ISENTRESS raltegravir tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RALTEGRAVIR POTASSIUM (UNII: 43Y000U234) (RALTEGRAVIR - UNII:22VKV8053U)

Available from:

Avera McKennan Hospital

INN (International Name):

RALTEGRAVIR POTASSIUM

Composition:

RALTEGRAVIR 400 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

ISENTRESS- RALTEGRAVIR TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ISENTRESS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ISENTRESS.
ISENTRESS (RALTEGRAVIR) FILM-COATED TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
ISENTRESS is a human immunodeficiency virus integrase strand transfer
inhibitor (HIV-1 INSTI) indicated:
In combination with other antiretroviral agents for the treatment of
HIV-1 infection in patients 4 weeks of age and older
(1).
The use of other active agents with ISENTRESS is associated with a
greater likelihood of treatment response (14).
DOSAGE AND ADMINISTRATION
ISENTRESS can be administered with or without food (2.1).
Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral
suspension for the ISENTRESS 400 mg film-
coated tablet.
See specific dosing guidance for chewable tablets and the formulation
for oral suspension (2.1).
Adults
400 mg film-coated tablet orally, twice daily (2.2).
During coadministration with rifampin in adults, 800 mg twice daily
(2.1).
Children and Adolescents
If at least 25 kg: One 400 mg film-coated tablet orally, twice daily.
If unable to swallow a tablet, consider the chewable
tablet, as specified in Table 1 (2.3).
If at least 3 kg to less than 25 kg: Weight based dosing, as specified
in Table 2. For patients weighing between 11 and 20
kg, either the chewable tablet or the formulation for oral suspension
can be used, as specified in Table 2 (2.3).
DOSAGE FORMS AND STRENGTHS
Film-Coated Tablets: 400 mg (3).
Chewable Tablets: 100 mg scored and 25 mg (3).
For Oral Suspension: Single-use packet of 100 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Severe, potentially life-threatening and fatal skin reactions have
been reported. This includes cases of Stevens-Johnson
syndrome, hypersensitivity reaction and toxic epidermal necrolysis.
Immediately discontinue treatment with
ISENTRESS and other susp