什么是洛迈拉？

洛迈拉类似于安非他明。这种药刺激中枢神经系统（神经和大脑），从而增加心率和血压，降低食欲。

洛美拉与饮食和运动一起用于治疗肥胖症，特别是在有高血压、高胆固醇或糖尿病等危险因素的人群中。

Lomaira也可用于本用药指南中未列出的用途。

重要信息

如果你有青光眼、甲状腺过度活动、严重的心脏问题、无法控制的高血压、晚期冠状动脉疾病、极度激动或有药物滥用史，就不应该使用洛美拉。

如果您在过去14天内使用过MAO抑制剂，如水碳酰肼、利奈唑啉、美蓝注射液、苯妥英钠、拉沙吉林、塞来吉林或曲尼环丙胺，请不要使用这种药物。

 

吃这药之前

如果您对Lomaira过敏，或者如果您有：

心脏病史（冠心病、心律失常、充血性心力衰竭、中风）；

严重或不受控制的高血压；

甲状腺功能亢进；

青光眼；

极度激动或紧张；

吸毒史；或

如果你吃其他减肥药。

如果您在过去14天内使用过MAO抑制剂，请不要使用Lomaira。可能发生危险的药物相互作用。MAO抑制剂包括水碳嗪、利奈唑胺、美蓝注射液、苯乙嗪、拉沙吉林、塞来吉林、环丙氨等。

怀孕期间的体重减轻会伤害未出生的婴儿，即使你超重。如果你怀孕了，不要用洛迈拉。如果你在治疗过程中怀孕了，立刻告诉你的医生。

使用洛美拉时不应哺乳。

告诉你的医生如果你曾经有过：

心脏病或冠状动脉疾病；

心脏瓣膜病；

高血压；

糖尿病（您的糖尿病药物剂量可能需要调整）；或

肾病。

Lomaira不允许16岁以下的人使用。

 

我该怎么去洛迈拉？

遵循处方标签上的所有说明，阅读所有药物指南或说明书。你的医生有时会改变你的剂量。严格按照指示用药。

洛美拉通常在早餐前服用，或在早餐后1至2小时服用。严格按照医生的给药说明操作。

切勿使用大量或超过规定时间的洛美拉。服用更多的这种药物不会使它更有效，并可能导致严重的，危及生命的副作用。

Lomaira仅供短期使用。抑制食欲的作用可能在几周后消失。

洛迈拉可能正在形成习惯。滥用可能导致上瘾、过量用药或死亡。出售或赠送Lomaira是违法的。

如果你认为这种药不起作用，或者如果你在4周内没有减掉至少4磅，请立即打电话给你的医生。

不要突然停止使用洛美拉，否则你会有不愉快的戒断症状。问你的医生如何安全地停止使用这种药。

在室温下储存，避免受潮和受热。不用的时候把瓶子关紧。

如果我错过一剂怎么办？

你要尽快吃药，但如果是在一天的晚些时候，就不要吃漏掉的剂量。不要一次服用两剂。

如果我过量会怎么样？

寻求紧急医疗护理或拨打毒物帮助热线1-800-222-1222。过量服用洛美拉可能致命。

过量的症状可能包括精神错乱、恐慌、幻觉、极度不安、恶心、呕吐、腹泻、胃痉挛、感到疲倦或沮丧、心跳不规则、脉搏微弱、癫痫或呼吸缓慢（呼吸可能停止）。

服用芬特明时应该避免什么？

避免驾驶或危险活动，直到你知道洛迈拉将如何影响你。你的反应可能会受损。

用这种药喝酒会引起副作用。

 

洛迈拉副作用

如果你有过敏反应的迹象：荨麻疹；呼吸困难；面部、嘴唇、舌头或喉咙肿胀，请寻求紧急医疗帮助。

如果您有下列情况，请立即致电您的医生：

感到呼吸短促，即使有轻微的劳累；

胸痛，感觉自己可能昏倒；

脚踝或脚肿胀；

在你的胸口跳动或跳动；

震颤，不安，失眠；

情绪或行为的异常变化；或

血压升高-严重头痛，视力模糊，颈部或耳朵肿大，焦虑，鼻出血。

常见的副作用可能包括：

瘙痒的；

头晕、头痛；

口干，味道不好；

腹泻、便秘、胃痛；或

对性的兴趣增加或减少。

这不是一个完整的副作用和其他可能发生的清单。打电话给你的医生寻求有关副作用的医疗建议。您可以拨打1-800-FDA-1088向FDA报告副作用。

 

 

还有什么药物会影响洛美拉？

与其他饮食药物如芬氟拉明（phen fen）或德克芬氟拉明（redux）一起服用洛美拉可导致一种罕见的致命性肺疾病，称为肺动脉高压。没有医生的建议，不要将此药与其他减肥药一起服用。

许多药物会影响洛美拉。这包括处方药和非处方药、维生素和草药产品。并非所有可能的交互都列在这里。告诉你的医生你目前的所有药物和任何你开始或停止使用的药物。

 

 

 

什么是洛迈拉？

洛迈拉类似于安非他明。这种药刺激中枢神经系统（神经和大脑），从而增加心率和血压，降低食欲。

洛美拉与饮食和运动一起用于治疗肥胖症，特别是在有高血压、高胆固醇或糖尿病等危险因素的人群中。

Lomaira也可用于本用药指南中未列出的用途。

重要信息

如果你有青光眼、甲状腺过度活动、严重的心脏问题、无法控制的高血压、晚期冠状动脉疾病、极度激动或有药物滥用史，就不应该使用洛美拉。

如果您在过去14天内使用过MAO抑制剂，如水碳酰肼、利奈唑啉、美蓝注射液、苯妥英钠、拉沙吉林、塞来吉林或曲尼环丙胺，请不要使用这种药物。

 

吃这药之前

如果您对Lomaira过敏，或者如果您有：

心脏病史（冠心病、心律失常、充血性心力衰竭、中风）；

严重或不受控制的高血压；

甲状腺功能亢进；

青光眼；

极度激动或紧张；

吸毒史；或

如果你吃其他减肥药。

如果您在过去14天内使用过MAO抑制剂，请不要使用Lomaira。可能发生危险的药物相互作用。MAO抑制剂包括水碳嗪、利奈唑胺、美蓝注射液、苯乙嗪、拉沙吉林、塞来吉林、环丙氨等。

怀孕期间的体重减轻会伤害未出生的婴儿，即使你超重。如果你怀孕了，不要用洛迈拉。如果你在治疗过程中怀孕了，立刻告诉你的医生。

使用洛美拉时不应哺乳。

告诉你的医生如果你曾经有过：

心脏病或冠状动脉疾病；

心脏瓣膜病；

高血压；

糖尿病（您的糖尿病药物剂量可能需要调整）；或

肾病。

Lomaira不允许16岁以下的人使用。

 

我该怎么去洛迈拉？

遵循处方标签上的所有说明，阅读所有药物指南或说明书。你的医生有时会改变你的剂量。严格按照指示用药。

洛美拉通常在早餐前服用，或在早餐后1至2小时服用。严格按照医生的给药说明操作。

切勿使用大量或超过规定时间的洛美拉。服用更多的这种药物不会使它更有效，并可能导致严重的，危及生命的副作用。

Lomaira仅供短期使用。抑制食欲的作用可能在几周后消失。

洛迈拉可能正在形成习惯。滥用可能导致上瘾、过量用药或死亡。出售或赠送Lomaira是违法的。

如果你认为这种药不起作用，或者如果你在4周内没有减掉至少4磅，请立即打电话给你的医生。

不要突然停止使用洛美拉，否则你会有不愉快的戒断症状。问你的医生如何安全地停止使用这种药。

在室温下储存，避免受潮和受热。不用的时候把瓶子关紧。

如果我错过一剂怎么办？

你要尽快吃药，但如果是在一天的晚些时候，就不要吃漏掉的剂量。不要一次服用两剂。

如果我过量会怎么样？

寻求紧急医疗护理或拨打毒物帮助热线1-800-222-1222。过量服用洛美拉可能致命。

过量的症状可能包括精神错乱、恐慌、幻觉、极度不安、恶心、呕吐、腹泻、胃痉挛、感到疲倦或沮丧、心跳不规则、脉搏微弱、癫痫或呼吸缓慢（呼吸可能停止）。

服用芬特明时应该避免什么？

避免驾驶或危险活动，直到你知道洛迈拉将如何影响你。你的反应可能会受损。

用这种药喝酒会引起副作用。

 

洛迈拉副作用

如果你有过敏反应的迹象：荨麻疹；呼吸困难；面部、嘴唇、舌头或喉咙肿胀，请寻求紧急医疗帮助。

如果您有下列情况，请立即致电您的医生：

感到呼吸短促，即使有轻微的劳累；

胸痛，感觉自己可能昏倒；

脚踝或脚肿胀；

在你的胸口跳动或跳动；

震颤，不安，失眠；

情绪或行为的异常变化；或

血压升高-严重头痛，视力模糊，颈部或耳朵肿大，焦虑，鼻出血。

常见的副作用可能包括：

瘙痒的；

头晕、头痛；

口干，味道不好；

腹泻、便秘、胃痛；或

对性的兴趣增加或减少。

这不是一个完整的副作用和其他可能发生的清单。打电话给你的医生寻求有关副作用的医疗建议。您可以拨打1-800-FDA-1088向FDA报告副作用。

 

 

还有什么药物会影响洛美拉？

与其他饮食药物如芬氟拉明（phen fen）或德克芬氟拉明（redux）一起服用洛美拉可导致一种罕见的致命性肺疾病，称为肺动脉高压。没有医生的建议，不要将此药与其他减肥药一起服用。

许多药物会影响洛美拉。这包括处方药和非处方药、维生素和草药产品。并非所有可能的交互都列在这里。告诉你的医生你目前的所有药物和任何你开始或停止使用的药物。

 

 

 

Lomaira (phentermine hydrochloride) Tablets

Date of Approval: September 13, 2016
Company: KVK Tech, Inc.
Treatment for: Weight Loss, Obesity

Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.

 

 

Lomaira

Generic Name: phentermine hydrochloride
Dosage Form: tablet

Medically reviewed by Drugs.com. Last updated on Dec 1, 2018.

 

Lomaira Description

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:

 

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.

Lomaira™ tablet is available as an oral tablet containing 8 mg of phentermine hydrochloride (equivalent to 6.4 mg of phentermine base). Each Lomaira™ tablet also contains the following inactive ingredients: Corn Starch, Magnesium Stearate, NF, Microcrystalline Cellulose 102, NF, Stearic Acid, NF, FD&C Blue #1, Sucrose and Pharmaceutical Glaze.

CLINICAL PHARMACOLOGY

Mechanism of Action

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Pharmacodynamics

Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Pharmacokinetics

Specific Populations

Renal Impairment

Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62%-85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment.

CLINICAL STUDIES

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” 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 “anorectic” 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 weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Indications and Usage for Lomaira

Lomaira™ tablets 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 in patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 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 patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m 2

 

The limited usefulness of agents of this class, including phentermine (see Clinical Pharmacology), should be measured against possible risk factors inherent in their use such as those described below.

Contraindications

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
• During or within 14 days following the administration of monoamine oxidase inhibitors
• Hyperthyroidism
• Glaucoma
• Agitated states
• History of drug abuse
• Pregnancy (see Precautions)
• Nursing (see Precautions)
• Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

Warnings

Coadministration with Other Drug Products for Weight Loss

Lomaira™ tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of phentermine and these drug products is not recommended.

Primary Pulmonary Hypertension

Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.

Valvular Heart Disease

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

Development of Tolerance, Discontinuation in Case of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Effect on the Ability to Engage in Potentially Hazardous Tasks

Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Risk of Abuse and Dependence

Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related stimulant drugs have been extensively abused. The possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Adverse Reactions/ Drug Abuse and Dependence and Overdosage.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Usage with Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

Use in Patients with Hypertension

Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in blood pressure).

Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Precautions

Information for Patients

Patients must be informed that phentermine hydrochloride is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended (see  Indications and Usage and Warnings).

Patients must be instructed on how much phentermine to take, and when and how to take it (see Dosage and Administration).

Advise pregnant women and nursing mothers not to use phentermine (see  Precautions).

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:

• Development of primary pulmonary hypertension (see  Warnings)
• Development of serious valvular heart disease (see Warnings)
• Effects on the ability to engage in potentially hazardous tasks (see  Warnings)
• The risk of an increase in blood pressure (see Warnings and Adverse Reactions)
• The risk of interactions (see Contraindications, Warnings, and Precautions/ Drug Interactions)

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance (see Warnings) and
• the risk of dependence and the potential consequences of abuse (see Warnings, Drug Abuse and Dependence, and Overdosage).

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.

Drug Interactions

Monoamine Oxidase Inhibitors

Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

Insulin and Oral Hypoglycemic Medications

Requirements may be altered (see Warnings)

Adrenergic Neuron Blocking Drugs

Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

 

Pregnancy

Pregnancy Category X

Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) (see Clinical Pharmacology ). Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Nursing Mothers

It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Phentermine was not studied in patients with renal impairment. Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment (see Clinical Pharmacology).

Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections:

- Primary pulmonary hypertension (see Warnings)

- Valvular heart disease (see Warnings)

- Effect on the ability to engage in potentially hazardous tasks (see Warnings)

- Withdrawal effects following prolonged high dosage administration (see Drug Abuse and
Dependence)

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.

Drug Abuse and Dependence

Controlled Substance

Phentermine is a Schedule IV controlled substance.

Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

Dependence

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Acute Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.

Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine ®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

Chronic Intoxication

Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence.

Lomaira Dosage and Administration

Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet three times a day ½ hour before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

 

 

HOW SUPPLIED/STORAGE AND HANDLING

Lomaira™ is available as follows:

Lomaira™ 8 mg is supplied as white butterfly shaped tablets with blue speckles, debossed “K1” on one side and bisected on the other side.

Bottles of 30, NDC 10702-001-03

Bottles of 60, NDC 10702-001-06

Bottles of 90, NDC 10702-001-09

Bottles of 250, NDC 10702-001-25

Bottles of 500, NDC 10702-001-50

Bottles of 1000, NDC 10702-001-10

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Keep out of the reach of children.

Manufactured by:
KVK-Tech, Inc.
110 Terry Drive
Newtown, PA 18940

 

Item ID# 006178/07

Manufacturer’s Code: 10702 09/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 Tablets

NDC 10702- 001-03

Lomaira TM CIV

(phentermine hydrochloride USP) tablets

8 mg

30 Tablets Rx Only

KVK-TECH, INC.

 

60 Tablets

NDC 10702- 001-06

Lomaira TM CIV

(phentermine hydrochloride USP) tablets

8 mg

60 Tablets Rx only

KVK-TECH, INC.

 

90 Tablets

NDC 10702- 001-09

Lomaira TM CIV

(phentermine hydrochloride USP) tablets

8 mg

90 Tablets Rx only

KVK-TECH, INC.

 

250 Tablets

NDC 10702- 001-25

Lomaira TM CIV

(phentermine hydrochloride USP) tablets

8 mg

250 Tablets Rx only

KVK-TECH, INC.

 

500 Tablets

NDC 10702- 001-50

Lomaira TM CIV

(phentermine hydrochloride USP) tablets

8 mg

500 Tablets Rx only

KVK-TECH, INC.

 

1000 Tablets

NDC 10702-001-10

Lomaira TM CIV

(phentermine hydrochloride USP) tablets

8 mg

Rx only 1000 Tablets

KVK-TECH, INC.

 

Lomaira  phentermine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10702-001 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 8 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STEARIC ACID   FD&C BLUE NO. 1   SUCROSE

Product Characteristics Color white, blue (Speckles) Score 2 pieces Shape FREEFORM (Butterfly Shape) Size 3mm Flavor   Imprint Code K;1 Contains

Packaging # Item Code Package Description   1 NDC:10702-001-03 30 TABLET in 1 BOTTLE   2 NDC:10702-001-06 60 TABLET in 1 BOTTLE   3 NDC:10702-001-09 90 TABLET in 1 BOTTLE   4 NDC:10702-001-25 250 TABLET in 1 BOTTLE   5 NDC:10702-001-50 500 TABLET in 1 BOTTLE   6 NDC:10702-001-10 1000 TABLET in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203495 09/12/2016

Labeler - KVK-TECH, INC. (173360061)

Registrant - AVANTHI INC. (832316694)
Establishment
Name	Address	ID/FEI	Operations
KVK-TECH, INC.		173360061	manufacture(10702-001)

 

KVK-TECH, INC.