Nitro-Time Controlled-Release Capsules

Generic Name: Nitroglycerin Controlled-Release Capsules (nye-troe-GLI-ser-in)
Brand Name: Nitro-Time

Nitro-Time Controlled-Release Capsules is used for:

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Preventing chest pain caused by heart disease. It also may be used for certain conditions as determined by your doctor.

Nitro-Time Controlled-Release Capsules is a nitrate vasodilator. It works by relaxing blood vessels in the body, which allows them to widen (dilate). This allows more blood to flow through the blood vessels easier, which reduces the workload on the heart.

Do NOT use Nitro-Time Controlled-Release Capsules if:

you are allergic to any ingredient in Nitro-Time Controlled-Release Capsules
you are currently taking a phosphodiesterase type 5 inhibitor (eg, sildenafil)

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

Before using Nitro-Time Controlled-Release Capsules:

Some medical conditions may interact with Nitro-Time Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have bleeding in the brain or have had a recent head injury
if you have heart problems, severe anemia, low blood pressure, or an overactive thyroid

Some MEDICINES MAY INTERACT with Nitro-Time Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Calcium channel blockers (eg, verapamil) or phosphodiesterase type 5 inhibitors (eg, sildenafil) because side effects, such as low blood pressure, may occur
Alteplase because the effectiveness of Nitro-Time Controlled-Release Capsules may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitro-Time Controlled-Release Capsules 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 Nitro-Time Controlled-Release Capsules:

Use Nitro-Time Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Nitro-Time Controlled-Release Capsules may be taken with or without food.
Swallow Nitro-Time Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.
Nitro-Time Controlled-Release Capsules lasts for about 12 hours. Do not take more of Nitro-Time Controlled-Release Capsules than prescribed. It is important to have a "nitrate-free" period of time each day for Nitro-Time Controlled-Release Capsules to continue to work well and to decrease the risk of physical dependence.
If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nitro-Time Controlled-Release Capsules.

Important safety information:

Nitro-Time Controlled-Release Capsules may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nitro-Time Controlled-Release Capsules. Using Nitro-Time Controlled-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Nitro-Time Controlled-Release Capsules may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit or stand up slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
Nitro-Time Controlled-Release Capsules may give you daily headaches. This should become less noticeable with time.
Other dose forms of Nitro-Time Controlled-Release Capsules (eg, sublingual, or under the tongue, tablets) may not work as well while you are taking Nitro-Time Controlled-Release Capsules.
Nitro-Time Controlled-Release Capsules takes about 1 to 2 hours to start working and should not be used for a sudden chest pain attack.
Use Nitro-Time Controlled-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
Nitro-Time Controlled-Release Capsules is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Nitro-Time Controlled-Release Capsules can cause harm to a fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Nitro-Time Controlled-Release Capsules during pregnancy. It is unknown if Nitro-Time Controlled-Release Capsules is excreted in breast milk. Do not breast-feed while taking Nitro-Time Controlled-Release Capsules.

When used for long periods of time without a break, Nitro-Time Controlled-Release Capsules 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 Nitro-Time Controlled-Release Capsules. Talk with your doctor if Nitro-Time Controlled-Release Capsules stops working well. Do not take more than prescribed.

When used for long periods of time without a break, some people develop a physical need to continue taking Nitro-Time Controlled-Release Capsules. This is known as physical DEPENDENCE. Do not suddenly stop taking Nitro-Time Controlled-Release Capsules without your doctor's approval. Stopping Nitro-Time Controlled-Release Capsules suddenly may cause serious, possibly life-threatening, WITHDRAWAL symptoms, including chest pain and heart attack. Having a nitrate-free period each day will help prevent tolerance, dependence, and withdrawal problems.

Possible side effects of Nitro-Time Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness, lightheadedness, or fainting when sitting up or standing; fast heartbeat; flushing of face and neck; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; frequent or continuous chest pain; pounding the chest.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include changes in heart rate; changes in vision; confusion; dizziness; flushing; nausea; persistent, throbbing headache; sweating; vomiting; weakness.

Proper storage of Nitro-Time Controlled-Release Capsules:

Store Nitro-Time Controlled-Release Capsules at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nitro-Time Controlled-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Nitro-Time Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Nitro-Time Controlled-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Nitro-Time Controlled-Release Capsules. 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.

Issue Date: August 6, 2008

Database Edition 08.3.1.002