rivo (clonazepam)
DESCRIPTION
Rivo is a brand of clonazepam uspTRANSCRIPT
Prepared by:
Rezaur Rahman SiddiquiProduct ExecutiveOrion Pharma Ltd
RivoClonazepam USP 0.5 & 2 mg Tablet
ANXIETY
PANIC DISORDER
SLEEP RELATED DISORDER
EPILEPSY
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Disease Part
Anxiety disorders are serious mental illnesses that involve intense feelings of fear, tension, worry or apprehension often associated with specific situations, events or objects. It may also be defined as a feeling of apprehension, often characterized by feeling of stress.
Anxiety
• Palpitation
• Tachycardia
• Sweating
• Tremor
• Hypertension
• Restlessness
• Agitation
• GIT disorder
•Sleep disturbance
Symptoms of Anxiety
Panic disorder Generalized Anxiety Disorder Phobic Anxiety Disorders
Simple or Specific Phobia Social Phobia & Agoraphobia
Post traumatic Stress Disorder
Types of Anxiety
Anxiety Disorders
Basic features
Panic disorders
Short-lived, recurrent, unpredictable episodes of intense anxiety
Anxiety is intermittent and unrelated to particular circumstances
Generalized Anxiety Disorders
This is most common type of anxiety Anxiety is unvarying and persistent GAD symptoms include trembling, muscular aches,
insomnia, abdominal upset & irritability.
Phobic Anxiety Disorders
Anxiety about specific situation or object Anxiety is intermittent and arises in particular
circumstances.
Types of AnxietyTypes of Anxiety
Types of AnxietyTypes of Anxiety
Specific phobiasSocial Anxiety
Disorder (Social Phobia)
Agoraphobia
People with specific phobias suffer from an intense fear reaction to a specific object or situation (such as spiders, dogs, or heights)
Fear is usually inappropriate to the situation
Characterized by extreme anxiety about being judged by others
This intense anxiety may lead to avoidance behavior.
Patients refuse to attend any social gathering or occasion
Agoraphobia is an anxiety disorder which primarily consists of the fear of experiencing a crowded place
In severe cases, an agoraphobic may be confined to their home Patients avoid any sort of crowded place (e.g. Market, busy roads)
Panic DisorderPanic Disorder
It’s an anxiety disorder and is characterized by unexpected and repeated episodes of intense fear accompanied by physical symptoms that may include chest pain, heart palpitation, shortness of breath, dizziness, or abdominal distress.
• The central feature of panic disorder is the occurrence of panic attacks.
• A panic attack is a discrete period of intense fear, discomfort or apprehension during which at least 4 of the 13 symptoms listed below develop suddenly, reaching a peak within 10 minutes after onset and then usually end within 20- 30 minutes.
Clinical FeaturesClinical
Features
• Palpitations or accelerated heart
rate
• Sweating
• Trembling or shaking
• Sensations of shortness of
breath
• Feeling of choking (Unpleasant)
• Chest pain or discomfort
Symptoms of Panic Attack
•Nausea or abdominal distress
•Feeling dizzy (Confuse),
unsteady
•Fear of losing control or going
crazy
•Fear of dying. (irrational fear of
death )
•Paresthesias (tingling
sensations)
•Chills or hot flushes
₪ Spontaneous, brief & isolated₪ Unexpected₪ Develops abruptly (within few
minutes)₪ Duration of 20 – 30 minutes
Characteristic of Panic Attack
Sleep related disorder
A sleep disorder is a disorder in the sleep patterns of a person.
It includes -•Insomnia•Sleepwalking•Sleep terrors •Parasomnias•REM Sleep Behavior Disorder (RBD)
Sleep terros
A night terror (Nightmare, feeling fear) characterized by extreme terror and a temporary inability to regain full consciousness.
Parasomnias
Automatic behavior that is not recalled may take place during light sleep. Sleep talking and sleepwalking are innocuous and common in normal children. Nightmares are frightening dreams from which the sufferer wakes
in a state of fear or agitation.
REM Sleep Behavior Disorder
REM (Rapid Eye Movement) sleep behavior disorder is one of the most dramatic sleep disorders.
People with the disorder thrash around in bed, responding physically and sometimes violently to their dreams.
Normally, people in REM sleep do not move their arms and legs.
People with REM sleep behavior disorder can harm themselves or their bed partner by flinging their arms and legs
Epilepsy
Any group of syndromes characterized by transient disturbances of the brain function that may be manifested as episodic impairment or loss of consciousness, psychic or sensory disturbances.
A single episode is called a seizure.
Classification of Epilepsy
1. Partial seizure
2. Primary Generalized seizure - Absence seizures- Atypical absence seizures- Myoclonic seizures- Atonic seizures- Tonic seizures- Clonic seizures- Tonic-clonic seizures
TO RELIEVE FROM
ANXIETYPANIC DISORDER
SLEEP RELATED DISORDEREPILEPSY
Brand name : Rivo 0.5 & Rivo 2 Generic name : Clonazepam USP Justification of name : Revive refreshness in vivoTherapeutic class : Anxiolytic & Anti-epilepticDosage form : TabletStrength : 0.5 mg & 2 mg Pack size : Rivo 0.5 (5x10’s) & Rivo 2 (3x10’s)
TP+VAT (Invoice Price) : Rivo 0.5 Tablet : Tk. 87.97/Box
Rivo 2 Tablet : Tk. 105.56/Box MRP/Box : Rivo 0.5 Tablet : Tk. 100/Box, Tk 2/Tab Rivo 2 Tablet : Tk. 120/Box, Tk 4/Tab
General information
Indication
Anxiety disorder
Panic disorder
Sleep related disorder
Epilepsy
Mechanism of Action
Mechanism of Action
Rivo
Binds to benzodiazepine receptor
Enhance the activity of GABA
Greater entry of chloride ions into neurons
More negative charge (Cl-) into neurons
Reduces of neural excitability
Reduction of Anxiety, Panic attack and Epilepsy
Mechanism of ActionMechanism of Action
Mechanism of ActionDosage and AdministrationDosage and Administration
Adults and elderly
Initial dose : 1 mg daily in divided dose (Elderly 0.5 mg), not to exceed 1.5 mg/day
Increment dose : 0.5 - 1 mg at intervals of 3 daysMaintenance dose: 4 - 8 mg/dayMaximum dose : 20 mg/day should be administered with
cautionDosing interval : b.i.d./t.i.d.
Up to 5 years : 0.25 mg daily in divided dose, increase gradually to 0.5 - 1 mg
5 - 12 years : 0.5 mg daily in divided dose, increase to 3 - 6 mg
Infants and children
Mechanism of ActionDosage and AdministrationDosage and Administration
Indication
Dosage Schedules
Anxiety Starting with 1mg/day followed by 4-8 mg/day in
divideddose
Panicdisorder
The initial dose for adults with panic disorder is 0.25 mg bid.
An Increase to the target dose for most patients of 1 mg/day
may be made after 3 days.
Epilepsy
Initially 1.5 mg/day divided into three doses then increments
of 0.5 mg to 1 mg every 3 days until seizures are adequately
controlled SleepRelateddisorder
Starting with 0.5 mg & then dose is increased by 0.25 mg
according to patient condition
Mechanism of ActionSide effectSide effect
CNS depression, drowsiness, fatigue, dizziness, muscle hypotonia, co-ordination disturbance, hypersalivation in infants, paradoxical aggression, irritability and mental change.
Mechanism of ActionUse in pregnancy and lactationUse in pregnancy and lactation
Pregnancy Category D
The use of Clonazepam during pregnancy or lactation should be avoided. Clonazepam is excreted into the breast milk and should therefore be avoided in breast-feeding mothers.
Mechanism of ActionUse in pregnancy and lactationUse in pregnancy and lactation
Pregnancy Category D
The use of Clonazepam during pregnancy or lactation should be avoided. Clonazepam is excreted into the breast milk and should therefore be avoided in breast-feeding mothers.
Mechanism of ActionJustification of launchingJustification of launching
•Provides fast-acting, short-term relief for mild to moderate anxiety
and the associated nervousness and tension as well as panic
disorder
•USFDA approved drugs for Panic disorder as well as for some types
of epilepsy
•Rapid onset of action providing quick control of panic attack
•Clonazepam’s long half life (18-54) allows convenient twice-a-day
dosing without interdose or rebound anxiety symptoms.
•Clonazepam does not produce extrapyramidal or anticholinergic
side effects
Clinical Aspect:
Mechanism of ActionJustification of launchingJustification of launching
Marketing Aspect:
Total Market SizeMarket Size
(Cr.)Growth %
Clonazepam 57.73 44.60Clonazepam 0.5 mg Tablet
39.62 49.77
Clonazepam 2 mg Tablet
18.00 34.77
Clonazepam is one of the most prescribing (20th) molecules in Bangladesh in
2010
It is well established molecule (over 14 years) with high growth rate 44.60%
Mechanism of ActionMajor CompetitorMajor Competitor
Sl No Brand Company Value (Cr) Share % Growth %Product
Age
Total Market 57.73 100.00 44.60 1 RIVOTRIL Roche 19.01 32.92 72.02 142 DISOPAN Incepta 9.79 16.96 0.38 93 EPICLON General 3.96 6.86 37.98 74 PASE Opsonin 3.70 6.41 71.54 65 EPITRA Square 3.54 6.13 77.12 56 EPNIL Sandoz 2.97 5.14 21.61 57 AROTRIL Aristo 2.79 4.83 37.07 78 CLORON Eskayef 2.55 4.42 40.43 79 LONAZEP Sun Pharma 1.91 3.31 66.55 11
10 LEPTIC Acme 1.75 3.04 29.29 5
Mechanism of ActionMarket ScenarioMarket Scenario
Value (Cr) Share % Growth %Clonazepam 57.73 44.60.5 mg 39.62 68.6 49.772 mg 18.00 31.2 34.77Drops 0.11 0.2
Mechanism of ActionRx TrendRx Trend
Mechanism of ActionTarget DoctorsTarget Doctors
All doctors, especially
GPCardiologistMedicine SpecialistsNeurologistInternee Doctor RMP & Psychiatrists
Mechanism of ActionPromotional ItemPromotional Item
Literature
Sample (1x4’s)
Mechanism of Action
Mechanism of Action
Mechanism of Action
Mechanism of Action
USP: Unique Selling PropositionUSP: Unique Selling Proposition
Mechanism of Action
Mechanism of Action
Bipolar DisorderBipolar Disorder
Bipolar disorder involves periods of elevated or irritable mood (mania), alternating with periods of depression. The "mood swings" between mania and depression can be very abrupt.
Drug Induce DrykinesiaDrug Induce Drykinesia
Dyskinesia means "abnormal movement.“Dyskinesia is a movement disorder which consists of effects including diminished voluntary movements[
Mechanism of Action
Choreiform movementChoreiform movement
Continual occurrence of rapid, highly complex jerky movements that appear to be well coordinated but are performed involuntarily
Tourette syndromeTourette syndrome
Tourette syndrome (TS) is a neurological disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics.
A tic is a sudden, repetitive movement or sound that can be difficult to control. Tics that involve movements are called motor tics and those that are sounds are called vocal tics.
Mechanism of Action
Why Rivo is better than other available benzodiazepines?
Why Rivo is better than other available benzodiazepines?
Parameter Rivo Alprazolam Bromazepam
Lorazepam Diazepam
TypeLong
actingShort-acting
Intermediate-acting
Intermediate-acting
Long acting
Half life (hrs) 18-54 6-20 12-20 10-18 20-100Onset of action Rapid Medium Medium Medium RapidRebound Anxiety
No Frequent Less Less No
Withdrawal effect
Less risk More risk Medium risk Medium risk Less risk
Sedation Moderate Moderate Moderate Moderate HighIndicationsAnxiety +++ ++ +++ ++ +++Panic attack +++ ++ 0 0 0Epilepsy +++ ++ 0 0 ++Sleep disorder +++ ++ + + +++
Mechanism of Action
Why opaque blister is used in Rivo Tablet?Why opaque blister is used in Rivo Tablet?
Clonazepam is light sensitive molecule.
To protect from light tablets are supplied in opaque blisters .
This ensures excellent quality of our product.
Thank You