Dexisun Concentrated Solution

The active substance is dexmedetomidine. Dexmedetomidine belongs to a group of medicines called psycholeptics. They are used for sedation in hospital.

DEXISUN is used:

• For sedation of patients in Intensive Care Unit (ICU) who have undergone surgery and are on a mechanical ventilator.
• For sedation when you receive certain surgical procedures under a local anaesthesia or nerve block or when you are receiving a breathing tube while awake.

DEXISUN should not be administered to you:

• if you are hypersensitive (allergic) to dexmedetomidine or to any other ingredient of DEXISUN.
• if you have any septic conditions (when chemical released in the blood to fight infections trigger inflammation throughout the body)
• if your condition is unstable following trauma injury.
• if you have a condition called hypovolaemia, where there is a decrease in the amount of blood circulating through your body.
• if you have been diagnosed with a condition called heart block.
• if you have heart failure which cannot be controlled.
• if you have liver failure
• if you have low blood pressure
• if you have acute cerebrovascular conditions, which includes conditions that affect the flow of blood through the brain.
• if you are pregnant of breastfeeding your baby (see Pregnancy and Breastfeeding).

DEXISUN should not be used outside an Intensive Care Unit setting or surgical operating theatres. There should be continuous monitoring of vital parameters.

You will not be expected to give yourself DEXISUN. It will be given to you by a person who is qualified to do so. During the administration of DEXISUN, your vital signs (blood pressure, heart rate and oxygen levels) will be monitored.

You should never receive DEXISUN as an injection; it will be given to you as a drip and may even be given via a device that accurately controls the drip rate. You should not be given DEXISUN for longer than 24 hours.

Dosage: Your doctor will determine the dose of DEXISUN according to the level of sedation he needs to achieve. At first, you will receive a higher dose over a period of 10 minutes. Once the desired level of sedation is achieved, the doctor will lower the dose in order to maintain the level of sedation.

If you receive more DEXISUN than you should: Since DEXISUN will be given to you by a doctor or nurse under carefully controlled conditions, it is unlikely that you will be given too much. If you have received too much DEXISUN, your doctor will manage the overdosage.

If you have any further questions on the use of DEXISUN, ask your doctor or pharmacist.

If you forget to use DEXISUN: Since a health care provider will administer DEXISUN, it is unlikely that the dose will be missed.

DEXISUN can have side effects. Not all side effects reported for DEXISUN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DEXISUN, please consult your doctor, pharmacist or any other healthcare professional for advice.

If any of the following happens, stop receiving DEXISUN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching.

These are very serious side effects. If you have them, you may have had a serious allergic reaction to DEXISUN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• change in breathing pattern or stopping breathing
• low or high blood pressure
• a slower than normal heartbeat, reduced heart function
• fast heart rate, irregular heartbeat
• chest pain or heart attack
• yellowing of the skin and eyes, also called jaundice

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• nausea, vomiting, dry mouth
• low oxygen levels in the body tissues
• agitation
• very high temperature (Hyperpyrexia)

Less frequent:

• infections or sepsis
• blood problems (such as abnormal clotting, low white or red blood cells)
• a condition where there is too much acid in the body
• thirst
• low or high blood sugar
• anxiety, confusion
• depression, nervousness
• hallucination (seeing something that is not really there)
• convulsion (fits), dizziness, headache
• nerve pain, numbness
• an abnormal sensation (pins and needles) in the fingers hands, toes, or feet
• speech problems
• disturbances in vision
• coughing
• increased saliva
• lung and breathing problems
• stomach pain, diarrhoea
• ulcers
• liver function problems
• kidney function problems
• increased sweating
• muscle weakness
• swelling
• pain
• chills and shivers
• Increased urination

If any of the side effects become serious, or if you notice any side-effects not listed in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DEXISUN.

Store all medicines out of reach of children.

Store at or below 25 ⁰ C in the original container. Do not refrigerate. Once diluted, the diluted should be used immediately. If not used immediately, the diluted solution may be stored at 2 – 8 ⁰ C during the 24 hour “in use” period. Discard any unused diluted solution after 24 hours.

Do not use DEXISUN after the expiry date stated on the vial. The expiry date refers to the last day of that month.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).