Adult Dosing

Hay fever/common cold/upper respiratory allergies

• 1 TAB (chlorpheniramine 4 mg/phenylephrine 10 mg) PO q4 hrs
• Max: 6 TABS/day

Pediatric Dosing

Hay fever/common cold/upper respiratory allergies

• TABS (>12 yrs)
• 1 TAB (chlorpheniramine 4 mg/phenylephrine 10 mg) PO q4 hrs
• Max: 6 TABS/day

• Solution (6-12 yrs)
• 2 teaspoonfuls or 10 mL [chlorpheniramine 1 mg/phenylephrine 2.5 mg]/5 mL PO q4 hrs
• Max: 60 mL/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporarily relief of symptoms due to hay fever or other upper respiratory allergies
• Temporarily relief of symptoms due to common cold

• Hypersensitivity to any of the ingredients of the product
• Concomitant use of monoamine oxidase inhibitor (MAOI) or within 2 wks of stopping MAOI
• Severe hypertension
• Coronary artery disease
• Urinary retention

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Dizziness, drowsiness, or blurred vision can occur with this drug, concomitant use of other sedatives and tranquilizers and alcohol abuse worsen these effects. Hence avoid concomitant use with these drugs and advise patients to avoid alcohol
• If new symptoms occur, redness or swelling is present, symptoms last for more than 7 days, or fever with headache, cough, or skin rash occurs, discontinue the therapy and further evaluate the patient, as these are the sign of serious condition
• Antihistamine produces paradoxical excitation in young children. Use of antihistamines is contraindicated in children < 2 yrs

Cautions: Use cautiously in

• Renal impairment
• Cardiac diseases
• Hypertension
• Thyroid disorder
• Diabetes mellitus
• Glaucoma
• Asthma
• Chronic bronchitis
• PUD
• Prostatic hypertrophy
• CNS depressant use
• Geriatric population

Supplemental Patient Information

• Advise patients to avoid driving a motor vehicle or operating machinery, as drowsiness can occur with this treatment
• Advise patients to consult their physician if symptoms do not improve in 7 days, or if new symptoms occur or fever gets worse or lasts for more than 3 days
• Advise patients to avoid alcohol

Pregnancy Category:B (chlorpheniramine), C (phenylephrine)

Breastfeeding: 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 when used in combination with a sympathomimetic agent or when lactation is not well established. The non-sedating antihistamines should be preferred. Phenylephrine is unlikely to reach the infant in large amounts, as the oral bioavailability of phenylephrine is only about 40%. However oral administration of phenylephrine decreases milk production. As no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 16 May 2011). Manufacturer advises to consult a health professional.

• CNS: Drowsiness, dizziness, paradoxical CNS stimulation (in children), incoordination, headache, seizures, toxic psychosis, restlessness, anxiety, nervousness, weakness, tremors, insomnia
• EENT: Blurred vision, diplopia, acute labyrinthitis
• CV: Hypertension, arrhythmias , hypotension, palpitations, tachycardia
• RESP: Thickening of bronchial secretions, chest tightness, respiratory depression, wheezing
• GI: Epigastric discomfort, dry mouth, constipation, obstruction, nausea
• HEMA: Hemolytic anemia, thrombocytopenia, agranulocytosis, pancytopenia, leukopenia
• GU: Retention , urinary hesitancy, dysuria, erectile dysfunction
• MISC: Anaphylactic/anaphylactoid reactions, dry mucous membranes, diaphoresis, photosensitivity

Chlorpheniramine

• Antihistaminic: Competitively antagonizes central and peripheral H1 receptors (non-selective antihistamine); suppresses the medullary cough center (antitussive); has 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

Phenylephrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract causing vasoconstriction, and by stimulating beta2-adrenergic receptors relaxes bronchial smooth muscle
• Metabolized in intestinal wall and liver
• Renally excreted 80% (2.6% unchanged)
• Half-life: 2-3 hrs

US Trade Name(s)

• Actifed Cold & Allergy
• Children's Triaminic Cold & Allergy
• Sudafed PE Sinus + Allergy

US Availability

Actifed Cold & Allergy, Sudafed PE Sinus + Allergy (chlorpheniramine/phenylephrine)

• TABS: 4 mg/10 mg

Children's Triaminic Cold & Allergy (chlorpheniramine/phenylephrine)

• SOLN: [1 mg/2.5 mg]/5 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Chemists' Own Children's Cold & Allergy Mixture
• Chemists' Own Infant's Cold & Allergy Drops
• Demazin Cold Relief Syrups

Australian Availability

Chemists' Own Children's Cold & Allergy Mixture (chlorpheniramine/phenylephrine)

• SOLN: [1.25 mg/2.5 mg]/5 mL

Chemists' Own Infant's Cold & Allergy Drops (chlorpheniramine/phenylephrine)

• DROPS: [1.25 mg/2.5 mg]/5 mL

Demazin Cold Relief Syrups (chlorpheniramine/phenylephrine)

• SYRUP: [1.25 mg/2.5 mg]/5 mL

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations