valganciclovir hydrochloride

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Overview

What is valganciclovir hydrochloride?

Valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.

Valganciclovir hydrochloride USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and povidone. The film-coat applied to the tablets contains hypromellose, iron oxide red, polyethylene glycol, polysorbate and titanium dioxide.

Valganciclovir hydrochloride USP is a white to off-white powder, slightly hygroscopic with a molecular formula of CHNO . HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride USP is L-Valine,2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride USP with solubility of 2.2 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0086 at pH 7.0. The pKa for valganciclovir hydrochloride USP is 7.5.

The chemical structure of valganciclovir hydrochloride USP is:

All doses in this insert are specified in terms of valganciclovir.

What does valganciclovir hydrochloride look like?

What are the available doses of valganciclovir hydrochloride?

• Tablets: 450 mg

What should I talk to my health care provider before I take valganciclovir hydrochloride?

How should I use valganciclovir hydrochloride?

What interacts with valganciclovir hydrochloride?

Sorry No Records found

What are the warnings of valganciclovir hydrochloride?

Sorry No Records found

What are the precautions of valganciclovir hydrochloride?

Sorry No Records found

What are the side effects of valganciclovir hydrochloride?

Sorry No records found

What should I look out for while using valganciclovir hydrochloride?

Valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see ].

What might happen if I take too much valganciclovir hydrochloride?

Experience with Valganciclovir Tablets

Dosage and Administration , Use in Specific Populations

Clinical Pharmacology ()

Warnings and Precautions

Clinical Pharmacology ()

Hematological toxicity

Hepatotoxicity:

Renal toxicity

Gastrointestinal toxicity

Neurotoxicity

How should I store and handle valganciclovir hydrochloride?

Store at room temperature 20° to 25°C (68°to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Valganciclovir Tablets USP, 450 mg are pink colored, modified capsule shaped, film coated tablets debossed with ‘RDY’ on one side and ‘762’ on other side and are supplied in bottles of 30’s and 60’s.Bottles of 30’s NDC 43598-356-30 Bottles of 60’s NDC 43598-356-60 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Valganciclovir Tablets USP, 450 mg are pink colored, modified capsule shaped, film coated tablets debossed with ‘RDY’ on one side and ‘762’ on other side and are supplied in bottles of 30’s and 60’s.Bottles of 30’s NDC 43598-356-30 Bottles of 60’s NDC 43598-356-60 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Valganciclovir Tablets USP, 450 mg are pink colored, modified capsule shaped, film coated tablets debossed with ‘RDY’ on one side and ‘762’ on other side and are supplied in bottles of 30’s and 60’s.Bottles of 30’s NDC 43598-356-30 Bottles of 60’s NDC 43598-356-60 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Valganciclovir Tablets USP, 450 mg are pink colored, modified capsule shaped, film coated tablets debossed with ‘RDY’ on one side and ‘762’ on other side and are supplied in bottles of 30’s and 60’s.Bottles of 30’s NDC 43598-356-30 Bottles of 60’s NDC 43598-356-60 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Valganciclovir is an antiviral drug with activity against CMV [see ].

Non-Clinical Toxicology

Valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see ].

Drug Interactions:

Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition

Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, doetilide) have not been performed, but caution is advised (see ).

Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

The most common adverse reactions and laboratory abnormalities reported in at least one indication by greater than or equal to 20% of adult patients treated with valganciclovir tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. The most common reported adverse reactions and laboratory abnormalities reported in greater than or equal to 20% of pediatric solid organ transplant recipients treated with valganciclovir tablets are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.

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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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