Loratadine and pseudoephedrine

Name: Loratadine and pseudoephedrine

Overdose

In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents. Loratadine is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.

Somnolence, tachycardia, and headache have been reported with doses of 40 to 180 mg of loratadine; pseudoephedrine. In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure.

The oral median lethal dose for the mixture of the two drugs was greater than 525 and 1839 mg/kg in mice and rats, respectively (approximately 10 and 58 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hour dose on a mg/m2 basis). The oral median lethal dose for loratadine was greater than 5000 mg/kg in rats and mice (greater than 2000 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hourdose on a mg/m2 basis). Single oral doses of loratadine showed no effects in rats, mice, and monkeys at doses as high as 10 times the maximum recommended human daily oral dose on a mg/m2 basis.

What happens if I miss a dose?

Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking loratadine and pseudoephedrine?

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of this medication.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Loratadine and pseudoephedrine dosing information

Usual Adult Dose for Allergic Rhinitis:

1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.

Usual Adult Dose for Nasal Congestion:

1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.

Usual Pediatric Dose for Allergic Rhinitis:

over 12 years:

1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.

Usual Pediatric Dose for Nasal Congestion:

over 12 years:

1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.

How do I store and/or throw out Loratadine and Pseudoephedrine?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Pharmacologic Category

  • Alpha/Beta Agonist
  • Decongestant
  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Piperidine Derivative

Dosing Adult

Cold, allergy symptoms: Oral:

Loratadine 5 mg/pseudoephedrine 120 mg per tablet: One tablet every 12 hours (maximum: 2 tablets/day)

Loratadine 10 mg/pseudoephedrine 240 mg per tablet: One tablet daily (maximum: 1 tablet/day)

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Also see individual agents.

Warnings/Precautions

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).

• Diabetes: Use with caution in patients with diabetes mellitus.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or glaucoma.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Renal impairment: Use with caution in patients with renal impairment.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Self-medication (OTC use): When used for self medication (OTC), do not exceed the recommended doses; discontinue use and contact healthcare provider if symptoms do not improve within 7 days or are accompanied by fever; if nervousness, dizziness, or sleeplessness occur; or if an allergic reaction to the formulation occurs.

For Healthcare Professionals

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 / pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)