Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
(Drug Layer) Hydromorphone HCl
JOHNSON & JOHNSON PTE. LTD.
N02AA03
8.72mg
TABLET, EXTENDED RELEASE
(Drug Layer) Hydromorphone HCl 8.72mg
ORAL
Prescription Only
Alza Corporation
ACTIVE
2009-03-18
NAME OF THE MEDICINAL PRODUCT Trade name: JURNISTA ® (hydromorphone hydrochloride) QUALITATIVE AND QUANTITATIVE COMPOSITION Each JURNISTA ® 8 mg prolonged-release tablet contains 8.72mg and delivers 8 mg hydromorphone HCl, equivalent to 7.12 mg hydromorphone base. For a full list of excipients, see section “Pharmaceutical Particulars”. PHARMACEUTICAL FORM JURNISTA ® 8 mg prolonged-release tablet: red, round, biconvex tablet, with ‘HM 8’ printed in black ink on one side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Treatment of severe chronic cancer pain. JURNISTA ® should be used in patients requiring continuous analgesia. POSOLOGY AND METHOD OF ADMINISTRATION As with other opioid analgesics, safe and effective administration of JURNISTA ® to patients with pain depends upon a comprehensive assessment of the patient. The nature of the pain as well as the concurrent medical status of the patient will affect selection of the dose. Owing to the varied response observed to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose of opioid therapy and titrated to an adequate level of analgesia, balanced against an acceptable frequency of adverse reactions. As with any strong opioid, appropriate prophylaxis for known adverse reactions (for example constipation), should be considered. Patients should be instructed to swallow the JURNISTA ® tablet whole with a glass of water, at approximately the same time each day, and never to chew, divide, or crush it. JURNISTA ® may be taken with or without food (see _Pharmacokinetic Properties_). JURNISTA ® should not be taken more than once every 24 hours. _ _ _Patients currently not routinely receiving opioids: _ The starting dose of Jurnista should be 8mg every 24 Прочитать полный документ
2 PRODUCT NAME JURNISTA ® (hydromorphone hydrochloride) DOSAGE FORMS AND STRENGTHS JURNISTA ® 8 mg prolonged-release tablet: red, round, biconvex tablet, with ‘HM 8’ printed in black ink on one side. Each JURNISTA ® 8 mg prolonged-release tablet contains 8.72mg and delivers 8 mg hydromorphone HCl, equivalent to 7.12 mg hydromorphone base. For a full list of excipients, see section “Pharmaceutical Particulars”. CLINICAL INFORMATION INDICATIONS Treatment of severe chronic cancer pain. JURNISTA ® should be used in patients requiring continuous analgesia. DOSAGE AND ADMINISTRATION As with other opioid analgesics, safe and effective administration of JURNISTA ® to patients with pain depends upon a comprehensive assessment of the patient. The nature of the pain as well as the concurrent medical status of the patient will affect selection of the dose. Owing to the varied response observed to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose of opioid therapy and titrated to an adequate level of analgesia, balanced against an acceptable frequency of adverse reactions. The lowest effective dose should be used for the shortest period of time (see _Dosage and Administration _ _– Stopping Treatment_ ). As with any strong opioid, appropriate prophylaxis for known adverse reactions (for example constipation), should be considered. DOSAGE - ADULTS JURNISTA ® should not be taken more than once every 24 hours. _ _ _PATIENTS CURRENTLY NOT ROUTINELY RECEIVING OPIOIDS_ _ _ The initial dose in patients currently not routinely receiving opioids should not exceed 8 mg every 24 hours. The dosage should not be titrated more frequently than every fourth dose (for example, if the first dose is given on a Monday, the dosage could be increased no earlier than the fourth dose, on Thursday). Because it may be more time consuming to titrate a patient to adequate analgesia using a controlled-release opioid preparation, it may be advisable to begin treatment with conventiona Прочитать полный документ