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Gabazolamine
Overview
What is Gabazolamine?
PRODUCT DESCRIPTION
Primary IngredientsGABAdone 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 AcidsAmino 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 GABAdone 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. 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. Patients with sleep disorders cannot acquire sufficient tryptophan from the diet to establish normal sleep architecture without ingesting a prohibitively large amount of calories, particularly calories from protein.
FlavonoidsFlavonoids 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 amounts of specially formulated flavonoids found in GABAdone cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.
Physical DescriptionGABAdone is a yellow to light brown powder. GABAdone contains L-Glutamic Acid, 5-Hydroxytryptophan as Griffonia Seed Extract, Acetyl L-Carnitine HCL, Gamma Amino Butyric Acid, Choline Bitartrate, Hydrolyzed Whey Protein, Cocoa, Ginkgo Biloba, Valerian Root, and Grape Seed Extract.
Other IngredientsGABAdone contains the following inactive or other ingredients, as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).
What does Gabazolamine look like?
What are the available doses of Gabazolamine?
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What should I talk to my health care provider before I take Gabazolamine?
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How should I use Gabazolamine?
INDICATIONS FOR USEGABAdone is intended for the clinical dietary management of the metabolic processes in patients with sleep disorders and sleep disorders associated with anxiety.
- Insomnia- Sleep maintenance insomnia- Sleep disorders of circadian origin- Sleep disorders associated with anxiety- Snoring
DOSAGE AND ADMINISTRATIONRecommended AdministrationFor the dietary management of the metabolic processes in patients 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 GABAdone should be taken without food to increase the absorption of key ingredients.
What interacts with Gabazolamine?
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What are the warnings of Gabazolamine?
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What are the precautions of Gabazolamine?
Sorry No Records found
What are the side effects of Gabazolamine?
Side effects to alprazolam, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, eg, drowsiness or light-headedness.
The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of alprazolam (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of alprazolam in patients with panic disorder, with or without agoraphobia.
These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions.
Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others.
(For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.)
Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event.
In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.
In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of alprazolam: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.
There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of alprazolam (see ).
To discontinue treatment in patients taking alprazolam, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every three days (see ). Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.
Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Therefore, the same precaution must be exercised when using doses of alprazolam greater than 4 mg/day in treating patients with panic disorders as is exercised with the use of any psychotropic drug in treating depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans.
As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.
Laboratory analyses were performed on all patients participating in the clinical program for alprazolam. The following incidences of abnormalities shown below were observed in patients receiving alprazolam and in patients in the corresponding placebo group. Few of these abnormalities were considered to be of physiological significance.
When treatment with alprazolam is protracted, periodic blood counts, urinalysis and blood chemistry analyses are advisable.
Minor changes in EEG patterns, usually low-voltage fast activity have been observed in patients during therapy with alprazolam and are of no known significance.
Post Introduction Reports:
| *None reported | ||||||||
| †Events reported by 1% or more of alprazolam patients are included | Array | |||||||
|---|---|---|---|---|---|---|---|---|
| Alprazolam | Placebo | Alprazolam | ||||||
| Number of Patients | 565 | 505 | 565 | |||||
| % of Patients Reporting: | ||||||||
| CENTRAL NERVOUS SYSTEM | ||||||||
| Drowsiness | 41.0 | 21.6 | 15.1 | |||||
| Light-headedness | 20.8 | 19.3 | 1.2 | |||||
| Depression | 13.9 | 18.1 | 2.4 | |||||
| Headache | 12.9 | 19.6 | 1.1 | |||||
| Confusion | 9.9 | 10.0 | 0.9 | |||||
| Insomnia | 8.9 | 18.4 | 1.3 | |||||
| Nervousness | 4.1 | 10.3 | 1.1 | |||||
| Syncope | 3.1 | 4.0 | * | |||||
| Dizziness | 1.8 | 0.8 | 2.5 | |||||
| Akathisia | 1.6 | 1.2 | * | |||||
| Tiredness/Sleepiness | * | * | 1.8 | |||||
| GASTROINTESTINAL | ||||||||
| Dry Mouth | 14.7 | 13.3 | 0.7 | |||||
| Constipation | 10.4 | 11.4 | 0.9 | |||||
| Diarrhea | 10.1 | 10.3 | 1.2 | |||||
| Nausea/Vomiting | 9.6 | 12.8 | 1.7 | |||||
| Increased Salivation | 4.2 | 2.4 | * | |||||
| CARDIOVASCULAR | ||||||||
| Tachycardia/Palpitations | 7.7 | 15.6 | 0.4 | |||||
| Hypotension | 4.7 | 2.2 | * | |||||
| SENSORY | ||||||||
| Blurred Vision | 6.2 | 6.2 | 0.4 | |||||
| MUSCULOSKELETAL | ||||||||
| Rigidity | 4.2 | 5.3 | * | |||||
| Tremor | 4.0 | 8.8 | 0.4 | |||||
| CUTANEOUS | ||||||||
| Dermatitis/Allergy | 3.8 | 3.1 | 0.6 | |||||
| OTHER | ||||||||
| Nasal Congestion | 7.3 | 9.3 | * | |||||
| Weight Gain | 2.7 | 2.7 | * | |||||
| Weight Loss | 2.3 | 3.0 | * | |||||
| Array | Array | |||||||
| Alprazolam | Placebo | |||||||
| Number of Patients | 1388 | 1231 | ||||||
| % of Patients Reporting: | ||||||||
| Central Nervous System | ||||||||
| Drowsiness | 76.8 | 42.7 | ||||||
| Fatigue and Tiredness | 48.6 | 42.3 | ||||||
| Impaired Coordination | 40.1 | 17.9 | ||||||
| Irritability | 33.1 | 30.1 | ||||||
| Memory Impairment | 33.1 | 22.1 | ||||||
| Light-headedness/Dizziness | 29.8 | 36.9 | ||||||
| Insomnia | 29.4 | 41.8 | ||||||
| Headache | 29.2 | 35.6 | ||||||
| Cognitive Disorder | 28.8 | 20.5 | ||||||
| Dysarthria | 23.3 | 6.3 | ||||||
| Anxiety | 16.6 | 24.9 | ||||||
| Abnormal Involuntary Movement | ||||||||
| Decreased Libido | 14.4 | 8.0 | ||||||
| Depression | 13.8 | 14.0 | ||||||
| Confusional State | 10.4 | 8.2 | ||||||
| Muscular Twitching | 7.9 | 11.8 | ||||||
| Increased Libido | 7.7 | 4.1 | ||||||
| Change in Libido(Not Specified) | ||||||||
| Weakness | 7.1 | 8.4 | ||||||
| Muscle Tone Disorders | 6.3 | 7.5 | ||||||
| Syncope | 3.8 | 4.8 | ||||||
| Akathisia | 3.0 | 4.3 | ||||||
| Agitation | 2.9 | 2.6 | ||||||
| Disinhibition | 2.7 | 1.5 | ||||||
| Paresthesia | 2.4 | 3.2 | ||||||
| Talkativeness | 2.2 | 1.0 | ||||||
| Vasomotor Disturbances | 2.0 | 2.6 | ||||||
| Derealization | 1.9 | 1.2 | ||||||
| Dream Abnormalities | 1.8 | 1.5 | ||||||
| Fear | 1.4 | 1.0 | ||||||
| Feeling Warm | 1.3 | 0.5 | ||||||
| Gastrointestinal | ||||||||
| Decreased Salivation | 32.8 | 34.2 | ||||||
| Constipation | 26.2 | 15.4 | ||||||
| Nausea/Vomiting | 22.0 | 31.8 | ||||||
| Diarrhea | 20.6 | 22.8 | ||||||
| Abdominal Distress | 18.3 | 21.5 | ||||||
| Increased Salivation | 5.6 | 4.4 | ||||||
| Cardio-Respiratory | ||||||||
| Nasal Congestion | 17.4 | 16.5 | ||||||
| Tachycardia | 15.4 | 26.8 | ||||||
| Chest Pain | 10.6 | 18.1 | ||||||
| Hyperventilation | 9.7 | 14.5 | ||||||
| Upper Respiratory Infection | 4.3 | 3.7 | ||||||
| Sensory | ||||||||
| Blurred Vision | 21.0 | 21.4 | ||||||
| Tinnitus | 6.6 | 10.4 | ||||||
| Musculoskeletal | ||||||||
| Muscular Cramps | 2.4 | 2.4 | ||||||
| Muscle Stiffness | 2.2 | 3.3 | ||||||
| Cutaneous | ||||||||
| Sweating | 15.1 | 23.5 | ||||||
| Rash | 10.8 | 8.1 | ||||||
| Other | ||||||||
| Increased | 32.7 | 22.8 | ||||||
| Decreased Appetite | 27.8 | 24.1 | ||||||
| Weight Gain | 27.2 | 17.9 | ||||||
| Weight Loss | 22.6 | 16.5 | ||||||
| Micturition Difficulties | 12.2 | 8.6 | ||||||
| Menstrual Disorders | 10.4 | 8.7 | ||||||
| Sexual Dysfunction | 7.4 | 3.7 | ||||||
| Edema | 4.9 | 5.6 | ||||||
| Incontinence | 1.5 | 0.6 | ||||||
| Infection | 1.3 | 1.7 | ||||||
| *Less Than 1% | ||||||||
| Placebo | ||||||||
| LOW | HIGH | LOW | HIGH | |||||
| HEMATOLOGY | ||||||||
| Hematocrit | * | * | * | * | ||||
| Hemoglobin | * | * | * | * | ||||
| Total WBC Count | 1.4 | 2.3 | 1.0 | 2.0 | ||||
| Neutrophil Count | 2.3 | 3.0 | 4.2 | 1.7 | ||||
| Lymphocyte Count | 5.5 | 7.4 | 5.4 | 9.5 | ||||
| Monocyte Count | 5.3 | 2.8 | 6.4 | * | ||||
| Eosinophil Count | 3.2 | 9.5 | 3.3 | 7.2 | ||||
| Basophil Count | * | * | * | * | ||||
| URINALYSIS | ||||||||
| Albumin | -- | * | -- | * | ||||
| Sugar | -- | * | -- | * | ||||
| RBC/HPF | -- | 3.4 | -- | 5.0 | ||||
| WBC/HPF | -- | 25.7 | -- | 25.9 | ||||
| BLOOD CHEMISTRY | ||||||||
| Creatinine | 2.2 | 1.9 | 3.5 | 1.0 | ||||
| Bilirubin | * | 1.6 | * | * | ||||
| SGOT | * | 3.2 | 1.0 | 1.8 | ||||
| Alkaline Phosphatase | * | 1.7 | * | 1.8 |
What should I look out for while using Gabazolamine?
Alprazolam tablets are contraindicated in patients with known
sensitivity to this drug or other benzodiazepines. Alprazolam may be used in
patients with open angle glaucoma who are receiving appropriate therapy, but is
contraindicated in patients with acute narrow angle glaucoma.
Alprazolam is contraindicated with ketoconazole and intraconazole, since
these medications significantly impair the oxidative metabolism mediated by
cytochrome P450 3A (CYP 3A) (see and ).
Certain adverse clinical events, some life-threatening, are a
direct consequence of physical dependence to alprazolam. These include a
spectrum of withdrawal symptoms; the most important is seizure (see ).
Even after relatively short-term use at the doses recommended for the treatment
of transient anxiety and anxiety disorder (ie, 0.75 to 4 mg per day), there is
some risk of dependence. Spontaneous reporting system data suggest that the risk
of dependence and its severity appear to be greater in patients treated with
doses greater than 4 mg/day and for long periods (more than 12 weeks). However,
in a controlled postmarketing discontinuation study of panic disorder patients,
the duration of treatment (three months compared to six months) had no effect on
the ability of patients to taper to zero dose. In contrast, patients treated
with doses of alprazolam greater than 4 mg/day had more difficulty tapering to
zero dose than those treated with less than 4 mg/day.
The Importance Of Dose And The Risks Of Alprazolam As A
Treatment For Panic Disorder:
Relapse or return of illness was defined as a return of symptoms
characteristic of panic disorder (primarily panic attacks) to levels
approximately equal to those seen at baseline before active treatment was
initiated. Rebound refers to a return of symptoms of panic disorder to a level
substantially greater in frequency, or more severe in intensity than seen at
baseline. Withdrawal symptoms were identified as those which were generally not
characteristic of panic disorder and which occurred for the first time more
frequently during discontinuation than at baseline.
In a controlled clinical trial in which 63 patients were randomized to
alprazolam and where withdrawal symptoms were specifically sought, the following
were identified as symptoms of withdrawal: heightened sensory perception,
impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle
cramps, muscle twitch, diarrhea, blurred vision, appetite decrease and weight
loss. Other symptoms, such as anxiety and insomnia, were frequently seen during
discontinuation, but it could not be determined if they were due to return of
illness, rebound or withdrawal.
In a larger database comprised of both controlled and uncontrolled studies in
which 641 patients received alprazolam, discontinuation-emergent symptoms which
occurred at a rate of over 5% in patients treated with alprazolam and at a
greater rate than the placebo treated group were as follows:
From the studies cited, it has not been determined whether these symptoms are
clearly related to the dose and duration of therapy with alprazolam in patients
with panic disorder.
In two controlled trials of six to eight weeks duration where the ability of
patients to discontinue medication was measured, 71%-93% of alprazolam treated
patients tapered completely off therapy compared to 89%-96% of placebo treated
patients. In a controlled postmarketing discontinuation study of panic disorder
patients, the duration of treatment (three months compared to six months) had no
effect on the ability of patients to taper to zero dose.
Seizures attributable to alprazolam were seen after drug discontinuance or
dose reduction in 8 of 1980 patients with panic disorder or in patients
participating in clinical trials where doses of alprazolam greater than 4 mg/day
for over 3 months were permitted. Five of these cases clearly occurred during
abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg. Three
cases occurred in situations where there was not a clear relationship to abrupt
dose reduction or discontinuation. In one instance, seizure occurred after
discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg
every three days from 6 mg daily. In two other instances, the relationship to
taper is indeterminate; in both of these cases the patients had been receiving
doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases
ranged from 4 to 22 weeks. There have been occasional voluntary reports of
patients developing seizures while apparently tapering gradually from
alprazolam. The risk of seizure seems to be greatest 24-72 hours after
discontinuation (see for recommended tapering and discontinuation schedule).
The medical event voluntary reporting system shows that
withdrawal seizures have been reported in association with the discontinuation
of alprazolam. In most cases, only a single seizure was reported; however,
multiple seizures and status epilepticus were reported as well. Ordinarily, the
treatment of status epilepticus of any etiology involves use of intravenous
benzodiazepines plus phenytoin or barbiturates, maintenance of a patent airway
and adequate hydration. For additional details regarding therapy, consultation
with an appropriate specialist may be considered.
Early morning anxiety and emergence of anxiety symptoms between
doses of alprazolam have been reported in patients with panic disorder taking
prescribed maintenance doses of alprazolam. These symptoms may reflect the
development of tolerance or a time interval between doses which is longer than
the duration of clinical action of the administered dose. In either case, it is
presumed that the prescribed dose is not sufficient to maintain plasma levels
above those needed to prevent relapse, rebound or withdrawal symptoms over the
entire course of the interdosing interval. In these situations, it is
recommended that the same total daily dose be given divided as more frequent
administrations (see ).
Withdrawal reactions may occur when dosage reduction occurs for
any reason. This includes purposeful tapering, but also inadvertent reduction of
dose (eg, the patient forgets, the patient is admitted to a hospital, etc.).
Therefore, the dosage of alprazolam should be reduced or discontinued gradually
(see ).
Alprazolam is not of value in the treatment of psychotic patients and should
not be employed in lieu of appropriate treatment for psychosis. Because of its
CNS depressant effects, patients receiving alprazolam should be cautioned
against engaging in hazardous occupations or activities requiring complete
mental alertness such as operating machinery or driving a motor vehicle. For the
same reason, patients should be cautioned about the simultaneous ingestion of
alcohol and other CNS depressant drugs during treatment with alprazolam.
Benzodiazepines can potentially cause fetal harm when administered to
pregnant women. If alprazolam is used during pregnancy, or if the patient
becomes pregnant while taking this drug, the patient should be apprised of the
potential hazard to the fetus. Because of experience with other members of the
benzodiazepine class, alprazolam is assumed to be capable of causing an
increased risk of congenital abnormalities when administered to a pregnant woman
during the first trimester. Because use of these drugs is rarely a matter of
urgency, their use during the first trimester should almost always be avoided.
The possibility that a woman of childbearing potential may be pregnant at the
time of institution of therapy should be considered. Patients should be advised
that if they become pregnant during therapy or intend to become pregnant they
should communicate with their physicians about the desirability of discontinuing
the drug.
Alprazolam Interaction With Drugs That Inhibit
Metabolism Via Cytochrome P450
3A:
in
vitro
The following are examples of drugs known to inhibit the metabolism of
alprazolam and/or related benzodiazepines, presumably through inhibition of CYP
3A.
Azole antifungal agents--Although interaction data with alprazolam are not available, ketoconazole and
intraconazole are potent CYP 3A inhibitors and the coadministration of
alprazolam with them is not recommended. Other azole-type antifungal agents
should also be considered potent CYP 3A inhibitors and the coadministration of
alprazolam with them is not recommended (see ).
Drugs Demonstrated To Be CYP 3A Inhibitors On The Basis Of
Clinical Studies Involving Alprazolam (Caution And Consideration Of Appropriate
Alprazolam Dose Reduction Are Recommended Dduring Coadministration With The
Following Drugs):
Nefazodone--Coadministration of nefazodone increased alprazolam concentration
two-fold.
Fluvoxamine--Coadministration of fluvoxamine approximately doubled the
maximum plasma concentration of alprazolam, decreased clearance by 49%,
increased half-life by 71%, and decreased measured psychomotor performance.
Cimetidine--Coadministration of cimetidine increased the maximum plasma
concentration of alprazolam by 86%, decreased clearance by 42%, and increased
half-life by 16%.
Other drugs possibly affecting alprazolam metabolism by
inhibition of CYP 3A are discussed in the section (see ).
What might happen if I take too much Gabazolamine?
OVERDOSEThere is a negligible risk of overdose with GABAdone as the total dosage of amino acids in a one month supply (60 capsules) is less than 25 grams. Overdose symptoms may include diarrhea, weakness, and nausea.
POST-MARKETING SURVEILLANCEPost-marketing surveillance has shown no serious adverse reactions. Reported cases of mild rash and itching may have been associated with allergies to GABAdone flavonoid ingredients, including cinnamon, cocoa, and chocolate. The reactions were transient in nature and subsided within 24 hours.
How should I store and handle Gabazolamine?
Storage and HandlingRISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Keep out of reach of children.Storage and HandlingRISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Keep out of reach of children.Storage and HandlingRISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Keep out of reach of children.How SuppliedGABAdone is supplied in blue and white, size 0 capsules in bottles of 60 capsules. Physician SupervisionGABAdone is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision. U.S. patent 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 # 68405-1004-02How SuppliedGABAdone is supplied in blue and white, size 0 capsules in bottles of 60 capsules. Physician SupervisionGABAdone is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision. U.S. patent 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 # 68405-1004-02
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLINICAL PHARMACOLOGY
Mechanism of ActionGABAdone acts by restoring and maintaining the balance of the neurotransmitters, serotonin, and acetylcholine that are required for maintaining normal sleep architecture. A deficiency of these neurotransmitters is associated with sleep disorders.
MetabolismThe amino acids in GABAdone are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in GABAdone. Circulating tryptophan and choline blood levels determine the production of serotonin and acetylcholine.
ExcretionGABAdone 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.
Non-Clinical Toxicology
Alprazolam tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alprazolam may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.Alprazolam is contraindicated with ketoconazole and intraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) (see and ).
Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam. These include a spectrum of withdrawal symptoms; the most important is seizure (see ). Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (ie, 0.75 to 4 mg per day), there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of alprazolam greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.
The Importance Of Dose And The Risks Of Alprazolam As A Treatment For Panic Disorder:
Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline.
In a controlled clinical trial in which 63 patients were randomized to alprazolam and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound or withdrawal.
In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received alprazolam, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with alprazolam and at a greater rate than the placebo treated group were as follows:
From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with alprazolam in patients with panic disorder.
In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 71%-93% of alprazolam treated patients tapered completely off therapy compared to 89%-96% of placebo treated patients. In a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose.
Seizures attributable to alprazolam were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of alprazolam greater than 4 mg/day for over 3 months were permitted. Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation. In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every three days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from alprazolam. The risk of seizure seems to be greatest 24-72 hours after discontinuation (see for recommended tapering and discontinuation schedule).
The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of alprazolam. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well. Ordinarily, the treatment of status epilepticus of any etiology involves use of intravenous benzodiazepines plus phenytoin or barbiturates, maintenance of a patent airway and adequate hydration. For additional details regarding therapy, consultation with an appropriate specialist may be considered.
Early morning anxiety and emergence of anxiety symptoms between doses of alprazolam have been reported in patients with panic disorder taking prescribed maintenance doses of alprazolam. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms over the entire course of the interdosing interval. In these situations, it is recommended that the same total daily dose be given divided as more frequent administrations (see ).
Withdrawal reactions may occur when dosage reduction occurs for any reason. This includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient forgets, the patient is admitted to a hospital, etc.). Therefore, the dosage of alprazolam should be reduced or discontinued gradually (see ).
Alprazolam is not of value in the treatment of psychotic patients and should not be employed in lieu of appropriate treatment for psychosis. Because of its CNS depressant effects, patients receiving alprazolam should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with alprazolam.
Benzodiazepines can potentially cause fetal harm when administered to pregnant women. If alprazolam is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the benzodiazepine class, alprazolam is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
Alprazolam Interaction With Drugs That Inhibit Metabolism Via Cytochrome P450
3A:
in vitro
The following are examples of drugs known to inhibit the metabolism of alprazolam and/or related benzodiazepines, presumably through inhibition of CYP 3A.
Azole antifungal agents--Although interaction data with alprazolam are not available, ketoconazole and intraconazole are potent CYP 3A inhibitors and the coadministration of alprazolam with them is not recommended. Other azole-type antifungal agents should also be considered potent CYP 3A inhibitors and the coadministration of alprazolam with them is not recommended (see ).
Drugs Demonstrated To Be CYP 3A Inhibitors On The Basis Of Clinical Studies Involving Alprazolam (Caution And Consideration Of Appropriate Alprazolam Dose Reduction Are Recommended Dduring Coadministration With The Following Drugs):
Nefazodone--Coadministration of nefazodone increased alprazolam concentration two-fold.
Fluvoxamine--Coadministration of fluvoxamine approximately doubled the maximum plasma concentration of alprazolam, decreased clearance by 49%, increased half-life by 71%, and decreased measured psychomotor performance.
Cimetidine--Coadministration of cimetidine increased the maximum plasma concentration of alprazolam by 86%, decreased clearance by 42%, and increased half-life by 16%.
Other drugs possibly affecting alprazolam metabolism by inhibition of CYP 3A are discussed in the section (see ).
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
PRECAUTIONS AND CONTRAINDICATIONSGABAdone is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of GABAdone.
ADVERSE REACTIONSOral 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 GABAdone capsule does not exceed 400 mg.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).