“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Valganciclovir (Valganciclovir)

Trade Name : Valganciclovir

NorthStar Rx LLC

TABLET, FILM COATED

Strength 450 mg/1

VALGANCICLOVIR HYDROCHLORIDE Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Valganciclovir (Valganciclovir) which is also known as Valganciclovir and Manufactured by NorthStar Rx LLC. It is available in strength of 450 mg/1 per ml. Read more

Valganciclovir (Valganciclovir) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Arrayn- Array
  • Arrayn- Array
  • Arrayn- Impairment of Fertility: Based on animal datau00a0and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.n- Array
  • Arrayn- Array
  • Arrayn- Array
  • Boxed Warning 08/2018
  • Warnings and Precautions 08/2018
  • Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
  • Adult Patients
  • Pediatric Patients
  • No data
  • Valganciclovir tablets should be taken with food (, ).
  • Valganciclovir tablets should not be broken or crushed ().
  • Adult patients should use valganciclovir tablets, not valganciclovir for oral solution n
  • Adults with renal impairment: Adjust dose based on creatinine clearance. For adult patients receiving hemodialysis a dose recommendation cannot be given (, , ).
  • Valganciclovir tablets, 450 mg are pink colored, oval shaped, film coated tablets debossed with u2018RDYu2019 on one side and u2018762u2019 on other side.u00a0
  • u2022 Tablets: 450 mg. n
  • Valganciclovir 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 [see ].
  • Hypersensitivity to valganciclovir or ganciclovir. n
  • No data
  • Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function (, n , ).
  • 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,u00a0headache, insomnia, urinary tract infection,u00a0 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.
  • u2022 Adult patients: Most common adverse reactions and laboratory abnormalities (reported in at least one indication by greater than or equal to 20% of patients) are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting .
  • u2022 Pediatric patients: Most common adverse reactions and laboratory abnormalities (reported in greater than or equal to 20% of pediatric solid organ transplant recipients) are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache .
  • In vivo
  • Established and other potentially significant drug interactions conducted with ganciclovir are listed in .
  • Table 9 Established and Other Potentially Significant Drug Interactions with Ganciclovir
  • Array
  • Imipenem-cilastatin: Seizures were reported in patients receiving ganciclovir and imipenem-cilastatin. Concomitant use is not recommended unless the potential benefits outweigh the risks. n
  • Cyclosporine or amphotericin B: When coadministered with valganciclovir, the risk of nephrotoxicity may be increased. Monitor renal function. (, )
  • Mycophenolate mofetil (MMF): When coadministered with valganciclovir, the risk of hematological and renal toxicity may be increased. Monitor for ganciclovir and MMF toxicity .
  • Other drugs associated with myelosuppression or nephrotoxicity: Due to potential for increased toxicity, consider for concomitant use with valganciclovir only if the potential benefits are judged to outweigh the risks. n
  • Didanosine: Ganciclovir coadministered with didanosine may increase didanosine levels. Monitor for didanosine toxicity (e.g., pancreatitis) .
  • Probenecid: May increase ganciclovir levels. Monitor for evidence of ganciclovir toxicity .
  • No data
  • Lactation: Breastfeeding is not recommended with use of valganciclovir .u00a0
  • Experience with Valganciclovir Tablets:u00a0An overdose of valganciclovir could also possibly result in increased renal toxicity [see Dosage and Administration (), Use in Specific Populations ()]. Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of valganciclovir [see ].
  • Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered [see Warnings and Precautions andu00a0see Clinical Pharmacology ()].u00a0
  • Reports of adverse reactions after overdoses with valganciclovir, some with fatal outcomes,u00a0have been received from clinical trials and during postmarketing experience. The majority of patients experienced one or more of the following adverse events: u00a0
  • Hematological toxicity: myelosuppression including pancytopenia,u00a0bone marrow failure, leukopenia, neutropenia, granulocytopenia u00a0
  • Hepatotoxicity: hepatitis, liver function disorder u00a0
  • Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute kidney injury, elevated creatinine u00a0
  • Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting u00a0
  • Neurotoxicity: generalized tremor, seizureu00a0
  • Valganciclovir tablets USP contains 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 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 almost white powder with a molecular formula of CHNOu00b7HCl and a molecular weight of 390.71. 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 is a polar hydrophilic compound with a saturation solubility of 6029 mg/mL in water at 25u00b0C and an n-octanol/water partition coefficient of 0.00701 at pH 5.1. The pKa for valganciclovir hydrochloride USP is 7.2.
  • The chemical structure of valganciclovir hydrochloride USP is:
  • All doses in this insert are specified in terms of valganciclovir.
  • No data
  • Long-term carcinogenicity studies have not been conducted with valganciclovir . However, upon oral administration, valganciclovir is rapidly and extensively converted to ganciclovir. Therefore, like ganciclovir, valganciclovir is a potential carcinogen.
  • Ganciclovir was carcinogenic in the mouse at oral doses that produced exposures approximately 0.1x and 1.4x, respectively, the mean drug exposure in humans following the recommended intravenous dose of 5 mg/kg, based on area under the plasma concentration curve (AUC) comparisons. At the higher dose, there was a significant increase in the incidence of tumors of the preputial gland in males, forestomach (nonglandular mucosa) in males and females, and reproductive tissues (ovaries, uterus, mammary gland, clitoral gland and vagina) and liver in females. At the lower dose, a slightly increased incidence of tumors was noted in the preputial and harderian glands in males, forestomach in males and females, and liver in females. Ganciclovir should be considered a potential carcinogen in humans.
  • Valganciclovir increases mutations in mouse lymphoma cells. In the mouse micronucleus assay, valganciclovir was clastogenic. Valganciclovir was not mutagenic in the Ames Salmonella assay. Ganciclovir increased mutations in mouse lymphoma cells and DNA damage in human lymphocytes . In the mouse micronucleus assay, ganciclovir was clastogenic. Ganciclovir was not mutagenic in the Ames Salmonella assay.
  • Valganciclovir is converted to ganciclovir and therefore is expected to have similar reproductive toxicity effects as ganciclovir [see n ]. Ganciclovir caused decreased mating behavior, decreased fertility, and an increased incidence of embryolethality in female mice following intravenous doses that produced an exposure approximately 1.7x the mean drug exposure in humans following the dose of 5 mg per kg, based on AUC comparisons. Ganciclovir caused decreased fertility in male mice and hypospermatogenesis in mice and dogs following daily oral or intravenous administration. Systemic drug exposure (AUC) at the lowest dose showing toxicity in each species ranged from 0.03 to 0.1x the AUC of the recommended human intravenous dose. Valganciclovir caused similar effects on spermatogenesis in mice, rats, and dogs. These effects were reversible at lower doses but irreversible at higher doses. It is considered likely that ganciclovir (and valganciclovir) could cause temporary or permanent inhibition of human spermatogenesis.u00a0u00a0
  • No data
  • 1. Brion, L.P., Fleischman, A.R., McCarton, C., Schwartz, G.J. A simple estimate of glomerular filtration rate in low birth weight infants during the first year of life: noninvasive assessment of body composition and growth. J of Ped 1986: 109(4): 698-707.
  • 2. NIOSH [2014]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. By Connor TH, MacKenzie B.A., DeBord D.G., Trout D.B., Ou2019Callaghan J.P., Cincinnati, O.H.: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2014-138 (Supersedes 2012-150).n
  • Valganciclovir Tablets USP, 450 mg are pink colored, oval shaped, film coated tablets debossed with u2018RDYu2019 on one side and u2018762u2019 on other side, and are supplied in bottles of 60u2019s.
  • Bottles of 60 NDC 16714-765-01
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) [See USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).u00a0
  • Serious Adverse Reactions
  • Inform patients that valganciclovir may cause granulocytopenia (neutropenia), anemia, thrombocytopenia and elevated creatinine levels and that dose modification or discontinuation of dosing may be required. Complete blood counts, platelet counts, and creatinine levels should be monitored frequently during treatment [see Warnings and Precautions ].u00a0
  • Pregnancy and Contraception
  • Inform females of reproductive potential that valganciclovir causes birth defects in animals. Advise them to use effective contraception during and for at least 30 days following treatment with valganciclovir. Similarly, advise males tou00a0use condoms during and for at least 90 days following treatment with valgancicloviru00a0[see ].
  • Carcinogenicity
  • Advise patients that valganciclovir is considered a potential carcinogen [see ].u00a0u00a0u00a0
  • u00a0Lactation
  • Advise mothers not to breast-feed if they are receiving valganciclovir because of the potential for hematologic toxicity and cancer in nursing infants, and because HIV can be passed to the baby in breast milk [see ].u00a0
  • Infertility
  • Advise patients that valganciclovir may cause temporary or permanent female and male infertility [see n n ].u00a0
  • Impairment of Cognitive Ability
  • Inform patients that tasks requiring alertness may be affected including the patientu2019s ability to drive and operate machinery as seizures, dizziness, and/or confusion have been reported with the use of valgancicloviru00a0[see ].u00a0
  • Use in Patients with CMV Retinitis
  • Inform patients that valganciclovir is not a cure for CMV retinitis, and they may continue to experience progression of retinitis during or following treatment. Advise patients to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with valganciclovir. Some patients will require more frequent follow-up.u00a0AdministrationInform adult patients that they should use valganciclovir tablets, not valganciclovir for oral solution [see .u00a0
  • Inform patients to take valganciclovir with food to maximize bioavailability.
  • For more information, call 1-844-375-6847.
  • PATIENT INFORMATIONu00a0
  • Arrayn- Valganciclovir Tablets USPn- u00a0
  • (val'' gan sye' kloe vir)n- Array
  • Arrayn- What is the most important information I should know about valganciclovir? n- Valganciclovir can cause serious side effects, including:
  • u2022 Valganciclovir can affect the bone marrow lowering the amount of your white blood cells, red blood cells, and platelets and may cause serious and life-threatening problems.
  • u2022 Kidney failure may happen in people who are elderly, people who take valganciclovir with certain other medicines, or people who are not adequately hydrated.
  • u2022 Valganciclovir may lower sperm count in males and cause fertility problems. Valganciclovir may also cause fertility problems in women. Talk to your healthcare provider if this is a concern for you.
  • u2022 Valganciclovir causes birth defects in animals. It is not known if valganciclovir causes birth defects in people. If you are a female who can become pregnant, you should use effective birth control during treatment with valganciclovir and for at least 30 days after treatment. n n n n n
  • o Tell your healthcare provider right away if you become pregnant during treatment with valganciclovir.
  • o Males should use condoms during treatment with valganciclovir, and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your healthcare provider if you have questions about birth control.u00a0
  • u2022 Valganciclovir causes cancer in animals and may potentially cause cancer in people. u00a0 n
  • Your healthcare provider will do regular blood test during treatment with n- valganciclovirn- to check you for side effects. Your healthcare provider may change your dose or stop treatment withn- valganciclovirn- if you have serious side effects.
  • Array
  • What is valganciclovir?
  • Array
  • In adults, valganciclovir tablets are used:
  • Arrayn- Valgn- anciclovirn- does not cure CMV retinitis.
  • In children valganciclovir tablets or oral solution are used:
  • Arrayn- Arrayn- Do not take n- valganciclovirn- if you have had a serious allergic reaction to valganciclovir, ganciclovir or any of the ingredients of n- valganciclovirn- . n- u00a0n- Array
  • Before you take n- valganciclovirn- , tell your healthcare provider about all of your medical conditions, including if you:
  • u2022 have low blood cell counts
  • u2022 have kidney problems
  • u2022 are receiving hemodialysis
  • u2022 are receiving radiation treatment
  • u2022 are pregnant or plan to become pregnant.u00a0n
  • u2022 are breastfeeding or plan to breastfeed.It is not known if valganciclovir passes into your milk. You should not breastfeed if you take valganciclovir.
  • u2022 You should not breastfeed if you have Human Immunodeficiency Virus (HIV-1) because of the risk of passing HIV-1 to your baby.
  • u2022 Talk to your healthcare provider about the best way to feed your baby. n n
  • Tell your healthcare provider about all the medicines you take,
  • Valganciclovir and other medicines may affect each other and cause serious side effects. Keep a list of your medicines to show your healthcare provider and pharmacist.
  • Arrayn- How should I take valganciclovir?
  • What should I avoid during treatment with n- valganciclovirn- ?
  • Valganciclovir can cause seizures, dizziness, and confusion. You should not drive a car or operate machinery until you know how valgancicloviru00a0affects you. u00a0 n
  • What are the possible side effects of n- valganciclovirn- ?
  • Valganciclovir may cause serious side effects, including:u00a0 See u201cn n u201d n n
  • The most common side effects of n- valganciclovirn- in adults include: n- u00a0
  • The most common side effects of n- Arrayn- in children include:
  • Arrayn- Array
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Keep valganciclovir tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of valganciclovir
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valganciclovir for a condition for which it was not prescribed. Do not give valganciclovir to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about valganciclovir that is written for health professionals.
  • What are the ingredients in valganciclovir tablets?
  • Arrayn- Active Ingredient: n- Array
  • Inactive Ingredients for Tablets: n- Array
  • This Patient Information has been approved by the U.S. Food and Drug Administration. u00a0
  • For more information, call 1-844-375-6847.
  • Rx Onlyu00a0
  • Manufactured for:
  • Northstar Rx LLC Memphis, TN 38141
  • Manufactured by
  • Dr. Reddyu2019s Laboratories Limited
  • Bachupally u2013 500 090 INDIA
  • Revised: 0918
  • Valganciclovir Tablets USP, 450 mg - Container Label

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.