Adult Dosing

Symptomatic treatment of common cold and flu symptoms

Ornex

• 2 tablets (650 mg/60 mg) PO q4-6 hrs; Max: 8 tablets/24 hrs

Ornex Maximum Strength

• 2 tablets (1000 mg/60 mg) PO q4-6 hrs; Max: 8 tablets/24 hrs

Sudafed Cold and Sinus

• 2 caps (650 mg/60 mg) PO q4-6 hrs; Max: 8 caps/24 hrs

Pediatric Dosing

Symptomatic treatment of common cold and flu symptoms

Ornex

• Safety and efficacy in pediatric patients <6 yrs have not been established
• 6-12yrs: 1 tablet PO q4-6 hrs; Max 4 tablets/24 hrs
• >12yrs: 2 tablets PO q4-6 hrs; Max 8 tablets/24 hrs

Ornex Maximum Strength

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of the following symptoms caused by the common cold
• Stuffy nose, sinus congestion
• Sinus congestion
• Headache
• Minor aches and pains
• Temporarily reduces fever

• Hypersensitivity to any of the ingredients of the product
• Concomitant use with MAO inhibitors or within 14 days of stopping MAOI therapy
• Concomitant use of acetaminophen-containing products

• N/A

Renal Dose Adjustment (Based on CrCl)

• Acetaminophen
• 10-50 mL/min: give q6 hrs
• <10 mL/min: give q8 hrs

• Pseudoephedrine
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Acetaminophen
• Hepatic impairment: Consider dose reduction; dose adjustments not defined

• Pseudoephedrine
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Overdosage of this product may cause severe liver damage, which may occur on exceeding recommended dosages, concomitant use with other drugs containing acetaminophen, or on consuming 3 or more alcoholic drinks every day while receiving therapy. Avoid concomitant use with any other drugs containing acetaminophen
• Therapy may cause GI obstruction, particularly in patients with severe narrowing of the esophagus, stomach, or intestine; use cautiously in these patients
• Discontinue therapy and consult a clinician if symptoms last more than 7 days or is accompanied or followed by fever, headache, skin rash, or cough; further evaluate the patient and provide appropriate therapy
• Pseudoephedrine can cause nervousness, dizziness, or sleeplessness; discontinue therapy if such symptoms occur

Cautions: Use cautiously in

• Cirrhosis of the liver
• Hepatic dysfunction
• Cardiovascular disease
• Hypertension
• Diabetes mellitus
• Glaucoma
• Thyroid disorder
• Enlarged prostate
• Alcoholism
• GI or GU obstruction

Supplemental Patient Information

• Instruct patients to strictly adhere to the recommended dose
• Instruct patients to avoid alcoholic beverages during therapy as it can increase the risk of liver damage

Pregnancy Category:C

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 amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant; however, it may cause irritability occasionally. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers with newborns whose lactation is not well established or mothers 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 12 Aug 2011). 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 12 Aug 2011). Manufacturer advises to consult a physician.

• CNS: Severe dizziness, anxiety, restless feeling, nervousness, insomnia
• CV: Arrhythmia, hypertension, chest pain
• GI: Nausea, stomach pain, loss of appetite, clay-colored stools, jaundice
• GU: Dark urine
• HEPA: Hepatotoxicity
• DERM: Skin rash, itching, easy bruising, redness under skin
• HYPERSENSITIVITY: Allergic reactions
• MISC: Unusual weakness, fever, chills, body aches, flu symptoms, tingling

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 85% (5-10% unchanged)
• Half-life: 1.25-3 hrs

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and reducing nasal congestion. Also, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors
• Metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs (depends on urine pH)

US Trade Name(s)

• Ornex
• Ornex Maximum Strength
• Sudafed Cold and Sinus

US Availability

Ornex (acetaminophen/pseudoephedrine)

• TABS: 325 mg/30 mg

Ornex Maximum Strength (acetaminophen/pseudoephedrine)

• TABS: 500 mg/30 mg

Sudafed Cold and Sinus

• CAPS: 325 mg/30 mg

Canadian Trade Name(s)

• Children's Tylenol Cold & Stuffy Nose
• Daytime Sinus Relief Extra Strength Tablets
• Dimetapp Daytime Cold Extra Strength Caplets
• Dristan ND Caplets
• Dristan Non-Drowsy Extra Strength Caplet
• Extra Strength Head Cold and Sinus
• Extra Strength Sinus Relief Daytime
• Extra Strength Sinus Relief
• Extra Strength Tylenol Cold & Sinus Daytime
• Extra Strength Tylenol Sinus Pain and Congestion Daytime
• Medicament Pour Les Sinus Extra-Fort Caplet
• Medicament Pour Les Sinus Regulier
• Regular Strength Tylenol Sinus Caplets
• Relievol Sinus Caplets Extra Strength Non Drowsy Formula
• Sinus Medication Day Regular Tablets
• Sinus Medication Daytime Relief
• Sinus Pain and Nasal Congestion Relief
• Sinus Relief Extra Strength Tablet
• Sinutab ND Extra Strength Tab
• Sinutab N.D.Reg Strength Tab
• Sudafed Head Cold & Sinus Extra Strength Tablets

Canadian Availability

Children's Tylenol Cold & Stuffy Nose (acetaminophen/pseudoephedrine)

• SUSP: [160 mg/15 mg]/5 mL

Daytime Sinus Relief Extra Strength Tablets, Dimetapp Daytime Cold Extra Strength Caplets, Dristan Non-Drowsy Extra Strength Caplet, Extra Strength Sinus Relief Daytime, Extra Strength Sinus Relief, Extra Strength Tylenol Cold & Sinus Daytime, Extra Strength Tylenol Sinus Pain and Congestion Daytime, Medicament Pour Les Sinus Extra-Fort Caplet, Relievol Sinus Caplets Extra Strength Non Drowsy Formula, Sinus Relief Extra Strength Tablet, Sinus Medication Daytime Relief, Sinutab ND Extra Strength Tab (acetaminophen/pseudoephedrine)

• TABS: 500 mg/30 mg

Extra Strength Head Cold and Sinus, Sudafed Head Cold & Sinus Extra Strength Tablets (acetaminophen/pseudoephedrine)

• TABS: 500 mg/60 mg

Dristan ND Caplets, Medicament Pour Les Sinus Regulier, Regular Strength Tylenol Sinus Caplets, Sinus Medication Day Regular Tablets, Sinus Pain and Nasal Congestion Relief, Sinutab N.D.Reg Strength Tab (acetaminophen/pseudoephedrine)

• TABS: 325 mg/30 mg

UK Trade Name(s)

• Boots Decongestant with Pain Relief Tablets
• Contac Non Drowsy Dual Relief Tablets
• Lemsip Max Flu Lemon
• Non-Drowsy Sinutab
• Otrivine Mu-Cron

UK Availability

Boots Decongestant with Pain Relief Tablets, Otrivine Mu-Cron(acetaminophen/pseudoephedrine)

• TABS: 500 mg/60 mg

Contac Non Drowsy Dual Relief Tablets, Non-Drowsy Sinutab (acetaminophen/pseudoephedrine)

• TABS: 500 mg/30 mg

Lemsip Max Flu Lemon (acetaminophen/pseudoephedrine)

• PWDR: [1000 mg/60 mg]/sachet

Australian Trade Name(s)

• Chemists' Own Sinus Pain Relief
• Lemsip Pharmacy Flu Strength Daytime
• Panadol Sinus Relief Original Formula
• Sinutab Sinus & Pain Relief Tablets
• Sudafed Sinus + Pain Relief Tablets

Australian Availability

Chemists' Own Sinus Pain Relief, Panadol Sinus Relief Original Formula, Sinutab Sinus & Pain Relief Tablets, Sudafed Sinus + Pain Relief Tablets (acetaminophen/pseudoephedrine)

• TABS: 500 mg/30 mg

Lemsip Pharmacy Flu Strength Daytime (acetaminophen/pseudoephedrine)

• PWDR: [1000 mg/60 mg]/sachet

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations