You are here: Home > Prescription(RX) Drugs > B > Bethanechol Chloride (Ncs Healthcare Of Ky, Inc Dba Vangard Labs)

Name:Bethanechol Chloride
Manufacturer:Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Category:Prescription Marketed Drugs


Bethanechol Chloride

BETHANECHOL CHLORIDE - bethanechol chloride tablet 
NCS HealthCare of KY, Inc dba Vangard Labs

----------

Bethanechol Chloride

DESCRIPTION

Bethanechol Chloride Tablets, USP

Bethanechol chloride, a cholinergic agent, is a synthetic ester which

is structurally and pharma-cologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]- -trimethyl-1-

propanaminium chloride. Its molecular formula is C H ClN O and its structural

formula is:

 Formula Structure: Bethanechol Chloride 10mg Tablets

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely

soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol

chloride, USP. Tablets also contain the following inactive ingredients: anhydrous

lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose,

sodium starch glycolate, (10 mg) FD&C Red # 40 and (25 mg and 50 mg) D&C Yellow

# 10 andFD&CYellow # 6.

CLINICAL PHARMACOLOGY

Bethanechol chloride acts principally by producing

the effects of stimulation of the parasympathetic nervous system. It increases the tone

of the detrusor urinae muscle, usually producing a contraction sufficiently strong to

initiate micturition and empty the bladder. It stimulates gastric motility, increases

gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the

nerve endings. When spontaneous stimulation is reduced and therapeutic

intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by

cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by

cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the GI and urinary tracts sometimes appear within 30 minutes after oral

administration of bethanechol chloride, but more often 60 to 90 minutes are required to

reach maximum effectiveness. Following oral administration, the usual duration of

action of bethanechol is one hour, although large doses (300 to 400 mg) have been

reported to produce effects for up to six hours. Subcutaneous injection produces a

more intense action on bladder muscle than does oral administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of cholinergic

stimulation are usually absent or minimal when orally or subcutaneously administered

in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects

usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in

15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and

defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary

muscles. Therapeutic test doses in normal human subjects have little effect on heart

rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged

quaternary amine moiety. The metabolic rate and mode of excretion of the drug

have not been elucidated.

A clinical study (Diokno, AC.; Lapides, J.; : 23-24, July 1977) was conducted

on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride

on the stretch response of bladder muscle in patients with urinary retention. Results

showed that 5 mg of the drug given subcutaneously stimulated a response that was

more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200

mg. All the oral doses, however, had a longer duration of effect than the subcutaneous

dose. Although the 50 mg oral dose caused little change in intravesical pressure in this

study, this dose has been found in other studies to be clinically effective in the

rehabilitation of patients with decompensated bladders.

INDICATIONS AND USAGE

Bethanechol chloride is indicated for the treatment of

acute postoperative and postpartum nonobstructive (functional) urinary retention and

for neurogenic atony of the urinary bladder with retention.

CONTRAINDICATIONS

Hypersensitivity to bethanechol chloride tablets,

hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced

bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy

and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the

gastrointestinal or bladder wall is in question, or in the presence of mechanical

obstruction; when increased muscular activity of the gastrointestinal tract or urinary

bladder might prove harmful, as following recent urinary bladder surgery,

gastrointestinal resection and anastomosis, or when there is possible gastrointestinal

obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute

inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked

vagotonia.

PRECAUTIONS

General

In urinary retention, if the sphincter fails to relax as bethanechol contracts

the bladder, urine may be forced up the ureter into the kidney pelvis. If there is

bacteriuria, this may cause reflux infection.

Drug Interactions

Special care is required if this drug is given to patients receiving

ganglion blocking compounds because a critical fall in blood pressure may occur.

Usually, severe abdominal symptoms appear before there is such a fall in the blood

pressure.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in

animals have not been performed to evaluate the effects upon fertility, mutagenic or

carcinogenic potential of bethanechol chloride.

Pregnancy

Animal reproduction

studies have not been conducted with bethanechol chloride. It is also not known

whether bethanechol chloride can cause fetal harm when administered to a pregnant

woman or can affect reproduction capacity. Bethanechol chloride should be given to a

pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is secreted in human milk.

Because many drugs are secreted in human milk and because of the potential for

serious adverse reactions from bethanechol chloride in nursing infants, 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been

established.

Information for Patients

Bethanechol chloride tablets should preferably be taken

one hour before or two hours after meals to avoid nausea or vomiting. Dizziness,

lightheadedness or fainting may occur, especially when getting up from a lying or

sitting position.

ADVERSE REACTIONS

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating; Respiratory: bronchial constriction, asthmatic attacks; Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a Whole: malaise; Nervous System: seizures.

OVERDOSAGE

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ('hot feeling'), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

DOSAGE AND ADMINISTRATION

Dosage must be individualized, depending on

the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating,

nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The

minimum effective dose is determined by giving 5 to 10 mg initially and repeating the

same amount at hourly intervals until satisfactory response occurs, or until a

maximum of 50 mg has been given. The effects of the drug sometimes appear within

30 minutes and are usually maximal within 60 to 90 minutes. The drug"s effects persist

for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see

OVERDOSAGE

HOW SUPPLIED

Bethanechol Chloride Tablets USP

Strength NDC # Pack Description

10 mg NDC 0615-2557-39 Blistercards of 30"s

White, oval shaped tablets

debossed with W965 on one

side and breakline on the

other side.

Pink, oval shaped tablets

debossed with W966 on one

side and breakline

Light yellow, oval shaped

tablets debossed with W967

on one side and breakline on

the other side.

Yellow, oval shaped tablets

debossed with W968 on one

side and breakline on the

other side.

Dispense in a tight container as defined in the USP.

Store at 20°-25°C (68°-77°F).

REFERENCES

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 0754

USA.

Rev.100809

PRINCIPAL DISPLAY PANEL

Bethanechol Chloride Tabs,

USP 10mg


Principal Display Panel-Bethanechol Chloride 10mg Tablets

BETHANECHOL CHLORIDE 
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-2557(NDC:64679-966)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
COLLOIDAL SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
FD&C RED NO. 40  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code W;966
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-2557-39 30 TABLET (30 TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040533 09/29/2003

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL, REPACK

Revised: 11/2010 NCS HealthCare of KY, Inc dba Vangard Labs



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback