Desloratadine Tablets

What is Desloratadine?

Desloratadine is a prescription medication containing the active substance desloratadine, presented as oral tablets. It belongs to a class of medicines called H1-receptor antagonists (antihistamines) and is the primary active metabolite of loratadine.

Mechanism of Action

Desloratadine works through selective peripheral H1-receptor antagonism:

• Histamine blockade: Blocks H1 receptors, preventing histamine from binding and triggering allergic symptoms
• Anti-inflammatory effects: Inhibits histamine release from mast cells and reduces expression of adhesion molecules
• Peripheral selectivity: Does not readily cross the blood-brain barrier, minimizing central nervous system effects

Imagine your allergic response as an alarm system - histamine is the alarm trigger. Desloratadine acts like a skilled technician who disables the alarm before it can sound, preventing the allergic symptoms from occurring.

Pharmacokinetics

Desloratadine is rapidly absorbed after oral administration, with peak plasma concentrations reached within approximately 3 hours. It has a half-life of about 27 hours, which allows for once-daily dosing. The medication is extensively metabolized in the liver, with approximately 87% of the dose excreted equally in urine and faeces.

What is Desloratadine Used For?

Desloratadine is indicated for the relief of symptoms associated with:

Allergic Rhinitis

This includes both seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis (year-round allergies). According to NICE BNF guidelines, symptoms treated include:

• Sneezing
• Runny or itchy nose
• Itchy palate
• Itchy, red or watery eyes
• Nasal congestion

Chronic Idiopathic Urticaria

This refers to hives of unknown cause lasting 6 weeks or longer. Symptoms treated include:

• Itching
• Hives (raised, red, itchy welts on the skin)

Approved Patient Groups

Before Using Desloratadine

Essential considerations before initiating treatment:

Medical History Assessment

• Kidney function impairment (renal impairment)
• Liver function impairment (hepatic impairment)
• Seizure disorders (personal or family history)
• Heart conditions (history of arrhythmias)
• Known allergies to desloratadine, loratadine, or tablet ingredients
• Lactose intolerance (tablets contain lactose monohydrate)

Required Baseline Tests

For most patients, no specific baseline tests are required. However, your doctor may recommend:

1. Renal function tests (creatinine clearance) if kidney problems are suspected
2. Liver function tests (ALT, AST) if liver disease history exists
3. Cardiac evaluation if history of heart rhythm abnormalities

Desloratadine Contraindications

Absolute contraindications where Desloratadine must not be used:

Absolute Contraindications

• Hypersensitivity to desloratadine or any of the excipients
• Hypersensitivity to loratadine or related antihistamines
• Severe hepatic impairment
• Children under 12 years of age

Special Warnings

Special Population Considerations

Elderly Patients (≥65 years)

• No dose adjustment generally necessary with normal renal/hepatic function
• Age-related decreases in renal function may require monitoring

Renal Impairment

• Creatinine clearance <50 mL/min: 5 mg every other day
• End-stage renal disease: Not studied; use with caution

Hepatic Impairment

• Mild to moderate impairment: Use with caution
• Severe impairment: Contraindicated

Pediatric Patients

• 12-17 years: 5 mg once daily (approved)
• 6-11 years: Not recommended
• Under 6 years: Not recommended

Desloratadine and Other Medicines

Desloratadine has a low potential for drug interactions. However, important considerations include:

Clinical Interactions

• Erythromycin and ketoconazole: May increase desloratadine plasma concentrations, though no clinically relevant effects observed at recommended doses
• Central nervous system depressants: While desloratadine is non-drowsy for most people, additive effects with alcohol or other sedatives are possible

Absorption and Timing

According to the NHS drug monitoring database, food does not significantly affect absorption:

• Can be taken with or without food
• No specific timing requirements regarding other medications
• Concurrent use with other antihistamines not recommended due to potential additive effects

Pregnancy & Breastfeeding

Pregnancy

• Not recommended during pregnancy unless clearly needed
• Limited data available on use in pregnant women
• Animal studies showed no direct harmful effects, but human data insufficient
• Discontinue if pregnancy occurs unless prescribed by doctor

Breastfeeding

• Not recommended while breastfeeding
• Small amounts of desloratadine may pass into breast milk
• Potential risk to infant cannot be excluded
• Discuss alternatives with your doctor

Contraception Requirements

• No specific contraception requirements mandated
• If planning pregnancy or could become pregnant, discuss alternative treatments

Driving & Machine Operation

• At recommended dose, not expected to affect driving or machine operation ability
• Clinical trials showed no impairment compared to placebo
• However, individual responses may vary
• Avoid driving or operating machinery if experiencing:
  • Drowsiness or fatigue
  • Dizziness
  • Blurred vision

Desloratadine Ingredients

Active Substance

• Desloratadine 5 mg per tablet

Excipients (Inactive Ingredients)

Allergen Warnings

• Contains lactose: Patients with lactose intolerance should consult doctor before use
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

How to Use Desloratadine

Preparation Steps

1. Wash hands thoroughly
2. Remove one tablet from blister pack
3. Inspect tablet (should be off-white to light-pink, circular, biconvex with 'L5' engraved)
4. Do not crush, chew, or break the tablet

Administration Technique

• Route: Oral
• With water: Swallow whole with a glass of water
• Timing: Can be taken with or without food
• Frequency: Once daily at approximately the same time each day

Special Instructions

1. Take exactly as prescribed by your doctor
2. Do not exceed recommended dose
3. If difficulty swallowing, consult your doctor (tablet should not be split)
4. Store in original packaging to protect from moisture

Desloratadine Dosage Guidelines

Standard Dosage Schedule

Treatment Duration

• Intermittent allergic rhinitis: Symptoms present less than 4 days per week or less than 4 weeks. Treatment duration depends on symptom occurrence.
• Persistent allergic rhinitis: Symptoms present 4 days or more per week and for more than 4 weeks. Longer-term treatment may be recommended.
• Urticaria: Duration varies from patient to patient. Follow your doctor's instructions.

Dose Adjustment Criteria

• No titration necessary - full therapeutic dose can be started immediately
• Do not increase dose if experiencing significant side effects
• Consult doctor for dose adjustments in renal impairment

Administration Instructions

Step-by-step administration guide:

Optimal Timing

1. Take at approximately the same time each day
2. Morning administration often recommended for allergic rhinitis
3. Maintain consistent blood levels for optimal symptom control

With Food and Drink

1. Food does not significantly affect absorption
2. May be taken with or without meals
3. Use caution when consuming alcohol
4. Take with water to aid swallowing

Special Considerations

• Do not take with grapefruit juice (may affect metabolism)
• Maintain adequate hydration
• If taking antacids, separate by at least 2 hours

Missed Dose Management

General Principles

• Do NOT double doses
• Take as soon as remembered unless close to next dose

Time-Based Guidance

Example Scenarios

• Usual dose at 8 AM, remember at 2 PM: Take immediately
• Usual dose at 8 AM, remember at 10 PM: Skip dose, take next day at 8 AM
• Consistent forgetting: Consider setting daily reminder

Overdose Information

Symptoms

• Headache
• Drowsiness
• Rapid heartbeat
• Nausea
• In clinical trials, doses up to 45 mg (9 times recommended dose) caused no significant adverse effects

Management

1. Seek immediate medical attention
2. Contact Poison Control Centre (UK: 111)
3. Bring medication packaging to medical facility
4. Symptomatic treatment:
   • Gastric lavage if performed soon after ingestion
   • Supportive care for symptoms
   • No specific antidote available

Important Notes

• Do not induce vomiting unless instructed by medical personnel
• Desloratadine is not effectively removed by haemodialysis
• Treatment is generally supportive and symptomatic

Possible Side Effects

Like all medicines, desloratadine can cause side effects, although not everyone experiences them. Side effects are generally mild to moderate.

Very Common (more than 1 in 10 people)

• Fatigue
• Dry mouth
• Headache

Common (1 in 10 to 1 in 100 people)

• Dizziness
• Nausea
• Diarrhoea
• Drowsiness

Uncommon (1 in 100 to 1 in 1,000 people)

• Rapid heartbeat
• Palpitations
• Muscle pain
• Hallucinations
• Seizures

Rare (1 in 1,000 to 1 in 10,000 people)

• Severe allergic reactions (anaphylaxis)
• Liver inflammation (hepatitis)
• Abnormal liver function tests
• Increased sensitivity to sunlight

Frequency Not Known

• Increased appetite
• Weight gain
• Aggression
• Depressed mood
• Abnormal behaviour

Serious Side Effects Requiring Immediate Action

Reporting Side Effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the UK Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

How to Store Desloratadine

Storage Conditions

• Store in original package to protect from moisture
• Keep at room temperature (15-25°C)
• Protect from light and excessive heat
• Keep out of sight and reach of children

In-Use Storage

• Do not transfer tablets to other containers
• Keep blister packs intact until use
• Avoid storage in bathrooms or near sinks

Expiry and Disposal

• Do not use after expiry date on carton and blister pack
• Expiry date refers to last day of that month
• Do not dispose via wastewater or household waste
• Return unused medication to pharmacy for safe disposal

Visual Inspection

• Do not use if tablets show changes in appearance
• Tablets should be off-white to light-pink, circular, biconvex
• One side engraved with 'L5', other side plain

Pack Information

Pack Sizes

• 7 tablets
• 10 tablets
• 14 tablets
• 15 tablets
• 20 tablets
• 28 tablets
• 30 tablets
• 50 tablets
• 100 tablets
• Not all pack sizes may be marketed

Components

• Desloratadine 5 mg tablets in blister packs
• Package leaflet included
• Original carton for protection

Appearance

• Off-white to light-pink tablets
• Circular, biconvex shape
• 'L5' engraved on one side, plain on other

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Harrow, Middlesex HA3 0BU, UK

Manufacturers

Glenmark Pharmaceuticals s.r.o
Fibichova 143, 566 17 Vysoké Mýto, Czech Republic

Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA, United Kingdom

This leaflet was last revised in 11/2024.

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