LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)

থেকে পাওয়া:

Preferred Pharmaceuticals Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. The use of levocetirizine dihydrochloride is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions (6.2) ]. Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis. Children 6 months to 11 years of age with impaired renal function. Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral r

পণ্য সারাংশ:

Levocetirizine dihydrochloride tablets, USP are white to off white, film-coated, biconvex, oval-shaped, scored, debossed with 'M 17' on one side and contain 5 mg levocetirizine dihydrochloride USP. This tablet is having functional scoring. They are supplied in unit of use HDPE bottles. 30 Tablets (NDC 68788-7189-3) 60 Tablets (NDC 68788-7189-6) 90 Tablets (NDC 68788-7189-9) 100 Tablets (NDC 68788-7189-1) Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLETS.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H -receptor
antagonist indicated for:
• The relief of symptoms associated with perennial allergic rhinitis
(1.1 )
• The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.2)
DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA (2.2)
• Adults and children 12 years of age and older: 5 mg once daily in
the evening
• Children 6 to 11 years of age: 2.5 mg once daily in the evening
• Renal Impairment
Adjust the dose in patients 12 years of age and older with decreased
renal function (12.3)
DOSAGE FORMS AND STRENGTHS
• Immediate release breakable (scored) tablets, 5 mg (3)
CONTRAINDICATIONS
• Patients with a known hypersensitivity to levocetirizine or any of
the ingredients of levocetirizine dihydrochloride tablets
or to cetirizine (4.1)
• Patients with end-stage renal disease at less than 10 mL/min
creatinine clearance or patients undergoing hemodialysis
(4.2)
• Children 6 months to 11 years of age with renal impairment (4.3)
WARNINGS AND PRECAUTIONS
• Avoid engaging in hazardous occupations requiring complete mental
alertness such as driving or operating machinery
when taking levocetirizine dihydrochloride tablets. (5.1)
• Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine dihydrochloride tablets.
(5.1)
• Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine dihydrochloride tablets if urinary
retenti