Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)
Mission Pharmacal Company
GUAIFENESIN
GUAIFENESIN 200 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
FLOWTUSS- HYDROCODONE BITARTRATE, GUAIFENESIN LIQUID Mission Pharmacal Company ---------- 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 Citiți documentul complet
FLOWTUSS- HYDROCODONE BITARTRATE, GUAIFENESIN LIQUID MISSION PHARMACAL COMPANY ---------- 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 Citiți documentul complet