Norepinephrine Bitartrate Injection USP 4 mg/2ml
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).
Please note that the leaflet also contains information about other strengths, Norepinephrine bitartrate 4mg/2ml Injection
WHAT IS IN THIS LEAFLET
- What Norepinephrine bitartrate is and what it is used for
- What you need to know before you take Norepinephrine bitartrate
- How to take Norepinephrine bitartrate
- Possible side effects
- How to store Norepinephrine bitartrate
- Contents of the pack and other information
1. WHAT NOREPINEPHRINE BITARTRATE IS AND WHAT IT IS USED FOR
Norepinephrine bitarterate for Solution
for Infusion is used in an emergency to increase blood pressure to normal
levels.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOREPINEPHRINE BITARTRATE
Do not takeNorepinephrine bitarterate
? if you are allergic to Norepinephrine bitarterate preparations or to any of the other ingredients of this medicine ( listed in section 6). Tell your doctor if any of the above applies to you before this medicine is used
Warnings and precautions
Talk to your doctor or pharmacist before taking norepinephrine bitarterate if you have:
? diabetes
? high blood pressure
? an overactive thyroid
? low levels of oxygen in the blood
? high levels of carbon dioxide in the blood
? clots or obstructions in the blood vessels supplying the heart, intestines, or other parts of the
? body low blood pressure following a heart attack
? a type of angina (chest pain) called
Prinzmetal?s angina.
? are elderly
Other medicines and Norepinephrine
bitarterate
Tell your doctor or pharmacist if you are taking, or have recently taken or
might take any other medicines.
A number of medicines are known to increase the toxic effects of Norepinephrine, such as:
? Monoamine oxidase inhibitors
(antidepressants)
? tricyclic antidepressants
? linezolid (an antibiotic)
? anaesthetics (especially anaesthetic gases)
? adrenergic-serotoninergic medicines, e.g.
used in the treatment of asthma and heart
conditions.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before taking
this medicine. Norepinephrine bitarterate may harm the unborn baby. Your doctor
will decide if you should be given Norepinephrine bitarterate.
Norepinephrine Concentrate contains sodium The 2 ml ampoule contains 6.7 mg sodium, and the 4 ml ampoule contains 13.3 mg sodium. Take into consideration if you are on a low-sodium diet.
3. HOW TO TAKE NOREPINEPHRINE BITARTRATE
Norepinephrine bitarterate will be given to you in hospital by a doctor or nurse. It is first diluted and then infused into a vein.
The recommended dose of Norepinephrine bitarterate will depend on your medical condition. The usual dose is between 0.4 and 0.8 mg per hour. Your doctor will determine the correct dose for you. After the initial dose, your doctor will assess your response and adjust the dose accordingly.
If you are given more or forget to take Norepinephrine bitarterate:
It is
unlikely that you will receive too much or too little of this medicine, as this
medicine will be given to you in hospital. However, talk to your doctor or
nurse if you have any concerns. Symptoms of overdose are severe high blood
pressure, slow heartbeat, violent headache, light sensitivity, pain in the
chest, pale colour, intense sweating and vomiting.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience:
? sudden itchy
rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing), feeling that you are
going to faint.
? pain and/or swelling at the injection
site
Tell your doctor as soon as possible if you experience
? slow heart rate
? abnormal heart rhythm
? breathing difficulties
? anxiety
? headaches
? cold extremities
? pain in the extremities
Your doctor will monitor your blood
pressure and blood volume.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE NOREPINEPHRINE BITARTRATE
Keep this medicine out of the sight and reach of children
Do not store above 25?C
Do not use this medicine after the expiry date which is stated on the carton
after EXP. The expiry date refers to the last day of that month.
From a microbiological point of view, the product should be used immediately
after dilution.
Do not use this medicine if the solution is brown in colour.
Do not throw away any medicines via wastewater. Ask your pharmacists how to
throw away medicines you no longer use. These measures will help protect the
environment.
6.
CONTENTS OF THE PACK AND FURTHER INFORMATION
What Norepinephrine bitartrate contains
1 ampoule of 2 ml contains:
Norepinephrine bitartrate equivalent to
Norepinephrine??????……..4mg
when diluted as recommended, each ml contains 80 micrograms Norepinephrine
bitartrate equivalent to 40 micrograms Norepinephrine base.
The other ingredients are:
? sodium chloride
? sodium hydroxide (for pH adjustment)
? hydrochloric acid (for pH adjustment)
? Water for Injections.
What Norepinephrine bitartrate looks like and contents of the pack:
This medicinal product is presented as a concentrate for solution for infusion. The solution is a clear colourless or yellowish solution.
It may be supplied in packs of 5 x 2 ml ampoules or 5 x 4 ml ampoules.
7. MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)