Rusaine 10 mg Solution

RUSAINE contains the active substance phenylephrine hydrochloride which belongs to a group of medicines know as vasoconstrictors. RUSAINE is used to increase blood pressure in adults during clinically significant hypotension (low blood pressure) because of vasodilation during septic shock or anaesthesia.

RUSAINE should not be administered to you:

• If you are hypersensitive (allergic) to phenylephrine hydrochloride or to any of the other ingredients of RUSAINE (listed in section 6).
• If you have uncontrolled high blood pressure.
• If you have an overactive thyroid (hyperthyroidism).
• If you have heart problems or heart failure.
• If you have a very slow heartbeat (less than 50 beats per minute).
• If you are under 18 years of age.

Warnings and precautions

Tell your doctor or health care provider before being given RUSAINE if:

• You have heart problems or conditions, including chest pain (angina pectoris).
• You have high blood pressure.
• You have an aneurysm (enlargement of an artery).
• You have Raynaud’s phenomenon (decreased blood flow to the fingers or other parts, causing cold fingers or toes, colour changes in your skin, numb and prickly feeling or stinging pain upon warming).
• If you have diabetes mellitus or closed angle glaucoma.
• If you are allergic to sulphites.
• If you have been diagnosed with autonomic dysfunction (when your autonomic system does not work properly).

Children

RUSAINE is not recommended for use in children due to insufficient data on efficacy, safety and dose recommendations.

You will not be expected to give yourself RUSAINE. It will be given to you by a person who is qualified to do so. RUSAINE will be given to you directly into a vein by an injection or infusion.

If you receive more RUSAINE than you should

Since a health care provider will administer RUSAINE, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use RUSAINE

Since a health care provider will administer RUSAINE, it is unlikely that the dose will be missed.

RUSAINE can have side effects. Not all side effects reported for RUSAINE are included in this leaflet. If any of the following happens, RUSAINE administration should be stopped and the patient should be managed at the hospital by a doctor or nurse:

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

These are all very serious side effects. If you have them, you may have had a serious reaction to RUSAINE. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if you notice any of the following:

• cardiac arrest (pain in the chest, back, jaw and other areas of your upper body that lasts more than a few minutes or that goes away and comes back, shortness of breath),
• chest pain, changes in the way your heart beats, irregular heartrate,
• cerebral haemorrhage (sudden or severe headache, changes in vision or balance, seizures (fits), weakness or numbness in arms or legs),
• hypertensive crisis (chest pain, anxiety, headache, blurred vision, shortness of breath, nausea (feeling sick) and vomiting (being sick)),
• difficulty breathing, shortness of breath, wheezing, cough, cold and clammy skin.

Tell your doctor if you notice any of the following:

Frequent:

• headache.

Less frequent:

• anxiety, excitability, agitation, confusion, shaking (tremor),
• paraesthesia (tingling or numbness of your hands and feet (pins and needles),
• psychotic states (e.g. psychosis),
• dilated pupils, worsening of angle - closure glaucoma (increased pressure in the eye, causing headache, eye pain, blurred vision),
• high or low blood pressure,
• dizziness, fainting, flushing (redness of your skin),
• nausea (feeling sick), vomiting (being sick),
• sweating, pale skin, goosebumps,
• skin blanching (whitening of the skin),
• muscle weakness,
• difficulty in urinating or initiating urination.

Frequency unknown:

• metabolism and nutrition disorders, metabolic disorders,
• nervousness, restlessness, sleeplessness,
• an increase in saliva,
• painful or difficulty in passing urine,
• excessive sweating,
• injection site tissue damage,
• changes in blood sugar levels.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist. This includes any possible side effects not listed in this leaflet. 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.

• Store at or below 25 °C.
• Store all medicine out of reach of children.
• Do not use after the expiry date which is stated on the carton or ampoule.
• Do not dispose of unused medicines in drains, sewerage systems or household waste.
• Return all unused medicine to your pharmacist.