Adult Dosing

Analgesic, antipyretic, antihistaminic

• 2 tabs [650 mg/4 mg] PO q4-6 hrs PRN
• Max: 12 tabs [3900 mg/24 mg]/day

Pediatric Dosing

Analgesic, antipyretic, antihistaminic

• 6-11 yrs
• 1 tab [325 mg/2 mg] PO q4-6 hrs PRN
• Max: 5 tabs [1625 mg/10 mg]/day

• >12 yrs
• 2 tabs [650 mg/4 mg] PO q4-6 hrs PRN
• Max: 12 tabs [3900 mg/24 mg]/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of minor aches, pains, and headache
• For reducing fever associated with colds or flu
• Temporary relief of runny nose and sneezing due to the common cold

• Hypersensitivity to any of the ingredients of the product
• Concomitant use with acetaminophen-containing products
• Pediatric patients <2 yrs

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

See Supplemental Patient Information

• Severe liver damage may occur on exceeding recommended dosages, concurrent use with other drugs containing acetaminophen. Adults having 3 alcoholic drinks everyday are susceptible for development of manifestations related to severe liver damage. Avoid using acetaminophen/chlorpheniramine combination drug with any other drug containing acetaminophen component
• Obtain medical history of patients for presence of any liver disease, breathing problems such as emphysema or chronic bronchitis, glaucoma, urinary obstruction, or prostatic hypertrophy; also, ask patients whether they are receiving treatment with any blood thinning agents such as warfarin, sedatives or tranquilizers
• Excitability may occur in all patients undergoing treatment with acetaminophen/chlorpheniramine, especially in children
• Drowsiness may occur during therapy; use caution when performing hazardous tasks
• Avoid concomitant use with alcoholic beverages, sedatives and tranquilizers as these may increase drowsiness
• Discontinue therapy and consult a clinician if new symptoms occur, redness or swelling is present, pain gets worse or persists for more than 5 days in children or 10 days in adults, and if fever gets worse or lasts more than 3 days

Cautions: Use cautiously in

• Hepatic impairment
• Renal impairment
• Asthma
• Bladder neck obstruction
• CNS depressant use
• COPD
• GI obstruction
• Angle-closure glaucoma
• Increased intraocular pressure
• Lower respiratory tract symptoms
• Prostatic hypertrophy
• Peptic ulcer disease
• Geriatric patients
• Patients <6 yrs

Supplemental Patient Information

• Advise patients receiving therapy to exercise caution while driving a motor vehicle or operating machinery as therapy may cause drowsiness

Pregnancy Category:B (acetaminophen), B (chlorpheniramine)

Breastfeeding: Acetaminophen component of this combination drug 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. Small, occasional doses of chlorpheniramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause adverse effects in the infant or interfere with lactation, particularly in combination with a sympathomimetic agent or when lactation is not well established. However, the nonsedating antihistamines are preferred alternatives . This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Maternal medication of acetaminophen 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 22 June, 2011). Manufacturer advises to consult a health professional.

• CNS: Paradoxical CNS stimulation, dizziness, drowsiness, headache
• EENT: Blurred vision
• GI: Hepatotoxicity, constipation, epigastric discomfort
• GU: Dysuria, urinary retention
• RESP: Thickened bronchial secretions

Acetaminophen

• Analgesic, antipyretic; acts primarily in the CNS, increasing 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

Chlorpheniramine

• I generation antihistamine; competitively antagonizes central and peripheral H1 receptors (non-selective antihistamine); suppresses the medullary cough center (antitussive); exhibits antidyskinetic, antiemetic and sedative effects due to its anticholinergic properties
• Well absorbed following oral administration
• Metabolized by GI tract, liver; CYP450: 2D6, 3A4 substrate
• Renally excreted (minimally unchanged)
• Half-life: 21-27 hrs

US Trade Name(s)

• Coricidin HBP Cold & Flu

US Availability

Coricidin HBP Cold & Flu (acetaminophen/chlorpheniramine)

• OTC TABS: 325 mg/2 mg

Canadian Trade Name(s)

• Coricidin II Cold and Flu

Canadian Availability

Coricidin II Cold and Flu (acetaminophen/chlorpheniramine)

• OTC TABS: 325 mg/2 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Chemists' Own Coldeze Tablets

Australian Availability

Chemists' Own Coldeze Tablets(paracetamol/chlorpheniramine)

• TABS: 500 mg/2 mg

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations