Clemastine Fumarate Syrup
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Questions & Answers
Side Effects & Adverse Reactions
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 fumarate 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.
History
There is currently no drug history available for this drug.
Other Information
Each teaspoonful (5 mL) of Clemastine Fumarate Syrup for oral administration contains clemastine 0.5 mg (present as clemastine fumarate 0.67 mg). Other ingredients: alcohol 5.5%, flavor, fumaric acid, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol in a buffered solution. Clemastine fumarate belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]- oxy]ethyl]-1-methylpyrrolidine fumarate and has the following structural formula:
C21H26CINO.C4H4O4 M.W. 459.97
CAS Registration Number 145976-57-9
Clemastine fumarate occurs as a colorless to faintly yellow, practically odorless, crystalline powder. Clemastine Fumarate Syrup has an approximate pH of 6.2.
Sources
Clemastine Fumarate Syrup Manufacturers
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Qualitest Pharmaceuticals, Inc
![Clemastine Fumarate Syrup [Qualitest Pharmaceuticals, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clemastine Fumarate Syrup | Qualitest Pharmaceuticals, Inc
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 (1.0 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).
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Silarx Pharmaceuticals, Inc
Clemastine Fumarate Syrup | Silarx Pharmaceuticals, Inc
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 (1.0 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).
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Teva Pharmaceuticals Usa Inc
Clemastine Fumarate Syrup | Teva Pharmaceuticals Usa Inc
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.
Pediatric Children aged 6 to 12 yearsFor 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 OverFor Symptoms of Allergic Rhinitis - The starting dose is 2 teaspoonfuls (1 mgclemastine) 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).
![Clemastine Fumarate Syrup [Silarx Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3f5dbf44-7cad-491f-ad5f-ad4bd06682a6&name=container120mL.jpg)
![Clemastine Fumarate Syrup [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b7e88fa7-fa92-48be-86ab-7e375d710251&name=image-02.jpg)
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