Phentermine Hydrochloride (Phentermine Hydrochloride)

Trade Name : phentermine hydrochloride

Eon Labs, Inc.

CAPSULE

Strength 15 mg/1

PHENTERMINE HYDROCHLORIDE Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Phentermine Hydrochloride (Phentermine Hydrochloride) which is also known as phentermine hydrochloride and Manufactured by Eon Labs, Inc.. It is available in strength of 15 mg/1 per ml. Read more

Phentermine Hydrochloride (Phentermine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index u226530 kg/m2, or u226527 kg/m in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
  • Below is a chart of body mass index (BMI) based on various heights and weights.
  • BMI is calculated by taking the patientu2019s weight, in kilograms (kg), divided by the patientu2019s height, in meters (m), squared. Metric conversions are as follows: pounds u00f7 2.2 = kg; inches x 0.0254 = meters.
  • BODY MASS INDEX (BMI), kg/mn
  • The limited usefulness of agents of this class, including phentermine, should be measured against possible risk factors inherent in their use such as those described below.
  • Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index u226530 kg/m, or u226527 kg/m in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). n
  • The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. n
  • No data
  • Capsules containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base, respectively).
  • 15 mg capsules: grey/yellow opaque body, filled with white to off-white powder, imprinted u201cu201d in black ink.
  • 30 mg capsules: yellow opaque cap and body, filled with white to off-white powder, imprinted u201cu201d in black ink.
  • 30 mg capsules: blue/clear, blue/white pellets, imprinted u201cu201d in black ink.
  • u2022
  • (3)
  • No data
  • 4n- 8.1
  • 4n- 8.3
  • No data
  • The following adverse reactions are described, or described in greater detail, in other sections:
  • The following adverse reactions to phentermine have been identified:
  • Cardiovascular
  • Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.
  • Central Nervous System
  • Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.
  • Gastrointestinal
  • Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
  • Allergic
  • Urticaria.
  • Endocrine
  • Impotence, changes in libido.
  • Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. n
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n
  • No data
  • 4n- 7.1
  • No data
  • 4n- 8.3
  • No data
  • The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
  • Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is u03b1,u03b1,dimethylphenethylamine hydrochloride. The structural formula is as follows:
  • CHN u2022 HCl M.W. 185.7
  • Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.
  • Phentermine hydrochloride capsules, USP are available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base).
  • a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide and sodium lauryl sulfate and
  • b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: corn starch, gelatin, pharmaceutical glaze, povidone, silicon dioxide, sodium lauryl sulfate and sucrose.
  • In addition, the 15 mg capsules contain FD&C blue No. 1, FD&C red No. 3, D&C yellow No. 10, FD&C red No. 40, titanium dioxide; the yellow 30 mg capsules contain FD&C red No. 3, D&C yellow No. 10, titanium dioxide; and the blue/clear 30 mg capsules contain FD&C blue No. 1, D&C red No. 28.
  • No data
  • Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.
  • In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with u201canorecticu201d drugs lost more weight on the average than those treated with placebo and diet.
  • The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an u201canorecticu201d drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.
  • The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeksu2019 duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.
  • Phentermine hydrochloride capsules, USP for oral administration, are available as:
  • 15 mgn- E882
  • 30 mgn- E647
  • 30 mgn- E5000
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Protect from moisture.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Keep out of the reach of children.
  • Patients must be informed that phentermine hydrochloride is a (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of phentermine with other drugs for weight loss is not recommended n n
  • Patients must be instructed on how much phentermine to take, and when and how to take it n .
  • Advise pregnant women and nursing mothers not to use phentermine n .
  • Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:
  • See also, for example, n .
  • The patients must also be informed about
  • Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law.
  • Manufactured for
  • Sandoz Inc.
  • Princeton, NJ 08540
  • Manufactured by
  • Epic Pharma, LLC
  • Laurelton, NY 11413
  • OS7330
  • Rev. 04/17
  • MF5000REV04/17
  • NDC
  • Phentermine Hydrochloride Capsules, USP CIV
  • 15 mg
  • Grey/Yellow
  • Rx only
  • 100 Capsules
  • Sandoz
  • NDC
  • Phentermine Hydrochloride Capsules, USP CIV
  • 30 mg
  • Blue/Clear
  • Rx only
  • 100 Capsules
  • Sandoz
  • NDC
  • Phentermine Hydrochloride Capsules, USP CIV
  • 30 mg
  • Yellow
  • Rx only
  • 100 Capsules
  • Sandoz

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