Hypertenipine
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS
Increased Angina and/or Myocardial Infarction: Rarely, patients, particularly those with severe
obstructive coronary artery disease, have developed documented increased frequency, duration
and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy
or at the time of dosage increase. The mechanism of this effect has not been elucidated.
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
INDICATIONS AND USAGE
1. Hypertension
Amlodipine besylate is indicated for the treatment of hypertension. It may be used alone or in
combination with other antihypertensive agents.
2. Coronary Artery Disease
Cronic Stable Angina
Amlodipine besylate is indicated for the symptomatic treatment of chronic stable angina.
Amlodipine besylate may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal’s or Variant Angina)
Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina.
Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs.
INDICATIONS FOR USE Hypertensa is intended for the clinical dietary management of the metabolic processes in patients with hypertension.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
Amlodipine besylate, USP is a long-acting calcium channel blocker.
Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methy l ] - 4 - ( 2 - c h l o r o p h e ny l ) - 1 , 4 - d i hydro-6-methy l - 3 , 5 - py r i d i n e d i c a r b ox y l a t e, monobenzenesulphonate. Its molecular formula is C20H25CIN2O5•C6H6O3S, and its structural formula is:
Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
PRODUCT DESCRIPTION Primary Ingredients Hypertensa consists of a proprietary blend of amino acids, cocoa, 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 proteins. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids in Hypertensa are equivalent to those found in the usual human diet. Patients with hypertension may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Arginine, for example, is a conditional amino acid. The body can make arginine in the liver, but the liver produced arginine can only be used in the liver itself. Arginine is needed to produce nitric oxide (NO). NO is required to dilate the constricted blood vessels that are the cause of high blood pressure. Patients with hypertension have an increase in the enzyme, arginase that degrades arginine before it can be used to produce NO. Some patients with hypertension have a resistance to the use of arginine that is similar to the mechanism found in insulin resistance that is genetically determined. Patients with hypertension cannot acquire sufficient arginine from the diet 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 Hypertensa cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response. Other Ingredients Hypertensa 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 Hypertensa is a yellow to light brown powder. Hypertensa contains L-Glutamine, L-Histadine, L-Arginine, L-Leucine, L-Cysteine, Whey Protein Hydrolysate, Choline Bitartrate, Cinnamon, Caffeine, Cocoa, Ginseng, and Grape Extract.
Sources
Hypertenipine Manufacturers
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Physician Therapeutics Llc
![Hypertenipine (Amlodipine Besylate, Arginine) Kit [Physician Therapeutics Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hypertenipine | Physician Therapeutics Llc
DOSAGE AND ADMINISTRATION
Adults: The usual initial antihypertensive oral dose of amlodipine besylate is 5 mg once daily with
a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic
insufficiency may be started on 2.5 mg once daily and this dose may be used when adding
amlodipine besylate to other antihypertensive therapy.
Dosage should be adjusted according to each patient’s need. In general, titration should proceed
over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level.
Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed
frequently.
The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose
suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg
for adequate effect. See ADVERSE REACTIONS section for information related to dosage and side
effects.
The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In
clinical studies the majority of patients required 10 mg (see CLINICAL PHARMACOLOGY, Clinical
studies).
Children: The effective antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg to
5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. See
CLINICAL PHARMACOLOGY.
Co-administration with Other Antihypertensive and/or Antianginal Drugs: Amlodipine besylate
has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates,
and/or sublingual nitroglycerin.DOSAGE AND ADMINISTRATION Recommended Administration For the dietary management of the metabolic processes associated with hypertension. Take (2) capsules once or twice daily, as directed by physician. As with most amino acid formulations Hypertensa should be taken without food to increase the absorption of key ingredients.
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