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