Pronunciation:
(KLEM as teen)
U.S. Brand Names:
Dayhist® Allergy [OTC]; Tavist® Allergy [OTC]
Synonyms:
Clemastine Fumarate
Generic Available:
Yes
Use:
Perennial and seasonal allergic rhinitis and other allergic symptoms including urticaria
Pregnancy Risk Factor:
B
Lactation:
Enters breast milk/not recommended
Contraindications:
Hypersensitivity to clemastine or any component of the formulation; narrow-angle glaucoma
Warnings/Precautions:
Safety and efficacy have not been established in children <6 years of age. Use caution with bladder neck obstruction, symptomatic prostate hypertrophy, asthmatic attacks, stenosing peptic ulcer, increased intraocular pressure, hyperthyroidism, cardiovascular disease, hypertension, and in the elderly. May cause drowsiness; use caution in performing tasks which require alertness.
Adverse Reactions:
Frequency not defined.
Cardiovascular: Palpitations, hypotension, tachycardia
Central nervous system: Dyscoordination, sedation, slight to moderate somnolence, sleepiness, confusion, restlessness, nervousness, insomnia, irritability, fatigue, headache, increased dizziness
Dermatologic: Rash, photosensitivity
Gastrointestinal: Diarrhea, nausea, xerostomia, epigastric distress, vomiting, constipation
Genitourinary: Urinary frequency, difficult urination, urinary retention
Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis
Ocular: Blurred vision
Otic: Tinnitus
Respiratory: Thickening of bronchial secretions
Miscellaneous: Anaphylaxis
Overdosage/Toxicology:
Symptoms of overdose include anemia, metabolic acidosis, hypotension, hypothermia
There is no specific treatment for an antihistamine overdose, however, most of its clinical toxicity is due to anticholinergic effects. For anticholinergic overdose with severe life-threatening symptoms, physostigmine 1-2 mg (0.5 mg or 0.02 mg/kg for children) I.V., slowly may be given to reverse these effects.
Drug Interactions:
Inhibits CYP2D6 (weak), 3A4 (weak)
Increased toxicity (CNS depression): CNS depressants, MAO inhibitors, tricyclic antidepressants, phenothiazines
Ethanol/Nutrition/Herb Interactions:
Ethanol: Avoid ethanol (may increase CNS depression).
Mechanism of Action:
Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract
Pharmacodynamics/Kinetics:
Onset of action: Peak effect: Therapeutic: 5-7 hours
Duration: 8-16 hours
Absorption: Almost complete
Metabolism: Hepatic
Excretion: Urine
Dosage:
Oral:
Infants and Children <6 years: 0.05 mg/kg/day as clemastine base or 0.335-0.67 mg/day clemastine fumarate (0.25-0.5 mg base/day) divided into 2 or 3 doses; maximum daily dosage: 1.34 mg (1 mg base)
Children 6-12 years: 0.67-1.34 mg clemastine fumarate (0.5-1 mg base) twice daily; do not exceed 4.02 mg/day (3 mg/day base)
Children 12 years and Adults:
1.34 mg clemastine fumarate (1 mg base) twice daily to 2.68 mg (2 mg base) 3 times/day; do not exceed 8.04 mg/day (6 mg base)
OTC labeling: 1.34 mg clemastine fumarate (1 mg base) twice daily; do not exceed 2 mg base/24 hours
Elderly: Lower doses should be considered in patients >60 years
Monitoring Parameters:
Look for a reduction of rhinitis, urticaria, eczema, pruritus, or other allergic symptoms
Patient Education:
Avoid alcohol; may cause drowsiness, may impair coordination or judgment
Nursing Implications:
Raise bed rails, institute safety measures, assist with ambulation
Dental Health: Effects on Dental Treatment:
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions:
No information available to require special precautions
Mental Health: Effects on Mental Status:
Drowsiness is common; may cause nervousness; rare reports of depression
Mental Health: Effects on Psychiatric Treatment:
Concurrent use with psychotropics may result in additive sedation
Dosage Forms:
Syrup, as fumarate [prescription formulation]: 0.67 mg/5 mL (120 mL) [0.5 mg base/5 mL; contains alcohol 5.5%; citrus flavor]
Tablet, as fumarate: 1.34 mg [1 mg base; OTC], 2.68 mg [2 mg base; prescription formulation]
Dayhist® Allergy, Tavist® Allergy: 1.34 mg [1 mg base]
International Brand Names:
Agasten® (BR); Alagyl® (JP); Alergosan® (YU); Benanzyl® (JP); Clamist® (IN); Clemanil® (JP); Clemastin® (BG, RO); Clemastinum® (PL); Fuluminol® (JP); Inbestan® (JP); Kinotomin® (JP); Lacretin® (JP); Mallermin-F® (JP); Marsthine® (JP); Masletine® (JP); Piloral® (JP); Tavegil® (DE, ES, GB, IT, LU, NL); Tavegyl® (AT, BG, CH, CO, CZ, DK, EG, HU, ID, JO, KW, LB, MT, NO, PT, RO, RU, SE, SI, TR, ZA); Tavist® (MX); Telgin-G® (JP); Xolamin® (JP)
References
"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,"Pediatrics, 2001, 108(3):776-89.
Kok TH, Taitz LS, Bennett MJ, et al, "Drowsiness Due to Clemastine Transmitted in Breast Milk,"Lancet, 1982, 1:914-5.