Microsoft word - shionogi claritin dry syrup 1 percent launched_2nd_080121_変更暦付き.doc
Long-acting selective H1 receptor antagonist for treatment of allergic
Claritin® Dry Syrup 1% Launched
－Includes Pediatric Indication for Children Ages Three and Older－
Schering-Plough K.K. (Headquarters: Osaka, President: Masao Torii) and Shionogi &
Co., Ltd. (Headquarters: Osaka, President: Motozo Shiono) today launched Claritin®
Dry Syrup 1% (generic name: Loratadine dry syrup 1%), a long-acting selective H1
receptor antagonist the two companies have been jointly developing as a treatment for
Claritin® is an antihistamine for effectively treating allergic rhinitis (seasonal and
perennial), urticaria, and itching associated with skin diseases (eczema, dermatitis, and
pruritus cutaneous). Schering Plough Corporation of the United States created Claritin®
and has marketed it for many years in more than 100 countries worldwide. Claritin® has
been prescribed to over 400 million people. In Japan, Schering-Plough K.K. and
Shionogi jointly market the prescription drugs Claritin® 10mg Tablet (launched
September 2, 2002) and Claritin® RediTabs®, 10mg Tablet (launched November 15,
2004), and intend to jointly market Claritin® Dry Syrup 1% as well.
Formulation Easy for Young Children to Take
Claritin® Dry Syrup 1% has been approved for pediatric use for children ages three and
older. With sugar added to the odorless and tasteless active ingredient, the product has a
slightly sweet flavor, which makes it easy for children to take. The formulation is also
easy to dispense and use because the companies designed it to suspend readily in water
In general, it is administered in solution as loratadine in once-daily oral doses of 5mg
(dry syrup: 0.5g) for children age three to seven and 10mg (dry syrup: 1.0g) for children
ages seven and older after a meal. Claritin® has also been recognized for its
effectiveness and safety for adults as a non-sedating (non-drowsy) antihistamine that
has little effect on concentration or scholastic performance. With medications for
children under the age of seven, not only effectiveness and safety but also dosing
frequency and being easy to take are considered important. Claritin® Dry Syrup 1%
covers all these factors, and is therefore expected to make a significant contribution to
The Claritin Family: A Broad Array of Products
Schering-Plough and Shionogi have also received approval for the additional indication
for children age seven and older for Claritin® 10mg Tablet and Claritin® RediTabs®,
10mg Tablet. With the addition of Claritin® Dry Syrup 1% for children ages three and
older, the Claritin® family of products is the first lineup of antihistamines in Japan that
is available in three dosage forms. It therefore offers a variety of choices to an
exceptionally broad range of patient age groups.
Claritin® Dry Syrup 1% Product Overview
Inactive ingredients: Sugar, hydroxypropylcellulose, aqueous silicon
Allergic rhinitis, urticaria, and itching associated with skin diseases
(eczema, dermatitis, and pruritus cutaneous)
Administration: Adults: Generally, one 10mg dose (dry syrup: 1g) as loratadine per day,
administered orally in solution after a meal. The dose is adjusted based
Children: Generally, one 5mg dose (dry syrup: 0.5g) as loratadine per
day for children from the age of three to seven, and one 10mg dose
(dry syrup: 1 g) per day for children ages seven and older, administered
Packaging: Claritin® Dry Syrup 1%: 100g (0.5g x 150 packets)
Characteristics: 1. Outstanding effectiveness in relieving allergic rhinitis, urticaria,
and itching associated with skin diseases
• For the first time in Japan, effectiveness against chronic allergic
rhinitis was confirmed three days after administration. Alleviation
of nasal symptoms was significantly better than with a placebo.
• Symptoms of seasonal allergic rhinitis were significantly reduced
compared with the placebo on the day of administration.
Moreover, the effect continues until administration ceases.
• For pediatric allergic rhinitis, lowered scores for the four nasal
symptoms of sneezing, dripping, congestion and intranasal
pruritus, which helps improve daily life.
• Demonstrated high rates of improvement of 89.1% for urticarial
pruritus and 87.5% for the appearance of macula.
• Alleviated symptoms of pruritus associated with atopic dermatitis,
including eczema, dermatitis, and pruritus cutaneous.
• Significantly reduced symptoms of pruritus associated with atopic
dermatitis compared with the placebo. (Source: overseas data)
• Alleviated day- and night-time itching from pediatric atopic
dermatitis from the day after administration began, and
substantially lowered main pruritus scores.
Little difference in the ability to drive compared with the placebo
was observed during studies of the effects on driving. As a result,
Claritin® has little effect on daily activities because it does not
exhibit the same sedative effect as other antihistamines.
3. Sustained antihistamine action
Sustained action against wheal and erythema induced by
histamines was observed during clinical trials. A single daily
dosage offers excellent clinical effectiveness.
4. Easy to use and rapid action
• Single daily dosage ensures a high rate of dosing compliance.
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