Pramlyte

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 Disorder

Escitalopram 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:

Chemical Structure

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.

*
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Ferrous glycine cysteinate, also known as FERROUS CYSTEINE GLYCINATE, and has the UNII code 8B4OP7RK5N, and is a proprietary ingredient containing pure chelates without interfering ions -resulting in high solubility and absorption;it is the only pure amino acid iron chelate supplement on the market, and is protected under US Patent No. 7,341,708.
DeltaFolateTM is a proprietary folate blend consisting of folinic acid, folic acid and methylfolic acid providing 8.73 mg of active vitamin B9 moiety.
§
CitraFolic® is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration.
L-Methylfolate magnesium is a magnesium salt of methylfolic acid - also known as LEVOMEFOLATE MAGNESIUM, and has the Unique Ingredient Identifier (UNII) code 1VZZ62R081; the active moiety being LEVOMEFOLIC ACID, and has the UNII 8S95DH25XC. L-methylfolate magnesium has the CAS #1429498-11-2.
#
PS-DHA and PS-EPA is an omega-3 derived complex comprising phospholated docosahexaenoic (DHA) and eicosapentaenoic acid (EPA), and is protected under U.S. Patent Nos. 7,935,365 and 5,965,413. It has the following two metabolic substrates*: (1) PS-DHA as the active ingredient phosphatidylserine-docosahexaenoate calcium salt (PS-DHA-Ca) - also known as 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and has UNII code 6WJM73T46K; the active moiety being phosphatidylserine-docosahexaenoic acid (PS-DHA) - also known as 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE, and has UNII code DVY07ILF1W. AND, (2) PS-EPA as the active ingredient phosphatidylserine-eiconosapentanoate calcium salt (PS-EPA-Ca) - also known as 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and has UNII code 9ABD9DRK7B; the active moiety being phosphatidylserine-eiconosapentanoic acid (PS-EPA) - also known as 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE, and has UNII code C3019D8IIA.
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 acid2.5 mg
Controlled-release citrated-pteroylmonoglutamic acid§ , USP1 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 pyrophosphate25 mcg
Flavin adenine dinucleotide (FAD)25 mcg
Nicotinamide adenine dinucleotide hydride (NADH)25 mcg
Pyridoxal 5' phosphate (P5P)25 mcg
Adenosylcobalamin50 mcg
Betaine (trimethylglycine)500 mcg
L-threonate magnesium1 mg

Pramlyte Manufacturers


  • 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]
  • Allegis Pharmaceuticals, Llc
    Pramlyte (Escitalopram Oxylate, Cholecalciferol, Pyridoxal Phosphate Anhydrous, Levomefolate Magnesium, And Methylcobalamin) Kit [Allegis Pharmaceuticals, Llc]

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