Clinical medicine profile
Clemastine
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- CONTRAINDICATIONS Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS- Drug Interactions ).
- Antihistamines should not be used in newborn or premature infants .
- Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (see PRECAUTIONS-Nursing Mothers ).
Precautions
- WARNINGS Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction.
- Use with CNS Depressants Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).
- Use in Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.
- Use in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. Pediatric Children aged 6 to 12 years For Symptoms of Allergic Rhinitis The starting dose is 1 teaspoonful (0.5 mg clemastine) twice daily. Since single doses of up to 2.25 mg clemastine were well tolerated by this age group, dosage may be increased as required, but not to exceed 6 teaspoonfuls daily (3 mg clemastine). For Urticaria and Angioedema The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily, not to exceed 6 teaspoonfuls daily (3 mg clemastine). Adults and Children 12 Years and Over For Symptoms of Allergic Rhinitis The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily. Dosage may be increased as required, but not to exceed 12 teaspoonfuls daily (6 mg clemastine). For Urticaria and Angioedema The starting dose is 4 teaspoonfuls (2 mg clemastine) twice daily, not to exceed 12 teaspoonfuls daily (6 mg clemastine).
Pediatric Use The safety and efficacy of Clemastine Fumarate Syrup has been confirmed in the pediatric population (age 6 years through 12). Safety and dose tolerance studies have confirmed pediatric patients 6 through 11 years tolerated dosage ranges of 0.75 to 2.25 mg clemastine. In pediatric patients particularly, antihistamines in overdosage may produce hallucinations, convulsions and death. Symptoms of antihistamine toxicity in pediatric patients may include fixed dilated pupils, flushed face, dry mouth, fever, excitation, hallucinations, ataxia, incoordination, athetosis, tonic- lonic convulsions, and postictal depression (see OVERDOSAGE ).
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation.
- Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION ).
- It should be noted that clemastine is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.
Adverse effects
- ADVERSE REACTIONS The most frequent adverse reactions are italicized: Nervous System Sedation , sleepiness , dizziness , disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.
- Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation.
- Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.
- Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles.
- Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis.
- Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses.
- General Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.
- To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Open multi-drug checker ↗- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Mechanism & disposition
It acts by competing with histamine for H1-receptor sites on effector cells.
Read complete mechanism
It acts by competing with histamine for H1-receptor sites on effector cells. Its anticholinergic actions give a drying effect on the nasal mucosa. Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
See product SmPC
of antihistamines is often partially delayed by the use of controlled release dosage forms. In these instances, plasma concentrations from identical doses of the immediate and controlled release dosage forms will not be similar. Tissue
of the antihistamines in humans has not been established. Antihistamines appear to be metabolized in the liver chiefly via mono- and didemethylation and glucuronide conjugation. Antihistamine metabolites and small amounts of unchanged drug are excreted in the urine. Small amounts...
is the major mode of elimination.
Pregnancy, lactation & diet
Pregnancy Teratogenic Effects Pregnancy Category B Oral reproduction studies performed with clemastine fumarate in rats and rabbits at doses up to 312 and 188 times the adult human doses respectively, have revealed no evidence of teratogenic effects. There are no adequate and well-controlled studies of clemastine fumarate in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
Nursing Mothers Although quantitative determinations of antihistaminic drugs in breast milk have not been reported, qualitative tests have documented the excretion of diphenhydramine, pyrilamine, and tripelennamine in human milk. Because of the potential for adverse reactions in nursing infants from antihistamines, a decision should be made whether to discontinue nursing or to discontinue the drug.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
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| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.