Paracetamol/Caffeine/Pyrilamine

DEA Class;  OTC

Common Brand Names; Midol Complete

Analgesics, Other combo

Acetaminophen: Acts on hypothalamus to produce analgesia

Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

Pyrilamine: Elicits mild diuretic properties

Indicated for temporary relief of symptoms associated with menstrual periods

Hypersensitivity to drug or components

Acetaminophen

Pruritic maculopapular rash

Urticaria

Laryngeal edema

Angioedema

Anaphylactoid reaction

Thrombocytopenia

Leukopenia

Pancytopenia

Neutropenia

Thrombocytopenic purpura

Agranulocytosis

Hepatotoxicity

Caffeine

Insomnia

Restlessness

Nervousness

Tremor

Tinnitus

Irritability

Nausea

Vomiting

Diarrhea

Tachycardia

Diuresis

Palpitations (dose dependent)

Pyrilamine

Sedation

Xerostomia

Blurred vision

Risk of hepatotoxicity; risk is higher in alcoholics or with use of more than one acetaminophen-containing product

Caution regarding daily acetaminophen consumption; do not exceed 3-4 g/day and do not take for prolonged duration G6PD deficiency

May cause CNS depression, which may impair mental and physical abilities; caution patients about performing tasks requiring mental alertness, including operating heavy machinery

Caution with glaucoma, difficulty in urination caused by prostate gland enlargement, and emphysema or chronic bronchitis

Allergic reactions reported with acetaminophen; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur

Additive sedation may occur if used with alcohol or sedative drugs

Acetaminophen associated with increased 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 category: C

Lactation: Excreted in breast milk

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

Adults

2 caplets PO q6hr prn; not to exceed 6 caplets/day

Pediatric

<12 years: Safety and efficacy not established

12 years or older: 2 caplets PO q6hr prn; not to exceed 8 caplets/day

acetaminophen/caffeine/pyrilamine

caplet

  • 500mg/60mg/15mg

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