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SELZENTRY
Overview
What is SELZENTRY?
SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells
SELZENTRY is available as film-coated tablets for oral administration containing either 150 or 300 mg of maraviroc and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, and magnesium stearate. The film coat [Opadry® II Blue (85G20583)] contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.
Maraviroc is chemically described as 4,4-difluoro--{(1)-3[-3-(3-isopropyl-5-methyl-4-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide.
The molecular formula is CHFNO and the structural formula is:
Maraviroc is a white to pale colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).
What does SELZENTRY look like?
What are the available doses of SELZENTRY?
Tablets: 150 mg and 300 mg ()
What should I talk to my health care provider before I take SELZENTRY?
How should I use SELZENTRY?
SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.
This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY in treatment-experienced subjects and one study in treatment-naïve subjects. Both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (NRTI, NNRTI, PI, or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with SELZENTRY:
The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see ). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.
Table 1 gives the recommended dose adjustments [].
What interacts with SELZENTRY?
Sorry No Records found
What are the warnings of SELZENTRY?
Sorry No Records found
What are the precautions of SELZENTRY?
Sorry No Records found
What are the side effects of SELZENTRY?
Sorry No records found
What should I look out for while using SELZENTRY?
SELZENTRY should not be used in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl < 30 mL/min) who are taking potent CYP3A inhibitors or inducers.
Hepatotoxicity has been reported with SELZENTRY use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of SELZENTRY should be evaluated immediately []
What might happen if I take too much SELZENTRY?
The highest dose administered in clinical studies was 1200 mg. The dose-limiting adverse event was postural hypotension, which was observed at 600 mg. While the recommended dose for SELZENTRY in patients receiving a CYP3A inducer without a CYP3A inhibitor is 600 mg twice daily, this dose is appropriate due to enhanced metabolism.
Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the intended exposure of 300 mg equivalents twice daily. However, no significant QT prolongation was seen in the studies in treatment-experienced subjects with HIV using the recommended doses of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to prolong the QT interval []
There is no specific antidote for overdose with maraviroc. Treatment of overdose should consist of general supportive measures including keeping the patient in a supine position, careful assessment of patient vital signs, blood pressure and ECG.
If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since maraviroc is moderately protein-bound, dialysis may be beneficial in removal of this medicine.
How should I store and handle SELZENTRY?
Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.SELZENTRY film-coated tablets are available as follows:150 and 300 mg tablets are blue, biconvex, oval, film-coated tablets debossed with "Pfizer" on one side and "MVC 150" or "MVC 300" on the other.Bottle packs 150 mg tabletsBottle packs 300 mg tabletsSELZENTRY film-coated tablets are available as follows:150 and 300 mg tablets are blue, biconvex, oval, film-coated tablets debossed with "Pfizer" on one side and "MVC 150" or "MVC 300" on the other.Bottle packs 150 mg tabletsBottle packs 300 mg tabletsSELZENTRY film-coated tablets are available as follows:150 and 300 mg tablets are blue, biconvex, oval, film-coated tablets debossed with "Pfizer" on one side and "MVC 150" or "MVC 300" on the other.Bottle packs 150 mg tabletsBottle packs 300 mg tabletsSELZENTRY film-coated tablets are available as follows:150 and 300 mg tablets are blue, biconvex, oval, film-coated tablets debossed with "Pfizer" on one side and "MVC 150" or "MVC 300" on the other.Bottle packs 150 mg tabletsBottle packs 300 mg tablets
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Maraviroc is an antiviral drug [].
Non-Clinical Toxicology
SELZENTRY should not be used in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl < 30 mL/min) who are taking potent CYP3A inhibitors or inducers.Hepatotoxicity has been reported with SELZENTRY use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of SELZENTRY should be evaluated immediately []
See “Interaction with Guanethidine” under.
A case of possible SELZENTRY-induced hepatotoxicity with allergic features has been reported in a study of healthy volunteers. Discontinuation of SELZENTRY should be considered in any patient with signs or symptoms of hepatitis, or with increased liver transaminases combined with rash or other systemic symptoms.
The safety and efficacy of SELZENTRY have not been specifically studied in patients with significant underlying liver disorders. In studies of treatment-experienced HIV-infected subjects, approximately 6% of subjects were co-infected with hepatitis B and approximately 6% were co-infected with hepatitis C. Due to the small number of co-infected subjects studied, no conclusions can be drawn regarding whether they are at an increased risk for hepatic adverse events with SELZENTRY administration. However, caution should be used when administering SELZENTRY to patients with pre-existing liver dysfunction or who are co-infected with viral hepatitis B or C.
The following adverse reactions are discussed in other sections of the labeling:
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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