ABACAVIR solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)

थमां उपलब्ध:

Pharmaceutical Associates, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Abacavir oral solution in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir oral solution is contraindicated in patients: • who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)]. • with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ( 5.1)]. • with moderate or severe hepatic impairment [see Use in Specific Populations ( 8.6)]. Teratogenic effects: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR)at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the

उत्पाद समीक्षा:

Abacavir oral solution USP is a clear yellowish, strawberry-banana flavored liquid. Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir. Supplied in: NDC 0121-0897-15: 15 mL unit dose cup NDC 0121-0897-20: Case contains 20 unit dose cups of 15 mL (NDC 0121-0897-15). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE. May be refrigerated.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ABACAVIR- ABACAVIR SOLUTION
Pharmaceutical Associates, Inc.
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MEDICATION GUIDE
Abacavir oral solution
(ah-BAH-kah-veer)
What is the most important information I should know about abacavir
oral solution?
Abacavir can cause serious side effects, including:
• Serious allergic reaction (hypersensitivity reaction) that can
cause death have happened with abacavir
oral solution and other abacavir-containing products. Your risk of
this allergic reaction is much higher if
you have a gene variation called HLA-B*5701. Your healthcare provider
can determine with a blood test
if you have this gene variation.
If you get a symptom from 2 or more of the following groups while
taking abacavir oral solution, call
your healthcare provider right away to find out if you should stop
taking abacavir oral solution.
Symptom(s)
Group 1
Fever
Group 2
Rash
Group 3
Nausea, vomiting, diarrhea, abdominal (stomach
area) pain
Group 4
Generally ill feeling, extreme tiredness, or achiness
Group 5
Shortness of breath, cough, sore throat
A list of these symptoms is on the Warning Card your pharmacist gives
you. Carry this Warning Card
with you at all times.
If you stop abacavir oral solution because of an allergic reaction,
never take abacavir oral solution or any
other abacavir-containing medicine (EPZICOM ®, TRIUMEQ ®, and
TRIZIVIR ®) again.
• If you have an allergic reaction, dispose of any unused abacavir
oral solution. Ask your pharmacist how
to properly dispose of medicines.
• If you take abacavir oral solution or any other
abacavir-containing medicine again after you have had an
allergic reaction, within hours you may get life-threatening symptoms
that may include very low blood
pressure or death.
• If you stop abacavir oral solution for any other reason, even for
a few days, and you are not allergic to
abacavir, talk with your healthcare provider before taking it again.
Taking abacavir oral solution again
can cause a serious allergic or life-threatening reaction, even if you
never had an allergic reaction to it
before.
If

उत्पाद विशेषताएं

ABACAVIR- ABACAVIR SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR ORAL
SOLUTION.
ABACAVIR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1998
WARNING: HYPERSENSITIVITY REACTIONS, AND LACTIC ACIDOSIS AND SEVERE
HEPATOMEGALY WITH STEATOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS
• Serious and sometimes fatal hypersensitivity reactions have
occurred with abacavir. (5.1)
• Hypersensitivity to abacavir is a multi-organ clinical syndrome.
(5.1)
• Patients who carry the HLA-B*5701 allele are at higher risk of
experiencing a hypersensitivity reaction to abacavir.
(5.1)
• Abacavir is contraindicated in patients with a prior
hypersensitivity reaction to abacavir and in HLA- B*5701-positive
patients.(4)
• Discontinue abacavir as soon as a hypersensitivity reaction is
suspected. Regardless of HLA-B*5701 status,
permanently discontinue abacavir if hypersensitivity cannot be ruled
out, even when other diagnoses are possible.
(5.1)
• Following a hypersensitivity reaction to abacavir, NEVER restart
abacavir oral solution or any other abacavir-
containing product. (5.1)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
• Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of
nucleoside analogues. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Related Products that are Removed
Not Recommended ( 5.6) 03/2017
INDICATIONS AND USAGE
Abacavir oral solution, a nucleoside analogue human immunodeficiency
virus (HIV-1) reverse transcriptase inhibitor, is
indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection. ( 1)
DOSAGE AND ADMINISTRATION
• Before initiating abacavir, screen for the HLA-B*5701 allele. (
2.1)
• Adults: 600 mg daily, admini