Valganciclovir hydrochloride for Oral

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Overview

What is Valganciclovir hydrochloride for Oral?

Valganciclovir hydrochloride for oral solution contains valganciclovir hydrochloride, USP (valganciclovir HCl), 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 is available as a powder blend for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir hydrochloride for oral solution are mannitol, sodium benzoate, sucralose, tartaric acid and tutti-frutti flavoring.

Valganciclovir HCl, USP is a white to almost white powder with a molecular formula of CHNO·HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl, USP is 7.6.

The chemical structure of valganciclovir HCl, USP is:

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

What does Valganciclovir hydrochloride for Oral look like?

What are the available doses of Valganciclovir hydrochloride for Oral?

Valganciclovir hydrochloride for oral solution 50 mg per mL, supplied as a white to off-white powder blend for constitution, forming a colorless to brownish yellow tutti-frutti flavored solution. Available in glass bottles containing approximately 100 mL of solution after constitution.

What should I talk to my health care provider before I take Valganciclovir hydrochloride for Oral?

Lactation: Breastfeeding is not recommended with use of valganciclovir ().

Pediatric use information for pediatric kidney transplant patients ages 4 months to 16 years and for pediatric heart transplant patients ages 1 to less than 4 months is approved for Roche Palo Alto LLC’s VALCYTE (valganciclovir hydrochloride) tablets and oral solution. However, due to Roche Palo Alto LLC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

How should I use Valganciclovir hydrochloride for Oral?

Valganciclovir hydrochloride for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:

Pediatric Patients

Valganciclovir hydrochloride for oral solution should be taken with food (, ).

What interacts with Valganciclovir hydrochloride for Oral?

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What are the warnings of Valganciclovir hydrochloride for Oral?

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What are the precautions of Valganciclovir hydrochloride for Oral?

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What are the side effects of Valganciclovir hydrochloride for Oral?

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What should I look out for while using Valganciclovir hydrochloride for Oral?

Valganciclovir hydrochloride for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation

What might happen if I take too much Valganciclovir hydrochloride for Oral?

Experience with Valganciclovir Hydrochloride Tablets:

[see Use in Specific Populations (8.6)]

[see Clinical Pharmacology (12.3)]

[see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]

Reports of adverse reactions after overdoses with valganciclovir, some with fatal outcomes, have been received from clinical trials and during post-marketing experience. The majority of patients experienced one or more of the following adverse events:

Hematological toxicity:

Hepatotoxicity:

Renal toxicity:

Gastrointestinal toxicity:

Neurotoxicity:

How should I store and handle Valganciclovir hydrochloride for Oral?

Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Valganciclovir hydrochloride for Oral Solution: Prior to dispensing to the patient, valganciclovir hydrochloride for oral solution must be prepared by the pharmacist Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Store constituted solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 49 days. Do not freeze.Valganciclovir hydrochloride for Oral Solution: Prior to dispensing to the patient, valganciclovir hydrochloride for oral solution must be prepared by the pharmacist Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Store constituted solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 49 days. Do not freeze.Valganciclovir hydrochloride for Oral Solution: Prior to dispensing to the patient, valganciclovir hydrochloride for oral solution must be prepared by the pharmacist Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Store constituted solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 49 days. Do not freeze.Valganciclovir hydrochloride for Oral Solution: Prior to dispensing to the patient, valganciclovir hydrochloride for oral solution must be prepared by the pharmacist Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Store constituted solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 49 days. Do not freeze.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Valganciclovir is an antiviral drug with activity against CMV .

Non-Clinical Toxicology

Valganciclovir hydrochloride for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation

Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol tablets plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

Calcium channel blockers may also have an additive effect when given with atenolol tablets (see ).

Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.

Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.

Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta blockers.

Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.

While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir or ganciclovir. Valganciclovir hydrochloride for oral solution should be avoided if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dL. Valganciclovir hydrochloride should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors may be considered.

Due to the frequency of neutropenia, anemia, and thrombocytopenia in patients receiving valganciclovir , complete blood counts with differential and platelet counts should be performed frequently, especially in patients with renal impairment and in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/μL at the beginning of treatment. Increased monitoring for cytopenias may be warranted if therapy with oral ganciclovir is changed to valganciclovir, because of increased plasma concentrations of ganciclovir after valganciclovir administration .

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 hydrochloride 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 hydrochloride for oral solution or 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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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

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