Theracodophen-low-90
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Questions & Answers
Side Effects & Adverse Reactions
Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may
produce irregular and periodic breathing.
Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Warning: Keep this product out of the reach of children.
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
Hydrocodone and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
INDICATIONS FOR USE
Theramine is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions.
History
There is currently no drug history available for this drug.
Other Information
Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light.
The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
Acetaminophen, 4’-Hyroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral administration
are available in a variety of strengths as described in the following table.
Strength Hydrocodone Bitartrate Acetaminophen
2.5 mg/500mg 2.5mg 500mg
5mg/500mg 5mg 500mg
7.5mg/325mg 7.5mg 325mg
7.5mg/500mg 7.5mg 500mg
7.5mg/650mg 7.5mg 650mg
7.5mg/750mg 7.5mg 750mg
10mg/325mg 10mg 325mg
10mg/500mg 10mg 500mg
10mg/650mg 10mg 650mg
10mg/660mg 10mg 660mg
10mg/750mg 10mg 750mg
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid; except the 7.5 mg/325 mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD and C Yellow Number 6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD and C Red Number 40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D and C Yellow Number 10 Aluminum Lake; the 10 mg/500 mg include FD and C Blue Number 2 Aluminum Lake; and the 10 mg/650 mg tablets include FD and C Blue Number 1 Aluminum Lake and D and C Yellow number 10 Aluminum Lake. Meets USP Dissolution Test 1.
PRODUCT DESCRIPTION
Primary Ingredients
Theramine consists of a proprietary blend of amino acids, cocoa, caffeine, cinnamon, 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 Theramine are equivalent to those found in the usual human diet. Patients with pain 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 reduce pain. Patients with pain disorders and inflammatory conditions have altered serotonin metabolism. Some patients with pain disorders and inflammatory conditions have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance. Patients with pain disorders and inflammatory conditions cannot acquire sufficient tryptophan from the diet to alter the perception of pain and the inflammatory process without ingesting a prohibitively large amount of calories, particularly calories from protein.
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 Theramine cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.
Other Ingredients
Theramine 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
Theramine is a yellow to light brown powder. Theramine contains L-Glutamine, L-Arginine, L-Histidine, and L-Serine, 5-Hydroxytryptophan as Griffonia Seed Extract, GABA, Choline Bitartrate, Cinnamon, Cocoa, Hydrolyzed Whey Protein, and Grape Seed Extract.
Sources
Theracodophen-low-90 Manufacturers
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Physician Therapeutics Llc
![Theracodophen-low-90 (Hydrocodone Bitartrate, Acetaminophen, .gamma.-aminobutyric Acid) Kit [Physician Therapeutics Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Theracodophen-low-90 | Physician Therapeutics Llc
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
2.5 mg/500 mg
5 mg/500 mg The usual adult dosage is one or two tablets every four to six
hours as needed for pain. The total daily dose should not
exceed 8 tablets. 7.5 mg/325 mg
7.5 mg/500 mg
7.5 mg/650 mg
The usual adult dosage is one tablet every four to six hours
as needed for pain. The total daily dose should not exceed
6 tablets. 7.5 mg/750 mg The usual adult dosage is one tablet every four to six hours
as needed for pain. The total daily dose should not exceed
5 tablets. 10 mg/325 mg
10 mg/500 mg
10 mg/650 mg
10 mg/660 mg
The usual adult dosage is one tablet every four to six hours
as needed for pain. The total daily dose should not exceed
6 tablets. 10 mg/750 mg The usual adult dosage is one tablet every four to six hours
as needed for pain. The total daily dose should not exceed
5 tablets.
DOSAGE AND ADMINISTRATION
Recommended Administration
For the dietary management of the metabolic processes associated with pain disorders and inflammatory conditions. Take (2) capsules one to three times daily or as directed by physician. As with most amino acid formulations Theramine should be taken without food to increase the absorption of key ingredients.Directions for use:
Must be administered under medical supervision.
For adults only. As a Medical Food, take one (1) or two (2) capsules every four hours or as directed by your medical practicioner.
For the dietary management of Myalgia.
Contains no added sugar, starch , wheat, yeast, preservatives, artificial flavor.
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