Levocetirizine Dihydrochloride (Page 5 of 5)

14.2 Chronic Idiopathic Urticaria

Adult Patients 18 Years of Age and Older

The efficacy of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria was evaluated in two multi-center, randomized, placebo-controlled, double-blind clinical trials of 4 weeks duration in adult patients 18 to 85 years of age with chronic idiopathic urticaria. The two trials included one 4-week dose-ranging trial and one 4-week single-dose level efficacy trial. Thee trails included 423 patients (139 males and 284 females). Most patients (> 90%) were Caucasian and the mean age was 41. Of these patients, 146 recieved levocetirizine dihydrochloride 5 mg once daily in the evening. Efficacy was assessed based on patient recording of pruritus severity on a severity score of 0 to 3 (0 = none to 3 = severe). The primary efficacy endpoint was the mean reflective pruritis severity score over the first week and over the entire treatment period. Additional efficacy variables were the instantaneous pruritis severity score, the number and size of wheals, and duration of pruritus.

The dose-ranging trial was conducted to evaluate the efficacy of levocetirizine dihydrochloride 2.5 mg, 5 mg, and 10 mg once daily in the evening. In this trial, each of the three doses of levocetirizine dihydrochloride demonstrated greater decrease in the reflective pruritis severity score than placebo and the difference was statistically significant for all three doses (see Table 6)

The single dose level trial evaluated the efficiency of levocetirizine dihydrochloride 5 mg once daily in the evening compared to placebo in patients with chronic idiopathic urticaria over a 4-week treatment period.

Levocetirizine dihydrochloride 5 mg demonstrated a greater decrease from baseline in the reflective pruritis severity score than placebo and the difference from placebo was statistically significant.

Duration of pruritus, number and size of wheals, and instantaneous pruritus severity score also showed significant improvement over placebo. The significant improvement in the instantaneous pruritis severity score over placebo confirmed end of dosing interval efficacy (see Table 6).

Table 6: Mean Reflective Pruritis Severity Score in Chronic Idiopathic Urticaria Trials

Treatment	N	Baseline	On Treatment Adjusted Mean	Difference from Placebo
				Estimate	95% CI	p-value
Dose-Ranging Trial – Reflective pruritis severity score
Levocetirizine dihydrochloride 2.5 mg	69	2.08	1.02	0.82	(0.58, 1.06)	< 0.001
Levocetirizine dihydrochloride 5 mg	62	2.07	0.92	0.91	(0.66, 1.16)	< 0.001
Levocetirizine 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
Levocetirizine dihydrochloride 5 mg	80	2.07	0.94	0.62	(0.38, 0.86)	< 0.001
Placebo	82	2.06	1.56

Pediatric Patients

There are no clinical efficacy trials in pediatric patients with chronic idiopathic urticaria [see Use in Specific Populations (8.4)].

16 HOW SUPPLIED/STORAGE AND HANDLING

Levocetirizine dihydrochloride tablets, USP 5 mg are white, oval, biconvex, film-coated functional scored tablets debossed with “S” on the left side of bisect and “G” on the right side of the bisect and other side “1” on the left side and “36” on the right side of the bisect. They are supplied in unit of use HDPE bottles.

30 tablets (NDC 71205-988-30)

60 tablets (NDC 71205-988-60)

90 tablets (NDC 71205-988-90)

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Somnolence

Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride.

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.

Dosing of Levocetirizine Dihydrochloride Tablets

Do not exceed the recommended daily dose in adults and adolescents 12 years of age and older of 5 mg once daily in the evening. In children 6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening. Advise patients to not ingest more than the recommended dose of levocetirizine dihydrochloride tablets because of the increased risk of somnolence at higher doses.

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Repackaged and Relabeled by:
Proficient Rx LP

Thousand Oaks, CA 91320

Rev. 09/19

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label

NDC 71205-988-90
Rx Only

Levocetirizine Dihydrochloride Tablets, USP

5 mg

For oral administration

90 Tablets

LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-988(NDC:69367-238) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE LACTOSE MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code SG;136 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71205-988-30 30 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:71205-988-60 60 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:71205-988-90 90 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203646 09/19/2019

Labeler — Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Operations
Proficient Rx LP		079196022	REPACK (71205-988), RELABEL (71205-988)

Revised: 03/2022 Proficient Rx LP