LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Ranbaxy Pharmaceuticals Inc.

INN (Jina la Kimataifa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Tungo:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. 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 (CL CR < 10 mL/min) and patients undergoing hemodialysis Children 6 months to 11 years of age with impaired renal function Pregnancy Category B There are

Bidhaa muhtasari:

Levocetirizine dihydrochloride tablets are white to off-white, oval-shaped, biconvex, functionally scored, film-coated tablets, debossed with ‘R’ and ‘I’ on either side of the scoreline on one side and ‘7’ and ‘3’ on either side of the scoreline on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in HDPE bottles and blisters. NDC 63304-433-03 Bottles of 10 NDC 63304-433-10 Bottles of 1000 NDC 63304-433-69 Blister pack of 10 Storage: Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
RANBAXY PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: B5424CC1-4A5B-41B3-874A-E0C0406C9BFA
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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: (1)
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DOSAGE AND ADMINISTRATION
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•
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Adjust the dose in patients 12 years of age and older with decreased
renal function (2.4, 12.3). (2)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (rate ≥ 2% and > placebo) were
somnolence, nasopharyngitis, fatigue, dry mouth,
and pharyngitis in subjects 12 years of age and older, and pyrexia,
somnolence, cough, and epistaxis in children 6 to 12
years of age. In subjects 1 to 5 years of age, the most common adverse
reactions (rate ≥ 2% and > placebo) were pyrexia,
diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of
age, the most common adverse reactions (rate ≥ 3% and
> placebo) were diarrhea and constipation. (6.1). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT RANBAXY PHARMACEUTICALS
INC. AT 1-888-RANBAXY
(726-2299) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
USE IN SPECIFIC POPULATIONS
•
Because levocetirizine dihydrochloride is substantially excreted by
the kidneys, the risk of adverse reactions to this drug
may be greater in patients with impaired renal function (8.6 and
12.3). (8)
•
1
The relief of symptoms associated with seasonal and perennial allergic
rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.3)
Adults and children 12 years of age and