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Levocetirizine Dihydrochloride

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Overview

What is Levocetirizine Dihydrochloride?

Levocetirizine dihydrochloride, the active component of Levocetirizine Dihydrochloride Oral Solution, 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 CHClNO·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 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, sucralose, artificial grape flavor, purified water.



What does Levocetirizine Dihydrochloride look like?



What are the available doses of Levocetirizine Dihydrochloride?

Levocetirizine Dihydrochloride Oral Solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL.

What should I talk to my health care provider before I take Levocetirizine Dihydrochloride?

How should I use Levocetirizine Dihydrochloride?

Levocetirizine dihydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age.

Levocetirizine dihydrochloride is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution. Levocetirizine dihydrochloride can be taken without regard to food consumption.


What interacts with Levocetirizine Dihydrochloride?

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What are the warnings of Levocetirizine Dihydrochloride?

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What are the precautions of Levocetirizine Dihydrochloride?

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What are the side effects of Levocetirizine Dihydrochloride?

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What should I look out for while using Levocetirizine Dihydrochloride?

The use of levocetirizine dihydrochloride is contraindicated in:


What might happen if I take too much Levocetirizine Dihydrochloride?

Overdosage has been reported with levocetirizine dihydrochloride.

Symptoms of overdose may include drowsiness in adults. In children agitation and restlessness may initially occur, followed by drowsiness. There is no known specific antidote to levocetirizine dihydrochloride. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine dihydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

The acute maximal non-lethal oral dose of levocetirizine was 240 mg/kg in mice (approximately 190 times the maximum recommended daily oral dose in adults, approximately 230 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 180 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m basis). In rats the maximal non-lethal oral dose was 240 mg/kg (approximately 390 times the maximum recommended daily oral dose in adults, approximately 460 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 370 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m basis).


How should I store and handle Levocetirizine Dihydrochloride?

Do not use after the expiration date. Unopened HUMALOG should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use HUMALOG if it has been frozen. In-use HUMALOG vials, cartridges, and HUMALOG KwikPen should be stored at room temperature, below 86°F (30°C) and must be used within 28 days or be discarded, even if they still contain HUMALOG. Protect from direct heat and light. See table below: Do not use after the expiration date. Unopened HUMALOG should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use HUMALOG if it has been frozen. In-use HUMALOG vials, cartridges, and HUMALOG KwikPen should be stored at room temperature, below 86°F (30°C) and must be used within 28 days or be discarded, even if they still contain HUMALOG. Protect from direct heat and light. See table below: Levocetirizine Dihydrochloride Oral Solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution available in 5 fl oz (148 mL) plastic bottle (0527-1917-69).Storage:Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86°F) [see USP Controlled Room Temperature].Levocetirizine Dihydrochloride Oral Solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution available in 5 fl oz (148 mL) plastic bottle (0527-1917-69).Storage:Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86°F) [see USP Controlled Room Temperature].Levocetirizine Dihydrochloride Oral Solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution available in 5 fl oz (148 mL) plastic bottle (0527-1917-69).Storage:Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86°F) [see USP Controlled Room Temperature].Levocetirizine Dihydrochloride Oral Solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution available in 5 fl oz (148 mL) plastic bottle (0527-1917-69).Storage:Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Levocetirizine, the active enantiomer of cetirizine, is an anti­histamine; its principal effects are mediated via selective inhibition of H receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. binding studies revealed that levocetirizine has an affinity for the human H-receptor 2-fold higher than that of cetirizine (Ki = 3 nmol/L 6 nmol/L, respectively). The clinical relevance of this finding is unknown.

Non-Clinical Toxicology
The use of levocetirizine dihydrochloride is contraindicated in:

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro

In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with levocetirizine dihydrochloride. 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 levocetirizine dihydrochloride. Concurrent use of levocetirizine dihydrochloride 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.

Use of levocetirizine dihydrochloride has been associated with somnolence, fatigue, asthenia and urinary retention .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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