Product Elements:
Lomaira phentermine hydrochloride starch, corn magnesium stearate cellulose, microcrystalline stearic acid fd&c blue no. 1 sucrose phentermine hydrochloride phentermine speckles k;1 butterfly shape
Indications and Usage:
Indications and usage 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 patientâs weight, in kilograms (kg), divided by the patientâs 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. table
Warnings:
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) â a rare, frequently fatal disease of the lungs â 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
Read more...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.
Dosage and Administration:
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.
Contraindications:
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
Adverse Reactions:
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.
Overdosage:
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 .
Description:
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. chemical-structure
Clinical Pharmacology:
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 âanorecticsâ or âanorexigenics.â 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 conditi
Read more...ons is 62%-85%. exposure increases can be expected in patients with renal impairment. use caution when administering phentermine to patients with renal impairment.
Mechanism of Action:
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 âanorecticsâ or âanorexigenics.â 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:
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:
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:
Clinical studies in relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with âanorecticâ 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 âanorecticâ 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
Read more... factors on weight loss. the natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeksâ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.
How Supplied:
How supplied/storage and handling lomaira⢠is available as follows: lomaira⢠8 mg is supplied as white butterfly shaped tablets with blue speckles, debossed âk1â 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 manufacturerâs code: 10702 09/16 company-logo
Package Label Principal Display Panel:
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. 30s 60s 90s 250s 500s 1000s