Loratadine

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# Overview
Loratadine is an antihistamine that is FDA approved for the treatment of runny nose, sneezing, itchy, watery eyes, itching of the nose or throat.   Common adverse reactions include xerostomia, headache, somnolence and fatigue.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Seasonal allergic rhinitis
- Dose: 10 mg PO daily

### Idiopathic urticaria
- Dose: 10 mg PO daily

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Loratadine in adult patients.

### NonGuideline-Supported Use

### Asthma
- 10-20 mg PO daily up to 8 weeks 

### Eosinophilic nonallergic rhinitis

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Seasonal allergic rhinitis
- Dose (2-5 years): 5 mg PO daily
- Dose (>6 years): 10 mg PO daily

### Idiopathic urticaria
- Dose 2-5 years: 5 mg PO daily
- Dose >6 years: 10 mg PO daily

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Loratadine in pediatric patients.

### NonGuideline-Supported Use

### Asthma
- <30 kg: 10 mg PO daily
- >30 kg: 20 mg PO daily

# Contraindications
- Hypersensitivity to loratadine

# Warnings
- Do not use if you have ever had an allergic reaction to this product or any of its ingredients
- Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
- When using this product do not take more than directed. Taking more than directed may cause drowsiness.
- Stop use and ask a doctor is an allergic reaction to this product occurs. Seek medical help right away.
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- In case of overdose, get medical help or contact a Poison Control Center right away.

# Adverse Reactions

## Clinical Trials Experience

### Dermatologic
- Rash

### Gastrointestinal
- Abdominal pain
- Diarrhea
- Stomatitis
- Xerostomia

### Hepatic
- Hepatic necrosis
- Hepatitis
- Jaundice

### Neurologic
- Anxiety
- Headache
- Hyperactivity
- Somnolence

### Respiratory
- Epistaxis
- Pharyngitis
- Upper respiratory infections
- Viral disease
- Wheezing

### Other
- Dysphonia
- Fatigue
- Influenza-like symptoms
- Malaise
- Somnolence
- Tooth disorder

## Postmarketing Experience
There is limited information regarding Loratadine Postmarketing Experience in the drug label.

# Drug Interactions
- Amiodarone: QT interval prolongation and Torsade de Pointes have been reported with the co-administration of loratadine and amiodarone.
- Carbamazepine: Loratadine increase plasma concentration of carbamazepine.
- Cimetidine: increases plasma concentrations of loratadine
- Ketoconazole: increases plasma concentrations of loratadine
- Mepenzolate
- Morphine: increases risk of paralytic ileus
- Morphine sulfate liposome: increases risk of paralytic ileus
- Oximorphone
- Umeclidinium

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
- Ask a health professional before use.
Pregnancy Category (AUS): B1
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Loratadine in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Loratadine during labor and delivery.

### Nursing Mothers
- Ask a health professional before use.

### Pediatric Use
- In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

### Geriatic Use
There is no FDA guidance on the use of Loratadine in geriatric settings.

### Gender
There is no FDA guidance on the use of Loratadine with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Loratadine with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Loratadine in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Loratadine in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Loratadine in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Loratadine in patients who are immunocompromised.

# Administration and Monitoring

### Administration
Oral

### Monitoring
There is limited information regarding Loratadine Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Loratadine and IV administrations.

# Overdosage
There is limited information regarding Loratadine overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
Loratadine is a tricyclic antihistamine, which acts as a selective inverse agonist of peripheral histamine H1-receptors.

## Structure
There is limited information regarding Loratadine Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Loratadine Pharmacodynamics in the drug label.

## Pharmacokinetics
Loratadine is given orally, is well absorbed from the gastrointestinal tract, and has rapid first-pass hepatic metabolism; it is metabolized by isoenzymes of the cytochrome P450 system, including CYP3A4, CYP2D6, and, to a lesser extent, several others. Loratadine is almost totally (9799%) bound to plasma proteins. Its metabolite desloratadine, which is largely responsible for the antihistaminergic effects, binds to plasma proteins by 7376%.

## Nonclinical Toxicology
There is limited information regarding Loratadine Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Loratadine Clinical Studies in the drug label.

# How Supplied
- Supplied as tablets of 10 mg in 30 tablet carton and 40 tablet bottle carton.

## Storage
- Store at 20-25C (68-77F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Loratadine Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Loratadine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Alavert
- Claritin
- Claritin Reditabs
- Clearatadine
- Triaminic Allerchews
- Children's Clear-Atadine
- Children's Dimetapp ND Allergy
- Children's Claritin

# Look-Alike Drug Names
There is limited information regarding Loratadine Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price