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Rx Item-Levocetirizine 2.5Mg/5Ml Solution 4 Oz By Taro Pharma

NDC 51672-4161-08 UPC/GTIN No.3-51672-41618-8 Mfg.Part No.416108BRAND: LEVOCETIRIZINE NDC: 51672-4161-08,51672416108 UPC: 3-51672-41618-8,351672416188 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Levocetirizine 2.5Mg/5Ml Solution 4 Oz By Taro Pharma

$73.59$51.41

Item No.:RX416709 NDC No.51672416108 UPC No.:351672416188 NDC No.51672-4161-08 UPC/GTIN No.3-51672-41618-8 MPN 416108 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx416709 Levocetirizine 2.5mg/5ml Solution 4 oz by Taro Pharma Item No.3416709 NDC No.51672416108 UPC No.351672416188 Other Name X

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XYZAL- levocetirizine dihydrochloride tablet, film coated
XYZAL- levocetirizine dihydrochloride solution
UCB, Inc.
1 INDICATIONS AND USAGE
1.1 Seasonal Allergic Rhinitis
XYZAL� is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
1.2 Perennial Allergic Rhinitis
XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.
1.3 Chronic Idiopathic Urticaria
XYZAL is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
2 DOSAGE AND ADMINISTRATION
XYZAL 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. XYZAL can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and Older
The recommended dose of XYZAL 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 XYZAL 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 XYZAL 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 XYZAL.
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.
3 DOSAGE FORMS AND STRENGTHS
XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL.
XYZAL tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg levocetirizine dihydrochloride.
4 CONTRAINDICATIONS
The use of XYZAL is contraindicated in:
4.1 Patients with known hypersensitivity
Patients with known hypersensitivity to levocetirizine or any of the ingredients of XYZAL, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions (6.2)].
4.2 Patients with end-stage renal disease
Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis
4.3 Pediatric patients with impaired renal function
Children 6 months to 11 years of age with impaired renal function
5 WARNINGS AND PRECAUTIONS
5.1 Somnolence
In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with XYZAL. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.
5.2 Urinary Retention
Urinary retention has been reported post-marketing with XYZAL. XYZAL should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as XYZAL may increase the risk of urinary retention. Discontinue XYZAL if urinary retention occurs.
6 ADVERSE REACTIONS
Use of XYZAL has been associated with somnolence, fatigue, asthenia, and urinary retention
DESCRIPTION
Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1 -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 C21 H25 ClN2 O3 �2HCl. The molecular weight is 461.8
XYZAL 5 mg tablets are formulated as immediate release, white, film-coated, oval-shaped scored tablets for oral administration. The tablets are imprinted on both halves of the scored line with the letter Y in red (Opacode� Red). Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and macrogol 400.
XYZAL 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, saccharin, flavoring (consisting of triacetin, natural & artificial flavors, dl-alpha-tocopherol), purified water.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Levocetirizine, the active enantiomer of cetirizine, is an anti-histamine; its principal effects are mediated via selective inhibition of H1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that levocetirizine has an affinity for the human H1 -receptor 2-fold higher than that of cetirizine (Ki = 3 nmol/L vs. 6 nmol/L, respectively). The clinical relevance of this finding is unknown.


NDC 51672-4161-08 UPC/GTIN No.3-51672-41618-8 Mfg.Part No.416108
RX ITEM-Levocetirizine 2.5Mg/5Ml Solutio
NDC 51672-4161-08 UPC/GTIN No.3-51672-41618-8 Mfg.Part No.416108

BRAND: LEVOCETIRIZINE NDC: 51672-4161-08,51672416108 UPC: 3-51672-41618-8,351672416188
Levocetirizine 2.5Mg/5Ml Solution 4 Oz B
BRAND: LEVOCETIRIZINE NDC: 51672-4161-08,51672416108 UPC: 3-51672-41618-8,351672416188

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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