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Furmium

Description:
Furmium (Olanzapine) is a psychotropic agent that belongs to the thienobenzodiazepine class.. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44.                                                                                                                                                                                                                                                                                      
  Pharmacodynamic properties:
Olanzapine is an antipsychotic agent that demonstrates a broad pharmacologic profile across a number of receptor systems. In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki:100nM) for serotonin 5 HT 2A/2C, 5HT3, 5HT6, dopamine D1, D2, D3, D4, D5: cholinergic muscarinic receptors m1- m5; 1 adrenergic; and histamine H1 receptors.
Pharmacokinetic properties:

  1. OIanzapine is well absorbed after oral administration.
  2. It achieves peak plasma concentrations within 5 to 8 hours.
  3. The absorption is not affected by food.
  4. Absolute oral bioavailabilitiy relative to intravenous administration has not been determined.
  5. OIanzapine is metabolized in the liver by conjugative and oxidative pathways.

Indications and Usage:
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and other psychosis where positive symptoms (e.g., deIusions, hallucinations, disordered thinking hostility, and suspiciousness) and/or negative symptoms (e.g., flattened affect, emotional and social withdrawal, poverty of speech) are prominent.

Posology and method of administration:
The recommended starting dose for Olanzapine is 10mg/day, administered as a single daily dose without regard to meals. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20mg daily.
Children:
Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients:

A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant.

Patients with renal and/or hepatic impairment:

A lower starting dose (5mg) should be considered for such patients in cases of moderate hepatic insufficiency (cirrhosis Child-Pugh Class A or B) the starting dose should be 5mg and only increase with condition. 

Female compared with male patient:

The starting dose and dose range need not be routinely altered for female patients relative to male patients.

Non-smoking patients compared with smoking patients:

The starting dose and dose range need not be routinely altered for non-smoking patients relative to smoking patients. When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status) consideration should be given to decreasing the starting dose.

Contraindications:
Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredients of the product. Olanzapine is contraindicated in patients with known risk  of narrow- angle glaucoma.
 

Special warnings and special precautions for use:
Concomitant illnesses as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored during this period.

 
Interaction with other medicaments and other forms of Interaction:

  1. Potential for Other Drugs to Affect Olanzapine:

Single-doses of antacid (Aluminium magnesium) or cimetidine did not affect the oral bioavailability of olanzapine. However, the concomitant administration of activated charcoal reduced the oral bioavailability of olanzapine by 50 to 60%.
Fluoxetine (60mg single dose or 60mg daily for 8 days) causes a mean 16% Increases in the maximum concentration of olanzapine and a mean 16% decrease in olanzapine clearance. Therefore dose modification is not routinely recommended. The metabolism of olanzapine may be induced by concomitant smoking (the clearance of olanzapine is 33% lower and the terminal elimination half-life is 21% longer in non-smokers compared to smokers) or carbamazepine therapy (clearance is increased 44% and the increase elimination half-life is reduced by 20% when administered with carbamazepine).

Use during pregnancy and lactation:

Pregnancy:

There are no adequate and well-controlled studies in pregnant women Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine. Nevertheless, because human experience is limited, this drug should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:

Olanzapine was excreted in milk of treated rats during lactation. It is not known if olanzapine is excreted in human milk. Patients should be advised not to breast feed an infant if they are taking olanzapine.

Effects on ability to drive and use machine:

Because olanzapine may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles.
 

Undesirable effects:

Frequent (>10%):

The only frequently undesirable effects associated with the use of oIanzapine in clinical trials were somnolence and weight gain. Weight gain was related to a lower pretreatment body mass Index (BMI) and initial starting dose of 15mg or greater.

Occasional (1-10%):

Occasional undesirable effects associated  with the use of olanzapine in clinical trials included dizziness, increased appetite, peripheral oedema, orthostatic hypotension and mild transient  anticholinergic effects including constipation and dry mouth.

Rare (<1%):

Photosensitivity reaction and rash were reported rarely. Rare reports of hepatitis and priapism have been received.
Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases. Seizures have been reported to occur rarely in patients treated with oIanzapine. In most of these cases a history of seizures or risk factors for seizures were reported.

Overdose:

Experience with olanzapine in over dosage is limited. In the patient taking the largest identified amount, 300mg, the only symptoms reported were drowsiness and slurred speech. In the limited number of patients who were evaluated in hospitals, including the patient taking 300mg, there were no observations indicating an adverse change in laboratory analysis or ECGs. Vital signs were usually within normal limits following overdoses.

Availability:
Furmium   5mg Tablet: pack of 10 tablets.
Furmium 10mg Tablet: pack of 10 tablets.