MOSETIFEN

MOSETIFEN
17 May

MOSETIFEN

Appetite Stimulants

Pizotifen has an appetite –stimulating action suitable for increasing 
 body weight in underweight anorectic patients. The compound is 
 well tolerated, permitting treatment of anorexia both in children and 
 adults.
-In elderly people Pizotifen has been shown to improve disturbed 
 mood by alleviating symptoms such as hopelessness, feeling of 
 dejection or oppression , asthenia , anxiety, restlessness, sleep 
 disturbances ,and impairment of concentration or memory..
-Owing to inhibitory effect on biogenic amines, Pizotifen is also 
 used for  prophylactic treatment of migraine.
-Pizotifen absorption is fast ( 0.5 to 0.8 hours ) and nearly complete.
-The absolute bioavailability of pizotifen is 78%. Maximum blood 
 levels  are reached 5 hours after a single 2 mg oral administration of 
 Pizotifen.
-91 % of Pizotifen is bound to plasma proteins.
-Pizotifen is extensively metabolized, about 55 % of pizotifen dose 
 is excreted in urine as metabolites ,and less than 1 % unchanged. 
 About 18%  of applied dose is found in feces.

Indecation

Mosetifen®  is used in:
-Anorexia of somatic origin in underweight patients, supplementary 
 to the treatment  of  underlying  conditions , such as infectious or 
 parasitic diseases (including convalescence) , chronic diarrhea , 
 anorexia nervosa.
 Note: priority should always be given to identifying and treating the 
 underlying causes. 
-Depressive mood in the elderly.

Dosage & Administration

•Anorexia in underweight patients:-
 Adults: starting with 0.5mg per day , the dosage should be 
 progressively  increased up to 0.5 mg three times daily.
Children: small initial dose should be gradually increased up to an 
 average maintenance dosage   of 0.025 mg/kg body weight daily, 
 this dose may be  given in 2 or 3 divided doses or as directed by the 
 physician. 


 ( Children below two years of age should not be given Mosetifen®)
•Mood elevation in elderly patient the dosage should be adjusted to
 Individual needs and the severity of the symptoms. A starting dose 
 of  0.5mg daily is recommended, preferably increasing by 0.5mg per 
 day. For most patients the daily optimum dose is 2 to 3mg in divided 
 doses, but up to 12mg were well tolerated. Following improvement, 
 usually within 6 to 8 weeks, gradual reduction or withdrawal of 
 treatment can be attained.  

 Each Tablet of Mosetifen® contains :
    0.5 mg Pizotifen ( as Pizotifen malate).
- Each 10 ml of Mosetifen® syrup contains:
    0.5 mg Pizotifen ( as Pizotifen malate).

Mosetifen® is contraindicated in patient with knownhypersensitivity 
 to pizotifen, and in children under 2 years of age.

-Central effects of sedatives, hypnotics, antihistamines (including 
 certain  common cold preparations), and alcohol may be enhanced 
 when used with  Mosetifen®.

-Mosetifen® should be administered in pregnancy only in necessary 
 circumstances.
-The use of Mosetifen®   is not recommended in nursing mothers.

 •The most common side effect is sedation ( including somnolence and 
 fatigue). 
•Other side  effects:
-Immune system disorders:
 Rare: Hypersensitivity reaction, face oedema.

- Psychiatric disorders:
  Rare: Depression, CNS stimulation(e.g. aggression, agitation) hallucination, 
  insomnia, anxiety.
- Nervous system disorders:
  Common: Sedation (including somnolence) dizziness:
  Rare: Paraesthesia. 
  Very rare: Seizures.
- Gastrointestinal disorders
   Common: Nausea, dry mouth.
   Uncommon: constipation.
- Skin and subcutaneous tissue disorders: 
    Rare: urticaria, rash. 
- Musculoskeletal and connective tissue disorders:
    Rare: Myalgia.
- General disorders:
    Common: Fatigue.


Overdose:-
 Symptoms, which may be expected are: drowsiness, nausea, 
 hypotension,  dizziness ,excitatory states( in children), respiratory 
 depression, convulsion  (particularly in children) and coma.
 Treatment: Administration of activated charcoal is recommended; in 
 case of   very recent intake , gastric lavage may be considered. If 
 necessary,  symptomatic treatment including monitoring of the 
 cardiovascular and  respiratory system. For excitatory states  or 
 

-In view of the slight anticholinergic effect of Pizotifen, caution is 
 required in  patients with narrow-angle glaucoma (except those 
 successfully treated by  surgery) or urinary retention.
-Mosetifen® increases appetite and may lead to an increase in body 
 weight.  However, weight gain is dependent on adequate food intake, 
 and anorexia  must be differentiated from malnutrition.
-Mosetifen® should be used with caution in patients with epilepsy.
-Patients being treated with Mosetifen®and presenting with sedation 
 and/or  somnolence episodes must be instructed to refrain from 
 driving or engaging  in activities where impaired alertness may put 
 themselves or others at risk.
-In patients with kidney insufficiency, dosage adjustment may be  
 necessary.

Mosetifen® tablets:
     Blister of 10 tablets, pack of 3 blisters.
 Mosetifen® syrup:
     Bottle of 100 ml.

- Store in a dry place, at a temperature below 30ºC.