Country: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
Acetaminophen; Tramadol hydrochloride
MIRACO NUTRIPHARM PTE. LTD.
N02AJ13
TABLET, FILM COATED
Acetaminophen 325mg; Tramadol hydrochloride 37.5mg
ORAL
Prescription Only
Standard Chem. & Pharm. Co., Ltd.
ACTIVE
2022-05-19
ULTRADOL F.C. TABLETS 37.5MG/325MG (TRAMADOL HCL + ACETAMINOPHEN) COMPOSITION Each ULTRADOL F.C. Tablet contains Tramadol HCl 37.5mg and Acetaminophen 325mg. PHARMACEUTICAL FORM ULTRADOL occurs as a light yellow capsular shaped, biconvex film‐coated tablet, branded "775" one side and "STD" on the other side. CLINICAL INFORMATION INDICATIONS ULTRADOL is indicated for the treatment of moderate to severe pain. DOSAGE AND ADMINISTRATION The tablets should be taken orally, whole, not divided or chewed, with sufficient liquid, without regard to food. ULTRADOL should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with ULTRADOL is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary, with breaks in treatment) to establish whether and to what extent further treatment is necessary. DOSAGE – ADULTS AND CHILDREN 16 YEARS OF AGE AND OVER The maximum single dose of ULTRADOL is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. The lowest effective dose should be used for the shortest period of time. TREATMENT WITHDRAWAL Do not stop use of ULTRADOL abruptly. Withdrawal symptoms may be relieved by tapering the medication (see _Warnings and Precautions – Treatment Withdrawal_ ). CHILDREN BELOW 16 YEARS OF AGE The use of ULTRADOL is contraindicated in children below 12 years of age (see _Contraindications_ ). The safety and effectiveness of ULTRADOL in children aged 12 to below 16 years of age has not been established (see _Contraindications and Warnings and Precautions – Other Risk Factors for Life- _ _threatening Respiratory Depression in Children_ ). Therefore, treatment is not recommended in this population. ELDERLY (75 YEARS OF AGE AND OLDER) Elimination of the active components may be prolonged in elderly patients over 75 years of age. Therefore, if necessary, the dosage interval may be extended according to the patients requirements. Прочитајте комплетан документ