Description
Desloratadine and pseudoephedrine is a combination of two medicines used to treat nasal congestion (stuffy nose), sneezing, and runny nose caused by hay fever.
Desloratadine works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
The pseudoephedrine causes narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.
This medicine is available only with your doctor's prescription.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
This product is available in the following dosage forms:
- Tablet, Extended Release, 12 HR
- Tablet, Extended Release, 24 HR
Before Using
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.
Pediatric
Desloratadine and pseudoephedrine combination is not recommended for use in pediatric patients under 12 years of age.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of desloratadine and pseudoephedrine combination in the elderly with use in other age groups, elderly patients are more likely to be sensitive to the effects of this drug.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Carbamazepine
- Clopidogrel
- Gemfibrozil
- 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 mellitus (sugar diabetes)—The decongestant in this medicine may put diabetic patients at a greater risk of having heart or blood vessel disease.
- Enlarged prostate or
- Urinary tract blockage or difficult urination—Some of the effects of antihistamines may make urinary problems worse.
- Glaucoma—A slight increase in inner eye pressure may occur.
- Heart or blood vessel disease or
- High blood pressure—The decongestant in this medicine may cause blood pressure to increase and may also speed up the heart rate.
- Kidney disease—Higher blood levels of desloratadine may result, which may increase the chance of side effects. If you are taking the 24 hour extended-release tablets, the dosage may need to be reduced. The 12 hour extended-release tablets should generally be avoided if you have kidney disease.
- Liver disease—Higher blood levels of desloratadine may result, which may increase the chance of side effects. This medicine should generally be avoided if you have liver disease.
- Overactive thyroid—If an overactive thyroid has caused a fast heart rate, desloratadine in this medicine may cause the heart rate to speed up further.
- Urinary retention—Condition may be worsened with use of pseudoephedrine
Proper Use
Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
Not taking over-the-counter antihistamines and decongestants while taking desloratadine and pseudoephedrine combination.
When taking desloratadine and pseudoephedrine extended-release tablet:
- Swallow it whole.
- Do not crush, break, or chew before swallowing.
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 oral dosage form (extended-release tablets [12 hour]):
- For nasal congestion or rhinorrhea
- Adults and teenagers—Oral, one tablet (2.5 milligrams desloratadine, 120 milligrams pseudoephedrine) two times a day 12 hours apart, taken with or without a meal
- Children 4 years of age and older—Use and dose must be determined by your doctor.
- Children and infants up to 4 years of age—Use is not recommended .
- For nasal congestion or rhinorrhea
- For oral dosage form (extended-release tablets [24 hour]):
- For nasal congestion or rhinorrhea
- Adults and teenagers—Oral, one tablet (5 milligrams desloratadine, 240 milligrams pseudoephedrine) daily, taken with or without a meal
- Children 4 years of age and older—Use and dose must be determined by your doctor.
- Children and infants up to 4 years of age—Use is not recommended .
- For nasal congestion or rhinorrhea
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Precautions
Desloratadine may cause dryness of the mouth, nose, and throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Side Effects
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.
Check with your doctor immediately if any of the following side effects occur:
Observed during clinical practice
- Abdominal or stomach pain area
- chills
- clay-colored stools
- cough
- dark urine
- difficult or labored breathing
- difficulty swallowing
- dizziness
- elevated liver enzymes
- fast heartbeat
- fast, pounding, or irregular heartbeat or pulse
- fever
- general tiredness and weakness
- headache
- hives
- irregular heartbeat
- itching
- light-colored stools
- loss of appetite
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- rash
- redness of skin
- shortness of breath
- skin rash
- swelling
- tightness in chest
- unpleasant breath odor
- unusual tiredness or weakness
- upper right abdominal pain
- vomiting of blood
- vomiting
- welts
- wheezing
- yellow eyes or skin
Symptoms of overdose
Get emergency help immediately if any of the following symptoms of overdose occur:
- Increased heart rate
- sleepiness or unusual drowsiness
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:
More common
- Dry mouth
- sleeplessness
- trouble sleeping
- unable to sleep
Less common
- Body aches or pain
- congestion
- dryness or soreness of throat
- hoarseness
- nervousness
- restlessness
- runny nose
- sleepiness or unusual drowsiness
- tender, swollen glands in neck
- trouble sitting still
- voice changes
- weight loss
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.
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