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Intelence

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Overview

What is Intelence?

INTELENCE (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).

The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. Its molecular formula is CHBrNO and its molecular weight is 435.28. Etravirine has the following structural formula:

Etravirine is a white to slightly yellowish brown powder. Etravirine is practically insoluble in water over a wide pH range. It is very slightly soluble in propylene glycol and slightly soluble in ethanol. Etravirine is soluble in polyethylene glycol (PEG)400 and freely soluble in some organic solvents (e.g., N,N-dimethylformamide and tetrahydrofuran).

INTELENCE is available as a white to off-white, oval tablet for oral administration containing 100 mg of etravirine. Each tablet contains the inactive ingredients hypromellose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and lactose monohydrate.



What does Intelence look like?



What are the available doses of Intelence?

100 mg tablets ()

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

How should I use Intelence?

INTELENCE , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

This indication is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

The following points should be considered when initiating therapy with INTELENCE:

The recommended oral dose of INTELENCE tablets is 200 mg (two 100 mg tablets) taken twice daily following a meal []. The type of food does not affect the exposure to etravirine. Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water. Once dispersed, patients should stir the dispersion well and drink it immediately. The glass should be rinsed with water several times and each rinse completely swallowed to ensure the entire dose is consumed.


What interacts with Intelence?

Sorry No Records found


What are the warnings of Intelence?

Sorry No Records found


What are the precautions of Intelence?

Sorry No Records found


What are the side effects of Intelence?

Sorry No records found


What should I look out for while using Intelence?

None


What might happen if I take too much Intelence?

There is no specific antidote for overdose with INTELENCE. Human experience of overdose with INTELENCE is limited. The highest dose studied in healthy volunteers was 400 mg once daily. Treatment of overdose with INTELENCE consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance. Because etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.


How should I store and handle Intelence?

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.LupinThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.LupinThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.LupinThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.LupinThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.LupinThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.LupinThis Product was Repackaged By:State of Florida DOH Central PharmacyINTELENCE tablets are supplied as white to off-white, oval tablets containing 100 mg of etravirine. Each tablet is debossed with "TMC125" on one side and "100" on the other side.They are supplied by as follows:INTELENCE tablets are supplied as white to off-white, oval tablets containing 100 mg of etravirine. Each tablet is debossed with "TMC125" on one side and "100" on the other side.They are supplied by as follows:


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Etravirine is an antiviral drug [].

Non-Clinical Toxicology
None

Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In Phase 3 clinical trials, Grade 3 and 4 rashes were reported in 1.3% of subjects receiving INTELENCE compared to 0.2% of placebo subjects. A total of 2.2% of HIV-1-infected subjects receiving INTELENCE discontinued from Phase 3 trials due to rash []. Rash occurred most commonly during the first 6 weeks of therapy.

Discontinue INTELENCE immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver transaminases should be monitored and appropriate therapy initiated. Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction.

The following adverse reactions are described in greater detail in other sections:

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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

Interactions

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