Regulatory Information
ZUELLIG PHARMA PTE. LTD.
ZUELLIG PHARMA PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** One 60 mg Imdur Durules once daily. The dose may be increased to 120 mg once daily. Imdur Durules should not be administered twice daily. If headache occurs, the initial dose may be reduced to half a 60 mg tablet daily until the headache disappears. Patients with severe renal impairment may require dosage reduction to half a tablet given once daily. Imdur Durules should not be chewed or crushed, and should be swallowed whole with half a glass of fluid. If care is taken to avoid crushing or chewing the tablet, half doses of the 60 mg tablet may be administered without affecting the sustained-release properties of Imdur Durules.
ORAL
Medical Information
**INDICATIONS** Imdur Durules are indicated for prophylactic treatment of angina pectoris. Imdur Durules are not recommended for the management of acute attacks of angina pectoris (see PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**CONTRAINDICATIONS** Known hypersensitivity to nitrates or to any of the components in Imdur, shock (including cardiogenic shock), hypotension, obstructive hypertrophic cardiomyopathy and pericarditis. Phosphodiesterase type 5 Inhibitors (e.g. sildenafil, tadalafil and vardenafil) must not be given concomitantly with Imdur Durules.
C01DA14
isosorbide mononitrate
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
AstraZeneca Pharmaceutical Co. Ltd
Laboratorios Alcalá Farma , S.L
Active Ingredients
Documents
Package Inserts
IMDUR Durules Tablet 60mg PI.pdf
Approved: September 15, 2022