Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Prochlorperazine mesilate 12.5 mg/mL;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Prochlorperazine mesilate 12.5 mg/mL
12.5 mg/mL
Solution for injection
Active: Prochlorperazine mesilate 12.5 mg/mL Excipient: Olamine Sodium chloride Sodium metabisulfite Sodium sulfite Water for injection
Ampoule, 10 x 1ml, 10 mL
Prescription
Prescription
Sanofi Chimie
Prochlorperazine is used for nausea and vomiting from whatever cause. It may also be used for migraine, schizophrenia (particularly in the chronic stage) and acute mania.
Package - Contents - Shelf Life: Ampoule, 1ml - 10 dose units - 60 months from date of manufacture stored at or below 25°C protect from light
1969-12-31
Stemetil® 1 STEMETIL ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING STEMETIL? Stemetil contains the active ingredient prochlorperazine. Stemetil is used to treat nausea, vomiting and dizziness due to various causes, including migraine (severe headache). For more information, see Section 1. Why am I using Stemetil? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE STEMETIL? Do not use if you have ever had an allergic reaction to prochlorperazine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Stemetil? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Stemetil and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE STEMETIL? • The usual recommended dose for nausea and vomiting is a 1 mL (12.5mg) injection More instructions can be found in Section 4. How do I use Stemetil? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING STEMETIL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Stemetil. • Call your doctor straight away if you notice any uncontrolled movements of the tongue, face, mouth or jaw, such as puffing of the cheeks, puckering of the mouth or chewing movements. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly or reduce the dosage, even if you are feeling better, without checking with your doctor first. • Do not take any medicines that cause drowsiness while you are taking Stemetil. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Stemetil affects you. • Stemetil may cause drowsine Read the complete document
ste-ccdsv6-dsv14-23nov22 Page 1 NEW ZEALAND DATA SHEET 1 STEMETIL Stemetil 12.5mg/mL solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Stemetil solution for injection contains 12.5 mg/mL prochlorperazine mesilate. Each ampoule contains 1 mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Stemetil solution for injection is clean, bright and not more than very pale yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prochlorperazine is used for nausea and vomiting from whatever cause. It may also be used for migraine, schizophrenia (particularly in the chronic stage) and acute mania. 4.2 DOSE AND METHOD OF ADMINISTRATION NAUSEA AND VOMITING Adults _Intramuscular _ _Treatment of nausea and vomiting _ 12.5 mg by deep intramuscular injection, followed by oral prochlorperazine six hours later, if necessary. ste-ccdsv6-dsv14-23nov22 Page 2 SCHIZOPHRENIA AND OTHER PSYCHOTIC DISORDERS Adults _Intramuscular _ 12.5 mg to 25 mg two or three times a day by deep intramuscular injection until oral treatment becomes possible. Children Intramuscular prochlorperazine should not be given to children. Elderly Prochlorperazine should be used cautiously in this group in psychotic disorders. Elderly patients susceptible to centrally-acting medicines hence lower initial dosage is recommended. There is an increased risk of drug-induced Parkinsonism in the elderly, particularly after prolonged use. Correct initial diagnosis of the disorder is important. Care should also be taken not to confuse adverse effects of prochlorperazine, e.g. orthostatic hypotension with effects due to the primary disorder. 4.3 CONTRAINDICATION Circulatory collapse, central nervous system depression (coma or drug intoxication), previous history of a hypersensitivity reaction (e.g. jaundice or blood dyscrasia) to phenothiazines especially to prochlorperazine, bone marrow depression. Hypersensitivity to prochlorperazine, other phenothiazines, or to any of the other ingredients of Stemetil. The use of prochlorperazine Read the complete document