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All about: Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets

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Generic Name: Dextromethorphan/Guaifenesin/Pseudoephedrine Controlled-Release and Sustained-Release Tablets (dex-troe-meth-OR-fan/gwye-FEN-e-sin/soo-doe-e-FED-rin)
Brand Name: Examples include Ambi 60/580/30 and Maxifed DM

Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets if:

  • you are allergic to any ingredient in Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets
  • you have severe high blood pressure, a fast heartbeat, or other severe heart problems (eg, heart blood vessel disease)
  • you are taking droxidopa or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • you are breast-feeding

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

Before using Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

Some medical conditions may interact with Ambi 60/580/30 Controlled-Release and 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 a history of glaucoma or increased pressure in the eye, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, stroke, trouble sleeping, or seizures
  • if you have chronic cough, a cough that produces large amounts of mucus, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema)
  • if you have had an unusual reaction to a sympathomimetic (eg, ephedrine)

Some MEDICINES MAY INTERACT with Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets's side effects
  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
  • Bromocriptine because the risk of its side effects may be increased by Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ambi 60/580/30 Controlled-Release and 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

Use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets by mouth with or without food.
  • Drink plenty of water while taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.
  • Swallow Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Ambi 60/580/30 Controlled-Release and 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.

Important safety information:

  • Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not take appetite suppressants while you are taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets without checking with your doctor first.
  • Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets contains pseudoephedrine and dextromethorphan. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine or dextromethorphan. If it does or if you are uncertain, contact your doctor or pharmacist.
  • Do NOT exceed the recommended dose or take Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets for longer than prescribed without checking with your doctor.
  • If your symptoms do not improve within 5 days, if they become worse, or if you have a fever, check with your doctor.
  • Tell your doctor or dentist that you take Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
  • Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.
  • Use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations and seizures.
  • Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets is should not be used in CHILDREN younger than 6 years old; 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets while you are pregnant. It is not known if Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.

Possible side effects of Ambi 60/580/30 Controlled-Release and 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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; 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 urinating; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; unusually pale skin.

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 blurred vision; change in amount or frequency of urination; confusion; hallucinations; increased thirst; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; unusually pale skin; vomiting.

Proper storage of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

Store Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets at room temperature, 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Ambi 60/580/30 Controlled-Release and 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 Ambi 60/580/30 Controlled-Release and 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: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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