REACTION?
First and foremost thing to be done is to stop the drug administration.
But every clinical setting takes a special concern to give a test dose before administering the therapeutic dose of mirtazapine.
- In case, you get any allergic reactions, stop the drug and inform your physician.
- Be clear in explaining what kind of allergy has occurred to you.
- Correctly note the onset of reaction and duration.
- It is better if you do not self-treat yourself under this situation.
WHAT ARE THE SIDE EFFECTS?
Every drug has side effects. It is not at all necessary that each patient taking the medicine should get a side effect. It is strictly based upon the patient characteristics and disease condition.
Some of the side effects associated with it are listed below:
- Sleep disturbances
- Constipation
- Weight gain
- Increased Appetite
- Weakness
- Dry Mouth
- Dizziness
- Sedation
- Hyponatremia
- Hypotension
Always inform your doctor about the side effects rather than taking making any other intervention. In case of any query and clarification, clear it with the doctor who prescribed you the drug.
DOES THIS MEDICATION HAS ANY DRUG INTERACTIONS?
It has a lot of interactions with other drugs, such as:
- Alpha-2-agonists
- Serotonin antagonists
- Aprepitants
- Buprenorphine
- Cimetidine
- Doxylamine
- Fluvoxamine
- Haloperidol
- Hydroxyzine
- Linezolid
- Metoclopramide
- Mifepristone
- Minocycline
- Mono-Amine Oxidase-Inhibitors (MAO-I)
- Nabilone
- Opioid Analgesic
- Quinine
- Ropinirole
- Sarilumab
- Selective Serotonin Re-uptake inhibitors (SSRIs)
- Thalidomide
- Warfarin
- Zolpidem
PRECAUTIONS
Before taking it, inform your doctor the following:
- If you are hypersensitive to the medicine.
- Tell about all other concomitantly taken medicines for other co-morbid conditions.
- Inform if you had taken any other antidepressants in the last 14 days.
- Tell about all other health conditions.
Major Psychiatric Precaution
- Suicidal thinking/behaviour
A patient group under the age group of 18-24 prescribed with it for Depression have shown higher suicidal behaviour. They require close monitoring and under severe cases needs medicine modification. Do not take the medication without a prescription. - Mania/hypomania
A study has shown a result of 0.2% incidence of mania in people treated with it.
Adverse Event Precaution
- Somnolence – Patients should be strictly cautious before engaging in activities which require alertness like driving and operating heavy machines
- Anti-cholinergic effects – The effects include like dry mouth, constipation, urinary retention, pupillary dilation etc.
- Hyperlipidemia – Patients are advised to do a routine lab investigation to examine their lipid profile and maintain it
- Hyponatremia – This will eventually cause hypotension, which exacerbates Cardio-vascular events
- Hypotension – Mainly orthostatic hypotension which will make you at increased of Cardio Vascular Events and Cerebro Vascular Accidents.
- Weight Gain – Weight gain of more than 7% is being reported by patients under it. Monitor your weight every week.
- Agranulocytosis – There may occur infection, fever, sore throat in few patients. These are indicative to agranulocytosis and must be reported to the physician immediately.
Disease-related precaution
- Renal and hepatic impairment: Medicine Label does not mention any dose adjustment during these impairments but required precautions are to be taken.
- Mania/Hypomania: Every depression patient must be tested and screened for bipolar disorders because its mono-therapy is contraindicated in bipolar disorders.
Discontinuation syndrome
Discontinuation syndrome is known to occur when you abruptly stop its therapy or interrupt the course of normal treatment.
Most common symptoms under this include:
- nausea
- diarrhoea
- vomiting
- a headache
- dizziness
- light-headedness
- increased appetite
- vivid dreams
- insomnia
- fatigue
- tremors
- chills
Concomitant illness
History of Cardio-vascular disease: It is associated with orthostatic hypotension. A history of Cardio-vascular disease will definitely be exacerbated with the occurrence of hypotension.
IS IT SAFE TO USE IF I AM PREGNANT?
It falls under Pregnancy category C.
Studies have shown that it crosses placenta when a maternal overdose occurs. It is a newer antidepressant drug and only a few studies on it reproductive toxicity is performed. All animal studies have reported teratogenic effects to the fetus. Studies carried out in pregnant patients showed no fetus malformation or a significant increase in any major teratogenic effects but it showed an increase in non-teratogenic effects.
Mirtazapine treatment is patient-tailored (Individualized), based on each patient’s condition and also calculating Risk: Benefit
IS IT SAFE TO USE IF I’M BREASTFEEDING?
All manufacturers label “Use with CAUTION” when used during breastfeeding (Nursing mother). The baby’s serum may show concentrations of the medicine during breastfed from the mother under its medication. Even then, no cases have been reported with side effects to the baby so far.
It is just that, you should make sure that your baby is not gaining weight in an unusual measure and neither oversleeps if you breastfeed your baby at the time of mirtazapine medication.
CAN THIS MEDICINE BE GIVEN TO CHILDREN AND INFANTS?
It is not indicated for children less than the age of 18.
One of the recent studies have shown that its usage in children under the age of 18 is associated with
- Behavioural changes
- Emotional changes
- Increased risk of suicidal ideation
- Self-harm
- Severe agitation
- Dis-inhibition
- De-personalization
- Emotional Liability
IS THIS MEDICINE AVAILABLE AS OVER THE COUNTER (OTC) PRODUCT?
No, it is a prescription only medicine.
You will need a prescription to buy mirtazapine even if for the lowest dose. The safety concerns related with these tabets are too high.
There are a lot of cases being reported to family physicians regarding attempts of self-harming or suicide attempt with its consumption. Instead, we advise you to talk to your family and friends about your depression and consult a physician.
FREQUENTLY ASKED QUESTIONS
- Can a diabetic patient take it?
It contains Lactose as an ingredient. It is advised you inform your physician on a prior basis if you are diabetic or lactose intolerant. Also, provide information about Oral Hypoglycemic agents you are taking because there are chances of lactic acidosis with metformin. - I feel better after taking it in a week. Can I stop taking it?
Complete the course of treatment as per instructed by the physician. Even though you feel better now, there are chances that your disease will relapse. There are also risks of withdrawal syndromes which include dizziness, agitation, headache. The doctor will gradually taper the dose and stop it. - What is the best time to take it?
It is associated with mild sedation, so its the best to take it during the night, before sleep when its given as once daily dose. When given as twice daily dose, it’s better to take the doses at the same time every day. - How to store these tablets?
Store the tablet under room temperature in the original package. Keep it out of reach from children and away from sunlight and moisture. - Can I throw away the unused/leftover tablets?
Do not throw away or flush the tablets. The unused medicines can either be returned to the pharmacy from where you have bought it or your pharmacist will provide you with information regarding the process of discarding the leftover tablets.
Reference
Wikipedia page on Major depressive disorder
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