Pronunciation:

lor-A-ta-deen, soo-doe-e-FED-rin SUL-fate

Brand Names:

• Alavert-D 12-Hour
• Allergy & Congestion Relief
• Claritin-D
• Claritin-D 12-Hour
• Claritin-D 24-Hour
• Clear-Atadine D

Dosage Forms:

• Tablet, Extended Release
• Tablet, Extended Release, 24 HR
• Tablet, Extended Release, 12 HR

Classifications:

Therapeutic—

Antihistamine, Less-Sedating/Decongestant Combination

Pharmacologic—

Antihistamine, Less-Sedating

Chemical—

Piperidine

Uses of This Medicine:

Loratadine and pseudoephedrine combination is used to relieve symptoms of allergies and cold, including runny or stuffy nose, sneezing, watery eyes, and itching of the eyes, nose or throat. It also helps reduce swelling of the nasal passages and restores easier breathing through the nose.

This medicine is available as an over-the-counter (OTC) product.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of loratadine and pseudoephedrine combination in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

Older adults—

No information is available on the relationship of age to the effects of loratadine and pseudoephedrine combination in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Carbamazepine
• Clarithromycin
• Guanethidine
• Iobenguane I 123
• Iobenguane I 131
• Methyldopa
• Midodrine
• Pitolisant

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart disease or
• High blood pressure or
• Kidney disease or
• Liver disease or
• Thyroid problems or
• Trouble urinating caused by enlarged prostate—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Follow the instructions on the medicine label.

Swallow the extended-release tablet whole with a full glass of water. Do not divide, crush, chew, or dissolve it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For symptoms of allergies and cold:
  • For oral dosage form (12 hour extended-release tablets):
    • Adults and children 12 years of age and older—One tablet every 12 hours. Each tablet contains 5 milligrams (mg) loratadine and 120 mg pseudoephedrine. Do not take more than 2 tablets in 24 hours.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (24 hour extended-release tablets):
    • Adults and children 12 years of age and older—One tablet once a day. Each tablet contains 10 milligrams (mg) loratadine and 240 mg pseudoephedrine. Do not take more than one tablet in 24 hours.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not use this medicine if the blister pack is open or torn.

Precautions While Using This Medicine:

If your or your child's symptoms do not improve within 7 days, or if they become worse (with fever), check with your doctor.

Do not use this medicine if you have used an MAO inhibitor (MAOI), including Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 2 weeks.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Dizziness

drowsiness

nervousness

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.