Claritin (Loratadine) - Summary

CLARITIN SUMMARY

Claritin (Loratadine) is an antihistamine.
Claritin (Loratadine) is used to relieve symproms of hay fever and allergy, including sneezing, runny nose, and red, itchy and tearing eyes.
It works by blocking histamine, a substance in the body that causes allergic symptoms. Loratadine may cause less drowsiness than other antihistamines.

CLARITIN is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 2 years of age or older.

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NEWS HIGHLIGHTS

Published Studies Related to Claritin (Loratadine)

A randomized study comparing the effect of loratadine added to montelukast with montelukast, loratadine, and beclomethasone monotherapies in patients with chronic asthma. [2009.06]
CONCLUSION: In this study, the addition of loratadine to montelukast produced a small numerical, but not statistically significant, improvement in FEV(1) and, in general, no consistent improvement in other asthma endpoints. No improvement of montelukast + loratadine versus beclomethasone was seen in any endpoint.

Single-dose desloratadine and montelukast and allergen-induced late airway responses. [2009.06]
Montelukast and desloratadine synergistically inhibit the allergen-induced early asthmatic response...

Onset of action of loratadine/montelukast in seasonal allergic rhinitis subjects exposed to ragweed pollen in the Environmental Exposure Unit. [2009.05]
Onset of action is recognized as an important pharmacologic property of allergic rhinitis (AR) medications. This study was designed to evaluate the onset of action of loratadine/montelukast (L/M; 10 mg/10 mg) versus placebo in subjects with ragweed-induced seasonal AR (SAR)... L/M was well tolerated.

Efficacy and safety of fixed-dose loratadine/montelukast in seasonal allergic rhinitis: effects on nasal congestion. [2009.05]
A need exists for safe, effective therapy for the relief of the symptoms of allergic rhinitis (AR) that also consistently relieves nasal congestion, the most common and bothersome symptom. This study was performed to assess efficacy and safety of a once-daily tablet containing 10 mg of loratadine, an antihistamine, and 10 mg of montelukast, a leukotriene antagonist (SCH 445761) versus placebo and pseudoephedrine (PSE; 240 mg once-daily formulation; active comparator)...

Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit. [2009.04]
BACKGROUND: Nasal congestion is considered to be one of the most bothersome symptoms of allergic rhinitis (AR) and often the most difficult to treat. Oral therapies providing safe, effective, and reliable relief of AR symptoms, including nasal congestion, are limited. OBJECTIVE: To evaluate the efficacy of a single dose of loratadine-montelukast (10 mg/10 mg) vs placebo and phenylephrine (10 mg) in relieving nasal congestion over 6 hours after ragweed pollen exposure in the environmental exposure unit at the Kingston General Hospital... CONCLUSIONS: Loratadine-montelukast was more effective than placebo and phenylephrine in relieving nasal congestion and other nasal and nonnasal symptoms resulting from ragweed pollen exposure. There was no statistically significant difference between phenylephrine and placebo.

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Clinical Trials Related to Claritin (Loratadine)

Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834) [Recruiting]
The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded.

Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539) [Recruiting]

Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED) [Completed]
This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.

Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)(COMPLETED) [Completed]
This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded. During the priming visit(s), subjects will be evaluated to determine if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects will complete symptom evaluations and if qualified, they will receive study medication and remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated. Adverse events will be collected throughout the study to assess safety and tolerability, and vital signs will be collected at Visit 1 and at the end of Visit 3.

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

Claritin review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Seasonal Allergies
Dosage & duration:		10 mg taken 1 per day for the period of as needed
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		After 4 to 5 days on the medication, Claritin greatly reduces itchiness, sneezing, scratchy throat associated with seasonal allergies
Side effects:		I experienced absolutely no adverse side effects. None whatsoever. No side effects at all. It does not take me 50 words to explain there were no side effects, but there were no side effects.
Comments:		Take 1 Claritin tablet every day during allergy season. I take the dose every moring. Again, 1 pill per day each morning during allergy season

Claritin review by 27 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		chronic sinus congestion
Dosage & duration:		1 pill every 4-6 hours or as needed taken as prescribed/when needed for the period of off and on until sinuses cleared
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The drug cleared my sinuses but took some time to become effective after use. The effect only lasted about half a day. I would take this off and on for about 3 months.
Side effects:		I felt like I was hopped up the whole time. My skin would feel crawly and I would be generally jittery and not able to focus. I lost concentration and felt high the whole time. It also made me feel really dehydrated.
Comments:		The medication was for my use during a sinus infection at first to help relieve congestion. When the sinus infection subsided I still had congestion fairly often so was prescribed to take is as needed. I would usually take one in the morning when it was worst. I stopped after a few months due to side effects and made diet changes to relieve it.

Claritin review by 37 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		allergies
Dosage & duration:		2 for 2 days, 4 for 2 days, then all (dosage frequency: once a day) for the period of 1 week
Other conditions:		asthma
Other drugs taken:		none at that time
		Reported Results
Benefits:		There were no benefits.
Side effects:		Absolutely none.
Comments:		I bought a 24-count box and took two as recommended each day. 2 days later having felt nothing, I took 4 for 2 days. Again 2 days later I still had not received any relief, so I took the entire box. Absolutely nothing happened. This was the name brand drug, not a generic.