OLANEX-F
Manufacturer Details
SUN PHARMA
Compositions:
Olanzapine 5mg,
Fluoxetine 20mg tablets,
|
Strength
|
Rate
|
Packing Style
|
|
5mg/20mg
|
98.00
|
10s tablets
|
List of Related Indications:
List Of Drugs:
- Olanzapine- Antipsyhotic agent- thienbenzodiazepine deri- (FDC- List )- (Jan 2000)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Use with caution when in combination with other centrally acting drugs and alcohol Concomittant administratin with antihypertensives can potentiate hypotension It antagonozes the effects of levodopa and dopamine agonists Concomittant administration with drugs like omeprazole and rifampicin may increase the olazapine clearance rate Inhibitors of CYP1A2 (eg. fluvoxamine ) inhibits its elimination Carbamazepine therapy causes an increase in the clearance of olanzapine
Indication:
Olanzepine pamoate Prolonged release powder for suspension for
I.M. injection (combi pack)
Each combipack contains-
a.Vial of Olanzepine pamoate Prolonged release powder for suspension.
Each vial contains:
Olanzepine pamoate monohydrate eq. to Olanzepine
210mg/300mg/400mg
After reconstitution each ml of suspension contains 150mg
b.Vial of vehicle : 3ml clear ,colourless to slight yellow sotution contains:
Manitol IP 5.070% w/v
Sodium carboxymethylcellulose IP - 0.770% w/v
Polysorbate 80 IP - 0.025% w/v
HCL IP - qs
NaoH IP - qs
Water for injection qs. to 100%
Indication-
For the treatment of schizophrenia
Approved by FDA on 14-10-2014 (Ref- FDA approved List
LIST OF DRUGS DURING 2006
Sr.No- 102
Name of the Drug- Olanzapine powder for oral suspension
(10mg/ml) Pharmacological Classification- For schizophrenia in adults
Date of Approval- 11-08-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Olanzapine Anti Psychotic 27-01-2000
2.Olanzapine powder for 11-08-2006
oral suspn. 10mg/5ml
For Schizophrenia in adults
3.Olanzapine Pamoate prolonged 14-10-2014
Release powder for suspn.
For I.M. Injection (combi pack)
Each Combipack contains-
i.Vial of Olanzapine pamoate
prlonged release powder for suspn.
Each vial contains -
Olanzapine pamoate monohydrate
eqv. to Olanzapine 210mg/300mg/405mg
After reconstituting each ml contains 150mg
ii. Vial of vehicle -3ml clear
colourless to slight yellow
solutions contains-
Mannitol IP 5.070%w/v
Sodium Carboxylmethyl
cellulose IP 0.77%
Polysorbate 80 IP 0.025% w/v
Hcl IP q.s.
water for Injection q.s. to 100%
For the treatment of Schizophrenia
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Olanzapine 5mg/10mg + 18-02-2003
Fluoxetine Hcl
eq. to Floxetine 20mg/20mg tablet
For the treatment of resistent depression only
PATENT EXPIRY DATES OF DRUGS (Ref -IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Olanzapine CNS Eli Lily & C0 23-04-2011
Schizophrenia
Adverse Reaction:
Mild , transcient antimuscarinic effects, agitation, behavoiural problems, Chest pain, fever, Flu-like symptoms, Inability to move eyes, Lip smacking, mood changes, Giddiness, loss of memory, Nervousness, puffung of cheeks, Swelling of feet or ankles, Changes in menstrualperiod, Hyperprolactinemia
Contra-Indications:
Hypersensitivity, angle-closure glaucoma, breast feeding
Special precautions:
Should be used cautiously in patients with a history of seizures, Alzhemers dementia, aspiration pneumonia, pregnancy, hepatic impairment, renal impairment, and depression
Dosages/ Overdosage Etc:
Date of Approval 2000
Indications
Schizophrenia
Dosage:
10mg daily adjusted toi usual range of 5-20 mg daily, doses of 15mg daily or greater only after reassessment
Pharmacology/ Pharmacokinetics:
Pharmacology:
Olanzapine is selective-monoaminergic antagonist with high affinity binding to receptors like sertonin, dopamine, muscarinic,histamine and adrenergic receptors.
Olanzapine binds weakly to GABA, BZD, and beta adrenergic receptors The proposed mechanism of action for antipychotic activity is mediated through a combination of dopamine and serotinin type antagonism.
Pregnancy and lactation:
Pregnancy Not recommended for use during pregnancy Breast feeding Contraindicated
