LEVOCETIRIZINE DIHYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

INN (Διεθνής Όνομα):

LEVOCETIRIZINE DIHYDROCHLORIDE

Σύνθεση:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. The use of levocetirizine dihydrochloride tablets 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. Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride

Περίληψη προϊόντος:

Levocetirizine dihydrochloride tablets, USP are white to off-white, film-coated, biconvex, oval shaped tablets with functional scoring; engraved "APO" on one side, “L” score “5” on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied  as follows: Bottles of 30s       NDC 63187-922-30 Bottles of 60s       NDC 63187-922-60 Bottles of 90s       NDC 63187-922-90 Storage Store levocetirizine dihydrochloride tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
PROFICIENT RX LP
----------
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
RECENT MAJOR CHANGES
Indications and Usage (1.1) 02/2017
Dosage and Administration (2.2) 02/2017
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H -receptor
antagonist indicated for:
3.
4.
DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA (2.2)
4.
5.
6.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
4.
5.
6.
WARNINGS AND PRECAUTIONS
4.
5.
6.
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).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP. AT
1-800-706-5575 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
1
The relief of symptoms associated with perennial allergic rhinitis
(1.1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.2)
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)
Immediate release breakable tablets (with functional scoring), 5 mg
(3)
Patients with a known hypersensitivity to levocetirizine or any of the
ingredie