Hypertenevide-12.5 (Page 5 of 5)

16. HOW SUPPLIED/STORAGE AND HANDLING

16 HOW SUPPLIED/STORAGE AND HANDLING
The tablets are available in the following strengths:
3.125 mg – White, film coated circular shaped tablets with ‘G’ engraved on one side and plain on the other side,
6.25 mg – White, film coated circular shaped tablets with ‘G’ engraved on one side and ‘41’ on the other side,
12.5 mg – White, film coated capsule shaped tablets with ‘G’ engraved on one side and ‘164’ engraved on the other side,
25 mg – White, film coated circular shaped tablets with ‘G41’ engraved on one side and ‘25’ on the other side.
– 3.125 mg
60’s: NDC 68462-162-60
100’s: NDC 68462-162-01
180’s: NDC 68462-162-18
500’s: NDC 68462-162-05
1000’s: NDC 68462-162-10
– 6.25 mg
60’s: NDC 68462-163-60
100’s: NDC 68462-163-01
180’s: NDC 68462-163-18
500’s: NDC 68462-163-05
1000’s: NDC 68462-163-10
– 12.5 mg
60’s: NDC 68462-164-60
100’s: NDC 68462-164-01
180’s: NDC 68462-164-18
500’s: NDC 68462-164-05
1000’s: NDC 68462-164-10
– 25 mg
60’s: NDC 68462-165-60
100’s: NDC 68462-165-01
180’s: NDC 68462-165-18
500’s: NDC 68462-165-05
1000’s: NDC 68462-165-10

Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light-resistant container.

17 PATIENT COUNSELING INFORMATION 17.1 Patient Advice 17.2 FDA-Approved Patient Labeling

17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (17.2).
17.1 Patient Advice
Patients taking carvedilol should be advised of the following:
– Patients should take carvedilol with food.
– Patients should not interrupt or discontinue using carvedilol without a physician’s advice.
– Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
– Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur.
– If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
– Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
– Diabetic patients should report any changes in blood sugar levels to their physician.
– Contact lens wearers may experience decreased lacrimation.
G
Glenmark
Glenmark Generics Inc., USA
Mahwah, NJ 07430
17.2 FDA-Approved Patient Labeling
PATIENT INFORMATION
Rx only
Carvedilol Tablets, USP
Read the Patient Information that comes with carvedilol before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about carvedilol, ask your doctor or pharmacist.
What is Carvedilol?
Carvedilol is a prescription medicine that belongs to a group of medicines called “beta-blockers”.
Carvedilol is used, often with other medicines, for the following conditions:
– To treat patients with high blood pressure (hypertension)
– To treat patients who had a heart attack that worsened how well the heart pumps
– Carvedilol is not approved for use in children under 18 years of age.
Who should not take Carvedilol?
Do not take carvedilol if you:
– Have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications)
– Are prone to asthma or other breathing problems
– Have a slow heartbeat or a heart that skips a beat (irregular heartbeat)
– Have liver problems
– Are allergic to any of the ingredients in carvedilol. The active ingredient is carvedilol. See the end of this leaflet for a list of all the ingredients in carvedilol.
What should I tell my doctor before taking Carvedilol?
Tell your doctor about all of your medical conditions, including if you:
– Have asthma or other lung problems (such as bronchitis or emphysema)
– Have problems with blood flow in your feet and legs (peripheral vascular disease) carvedilol can make some of your symptoms worse.
– Have diabetes
– Have thyroid problems
– Have a condition called pheochromocytoma
– Have had severe allergic reactions
– Are pregnant or trying to become pregnant. It is not known if carvedilol is safe for your unborn baby. You and your doctor should talk about the best way to control your high blood pressure during pregnancy.
– Are breastfeeding. It is not known if carvedilol passes into your breast milk. You should not breastfeed while using carvedilol.
– Are scheduled for surgery and will be given anesthetic agents
– Are taking prescription or non-prescription medicines, vitamins, and herbal supplements. Carvedilol and certain other medicines can affect each other and cause serious side effects. Carvedilol may affect the way other medicines work. Also, other medicines may affect how well carvedilol works. Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.
How should I take Carvedilol?
It is important for you to take your medicine every day as directed by your doctor. If you stop taking carvedilol suddenly, you could have chest pain and/or a heart attack. If your doctor decides that you should stop taking carvedilol, your doctor may slowly lower your dose over a period of time before stopping it completely.
– Take carvedilol exactly as prescribed. Your doctor will tell you how many tablets to take and how often. In order to minimize possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
– Do not stop taking carvedilol and do not change the amount of carvedilol you take without talking to your doctor.
– Tell your doctor if you gain weight or have trouble breathing while taking carvedilol.
– Take carvedilol with food.
– If you miss a dose of carvedilol, take your dose as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take 2 doses at the same time.
– If you take too much carvedilol, call your doctor or poison control center right away.
What should I avoid while taking Carvedilol?
Carvedilol can cause you to feel dizzy, tired, or faint. Do not drive a car, use machinery, or do anything that needs you to be alert if you have these symptoms.
What are possible side effects of Carvedilol?
– Low blood pressure (which may cause dizziness or fainting when you stand up). If these happen, sit or lie down right away and tell your doctor.
– Tiredness. If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert.
– Slow heartbeat.
– Changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
– Carvedilol may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
– Carvedilol may mask the symptoms of hyperthyroidism (overactive thyroid).
Worsening of severe allergic reactions.
– Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on Carvedilol. These reactions can be life-threatening.
Other side effects of carvedilol include shortness of breath, weight gain, diarrhea, and fewer tears or dry eyes that become bothersome if you wear contact lenses. Rare serious allergic reactions have happened in patients who were on carvedilol.
Call your doctor if you have any side effects that bother you or don’t go away.
How should I store Carvedilol?
– Store carvedilol at less than 86°F (30°C). Keep the tablets dry.
– Safely, throw away carvedilol that is out of date or no longer needed.
– Keep carvedilol and all medicines out of the reach of children.
General Information about Carvedilol
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use carvedilol for a condition for which it was not prescribed. Do not give carvedilol to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about carvedilol. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about carvedilol that is written for healthcare professionals. You can also find out more about carvedilol by visiting the website www.glenmarkgenerics.com or calling 1 (888)721-7115. This call is free.
What are the ingredients in Carvedilol?
Active Ingredient: Carvedilol USP.
Inactive Ingredients: Colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.
Carvedilol tablets, USP come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg.
Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
G
Glenmark
Glenmark Generics Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkgenerics.com
August 2010

G

Glenmark

NDC 68462-164-01

CARVEDILOL TABLETS USP

12.5 mg

Pharmacist: Please dispense with patient information leaflet provided separately.

Rx only 100 Tablets

Each tablet contains carvedilol USP, 12.5 mg.

Product meets USP Dissolution Test 2 DOSAGE : See accompanying prescribing information.

Store below 30°C (86°F).

Dispense in a tight, light-resistant container. Protect from moisture.

Important : Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403513, India.

GO/DRUGS/648

Manufactured for:
Glenmark Generics Inc., USA
Mahwah, NJ 07430

N3 68462 16401 3

Lot No.:

Exp.:

01/10

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

Hypertensa™ PRODUCT INFORMATION Hypertensa (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 associated with hypertension (HT). 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 (e.g., for PKU, AIDS patients, cardiovascular disease, sleep disorders) 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 f 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. Hypertensa has been developed, manufactured, and labeled in accordance with both the statutory and the FDA regulatory definition of a Medical Food. Hypertensa must be used while the patient is under the ongoing care of a physician. HYPERTENSION (HT) HT 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 f r 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 hypertension responds to an arginine formulation by decreasing the blood pressure, a deficiency of arginine is assumed to exist. Patients with hypertension are known to have nutritional deficiencies of arginine, choline, flavonoids, and certain antioxidants. Patients with hypertension frequently exhibit reduced plasma levels of arginine and have been shown to respond to oral administration of an arginine formulation. Research has shown that arginine reduced diets result in a fall of circulating arginine. Patients with hypertension have activation of the arginase pathway that diverts arginine from the production of nitric oxide to production of deleterious nitrogen molecules such as peroxynitrite leading to a reduced level of production of nitric oxide for a given arginine blood level. Research has also shown that a genetic predisposition can lead to increased arginine requirements in certain patients with hypertension. Arginine is required to fully potentiate nitric oxide synthesis by the arterioles. A deficiency of arginine leads to reduced nitric oxide production by the arterioles. Low fat diets, frequently used by patients with hypertension, are usually arginine deficient. Flavonoids potentiate the production of nitric oxide by the arterioles thereby reducing blood pressure in hypertensive patients. Low fat diets and diets deficient in flavonoid rich foods result in inadequate arginine and flavonoid concentrations, impeding nitric oxide production in certain patients with hypertension. Provision of arginine, choline, and flavonoids with antioxidants, in the correct proportions can restore the production of beneficial nitric oxide, thereby reducing blood pressure.

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.

CLINICAL PHARMACOLOGY Mechanism of Action Hypertensa acts by restoring and maintaining the balance of NO in patients with hypertension. Metabolism The amino acids in Hypertensa are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in Hypertensa. Circulating arginine and choline blood levels determine the production of NO and acetylcholine. Excretion Hypertensa 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 Hypertensa is intended for the clinical dietary management of the metabolic processes in patients with hypertension.

CLINICAL EXPERIENCE Administration of Hypertensa has demonstrated significant functional improvements in blood pressure when used for the dietary management of the metabolic processes associated with hypertension. Administration of Hypertensa results in the reduction of blood pressure in hypertensive patients. Hypertensa has no effect on normal blood pressure.

PRECAUTIONS AND CONTRAINDICATIONS Hypertensa is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of Hypertensa.

ADVERSE REACTIONS Oral supplementation with L-arginine at high doses up to 15 grams daily is generally well tolerated. The most commonly reported adverse reactions at 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 Hypertensa capsule does not exceed 400 mg.

DRUG INTERACTIONS Hypertensa does not directly influence the pharmacokinetics of prescription drugs. Clinical experience has shown that administration of Hypertensa may allow for lowering the dose of co-administered drugs under physician supervision. 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 Hypertensa flavonoid ingredients, including cocoa and chocolate. The reactions were transient in nature and subsided within 24 hours.

OVERDOSE There is a negligible risk of overdose with Hypertensa as the total dosage of amino acids in a one month supply (90 capsules) is less than 36 grams. Overdose symptoms may include diarrhea, weakness, and nausea.

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.

How Supplied Hypertensa is supplied in green and white, size 0 capsules in bottles of 60 and 90 capsules. Physician Supervision Hypertensa 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: 68405-1007-02 NDC: 68405-1007-03

Storage Store at room temperature, 59-86OF (15-30OC) Protect from light and moisture. Hypertensa is supplied to physicians in a recyclable plastic bottle with a child-resistant cap.

PHYSICIAN THERAPEUTICS HYPERTENSA Medical Food Rx only 90 Capsules Directions for use: Must be administered under physician supervision. For adults only. As a Medical Food, take two (2) capsules four times daily in between meals or as directed by physician. For the dietary management of hypertension. Contains no added sugar, starch, wheat, yeast, preservatives, artifical 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# 68405-1007-03 Ingredients: Each serving (per 2 capsules) contains: Proprietary Amino Acid Blend L-Glutamine L-Histadine, L-Arginine, L-Leucine, L-Cysteine, Whey Protein Hydrolysate, Choline Bitatarate, Cinnamon (bark), Caffeine, Cocoa(6% Theobromine) (fruit), Ginseng, Grape Extract (20% Polyphenol) (seed) other indgredients: Tricalcium phosphate, gelatin, silicon dioxide, vegetable magnesium stearate, microcrystalline cellulose, chlorophyllin copper complex, titanium dioxide. Distributed exclusive by: A Division of Targeted Medical Pharma, Inc Los Angeles, CA 90077 www.ptlcentral.com Patent Pending

68405-027-36 For the Dietary Management of Hypertension. Two capsules twice daily or as directed by physician, See product label and insert. Hypertensa
Medical Food PHYSICIAN THERAPEUTICS Hypertensa + Carvedilol 12.5 mg A Convenlence Pakced Medical Food And Drug Hypertenevide-12.5 PHYSICIAN THERPEUTICS > Hypertensa 90 Capsules > Carvedilol 12.5 mg 30 Tablets No Refills Without Physician Authorization. Rx Only NDC# 68405-027-36 of this co-pack. As prescribed by physicain, See product label and product information insert. Carvedilol 12.5 mg Rx Drug Manufactured and Distributed by Physician Therapeutics, A Divisions of Targeted Medical Pharma Inc. Los Angeles, CA 90077 www.ptlcentral.com B-NDC# 68405-8027-36

Hypertensa Label
(click image for full-size original)

CarvedilolLabel
(click image for full-size original)

Hypertenivide -- 12.5
(click image for full-size original)

HYPERTENEVIDE-12.5 carvedilol, arginine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68405-027
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68405-027-36 1 KIT (KIT) in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30
Part 2 1 BOTTLE 90
Part 1 of 2
CARVEDILOL carvedilol tablet
Product Information
Item Code (Source) NDC:52959-204(NDC:68462-164)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL (CARVEDILOL) CARVEDILOL 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G;164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-204-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 07/07/2011
Part 2 of 2
HYPERTENSA arginine capsule
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARGININE (ARGININE) ARGININE 60 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
GELATIN
Product Characteristics
Color green (GREEN WHITE) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code ;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 90 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Medical Food 07/07/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/07/2011
Labeler — Physician Therapeutics LLC (931940964)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Limited 677318665 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

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