day without work [12:<12 years of age: Initially, 1.34 mg twice daily (as oral solution). 101 May increase dosage as necessary, not to exceed 4.02 mg daily. 101 103 a Children 12 years of age: 2.68 mg 1 3 times daily (as tablets or oral solution), not to exceed 8.04 mg daily. 101 102 103 a Common Cold Oral Self-medication in children 12 years of age: Usually, 1.34 mg every 12 hours (as tablets), not to exceed 2.68 mg daily unless otherwise directed by a clinician. a Adults Allergic Conditions Allergic Rhinitis Oral Initially, 1.34 mg every 12 hours (as tablets or oral solution); this is the maximum dosage recommended for self-medication . a When used under the direction of a clinician, may increase dosage as necessary, not to exceed 8.04 mg daily. 101 102 103 a Allergic Skin Disorders Oral 2.68 mg 1 3 times daily (as tablets or oral solution), not to exceed 8.04 mg daily. 101 102 103 a Common Cold Oral Self-medication : Usually, 1.34 mg every 12 hours (as tablets), not to exceed 2.68 mg daily unless otherwise directed by a clinician. a Prescribing Limits Pediatric Patients Allergic Conditions Allergic Rhinitis Oral Children 6 to> <12 years of age: Maximum 4.02 mg daily. 101 a Children 12 years of age: For self-medication , maximum 1.34 mg every 12 hours. a When used under the direction of a clinician, maximum 8.04 mg daily. 101 102 a Allergic Skin Disorders Oral Children 6 to> <12 years of age: Maximum 4.02 mg daily. 101 a Children 12 years of age: Maximum 8.04 mg daily. 101 102 a Common Cold Oral Children 12 years of age: For self-medication , maximum 2.68 mg daily unless otherwise directed by a clinician. a Adults Allergic Conditions Allergic Rhinitis Oral Self-medication : Maximum 1.34 mg every 12 hours. a When used under the direction of a clinician, maximum 8.04 mg daily. 101 102 a Allergic Skin Disorders Oral Maximum 8.04 mg daily. 101 102 a Common Cold Oral Self-medication : Maximum 2.68 mg daily unless otherwise directed by a clinician. a Special Populations Geriatric Patients Reduce dosage if mild adverse effects occur. b (See Geriatric Use under Cautions.) Cautions for Clemastine Fumarate Contraindications Use contraindicated in neonates and premature infants. 101 103 a (See Pediatric Use under Cautions.) Women who are breast-feeding. 101 102 103 (See Lactation under Cautions.) Patients receiving MAO inhibitor therapy. 102 (See Interactions.) Known hypersensitivity to clemastine, other antihistamines with similar chemical structure, or any ingredient in the formulation. 101 102 103 Warnings/Precautions Warnings Concomitant Diseases Because of anticholinergic effects, use with extreme caution in patients with angle-closure glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, or symptomatic prostatic hypertrophy. 101 102 103 b Use with caution in patients with history of bronchial asthma, increased IOP, hyperthyroidism, or cardiovascular disease (e.g., hypertension). 101 102 103 CNS Effects Risk of drowsiness. 101 103 b (See CNS Depressants under Interactions and also see Advice to Patients.) Possible excitability (especially in children). 104 105 b (See Pediatric Use under Cautions.) Specific Populations Pregnancy Category B. 101 103 106 Lactation Distributed into milk. Some manufacturers recommend discontinuance of nursing or the drug because of potential risk to nursing infants (see Contraindications under Cautions). 101 102 103 However, AAP states that the drug may be used with caution during breast-feeding. 106 Pediatric Use Contraindicated in neonates and premature infants. 101 103 a Possible paradoxical excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures), especially in children. 104 105 b Safety and efficacy of tablets not established in children> <12 years of age. 102 a Safety and efficacy of oral solution not established in children> <6 years of age. 101 103 a Risk of overdosage and toxicity (including death) in children> <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommended not to use such preparations in children> <2 years of age; safety and efficacy in older children under evaluation. Because children 2 3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations agreed to voluntarily revise the product labeling to state that such preparations should not be used in children> <4 years of age. FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about . Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage. Geriatric Use Possible increased risk of dizziness, sedation, and hypotension in patients 60 years of age. 101 102 103 (See Geriatric Patients under Dosage and Administration.) Common Adverse Effects Sedation, 101 102 103 sleepiness, 101 102 103 dizziness, 101 102 103 disturbed coordination, 101 102 103 epigastric distress, 101 102 103 thickening of bronchial secretions. 101 102 103 Interactions for Clemastine Fumarate Specific Drugs and Laboratory Tests Drug or Test Interaction Comments CNS depressants (e.g., alcohol, hypnotics, sedatives, tranquilizers) Possible additive CNS depression 101 102 103 104 105 b Avoid concomitant use 101 103 MAO inhibitors MAO inhibitors prolong and intensify anticholinergic effects of antihistamines 101 102 103 b Concomitant use contraindicated 102 Test, antigen or histamine Inhalation-challenge testing with histamine or antigen: Possible suppression of test response Antigen skin testing: Possible suppression of wheal and flare reactions Clemastine Fumarate Pharmacokinetics Absorption Bioavailability Rapidly and almost completely absorbed from the GI tract. 101 102 103 a Peak plasma concentrations achieved within 2 5 hours following oral administration. 101 102 103 Onset Antihistaminic effect is maximal within 5 7 hours. 101 102 103 Duration Antihistaminic effect persists for 10 12 hours and, in some individuals, up to 24 hours. 101 102 103 Distribution Extent Distribution into human body fluids and tissues not fully characterized. Distributed into milk. Elimination Metabolism Exact metabolic fate not clearly established, but appears to be extensively metabolized. Elimination Route Excreted principally in urine as unchanged drug and metabolites. 101 102 103 Stability Storage Oral Tablets Tight, light-resistant containers at 20 25 C. 102 Oral Solution Tight, light-resistant, upright containers 103 at 20 25 C. 101 103 Actions Blocks H 1 -receptor sites, thereby preventing the action of histamine on the cell. 101 103 b Suppresses flare and pruritus that accompany the endogenous release of histamine. 101 b Has anticholinergic and sedative effects. 101 102 103 Antihistamines do not block the stimulating effect of histamine on gastric acid secretion, which is mediated by H 2 -receptors of the parietal cells. b Advice to Patients Risk of drowsiness; avoid alcohol and avoid engaging in hazardous tasks (e.g., operating machinery, driving a motor vehicle) until effects on individual are known. 101 102 103 104 105 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses. 101 102 103 Importance of patients already receiving another CNS depressant (e.g., sedative, tranquilizer) not undertaking self-medication without first consulting a clinician. 104 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 101 102 103 Importance of informing patients of other important precautionary information. 101 102 103 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Clemastine Fumarate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Solution 0.67 mg/5 mL* Clemastine Fumarate Syrup Tablets 1.34 mg* Clemastine Fumarate Tablets Dayhist Allergy Major Tavist Allergy (formerly Tavist-1 ) (scored) Novartis 2.68 mg* Clemastine Fumarate Tablets (scored) AHFS DI Essentials. Copyright 2017, Selected Revisions February 1, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 101. Teva Pharmaceuticals. Clemastine fumarate syrup prescribing information. Sellersville, PA; 2003 Apr. 102. Teva Pharmaceuticals. Clemastine fumarate tablets prescribing information. Sellersville, PA; 2003 Aug. 103. Major Pharmaceuticals. Clemastine fumarate syrup prescribing information. Livonia, MI; 2001 May. 104. Major Pharmaceuticals. Dayhist Allergy product information. Livonia, MI. From Major Pharmaceuticals website (). Accessed 2008 Jan 17. 105. Novartis. East Hanover, NJ: Personal communication. 106. Clemastine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:341-2. a. AHFS Drug Information 2008. McEvoy GK, ed. Clemastine Fumarate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:14-5. b. AHFS Drug Information 2008. McEvoy GK, ed. Antihistamines General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1-8. Next Interactions Print this page Add to My Med List More about clemastine Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: antihistamines Consumer resources Clemastine Clemastine Tablets Clemastine Syrup Professional resources Clemastine (FDA) Clemastine Syrup (FDA) Clemastine (Wolters Kluwer) Other brands: 12 Hour Allergy Relief , Dayhist Allergy , Leader Allerhist Related treatment guides Allergic Rhinitis Allergic Reactions Urticaria> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Sandoz Inc. Teva Pharmaceuticals USA, Inc. Drug Class Antihistamines Related Drugs Urticaria Zyrtec , promethazine , loratadine , cetirizine , Claritin , diphenhydramine , Benadryl , fexofenadine , More... Allergic Reactions prednisone , promethazine , loratadine , triamcinolone , diphenhydramine , Benadryl , EpiPen , Phenergan , More... Allergic Rhinitis prednisone , Zyrtec , promethazine , fluticasone nasal , loratadine , cetirizine , Flonase , triamcinolone , More... Clemastine Rating 2 User Reviews 8.0 /10 2 User Reviews 8.0 Rate it! Clemastine Images Clemastine systemic 2.68 mg (93 308 ) View all images} } that every one
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