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 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 inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. In laboratory animals, no anticholinergic or alpha1-adrenergic-receptor blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier.

Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines.

It has the potential for excitatory side effects. At the recommended oral dose, it has little or no pressor effect in normotensive adults. Pharmacokinetics The pharmacokinetics of fexofenadine hydrochloride in subjects with seasonal allergic rhinitis were similar to those in healthy volunteers. Absorption The pharmacokinetics of fexofenadine hydrochloride and pseudoephedrine hydrochloride when administered separately have been well characterized.

Fexofenadine pharmacokinetics were linear for oral doses of fexofenadine hydrochloride up to a total daily dose of mg mg twice daily. Peak fexofenadine plasma concentrations were similar between adolescent 12—16 years of age and adult subjects. The bioavailability of fexofenadine hydrochloride and pseudoephedrine hydrochloride from the extended-release tablets is similar to that achieved with separate administration of the components. Coadministration of fexofenadine and pseudoephedrine does not significantly affect the bioavailability of either component.

The rate or extent of pseudoephedrine absorption was not affected by food. The protein binding of pseudoephedrine in humans is not known. Pseudoephedrine hydrochloride is extensively distributed into extravascular sites apparent volume of distribution between 2. Elimination The mean elimination half-life of fexofenadine was 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 12 HOUR Extended-Release Tablets are indicated for the relief of seasonal allergic rhinitis in adults and children 12 years of age and older.

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 12 HOUR should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function.

Occasionally, the inactive ingredients of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 12 HOUR may be eliminated in the feces in a form that may resemble the original tablet. Due to its pseudoephedrine component, Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 12 HOUR is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase MAO inhibitor therapy or within fourteen 14 days of stopping such treatment see Drug Interactions section.

It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats.

Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis.

Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine hydrochloride administered alone distributes into breast milk of lactating human females.

A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

In addition, the doses of the individual components in Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 12 HOUR exceed the recommended individual doses for pediatric patients under 12 years of age. The pseudoephedrine component of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 12 HOUR is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Information for Patients Patients taking Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should receive the following information: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are prescribed for the relief of symptoms of seasonal allergic rhinitis.

Patients should be instructed to take Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets only as prescribed. Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the doctor. Patients should also be advised against the concurrent use of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets with over-the-counter antihistamines and decongestants. The product should not be used by patients who are hypersensitive to it or to any of its ingredients.

Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase MAO inhibitor or within 14 days of stopping use of MAO inhibitor. There was no evidence of tolerance to these effects after 28 days of dosing.

The clinical significance of these observations is unknown. This concentration was at least 21 times the therapeutic plasma concentration in man based on a 60 mg twice daily fexofenadine hydrochloride dose. No statistically significant increase in mean QT interval compared to placebo was observed in subjects with seasonal allergic rhinitis given fexofenadine hydrochloride capsules in doses of 60 mg to mg twice daily for 2 weeks or in 40 healthy volunteers given fexofenadine hydrochloride as an oral solution at doses up to mg twice daily for 6 days.

Statistically significant reductions in symptom scores were observed following the first 60 mg dose, with the effect maintained throughout the hour interval. In general, there was no additional reduction in total symptom scores with higher doses of fexofenadine hydrochloride up to mg twice daily. Although the number of subjects in some of the subgroups was small, there were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race.

Onset of action for reduction in total symptom scores, excluding nasal congestion, was observed at 60 minutes compared to placebo following a single 60 mg fexofenadine hydrochloride dose administered to subjects with seasonal allergic rhinitis who were exposed to ragweed pollen in an environmental exposure unit. 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.

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Due to its pseudoephedrine component, Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase MAO inhibitor therapy or within fourteen 14 days of stopping such treatment see Drug Interactions section.

It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures.

Manifestations of patient idiosyncrasy to adrenergic agents include: Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Patients taking Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should receive the following information: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are prescribed for the relief of symptoms of seasonal allergic rhinitis. Patients should be instructed to take Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets only as prescribed.

Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the doctor. Patients should also be advised against the concurrent use of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets with over-the-counter antihistamines and decongestants. The product should not be used by patients who are hypersensitive to it or to any of its ingredients.

Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase MAO inhibitor or within 14 days of stopping use of MAO inhibitor. It also should not be used by patients with severe hypertension or severe coronary artery disease. Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.

Patients should be advised to take the tablet on an empty stomach with water. Patients should be directed to swallow the tablet whole. Patients should be cautioned not to break or chew the tablet. Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children.

Fexofenadine

Fexofenadine hydrochloride inhibited antigen -induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in fexofenadine. There was generico revia naltrexone 50mg evidence 120mg tolerance to pseudoephedrine effects after 28 days of dosing. Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the hcl mucosa. The rate or extent of pseudoephedrine absorption was not affected by food. Across several trials, no clinically significant hcl differences were observed in the pharmacokinetics of fexofenadine hydrochloride. Peak fexofenadine plasma concentrations were similar between adolescent years of age and adult subjects. Pseudoephedrine has been shown and have a mean elimination half-life of 4—6 hours which is dependent on urine pH. It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. It has the potential for excitatory side effects. This observed increase in the bioavailability of fexofenadine may be due to transport-related effects, fexofenadine hcl 60mg and pseudoephedrine hcl 120mg, such as p-glycoprotein. The effect on pseudoephedrine pharmacokinetics is unknown. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. In general, there was no additional reduction 60mg total symptom scores with higher doses of fexofenadine hydrochloride up to mg twice daily.

Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride administered alone distributes into breast milk of lactating human females. The percent of subjects who withdrew prematurely because 120mg adverse events was 3. Single doses of fexofenadine hydrochloride up to mg 6 healthy volunteers at this dose leveland doses up to mg twice hcl for one month 3 healthy volunteers at this dose levelwere administered without the development of clinically significant adverse events. Interactions with Fruit Juices Fruit juices such as grapefruit, fexofenadine hcl 60mg and pseudoephedrine hcl 120mg, orange and apple may reduce the bioavailability and exposure of fexofenadine. It also should not be used 60mg patients with severe hypertension or severe coronary artery disease. Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. At the recommended oral dose, it has little or no pressor effect in normotensive adults. The elimination half-life is decreased at urine pH lower than 6 and may be hcl at benicar drug price pH higher than 8. Patients should be directed to swallow the tablet whole. In a double-blind, placebo-controlled, crossover study of the acute effects of single doses of fexofenadine mg, olopatadine 10 mg, and chlorphenamine 4 mg on cognitive and psychomotor performance in 11 healthy Japanese volunteers, both chlorphenamine and olopatadine reduced behavioral activity while fexofenadine was similar to placebo 44C. Because elderly patients and more likely to have decreased renal function, care fexofenadine be taken in dose selection, and it may be useful to monitor renal function. Moreover, no sedative or pseudoephedrine central nervous system effects were observed. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis.

DESCRIPTION

Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant. No data are available on the pharmacokinetics of pseudoephedrine in renally-impaired subjects, fexofenadine hcl 60mg and pseudoephedrine hcl 120mg. In vivo animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases fexofenadine gastrointestinal secretion, 120mg erythromycin may also decrease biliary excretion. Statistically significant reductions in symptom scores were observed following the first 60 mg dose, with the effect maintained throughout the hour interval. Although the number of subjects in some of the hcl was small, there were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. 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. Although the number of subjects in some of the subgroups was small, there were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race. Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal hcl. Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elimination half-life is decreased at urine pH lower than 6 and may be increased at urine pH higher than 8. Coadministration of fexofenadine and pseudoephedrine does buy propecia online 4 fexofenadine affect the bioavailability pseudoephedrine either component. However, and of 60mg hydrochloride with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine.

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