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Guaifenesin / Hydrocodone Dosage

Applies to the following strengths: 100 mg-5 mg/5 mL; 300 mg-2.5 mg; 200 mg-2.5 mg/5 mL; 300 mg-3.5 mg/5 mL; 90 mg-3 mg/5 mL; 100 mg-3.5 mg/5 mL; 1200 mg-10 mg; 100 mg-2.5 mg/5 mL; 100 mg-4 mg/5 mL; 1000 mg-10 mg; 575 mg-5 mg; 300 mg-5 mg; 150 mg-5 mg/5 mL; 200 mg-7.5 mg/5 mL; 600 mg-5 mg

Usual Adult Dose for Cough

10 mL orally every 4 to 6 hours
Maximum dose: 60 mL in 24 hours

Comments:
-Each 5 mL contains hydrocodone 2.5 mg-guaifenesin 200 mg
-Measure dose with accurate measuring device.

Use: Symptomatic relief of cough and to loosen mucus associated with the common cold.

Renal Dose Adjustments

Severe renal impairment: Use with caution

Liver Dose Adjustments

Severe hepatic impairment: Use with caution

Dose Adjustments

Elderly: Use with caution

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioids intended for outpatient use. The new FDA Opioid Analgesic REMS is a designed to assist in communicating the serious risks of opioid pain medications to patients and health care professionals. It includes a medication guide and elements to assure safe use. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK EVALUATION AND MITIGATION STRATEGY (REMS):
-Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
-Opioid Analgesic REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally as needed
-Measure each dose with an accurate measuring device; a household teaspoon is not an accurate measuring device

Storage requirements:
-Protect from light

General:
-This drug is not indicated for pediatric patients under 18 years of age; use of hydrocodone in children less than 6 years of age has been associated with fatal respiratory depression.

Monitoring:
-Monitor for the development of addiction, abuse, or misuse

Patient advice:
-Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child should be considered a medical emergency as it can result in death.
-Patients should understand the risks of life-threatening respiratory depression, and should be informed as to when this risk is greatest.
-Women of child bearing potential should understand that prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome and prompt recognition and treatment will be necessary; breastfeeding women should speak to their health care provider prior to using this drug.
-Patients should discuss concomitant medication use with their healthcare provider to prevent significant drug interactions.
-Patients should not consume alcoholic beverages or take this drug with benzodiazepines or other CNS depressants; patients should avoid driving or operating machinery while taking this drug.
-Patients should be instructed to read the US FDA-approved Medication Guide each time this drug is dispensed; they should understand the safe use, serious risks, and proper storage and disposal of this drug.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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