Product Information
Registration Status: ActiveSIN10515P
IMDEX CR TABLET 60mg is approved to be sold in Singapore with effective from 1998-08-12. It is marketed by DUOPHARMA (SINGAPORE) PTE LTD, with the registration number of SIN10515P.
This product contains Isosorbide Mononitrate 60mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by UPHA PHARMACEUTICAL MANUFACTURING (M) SDN BHD in MALAYSIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold by AstraZeneca under the trade name Imdur. Isosorbide mononitrate is used to for the the prophylactic treatment of angina pectoris; that is, it is taken in order to prevent or at least reduce the occurrence of angina. Research on Isosorbide mononitrate as a cervical ripener to reduce time at hospital to birth is supportive. Isosorbide mononitrate is an active metabolite of isosorbide dinitrate and exerts qualitatively similar effects. Isosorbide mononitrate reduces the workload of the heart by producing venous and arterial dilation. By reducing the end diastolic pressure and volume, isosorbide mononitrate lowers intramural pressure, hence leading to an improvement in the subendocardial blood flow. The net effect when administering isosorbide mononitrate is therefore a reduced workload for the heart and an improvement in the oxygen supply/demand balance of the myocardium. The adverse reactions which follow have been reported in studies with isosorbide mononitrate: Very common. Headache predominates (up to 30%) necessitating withdrawal of 2 to 3 % of patients, but the incidence reduces rapidly as treatment continues . Common. Tiredness, sleep disturbances (6%) and gastrointestinal disturbances (6%) have been reported during clinical trials with isosorbide mononitrate modified release tablets, but at a frequency no greater than for placebo. Hypotension (4 to 5%), poor appetite (2.5%), nausea (1%). Adverse effects associated with the clinical use of the drug are as expected with all nitrate preparations. They occur mainly in the early stages of treatment. Hypotension (4%) with symptoms such as dizziness and nausea (1%) have been reported. These symptoms generally disappear during long-term treatment. Other reactions that have been reported with isosorbide mononitrate modified release tablets include tachycardia, vomiting, diarrhoea, vertigo and heartburn
Indication
For the prevention of angina pectoris due to coronary artery disease and the treatment of acute and chronic angina pectoris, hypertension, and myocardial infarction.
Mechanism of Action
Similar to other nitrites and organic nitrates, Isosorbide Mononitrate is converted to nitric oxide (NO), an active intermediate compound which activates the enzyme guanylate cyclase (Atrial natriuretic peptide receptor A). This stimulates the synthesis of cyclic guanosine 3',5'-monophosphate (cGMP) which then activates a series of protein kinase-dependent phosphorylations in the smooth muscle cells, eventually resulting in the dephosphorylation of the myosin light chain of the smooth muscle fiber. The subsequent release of calcium ions results in the relaxation of the smooth muscle cells and vasodilation.
Pharmacokinetics
- Absorption
- 100%
- Distribution
- * 0.6 to 0.7 L/kg
- Metabolism
- Hepatic
- Elimination
Clearance
* 120–122 mL/min [Single dose of 60 mg PO] * 151–187 mL/min [Single dose of extended-release tablet 60 mg PO] * 132-151 mL/min [Multiple doses of extended release tablet 60 mg PO] * 119-140 mL/min [Multiple doses of extended release tablet 120 mg PO]
Toxicity
Symptoms of overdose include vasodilatation, venous pooling, reduced cardiac output, and hypotension. There are no data suggesting what dose of isosorbide mononitrate is likely to be life-threatening in humans. In rats and mice, there is significant lethality at doses of 2000 mg/kg and 3000 mg/kg, respectively.
Active Ingredient/Synonyms
IS 5-MN | IS-5-MN | IS-5MN | ISMN | Iso-5-mononitrate | Isosorbide 5-mononitrate | Isosorbide 5-nitrate | Isosorbide-5-mononitrate | isosorbidi mononitras | mononitrate d'isosorbide | mononitrato de isosorbida | Monosorbitrate | Isosorbide Mononitrate |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.