Atropine/ hyoscyamine/ phenylephrine/ pseudoephedrine/ scopolamine sustained-release tablets

Generic Name: atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine (AT-row-peen/hye-oh-SYE-a-meen/fen-ill-EF-rin/sue-do-eh-FED-rin/skoe-POL-a-meen)
Brand Name: Sta-D

Atropine/ hyoscyamine/ phenylephrine/ pseudoephedrine/ scopolamine sustained-release tablets is used for:

Relieving symptoms such as congestion and runny nose due to upper airway irritation caused by colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets is a decongestant and anticholinergic combination. It works by decreasing secretions in the airway. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage.

Do NOT use atropine/ hyoscyamine/ phenylephrine/ pseudoephedrine/ scopolamine sustained-release tablets if:

  • you are allergic to any ingredient in atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets
  • you are pregnant or breast-feeding
  • you are taking sodium oxybate (GHB)
  • you are taking or have taken medicine for high blood pressure or depression in the last 14 days, or you have taken furazolidone within the last 5 days
  • you have a history of narrow-angle glaucoma; a blockage of your stomach, bowel, or bladder; peptic ulcer disease; severe intestinal or bowel problems; difficulty urinating; inflammation of the esophagus from reflux disease; difficulty swallowing; or uncontrolled bleeding
  • you have severe heart disease or severe high blood pressure

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

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Before using atropine/ hyoscyamine/ phenylephrine/ pseudoephedrine/ scopolamine sustained-release tablets:

Some medical conditions may interact with atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine 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 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 diabetes, an enlarged prostate, a history of 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, myasthenia gravis (muscle weakness), or an overactive thyroid

Some MEDICINES MAY INTERACT with atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Furazolidone, medicines for treating high blood pressure such as alpha-blockers (eg, prazosin, guanethidine, methyldopa), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), or medicines for treating depression such as monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects may be increased
  • Alkalizers (eg, calcium or magnesium antacids), anesthetics (eg, chloroform, lidocaine), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, or sodium bicarbonate because they may increase the risk of atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets's side effects
  • Bromocriptine, certain stimulants (eg, doxapram), cocaine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets
  • Clonidine, guanabenz, guanethidine, or phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased by atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine 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 atropine/ hyoscyamine/ phenylephrine/ pseudoephedrine/ scopolamine sustained-release tablets:

Use atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow whole. Do not break, crush, or chew before swallowing.
  • If you also take an antacid, certain medicine for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole, do not take them within 2 or 3 hours before or after taking atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets. Check with your doctor if you have questions.
  • If you miss a dose of atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine 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 atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets.

Important safety information:

  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • If your symptoms do not get better within 7 days or if they get worse, or if you develop a high fever or persistent headache, check with your doctor.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets may interfere with certain lab test results. Be sure your doctors and lab personnel know that you are taking atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine 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.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Do not take diet or appetite control medicines while you are taking atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets without checking with your doctor.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets.
  • Diabetes patients - Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before you change the dose of your diabetes medicine.
  • Caution is advised when using atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets the ELDERLY; they may be more sensitive to its effects.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets should not be used in CHILDREN younger than 12 years old without checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets while you are pregnant. It is not known if atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets is found in breast milk. If you are or will be breast-feeding while you use atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time, atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets may not work as well. This is known as TOLERANCE. Increasing the dose will cause toxic side effects to occur. If you suddenly stop taking atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets, WITHDRAWAL symptoms, including depression, may occur.

Possible side effects of atropine/ hyoscyamine/ phenylephrine/ pseudoephedrine/ scopolamine 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:

Blurred vision; clumsiness; constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); flushing; giddiness; headache; lack of energy; nausea; nervousness; tearing; trouble sleeping; unusual tiredness or weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty swallowing; mental or mood changes; fast or irregular heartbeat; unusual bleeding or bruising; trouble urinating; vomiting.

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/), or emergency room immediately. Symptoms may include convulsions; 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; vomiting.

Proper storage of atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets:

Store atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine sustained-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine 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 atropine/hyoscyamine/phenylephrine/pseudoephedrine/scopolamine 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: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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