Pseudoephedrine Desloratadine

Pseudoephedrine/desloratadine is a combination medication used for the relief of nasal and nonnasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents aged 12 years and older.

• Pseudoephedrine/desloratadine is available under the following different brand names: Clarinex-D 12 Hr, Clarinex-D 24 Hr

Common side effects of Pseudoephedrine/desloratadine include:

• dry mouth
• headache
• trouble sleeping (insomnia)
• tiredness
• throat discomfort
• nausea
• dizziness
• stomach upset or pain
• loss of appetite
• constipation
• flushing (warmth, redness, or tingly feeling under the skin),
• restlessness or excitability (especially in children)
• skin rash or itching
• drowsiness
• problems with memory or concentration

Serious side effects of Pseudoephedrine/desloratadine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• lightheadedness
• tremors
• severe weakness
• irregular heartbeats
• seizure
• fever
• skin redness
• small pimples

Rare side effects of Pseudoephedrine/desloratadine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 120 mg/2.5 mg
• 240 mg/5 mg

Allergic rhinitis/congestion

Adult dosage

• Clarinex-D 12 hours: 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) orally every 12 hours
• Clarinex-D 24 hours: 1 tablet (5 mg desloratadine/240 mg pseudoephedrine) orally every 24 hours

Pediatric dosage

• Children younger than 12 years
  • Safety and efficacy not established
• Children aged 12 years and older
• Clarinex-D 12 hours: 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) orally every 12 hours
• Clarinex-D 24 hours: 1 tablet (5 mg desloratadine/240 mg pseudoephedrine) orally every 24 hours

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Pseudoephedrine/desloratadine has severe interactions with the following drugs:
  • dihydroergotamine
  • dihydroergotamine inhaled
  • dihydroergotamine intranasal
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • isocarboxazid
  • linezolid
  • methylergonovine
  • phenelzine
  • procarbazine
  • rasagiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Pseudoephedrine/desloratadine has serious interactions with at least 32 other drugs
• Pseudoephedrine/desloratadine has moderate interactions with at least 99 other drugs
• Pseudoephedrine/desloratadine has minor interactions with the following drugs:
  • desmopressin
  • erythromycin base

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity; adverse reaction to sympathomimetics
• Severe hypertension (HTN), severe coronary artery disease
• Concurrent monoamine oxidase (MAO) inhibitors or within 2 weeks of discontinuance of MAO inhibitors
• Hepatic impairment
• Urinary retention
• Narrow-angle glaucoma
• Clarinex-D 12 hours: Also, renal impairment

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Pseudoephedrine/desloratadine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Pseudoephedrine/desloratadine?"

Cautions

• Caution in renal impairment, HTN, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, and benign prostate hypertrophy
• Concomitant antihistamines or decongestants (generally avoid)
• Seizures and tachycardia reported

Pregnancy and Lactation

• The limited available data on pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; there are no adequate and well-controlled studies on pregnant women
• Most studies examining the use of pseudoephedrine during pregnancy did not find an association with an increased risk for congenital anomalies; a few case-control studies conducted reported potential associations with isolated genetic disorders; however, methodological limitations of these studies interpreted results as unreliable
• Reproductive potential
  • There are no data available on human infertility associated with desloratadine, pseudoephedrine, or combination; there are no animal fertility studies with combination or pseudoephedrine alone
  • Female: There were no clinically relevant effects of desloratadine on female fertility in rats
  • Male: A male-specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg and more in rats (approximately 65 times the RHD); male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the RHD)
• Lactation
  • Desloratadine and pseudoephedrine both pass into breast milk; there are no sufficient data on the effects of desloratadine on breastfed infants or the effects of desloratadine on milk production
  • Pseudoephedrine has been reported to reduce milk production and cause irritability in breastfed infants; the decision should be made whether to discontinue nursing or discontinue the drug, considering the developmental and health benefits of breastfeeding, the nursing mother’s clinical need, any potential adverse effects on the breastfed infant from therapy, or underlying maternal condition