Imdur 10mg - Imdur Tablets 60mg - Summary of Product Characteristics (SmPC) - (eMC)
Administration of Imdur Tablets once daily, taken early 10mg the morning on arising, provided at least 12 hours of antianginal activity. In a placebo-controlled parallel study, 30, 60, and mg of Imdur Tablets imdur administered once 10mg for up to 6 imdur. Prior to randomization, all patients completed a 1- 10mg 3-week single-blind placebo phase to demonstrate nitrate responsiveness and total 10mg treadmill time reproducibility.
Exercise tolerance tests using the Bruce Protocol were conducted prior to and at 4 and 12 hours after the morning dose imdur days 1, 7, imdur 10mg, 14, 28 and 42 of the double-blind period.
Imdur Tablets 30 and 60 mg only doses evaluated acutely demonstrated a significant increase from baseline in total treadmill imdur relative to placebo at 4 and 12 hours after the administration of the first 10mg. At imdur 42, the and mg dose of 10mg Tablets demonstrated a significant increase in imdur treadmill time at 4 and 12 hours post dosing, but by day 42, imdur 10mg, the 30 and 60 mg doses no longer were differentiable from placebo, imdur 10mg.
Throughout chronic dosing, rebound was not observed in any Imdur treatment group, imdur 10mg.
Pooled data from two other trials, imdur 10mg, comparing Imdur Tablets 60 mg once daily, ISDN 30 mg QID, and placebo QID in patients with chronic stable angina using a randomized, double-blind, imdur 10mg, three-way crossover design found statistically significant increases in 10mg tolerance times for Imdur Tablets compared to placebo at hours 4, imdur 10mg, 8 and 10mg and to ISDN at hour 4.
The increases in imdur tolerance on imdur 14, although statistically significant compared to placebo, were about half of that seen on day 1 of the trial, imdur 10mg. Indications and Usage for Imdur Imdur Tablets are indicated for the prevention of angina pectoris due to coronary artery disease.
The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product 10mg be useful in aborting an acute anginal episode. This strategy is inappropriate for organic nitrates. Several imdur clinical trials have used exercise testing to assess the antianginal efficacy of continuously delivered nitrates, imdur 10mg. In the large majority of these trials, active imdur were indistinguishable from placebo after 24 hours or less of continuous therapy.
Attempts to overcome tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from 10mg body for several hours has their antianginal efficacy been restored, imdur 10mg.
Imdur Tablets 60mg
IMDUR Tablets, imdur 10mg, during long-term use over 42 days dosed at mg once daily, 10mg to improve exercise performance at 4 hours and 10mg 12 hours after dosing 10mg its 10mg although better imdur placebo are less than or at best equal to the effects of the first dose of 60 mg.
After imdur administration, imdur 10mg, ISMN vibramycin 200mg preis distributed into total body water in about imdur minutes with a volume of distribution of 10mg 0. Isosorbide mononitrate is primarily metabolized by the liver, but unlike oral isosorbide dinitrate, it is not subject to first-pass metabolism.
The metabolites are imdur pharmacologically active. The mean plasma elimination imdur of ISMN is approximately 5 hours. The disposition of ISMN in patients with various degrees of renal insufficiency, imdur 10mg, liver cirrhosisor cardiac dysfunction was evaluated and found to be similar to that observed in healthy subjects, imdur 10mg.
The elimination half-life of Imdur was not 10mg, and there was no drug accumulation in patients with chronic renal failure after multiple oral dosing.
In single- and multiple-dose studies, the pharmacokinetics of ISMN were dose proportional between 30 mg and mg. Differences between imdur two age 10mg, however, imdur 10mg, were not statistically significant, imdur 10mg. There are no adequate and well-controlled studies in pregnant women. Isosorbide mononitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers It is not known whether isosorbide mononitrate is excreted in human milk.
Isosorbide mononitrate
Because many drugs are excreted in 10mg milk, caution should be exercised imdur isosorbide mononitrate is administered to a nursing woman. Pediatric Use Safety and effectiveness of isosorbide mononitrate in pediatric 10mg have not been established, imdur 10mg.
Geriatric Use Imdur studies of Ismo isosorbide mononitrate did 10mg include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, imdur 10mg. Other reported clinical imdur has not identified differences in responses between the elderly and younger patients.
Nebistar SA Tablet Full Review
These hemodynamic changes may have protean manifestations, imdur 10mg, including increased intracranial pressure, with any or all of persistent 10mg headache, confusion, 10mg moderate fever 10mg vertigo ; palpitations ; visual disturbances; nausea and vomiting possibly with colic and even bloody diarrhea ; syncope especially in the upright posture ; air hunger and dyspnealater followed by reduced ventilatory imdur diaphoresis, with 10mg skin either flushed or cold and clammy; heart block and bradycardia ; paralysis ; coma ; seizures and death.
Laboratory determinations of serum levels of isosorbide mononitrate and its metabolites are not widely available, and such imdur have, imdur 10mg, in any event, no established role in the management of isosorbide mononitrate overdose.
There are no data suggesting what dose of isosorbide mononitrate is likely to be life-threatening in humans, imdur 10mg. No data are available to suggest physiological maneuvers e. In particular, imdur 10mg, dialysis is known to be ineffective in removing isosorbide mononitrate from the body. No specific antagonist to the vasodilator effects imdur isosorbide mononitrate is known, imdur 10mg, and no intervention has been subject to controlled study as a 10mg of isosorbide mononitrate overdose.
Because the hypotension associated with isosorbide mononitrate overdose is the result of venodilatation and arterial hypovolemiaprudent therapy in this situation should be directed toward an increase in central imdur volume, imdur 10mg.
Passive elevation of the patient's legs 10mg be sufficient, imdur 10mg, but intravenous infusion of normal saline or similar fluid may also be imdur. The use of epinephrine or other arterial vasoconstrictors in this setting is likely to imdur more harm than good. This medicine may impair your thinking or reactions.
Imdur careful if you drive or do anything that requires you to be alert. 10mg getting up too fast from a sitting or lying position, or you may feel dizzy, imdur 10mg.
isosorbide mononitrate
Get up slowly and imdur yourself to prevent a fall. Alcohol may increase certain side effects 10mg Imdur dizziness, imdur 10mg, drowsiness, feeling light-headed, or fainting.
Imdur side effects Get emergency medical imdur if you have signs of an allergic reaction to Imdur: Call your doctor at once if you have: Imdur can cause severe headaches. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking this medicine to avoid headaches.
Common Imdur side effects may include: This 10mg not a complete list of side effects 10mg others may imdur. Absorption is not significantly affected by food intake and there is no accumulation during steady state.
Imdur exhibits dose proportional kinetics up to mg. The tablets are divisible, imdur 10mg, imdur 10mg.
In placebo-controlled studies, imdur 10mg, Imdur once daily has been shown to effectively control 10mg pectoris both in terms of exercise capacity and symptoms, and also in reducing signs of myocardial ischaemia. This can be avoided by allowing low plasma levels for a certain 10mg of the dosage interval.
Imdur, when administered once daily in the morning, imdur 10mg, produces a plasma profile of high levels during the day and low levels during imdur night, imdur 10mg.
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