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Monoket
Overview
What is Monoket?
monoket, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is CHNO and the molecular weight is 191.14. The chemical name for monoket is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula:
monoket is available in 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.
What does Monoket look like?
What are the available doses of Monoket?
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What should I talk to my health care provider before I take Monoket?
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How should I use Monoket?
monoket is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
The recommended regimen of monoket tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function.
As noted above (), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for monoket tablets provides a daily nitrate-free interval to minimize the development of tolerance.
As also noted under , well-controlled studies have shown that tolerance to monoket tablets occurs to some extent when using the twice-daily regimen in which the two doses are given seven hours apart. This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least seven hours after the second dose. The duration (if any) of antianginal activity beyond fourteen hours has not been studied.
In clinical trials, monoket has been administered in a variety of regimens and doses. Doses above 20 mg twice a day (with the doses seven hours apart) have not been adequately studied. Doses of 5 mg twice a day are clearly effective (effectiveness based on exercise tolerance) for only the first day of a twice-a-day (with doses 7 hours apart) regimen.
What interacts with Monoket?
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What are the warnings of Monoket?
Cyclobenzaprine Hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Amplification of the vasodilatory effects of monoket by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings.
If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
What are the precautions of Monoket?
General
Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral isosorbide mononitrate is not known.
Information for Patients
Patients should be told that the antianginal efficacy of monoket tablets can be maintained by carefully following the prescribed schedule of dosing (two doses taken seven hours apart). For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later.
As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide mononitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide mononitrate-induced headaches with no deleterious effect on isosorbide mononitrate's antianginal efficacy.
Treatment with isosorbide mononitrate may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.
Array
Concomitant use of monoket® with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS).
The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenicity was observed in rats exposed to isosorbide mononitrate in their diets at doses of up to 900 mg/kg/day for the first six months and 500 mg/kg/day for the remaining duration of a study in which males were dosed for up to 121 weeks and females were dosed for up to 137 weeks. No evidence of mutagenicity was seen in vitro in the Salmonella test (Ames test), in human peripheral lymphocytes, in Chinese hamster cells (V79) or, in vivo in the rat micronucleus test. In a study on the fertility and breeding capacity of two generations of rats, monoket had no adverse effects on fertility or general reproductive performance with oral doses up to 120 mg/kg/day. A dose of 360 mg/kg/day was associated with increased mortality in treated males and females and a reduced fertility index. (See table at end of section for animal-to-human dosage comparisons.)
Pregnancy
Teratogenic Effects
Nonteratogenic Effects
| Multiple of MRHD* | |||
| Species | Daily dose | Based on: | |
| (mg/kg) | Body Weight | Body Surface | |
| Rabbit | 810 | 1013 | 375 |
| Rat | 900 | 1125 | 195 |
| 540 | 675 | 117 | |
| 500 | 625 | 108 | |
| 360 | 450 | 78 | |
| 270 | 338 | 59 |
Nursing Mothers
It is not known whether isosorbide mononitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide mononitrate is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of isosorbide mononitrate in pediatric patients have not been established.
Geriatric Use
Clinical studies of monoket did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Monoket?
Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy.
The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment.
Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:
Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia.
Dermatologic: sweating.
Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight.
Genitourinary: prostatic disorder.
Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, paresthesia, susurrus aurium.
Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo.
Respiratory: asthma, dyspnea, sinusitis.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see .
| 6 Placebo-Controlled Studies | ||||
| Dose | Placebo | 5 mg | 10 mg | 20 mg |
| Patients | 160 | 54 | 52 | 159 |
| Headache | 6% (0%) | 17% (0%) | 13% (0%) | 35% (5%) |
| Fatigue | 2% (0%) | 0% (0%) | 4% (0%) | 1% (0%) |
| Upper | ||||
| Respiratory | ||||
| Infection | <1% (0%) | 0% (0%) | 4% (0%) | 1% (0%) |
| Pain | <1% (0%) | 4% (0%) | 0% (0%) | <1% (0%) |
| Dizziness | 1% (0%) | 0% (0%) | 0% (0%) | 4% (0%) |
| Nausea | <1% (0%) | 0% (0%) | 0% (0%) | 3% (2%) |
| Increased | ||||
| Cough | <1% (0%) | 0% (0%) | 2% (0%) | <1% (0%) |
| Rash | 0% (0%) | 2% (2%) | 0% (0%) | <1% (0%) |
| Abdominal | ||||
| Pain | <1% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Allergic | ||||
| Reaction | 0% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Cardiovascular | ||||
| Disorder | 0% (0%) | 2% (0%) | 0% (0%) | 0% (0%) |
| Chest Pain | <1% (0%) | 0% (0%) | 2% (0%) | <1% (0%) |
| Diarrhea | 0% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Flushing | 0% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Emotional | ||||
| Lability | 0% (0%) | 2% (0%) | 0% (0%) | 0% (0%) |
| Pruritus | 1% (0%) | 2% (2%) | 0% (0%) | 0% (0%) |
What should I look out for while using Monoket?
Isosorbide mononitrate is contraindicated in patients who are allergic to it.
Do not use monoket® in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.
Amplification of the vasodilatory effects of monoket by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings.
If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
What might happen if I take too much Monoket?
How should I store and handle Monoket?
StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) []. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) []. monoket (isosorbide mononitrate tablets, USP), 10 mg are white, round, scored and engraved "10" on one side and engraved "SCHWARZ 610" on the other. They are supplied as follows: monoket (isosorbide mononitrate tablets, USP), 20 mg are white, round, scored and engraved "20" on one side and engraved "SCHWARZ 620" on the other. They are supplied as follows: monoket (isosorbide mononitrate tablets, USP), 10 mg are white, round, scored and engraved "10" on one side and engraved "SCHWARZ 610" on the other. They are supplied as follows: monoket (isosorbide mononitrate tablets, USP), 20 mg are white, round, scored and engraved "20" on one side and engraved "SCHWARZ 620" on the other. They are supplied as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents 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 the body for several hours has their antianginal efficacy been restored.
The drug-free interval sufficient to avoid tolerance to isosorbide mononitrate has not been completely defined. In the only regimen of twice-daily isosorbide mononitrate that has been shown to avoid development of tolerance, the two doses of monoket tablets are given 7 hours apart, so there is a gap of 17 hours between the second dose of each day and the first dose of the next day. Taking account of the relatively long half-life of isosorbide mononitrate this result is consistent with those obtained for other organic nitrates.
The asymmetric twice-daily regimen of monoket tablets successfully avoided significant rebound/withdrawal effects. The incidence and magnitude of such phenomena have appeared, in studies of other nitrates, to be highly dependent upon the schedule of nitrate administration.
Non-Clinical Toxicology
Isosorbide mononitrate is contraindicated in patients who are allergic to it.Do not use monoket® in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.
Amplification of the vasodilatory effects of monoket by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings.
If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
Concomitant use of monoket® with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS).
The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral isosorbide mononitrate is not known.
Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy.
The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment.
Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:
Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia.
Dermatologic: sweating.
Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight.
Genitourinary: prostatic disorder.
Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, paresthesia, susurrus aurium.
Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo.
Respiratory: asthma, dyspnea, sinusitis.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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