A2873 Spinal
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Escitalopram oxalate oral solution is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
Escitalopram oxalate oral solution is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
History
There is currently no drug history available for this drug.
Other Information
Escitalopram oxalate is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:
The molecular formula is C20H21FN2O • C2H2O4 and the molecular weight is 414.40.
Escitalopram oxalate USP occurs as a fine, white to almost white, crystalline powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane.
Escitalopram oxalate USP is available as an oral solution.
Escitalopram oxalate oral solution contains escitalopram oxalate USP equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: anhydrous citric acid, DL – malic acid, glycerin, methylparaben, natural peppermint flavor, noncrystalizing sorbitol solution, propylene glycol, propylparaben, purified water, and sodium citrate.
Sources
A2873 Spinal Manufacturers
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Smiths Medical Asd, Inc.
![A2873 Spinal () C47916 [Smiths Medical Asd, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
A2873 Spinal | Clinical Solutions Wholesale, Llc
Pyrazinamide should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.
Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients.
Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 to 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table).
Alternatively, a twice weekly dosing regimen (50 to 70 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluating the twice weekly regimen, doses of pyrazinamide in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported.
The table is taken from the CDC-American Thoracic Society joint recommendations: 4
Recommended Drugs for the Initial Treatment of Tuberculosis in Children and AdultsDaily Dose*
Maximal Daily
Dose in
Children
and Adults
Twice Weekly Dose
Drug
Children
Adults
Children
Adults
Isoniazid
10 to 20 mg/kg
PO or IM
5 mg/kg
PO or IM
300 mg
20 to 40 mg/kg
Max. 900 mg
15 mg/kg
Max. 900 mg
Rifampin
10 to 20 mg/kg
PO
10 mg/kg
PO
600 mg
10 to 20 mg/kg
Max. 600 mg
10 mg/kg
Max. 600 mg
Pyrazinamide
15 to 30 mg/kg
PO
15 to 30 mg/kg
PO
2 g
50 to 70 mg/kg
50 to 70 mg/kg
Streptomycin
20 to 40 mg/kg
IM
15 mg/kg**
IM
1 g**
25 to 30 mg/kg
IM
25 to 30 mg/kg
IM
Ethambutol
15 to 25 mg/kg
PO
15 to 25 mg/kg
PO
2.5 g
50 mg/kg
50 mg/kg
Definition of abbreviations: PO = perorally; IM = intramuscularly.
* Doses based on weight should be adjusted as weight changes.
**In persons older than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
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