Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see CONTRAINDICATIONS). Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets for oral administration contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. Tablets also contain as excipients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, carnauba wax, stearic acid, silicon dioxide, hypromellose and polyethylene glycol.
Fexofenadine hydrochloride, one of the active ingredients, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride and the following chemical structure:
The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl. Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH.
Pseudoephedrine hydrochloride, the other active ingredient, is an adrenergic (vasoconstrictor) agent with the chemical name [S-(R*,R*)]-α-[1-(methylamino)ethyl]-benzenemethanol hydrochloride and the following chemical structure:
The molecular weight is 201.70. The molecular formula is C10H15NO•HCl. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform.
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Manufacturers
Physicians Total Care, Inc.
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride | Physicians Total Care, Inc.
The recommended dose of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets is one tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function. (See CLINICAL PHARMACOLOGY and PRECAUTIONS.)
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets may be eliminated in the feces in a form that may resemble the original tablet. (See PRECAUTIONS, Information for Patients.)
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride | Rebel Distributors Corp
The recommended dose of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets is one tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function. (See CLINICAL PHARMACOLOGY and PRECAUTIONS.)
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets may be eliminated in the feces in a form that may resemble the original tablet. (See PRECAUTIONS, Information for Patients.)