Archive for the ‘antianginal agents’ Category

Sorbitrate

Sorbitrate

Why is Sorbitrate prescribed?

Isordil is prescribed to relieve or prevent angina pectoris (suffocating chest pain). Angina pectoris occurs when the arteries and veins become constricted and sufficient oxygen does not reach the heart. Isordil dilates the blood vessels by relaxing the muscles in their walls. Oxygen flow improves as the vessels relax, and chest pain subsides.

In swallowed capsules or tablets, Isordil helps to increase the amount of exercise you can do before chest pain begins.

In chewable or sublingual (held under the tongue) tablets, Isordil can help relieve chest pain that has already started or prevent pain expected from a strenuous activity such as walking up a hill or climbing stairs.

Most important fact about Sorbitrate

Isordil may cause severe low blood pressure (possibly marked by dizziness or fainting), especially when you stand or sit up quickly. People taking diuretic medication or those who have low blood pressure should use Isordil with caution.

How should you take Sorbitrate?

Swallowed capsules or tablets should be taken on an empty stomach. While regular tablets may be crushed for easier use, sustained- or prolonged-release products should not be chewed, crushed or altered.

Chewable tablets should be chewed thoroughly and held in the mouth for a couple of minutes. Do not eat, drink, smoke, or use chewing tobacco while a sublingual tablet is dissolving.

This drug’s effectiveness is closely linked to the dose, so follow your doctor’s instructions carefully.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Isordil.

Headache is the most common side effect; usually, standard headache treatments with over-the-counter pain products will relieve the pain. The headaches associated with Isordil usually subside within 2 weeks after treatment with the drug begins. Do not change your dose to avoid the headache. At a dose that eliminates headaches, the drug may not be as effective against angina.

Why should Sorbitrate not be prescribed?

You should not take Isordil if you have had a previous allergic reaction to it or to other nitrates or nitrites.

Special warnings about Sorbitrate

You should use Isordil with caution if you have anemia, the eye condition called glaucoma, a previous head injury or heart attack, heart disease, low blood pressure, or thyroid disease.

If you stop using Isordil, you should follow your doctor’s plan for a gradual withdrawal schedule. Abruptly stopping Sorbitrate could result in additional chest pain.

Some people may develop a tolerance to Isordil, which causes its effects to be reduced over time. Tell your doctor if you think Isordil is starting to lose its effectiveness.

Possible food and drug interactions when taking Sorbitrate

If Isordil is taken with certain other drugs, the effects of either could be increased, decreased, or altered.

Extreme low blood pressure (marked by dizziness, fainting, and numbness) may occur if you take Isordil with certain other high blood pressure drugs such as diltiazem and nifedipine, as well as the impotence remedy sildenafil.

Alcohol may interact with Isordil and produce a swift decrease in blood pressure, possibly causing dizziness and fainting.

Special information if you are pregnant or breastfeeding

The effects of Isordil in pregnancy have not been adequately studied. Isordil should be used only when the benefits of therapy clearly outweigh the potential risks to the developing baby. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known if Isordil appears in breast milk; therefore, nursing mothers should use Isordil with caution.

Recommended dosage for Sorbitrate

Because you can develop a tolerance to Sorbitrate, your doctor may schedule a daily period of time when you do not take any drug.

ADULTS

The usual sublingual starting dose for the treatment of angina pectoris is 2.5 milligrams to 5 milligrams. Your doctor will increase this initial dose gradually until the pain subsides or side effects prove bothersome.

The usual sublingual starting dose for the prevention of an impending attack of angina pectoris is usually 5 or 10 milligrams every 2 to 3 hours.

To prevent chronic stable angina pectoris, the usual starting dose for swallowed, immediately released Isordil is 5 to 20 milligrams. Your doctor may increase this initial dose to 10 to 40 milligrams every 6 hours.

To prevent chronic stable angina pectoris with controlled-release Isordil, the usual initial dose is 40 milligrams. Your doctor may increase this dose from 40 to 80 milligrams given every 8 to 12 hours.

CHILDREN

The safety and effectiveness of Isordil have not been established for children.

Overdosage

Any medication taken in excess can have serious consequences. Severe overdosage of Isordil can be fatal. If you suspect an overdose, seek medical help immediately.

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Nitrostat Tablets

Nitrostat Tablets

Why is Nitrostat Tablets prescribed?

Nitroglycerin is prescribed to prevent and treat angina pectoris (suffocating chest pain). This condition occurs when the coronary arteries become constricted and are not able to carry sufficient oxygen to the heart muscle. Nitroglycerin is thought to improve oxygen flow by relaxing the walls of arteries and veins, thus allowing them to dilate.

Nitroglycerin is used in different forms. As a patch or ointment, nitroglycerin may be applied to the skin. The patch and the ointment are for

Swallowing nitroglycerin in capsule or tablet form also helps to

In the form of sublingual (held under the tongue) or buccal (held in the cheek) tablets, or in oral spray (sprayed on or under the tongue), nitroglycerin helps relieve chest pain that has

Most important fact about Nitrostat Tablets

Nitroglycerin may cause severe low blood pressure (possibly marked by dizziness or light-headedness), especially if you are in an upright position or have just gotten up from sitting or lying down. You may also find your heart rate slowing and your chest pain increasing. People taking diuretic medication, or who have low systolic blood pressure (less than 90 mm Hg) should use nitroglycerin with caution.

How should you take Nitrostat Tablets?

Since nitroglycerin is available in many forms, it is crucial for you to follow your doctor’s directions for taking the type of nitroglycerin prescribed for you. Never interchange brands.

Ideally, you should take nitroglycerin while sitting down—especially if you feel dizzy or light-headed—so as to avoid a fall.

Avoid puncturing the spray container and keep it away from excess heat.

Do not open the container of sublingual tablets until you need a dose. Close the container tightly immediately after each use. Do not put other medications, a cotton plug, or anything else in the container. Keep the sublingual tablets handy at all times. Keep the patches in the protective pouches they come in until use.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking nitroglycerin.

Why should Nitrostat Tablets not be prescribed?

You should not be using nitroglycerin if you are allergic to it or to the adhesive in the patch, if you have a head injury, or if you have any condition caused by increased fluid pressure in your head. Nitroglycerin should not be taken if you have severe anemia or if you recently had a heart attack. The capsule form should not be used if you have closed-angle glaucoma (pressure in the eye) or suffer from postural hypotension (dizziness upon standing up). Do not take the tablets if you are using the impotence drug sildenafil.

Special warnings about Nitrostat Tablets

If your vision becomes blurry or your mouth becomes dry while taking nitroglycerin, it should be discontinued. Contact your doctor immediately if these symptoms develop.

You may develop acute headaches if you take nitroglycerin excessively. Also, some people may develop a tolerance to nitroglycerin, and it may become less beneficial over time, especially if used in excess.

Nitroglycerin tablets lose their effectiveness when exposed to air. If you are taking sublingual nitroglycerin, you may notice a burning or tingling sensation. This does not necessarily mean that tablets which have been exposed to air for a long period of time are still good.

Take no more than the smallest possible amount needed to relieve pain.

Daily headaches may be an indicator of the drug’s activity. Do not change your dose to avoid the headache, because you may reduce the drug’s effectiveness at the same time.

Before taking nitroglycerin, tell your doctor if you have had a recent heart attack, head injury, or stroke; or if you have anemia, glaucoma (pressure in the eye), or heart, kidney, liver, or thyroid disease.

If you use a patch, dispose of it carefully. There is enough drug left in a used patch to be harmful to children and pets.

Since nitroglycerin can cause dizziness, you should observe caution while driving, operating machinery, or performing other tasks that demand concentration.

The benefits of applying nitroglycerin to the skin of people experiencing heart attacks or congestive heart failure have not been established. If you are using the medication for these conditions, your doctor will monitor you to prevent low blood pressure and pounding heartbeat.

Possible food and drug interactions when taking Nitrostat Tablets

If nitroglycerin is taken with certain other drugs, the effects of either could be increased, decreased, or altered.

Taken with many high blood pressure drugs, nitroglycerin may cause extreme low blood pressure (dizziness, fainting, numbness). Take particular care with calcium channel blockers such as nifedipine and verapamil, as well as isosorbide dinitrate, isosorbide mononitrate, blood vessel dilators such as minoxidil, and beta-blocker medications such as atenolol. Nitroglycerin may also cause a severe drop in blood pressure when taken with the impotence drug sildenafil.

Aspirin can increase the effects of nitroglycerin.

Alcohol may interact with nitroglycerin and cause a swift decrease in blood pressure, possibly causing dizziness and fainting.

Also be alert for an interaction with dihydroergotamine. Check with your doctor if you are uncertain about any combination you plan to take.

Special information if you are pregnant or breastfeeding

It has not been determined whether nitroglycerin might harm a fetus or a pregnant woman. As a result, nitroglycerin should be used only when the benefits of therapy clearly outweigh the potential risks to the fetus and woman. It is not known if nitroglycerin appears in breast milk; therefore, a nursing mother should use nitroglycerin only on advice of her doctor.

Recommended dosage for Nitrostat Tablets

The following section is intended to provide guidelines for taking nitroglycerin. Follow your doctor’s instructions carefully for using nitroglycerin in the form prescribed for you.

ADULTS

At the first sign of chest pain, 1 tablet should be dissolved under the tongue or inside the cheek. You may repeat the dose every 5 minutes until the pain is relieved. If your pain continues after you have taken 3 tablets in a 15-minute period, notify your doctor or seek medical attention immediately.

You may take sublingual or buccal nitroglycerin from 5 to 10 minutes before starting activities that may cause chest pain.

A patch is applied to the skin for 12 to 14 hours. After this time, the patch is removed; it is not applied again for 10 to 12 hours (a “patch-off” period). Apply the patch as soon as you remove it from its protective pouch.

At the first sign of chest pain, spray 1 or 2 pre-measured doses onto or under the tongue. You should not use more than 3 doses within a 15-minute period. If your chest pain continues, you should contact your doctor or seek medical attention immediately.

The spray can be used 5 to 10 minutes before activity that might precipitate an attack.

Your initial dose may be a daily total of 1 inch of ointment. Apply one-half inch on rising in the morning, and the remaining one-half inch 6 hours later. If needed, follow your doctor’s instructions for increasing your dosage. Apply in a thin, uniform layer, regardless of the amount of your dosage. There should be a daily period where no ointment is applied. Usually, the “ointment-off” period will last from 10 to 12 hours.

Absorption varies with site of application—more is absorbed through the chest.

The smallest effective amount should be taken 2 or 3 times a day at 8- to 12-hour intervals.

CHILDREN

The safety and effectiveness of nitroglycerin have not been established for children.

OLDER ADULTS

In general, dosages less than the above adult dosages are recommended, since the elderly may be more susceptible to low blood pressure and headaches.

Overdosage

Any medication taken in excess can have serious consequences. Severe overdosage of nitroglycerin may result in death. If you suspect an overdose, seek medical attention immediately.

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Nitrostat

Nitrostat

Nitrostat is used for:

Preventing or relieving a sudden attack of angina (chest pain) caused by heart disease. It may also be used for other conditions as determined by your doctor.

Nitrostat is a nitrate. It works by dilating (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Dilating blood vessels allows blood to flow more easily. This reduces the heart’s workload and the amount of oxygen needed by the heart.

Do NOT use Nitrostat if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nitrostat :

Some medical conditions may interact with Nitrostat . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Nitrostat . Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitrostat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitrostat :

Use Nitrostat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Nitrostat .

Important safety information:

When used at higher doses or more often than prescribed, Nitrostat may not work as well. This is known as TOLERANCE. Tolerance to other nitrates and nitrites may also occur. Increasing the dose is not effective in managing tolerance to Nitrostat . Talk with your doctor if Nitrostat stops working well. Do not take more than prescribed.

Possible side effects of Nitrostat :

All medicines may cause side effects, but many people have no, or minor, side effects.

Burning or tingling sensation; dizziness; headache; lightheadedness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; nausea; new or worsening chest pain; pale skin; pounding in the chest; severe dizziness or headache; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Nitrostat in the original container, tightly closed, at or below 77 degrees F (25 degrees C). Protect from heat, moisture, and light. Do not store in bathroom. Keep Nitrostat out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Nitrostat . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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NitroMist

NitroMist

Generic Name:

Treatment for:

The U.S. Food and Drug Administration (FDA) has approved NitroMist (Nitroglycerin Lingual Aerosol) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Data from the NitroMist clinical trials demonstrate the drug’s efficacy in the treatment of angina. In a double-blind, single-center, placebo-controlled, 4-period crossover study in 30 subjects with stable angina pectoris, doses of 0.2, 0.4, and 0.8 mg of nitroglycerin delivered by NitroMist were compared to placebo. The primary efficacy endpoint was exercise tolerance as measured by time to development of moderate angina while on an exercise treadmill. The primary endpoint was achieved with all three nitroglycerin oral spray groups demonstrating statistically significantly increase in time to angina compared to placebo (p less than or equal to 0.0003).

About NitroMist

NitroMist is an oral spray formulation of the drug most often used to treat angina pectoris, nitroglycerin. Angina is pain in the chest due to lack of blood and oxygen supply to the heart muscle resulting from an acute coronary syndrome and must be treated emergently. The American Heart Association estimates that over six million people in the United States suffer from angina.

Important Safety Information

Administration of NitroMist is contraindicated in patients who are using PDE5 inhibitors such as Viagra (sildenafil), Levitra (vardenafil), and Cialis (tadalafil). These products have been shown to potentiate the hypotensive effects of nitrate drugs such as NitroMist. NitroMist is also contraindicated in patients with severe anemia, increased intracranial pressure, or with a known hypersensitivity to nitrates or nitrites. Excessive use may lead to the development of tolerance. Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. The drug should therefore be used with caution in patients who may be volume-depleted or who are already hypotensive. Nitroglycerin produces dose-related headaches, which may be severe.

Source:

NitroMist – Highlights of Prescribing Information

These highlights do not include all the information needed to use nitromist safely and effectively. See full

NitroMist Indications and Usage

NitroMist is a nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

NitroMist Dosage and Administration

NitroMist Dosage Forms and Strengths

Lingual aerosol, 400 mcg per spray, 230 metered sprays per container

NitroMist Contraindications

NitroMist Warnings and Precautions

NitroMist Adverse Reactions

Most common adverse reactions are headache, flushing, hypotension, and syncope.

To report SUSPECTED ADVERSE REACTIONS, contact NovaDel Pharma at 1-908-782-3431 and or FDA at 1-800-FDA-1088 or

NitroMist Drug Interactions

NitroMist Patient Counseling Information

For more information, please see

More NitroMist resources

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