Cromolux may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromolux in the following countries:
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Metronidazol Heumann may be available in the countries listed below.
Metronidazole is reported as an ingredient of Metronidazol Heumann in the following countries:
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Vikcef-T may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Vikcef-T in the following countries:
Tazobactam is reported as an ingredient of Vikcef-T in the following countries:
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Mepi Mynol may be available in the countries listed below.
Epinephrine is reported as an ingredient of Mepi Mynol in the following countries:
Mepivacaine hydrochloride (a derivative of Mepivacaine) is reported as an ingredient of Mepi Mynol in the following countries:
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Sunzepan may be available in the countries listed below.
Diazepam is reported as an ingredient of Sunzepan in the following countries:
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Fasiclor may be available in the countries listed below.
Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Fasiclor in the following countries:
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Zopicon may be available in the countries listed below.
Zopiclone is reported as an ingredient of Zopicon in the following countries:
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Replenine may be available in the countries listed below.
UK matches:
Coagulation Factor IX, Human is reported as an ingredient of Replenine in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Pergolide ratiopharm may be available in the countries listed below.
Pergolide mesilate (a derivative of Pergolide) is reported as an ingredient of Pergolide ratiopharm in the following countries:
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Traumicid may be available in the countries listed below.
Clonixin lysine salt (a derivative of Clonixin) is reported as an ingredient of Traumicid in the following countries:
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Ketoconazole is reported as an ingredient of Kétoconazole Mylan in the following countries:
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Mirta TAD may be available in the countries listed below.
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Prochlorperazine maleate (a derivative of Prochlorperazine) is reported as an ingredient of Chloropernazinum in the following countries:
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Vasonit may be available in the countries listed below.
Isosorbide Mononitrate is reported as an ingredient of Vasonit in the following countries:
Pentoxifylline is reported as an ingredient of Vasonit in the following countries:
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In the U.S.
Available Dosage Forms:
Butalbital and aspirin combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
When you use butalbital for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.
Some of these medicines also contain caffeine. Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.
Butalbital and aspirin combination is sometimes also used for other kinds of headaches or other kinds of pain, as determined by your doctor.
These medicines are available only with your doctor's prescription.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
For butalbital:
For aspirin:
For caffeine:
For butalbital:
For aspirin:
For caffeine:
For butalbital:
For aspirin:
For caffeine:
Although this combination medicine has not been reported to cause problems, the chance always exists, especially if the medicine is taken for a long time or in large amounts.
For butalbital:
For aspirin:
For caffeine:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
Take butalbital and aspirin combination with food or a full glass (8 ounces) of water to lessen stomach irritation.
Do not take butalbital and aspirin combination if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.
Take butalbital and aspirin combination only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital and aspirin combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and aspirin combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take butalbital and aspirin combination to relieve frequent headaches. Taking too much of this combination medicine can also lead to stomach problems or to other medical problems.
butalbital and aspirin combination will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take butalbital and aspirin combination as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.
People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.
The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of butalbital and aspirin combination, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Check with your doctor:
Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain a barbiturate, aspirin, or other salicylates, including diflunisal, check with your health care professional. Taking them together with butalbital and aspirin combination may cause an overdose.
The butalbital in butalbital and aspirin combination will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using butalbital and aspirin combination.
butalbital and aspirin combination may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to butalbital and aspirin combination before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking butalbital and aspirin combination. Serious side effects may occur if your medical doctor or dentist gives you certain other medicines without knowing that you have taken butalbital.
Do not take butalbital and aspirin combination for 5 days before any planned surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.
Before you have any medical tests, tell the person in charge that you are taking butalbital and aspirin combination. Caffeine (present in some butalbital and aspirin combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of some other tests may also be affected by butalbital and aspirin combinations.
If you have been taking large amounts of butalbital and aspirin combination, or if you have been taking it regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects.
If you think you or anyone else may have taken an overdose of butalbital and aspirin combination, get emergency help at once. Taking an overdose of butalbital and aspirin combination or taking alcohol or CNS depressants with butalbital and aspirin combination may lead to unconsciousness or death. Symptoms of overdose of butalbital and aspirin combination include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness; severe drowsiness; shortness of breath or troubled breathing; and severe weakness.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Ciprofloxacino Lasa may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacino Lasa in the following countries:
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Cefuroxime Panpharma may be available in the countries listed below.
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Cefuroxime Panpharma in the following countries:
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Glandosane may be available in the countries listed below.
Carmellose sodium salt (a derivative of Carmellose) is reported as an ingredient of Glandosane in the following countries:
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Depronal may be available in the countries listed below.
Dextropropoxyphene hydrochloride (a derivative of Dextropropoxyphene) is reported as an ingredient of Depronal in the following countries:
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Cetiriz may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetiriz in the following countries:
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Amoxicillina + Acido clavulanico IBI may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillina + Acido clavulanico IBI in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicillina + Acido clavulanico IBI in the following countries:
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Scantensin may be available in the countries listed below.
Captopril is reported as an ingredient of Scantensin in the following countries:
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Aquacel may be available in the countries listed below.
Carmellose is reported as an ingredient of Aquacel in the following countries:
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Aritmal may be available in the countries listed below.
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Aritmal in the following countries:
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Ondansan may be available in the countries listed below.
Ondansetron hydrochloride dihydrate (a derivative of Ondansetron) is reported as an ingredient of Ondansan in the following countries:
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Definition of Colorectal Cancer: The colon and rectum are part of the large intestine (large bowel). Colon and rectum cancers, which are sometimes referred to together as "colorectal cancer," arise from the lining of the large intestine. (When cancer arises from the lining of an organ like the large intestine, it is called a carcinoma.)
Other types of colon cancer are rare, and include lymphoma, carcinoid tumors, melanoma, and sarcomas. Use of the term "colon cancer" for the rest of this article refers to colon "carcinoma" and not the other, rare types of colon cancer. More...
The following drugs and medications are in some way related to, or used in the treatment of Colorectal Cancer. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
See sub-topics
Medical Encyclopedia:
Harvard Health Guide:
Carbimazol Hexal may be available in the countries listed below.
Carbimazole is reported as an ingredient of Carbimazol Hexal in the following countries:
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Mirtazapin Almus may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapin Almus in the following countries:
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Methotrax may be available in the countries listed below.
Methotrexate is reported as an ingredient of Methotrax in the following countries:
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Ulcusol may be available in the countries listed below.
Glutamine is reported as an ingredient of Ulcusol in the following countries:
Sodium Gualenate is reported as an ingredient of Ulcusol in the following countries:
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In the US, Methohexital (methohexital systemic) is a member of the drug class general anesthetics and is used to treat Anesthesia and Anesthetic Adjunct.
US matches:
Rec.INN
N01AF01,N05CA15
0000151-83-7
C14-H18-N2-O3
262
Anesthetic, injectable
2,4,6(1H,3H,5H)-Pyrimidinetrione, 1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-
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Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Célécoxib may be available in the countries listed below.
Célécoxib (DCF) is known as Celecoxib in the US.
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Glossary
| DCF | Dénomination Commune Française |
Medigox may be available in the countries listed below.
Metildigoxin is reported as an ingredient of Medigox in the following countries:
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Mirtazapina Combino Pharm may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapina Combino Pharm in the following countries:
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Tamsulogen may be available in the countries listed below.
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulogen in the following countries:
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Megion may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Megion in the following countries:
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Megion in the following countries:
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Permutanol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cypermethrin is reported as an ingredient of Permutanol in the following countries:
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Clomidep may be available in the countries listed below.
Clomipramine hydrochloride (a derivative of Clomipramine) is reported as an ingredient of Clomidep in the following countries:
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Naproxen Natrium-B may be available in the countries listed below.
Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Naproxen Natrium-B in the following countries:
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Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5 dinitrate, an organic nitrate whose structural formula is
and whose molecular weight is 236.14. The organic nitrates are vasodilators, active on both arteries and veins. Each dilatrate®-SR sustained release capsule contains 40 mg of isosorbide dinitrate, in a microdialysis delivery system that causes the active drug to be released over an extended period. Each capsule also contains ethylcellulose, lactose, pharmaceutical glaze, starch, sucrose and talc. The capsule shells contain D&C Red 33, D&C Yellow 10, gelatin and titanium dioxide.
The principal pharmacological action of isosorbide dinitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.
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 no more effective than placebo after 24 hours (or less) of continuous therapy. Attempts to overcome nitrate 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 kinetics of absorption of isosorbide dinitrate from dilatrate®-SR sustained release capsules have not been well studied. Studies of immediate-release formulations of ISDN have found highly variable bioavailability (10 to 90%), with extensive first-pass metabolism in the liver. Most such studies have observed progressive increases in bioavailability during chronic therapy; it is not known whether similar increases in bioavailability appear during the course of chronic therapy with dilatrate®-SR sustained release capsules.
Once absorbed, the distribution volume of isosorbide dinitrate is 2-4 L/kg and this volume is cleared at the rate of 2-4 L/min, so ISDN’s half-life in serum is about an hour. Since the clearance exceeds hepatic blood flow, considerable extrahepatic metabolism must also occur. Clearance is affected primarily by denitration to the 2-mononitrate (15 to 25%) and the
5-mononitrate (75 to 85%).
Both metabolites have biological activity, especially the 5-mononitrate. With an overall half-life of about 5 hours, the 5-mononitrate is cleared from the serum by denitration to isosorbide; glucuronidation to the 5-mononitrate glucuronide; and denitration/hydration to sorbitol. The
2-mononitrate has been less well studied, but it appears to participate in the same metabolic pathways with a half-life of about 2 hours.
The interdosing interval sufficient to avoid tolerance to avoid tolerance to ISDN has not been well defined. Studies of nitroglycerin (an organic nitrate with a very short half-life) have shown that dosing intervals of 10-12 hours are usually sufficient to prevent or attenuate tolerance. Dosing intervals that have succeeded in avoiding tolerance during trials of moderate doses
(e.g., 30 mg) of immediate release ISDN have generally been somewhat longer (at least
14 hours), but this is consistent with the longer half-lives of ISDN and its active metabolites.
An interdosing interval sufficient to avoid tolerance with dilatrate®-SR has not been demonstrated. In an eccentric dosing study, 40 mg capsules of dilatrate®-SR were administered daily at 0800 and 1400 hours. After two weeks of this regimen, dilatrate®-SR was statistically indistinguishable from placebo. Thus, the necessary interdosing interval sufficient to avoid tolerance remains unknown, but it must be greater than 18 hours.
Few well-controlled clinical trials of organic nitrates have been designed to detect rebound or withdrawal effects. In one such trial, however, subjects receiving nitroglycerin had less exercise tolerance at the end of the daily interdosing interval than the parallel group receiving placebo. The incidence, magnitude, and clinical significance of similar phenomena in patients receiving ISDN have not been studied.
In clinical trials, extended-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 40 to 160 mg. A controlled trial using a single
40 mg sustained release oral dose of isosorbide dinitrate (dilatrate®-SR) has demonstrated effective reductions in exercise-related angina for up to 8 hours. Antianginal activity is present about 1 hour after dosing.
Adequate multiple-dose trials of dilatrate®-SR sustained release capsules have not been reported.
Most controlled trials of multiple-dose immediate-release oral ISDN taken every 12 hours (or more frequently) for several weeks have shown statistically significant antianginal efficacy for only 2 hours after dosing. Once-daily regimens, and regimens with one daily interdosing interval of at least 14 hours (e.g., a regimen providing doses at 0800, 1400 and 1800 hours), have shown efficacy after the first dose of each day that was similar to that shown in the single dose studies cited above. The efficacy of subsequent doses has not been demonstrated. From large, well-controlled studies of other nitrates, it is reasonable to believe that the maximal achievable daily duration of antianginal effect from isosorbide dinitrate is about 12 hours. No dosing regimen for dilatrate®-SR sustained release capsules has actually been shown to achieve this duration of effect.
dilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide dinitrate is contraindicated in patients who are allergic to it.
Amplification of the vasodilatory effects of dilatrate®-SR 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 extended-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of extended-release oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide dinitrate. 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 dinitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to isosorbide dinitrate develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.
Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the interdosing intervals in some of these trials, anginal attacks have been more easily provoked than before treatment and patients have demonstrated hemodynamic rebound and decreased exercise tolerance. The importance of these observations to the routine, clinical use of controlled-release oral isosorbide dinitrate is not known.
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.
Patients should be told that the antianginal efficacy of isosorbide dinitrate is strongly related to its dosing regimen, so the prescribed schedule of dosing should be followed carefully. In particular, daily headaches sometimes accompany treatment with isosorbide dinitrate. 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 dinitrate, 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 dinitrate-induced headaches with no deleterious effect on isosorbide dinitrate’s antianginal efficacy.
Treatment with isosorbide dinitrate may be associated with lightheadedness 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.
The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
No long-term studies in animals have been performed to evaluate the carcinogenic potential of isosorbide dinitrate. In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed isosorbide dinitrate at 25 or
100 mg/kg/day.
At oral doses 35 and 150 times the daily Maximum Recommended Human Dose (MRHD), isosorbide dinitrate has been shown to cause a dose related increase in embryotoxicity (increase in mummified pups) in rabbits. There are no adequate, well-controlled studies in pregnant women. Isosorbide dinitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether isosorbide dinitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide dinitrate is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of dilatrate®-SR 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.
Adverse reactions to isosorbide dinitrate are generally dose related, and almost all of these reactions are the result of isosorbide dinitrate’s activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see OVERDOSAGE).
Data are not available to allow estimation of the frequency of adverse reactions during treatment with dilatrate®-SR sustained release capsules.
The ill effects of isosorbide dinitrate overdose are generally the results of isosorbide dinitrate’s capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures and death.
Laboratory determinations of serum levels of isosorbide dinitrate and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of isosorbide dinitrate overdose.
There are no data suggesting what dose of isosorbide dinitrate is likely to be life-threatening in humans. In rats, the median acute lethal dose (LD50) was found to be 1100 mg/kg.
No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of isosorbide dinitrate and its active metabolites. Similarly, it is not known which, if any, of these substances can usefully be removed from the body by hemodialysis.
No specific antagonist to the vasodilator effects of isosorbide dinitrate is known, and no intervention has been subject to controlled study as a therapy of isosorbide dinitrate overdose. Because the hypotension associated with isosorbide dinitrate overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward an increase in central fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary. The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.
In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of isosorbide dinitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required.
Nitrate ions liberated during metabolism of isosorbide dinitrate can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moieties of isosorbide dinitrate are quantitatively applied to oxidation of hemoglobin, about 1 mg/kg of isosorbide dinitrate should be required before any of these patients manifests clinically significant (≥ 10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of isosorbide dinitrate. In one study in which 36 patients received 2-4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 4.8-6.9 mg of bioavailable isosorbide dinitrate per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo. Notwithstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible. Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial p02. Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.
When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1-2 mg/kg intravenously.
As noted above (CLINICAL PHARMACOLOGY), multiple studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for organic nitrates including dilatrate®-SR must provide a daily nitrate-free interval to avoid the development of tolerance. To achieve the necessary nitrate-free interval with immediate-release oral ISDN, it appears that at least one of the daily interdose intervals must be at least 14 hours long. The necessary interdose interval for dilatrate®-SR has not been clearly identified, but it must be greater than 18 hours.
As noted under Clinical Pharmacology, only one trial has ever studied the use of extended-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of dilatrate®-SR was administered twice daily in doses given 6 hours apart. After 4 weeks, dilatrate®-SR could not be distinguished from placebo.
Large controlled studies with other nitrates suggest that no dosing regimen with dilatrate®-SR should be expected to provide more than about 12 hours of continuous antianginal efficacy per day.
In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 to 480 mg.
Do not exceed 160 mg (4 capsules) per day.
dilatrate®-SR (isosorbide dinitrate) 40 mg sustained release capsules are opaque pink and colorless capsules with white beadlets and are imprinted “Schwarz” and “0920”. They are supplied as follows:
Bottles of 100
NDC 0091-0920-01
Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].
Manufactured for:
By Sandoz Inc.
Princeton, NJ 08540, USA
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Ranitidine Biostam may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidine Biostam in the following countries:
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Chlorzoxazone is reported as an ingredient of Strifon in the following countries:
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Proculin may be available in the countries listed below.
Boric Acid is reported as an ingredient of Proculin in the following countries:
Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Proculin in the following countries:
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Nocon may be available in the countries listed below.
Oxymetazoline is reported as an ingredient of Nocon in the following countries:
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Dorociplo may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Dorociplo in the following countries:
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In the US, Microzide (hydrochlorothiazide systemic) is a member of the drug class thiazide diuretics and is used to treat Diabetes Insipidus, Edema, High Blood Pressure, Nephrocalcinosis and Osteoporosis.
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Hydrochlorothiazide is reported as an ingredient of Microzide in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0040596-69-8
C19-H34-O3
310
Insecticide
Pediculocide
2,4-Dodecadienoic acid, 11-methoxy-3,7,11-trimethyl-, 1-methylethyl ester, (E,E)-
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Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Moxonidin Wörwag may be available in the countries listed below.
Moxonidine hydrochloride hydrate (a derivative of Moxonidine) is reported as an ingredient of Moxonidin Wörwag in the following countries:
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Dolagis may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Carprofen is reported as an ingredient of Dolagis in the following countries:
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Bedoxine may be available in the countries listed below.
Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Bedoxine in the following countries:
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Alendro KSK may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendro KSK in the following countries:
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Metfor may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metfor in the following countries:
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Union Uno may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Union Uno in the following countries:
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Benadryl is a brand name of diphenhydramine, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Benadryl:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Benadryl. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Benadryl.
