FLOWTUSS- hydrocodone bitartrate, guaifenesin liquid

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Disponível em:

Mission Pharmacal Company

DCI (Denominação Comum Internacional):

GUAIFENESIN

Composição:

GUAIFENESIN 200 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

FLOWTUSS is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older. Important Limitations of Use: - Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4) ]. - Hypersensitivity to hydrocodone, guaifenesin, or any of the inactive ingredients in FLOWTUSS [ see Adverse Reactions (6) ]. Teratogenic Effects Pregnancy Category C There are no adequate and well controlled studies of FLOWTUSS in pregnant women. Reproductive toxicity studies have not been conducted with FLOWTUSS; however, studies are available with an individual active ingredient or related active ingredient. Hydrocodone was teratogenic in hamsters. Codeine, an opiate related to hydrocodone, increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, FLOWTUSS should be used during pregnancy only if the benefit justifies the potential risk to th

Resumo do produto:

FLOWTUSS (hydrocodone bitartrate and guaifenesin) oral solution is supplied as a violet-colored, black raspberry flavored liquid containing 2.5 mg hydrocodone bitartrate and 200 mg guaifenesin in each 5 mL. It is available in: White HDPE bottles of 16 fl. oz. (473 mL): NDC 0178-3482-16 White HDPE bottles of 4 fl. oz. (118 mL): NDC 0178-3482-04 Store solution at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a childresistant closure.

Status de autorização:

New Drug Application

Folheto informativo - Bula

FLOWTUSS- HYDROCODONE BITARTRATE, GUAIFENESIN LIQUID
Mission Pharmacal Company
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MEDICATION GUIDE
FLOWTUSS (Floh-tus)
(hydrocodone bitartrate and guaifenesin) oral solution, C-II
What is the most important information I should know about FLOWTUSS?
FLOWTUSS is not for children under 18 years of age.
FLOWTUSS can cause serious side effects, including:
Addiction, abuse and misuse. Taking FLOWTUSS or other medicines that
contain an opioid can cause
addiction, abuse and misuse, which can lead to overdose and death.
This can happen even if you take
FLOWTUSS exactly as prescribed by your healthcare provider. Your risk
of addiction, abuse, and misuse
is increased if you or a family member has a history of drug or
alcohol abuse or addiction, or mental
health problems.
Do not share your FLOWTUSS with other people.
Keep FLOWTUSS in a safe place away from children.
Life-threatening breathing problems (respiratory depression). FLOWTUSS
can cause breathing problems
(respiratory depression) that can happen at any time during treatment
and can lead to death. Your risk of
breathing problems is greatest when you first start taking FLOWTUSS,
are taking other medicines that
can cause breathing problems, have certain lung problems, are elderly
or have certain other health
problems. Children are at higher risk for respiratory depression.
Breathing problems can happen even if
you take FLOWTUSS exactly as prescribed by your healthcare provider.
Call your healthcare provider or get emergency medical help right away
if anyone taking FLOWTUSS
has any of the symptoms below:
increased sleepiness
confusion
difficulty breathing
shallow breathing
limpness
Keep FLOWTUSS in a safe place away from children. Accidental use of
even 1 dose of FLOWTUSS,
especially by a child, is a medical emergency and can cause breathing
problems (respiratory depression)
which can lead to death. If a child accidentally takes FLOWTUSS, get
emergency medical help right
away.
Overdose and death due to medicine dosing errors. Overdose and death
can happen if you

Características técnicas

FLOWTUSS- HYDROCODONE BITARTRATE, GUAIFENESIN LIQUID
MISSION PHARMACAL COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLOWTUSS™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLOWTUSS.
FLOWTUSS (HYDROCODONE BITARTRATE AND GUAIFENESIN) ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 2014
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4
INTERACTION;
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS;
INTERACTION WITH
ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME
RECENT MAJOR CHANGES
Boxed Warning 5/2018
Indications and Usage (1) 5/2018
Dosage and Administration (2.1, 2.3) 5/2018
Contraindications (4) 5/2018
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.8, 5.9,
5.11, 5.12, 5.13, 5.14, 5.15) 5/2018
INDICATIONS AND USAGE
FLOWTUSS is a combination of hydrocodone, an opioid agonist; and
guaifenesin an expectorant, indicated for the
symptomatic relief of cough and to loosen mucus associated with the
common cold in patients 18 years of age and older.
(1) (1)
Important Limitations of Use (1) (1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve FLOWTUSS
for use in adult patients for whom the benefits of cough suppression
are expected to outweigh the risks, and in whom an
adequate assessment of the etiology of the cough has been made.
DOSAGE AND ADMINISTRATION
Adults 18 years of age and older: 10 mL every 4 to 6 hours as needed,
not to exceed 6 doses (60 mL) in 24 hours. (2.2)
Measure FLOWTUSS with an accurate milliliter measuring device. (2.1,
5.5)
Do not increase the dose or dosing frequency. (2.1)
Prescribe for the shortest duration consistent with treatment goals.
(2.3)
Reevaluate patients with unresponsive cough in 5 days or sooner for
possible underlying pathology. (2.3)
Reevaluate patient prior to refilling. (2