Home – Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride

Camber Pharmaceuticals, Inc.
Hetero Labs Limited

HIGHLIGHTS OF PRESCRIBING INFORMATION RECENT MAJOR CHANGES Warningsand Precautions, Urinary Retention (5.2) [09/2012]INDICATIONS AND USAGE11.3DOSAGE AND ADMINISTRATION2.12.22.412.3DOSAGE FORMS AND STRENGTHS3CONTRAINDICATIONS444WARNINGS AND PRECAUTIONSSide Effects6.1To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.USE IN SPECIFIC POPULATIONS8.612.312.3Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS & USAGE
- 1.3 Chronic Idiopathic Urticaria
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 LEVOCETIRIZINE DIHYDROCHLORIDE CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
- 5.1 Somnolence
- 5.2 Urinary Retension
6 LEVOCETIRIZINE DIHYDROCHLORIDE ADVERSE REACTIONS
- 6.1 Clinical Trials Experience
- 6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
- 7.1 Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine
- 7.2 Ritonavir
8 USE IN SPECIFIC POPULATIONS
10 OVERDOSAGE
11 LEVOCETIRIZINE DIHYDROCHLORIDE DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
- 13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility
- 13.2 Animal Pharmacology & OR Toxicology
14 CLINICAL STUDIES
- 14.2 Chronic Idiopathic Urticaria
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

1 INDICATIONS & USAGE

1.3 Chronic Idiopathic Urticaria

Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.

2 DOSAGE & ADMINISTRATION

2.1 Adults and Children 12 Years of Age and Older

2.2 Children 6 to 11 Years of Age

Clinical Pharmacology (12.3 )

2.3 Children 6 months to 5 Years of Age

2.4 Dose Adjustment for Renal and Hepatic Impairment

_CR
_CR
_CR
_CR

3 DOSAGE FORMS & STRENGTHS

4 CONTRAINDICATIONS

4.1 Patients with known hypersensitivity

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 ) ].

4.2 Patients with end-stage renal disease

_CR

4.3 Pediatric patients with impaired renal function

5 WARNINGS AND PRECAUTIONS

5.1 Somnolence

5.2 Urinary Retension

Urinary retention has been reported post-marketing with levocetirizine dihydrochloride. Levocetirizine dihydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine dihydrochloride may increase the risk of urinary retention. Discontinue levocetirizine dihydrochloride if urinary retention occurs.

6 ADVERSE REACTIONS

Warnings and Precautions (5 )

6.1 Clinical Trials Experience

Adults and Adolescents 12 years of Age and Older

Table 1Adverse Reactions Reported in ≥ 2%* of Subjects Aged 12 Years and Older Exposed to Levocetirizine Dihydrochloride 2.5 mg or 5 mg Once Daily in Placebo-Controlled Clinical Trials 1 to 6 Weeks in Duration

Adverse Reactions	Levocetirizine dihydrochloride 2.5 mg (n = 421)	Levocetirizine dihydrochloride 5 mg (n = 1070)	Placebo (n = 912)
Somnolence	22 (5%)	61 (6%)	16 (2%)
Nasopharyngitis	25 (6%)	40 (4%)	28 (3%)
Fatigue	5 (1%)	46 (4%)	20 (2%)
Dry Mouth	12 (3%)	26 (2%)	11 (1%)
Pharyngitis	10 (2%)	12 (1%)	9 (1%)

Pediatric Patients 6 to 12 Years of Age

Table 2 Adverse Reactions Reported in ≥2%* of Subjects Aged 6 to 12 Years Exposed to Levocetirizine Dihydrochloride 5 mg Once Daily in Placebo-Controlled Clinical Trials 4 and 6 Weeks in Duration

Adverse Reactions	Levocetirizine Dihydrochloride 5 mg (n = 243)	Placebo (n = 240)
Pyrexia	10 (4%)	5 (2%)
Cough	8 (3%)	2 (<1%)
Somnolence	7 (3%)	1 (<1%)
Epistaxis	6 (2%)	1 (<1%)

Clinical trial information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.

Long-Term Clinical Trials Experience

Laboratory Test Abnormalities

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

In vitroin vivo

7.1 Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine

7.2 Ritonavir

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

Teratogenic Effects:

²

8.3 Nursing Mothers

8.4 Pediatric Use

Clinical Studies (14 )

Adverse Reactions (6.1 )

Dosage and Administration ( 2.2 ) Clinical Studies (14 ) Clinical Pharmacology (12.3)

Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.

8.5 Geriatric Use

8.6 Renal Impairment

Dosage and Administration (2) Clinical Pharmacology (12.3 )

8.7 Hepatic Impairment

Clinical Pharmacology (12.3 )

10 OVERDOSAGE

²²

Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.

11 DESCRIPTION

₁₂₁₂₅₂₃

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

₁In vitro₁

12.2 Pharmacodynamics

12.3 Pharmacokinetics

• Absorption
_max_max
•   Distribution

  •   Metabolism

  •   Elimination
Dosage and Administration (2.3 )
    • Drug Interaction Studies
In vitro_max

in vivo Drug Interactions (7)
•   Pediatric Patients
_max

Pharmacokinetic information in pediatric patients (age 1 to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
•   Geriatric Patients
Dosage and Administration (2)
•    Gender

•    Race

•   Renal Impairment

Dosage and Administration (2.4 )
   •    Hepatic Impairment

Dosage and Administration (2 )

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility

²²²

Pediatricuse information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.

13.2 Animal Pharmacology & OR Toxicology

²

²

14 CLINICAL STUDIES

14.2 Chronic Idiopathic Urticaria

Adult Patients 18 Years of Age and Older

Table 3 Mean Reflective Pruritus Severity Score in Chronic Idiopathic Urticaria Trials

Treatment	N	Baseline	On Treatment Adjusted Mean	Difference from Placebo
Treatment	N	Baseline	On Treatment Adjusted Mean	Estimate	95% CI	p-value
Dose-Ranging Trial - Reflective pruritis severity score
Levocetrizine dihydrochloride 2.5 mg	69	2.08	1.02	0.82	(0.58, 1.06)	<0.001
Levocetrizine dihydrochloride 5 mg	62	2.07	0.92	0.91	(0.66, 1.16)	<0.001
Levocetrizine dihydrochloride 10 mg	55	2.04	0.73	1.11	(0.85, 1.37)	<0.001
Placebo	60	2.25	1.84
Chronic Idiopathic Urticaria Trial - Reflective pruritis severity score
Levocetrizine dihydrochloride 5 mg	80	2.07	0.94	0.62	(0.38, 0.86)	<0.001
Placebo	82	2.06	1.56

Pediatric Patients

Use in Specific Populations (8.4 )

16 HOW SUPPLIED/STORAGE AND HANDLING

Storage:
Store at 20 to 25° C (68 to 77° F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

17.1 Somnolence

17.2 Concomitant Use of Alcohol and other Central Nervous System Depressants

Instruct patients to avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur.

17.3 Dosing of Levocetirizine Dihydrochloride

HETERO^TM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL