acetaminophen/guaifenesin

Adult Dosing

Temporarily relief of cold/fever

1 packet PO q6 hrs prn; Max: 4 packets/day
Dissolve the content of 1 packet in 8 oz of hot water and consume entire drink within 10-15 minutes

Pediatric Dosing

Temporarily relief of cold/fever (>12 yrs)

1 packet PO q6 hrs prn; Max: 4 packets/day
Dissolve the content of 1 packet in 8 oz of hot water and consume entire drink within 10-15 minutes

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Temporarily relief of cold symptoms

Sore throat
Minor aches and pains
Headaches
Nasal congestion

Temporarily reduce fever
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Concomitant use of any drug containing acetaminophen
Children <4 yrs

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment (Based on CrCl)

Acetaminophen

10-50 mL/min: give in q6 hrs
<10 (mL/min): give in q8 hrs

Guaifenesin

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Acetaminophen

Hepatic impairment: Decrease dose, dose adjustments not defined

Guaifenesin

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

Overdosage can cause liver damage; severe liver damage have occurred with exceeding recommended dosages/concomitant use with other drugs containing acetaminophen/having 3 or more alcoholic drinks every day while continuing therapy. Avoid concomitant use with any other drug containing acetaminophen
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Discontinue the drug and further evaluate the patient and provide appropriate therapy
If new symptoms occurs, redness or swelling is present, pain gets worse or lasts for more than 7 days, fever gets worse or lasts for more than 3 days, nervousness, dizziness or sleeplessness occurs, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts, discontinue the therapy and further evaluate the patients as these are the sign of serious condition

Cautions: Use cautiously in

Renal impairment
Hepatic impairment
Cough with excessive phlegm
Chronic cough
Alcohol abuse
Anicoagulant use

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:B (acetaminophen), C (guaifenesin)

Breastfeeding: Acetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 May 2011). Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 11 May 2011). No studies conducted on excretion of guaifenesin in milk or its effect on breastfed infants. As it is given to infants as young as 2 month of age, it is unlikely that usual maternal doses amounts in milk are as large as those given directly to infants and would harm the breastfed infants especially in infants over 2 months of age. Avoid the use of products with high alcohol content while nursing. This information is based on based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 May 2011).

Adverse Reactions ⬆ ⬇

CNS: Dizziness, headache
GI: Hepatotoxicity, nausea, diarrhea, vomiting
GU: Renal tubular necrosis, acute analgesic nephropathy
HEMA: Chronic anemia, thrombocytopenia
DERM: Rash, urticaria
MISC: Anaphylactic/anaphylactoid reactions

Clinical Pharmacology ⬆ ⬇

Acetaminophen

Analgesic, antipyretic; increases the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1 and COX-2, enzymes involved in prostaglandin (PG) synthesis, reduces fever through direct action on hypothalamic heat-regulating center
Rapid and almost complete absorption
Metabolized by liver; CYP450: CYP2E1, CYP1A2
Excreted in urine (5-10% unchanged)
Half-life: 2-4 hrs

Guaifenesin

Expectorant; act as an irritant to gastric vagal receptors, and recruit efferent parasympathetic reflexes, causing less viscous mucus mixture and provoke cough, thus facilitating removal of viscous mucus and making nonproductive coughs more productive and less frequent
Rapidly absorbed from GI tract
Metabolized by hydrolysis
Renally excreted mainly as metabolite
Half-life: 1 hr

Brands and Availability ⬆ ⬇