acetaminophen/pheniramine/phenylephrine (Theraflu Cold and Sore Throat, Theraflu Flu and Sore Throat)

Dosing and uses of Theraflu Cold and Sore Throat, Theraflu Flu and Sore Throat (acetaminophen/pheniramine/phenylephrine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/pheniramine/phenylephrine

powder

• 325mg/20mg/10mg per packet

 

Allergy Symptoms & Common Cold

Dissolve contents of 1 packet in 8 oz of hot water; consume entire 8 oz within 10-15 minutes; not to exceed acetaminophen 1 g/dose or 4 g/day

 

Pediatric dosage forms and strengths

acetaminophen/pheniramine/phenylephrine

powder

• 325mg/20mg/10mg per packet

 

Allergy Symptoms & Common Cold

<12 years: Ask a pediatrician

≥12 years: Dissolve contents of 1 packet in 8 oz of hot water; consume entire 8 oz within 10-15 minutes; not to exceed acetaminophen 1 g/dose or 4 g/day

 

Theraflu Cold and Sore Throat, Theraflu Flu and Sore Throat (acetaminophen/pheniramine/phenylephrine) adverse (side) effects

Frequency not defined

Hypotension

Palpitations

Reflex hypertension

Severe peripheral and visceral vasoconstriction

Tachycardia

Confusion

Dizziness

Depression

Distress

Euphoria

Fatigue

Headache

Insomnia

Irritability

Restlessness

Sedation

Tremors

Dermatologic rash

Anorexia

Agranulocytosis

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Hemolytic anemia

Thrombocytopenia

Bilirubin and alkaline phosphatase may increase

Thickening of bronchial secretions

Wheezing

 

Warnings

Contraindications

Hypersensitivity

Asthma

< 2 years old

Narrow-angle glaucoma

Symptomatic prostate hypertrophy

Bladder-neck obstruction

Stenosing peptic ulcer

Use within 14 days of MAO inhibitor therapy

G-6-PD deficiency

Severe hepatic impairment

 

Cautions

Pheniramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates

Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe atherosclerosis

Acetaminophen: Hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

 

Pregnancy and lactation

Pregnancy: C

Lactation: excreted in breast milk, use caution

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Theraflu Cold and Sore Throat, Theraflu Flu and Sore Throat (acetaminophen/pheniramine/phenylephrine)

Mechanism of action

Acetaminophen: Blocks pain impulse generation peripherally & may inhibit prostaglandin generation in CNS; reduces fever by inhibiting the hypothalamic heat-regulating center

Pheniramine: competes with histamine for histamine H1- receptor sites on effector cells; antihistamines antagonize the effects of histamine mediated through activation of H1- receptor sites, thereby reduces intensity of allergic reactions & tissue injury caused by histamine release

Phenylephrine: vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion & tissue hyperemia