Levocetirizine Dihydrochloride

Add Info

Levocetirizine Dihydrochloride Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

Levocetirizine dihydrochloride is a histamine H

-receptor antagonist indicated for:

• The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (

1.3

)

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.

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.

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H

-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C

ClN

•2HCl. The molecular weight is 461.82 and the chemical structure is shown below:

Levocetirizine dihydrochloride is a white, crystalline powder and is water soluble.

Levocetirizine dihydrochloride 5 mg tablets are white film coated, scored, round shaped tablets for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose and opadry white YS-1-7003 which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Sources

Levocetirizine Dihydrochloride Manufacturers

Remedyrepack Inc.

Levocetirizine Dihydrochloride | Remedyrepack Inc.

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.

The recommended dose of levocetirizine dihydrochloride tablets are 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.

The recommended dose of levocetirizine dihydrochloride tablets are 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see

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.

In adults and children 12 years of age and older with:

• Mild renal impairment (creatinine clearance [CL

CR

] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended;

• Moderate renal impairment (CL

CR

= 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended;

• Severe renal impairment (CL

CR

= 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended;

• End-stage renal disease patients (CL

CR

< 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride

tablets.

No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Perrigo New York Inc

Levocetirizine Dihydrochloride | Perrigo New York Inc

Levocetirizine dihydrochloride is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
The recommended initial dose of levocetirizine dihydrochloride is 1.25 mg (1/2 teaspoon oral solution) [2.5 mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see 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. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
• Mild renal impairment (creatinine clearance [CL CR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Vensun Pharmaceuticals, Inc.

Levocetirizine Dihydrochloride | Vensun Pharmaceuticals, Inc.

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [ see Clinical Pharmacology (12.3)].
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Synthon Pharmaceuticals, Inc.

Levocetirizine Dihydrochloride | Synthon Pharmaceuticals, Inc.

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Physicians Total Care, Inc.

Levocetirizine Dihydrochloride | Physicians Total Care, Inc.

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Perrigo New York Inc

Levocetirizine Dihydrochloride | Elorac, Inc.

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

For pediatric patients above eight years of age: The recommended dosage schedule for pediatric patients weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For pediatric patients over 100 pounds the usual adult dose should be used.

Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

Primary and secondary syphilis: 300 mg a day in divided doses for at least 10 days.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for at least 7 days.

Nongonococcal urethritis caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for at least 7 days.

Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

Inhalational anthrax (post-exposure):
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
CHILDREN: weighing less than 100 pounds (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 pounds or more should receive the adult dose.

When used in streptococcal infections, therapy should be continued for 10 days.

Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.) If gastric irritation occurs, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.

No Recall
Bryant Ranch Prepack

Levocetirizine Dihydrochloride | Bryant Ranch Prepack

Levocetirizine dihydrochloride is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
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.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR< 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Dr.reddy’s Laboratories Ltd.

Levocetirizine Dihydrochloride | Dr.reddy's Laboratories Ltd.

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet ) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet ) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet ) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology(12.3)].
2.3 Children 6 months to 5 Years of Age
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.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Winthrop U.s.

Levocetirizine Dihydrochloride | Winthrop U.s.

Levocetirizine Dihydrochloride is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine Dihydrochloride can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of Levocetirizine Dihydrochloride is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of Levocetirizine Dihydrochloride is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
The recommended initial dose of Levocetirizine Dihydrochloride is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive Levocetirizine Dihydrochloride .
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Sun Pharma Global Fze

Levocetirizine Dihydrochloride | Virtair Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Camber Pharmaceuticals, Inc.

Levocetirizine Dihydrochloride | Camber Pharmaceuticals, Inc.

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption. 2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablets are 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening. 2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride tablets are 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3 )]. 2.3 Children 6 months to 5 Years of Age
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. 2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:

• Mild renal impairment (creatinine clearance [CL CR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended;
• Moderate renal impairment (CL CR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended;
• Severe renal impairment (CL CR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended;
• End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride
tablets.

No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Levocetirizine Dihydrochloride | Lake Erie Medical Dba Quality Care Products Llc

Levocetirizine is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (½ tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine is 2.5 mg (½ tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [seeClinical Pharmacology (12.3)].
2.3 Children 6 Months to 5 Years of Age
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.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Dispensing Solutions, Inc.

Levocetirizine Dihydrochloride | Dispensing Solutions, Inc.

Levocetirizine is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (½ tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine is 2.5 mg (½ tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [seeClinical Pharmacology (12.3)].
2.3 Children 6 Months to 5 Years of Age
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.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Pd-rx Pharmaceuticals, Inc.

Levocetirizine Dihydrochloride | Ascend Laboratories, Llc

2.1 Schizophrenia
Adults
Dose Selection— Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine is not indicated for use in doses above 20 mg/day.
Dosing in Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Maintenance Treatment — The effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studie (14.1)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Adolescents
Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.1)].
Maintenance Treatment — The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Bipolar I Disorder (Manic or Mixed Episodes)
Adults
Dose Selection for Monotherapy — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Short-term (3-4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2)].
Maintenance Monotherapy — The benefit of maintaining bipolar I patients on monotherapy with oral olanzapine at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [seeClinical Studies (14.2)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Dose Selection for Adjunctive Treatment — When administered as adjunctive treatment to lithium or valproate, oral olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals.
Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2)]. The safety of doses above 20 mg/day has not been evaluated in clinical trials.
Adolescents
Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.2)].
Maintenance Treatment — The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.4 Olanzapine IntraMuscular: Agitation Associated with Schizophrenia and Bipolar I Mania
Dose Selection for Agitated AdultPatients with Schizophrenia and Bipolar I Mania — The efficacy of intramuscularolanzapine for injection in controlling agitation in these disorders wasdemonstrated in a dose range of 2.5 mg to 10 mg. The recommended dose in thesepatients is 10 mg. A lower dose of 5 or 7.5 mg may be considered when clinicalfactors warrant [see Clinical Studies (14.3)]. If agitation warrantingadditional intramuscular doses persists following the initial dose, subsequentdoses up to 10 mg may be given. However, the efficacy of repeated doses ofintramuscular olanzapine for injection in agitated patients has not beensystematically evaluated in controlled clinical trials. Also, the safety oftotal daily doses greater than 30 mg, or 10 mg injections given more frequentlythan 2 hours after the initial dose, and 4 hours after the second dose have notbeen evaluated in clinical trials. Maximal dosing of intramuscular olanzapine(e.g., 3 doses of 10 mg administered 2-4 hours apart) may be associated with asubstantial occurrence of significant orthostatic hypotension [see Warnings andPrecautions (5.6)]. Thus, it is recommended that patients requiring subsequentintramuscular injections be assessed for orthostatic hypotension prior to theadministration of any subsequent doses of intramuscular olanzapine for injection.The administration of an additional dose to a patient with a clinicallysignificant postural change in systolic blood pressure is not recommended.
Ifongoing olanzapine therapy is clinically indicated, oral olanzapine may beinitiated in a range of 5-20 mg/day as soon as clinically appropriate [seeDosage and Administration (2.1, 2.2)].
IntramuscularDosing in Special Populations — A dose of 5 mg/injection should be consideredfor geriatric patients or when other clinical factors warrant. A lower dose of2.5 mg/injection should be considered for patients who otherwise might bedebilitated, be predisposed to hypotensive reactions, or be morepharmacodynamically sensitive to olanzapine [see Warnings and Precautions(5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)].
Administrationof olanzapine IntraMuscular — olanzapine IntraMuscular is intended forintramuscular use only. Do not administer intravenously or subcutaneously.Inject slowly, deep into the muscle mass.
Parenteraldrug products should be inspected visually for particulate matter anddiscoloration prior to administration, whenever solution and container permit.
2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.

Adults

Oral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.
Children and Adolescents (10-17 years of age)

Dosage and Administration information for pediatric patients (10-17 years) is approved for Eli Lilly and Company’s olanzapine tablets and olanzapine orally disintegrating tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Safety and efficacy of olanzapine and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.

Table 1: Approximate Dose Correspondence Between Symbyaxa and theCombination of olanzapine and Fluoxetine

For
Symbyax
(mg/day)
Use in Combination
olanzapine
(mg/day)
Fluoxetine
(mg/day)
3 mg olanzapine/25 mg fluoxetine
2.5
20
6 mg olanzapine/25 mg fluoxetine
5
20
12 mg olanzapine/25 mg fluoxetine
10+2.5
20
6 mg olanzapine/50 mg fluoxetine
5
40+10
12 mg olanzapine/50 mg fluoxetine
10+2.5
40+10

a Symbyax (olanzapine/fluoxetine HCl) is a fixed-dose combination of olanzapine and fluoxetine.

While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.

Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.
2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special Populations
The starting dose of oral olanzapine 2.5-5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be Pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under < 10 years of age” [see Warnings and Precautions (5.14), Drug Interactions (7), and Clinical Pharmacology (12.3)].

No Recall
Glenmark Generics Inc.,usa

Levocetirizine Dihydrochloride | Glenmark Generics Inc.,usa

Levocetirizine dihydrochloride is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older

The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening
2.2 Children 6 to 11 Years of Age

The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
The recommended initial dose of levocetirizine dihydrochloride tablets is 1.25 mg once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
• Mild renal impairment (creatinine clearance [CL CR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Aidarex Pharmaceuticals Llc

Levocetirizine Dihydrochloride | Aidarex Pharmaceuticals Llc

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride tablet is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride tablet is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age
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.
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Teva Pharmaceuticals Usa Inc

Levocetirizine Dihydrochloride | Teva Pharmaceuticals Usa Inc

Levocetirizine dihydrochloride is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of levocetirizine dihydrochloride is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (½ tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of levocetirizine dihydrochloride is 2.5 mg (½ tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
• Mild renal impairment (creatinine clearance [CL CR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Micro Labs Limited

Levocetirizine Dihydrochloride | Micro Labs Limited

Levocetirizine Dihydrochloride is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine Dihydrochloride Tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of Levocetirizine Dihydrochloride Tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age
The recommended dose of Levocetirizine Dihydrochloride Tablets is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.4 Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CLCR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive Levocetirizine Dihydrochloride Tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
American Health Packaging

Levocetirizine Dihydrochloride | American Health Packaging

Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older

The recommended dose of levocetirizine dihydrochloride tablets are 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
2.2 Children 6 to 11 Years of Age

The recommended dose of levocetirizine dihydrochloride tablets are 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of Age

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.
2.4 Dose Adjustment for Renal and Hepatic Impairment

In adults and children 12 years of age and older with:
• Mild renal impairment (creatinine clearance [CL CR] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

No Recall
Sciegen Pharmaceuticals, Inc.

Levocetirizine Dihydrochloride | Western Family Foods Inc

• do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years of age and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

No Recall