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Clemastine (Clemastine Fumarate) - Summary



CLEMASTINE FUMARATE SYRUP, 0.5 mg/5 mL (present as clemastine fumarate 0.67 mg/5 mL)

Each 5 mL (teaspoonful) of Clemastine Fumarate Syrup for oral administration contains clemastine 0.5 mg (present as clemastine fumarate 0.67 mg). Other ingredients: Alcohol 5.5%, Flavors, Maleic Acid, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sodium Hydroxide, and Sorbitol. Clemastine fumarate belongs to the benzhydryl ether group of antihistaminic compounds.

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.

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Published Studies Related to Clemastine

Efficacy and safety of clemastine-pseudoephedrine-acetaminophen versus pseudoephedrine-acetaminophen in the treatment of seasonal allergic rhinitis in a 1-day, placebo-controlled park study. [2003.01]
CONCLUSIONS: Treatment with CPA was safe and highly effective in reducing symptoms associated with SAR. It was more effective than either PA or placebo over most of the postdose observation period.

Administration of clemastine--H1 histamine receptor blocker in the prevention of haemodynamic disorders after protamine sulfate administration in patients subjected to coronary artery bypass grafting in extracorporeal circulation. [2000.07]
INTRODUCTION: Adverse effects of protamine administration after CPB: fall in arterial blood pressure and pulmonary hypertension are still a source of problems... We conclude that administration of clemastine is connected with the normalization of ABP during and after protamine reversal of heparin coagulation during CABG operations.

Effectiveness of clemastine fumarate for treatment of rhinorrhea and sneezing associated with the common cold. [1997.10]
Limited data support the use of first-generation antihistamines for treatment of the common cold. The purpose of this study was to test the effectiveness of clemastine fumarate, a first-generation antihistamine, for treatment of sneezing and rhinorrhea associated with naturally occurring common colds...

Low dose clemastine inhibits sneezing and rhinorrhea during the early nasal allergic reaction. [1997.03]
BACKGROUND: Clemastine (1 mg) is currently available over-the-counter for the treatment of allergic rhinitis. OBJECTIVE: To evaluate the efficacy of half the standard dose of clemastine (0.5 mg) in inhibiting the nasal response to allergen and the cutaneous response to histamine... CONCLUSIONS: The data show that clemastine, given at half the usual dose four and six hours prior to allergen challenge, provides relief for sneezing and rhinorrhea and suggests that this dose might be useful in the treatment of allergic rhinitis.

The pharmacokinetics and bioavailability of clemastine and phenylpropanolamine in single-component and combination formulations. [1996.10]
Studies were conducted in healthy male volunteers (n = 171; age range, 19-49 years; 22-27 subjects per study) to examine the following: pharmacokinetics and dose proportionality of the antihistamine clemastine; the effect of coadministration of phenylpropanolamine and clemastine on the pharmacokinetics of the two drugs; and the bioavailability of clemastine tablets and combination tablets of clemastine and sustained-release phenyl-propanolamine under fasted and fed conditions after single-dose administration and at steady state...

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Clinical Trials Related to Clemastine

Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis [Not yet recruiting]
Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.

Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis [Recruiting]
The main purpose of this study is to assess clemastine as a remyelinating agent in patients with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with multiple sclerosis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. The study will also assess the robustness and stability of this clinical effect in patients taking clemastine for up to 3 months. Patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.

Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis [Not yet recruiting]

AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study [Recruiting]
This is a multicenter study recruiting patients with angioedema induced by ACEI.

Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which the investigators have been previously treated in the investigators centers with current "standard" therapy (250 mg methylprednisolon and 2 mg clemastine).

In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention.

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Page last updated: 2007-05-02

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