acetaminophen/clemastine/pseudoephedrine

Adult Dosing

Allergy/Common cold

2 tabs PO q6 hrs PRN
Max: 8 tabs/day

Pediatric Dosing

Allergy/Common cold

Children >12 yrs

2 tabs PO q6 hrs PRN
Max: 8 tabs/day

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Treatment of rhinitis, itching and watery eyes, sinus congestion, sneezing, and pain or fever associated with allergies or the common cold

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the drug
Concomitant use with MAO inhibitors or within 14 days of stopping MAOI therapy

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Use with caution; dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Death may occur from the misuse of this drug in very young children
Overdose of this product may cause severe liver damage or death, 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
Avoid therapy in patients allergic to acetaminophen, clemastine, or pseudoephedrine, or to any other antihistamines, decongestants, caffeine pills, diet pills, stimulants, or ADHD medications
Instruct patients to avoid using any other cough, cold, allergy, or pain medication without consulting their clinician while receiving therapy
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
Advise patients to avoid driving a motor vehicle or operating machinery, as therapy may cause side effects which may impair thinking
Avoid becoming overheated or dehydrated during exercise or in hot weather
Instruct women of childbearing potential to inform their clinician if they are pregnant, breastfeeding, or planning to become pregnant during course of therapy
Antihistamine produces paradoxical excitation in young children. Use of antihistamines is contraindicated in children <2 yrs

Cautions: Use cautiously in

Renal impairment
Hepatic impairment
Cirrhosis of the liver
Heart disease
High blood pressure
Diabetes mellitus
Glaucoma
Thyroid disorder
Enlarged prostate
Dysuria
Alcoholism

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/Breast Feeding ⬆ ⬇

Pregnancy Category:NR

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 clemastine are acceptable during breastfeeding; larger doses or prolonged use may cause drowsiness and other effects in the infant or reduce milk production, especially in combination with a sympathomimetic or before lactation is well established. Single bedtime doses after the last feeding of the day may be sufficient for most women and will minimize any effects of the drug. 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). 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 8 Dec, 2011). Manufacturer advises to consult a physician.

Adverse Reactions ⬆ ⬇

CNS: Confusion, hallucinations, unusual thoughts or behavior, severe dizziness, anxiety, restless feeling, nervousness, seizure, drowsiness, impaired concentration, excitability, insomnia, mild headache
CV: Arrhythmia, hypertension, chest pain
GU: Less urination, dark urine
RESP: Respiratory depression
EENT: Tinnitus, blurred vision
GI: Nausea, stomach pain, loss of appetite, clay-colored stools, jaundice, dry mouth, constipation
DERM: Skin rash, itching, easy bruising, redness under skin
HYPERSENSITIVITY: Allergic reactions
MISC: Low fever, unusual weakness, fever, chills, body aches, flu symptoms, tingling

Clinical Pharmacology ⬆ ⬇

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

Clemastine

First generation histamine H1 antagonist; competitively antagonizes histamine at H1 receptor sites
Rapid and complete absorption
Primarily metabolized by liver; CYP450: Unknown
Excreted principally in urine
Half-life: 4-6 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)

Brands and Availability ⬆ ⬇