Product Description

Structure of Midazolam Structure of Benzodiazepine

Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1methyl-4H- imidazo[1,5-a] [1,4] benzodiazepine hydrochloride

Midazolam is a benzodiazepine available as midazolam hydrochloride. Midazolam is a short-acting benzodiazepine central nervous system (CNS) depressant. CNS Dosage form injection. available as intravenous or intramuscular

It is used for inducing sedation and amnesia before medical procedures. It has potent anxiolytic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative properties.

Neurons: are cells that send & receive electrochemical signals to & from the brain and nervous system Neurons consist of a cell body with branching dendrites(signal receivers) & a projection called axon which conduct nerve signals Neurotransmitters are the chemicals which allow the transmission of signals from one neuron to the next neuron

Benzodiazepines
Benzodiazepines enhance the effect of the neurotransmitter gamma-aminobutyric acid, which decrease the excitability of neurons. This reduces the communication between neurons and therefore has a calming effect on many of the functions of the brain. They can be very useful in intensive care to sedate patients receiving mechanical ventilation. Benzodiazepines are well known for their strong muscle-relaxing properties and can be useful in the treatment of muscle spasms.

ModeofAction
Midazolam is an imidazolebenzodiazepine that has central nervous system (CNS) depressant effects at all levels of the CNS. It acts on the receptor complex of g aminobutyric acid (GABA), an inhibitory neurotransmitter. Binding to this receptor complex facilitates the opening of chloride channelssothatchloridecanenterthecell and hyperpolarization can occur. This makes it difficult for excitatory neurotransmitters to depolarize the cell resulting in clinical effects like CNS

Clinical pharmacology
Sedation in adult & pediatric patients is achieved within 3 to 5 minutes after intravenous (IV) injection. Onset time of sedative effects after IM administration in adults is 15 minutes, with peak sedation occurring 30 to 60 minutes following injection. (Cmax): 90 ng/ml, (Tmax): 0.5 hour. Duration of action: Approximately 2 hours Elimination half life: 1.8 to 6.4 hours

Pharmacokinetics
Absorption: Absorption of midazolam from the muscle tissue is rapid and complete. Maximum plasma concentrations are reached within 30 minutes. Distribution: Absolute bioavailability is 36%. Approximately 96% is protein bound. Metabolism: Substantial intestinal and hepatic first-pass metabolism by CYP-450. Active metabolite is alphahydroxymidazolam. Elimination: Urine (as glucuronide conjugates); 2 hours (elimination half-life), prolonged in neonates, elderly and hepatic impairment.

Indications

Intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia. Intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography & cardiac catheterization, oncology procedures, radiologic procedures, & other procedures either alone or in combination with other CNS depressants.

Indications

Intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesiacanbeattainedwithinarelativelynarrow dose range & in a short period of time. Intravenous MIDFAST can also be used as a component of intravenous supplementation of nitrousoxide & oxygen(balancedanesthesia).

Continuous intravenous infusion for sedation of intubated & mechanically ventilated patients as a component of anesthesia or during treatment in a criticalcaresetting.

Dosage & administration

Intramuscularly
For preoperative sedation /anxiolysis/amnesia (induction of sleepiness or drowsiness & relief of apprehension & to impair memory of perioperative events). The recommended premedication dose of MIDFAST for adult patients below the age of 60 years is 0.07 to 0.08 mg/kg IM (approximately 5 mg IM) administered up to 1 hour before surgery.

Dosage & administration

Intravenously
Sedation/anxiolysis/amnesiaforprocedures 1. Healthy Adults Below the Age of 60 : No more than 2.5 mg should be given over a period of at least 2 minutes. 2. Patients Age 60 or Older, & Debilitated or Chronically Ill Patients : No more than 1.5 mg should begivenoveraperiodofnolessthan2minutes. 3. Maintenance Dose : Additional doses to maintain the desired level of sedation may be given in increments of 25% of the dose used to first reach the sedative endpoint.

Dosage & administration

ForContinuousInfusion
UsualAdultDose: Forloadingdose:0.01to0.05mg/kg(approximately0.5 to4mgforatypicaladult)maybegivenslowlyor infusedoverseveralminutes. Formaintenanceofsedation,theusualinitialinfusion rateis0.02to0.1mg/kg/hr(1to7mg/hr).

Dosage & administration

ForContinuousInfusion
PEDIATRICPATIENTS 1. PediatricPatientsLessThan6MonthsofAge:

Thedosingrecommendationsareunclearasthis population is particularly vulnerable to airway obstruction&hypoventilation.

2. Pediatric Patients 6 Months to 5 Years of Age :Initial dose 0.05 to 0.1 mg/kg; total dose up to 0.6mg/kg 3. Pediatric Patients 6 to 12 Years of Age : Initial dose 0.025 to 0.05 mg/kg; total dose up to 0.4

CONTRAINDICATIONS
Midazolam is contraindicated in patients with a known hypersensitivitytothedrug. Benzodiazepines are contraindicated in patients with acute narrowangleglaucoma. Midazolam is not intended for intrathecal or epidural administrationduetothepresenceofthepreservativebenzyl alcoholinthedosageform.

ADVERSEEFFECTS
The following additional adverse reactions have been reportedafterintramuscularadministrationattheinjection site:

Adults
Pain,induration,redness,musclestiffness,headache.

PediatricPatients
The following adverse events related to the use of IV midazolam in pediatric patients were reported in the medical literature: desaturation, apnea, hypotension, paradoxical reactions, hiccough, seizurelike activity &

Overdosage
The manifestations of midazolam overdosage reported are similar to those observed with other benzodiazepines, including sedation, somnolence, confusion, impaired coordination, diminished reflexes, coma & untoward effects on vital signs. No evidence of specific organ toxicity from midazolam overdosage has been reported.

Treatment of Overdosage
Treatment of injectable midazolam overdosage is the same as that followed for overdosage with other benzodiazepines. Flumazenil, a specific benzodiazepinereceptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines &maybeusedinsituationswhenanoverdosewith abenzodiazepineisknownorsuspected. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of

PRESENTATION
EACHBOXCONTAINS5VIALOFMIDFASTINJECTION (5mg/5ml) PRICING:MRP:Rs.250/box EACHBOXCONTAINS5VIALOFMIDFASTINJECTION (10mg/10ml) PRICING:MRP:Rs.400/box EACH BOX CONTAINS 10 AMPOULE OF MIDFAST INJECTION(5mg/ml) PRICING:MRP:Rs.385/box

STORAGE

Strengths:High quality product Strong sales and marketing team Strong brand equity

Weakness: Cluttered market Late entrance

Opportunities:-

Threats:-

Growth in hospital industry. Price wars. Pricing as per industry Many substitutes available. Entrant of new molecule. standard. Market size increasing.

TARGET CUSTOMERS ANESTHESIOLOGISTS

(For pre operative sedation)

INTENSIVISTS
(For mechanical ventilation)

USP
Most popular BZD in ICU Faster recovery time & high effectiveness Produces profound sedation

Market analysis
Total market of Midazolam inj as a whole:Rs.5.5 cr
BRAND
MEZOLAM

COMPANY

PACK
10ML 5 ML 1 ML

STRENGTH 1mg/ml 5 mg/ml 5mg/ml

MARKETVALUE
1.3Cr 1.0 Cr 0.2 Cr

NEONLabs

FULSED

RANBAXY

10 ML 5 ML 1 ML

1mg/ml 1mg/ml 5mg/ml 1mg/ml 1mg/ml 5mg/ml

0.63 cr 0.38 cr 0.11 cr 10,000 50,000 25 lacs

MIDZEE

GLAND PHARMA

10 ML 5 ML 1 ML

COMPETITORS
BRANDS FULSED MIDZEE BENZOSED MIDOSED MEZOLAM

COMPANY RANBAXY GLANDPHARMA TROIKAA SUNPHARMA NEON

PRICING (Rs.)
BRANDS Midfast Mezolam Fulsed Midzee 1ml
38.5 35.10 32 24

5ml
50 40.50 33.70 33

10ml
80 68.40 60.40 54

How are you going to create a Brand

That Stands Out in a Sea of Brands???