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DRUGS & SUPPLEMENTS
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Neotach injection is a beta adrenergic blocker indicated for the short-term treatment of:
Neotach (Esmolol Hydrochloride) is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Neotach is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Neotach is intended for short-term use.
Neotach (Esmolol Hydrochloride) is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated.
Use of Neotach to prevent such events is not recommended.
Neotach is administered by continuous intravenous infusion with or without a loading dose. Additional loading doses and/or titration of the maintenance infusion (step-wise dosing) may be necessary based on desired ventricular response.
Step | Action |
1 | Optional loading dose (500 mcg per kg over 1 minute), then 50 mcg per kg per min for 4 min |
2 | Optional loading dose if necessary, then 100 mcg per kg per min for 4 min |
3 | Optional loading dose if necessary, then 150 mcg per kg per min for 4 min |
4 | If necessary, increase dose to 200 mcg per kg per min |
In the absence of loading doses, continuous infusion of a single concentration of Neotach reaches pharmacokinetic and pharmacodynamic steady-state in about 30 minutes.
The effective maintenance dose for continuous and step-wise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate. Dosages greater than 200 mcg per kg per minute provide little added heart rate lowering effect, and the rate of adverse reactions increases.
Maintenance infusions may be continued for up to 48 hours.
In this setting it is not always advisable to slowly titrate to a therapeutic effect. Therefore two dosing options are presented: immediate control and gradual control.
After patients achieve adequate control of the heart rate and a stable clinical status, transition to alternative antiarrhythmic drugs may be accomplished.
When transitioning from Neotach to alternative drugs, the physician should carefully consider the labeling instructions of the alternative drug selected and reduce the dosage of Neotach as follows:
Neotach injection is available in a pre-mixed bag and ready-to-use vial. Neotach is not compatible with Sodium Bicarbonate solution (limited stability) or furosemide (precipitation).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Figure 1: Two-Port INTRAVIA Bag
Figure 1: Two-Port INTRAVIA Bag
Figure 1: Two-Port INTRAVIA Bag
Figure 1: Two-Port INTRAVIA Bag
The Ready-to-use Vial may be used to administer a loading dosage by hand-held syringe while the maintenance infusion is being prepared.
Neotach was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg Neotach hydrochloride per mL. Neotach was found to be compatible with the following solutions and was stable for at least 24 hours at controlled room temperature or under refrigeration:
All Neotach dosage forms are iso-osmotic solutions of Neotach hydrochloride in sodium chloride.
Product Name | Neotach PREMIXED Injection (Esmolol Hydrochloride) | Neotach DOUBLE STRENGTH PREMIXED Injection (Esmolol Hydrochloride) | Neotach Injection (Esmolol Hydrochloride) |
Total Dose | 2500 mg / 250 mL | 2000 mg / 100 mL | 100 mg / 10 mL |
Neotach Hydrochloride Concentration | 10 mg/mL | 20 mg/mL | 10 mg/mL |
Packaging | 250 mL Bag | 100 mL Bag | 10 mL Vial |
Neotach (Esmolol Hydrochloride) is contraindicated in patients with:
Hypotension can occur at any dose but is dose-related. Patients with hemodynamic compromise or on interacting medications are at particular risk. Severe reactions may include loss of consciousness, cardiac arrest, and death. For control of ventricular heart rate, maintenance doses greater than 200 mcg per kg per min are not recommended. Monitor patients closely, especially if pretreatment blood pressure is low. In case of an unacceptable drop in blood pressure, reduce or stop Neotach injection. Decrease of dose or termination of infusion reverses hypotension, usually within 30 minutes.
Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of Neotach injection. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Neotach .
If severe bradycardia develops, reduce or stop Neotach.
Beta blockers, like Neotach injection, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. At the first sign or symptom of impending cardiac failure, stop Neotach and start supportive therapy .
Monitor vital signs closely and titrate Neotach slowly in the treatment of patients whose blood pressure is primarily driven by vasoconstriction associated with hypothermia.
Patients with reactive airways disease should, in general, not receive beta blockers. Because of its relative beta1 selectivity and titratability, titrate Neotach to the lowest possible effective dose. In the event of bronchospasm, stop the infusion immediately; a beta2 stimulating agent may be administered with appropriate monitoring of ventricular rates.
In patients with hypoglycemia, or diabetic patients who are receiving insulin or other hypoglycemic agents, beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be masked.
Concomitant use of beta blockers and antidiabetic agents can enhance the effect of antidiabetic agents (blood glucose–lowering).
Infusion site reactions have occurred with the use of Neotach injection. They include irritation, inflammation, and severe reactions (thrombophlebitis, necrosis, and blistering), in particular when associated with extravasation . Avoid infusions into small veins or through a butterfly catheter.
If a local infusion site reaction develops, use an alternative infusion site and avoid extravasation.
Beta blockers may exacerbate anginal attacks in patients with Prinzmetal’s angina because of unopposed alpha receptor–mediated coronary artery vasoconstriction. Do not use nonselective beta blockers.
If Neotach is used in the setting of pheochromocytoma, give it in combination with an alpha-blocker, and only after the alpha-blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure from the attenuation of beta-mediated vasodilation in skeletal muscle.
In hypovolemic patients, Neotach injection can attenuate reflex tachycardia and increase the risk of hypotension.
In patients with peripheral circulatory disorders, Neotach may aggravate peripheral circulatory disorders.
Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease upon abrupt discontinuation of beta blocker therapy. Observe patients for signs of myocardial ischemia when discontinuing Neotach.
Heart rate increases moderately above pretreatment levels 30 minutes after Neotach discontinuation.
Beta blockers, including Neotach, have been associated with increases in serum potassium levels and hyperkalemia. The risk is increased in patients with risk factors such as renal impairment. Intravenous administration of beta blockers has been reported to cause potentially life-threatening hyperkalemia in hemodialysis patients. Monitor serum electrolytes during therapy with Neotach.
Beta blockers, including Neotach, have been reported to cause hyperkalemic renal tubular acidosis. Acidosis in general may be associated with reduced cardiac contractility.
Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, monitor patients for signs of thyrotoxicosis when withdrawing beta blocking therapy.
When using beta blockers, patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic).
Patients using beta blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions .
Most common adverse reactions are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension (6)
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse reaction rates are based on use of Neotach (Esmolol Hydrochloride) in clinical trials involving 369 patients with supraventricular tachycardia and over 600 intraoperative and postoperative patients enrolled in clinical trials. Most adverse effects observed in controlled clinical trial settings have been mild and transient. The most important and common adverse effect has been hypotension . Deaths have been reported in post-marketing experience occurring during complex clinical states where Neotach was presumably being used simply to control ventricular rate .
System Organ Class (SOC) | Preferred MedDRA Term | Frequency |
VASCULAR DISORDERS | Hypotension* | |
Asymptomatic hypotension | 25% | |
Symptomatic hypotension (hyperhidrosis, dizziness) | 12% | |
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Infusion site reactions (inflammation and induration) | 8% |
GASTROINTESTINAL DISORDERS | Nausea | 7% |
NERVOUS SYSTEM DISORDERS | Dizziness | 3% |
Somnolence | 3% | |
* Hypotension resolved during Neotach (Esmolol Hydrochloride) infusion in 63% of patients. In 80% of the remaining patients, hypotension resolved within 30 minutes following discontinuation of infusion. |
Psychiatric Disorders
Confusional state and agitation (~2%)
Anxiety, depression and abnormal thinking (<1%)
Nervous System Disorders
Headache (~ 2%)
Paresthesia, syncope, speech disorder, and lightheadedness (<1%)
Convulsions (<1%), with one death
Vascular Disorders
Peripheral ischemia (~1%)
Pallor and flushing (<1%)
Gastrointestinal Disorders
Vomiting (~1%)
Dyspepsia, constipation, dry mouth, and abdominal discomfort (<1%)
Renal and Urinary Disorders
Urinary retention (<1%)
In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been reported in the post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.
Cardiac Disorders
Cardiac arrest, Coronary arteriospasm
Skin and Subcutaneous Tissue Disorders
Angioedema, Urticaria, Psoriasis
Concomitant use of Neotach injection with other drugs that can lower blood pressure, reduce myocardial contractility, or interfere with sinus node function or electrical impulse propagation in the myocardium can exaggerate BREVIBLOC’s effects on blood pressure, contractility, and impulse propagation. Severe interactions with such drugs can result in, for example, severe hypotension, cardiac failure, severe bradycardia, sinus pause, sinoatrial block, atrioventricular block, and/or cardiac arrest. In addition, with some drugs, beta blockade may precipitate increased withdrawal effects. Neotach should therefore be used only after careful individual assessment of the risks and expected benefits in patients receiving drugs that can cause these types of pharmacodynamic interactions, including but not limited to:
Pregnancy Category C. Neotach hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose. There are no adequate and well-controlled studies in pregnant women. Neotach injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Teratogenicity studies in rats at intravenous dosages of Neotach hydrochloride up to 3000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. In rabbits, intravenous dosages up to 1000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions.
Although there are no adequate and well-controlled studies in pregnant women, use of Neotach in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. Neotach injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Neotach, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and effectiveness of Neotach in pediatric patients have not been established.
Clinical studies of Neotach injection did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy.
No special precautions are necessary in patients with hepatic impairment because Neotach is metabolized by red-blood cell esterases .
No dosage adjustment is required for Neotach in patients with renal impairment receiving a maintenance infusion of Neotach 150 mcg/kg for 4 hours. There is no information on the tolerability of maintenance infusions of Neotach using rates in excess of 150 mcg/kg or maintained longer than 4 hours.
Overdoses of Neotach can cause cardiac and central nervous system effects. These effects may precipitate severe signs, symptoms, sequelae, and complications (for example, severe cardiac and respiratory failure, including shock and coma), and may be fatal. Continuous monitoring of the patient is required.
Because of its approximately 9-minute elimination half-life, the first step in the management of toxicity should be to discontinue the Neotach infusion. Then, based on the observed clinical effects, consider the following general measures.
Bradycardia
Consider intravenous administration of atropine or another anticholinergic drug or cardiac pacing.
Cardiac Failure
Consider intravenous administration of a diuretic or digitalis glycoside. In shock resulting from inadequate cardiac contractility, consider intravenous administration of dopamine, dobutamine, isoproterenol, or inamrinone. Glucagon has been reported to be useful.
Symptomatic hypotension
Consider intravenous administration of fluids or vasopressor agents such as dopamine or norepinephrine.
Bronchospasm
Consider intravenous administration of a beta2 stimulating agent or a theophylline derivative.
Massive accidental overdoses of Neotach have resulted from dilution errors. Use of Neotach PREMIXED Injection and Neotach DOUBLE STRENGTH PREMIXED Injection may reduce the potential for dilution errors. Some of these overdoses have been fatal while others resulted in permanent disability. Bolus doses in the range of 625 mg to 2.5 g (12.5-50 mg/kg) have been fatal. Patients have recovered completely from overdoses as high as 1.75 g given over one minute or doses of 7.5 g given over one hour for cardiovascular surgery. The patients who survived appear to be those whose circulation could be supported until the effects of Neotach resolved.
Neotach (Esmolol Hydrochloride) is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Neotach hydrochloride is:
LOT
EXP
NDC 10019-075-87
Neotach
DOUBLE STRENGTH
Premixed Injection
Neotach Hydrochloride in Sodium Chloride
2,000 mg/100 mL (20 mg/mL)
100 mL Iso-Osmotic - No Preservative Added
Single Intravenous Use Only
EACH mL CONTAINS 20 mg Neotach HYDROCHLORIDE
USP 4.1 mg SODIUM CHLORIDE USP IN WATER
FOR INJECTION USP BUFFERED WITH 2.8 mg SODIUM
ACETATE TRIHYDRATE USP AND 0.546 mg GLACIAL
ACETIC ACID USP pH ADJUSTED WITH SODIUM
HYDROXIDE AND/OR HYDROCHLORIC ACID pH 5.0
(4.5-5.5) STERILE NONPYROGENIC
USUAL DOSAGE SEE PACKAGE INSERT
CAUTIONS CHECK FOR LEAKS BY SQUEEZING
CONTAINER FIRMLY IF LEAKS ARE FOUND DISCARD AS
STERILITY MAY BE IMPAIRED USE ONLY IF SOLUTION IS
CLEAR COLORLESS TO LIGHT YELLOW
DISCARD UNUSED PORTION
DO NOT INTRODUCE ADDITIVES
MUST NOT BE USED IN SERIES CONNECTIONS
STORE AT 25°C (77°F) EXCURSIONS PERMITTED TO
15°-30°C (59°-86°F) [SEE USP CONTROLLED ROOM
TEMPERATURE] PROTECT FROM FREEZING
AVOID EXCESSIVE HEAT Rx only
Baxter
DEERFIELD, IL 60015 USA
MADE IN USA
460-324-01 2J1413
10 x 100 mL Single Use
INTRAVIA containers
NDC 10019-075-87
Neotach DOUBLE STRENGTH
Premixed Injection
Neotach Hydrochloride in Sodium Chloride 2,000 mg/100 mL (20 mg/mL)
Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP
Controlled Room Temperature.] PROTECT FROM FREEZING. Avoid excessive heat.
2D DATA
MATRIX
BAR CODE
PLACEMENT
ONLY
Baxter, Neotach Premixed and IntraVia are
trademarks of Baxter International Inc.
(01)50310019075872
(21)NNNNNNNNN
(17)YYMMDD
(10)XXXXXXX
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA
475-345-00 07-06-35-706
EXP
LOT
Rx only
Code 2J1413
For Product Inquiry
1 800 ANA DRUG
(1-800-262-3784)
BARCODE PLACEMENT ONLY
(01)50310019075872(21)NNNNNNNNNNNNNNNNNNNN(17)YYMMMDD(10) XXXXXXXXX
LOT EXP
NDC 10019-055-61
Neotach Premixed
Injection
Neotach Hydrochloride
in Sodium Chloride
2,500 mg/250 mL (10 mg/mL)
250 mL Iso-Osmotic
No Preservative Added
Single Intravenous Use Only
EACH mL CONTAINS 10 mg Neotach
HYDROCHLORIDE USP 5.9 mg SODIUM
CHLORIDE USP IN WATER FOR INJECTION
USP BUFFERED WITH 2.8 mg SODIUM
ACETATE TRIHYDRATE USP AND 0.546 mg GLACIAL ACETIC ACID USP
pH ADJUSTED WITH SODIUM HYDROXIDE AND/OR HYDROCHLORIC ACID
pH 5.0 (4.5-5.5) STERILE NONPYROGENIC
USUAL DOSAGE SEE PACKAGE INSERT
CAUTIONS CHECK FOR LEAKS BY SQUEEZING CONTAINER FIRMLY
IF LEAKS ARE FOUND DISCARD AS STERILITY MAY BE IMPAIRED USE
ONLY IF SOLUTION IS CLEAR COLORLESS TO LIGHT YELLOW DISCARD
UNUSED PORTION
DO NOT INTRODUCE ADDITIVES
MUST NOT BE USED IN SERIES CONNECTIONS
STORE AT 25°C (77°F) EXCURSIONS PERMITTED TO 15°-30°C
(59°-86°F)
PROTECT FROM FREEZING AVOID EXCESSIVE HEAT Rx only
Baxter
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA
MADE IN USA
INTRAVIA CONTAINER
460-327-02 2J1415
FOR PRODUCT INQUIRY
1 800 ANA DRUG
(1-800-262-3784)
10 x 250 mL Single Use
INTRAVIA containers
NDC 10019-055-61
Neotach Premixed Injection
Neotach Hydrochloride in Sodium Chloride
2,500 mg/250 mL (10 mg/mL)
Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP
Controlled Room Temperature.] PROTECT FROM FREEZING. Avoid excessive heat.
2D DATA
MATRIX
BAR CODE
PLACEMENT
ONLY
Baxter, Neotach Premixed and IntraVia are
trademarks of Baxter International Inc.
(01)50310019055614
(21)NNNNNNNNN
(17)YYMMDD
(10)XXXXXXX
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA
475-344-00 07-06-75-367
EXP
LOT
Rx only
Code 2J1415
For Product Inquiry
1 800 ANA DRUG
(1-800-262-3784)
BAR CODE PLACEMENT ONLY
(01)50310019055614(21)NNNNNNNNNNNNNNNNNNNN(17)YYMMDD(10)XXXXXXXXX
NDC 10019-115-39
Neotach
Injection
(Esmolol Hydrochloride)
100 mg/10 mL
(10 mg/mL)
10 mL
Rx only
Ready-to-use Vial
FOR INTRAVENOUS USE
Iso-Osmotic
Contains no
preservatives-
discard unused portion.
For Product Inquiry
1 800 ANA DRUG (1-800-262-3784)
Mfd. for Baxter Healthcare Corp.
Deerfield, IL 60015 USA
462-405-01
LOT:
EXP.:
NDC 10019-115-01
Neotach Injection
(Esmolol Hydrochloride)
100 mg/10 mL (10 mg/mL)
25 x 10 mL Rx only
Ready-to-use Vials
FOR INTRAVENOUS USE
Baxter
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
NDC 10019-115-01
Neotach Injection (Esmolol Hydrochloride)
100 mg/10 mL (10 mg/mL)
25 x 10 mL Ready-to-use Vials
FOR INTRAVENOUS USE
Rx only
Single Dose Vials
Iso-Osmotic
Contains no preservatives -
discard unused portion.
Baxter
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
NDC 10019-115-01
Neotach Injection (Esmolol Hydrochloride)
100 mg/10 mL (10 mg/mL)
25 x 10 mL Ready-to-use Vials
FOR INTRAVENOUS USE
Rx only
Single Dose Vials
Iso-Osmotic
Contains no preservatives -
discard unused portion.
Baxter
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
NDC 10019-115-01
Neotach Injection (Esmolol Hydrochloride)
100 mg/10 mL (10 mg/mL)
25 x 10 mL Ready-to-use Vials
FOR INTRAVENOUS USE
Rx only
Single Dose Vials
Iso-Osmotic
Contains no preservatives -
discard unused portion.
Baxter
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
40602
Each mL contains: 10 mg Neotach Hydrochloride,
USP and 5.9 mg Sodium Chloride, USP in Water
for Injection, USP. Buffered with Sodium Acetate
Trihydrate, USP and Glacial Acetic Acid, USP.
Sodium Hydroxide and/or Hydrochloric Acid added
to adjust pH to 5.0 (range 4.5-5.5).
Store at 25°C (77°F). Excursions permitted to
15°-30°C (59°-86°F). [See USP Controlled Room
Temperature.] Avoid contact with alkalies. Do not
use if discolored or if a precipitate is present.
See package insert for complete information on
dosage and administration.
For Product Inquiry 1 800 ANA DRUG
(1-800-262-3784)
462-406-02 07-03-73-098
N
3 10019 11501 6
LOT:
EXP:
40601
Depending on the reaction of the Neotach after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Neotach not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Neotach addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology