Friday, September 16, 2016

Pediatex TDM Suspension


Pronunciation: SOO-doe-e-FED-rin/trye-PROE-li-deen/DEX-troe-meth-OR-fan
Generic Name: Pseudoephedrine/Triprolidine/Dextromethorphan
Brand Name: Pediatex TDM


Pediatex TDM Suspension is used for:

Relieving symptoms of hay fever, allergies, or the common cold, including cough, nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy or watery eyes. It may also be used for other conditions as determined by your doctor.


Pediatex TDM Suspension is an antihistamine, decongestant, and cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.


Do NOT use Pediatex TDM Suspension if:


  • you are allergic to any ingredient in Pediatex TDM Suspension

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you are unable to urinate or are having an asthma attack

  • you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

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



Before using Pediatex TDM Suspension:


Some medical conditions may interact with Pediatex TDM Suspension. 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 adrenal gland problems (eg, an adrenal gland tumor), a heart problem (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems

  • if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

  • if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems

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


  • Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased

  • Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Pediatex TDM Suspension's side effects

  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pediatex TDM Suspension

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pediatex TDM Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pediatex TDM Suspension 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 Pediatex TDM Suspension:


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


  • Pediatex TDM Suspension may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Shake well before each use.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Pediatex TDM Suspension and 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 Pediatex TDM Suspension.



Important safety information:


  • Pediatex TDM Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pediatex TDM Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Pediatex TDM Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Avoid drinking alcohol while you are taking Pediatex TDM Suspension.

  • Do not take diet or appetite control medicines while you are taking Pediatex TDM Suspension without checking with your doctor.

  • If your symptoms do not get better within 7 days, if they get worse, or if they occur along with a fever, headache, or rash, check with your doctor.

  • Diabetes patients - Pediatex TDM Suspension may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

  • Pediatex TDM Suspension has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not use Pediatex TDM Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • Do not exceed the recommended dose or take Pediatex TDM Suspension for longer than prescribed without checking with your doctor.

  • If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Pediatex TDM Suspension.

  • Pediatex TDM Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pediatex TDM Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Pediatex TDM Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pediatex TDM Suspension for a few days before the tests.

  • Tell your doctor or dentist that you take Pediatex TDM Suspension before you receive any medical or dental care, emergency care, or surgery.

  • Use Pediatex TDM Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.

  • Pediatex TDM Suspension is not recommended for use in CHILDREN younger than 6 years without first checking with your doctor.

  • Caution is advised when using Pediatex TDM Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.

  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Pediatex TDM Suspension while you are pregnant. Pediatex TDM Suspension is found in breast milk. Do not breast-feed while taking Pediatex TDM Suspension.


Possible side effects of Pediatex TDM Suspension:


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 (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; upset stomach; vomiting; 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); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of the mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).



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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Pediatex TDM Suspension:

Store Pediatex TDM Suspension 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 Pediatex TDM Suspension out of the reach of children and away from pets.


General information:


  • If you have any questions about Pediatex TDM Suspension, please talk with your doctor, pharmacist, or other health care provider.

  • Pediatex TDM Suspension 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.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pediatex TDM Suspension. 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: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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