Pramlyte
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: This product contains iron. EnLyte® should not be used by individuals at risk for iron overload (including transfusional overload) or other conditions for which iron is contraindicated.
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
1.1 Major Depressive Disorder
Escitalopram 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.
1.2 Generalized Anxiety DisorderEscitalopram 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 six months and which the person finds difficult to control. It must be associated with at least three 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.
INDICATIONS AND USAGE: EnLyte® is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias 12 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin13, pregnancy, infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.14,43
EnLyte® is not a drug, but may be used as monotherapy ("rescue" therapy) or adjunctive therapy as determined by your licensed medical practitioner. The adjunctive use of EnLyte® enables medical practitioners to combine therapeutic modalities (dietary management and drug therapy).18,19 In patients with suboptimal folate levels – and as determined by your licensed medical practitioner, EnLyte® may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or vascular nature such as may be found with depression; or EnLyte® may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or methylation metabolic imbalance as may be found with depressed patients.
History
There is currently no drug history available for this drug.
Other Information
Escitalopram tablets, USP are orally administered selective serotonin reuptake inhibitors (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram 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 slightly-yellow 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 tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 10 mg escitalopram base. The 10 mg tablets are scored. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, talc, magnesium stearate, opadry white (Titanium dioxide, Hypromellose 3cP, Hypromellose 6cP, Macrogol and Polysorbate 80).
DESCRIPTION: EnLyte® is an orally-administered prescription folate-containing product for the clinical dietary management of depression related to suboptimal folate levels associated with metabolic imbalances in transformylation and/or methylation biochemistry.1-8,20
Folate appears to enhance synthesis and/or regeneration of tetrahydrobiopterin (BH4), which is an essential cofactor in the biosynthesis of monoamine neurotransmitters serotonin, dopamine and norepinephrine.15,16,17Additionally, folate may normalize elevated homocysteine levels and reduce the risk of neural tube defects. Elevated homocysteine has been observed among women with neural tube defect (NTD)-affected pregnancies.36 The protective effect of DeltaFolateTM in EnLyte® comes in supplying an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease the risk of bioavailability-interference such as might occur with inborn or environmental folate-malabsorption. This allows the folate substrate, THF, to be utilized in transformylation and/or methylation biochemistry.1-8,14
EnLyte® can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
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| INGREDIENTS:*Each oval, annatto-colored MULTIPHASIC soft gelatin capsule contains the following dietary ingredients: | |
| FeGC as ferrous glycine cysteinate (1.5mg elemental iron) from pure amino acid chelate† | 13.6 |
| PS-DHA as phosphatidylserine-docosahexaenoic acid from PS-DHA-Ca† | 6.4 mg |
| PS-EPA as phosphatidylserine-eicosapentaenoate acid from PS-EPA-Ca† | 800 mcg |
| DeltaFolateTM‡ (16 mg) comprised of - | |
| Formyltetrahydrofolic acid | 2.5 mg |
| Controlled-release citrated-pteroylmonoglutamic acid§ , USP | 1 mg |
| L-methylfolate magnesium¶ | 7 mg |
| Citrates § (citric acid, sodium citrates) | 5.5 mg |
| ALSO CONTAINS*: The following distinct dietary ingredients as necessary cofactors, coenzymes and co-metabolites for advanced folate supplementation: | |
| Phosphatidylserine# | 12 mg |
| Ascorbates [as 24 mg magnesium ascorbate and 1 mg zinc ascorbate] | 25 mg |
| Thiamine pyrophosphate | 25 mcg |
| Flavin adenine dinucleotide (FAD) | 25 mcg |
| Nicotinamide adenine dinucleotide hydride (NADH) | 25 mcg |
| Pyridoxal 5' phosphate (P5P) | 25 mcg |
| Adenosylcobalamin | 50 mcg |
| Betaine (trimethylglycine) | 500 mcg |
| L-threonate magnesium | 1 mg |
Sources
Pramlyte Manufacturers
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Allegis Pharmaceuticals, Llc
![Pramlyte (Escitalopram, Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (Thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-threonate And Betaine) Kit [Allegis Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pramlyte | Allegis Pharmaceuticals, Llc
Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive DisorderInitial Treatment
Adolescents
The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram (10 to 20 mg/day) demonstrated the effectiveness of escitalopram [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
Adults
The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologicaltherapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use escitalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Generalized Anxiety DisorderInitial Treatment
Adults
The recommended starting dose of escitalopram tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram TabletsSSymptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram. Conversely, at least 14 days should be allowed after stopping escitalopram before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Tablets, USP with Other MAOIs such as Linezolid or Methylene BlueDo not start escitalopram in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving escitalopram therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
DOSAGE AND ADMINISTRATION: The recommended dose is one softgel daily or as directed under medical supervision to achieve a satisfactory folate-maintenance level. Some individuals may require larger doses as determined by a licensed medical practitioner.
EnLyte® is best absorbed when taken on an empty stomach. During times of medication transition, the amount of EnLyte® may be increased as per direction of your licensed medical practitioner in order to achieve a "rescue" effect.
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Allegis Pharmaceuticals, Llc
Pramlyte | Allegis Pharmaceuticals, Llc
Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive DisorderInitial Treatment
Adolescents
The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram (10 to 20 mg/day) demonstrated the effectiveness of escitalopram [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
Adults
The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologicaltherapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use escitalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Generalized Anxiety DisorderInitial Treatment
Adults
The recommended starting dose of escitalopram tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram TabletsSSymptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram. Conversely, at least 14 days should be allowed after stopping escitalopram before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Tablets, USP with Other MAOIs such as Linezolid or Methylene BlueDo not start escitalopram in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving escitalopram therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
Suggested Use: As a dietary supplement take 1 softgel by mouth daily, or as directed by a healthcare practitioner.
![Pramlyte (Escitalopram Oxylate, Cholecalciferol, Pyridoxal Phosphate Anhydrous, Levomefolate Magnesium, And Methylcobalamin) Kit [Allegis Pharmaceuticals, Llc]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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