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|DuraHist Sustained-Release Tablets

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DuraHist Sustained-Release Tablets

Generic Name: Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets (klor-fen-EER-a-meen/sue-do-eh-FED-rin/meth-skoe-POL-a-meen)
Brand Name: Examples include DuraHist and Xiral SR

DuraHist Sustained-Release Tablets is used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

DuraHist Sustained-Release Tablets is an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use DuraHist Sustained-Release Tablets if:

you are allergic to any ingredient in DuraHist Sustained-Release Tablets
you are pregnant or breast-feeding
you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor within the last 14 days
you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding
you are unable to urinate or are having an asthma attack

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

Before using DuraHist Sustained-Release Tablets:

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

if you are planning to become pregnant
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 a history of diabetes, an enlarged prostate, bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

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

Alpha-blockers (eg, prazosin, guanethidine, methyldopa), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline)
Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, or sodium bicarbonate because the side effects of DuraHist Sustained-Release Tablets may be increased
Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because side effects may be increased by DuraHist Sustained-Release Tablets
Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by DuraHist Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if DuraHist Sustained-Release Tablets 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 DuraHist Sustained-Release Tablets:

Use DuraHist Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

DuraHist Sustained-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Do not take DuraHist Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after taking DuraHist Sustained-Release Tablets.
Swallow whole. Do not crush or chew before swallowing. Some brands of DuraHist Sustained-Release Tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.
If you miss a dose of DuraHist Sustained-Release Tablets and you are taking it regularly, 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 DuraHist Sustained-Release Tablets.

Important safety information:

DuraHist Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to DuraHist Sustained-Release Tablets. Using DuraHist Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
If your symptoms do not improve within 7 days or if you develop a high fever or persistent headache, check with your doctor.
DuraHist Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
DuraHist Sustained-Release Tablets may cause your eyes to become sensitive to sunlight. Wearing sunglasses may help.
DuraHist Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.
Do not take diet or appetite control medicines while you are taking DuraHist Sustained-Release Tablets without checking with your doctor.
DuraHist Sustained-Release Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take DuraHist Sustained-Release Tablets.
DuraHist Sustained-Release Tablets may interfere with certain lab test results. Be sure your doctors and lab personnel know that you are taking DuraHist Sustained-Release Tablets.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using DuraHist Sustained-Release Tablets.
Diabetes patients - DuraHist Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Caution is advised when using DuraHist Sustained-Release Tablets the ELDERLY because they may be more sensitive to its effects.
Caution is advised when using DuraHist Sustained-Release Tablets in CHILDREN because they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: It is unknown if DuraHist Sustained-Release Tablets can cause harm to the fetus. If you become pregnant while taking DuraHist Sustained-Release Tablets, discuss with your doctor the benefits and risks of using DuraHist Sustained-Release Tablets during pregnancy. DuraHist Sustained-Release Tablets is excreted in breast milk. Do not breast-feed while taking DuraHist Sustained-Release Tablets.

Possible side effects of DuraHist Sustained-Release Tablets:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

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/findyour.htm), or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of DuraHist Sustained-Release Tablets:

Store DuraHist Sustained-Release Tablets in a tightly closed container between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep DuraHist Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about DuraHist Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
DuraHist Sustained-Release Tablets 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 DuraHist Sustained-Release Tablets. 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: November 1, 2006

Database Edition 06.4.1.002

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