Sentroxatine (Page 9 of 9)
17.1 General Information 17.2 Clinical Worsening and Suicide Risk 17.3 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions 17.4 Allergic Reactions and Rash 17.5 Abnormal Bleeding 17.6 Hyponatremia 17.7 Potential for Cognitive and Motor Impairment 17.8 Use of Concomitant Medications 17.9 Discontinuation of Treatment 17.10 Use in Specific Populations
17 PATIENT COUNSELING INFORMATION
See the FDA-approved Medication Guide.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine.
17.1 General Information
Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine capsules and to reread it each time the prescription is renewed.
Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine capsules and should counsel them in its appropriate use. Healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking fluoxetine capsules.
17.2 Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Box Warning and Warnings and Precautions (5.1)].
17.3 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions
Patients should be cautioned about the risk of serotonin syndrome or NMS-like reactions with the concomitant use of fluoxetine and triptans, tramadol, or other serotonergic agents [see Warnings and Precautions (5.2) and Drug Interactions (7.3)].
Patients should be advised of the signs and symptoms associated with serotonin syndrome or NMS-like reactions that may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, in which the symptoms may include hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be cautioned to seek medical care immediately if they experience these symptoms.
17.4 Allergic Reactions and Rash
Patients should be advised to notify their physician if they develop a rash or hives [see Warnings and Precautions (5.3)]. Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing. Patients should be cautioned to seek medical care immediately if they experience these symptoms.
17.5 Abnormal Bleeding
Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions (5.7) and Drug Interactions (7.6)]. Patients should be advised to call their doctor if they experience any increased or unusual bruising or bleeding while taking fluoxetine.
17.6 Hyponatremia
Patients should be advised that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including fluoxetine. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death [see Warnings and Precautions (5.8)].
17.7 Potential for Cognitive and Motor Impairment
Fluoxetine may impair judgment, thinking, or motor skills. Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected [see Warnings and Precautions (5.11)].
17.8 Use of Concomitant Medications
Patients should be advised to inform their physician if they are taking, or plan to take, any prescription medication, including Symbyax®, Sarafem®, or over-the-counter drugs, including herbal supplements or alcohol. Patients should also be advised to inform their physicians if they plan to discontinue any medications they are taking while on fluoxetine.
17.9 Discontinuation of Treatment
Patients should be advised to take fluoxetine exactly as prescribed, and to continue taking fluoxetine as prescribed even after their symptoms improve. Patients should be advised that they should not alter their dosing regimen, or stop taking fluoxetine without consulting their physician [see Warnings and Precautions (5.13)]. Patients should be advised to consult with their healthcare provider if their symptoms do not improve with fluoxetine.
17.10 Use in Specific Populations
Pregnancy — Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].
Nursing Mothers — Patients should be advised to notify their physician if they intend to breast-feed an infant during therapy. Because fluoxetine is excreted in human milk, nursing while taking fluoxetine is not recommended [see Use in Specific Populations (8.3)].
Pediatric Use — Fluoxetine is approved for use in pediatric patients with MDD and OCD [see Box Warning and Warnings and Precautions (5.1)]. Limited evidence is available concerning the longer-term effects of fluoxetine on the development and maturation of children and adolescent patients. Height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see Warnings and Precautions (5.6) and Use in Specific Populations (8.4)].
Manufactured by: PLIVA
for: PLIVA®, Inc., Pomona, NY 10970
Dist. by Barr Laboratories, Inc., Pomona, NY 10970
Iss. 1/2010
MEDICATION GUIDE
FLUOXETINE CAPSULES USP
Rx only
Read the Medication Guide that comes with fluoxetine capsules USP before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about fluoxetine capsules USP.
What is the most important information I should know about fluoxetinecapsules USP?
Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:
Talk to your, or your family member’s, healthcare provider about:
– all risks and benefits of treatment with antidepressant medicines
– all treatment choices for depression or other serious mental illness
1. Antidepressant medicines may increase suicidal thoughts or actions in some
children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes
of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in
myself or a family member?
– Pay close attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed
– Call the healthcare provider right away to report new or sudden changes in
mood, behavior, thoughts, or feelings.
– Keep all follow-up visits with the healthcare provider as scheduled. Call
the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
– thoughts about suicide or dying
– attempts to commit suicide
– new or worse depression
– new or worse anxiety
– feeling very agitated or restless
– panic attacks
– trouble sleeping (insomnia)
– new or worse irritability
– acting aggressive, being angry, or violent
– acting on dangerous impulses
– an extreme increase in activity and talking (mania)
– or other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
– Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
– Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
– Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
– Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
– Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
What are fluoxetine capsules USP?
Fluoxetine capsules USP are a prescription medicine used:
– for short and long-term treatment of depression in adults and children over the age of 8.
– for short and long-term treatment of Obsessive Compulsive Disorder (OCD) in adults and children over the age of 7.
– for short and long-term treatment of Bulimia Nervosa in adults.
– for short-term treatment of Panic Disorder, with or without agoraphobia, in adults.
The symptoms of depression (Major Depressive Disorder) include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. With treatment, some of your symptoms of depression may improve.
OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). With treatment, some of your symptoms of OCD may improve.
Panic Disorder is an anxiety disorder that includes panic attacks, which are sudden feelings of terror for no reason. You may also have physical symptoms, such as; fast heartbeat, chest pain, breathing difficulty, dizziness. With treatment, some of your symptoms of Panic Disorder may improve.
Bulimia Nervosa, involves periods of overeating followed by purging (e.g., vomiting, excessive laxative use). With treatment, some of your symptoms of Bulimia Nervosa may improve.
If you do not think you are getting better, call your doctor.
Who should not take fluoxetine capsules USP?
– Do not take fluoxetine capsules USP if you take a Monoamine Oxidase Inhibitor (MAOI) or if you stopped taking an MAOI in the last 2 weeks.
– Do not take an MAOI within 5 weeks of stopping fluoxetinecapsules USP. People who take fluoxetine capsules USP close in time to an MAOI can have serious and life-threatening side effects, with symptoms including:
– high fever
– continued muscle spasms that you can not control
– rigid muscles
– changes in heart rate and blood pressure that happen fast
– confusion
– unconsciousness
Ask your doctor or pharmacist if you are not sure if your medicine is an MAOI.
– Do not take fluoxetine capsules USP if you take Mellaril® (thioridazine). Do not take Mellaril®within 5 weeks of stopping fluoxetinecapsules USP. Mellaril® can cause serious heart rhythm problems and you could die suddenly.
– Do not take fluoxetine capsules USP if you take the antipsychotic medicine pimozide (Orap®).
What should I tell my doctor before taking fluoxetinecapsules USP?
Fluoxetine capsules USP may not be right for you. Before starting fluoxetine capsules USP, tell your doctor about all your medical conditions, including if you have or had any of the following:
– seizures (convulsions)
– bipolar disorder (mania)
– are pregnant or plan to become pregnant. It is not known if fluoxetine
capsules USP will harm your unborn baby.
– are breast-feeding or plan to breast-feed. Fluoxetine can pass into your
breast milk and may harm your baby. You should not breast-feed while taking fluoxetine capsules USP. Talk to your doctor about the best way to feed your baby if you take fluoxetine capsules USP.
Tell your doctor about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine capsules USP and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take fluoxetine capsules USP with your other medicines. Do not start or stop any medicine while taking fluoxetine capsules USP without talking to your doctor first.
If you take fluoxetinecapsules USP, you should not take any other medicines that contain fluoxetine hydrochloride:
– Symbyax®
– Sarafem®
– Prozac® Weekly™
You could take too much medicine (overdose).
How should I take fluoxetinecapsules USP?
– Take fluoxetine capsules USP exactly as prescribed. Your doctor may need to change (adjust) the dose of fluoxetine capsules USP until it is right for you.
– If you miss a dose of fluoxetine capsules USP, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine capsules USP at the same time.
– To prevent serious side effects, do not stop taking fluoxetinecapsules USP suddenly. If you need to stop taking fluoxetine capsules USP, your doctor can tell you how to safely stop taking them.
– If you take too many fluoxetine capsules USP, call your doctor or poison control center right away, or get emergency treatment.
– Fluoxetine capsules USP can be taken with or without food.
– Fluoxetine capsules USP are usually taken once a day.
– If you do not think you are getting better or have any concerns about your condition while taking fluoxetine capsules USP, call your doctor.
What should I avoid while taking fluoxetinecapsules USP?
– Fluoxetine capsules USP can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how fluoxetine capsules USP affect you.
What are the possible side effects of fluoxetine capsules USP?
Fluoxetine capsules USP may be associated with the following serious risks:
– Serotonin Syndrome: This is a condition that can be life threatening. Call your doctor right away if you become severely ill and have some or all of these symptoms:
– agitation
– hallucinations
– problems with coordination
– racing heart beat
– over-active reflexes
– fever
– nausea, vomiting, and diarrhea
– Severe allergic reactions: Tell your doctor right away if you get red itchy welts (hives) or, a rash alone or with fever and joint pain, while taking fluoxetine capsules USP. Call your doctor right away if you become severely ill and have some or all of these symptoms:
– swelling of your face, eyes, or mouth
– trouble breathing
– Abnormal bleeding: Tell your doctor if you notice any increased or unusual bruising or bleeding while taking fluoxetine capsules USP, especially if you take one of these medicines:
– the blood thinner warfarin (Coumadin®, Jantoven®)
– a non-steroidal anti-inflammatory drug (NSAID)
– aspirin
– Mania: You may have a high mood, become extremely irritable, have too much energy, feel pressure to keep talking, or have a decreased need for sleep.
– Seizures
– Loss of appetite
– Low salt (sodium) levels in the blood (hyponatremia): Call your doctor right away if you become severely ill and have some or all of these symptoms:
– headache
– feel weak
– confusion
– problems concentrating
– memory problems
– feel unsteady
Common possible side effects of fluoxetine capsules USP include: abnormal dreams, orgasm problems, decreased appetite, anxiety, weakness, diarrhea, dry mouth, indigestion, flu, difficulty maintaining an erection for sexual activity, trouble sleeping, decreased sex drive, feeling sick to your stomach, nervousness, sore throat, rash, watery nasal discharge, sleepiness, sweating, tremor (shakes), hot flashes, and yawn.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects with fluoxetine capsules USP. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store fluoxetinecapsules USP?
– Store fluoxetine capsules USP at room temperature, between 68°F to 77°F (20°C to 25°C).
– Keep fluoxetine capsules USP away from light.
– Keep fluoxetine capsules USP bottle closed tightly.
Keep fluoxetinecapsules USP and all medicines out of the reach of children.
General information about fluoxetinecapsules USP
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine capsules USP for a condition for which they were not prescribed. Do not give fluoxetine capsules USP to other people, even if they have the same condition. They may harm them.
This Medication Guide summarizes the most important information about fluoxetine capsules USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about fluoxetine capsules USP that was written for healthcare professionals. For more information about fluoxetine capsules USP call 1-888-838-2872, MEDICAL AFFAIRS.
What are the ingredients in fluoxetine capsules USP?
Active ingredient: fluoxetine hydrochloride.
Inactive ingredients: ammonium hydroxide, DandC Yellow #10, FDandC Blue #1, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, and titanium dioxide.
Symbyax® and Sarafem® are registered trademarks of Eli Lilly and Company.
Prozac® Weekly™ is a trademark of Eli Lilly and Company.
Mellaril® is a registered trademark of Novartis AG Corporation.
Orap® is a registered trademark of Teva Pharmaceuticals USA.
Coumadin® is a registered trademark of Bristol Myers Squibb.
Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.
Manufactured by: PLIVA Krakow Pharmaceutical Company S.A.
Krakow, Poland
for: PLIVA®, Inc., Pomona, NY 10970
Dist. by Barr Laboratories, Inc., Pomona, NY 10970
Iss. 1/2010
EACH CAPSULE CONTAINS:
*Fluoxetine Hydrochloride, USP
equivalent to Fluoxetine …………….. 10 mg
Dispense in a tight, light-resistant container.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]..
PROTECT FROM LIGHT.
USUAL DOSAGE: See package brochure.
Company S.A. Krakow. Poland
for PLIVA®, Inc. Pomona, NY 10970
Dist. by Barr Laboratories, Inc.
Pomona, NY 10970
R03-09 (v.2)
10001858
barr NDC 50111-647-01
Fluoxetine
Capsule, USP
10 mg*
PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE
R only
100 Capsules
N3 50111 64701 5
Control No:
Exp. Date:
Sentra PM™PRODUCT INFORMATION
Sentra PM (U.S. patent pending) capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids and polyphenol ingredients in specific proportions, for the dietary management of the metabolic processes of sleep disorders (SD). Must be administered under physician supervision.
Medical Foods Medical Food products are often used in hospitals (e.g., for burn victims or kidney dialysis patients) and outside of a hospital setting under a physician’s care for the dietary management of diseases in patients with particular medical or metabolic needs due to their disease or condition. Congress defined “Medical Food” in the Orphan Drug Act and Amendments of 1988 as “a system which is formulated to be consumed or administered enterally [or orally] under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical Foods are complex formulated products, requiring sophisticated and exacting technology. Sentra PM has been developed, manufactured, and labeled in accordance with both the statutory and the FDA regulatory definition of a Medical Food. Sentra PM must be used while the patient is under the ongoing care of a physician.
SLEEP DISORDERS (SD)
SD as a Metabolic Deficiency Disease A critical component of the definition of a Medical Food is the requirement for a distinctive nutritional deficiency. FDA scientists have proposed a physiologic definition of a distinctive nutritional deficiency as follows: “the dietary management of patients with specific diseases requires, in some instances, the ability to meet nutritional requirements that differ substantially from the needs of healthy persons. For example, in establishing the recommended dietary allowances for general, healthy population, the Food and Nutrition Board of the Institute of Medicine National Academy of Sciences, recognized that different or distinctive physiologic requirements may exist for certain persons with “special nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth, other medical conditions and drug therapies. Thus, the distinctive nutritional needs associated with a disease reflect the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism, and excretion.” It was also proposed that in patients with certain disease states who respond to nutritional therapies, a physiologic deficiency of the nutrient is assumed to exist. For example, if a patient with sleep disorders responds to a tryptophan formulation by improving the duration and quality of sleep, a deficiency of tryptophan is assumed to exist.
Patients with sleep disorders are known to have nutritional deficiencies of tryptophan, choline, flavonoids, and certain antioxidants. Patients with sleep disorders frequently exhibit reduced plasma levels of tryptophan and have been shown to respond to oral administration of tryptophan or a 5-hydoxytryptophan formulation. Research has shown that tryptophan reduced diets result in a fall of circulating tryptophan. Patients with sleep disorders have activation of the tryptophan degradation pathway that increases the turnover of tryptophan leading to a reduced level of production of serotonin for a given tryptophan blood level. Research has also shown that a genetic predisposition can lead to increased tryptophan requirements in certain patients with sleep disorders.
Choline is required to fully potentiate acetylcholine synthesis by brain neurons. A deficiency of choline leads to reduced acetylcholine production by the neurons. Low fat diets, frequently used by patients with sleep disorders, are usually choline deficient. Flavonoids potentiate the production of acetylcholine by the neurons thereby inducing REM sleep. Low fat diets and diets deficient in flavonoid rich foods result in inadequate flavonoid concentrations, impeding acetylcholine production in certain patients with sleep disorders. Provision of tryptophan, choline, and flavonoids with antioxidants, in specific proportions can restore the production of beneficial serotonin and acetylcholine, thereby improving sleep quality.
PRODUCT DESCRIPTION
Primary Ingredients
Sentra PM consists of a proprietary blend of amino acids, cocoa, ginkgo biloba and flavonoids in specific proportions. These ingredients fall into the category of “Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.
Amino Acids
Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids in Sentra PM are equivalent to those found in the usual human diet; however the formulation uses specific ratios of the key ingredients to elicit a therapeutic response. Patients with sleep disorders may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Tryptophan, for example, is an obligatory amino acid. The body cannot make tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to produce serotonin. Serotonin is required to induce sleep. Patients with sleep disorders have altered serotonin metabolism. Some patients with sleep disorders have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance that is genetically determined. Patients with sleep disorders frequently cannot acquire sufficient tryptophan from the diet without ingesting a prohibitively large amount of calories, particularly protein rich calories.
Flavonoids
Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in Sentra PM cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.
Other Ingredients
Sentra PM contains the following inactive or other ingredients, as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).
Physical Description
Sentra PM is a yellow to light brown powder. Sentra PM contains L-Glutamic Acid, 5-Hydroxytryptophan as Griffonia Seed Extract, Acetylcarnitine HCL, Choline Bitartrate, Cinnamon, Cocoa, Ginkgo Biloba, and Hawthorn Berry.
CLINICAL PHARMACOLOGY
Mechanism of Action
Sentra PM acts by restoring and maintaining the balance of the neurotransmitters, serotonin and acetylcholine, that are associated with sleep disorders.
Metabolism
The amino acids in Sentra PM are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in Sentra PM. Circulating tryptophan and choline blood levels determine the production of serotonin and acetylcholine.
Excretion
Sentra PM is not an inhibitor of cytochrome P450 1A2, 2C9, 2C19, 2D6, or 3A4. These isoenzymes are principally responsible for 95% of all detoxification of drugs, with CYP3A4 being responsible for detoxification of roughly 50% of drugs. Amino acids do not appear to have an effect on drug metabolizing enzymes.
INDICATIONS FOR USE
Sentra PM is intended for the clinical dietary management of the metabolic processes associated with sleep disorders.
CLINICAL EXPERIENCE
The administration of Sentra PM has demonstrated significant functional improvement in the quality and quantity of sleep when used for the dietary management of the metabolic processes associated with sleep disorders. Administration of Sentra PM results in the induction and maintenance of sleep in patients with sleep disorders. Sentra PM has no effect on normal blood pressure.
PRECAUTIONS AND CONTRAINDICATIONS
Sentra PM is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of Sentra PM.
ADVERSE REACTIONS
Oral supplementation with L-tryptophan or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each Sentra PM capsule does not exceed 400 mg.
DRUG INTERACTIONS
Sentra PM does not directly influence the pharmacokinetics of prescription drugs. Clinical experience has shown that administration of Sentra PM may allow for lowering the dose of co-administered drugs under physician supervision.
OVERDOSE
There is a negligible risk of overdose with Sentra PM as the total dosage of amino acids in a one month supply (60 capsules) is less than 24 grams. Overdose symptoms may include diarrhea, weakness, and nausea.
POST-MARKETING SURVEILLANCE
Post-marketing surveillance has shown no serious adverse reactions. Reported cases of mild rash and itching may have been associated with allergies to Sentra PM flavonoid ingredients, including cinnamon, cocoa, and chocolate. The reactions were transient in nature and subsided within 24 hours.
DOSAGE AND ADMINISTRATION
Recommended Administration For the dietary management of the metabolic processes associated with sleep disorders. Take (2) capsules daily at bedtime. An additional dose of one or two capsules may be taken after awakenings during the night. As with most amino acid formulations Sentra PM should be taken without food to increase the absorption of key ingredients.
How Supplied
Sentra PM is supplied in red and white, size 0 capsules in bottles of 60 capsules.
Physician Supervision
Sentra PM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.
Sentra PM is supplied to physicians in a recyclable plastic bottle with a child-resistant cap.
U.S. patents pending.
Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225
Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com
© Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved
NDC # 68405-1003-02
Storage
Store at room temperature, 59-86OF (15-30OC). Protect from light and moisture.
PHYSICIAN THERAPEUTICS SENTRA PM Medical Food Rx only 60 Capsules Directions for use: Must be administered under medical supervision. For adults only. As a Medical Food, take two (2) capsules at bedtime or as directed by your medical practitioner. For the dietary management of sleep disorders. Contains no added sugar, starch, wheat, yeast, preservatives, artificial color or flavor. Storage: Keep tightly closed in a cool dry place 8-320 C (45-900F), relative humidity, below 50%. Warning: Keep this product out of the reach of children. NDC# 68405-1003-02 Ingredients: Each serving (2 capsules) contains: Proprietary Amino Acid blend Choline Bitartrate, Glutamic Acid (L-Glutamic Acid), Cocoa Extract (fruit), Proprietary Herbal Blend Ginkgo Biloba (leaves), Griffonia Seed Extract (5-HTP), Hawthorn Berry (fruit), Acetyl L-Carnitine HCl, Dextrose Other Ingredients: Gelatin, Cellulose, Dicalcium Phosphate, Silicon Dioxide and Vegetable Magnesium Stearate.
Distributed by: Physician Therapeutics LLC, Los Angeles, CA 90077 www.ptlcentral.com Patent Pending
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| Labeler — Physician Therapeutics LLC (931940964) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pliva | 824750777 | manufacture | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| H.J. Harkins Company, Inc | 147681894 | repack | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Targeted Medical Pharma, Inc. | 126962740 | manufacture | |
Revised: 08/2011 Physician Therapeutics LLC
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.