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  • Razin
    / CTS


    Active Ingredient
    Phentermine (as resinate) 15 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    30 X 15 mg

    not in the basket chart 57843 18284

    Related information


    Dosage

    Adults and children aged over 16 years: One capsule daily at breakfast, swallowed whole.


    Indications

    For the treatment of severe obesity that has not responded to an appropriate diet- a minimal body mass index of 30 kg/m² is required.


    Contra-Indications

    Known hypersensitivity or idiosyncrasy to sympathomimetic amines or to any of its excipients.
    Pulmonary artery hypertension, Existing heart valve abnormalities or heart murmurs, Moderate to severe arterial hypertension, Cerebrovascular disease, Severe cardiac disease including arrhythmias, Advanced arteriosclerosis, Hyperthyroidism, Agitated states or a history of psychiatric illness including anorexia nervosa and depression, Glaucoma, History of drug/alcohol abuse or dependence, Concomitant treatment with monoamine oxidase (MAO) inhibitors or within 14 days following their administratio, Co-administration of drug products for weight loss.


    Special Precautions

    The drug may be used for a period of up to 3 months of treatment. the drug is indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and other drug products for weight loss have not been established. Therefore, coadministration of drug products for weight loss is not recommended.
    Since the selective serotonin reuptake inhibitors (e.g fluoxetine, sertraline, paroxetine), ergot like drugs and clomipramine affect serotonin disposition there remains a theoretical risk that
    combination of these agents with phentermine may also be associated with cardiac valvular disease and is not recommended. There is no direct scientific evidence to confirm this theory.
    Valvular Heart Disease: Serious regurgitate 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 etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known.
    Primary Pulmonary Hypertension (PPH): Cases of severe, sometime fatal primary pulmonary hypertension, have been reported in patients who have received anorectics. In a case-control epidemiological study, the duration of treatment with anorectic agents, not including phentermine, beyond three months significantly increases the risk of PPH. However, patients treated with phentermine require medical review at least every 3 months .
    PPH has been reported in patients receiving phentermine combined with fenfluramine / dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been very rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea.
    Other early symptoms include: angina pectoris, syncope, lower extremity edema or the unexplained onset or aggravation of diminished exercise tolerance. Under these circumstances,
    treatment should be immediately discontinued and the patient referred to a specialist unit for investigation.
    Use with Caution in the Following Circumstances:
    should be used with caution in patients with mild hypertension. In the first days of treatment, determine that there is no loss of blood pressure control.
    In patients receiving phentermine, response to insulin and oral hypoglycaemic agents may vary due to alterations in dietary regimes. This should be kept in mind if phentermine is used in diabetic patients.
    Inappropriate use has been reported with similar drugs and the possibility of this occurrence should be considered with phentermine .
    Cardiovascular and cerebrovascular events have rarely been reported, mainly in association with rapid weight loss. Weight loss should be gradual and controlled in obese patients undergoing treatment . The drug should be used with caution in patients with established coronary
    artery disease. A single case of exacerbation of angina pectoris in a patient with established coronary artery disease has been reported.
    Phentermine should be used with caution in patients receiving psychotrophic drugs, including sedatives and agents with sympathomimetic activity.
    The drug should be used with caution in epileptic patients.
    The drug should be used with caution in patients receiving anti-hypertensive agents.
    Use in the elderly
    The drug is not recommended for the elderly.
    Paediatric Use
    Phentermine are not recommended for use in pediatric patients under 16 years of age.
    Effects on laboratory tests
    There are no reports to-date to suggest that phentermine interferes with laboratory or diagnostic tests.
    Excipients
    Contains lactose. Patients with rare hereditary problems of galactose intolerance, total
    lactase deficiency or glucose-galactose malabsorption should not take this medicine.
    Contains Sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.


    Side Effects

    Cardiovascular: Primary pulmonary hypertension, palpitation, tachycardia, levation of blood pressure and precordial pain. Rarely, cases of cardiovascular or cerebrovascular accidents have been described in patients treated with anorectic agents. In particular stroke, angina, myocardial infraction, cardiac failure and cardiac arrest have been reported.
    Central Nervous System: Overstimulation, restlessness, nervousness, dizziness, headache, insomnia, euphoria may occur and this may be followed by fatigue and depression, dysphoria, tremor, headache; rarely psychotic episodes and hallucinations at recommended doses with some drugs in this class.
    Gastrointestinal: Dryness of the mouth, abdominal cramps, unpleasant taste, diarrhea, constipation, nausea, vomiting, other gastrointestinal disturbances.
    Allergic Reaction: Urticaria, rash, facial edema.
    Endocrine Effects: Impotence, changes in libido.
    Other: Micturition disturbances.


    Drug interactions

    Use Razin with caution in patients receiving sympathomimetic agents. Response to insulin and oral hypoglycaemic agents may vary in patients receiving phentermine. Phentermine antagonises adrenergic neurone blocking drugs such as clonidine, methyldopa and guanethidine and may decrease their hypotensive effect. The effects of phentermine are potentiated by monoamine oxidase inhibitors (see contraindications) and may result in a hypertensive crisis. The concurrent use of thyroid hormones with Razin may increase the CNS stimulation that can occur with Razin. Alcohol may increase CNS side effects such as dizziness, light-headedness and confusion and its concurrent use should be avoided with Razin. Serotonin reuptake inhibitors and tricyclic antidepressants may interact with Razin by increasing serotonin levels, and Razin should be used with caution in those taking these agents. Since the selective serotonin reuptake inhibitors (eg fluoxetine, sertraline, fluvoxamine, paroxetine), ergot derived drugs and clomipramine affect serotonin metabolism there remains a theoretical risk that combination of these agents with phentermine may also be associated with cardiac valvular disease, although there is no direct scientific evidence to confirm this theory. In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine Cmax and AUC increase 13% and 42% respectively.


    Pregnancy and Lactation

    Effects on fertility
    In rats, administration of phentermine at a dose 10 times the maximum human dose on a mg/m2 basis abolished oestrous cycling. There is no information on the potential of phentermine to impair fertility in humans.
    Pregnancy
    Weight reduction using appetite suppression drugs is not recommended during pregnancy. In rats, administration of phentermine during late gestation at a dose 7 times the maximum human dose on a mg/m2 basis had no adverse effects on dams or offspring. There is no information on the teratological potential of phentermine. Because of inadequate evidence of safety in human pregnancy, the drug should not be used in pregnant women.
    Lactation
    There is no data available on the safety in lactation and as such, its use in lactating women should be avoided.


    Overdose

    Symptoms: Initially irritability, rapid respiration, agitation, euphoria, restlessness, hyperreflexia, disorientation and tremor, aggressiveness, hallucinations and panic states may occur, followed by cardiac arrhythmias, convulsions, fatigue, central nervous system depression and coma.
    Cardiovascular consequences include hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps.
    Treatment: The treatment is largely symptomatic. Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully
    conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. Diazepam, preferably by mouth
    (cautiously by intravenous injection) can be used to control marked excitement and convulsions.
    Provided renal function is adequate, elimination of phentermine has been shown to be assisted by acidification of the urine. There is insufficient experience to recommend haemodialysis or
    peritoneal dialysis.


    Important notes

    The drug may impair the ability to perform activities requiring mental alertness, such as driving and operating machinery, and patients therefore should be cautioned accordingly.


    Manufacturer
    CTS Chemical Industries Ltd
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