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GANCICLOVIR SODIUM

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Overview

What is Ganciclovir?

Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).

Ganciclovir for Injection, USP is available as sterile lyophilized powder in strength of 500 mg per vial for intravenous administration only.  Each vial of Ganciclovir for Injection, USP contains the equivalent of 500 mg ganciclovir as the sodium salt (46 mg sodium). Reconstitution with 10 mL of Sterile Water for Injection, USP, yields a solution with pH 11 and a ganciclovir concentration of approximately 50 mg/mL.  Further dilution in an appropriate intravenous solution must be performed before infusion (see ).

Ganciclovir is a white to off-white crystalline powder.  The chemical name for ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine.  Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022.  The pKs for ganciclovir are 2.2 and 9.4.

Ganciclovir, when formulated as monosodium salt in the IV dosage form, is a white to off-white lyophilized powder.  The chemical name for ganciclovir sodium is 9-[[2-hydroxy-1-hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt.  The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C.

     The structural formulas are as follows:

ganciclovir sodium

CHNNaOM.W.  277.22

ganciclovir

CHNO                                                                                                            M.W.  255.23

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



What does Ganciclovir look like?



What are the available doses of Ganciclovir?

Sorry No records found.

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

Sorry No records found

How should I use Ganciclovir?

Ganciclovir for injection is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS).  Ganciclovir for injection is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease (see ).

SAFETY AND EFFICACY OF HAS NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOR FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS.

CAUTION – DO NOT ADMINISTER GANCICLOVIR FOR INJECTION, USP SOLUTION BY RAPID OR BOLUS INTRAVENOUS INJECTION. THE TOXICITY OF GANCICLOVIR FOR INJECTION, USP MAY BE INCREASED AS A RESULT OF EXCESSIVE PLASMA LEVELS.

CAUTION – INTRAMUSCULAR OR SUBCUTANEOUS INJECTION OF RECONSTITUTED GANCICLOVIR FOR INJECTION, USP SOLUTION MAY RESULT IN SEVERE TISSUE IRRITATION DUE TO HIGH pH (11).


What interacts with Ganciclovir?

Ganciclovir for injection is contraindicated in patients with hypersensitivity to ganciclovir or acyclovir.



What are the warnings of Ganciclovir?

Hematologic

Ganciclovir for injection should, therefore, be used with caution in patients with pre-existing cytopenias or with a history of cytopenic reactions to other drugs, chemicals or irradiation.  Granulocytopenia usually occurs during the first or second week of treatment but may occur at any time during treatment.  Cell counts usually begin to recover within 3 to 7 days of discontinuing drug.  Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving ganciclovir for injection solution for treatment of CMV retinitis.

Impairment of Fertility

Animal data indicate that administration of ganciclovir causes inhibition of spermatogenesis and subsequent infertility. These effects were reversible at lower doses and irreversible at higher doses (see , and ).  Although data in humans have not been obtained regarding this effect, it is considered probable that ganciclovir at the recommended doses causes temporary or permanent inhibition of spermatogenesis.  Animal data also indicate that suppression of fertility in females may occur.

Teratogenesis

Because of the mutagenic and teratogenic potential of ganciclovir, women of childbearing potential should be advised to use effective contraception during treatment.  Similarly, men should be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir for injection (see , : ).


What are the precautions of Ganciclovir?

General

In clinical studies with ganciclovir for injection, the maximum single dose administered was 6 mg/kg by intravenous infusion over 1 hour. Larger doses have resulted in increased toxicity.  It is likely that more rapid infusions would also result in increased toxicity (see .  Administration of ganciclovir for injection solution should be accompanied by adequate hydration.

Initially reconstituted solutions of ganciclovir for injection have a high pH (pH 11). Despite further dilution in intravenous fluids, phlebitis and/or pain may occur at the site of intravenous infusion. Care must be taken to infuse solutions containing ganciclovir for injection only into veins with adequate blood flow to permit rapid dilution and distribution (see ).

Since ganciclovir is excreted by the kidneys, normal clearance depends on adequate renal function. IF RENAL FUNCTION IS IMPAIRED, DOSAGE ADJUSTMENTS ARE REQUIRED FOR GANCICLOVIR FOR INJECTION.  Such adjustments should be based on measured or estimated creatinine clearance values (see ).

Information for Patients

All patients should be informed that the major toxicities of ganciclovir are granulocytopenia (neutropenia), anemia and thrombocytopenia and that dose modifications may be required, including discontinuation.  The importance of close monitoring of blood counts while on therapy should be emphasized. Patients should be informed that ganciclovir has been associated with elevations in serum creatinine.

Patients should be advised that ganciclovir has caused decreased sperm production in animals and may cause infertility in humans. Women of childbearing potential should be advised that ganciclovir causes birth defects in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment with ganciclovir for injection.  Similarly, men should be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir for injection.

Patients should be advised that ganciclovir causes tumors in animals.  Although there is no information from human studies, ganciclovir should be considered a potential carcinogen.

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All HIV+ Patients

These patients may be receiving zidovudine.  Patients should be counseled that treatment with both ganciclovir and zidovudine simultaneously may not be tolerated by some patients and may result in severe granulocytopenia (neutropenia). Patients with AIDS may be receiving didanosine. Patients should be counseled that concomitant treatment with both ganciclovir and didanosine can cause didanosine serum concentrations to be significantly increased.

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HIV+ Patients with CMV Retinitis

Ganciclovir is not a cure for CMV retinitis, and immunocompromised patients may continue to experience progression of retinitis during or following treatment. Patients should be advised to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with ganciclovir for injection.  Some patients will require more frequent follow-up.

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Transplant Recipients

Transplant recipients should be counseled regarding the high frequency of impaired renal function in transplant recipients who received ganciclovir for injection solution in controlled clinical trials, particularly in patients receiving concomitant administration of nephrotoxic agents such as cyclosporine and amphotericin B.  Although the specific mechanism of this toxicity, which in most cases was reversible, has not been determined, the higher rate of renal impairment in patients receiving ganciclovir for injection solution compared with those who received placebo in the same trials may indicate that ganciclovir for injection played a significant role.

Laboratory Testing

Due to the frequency of neutropenia, anemia and thrombocytopenia in patients receiving ganciclovir for injection (see ), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/mcL at the beginning of treatment.  Increased serum creatinine levels have been observed in trials evaluating both ganciclovir for injection.  Patients should have serum creatinine or creatinine clearance values monitored carefully to allow for dosage adjustments in renally impaired patients (see ).

Drug Interactions

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Didanosine

When the standard intravenous ganciclovir induction dose (5 mg/kg infused over 1 hour every 12 hours) was coadministered with didanosine at a dose of 200 mg orally every 12 hours, the steady-state didanosine AUC increased 70 ± 40% (range: 3% to 121%, n=11) and C increased 49 ± 48% (range: -28% to 125%). In a separate study, when the standard intravenous ganciclovir maintenance dose (5 mg/kg infused over 1 hour every 24 hours) was coadministered with didanosine at a dose of 200 mg orally every 12 hours, didanosine AUC increased 50 ± 26% (range: 22% to 110%, n=11) and C increased 36 ± 36% (range: -27% to 94%) over the first didanosine dosing interval.  Didanosine plasma concentrations (AUC) were unchanged during the dosing intervals when ganciclovir was not coadministered. Ganciclovir pharmacokinetics were not affected by didanosine. In neither study were there significant changes in the renal clearance of either drug.

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Zidovudine

At an oral dose of 1000 mg of ganciclovir every 8 hours, mean steady-state ganciclovir AUC decreased 17 ± 25% (range: -52% to 23%) in the presence of zidovudine, 100 mg every 4 hours (n=12). Steady-state zidovudine AUC increased 19 ± 27% (range: -11% to 74%) in the presence of ganciclovir.  No drug-drug interaction studies have been conducted with IV ganciclovir and zidovudine.

Since both zidovudine and ganciclovir have the potential to cause neutropenia and anemia, some patients may not tolerate concomitant therapy with these drugs at full dosage.

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Probenecid

At an oral dose of 1000 mg of ganciclovir every 8 hours (n=10), ganciclovir AUC increased 53 ± 91% (range: -14% to 299%) in the presence of probenecid, 500 mg every 6 hours. Renal clearance of ganciclovir decreased 22 ± 20% (range: -54% to -4%), which is consistent with an interaction involving competition for renal tubular secretion.  No drug-drug interaction studies have been conducted with IV ganciclovir and probenecid.

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Imipenem-cilastatin

Generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin.  These drugs should not be used concomitantly unless the potential benefits outweigh the risks.

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Other Medications

It is possible that drugs that inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia and germinal layers of skin and gastrointestinal mucosa may have additive toxicity when administered concomitantly with ganciclovir. Therefore, drugs such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues, should be considered for concomitant use with ganciclovir only if the potential benefits are judged to outweigh the risks.

No formal drug interaction studies of ganciclovir for injection and drugs commonly used in transplant recipients have been conducted.  Increases in serum creatinine were observed in patients treated with ganciclovir for injection plus either cyclosporine or amphotericin B, drugs with known potential for nephrotoxicity (see ). In a retrospective analysis of 93 liver allograft recipients receiving ganciclovir (5 mg/kg infused over 1 hour every 12 hours) and oral cyclosporine (at therapeutic doses), there was no evidence of an effect on cyclosporine whole blood concentrations.

Carcinogenesis, Mutgenesis‡

Ganciclovir was carcinogenic in the mouse at oral doses of 20 and 1000 mg/kg/day (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 dose of 1000 mg/kg/day 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 dose of 20 mg/kg/day, 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.  No carcinogenic effect was observed in mice administered ganciclovir at 1 mg/kg/day (estimated as 0.01x the human dose based on AUC comparison). Except for histiocytic sarcoma of the liver, ganciclovir-induced tumors were generally of epithelial or vascular origin. Although the preputial and clitoral glands, forestomach and harderian glands of mice do not have human counterparts, ganciclovir should be considered a potential carcinogen in humans.

Ganciclovir increased mutations in mouse lymphoma cells and DNA damage in human lymphocytes at concentrations between 50 to 500 and 250 to 2000 mcg/mL, respectively. In the mouse micronucleus assay, ganciclovir was clastogenic at doses of 150 and 500 mg/kg (IV) (2.8 to 10x human exposure based on AUC) but not 50 mg/kg (exposure approximately comparable to the human based on AUC). Ganciclovir was not mutagenic in the Ames Salmonella assay at concentrations of 500 to 5000 mcg/mL.

Impairment of Fertility‡

Ganciclovir caused decreased mating behavior, decreased fertility, and an increased incidence of embryolethality in female mice following intravenous doses of 90 mg/kg/day (approximately 1.7x the mean drug exposure in humans following the dose of 5 mg/kg, based on AUC comparisons). Ganciclovir caused decreased fertility in male mice and hypospermatogenesis in mice and dogs following daily oral or intravenous administration of doses ranging from 0.2 to 10 mg/kg. 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.

Pregnancy‡: Category C

Ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (2x the human exposure based on AUC comparisons), respectively. Effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryolethality.

Daily intravenous doses of 90 mg/kg administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach (see   The drug exposure in mice as estimated by the AUC was approximately 1.7x the human AUC.

Ganciclovir may be teratogenic or embryotoxic at dose levels recommended for human use.  There are no adequate and well-controlled studies in pregnant women.  Ganciclovir for injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Nursing Mothers

It is not known whether ganciclovir is excreted in human milk. However, many drugs are excreted in human milk and, because carcinogenic and teratogenic effects occurred in animals treated with ganciclovir, the possibility of serious adverse reactions from ganciclovir in nursing infants is considered likely (see ).  Mothers should be instructed to discontinue nursing if they are receiving ganciclovir for injection.  The minimum interval before nursing can safely be resumed after the last dose of ganciclovir for injection is unknown.

Pediatric Use

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SAFETY AND EFFICACY OF GANCICLOVIR FOR INJECTION IN PEDIATRIC PATIENTS HAVE NOT BEEN ESTABLISHED.  THE USE OF GANCICLOVIR FOR INJECTION IN THE PEDIATRIC POPULATION WARRANTS EXTREME CAUTION DUE TO THE PROBABILITY OF LONG-TERM CARCINOGENICITY AND REPRODUCTIVE TOXICITY.  ADMINISTRATION TO PEDIATRIC PATIENTS SHOULD BE UNDERTAKEN ONLY AFTER CAREFUL EVALUATION AND ONLY IF THE POTENTIAL BENEFITS OF TREATMENT OUTWEIGH THE RISKS.

The spectrum of adverse events reported in 120 immunocompromised pediatric clinical trial participants with serious CMV infections receiving ganciclovir for injection solution were similar to those reported in adults. Granulocytopenia (17%) and thrombocytopenia (10%) were the most common adverse events reported.

Sixteen pediatric patients (8 months to 15 years of age) with life- or sight-threatening CMV infections were evaluated in an open-label, ganciclovir for injection solution, pharmacokinetics study.  Adverse events reported for more than one pediatric patient were as follows: hypokalemia (4/16, 25%), abnormal kidney function (3/16, 19%), sepsis (3/16, 19%), thrombocytopenia (3/16, 19%), leukopenia (2/16, 13%), coagulation disorder (2/16, 13%), hypertension (2/16, 13%), pneumonia (2/16, 13%) and immune system disorder (2/16, 13%).

There has been very limited clinical experience using ganciclovir for injection for the treatment of CMV retinitis in patients under the age of 12 years. Two pediatric patients (ages 9 and 5 years) showed improvement or stabilization of retinitis for 23 and 9 months, respectively. These pediatric patients received induction treatment with 2.5 mg/kg tid followed by maintenance therapy with 6 to 6.5 mg/kg once per day, 5 to 7 days per week. When retinitis progressed during once-daily maintenance therapy, both pediatric patients were treated with the 5 mg/kg bid regimen. Two other pediatric patients (ages 2.5 and 4 years) who received similar induction regimens showed only partial or no response to treatment. Another pediatric patient, a 6-year-old with T-cell dysfunction, showed stabilization of retinitis for 3 months while receiving continuous infusions of ganciclovir for injection at doses of 2 to 5 mg/kg/24 hours. Continuous infusion treatment was discontinued due to granulocytopenia.

Eleven of the 72 patients in the placebo-controlled trial in bone marrow transplant recipients were pediatric patients, ranging in age from 3 to 10 years (5 treated with ganciclovir for injection and 6 with placebo). Five of the pediatric patients treated with ganciclovir for injection received 5 mg/kg intravenously bid for up to 7 days; 4 patients went on to receive 5 mg/kg qd up to day 100 posttransplant. Results were similar to those observed in adult transplant recipients treated with ganciclovir for injection. Two of the 6 placebo-treated pediatric patients developed CMV pneumonia vs none of the 5 patients treated with ganciclovir for injection. The spectrum of adverse events in the pediatric group was similar to that observed in the adult patients.

Geriatric Use

The pharmacokinetic profiles of ganciclovir for injection in elderly patients have not been established. Since elderly individuals frequently have a reduced glomerular filtration rate, particular attention should be paid to assessing renal function before and during administration of ganciclovir for injection (see ).

Clinical studies of ganciclovir for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.  Ganciclovir for injection is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly (see and ).

Use in Patients with Renal Impairment

Ganciclovir for injection should be used with caution in patients with impaired renal function because the half-life and plasma/serum concentrations of ganciclovir will be increased due to reduced renal clearance (see and ).

Hemodialysis has been shown to reduce plasma levels of ganciclovir by approximately 50%.


What are the side effects of Ganciclovir?

Sorry No records found


What should I look out for while using Ganciclovir?

Ganciclovir for injection is contraindicated in patients with hypersensitivity to ganciclovir or acyclovir.


What might happen if I take too much Ganciclovir?

Overdosage with ganciclovir for injection has been reported in 17 patients (13 adults and 4 children under 2 years of age). Five patients experienced no adverse events following overdosage at the following doses: 7 doses of 11 mg/kg over a 3-day period (adult), single dose of 3500 mg (adult), single dose of 500 mg (72.5 mg/kg) followed by 48 hours of peritoneal dialysis (4-month-old), single dose of approximately 60 mg/kg followed by exchange transfusion (18-month-old), 2 doses of 500 mg instead of 31 mg (21-month-old).

Irreversible pancytopenia developed in 1 adult with AIDS and CMV colitis after receiving 3000 mg of ganciclovir for injection solution on each of 2 consecutive days.  He experienced worsening GI symptoms and acute renal failure that required short-term dialysis. Pancytopenia developed and persisted until his death from a malignancy several months later. Other adverse events reported following overdosage included: persistent bone marrow suppression (1 adult with neutropenia and thrombocytopenia after a single dose of 6000 mg), reversible neutropenia or granulocytopenia (4 adults, overdoses ranging from 8 mg/kg daily for 4 days to a single dose of 25 mg/kg), hepatitis (1 adult receiving 10 mg/kg daily, and one 2 kg infant after a single 40 mg dose), renal toxicity (1 adult with transient worsening of hematuria after a single 500 mg dose, and 1 adult with elevated creatinine (5.2 mg/dL) after a single 5000 to 7000 mg dose), and seizure (1 adult with known seizure disorder after 3 days of 9 mg/kg). In addition, 1 adult received 0.4 mL (instead of 0.1 mL) ganciclovir for injection solution by intravitreal injection, and experienced temporary loss of vision and central retinal artery occlusion secondary to increased intraocular pressure related to the injected fluid volume.

Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered (see ).


How should I store and handle Ganciclovir?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Ganciclovir for Injection, USP is supplied as follows:Vial stoppers do not contain natural rubber latex.Ganciclovir for Injection, USP is supplied as follows:Vial stoppers do not contain natural rubber latex.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

BECAUSE THE MAJOR ELIMINATION PATHWAY FOR GANCICLOVIR IS RENAL, DOSAGE REDUCTIONS ACCORDING TO CREATININE CLEARANCE ARE REQUIRED FOR GANCICLOVIR FOR INJECTION.  FOR DOSING INSTRUCTIONS IN PATIENTS WITH RENAL IMPAIRMENT, REFER TO DOSAGE AND ADMINISTRATION.

Non-Clinical Toxicology
Ganciclovir for injection is contraindicated in patients with hypersensitivity to ganciclovir or acyclovir.

As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).

In clinical studies with ganciclovir for injection, the maximum single dose administered was 6 mg/kg by intravenous infusion over 1 hour. Larger doses have resulted in increased toxicity.  It is likely that more rapid infusions would also result in increased toxicity (see .  Administration of ganciclovir for injection solution should be accompanied by adequate hydration.

Initially reconstituted solutions of ganciclovir for injection have a high pH (pH 11). Despite further dilution in intravenous fluids, phlebitis and/or pain may occur at the site of intravenous infusion. Care must be taken to infuse solutions containing ganciclovir for injection only into veins with adequate blood flow to permit rapid dilution and distribution (see ).

Since ganciclovir is excreted by the kidneys, normal clearance depends on adequate renal function. IF RENAL FUNCTION IS IMPAIRED, DOSAGE ADJUSTMENTS ARE REQUIRED FOR GANCICLOVIR FOR INJECTION.  Such adjustments should be based on measured or estimated creatinine clearance values (see ).

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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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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).