Loratadine-D 24 Hour

Do not use loratadine and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold or allergy medicine within the past few days.

Store at room temperature away from moisture and heat.

• If you have an allergy to loratadine, pseudoephedrine, or any other part of Loratadine-D 24 Hour (loratadine and pseudoephedrine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with Loratadine-D 24 Hour.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Applies to loratadine / pseudoephedrine: oral tablet extended release 12 hour, oral tablet extended release 24 hour

Applies to loratadine / pseudoephedrine: oral tablet extended release

Nervous system

Nervous system side effects of loratadine have included headaches in approximately 7% of treated patients. Loratadine has not been shown to cause significant drowsiness, sedation, or impair psychomotor skills.

Nervous system side effects of pseudoephedrine have included nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache, somnolence, and dizziness have also occurred in patients receiving pseudoephedrine.[Ref]

Cardiovascular

Cardiovascular side effects of loratadine have included at least one report of syncopal episodes, premature ventricular complexes, and a prolonged QT interval.[Ref]

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

Adverse effects which have been reported during therapy with loratadine and pseudoephedrine included dizziness, syncopal episodes, palpitations, ventricular arrhythmias including torsades de pointes, cardiac arrest, and cardiac death.[Ref]

Gastrointestinal

Gastrointestinal side effects have included anorexia and gastric irritation in approximately 5% of patients treated with pseudoephedrine. Dry mouth, nose, or throat have occurred in up to 15% of patients. Gastrointestinal effects of loratadine have been rare and included nausea and dry mouth. A few cases of mechanical upper gastrointestinal tract obstruction have been reported with Claritin-D 24 Hour tablets (brand of loratadine-pseudoephedrine), primarily in patients who have difficulty swallowing tablets or in whom there is upper gastrointestinal tract narrowing or abnormal esophageal peristalsis. Ischemic colitis has been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects of pseudoephedrine have included reports of fixed drug eruptions.[Ref]

Some side effects of Loratadine-D 24 Hour may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.