Dosing and uses of Obredon, Flowtuss (hydrocodone/guaifenesin)
Adult dosage forms and strengths
oral solution: Schedule II
- (2.5mg/200mg)/5mL
Cough
Indicated for symptomatic relief of cough and to loosen mucus associated with the common cold/flu
10 mL (ie, 5mg hydrocodone/400 mg guaifenesin) PO q4-6hr; not to exceed 6 doses (60 mL) in 24 hr
Pediatric dosage forms and strengths
<18 years: Safety and efficacy not established
Obredon, Flowtuss (hydrocodone/guaifenesin) adverse (side) effects
Frequency not defined
Common
- Central nervous system: Headache, dizziness, sedation (somnolence)
- Gastrointestinal system: Nausea, diarrhea
- Cardiovascular system: Decreased blood pressure
- Vascular system: hot flush
Other
- Respiratory depression
- Drug dependence
- Increased intracranial pressure
- Decreased mental alertness with impaired mental and/or physical abilities
- Paralytic ileus
Warnings
Contraindications
Known hypersensitivity to hydrocodone bitartrate, guaifenesin, or the inactive ingredients
Coadministration with MAOI therapy or within 14 days of stopping MAOIs
Cautions
Hydrocodone may cause dose-related respiratory depression by directly acting on brain stem respiratory center; use with caution and keep out of reach of children
The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing ICp
Hydrocodone can produce drug dependence and has the potential for abuse
May produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks; avoid concurrent use with alcohol or other CNS depressants because of additional impairment
Caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions
Concurrent use of anticholinergics with hydrocodone may produce paralytic ileus
Coadministration with MAOIs or tricyclic antidepressants one may increase the effect of either the antidepressant or hydrocodone (also see Contraindications)
Not be used for a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm requiring expectoration
Caution in patients with diabetes, thyroid disease, Addison disease, prostatic hypertrophy, urethral stricture, or asthma
Caution in patients with severe renal or hepatic impairment
Pregnancy and lactation
Pregnancy category: C; use in mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used
Lactation: Hydrocodone is known to be distributed in human breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Obredon, Flowtuss (hydrocodone/guaifenesin)
Mechanism of action
Hydrocodone: Centrally-acting opioid antitussive
Guaifenesin: Elicits expectorant action that promotes or facilitates the removal of secretions from the respiratory tract
Pharmacokinetics
Hydrocodone
- Half-life: 5 hr
- Peak plasma time: 1.25 hr
- Peak plasma concentration: 12.6 ng/mL
- AUC: 80.9 ng•hr/mL
Guaifenesin
- Half-life: 20 minutes
- Peak plasma time: 1.25 hr
- Peak plasma concentration: 3.7 mcg/mL
- AUC: 4.2 mcg•hr/mL
Administration
Instructions
May take with or without food
Measure dose with accurate milliliter measuring device
Do not use a household teaspoon to measure the dose
