what condition is the cholinergic drug bethanechol (duvoid) used to treat?
What is Bethanechol Chloride and how is it used?
Bethanechol Chloride is a prescription medicine used to treat the symptoms of Urinary Retention. Bethanechol Chloride may exist used alone or with other medications.
Bethanechol Chloride belongs to a class of drugs called Cholinergics, Genitourinary.
What are the possible side furnishings of Bethanechol Chloride?
Bethanechol Chloride may cause serious side effects including:
- difficulty breathing,
- closing of your throat,
- swelling of your lips, natural language or face up,
- hives,
- shortness of breath,
- wheezing, and
- tightness in your breast
Get medical help right away, if yous accept whatever of the symptoms listed to a higher place.
The most common side effects of Bethanechol Chloride include:
- dizziness,
- drowsiness,
- headache,
- nausea,
- vomiting,
- diarrhea,
- abdominal discomfort,
- slow heartbeats followed by fast heartbeats,
- flushing or warmth almost the face,
- sweating, and
- violent eyes
Tell the doctor if you have any side effect that bothers yous or that does not go away.
These are not all the possible side effects of Bethanechol Chloride. For more data, ask your doctor or pharmacist.
Call your doctor for medical communication well-nigh side effects. You may written report side effects to FDA at 1-800-FDA-1088.
DESCRIPTION
Bethanechol chloride (bethanechol) , a cholinergic agent, is a constructed esler which is structurally and pharmacologically related to acetylcholine.
It is designated chemically every bit Z-[(aminocarbony) oxy]-N, Due north, (5-trimethyl-ane-propanaminium chloride. Its molecular formula is C7H17CINtwo02 and its structural formula is:
Information technology 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 assistants contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and l mg) D&C~ Yellow # ten Lake and FD&C Yellow # 6 Lake.
DOSAGE AND ADMINISTRATION
Dosage must be individualized, depending on the type and severity of the condition to exist treated.
Preferably give the drug when the stomach is empty. If taken soon later on eating, nausea and vomiting may occur.
The usual developed oral dose ranges from 10 to 50 mg three or four times a day. The minimum constructive dose is adamant past giving 5 to x mg initially and repeating the aforementioned 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 inside xxx minutes and are usually maximal inside 60 to 90 minutes. The drug's furnishings persist for nigh one 60 minutes.
If necessary, the furnishings of the drug tin can be abolished promptly by atropine (encounter OVERDOSAGE).
HOW SUPPLIED
Bethanechol Chloride Tablets USP
| Forcefulness | NDC# | Pack | Description |
| 5 mg | NDC 64679965-01 | Bottle of 100'due south | White, oval shaped tablets debossed with W965 on one side and breakline on the other side. |
| 10 mg | NDC 64679966-01 | Bottle of 100'southward | Pink, oval shaped tablets debossed with W966 on one side and breakline on the other side. |
| 25 mg | NDC 64679967-01 | Bottle of 100'south | Light xanthous, oval shaped tablets debossed with W967 on one side and breakline on the other side. |
| l mg | NDC 64679968-01 | Bottle of 100's | Yellow, oval shaped tablets debossed with W968 on i side and breakline on the other side. |
Manipulate in a tight container as defined in the USP.
Store at 20°-25°C (68°-77°F).
Bottle contains desiccant.
Manufactured by: Wockhardt Limited, Bombay, Republic of india. Distributed past: Wockhardt USA LLC., 20 Waterview Blvd. Parsippany, NJ 07054, Usa. Revised: Aug 2010
Side Effects & Drug Interactions
SIDE EFFECTS
Agin reactions are rare following oral administration of bethanechol, simply 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 equally a Whole. angst; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in claret force per unit area with reflex tachycardia, vasomotor response; Pare: flushing producing a feeling of warmth, sensation of oestrus 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: angst; Nervous Organisation: seizures.
DRUG INTERACTIONS
Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical autumn in blood pressure level may occur. Usually, astringent abdominal symptoms announced before there is such a fall in the blood pressure.
SLIDESHOW
Digestive Disorders: Common Misconceptions See SlideshowWARNINGS
No information provided.
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 crusade reflux infection.
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
Teratogenic Furnishings
Pregnancy Category C. 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 adult female or can bear upon reproduction capacity. Bethanechol chloride should exist given to a significant 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 agin reactions from bethanechol chloride in nursing infants, a decision should be fabricated whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Prophylactic and effectiveness in pediatric patients have not been established.
OVERDOSE
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. Echo doses can be given every two hours, co-ordinate 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 every bit needed until the desired effect is obtained or adverse furnishings of atropine prevent further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous road may be employed.
The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.
CONTRAINDICATIONS
Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary avenue disease, epilepsy and parkinsonism.
Bethanechol chloride should not be employed when the force 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 at that place is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, astute inflammatory lesions of the alimentary canal, or peritonitis; or in marked vagotonia.
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, ordinarily producing a contraction sufficiently potent to initiate micturition and empty the bladder. Information technology stimulates gastric movement, increases gastric tone and often restores dumb rhythmic peristalsis.
Stimulation of the parasympathetic nervous system releases acetylcholine at the nervus endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine tin can be given, but it is quickly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its furnishings are more prolonged than those of acetylcholine.
Effects on the GI and urinary tracts sometimes appear within xxx minutes after oral administration of bethanechol chloride, only more often lx to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one 60 minutes, 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 furnishings are prominent. Muscarinic effects normally occur within 5 to 15 minutes subsequently subcutaneous injection, reach a maximum in fifteen to 30 minutes, and disappear within ii 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 center charge per unit, blood pressure or peripheral circulation.
Bethanechol chloride does not cross the blood-brain bulwark because of its charged quaternary amine moiety. The metabolic rate and fashion of excretion of the drug have not been elucidated.
A clinical study (Diokno, AC.; Lapides, J.; Urol x : 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 memory. 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, all the same, had a longer duration of effect than the subcutaneous dose. Although the l mg oral dose caused piffling 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.
PATIENT Data
Bethanechol chloride tablets should preferably be taken one hr before or ii hours after meals to avoid nausea or airsickness. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.
From 
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