Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PROCHLORPERAZINE MALEATE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
PROCHLORPERAZINE MALEATE
1000 Tablet Tablets; 500 Tablet Tablets; 100 Tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_Consumer Medication Information Leaflet (RIMUP) _ 1 PROCHLOR TABLET 5MG Prochlorperazine Maleate 5mg WHAT IS IN THE LEAFLET? 1. What Prochlor is used for 2. How Prochlor works 3. Before you use Prochlor 4. How to use Prochlor 5. While you are using it 6. Side effects 7. Storage and Disposal of Prochlor 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PROCHLOR IS USED FOR Prochlor is indicated in the management of psychotic conditions including the treatment of schizophrenia and for the quieting effect in hyperactive or excited psychotic patients Prochlor is used to treat nausea, vomiting and dizziness due to various causes, including migraine (severe headache) or drug induced emesis (vomiting) and for the short-term symptomatic relief or vertigo as occurs in the Meniere’s disease (an inner ear disorder that affects balance and hearing) or labyrinthitis (irritation and swelling of the inner ear) HOW PROCHLOR WORKS Prochlor belongs to a group of medicines called phenothiazines. It helps to correct chemical imbalances in the brain, allowing it to function correctly. These chemicals may also affect the parts of the brain which control nausea (feeling sick) and vomiting. BEFORE YOU USE PROCHLOR - _When you must not take it _ Do not take Prochlor if you have an allergy to: • Prochlor • severe central nervous system depression • severe cardiovascular disease. • the group of medicines called Phenothiazines • of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction to Prochlor may include: • shortness of breath, wheezing or difficulty in breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin Prochlor must not be given to anyone who is unconscious or in a coma. Do not take any medicines that cause drowsiness while you are taking Prochlor. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are Baca dokumen lengkap
DESCRIPTION PHARMACOKINETICS INDICATIONS DOSAGE PHARMACODYNAMICS A 6.5 mm diameter, round, convex, scored pink tablet marked “UP” on one side containing 5mg prochlorperazine maleate per tablet. Prochlor is indicated in the management of psychotic conditions including the treatment of schizophrenia and for production of quieting effect in hyperactive or excited psychotic patients. Prochlor can also be used to control severe nausea and vomiting including that associated with migraine or drug induced emesis and for the short-term symptomatic relief or vertigo as occurs in Meniere's disease or labyrinthitis. Prochlorperazine is a piperazine type of phenothiazine. Its antipsy- chotic effect may be due to the blockage of postsynaptic mesolim- bic dopaminergic receptors in the brain, which also increases prolactin release by the pituitary. An alpha adrenergic blocking effect is also produced which depresses the release of hypothalamic and hypophyseal hormones. Prochlorperazine acts centrally to inhibit or block the dopamine (D2) receptors in the medulary chemoreceptor trigger zone (CTZ) and peripherally by blocking the vagus nerve in the gastro- intestinal tract. Its antiemetic effect may be augmented by their anticholinergic, sedative and antihistaminic effects. Prochlorperazine is well absorbed from the GI tract but is subject to considerable first pass metabolism from the gut wall. It is also extensively metabolised in the liver and is excreted in the urine and bile. Plasma concentrations following oral administration are much lower than those following intramuscular injection, and are subject to wide inter-subject variation. There is no simple correla- tion between plasma concentrations of prochlorperazine and its metabolites, and therapeutic effect. Prochlorperazine may be metabolised by hydroxylation and conjugation with glucuronic acid, N-oxidation, oxidation of the sulfur atom and dealkylation. Plasma half-life is reported to be only a few hours but elimination of the metabolites may be very prolonged. Proch Baca dokumen lengkap