Rescriptor
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Questions & Answers
Side Effects & Adverse Reactions
ALERT: Find out about medicines that should NOT be taken with RESCRIPTOR. This statement is included on the product’s bottle label.
Because delavirdine may inhibit the metabolism of many different drugs (e.g., antiarrhythmics, calcium channel blockers, sedative hypnotics, and others), serious and/or life-threatening drug interactions could result from inappropriate coadministration of some drugs with delavirdine. In addition, some drugs may markedly reduce delavirdine plasma concentrations, resulting in suboptimal antiviral activity and subsequent emergence of drug resistance. All prescribers should become familiar with the following tables in this package insert: Table 5, Drugs That Are Contraindicated With RESCRIPTOR;Table 6, Drugs That Should Not Be Coadministered With RESCRIPTOR;and Table 7, Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction. Additional details on drug interactions can be found in Tables 1 and 2 under the CLINICAL PHARMACOLOGY section.
Concomitant use of lovastatin or simvastatin with RESCRIPTOR is not recommended. Caution should be exercised if RESCRIPTOR is used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (e.g., atorvastatin or cerivastatin). The risk of myopathy including rhabdomyolysis may be increased when RESCRIPTOR is used in combination with these drugs.
Particular caution should be used when prescribing sildenafil in patients receiving RESCRIPTOR. Coadministration of sildenafil with RESCRIPTOR is expected to substantially increase sildenafil concentrations and may result in an increase in sildenafil-associated adverse events, including hypotension, visual changes, and priapism (see PRECAUTIONS: Drug Interactions and Information for Patients, and the complete prescribing information for sildenafil).
Concomitant use of St. John’s Wort (hypericum perforatum) or St. John’s wort-containing products and RESCRIPTOR is not recommended. Coadministration of St. John’s wort with NNRTIs, including RESCRIPTOR, is expected to substantially decrease NNRTI concentrations and may result in suboptimal levels of RESCRIPTOR and lead to loss of virologic response and possible resistance to RESCRIPTOR or to the class of NNRTIs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
RESCRIPTOR Tablets are indicated for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.
The following should be considered before initiating therapy with RESCRIPTOR in treatment-naive patients. There are insufficient data directly comparing antiretroviral regimens containing RESCRIPTOR with currently preferred 3-drug regimens for initial treatment of HIV. In studies comparing regimens consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) (currently considered suboptimal) to RESCRIPTOR plus 2 NRTIs, the proportion of patients receiving the regimen containing RESCRIPTOR who achieved and sustained an HIV-1 RNA level <400 copies/mL over 1 year of therapy was relatively low (see DESCRIPTION OF CLINICAL STUDIES).
Resistant virus emerges rapidly when RESCRIPTOR is administered as monotherapy. Therefore, RESCRIPTOR should always be administered in combination with other antiretroviral agents.
History
There is currently no drug history available for this drug.
Other Information
RESCRIPTOR Tablets contain delavirdine mesylate, a synthetic non-nucleoside reverse transcriptase inhibitor (NNRTI) of the human immunodeficiency virus type 1 (HIV-1). The chemical name of delavirdine mesylate is piperazine, 1-[3-[(1-methyl-ethyl)amino]-2- pyridinyl]-4-[[5-[(methylsulfonyl)amino]-1H-indol-2-yl]carbonyl]-, monomethanesulfonate. Its molecular formula is C22H28N6O3S•CH4O3S, and its molecular weight is 552.68. The structural formula is:
Delavirdine mesylate is an odorless white-to-tan crystalline powder. The aqueous solubility of delavirdine free base at 23°C is 2,942 mcg/mL at pH 1.0, 295 mcg/mL at pH 2.0, and 0.81 mcg/mL at pH 7.4.
Each RESCRIPTOR Tablet, for oral administration, contains 200 mg of delavirdine mesylate (henceforth referred to as delavirdine). Inactive ingredients consist of carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose. In addition, the 200-mg tablet contains hypromellose, Opadry White YS-1-18202-A, and Pharmaceutical Ink Black.
Sources
Rescriptor Manufacturers
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Kaiser Foundation Hospitals
![Rescriptor (Delavirdine Mesylate) Tablet [Kaiser Foundation Hospitals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rescriptor | Kaiser Foundation Hospitals
The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.
The 100-mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.
RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.
Patients taking both RESCRIPTOR and antacids should be advised to take them at least 1 hour apart.
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Viiv Healthcare Company
Rescriptor | Viiv Healthcare Company
The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.
The 100-mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.
RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.
Patients taking both RESCRIPTOR and antacids should be advised to take them at least 1 hour apart.
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Agouron
Rescriptor | Agouron
The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100 mg or two 200 mg tablets) three times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.
The 100 mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100 mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200 mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200 mg tablets are approximately one-third smaller in size than the 100 mg tablets.
RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics-Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.
Patients taking both RESCRIPTOR and antacids should be advised to take them at least one hour apart.
![Rescriptor (Delavirdine Mesylate) Tablet [Viiv Healthcare Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eb28dcd2-c457-4137-9eec-00062e5a601b&name=2cd0cdcf-0946-45bf-9e48-4c48d72ba8f7-05.jpg)
![Rescriptor (Delavirdine Mesylate) Tablet [Agouron]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2d16f118-c185-4956-8a55-f0dbd5182b50&name=productdisc.jpg)
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