|Composition||:||Newfranil 50: Each capsule contains clomipramine hydrochloride 50 mg.|
|Excipients||:||Magnesium Stearate, Maize Starch.|
|Pharmacodynamic properties||:||Newfranil is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants.
The active substance is completely absorbed by the oral route.
Newfranil has an antidepressive effect of rapid onset its therapeutic activity being characterized by a high degree of safety and reliability.
|Mechanism of Action||:|| Newfranil exerts a comprehensive action on the depressive syndrome as a whole, including in particular, typical features such as psychomotor retardation, depressed mood, and existential anxiety. Its effect usually in within the first week of treatment.
The therapeutic activity of Newfranil is believed to be based on its ability to inhibit the re –uptake of noradrenaline and serotonin into the respective neurons, the re –uptake of serotonin, however, being more strongly inhibited than by other tricyclic antidepressants.
|Indications||:||Depressive states of varying aetiology and symptomatology endogenous reactive, neurotic, organic, masked, and evolutional forms of depression. Depression associated with schizophrenia and personality disorders. Depressive syndromes due to presenility or senility, to chronic painful conditions, and to chronic somatic diseases. Depressive mood disorders of a reactive neurotic, or psychopathic nature, including their somatic equivalents in children.
Further Indications: obsessive compulsive syndromes, phobias and panic attacks. Cataplexy accompanying narcolepsy, chronic painful conditions, and nocturnal enuresis (from the age of 5 years onwards, and provided the possibility of organic causes has first been excluded)
|Contraindications||:||- Concomitant treatment with clomipramine and MAO inhibitor is absolutely contraindicated.
- Known hypersensitivity to tricyclic antidepressants belonging to the dibenzazepine group.
|Warnings and precautions||:||- Treatment with Newfranil should be given only under medical supervision.
- Particular caution is indicated when employing tricyclic antidepressants in the presence of heart failure or circulatory debility , in the acute stage of myocardial infarction , a low convulsion threshold.
- disorders of micturition due to an impeded flow of urine ( e.g. in disease of the prostate or glaucoma) .
- Before initiating treatment it is advisable to check the patient s blood pressure, because individuals with low blood pressure or a labile circulation may react to the drug with a fall of blood pressure, this can be controlled by reducing the dosage or administrating circulatory stimulants.
- Occurrences of agranulocytosis have been connected with the use of tricyclic antidepressants.it is therefore also advised to perform blood counts during treatment with clomipramine, especially if the patient develops fever, an influenza infection, or sore throat .
- the patient’s reaction e.g. as a road-user, may be impaired by clomipramine.
|Undesirable effects||:||At the start of treatment ,Clomipramine may give rise to accompanying anticholinergic reactions such as sweating , dryness of the mouth , a fine tremor, dizziness , blurring of vision , and disturbances of micturition ,as well as postural hypotension , which generally disappear after a few days either spontaneously or following a decrease in the dosage .|
|Pregnancy and lactation||:||Pregnancy: Category C, There are no adequate and well-controlled studies in pregnant women with Newfranil; therefore, Newfranil should be used during pregnancy only if the potential benefit the potential risk to the fetus.
Breast-feeding: Since the active substance passes into the breast milk, nursing mothers receiving Newfranil should not breast feed their infants.
|Drug Interactions||:||Clomipramine may diminish or abolish the antihypertensive effect of adrenergic neuron inhibitors such as guanethidine (if necessary, antihypertensive of different type should be used).
If Clomipramine is to be employed following treatment with an MAO inhibitor, this should be done only after an interval of at least 14 days has elapsed because otherwise sever interactions may occur.
|Dosage & Administration||:||The dosage and mode of administration should be determined individually and adapted to the patient’s conditions.
- Depression, obsessive compulsive syndrome and phobias: initiate treatment with one capsule of 25 mg 2-3 times daily. During the first week of treatment ,raise the daily dosage stepwise to 4-6 capsules of 25mg in divided doses with meals to reduce gastrointestinal side effects in severe cases this dosage can be exceeded. Once a distinct improvement has occurred, adjust the daily dosage to maintenance level averaging 2-4 capsules of 25 mg.
- In chronic painful conditions: The dosage must be individualized (10-150 mg daily) taking account of such concomitant analgesic medication as the patient may be receiving (and of the possibility of reducing the doses of the analgesic).
- In cases of cataplexy accompanying narcolepsy: Newfranil should be given orally in daily dose of 25-75 mg possibly in combination with methylphenidate (Ritalen).
- Geriatrics & pediatrics : Initially 1 capsule of 25 mg daily and should be gradually increased (also given in divided doses with meals to reduce gastrointestinal side effects) during the first two weeks up to the daily maximum of 3 mg/kg or 100 mg .Thereafter, the dosage may be increased gradually over the next several weeks up to a daily maximum of 200 mg.
And then adhered to, until the end of treatment .The total daily dose may be given once daily at bedtime to minimize daytime sedation.
- Panic attacks :initiate treatment with one capsule of 25 mg possibly in combination with a benzodiazepine .Depending on how the medication is tolerated , raise the dosage until the desired response is obtained , while at the same time gradually withdrawing the benzodiazepine .The daily dosage required varies greatly from patient to patient and lies between 25-150 mg if necessary .It is recommended that treatment should not be stopped before 6 months and during this time the maintenance dose should be slowly reduced.
|Storage||:||Store at temperature (15 – 30)°C, Keep away from children.|
|Packaging||:||Newfranil 50: Carton box of 20 capsules and blister packed capsules with enclosed leaflet.|