ABACAVIR- abacavir sulfate solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Rising Pharmaceuticals, Inc.

INN (Nome Internazionale):

ABACAVIR SULFATE

Composizione:

ABACAVIR 20 mg in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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)] . 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 background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACD

Dettagli prodotto:

Abacavir Oral Solution USP: It is a clear to opalescent, yellowish, strawberry-banana-flavored liquid. Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir. It is packaged in opaque bottles with child-resistant closure. This product does not require reconstitution.             Bottles of 240 mL                               NDC 64980-405-24 Store at 20 ° to 25 °C (68° to 77 °F). [see USP Controlled Room Temperature ]. DO NOT FREEZE. May be refrigerated.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ABACAVIR - ABACAVIR SULFATE SOLUTION
Rising Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Abacavir Oral Solution USP
(a bak' a vir)
What is the most important information I should know about abacavir
oral solution?
Abacavir oral solution can cause serious side effects, including:
•
Serious allergic reactions (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 or any other abacavir-
containing medicine (EPZICOM, TRIUMEQ, or 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 oral solution, 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

Scheda tecnica

ABACAVIR - ABACAVIR SULFATE SOLUTION
RISING PHARMACEUTICALS, INC.
----------
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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 A 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 OR ANY
OTHER ABACAVIR-CONTAINING PRODUCT. (5.1)
INDICATIONS AND USAGE
Abacavir, 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 oral solution, screen for the HLA-B*5701
allele. (2.1)
Adults: 600 mg daily, administered as either 300 mg twice daily or 600
mg once daily. (2.2)
Pediatric Patients Aged 3 Months and Older: Administered either once
or twice daily. Dose should be
calculated on body weight (kg) and should not exceed 600 mg daily.
(2.3)
Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg
twice daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Oral Solution: 20 mg per mL (3)
CONTRAINDICATIONS
Presence of HLA-B*5701 allele. (4)
Prior hypersensitivity reaction to abacavi