Panbesy

Panbesy 15: Red and natural colour capsules.
Panbesy 15 contains phentermine hydrochloride 15 mg.
Panbesy 30: Blue and natural colour capsules.
Panbesy 30 contains phentermine hydrochloride 30 mg.
Excipients/Inactive Ingredients: Saccharose, maize starch, povidone type K29-32, dewaxed shellac, talc.

Pharmacology: Mechanism of action: Phentermine is an indirect-acting sympathomimetic agent that acts by releasing noradrenaline from the presynaptic vesicles in the lateral hypothalamus. This increase in noradrenaline concentration in the synaptic cleft results in the stimulation of beta₂-adrenergic receptors. Phentermine is classified as an indirect sympathomimetic due to the increase in the level of norepinephrine, dopamine and its indirect effect towards serotonin. Some reports have indicated that phentermine inhibits the neuropeptide Y which is a principal signaling pathway for the induction of hunger. This combined effect produces a continuous flight-or-fight response in the body which reduces the hunger signal as this state is on the immediate need for energy.
Pharmacokinetics: Due to the sustained release formulation Panbesy has a long half-life 23 hours at steady state and a Cmax of 166 ng/ml.

For use as an adjunct to the treatment of patients with moderate to severe obesity.

Adults and children over 12 years: The usual dose is one 15 mg capsule daily at breakfast and again at lunchtime if required. Alternatively, one 30 mg capsule can be taken at breakfast. Taking Panbesy any later than lunchtime may cause trouble sleeping at night.
Method of administration: Oral.

Symptoms: Initially irritability, agitation, disorientation and tremor may occur, followed by cardiac arrhythmias, convulsions, hallucinations and coma.
Treatment: The stomach should be emptied by emesis or stomach tube and washed out with water if the preparation has been ingested within the last three or four hours. Diazepam, preferably by mouth (cautiously by intravenous injection) should be used to control marked excitement and convulsions. Provided renal function is adequate, elimination of phentermine may be assisted by acidification of the urine by agents such as lysine hydrochloride or arginine hydrochloride.

Hypersensitivity to the active substance(s) or to any of the excipients listed in Description.
Epilepsy.
Hypersensitivity to sympathomimetic amines.
Advanced arteriosclerosis.
Severe hypertension.
Children under 12 years.
Hyperexcitability.
Patients with cardiovascular disease.
Hyperthyroidism.
Glaucoma.
Patients with a history of drug abuse.
During or 14 days following administration of monoamine oxidase inhibitors.

Tolerance: Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect: rather the drug should be discontinued.
Caution is to be exercised in prescribing Phentermine hydrochloride for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Phentermine hydrochloride and the concomitant dietary regimen. Phentermine hydrochloride may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. The possibility of abuse of Phentermine hydrochloride should be kept in mind when evaluating the desirability of including the drug as part of a weight reduction program.
Effects of ability to drive and use of machinery: Phentermine may cause blurred vision, dizziness or tiredness in some patients.
Use in Children: The administration of Panbesy should be avoided in children under the age of 12 years.

Panbesy should not be used during pregnancy and lactation.

Among the side effects which are relatively common are: dryness of the mouth, restlessness, headache, insomnia, irritability, dizziness, tremor.
Larger doses may give rise to: fatigue, mental depression, an increase in blood pressure, fever, cardiovascular reactions, disorientation, hallucinations, convulsions, palpitation, tachycardia, overstimulation, euphoria, dysphoria, psychotic episodes, unpleasant taste, diarrhoea, constipation, other gastrointestinal disturbances, urticaria, impotence, changes in libido.

Like other sympathomimetics, phentermine may interact with a number of drugs.
Phentermine should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Concurrent use of beta blockers and amphetamines may produce severe hypertension.
Patients receiving amphetamines and tricyclic antidepressants require careful monitoring as the risk of cardiovascular effects may be increased.
Concomitant use of sympathomimetics with volatile anaesthetics is associated with an increased risk of cardiac arrhythmias.

Store in below 25°C.

Anti-Obesity Agents

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

POM