Adult Dosing

Symptomatic relief of hay fever or other upper respiratory allergies, and the common cold

• 1 Tablet (chlorpheniramine 2 mg/ibuprofen 200 mg/pseudoephedrine 30 mg) PO q4-6 hrs; Max: 6 tabs/day

Pediatric Dosing

Symptomatic relief of hay fever or other upper respiratory allergies, and the common cold

• Children >12 yrs: 1 Tablet (chlorpheniramine 2 mg/ibuprofen 200 mg/pseudoephedrine 30 mg) PO q4-6 hrs; Max: 6 tabs/day
• Children 6-11 yrs: 5 mL (chlorpheniramine 1 mg/ibuprofen 200 mg/pseudoephedrine 30 mg) PO qid, Max: 4 doses/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of symptoms associated with hay fever or other upper respiratory allergies, and the common cold (runny nose, itchy, watery eyes, itching of the nose or throat, sneezing, nasal congestion, sinus pressure, headache, minor aches and pains, fever)

• Hypersensitivity to any of the ingredients of the product
• Concomitant use of monoamine oxidase inhibitor (MAOI) inhibitor, or 2 weeks after stopping the MAOI drug
• Aspirin or NSAID-induced asthma or urticaria
• Aspirin triad
• Before or after cardiac surgery

• N/A

Renal Dose Adjustment

• Renal impairment: Caution advised; dose adjustments not defined

Hepatic Dose Adjustment

• Liver cirrhosis: Caution advised; dose adjustments not defined

See Supplemental Patient Information

• Severe allergic reactions can occur with usage of this drug. Patients allergic to aspirin are more susceptible. Asthma (wheezing), blisters, facial swelling, hives, rash, shock and skin reddening are the associated symptoms. On development of allergic reactions stop usage of this drug and provide medical help immediately
• Avoid usage of this drug in those with allergic reaction to any other pain reliever/fever reducer and in conditions right before or after surgery
• Patients having stomach bleeding, history of stomach problems, such as heartburn, patients on blood thinning (anticoagulant) or steroid drug, those making concomitant use of other drugs containing NSAID, those using this drug for more than suggested duration are prone to stomach bleeding. Use cautiously in these patients
• If patients experience symptoms like fainting, vomit blood, bloody or black stool, severe stomach pain, fever more than 3 days, nasal congestion more than 7 days, redness and swelling in the painful area, nervous, dizzy, or sleepless or any new symptom appears, suspect stomach bleeding and immediately discontinue the drug
• Dosage more than directed and prolong use of this drug, can increase the risk of heart attack or stroke, as ibuprofen decrease the benefit of aspirin used for heart attack or stroke
• Drowsiness can occur, concomitant use of alcohol, sedatives, and tranquilizers can increase drowsiness, hence use cautiously

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Cardiac diseases
• Hypertension
• Thyroid disorder
• Peptic ulcer disease
• Coagulation disorder
• Diabetes mellitus
• Glaucoma
• Prostatic hypertrophy
• Asthma
• COPD
• GI bleeding
• History of GI disorder
• CNS depressant use
• Chronic use of alcohol
• Bladder neck obstruction
• Urinary retention
• Concomitant use of anticoagulant
• Concomitant use of diuretic
• Elderly patients (>65 yrs)
• Prolong use

Supplemental Patient Information

• Patients should be advised to avoid alcoholic drink
• Patients should be warned against driving a motor vehicle or operating machinery, as drug can cause drowsiness

Pregnancy Category:B [Chlorpheniramine]; C (contraindicated in 3rd trimester)[Ibuprofen]; C [Pseudoephedrine]

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 nonsedating antihistamines should be preferred. Extremely low levels of ibuprofen is excreted in breastmilk, due to its shorter half-life and use in infants in doses much higher than those excreted in breastmilk, prefer ibuprofen as an analgesic or anti inflammatory agent in nursing mothers. Small amount of pseudoephedrine is excreted in breastmilk and are unlikely to harm the nursing infant, occasionally cause irritability. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers of newborns or who are having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 March 2011).

• CNS: Drowsiness, nervousness, stroke, headache, dizziness, paradoxical CNS stimulation, incoordination, seizures, toxic psychosis, anxiety, insomnia
• CV: MI, stroke, thromboembolism, CHF, hypertension, edema, arrhythmias , hypotension, palpitations, tachycardia
• GI: GI bleeding, abdominal pain, GI ulcer, GI perforation, hepatotoxicity, dyspepsia, nausea, constipation, elevated liver transaminases, dry mouth, GI obstruction, epigastric discomfort
• RESP: Asthma, bronchospasm, thickening of bronchial secretions, chest tightness, respiratory depression, wheezing, dry mucous membranes
• DERM: Hives, skin reddening, rash, blister, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, ecchymosis, photosensitivity, diaphoresis
• GU: Renal papillary necrosis, nephrotoxicity, urinary retention, urinary hesitancy, dysuria, erectile dysfunction
• HEMA: Thrombocytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, neutropenia, pancytopenia, leukopenia,
• EENT: Tinnitus, blurred vision, diplopia, acute labyrinthitis
• MISC: Anaphylactic/anaphylactoid reaction

Chlorpheniramine

• Antihistamine; blocks the action of endogenous histamine by binding to the histamine H1 receptor thus leading to temporary relief of the negative symptoms brought on by histamine
• Extensively metabolized by liver
• Renally excreted
• Half-life: 16 hrs

Ibuprofen

• NSAID; precise mechanism of action unknown; inhibits cyclooxygenase and lipoxygenase results in reduction of prostaglandin synthesis
• Well absorbed (80% from GI tract)
• Metabolized by liver; CYP450: CYP2C9
• Primarily excreted in urine (<1% unchanged)
• Half-life: 2-4 hrs

Pseudoephedrine

• Adrenergic agent; 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 by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs

US Trade Name(s)

• Advil Allergy Sinus

US Availability

Advil Allergy Sinus (chlorpheniramine/ibuprofen/pseudoephedrine )

• TABS: 2 mg/200 mg/30 mg
• SUSP: [1 mg/100 mg/15 mg]/5 mL

Canadian Trade Name(s)

• Advil Cold and Sinus Nighttime
• Advil Cold and Sinus Plus
• Children's Advil Cold and Flu Multi Symptom

Canadian Availability

Advil Cold and Sinus Nighttime, Advil Cold and Sinus Plus

• TABS: 2 mg/200 mg/30 mg

Children's Advil Cold and Flu Multi Symptom

• SUSP: [1 mg/100 mg/15 mg]/5 mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations

Drug Name: Chlorpheniramine 2 MG / Ibuprofen 200 MG / Pseudoephedrine 30 MG Oral Tablet [Advil Allergy Sinus]

Ingredient(s): Chlorpheniramine mixture with Ibuprofen and Pseudoephedrine

Imprint: Advil;A;S

Color(s): Orange

Shape: Oval

Size (mm): 15.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Pfizer Consumer Healthcare

DEA Schedule:
Non-Scheduled