INTRODUCTION

MIDORISE 5 contains Midodrine which belongs to the group of medicines called Alpha -1 Selective Adrenergic Receptor Agonist. It is used to treat low blood pressure (hypotension) in adults. Symptoms of low blood pressure include blurred or fading vision, dizziness or light-headedness, fainting, feeling sick, difficult in concentrating.

Midodrine acts on the blood vessels via the sympathetic nervous system (part of nervous system that cause increase in heart rate, blood pressure, breathing rate, and dilatation of pupil) to correct imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up which may cause low blood pressure. Your doctor may regularly monitor the blood pressure when you are lying down and when you are standing up as there may be a risk of your blood pressure rising when you lie down (Ex. at night).

MIDORISE 5 is not recommended for use in patients having severe heart disease. MIDORISE 5 should be used with caution in patient having severe kidney disease, liver problems. Consult your doctor for advice before taking MIDORISE 5, if you are pregnant or breast-feeding. MIDORISE 5 is not recommended for use in children and adolescents below the age of 18 years. The most common side effects of taking MIDORISE 5 are increased blood pressure when lying down, headache, nausea (feeling sick), vomiting, heartburn. Consult your doctor if the symptom worsens.

USES OF MIDORISE 5

• To treat certain severe forms of low blood pressure in adults by increasing the blood pressure

HOW MIDORISE 5 WORKS

MIDORISE 5 acts on the blood vessels via the sympathetic nervous system (part of nervous system that cause increase in heart rate, blood pressure, breathing rate, and dilatation of pupil) to correct the imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up which may cause low blood pressure.

DIRECTIONS FOR USE

Take MIDORISE 5 as advised by your physician. Swallow this medicine, do not crush, or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF MIDORISE 5

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods, sugary snacks, and drinks. Avoid drinking too much liquid along with your meals, drink slowly in between meals. Consult your doctor if your symptom does not improve.

Headache:

Apply hot or cold-water bag on your head. Try taking rest in a quiet and dark room. Massage with mild pressure on scalp or head.

Dizziness or lightheadedness:

When you feel dizzy, lie or sit down immediately. If you're experiencing a severe episode of vertigo, lie in a dark and quite place with eyes closed. Driving should be avoided, if you experience frequent dizziness without warning. Talk to your doctor if the symptom worsens.

Heartburn:

Symptoms of heartburn can be reduced by avoiding lying down for at least two hours after eating. Avoiding fatty foods, chocolates and citrus foods may also help. Antacid medications may be prescribed by your doctor to get rid of the symptoms immediately.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

• reserpine and guanethidine (medicines used to reduce high blood pressure)
• antihistamines like cetirizine, chlorpheniramine (used to treat allergies)
• hormones for the thyroid like thyroxine
• tricyclic antidepressants like clomipramine, amoxapine, amitriptyline and MAO-inhibitors such as selegiline, isocarboxazid, phenelzine, (both used to treat depression)
• vasoconstrictors like epinephrine, dopamine, phenyl epinephrine (medicines that narrow blood vessels)
• sympathomimetic agents such as ephedrine, isoproterenol, metaproterenol, (medicines that have a stimulating effect on certain parts of the nervous system)
• prazosin and phentolamine (medicines used to treat heart disease
• digitalis preparations such as digitoxin, digoxin (medicines used to treat heart disease)
• fludrocortisone acetate (medicine used to reduce inflammation)
• perphenazine (medicine used to treat mental or mood disorders)
• amiodarone (medicine used to treat irregular heartbeat)
• metoclopramide (medicine used to prevent vomiting)

Overdosage:

If you or anyone else accidentally take too much of MIDORISE 5, consult your doctor immediately or visit the nearby hospital. The most common symptoms of overdose are high blood pressure (hypertension), slow heart rate (bradycardia), difficulty urinating and feeling of coldness.

SYNOPSIS

MORE INFORMATION

• Keep MIDORISE 5 out of reach of children
• Store at room temperature

FAQs ABOUT MIDORISE 5

Can MIDORISE 5 cause heart palpitations?

Yes, MIDORISE 5 may cause irregular and fast heartbeat as it is one of the side effects of this medicine. This may result in the risk of falling down. Other symptoms include blurred vision, weakness, or tiredness, feeling sick.  Consult your doctor immediately if you experience any abnormal heartbeat or signs of abnormal heartbeat (such as chest pain, dizziness, fainting).

How does MIDORISE 5 works?

MIDORISE 5 acts on the blood vessels via the sympathetic nervous system (part of nervous system that cause increase in heart rate, blood pressure, breathing rate, and dilatation of pupil) to correct the imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up which may cause low blood pressure.

Is it safe to use MIDORISE 5 in older patients?

Yes, but it should be used with caution in elderly with regular monitoring of blood pressure levels and your doctor may monitor your vital organs as it may cause damage to liver, kidney, and heart.

What happens if I stop taking MIDORISE 5?

Do not stop taking MIDORISE 5 without talking to your doctor first. Stopping this medicine suddenly can cause your blood pressure to fall and may increase the risk of blurred vision, dizziness, fainting or death.

Who should not take MIDORISE 5?

You should not use MIDORISE 5 if you have severe heart disease, overactive thyroid, an adrenal gland tumour, kidney disease, heart disease, liver disease, painful urination, or if your blood pressure is high even while lying down. Consult your doctor immediately if you experience any unusual effects.

REFERENCES

1. Goodman and Gillman’s. the pharmacological basis of therapeutics. 12th edition. Adrenergic Agonist and Antagonist. Page- 295-297.

2. William Smith, Hong Wan, David Much, Antoine G. Robinson and Patrick Martin.  Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study.  NIH National Library of Medicine, National center for biotechnology information. PubMed Central. July 2016. [Accessed 20th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4951503/

3. Achuthan Sourianarayanane, MD, MRCP,  David S. Barnes, MD and Arthur J. McCullough, MD. Beneficial Effect of Midodrine in Hypotensive Cirrhotic Patients with Refractory Ascites. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. February 2011. [Accessed 20th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3061020/

4. Tiofarma B.V. Health Products Regulatory Authority (HPRA). [Revised in August 2021] [Accessed 20th May 2022] http://www.hpra.ie/img/uploaded/swedocuments/56f4c194-cebb-4cee-b24e-b8ce367e433c.pdf

5. MIAS Pharma Limited. Electronic Medicines Compendium (EMC). [Revised in April 2021] [Accessed 20th May 2022] https://www.medicines.org.uk/emc/files/pil.12496.pdf

6. Shire US Inc. U.S. Food & Drug Administration. [Revised in January 2017] [Accessed 20th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019815s010lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Kidney function test