Axcel Phentermine

Each tablet contains Phentermine Hydrochloride equivalent to Phentermine 30mg.

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 d/l-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. Typical 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: Following the administration of phentermine, phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours.
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% to 85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment.

Adjunctive therapy to diet, in patients with obesity and a body mass index (BMI) of ≥ 30, who have not responded to an appropriate weight-reducing regimen alone.
Note: Short-term efficacy only has been demonstrated with regard to weight reduction. No significant data on changes in morbidity or mortality are yet available.

Exogenous Obesity: Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast for appetite control. The dosage may be adjusted to the patient's need. For some patients, ½ tablet daily may be adequate, while in some cases it may be desirable to give ½ tablets two times a day. Patients require medical review after a defined course of treatment, which should not exceed three months. It is not recommended for use in pediatric patients below 16 years of age and also elderly. Late evening medication should be avoided because of the possibility of resulting insomnia.

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 has been suggested on pharmacologic grounds for possible acute, severe hypertension, ii 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.

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.
Nursing.
Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines.

Coadministration with Other Drug Products for Weight Loss: Phentermine is 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 slopped 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.
Risk of Abuse and Dependence: Phentermine is related chemically and pharmacologically to amphetamine (d- and d/l-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. 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.
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.
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.
Use in Pregnancy: Because of inadequate evidence of safety in human pregnancy, Phentermine should not be used in pregnant women.
Use in Lactation: There is no data available on the safety of Phentermine in lactation. Use in lactating women should be avoided.
Use in Children: 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.
Use in the Elderly: 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 maybe 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.

Use in Pregnancy: Because of inadequate evidence of safety in human pregnancy, Phentermine should not be used in pregnant women.
Use in Lactation: There is no data available on the safety of Phentermine in lactation. Use in lactating women should be avoided.

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.

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.
Adrenergic Neuron Blocking Drugs: Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Store below 30°C. Protect from light.

Anti-Obesity Agents

A08AA01 - phentermine ; Belongs to the class of centrally acting antiobesity products. Used in the treatment of obesity.

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