Belladonna
Indications: Bowel syndrome, irritable; Enterocolitis; Ulcer, peptic, adjunct
DESCRIPTION:
CLINICAL PHARMACOLOGY:
Belladonna provides natural belladonna alkaloids to provide peripheral anticholinergic/antispasmodic action .
INDICATIONS AND USAGE:
Based on a review by the National Academy of Sciences--National Research Council and/or other information, FDA has classified the indications as "possibly" effective:
For use as adjunctive therapy in the treatment of peptic ulcer.
IT SHOULD BE NOTED AT THIS POINT IN TIME THAT THERE IS A LACK OF CONCURRENCE AS TO THE VALUE OF ANTICHOLINERGICS/ANTISPASMODICS IN THE TREATMENT OF GASTRIC ULCER. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODICS DRUGS AID IN THE HEALING OF A PEPTIC ULCER, DECREASE THE RATE OF RECURRENCES, OR PREVENT COMPLICATION.
May also be useful in the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), and acute enterocolitis.
Final classification of the less-than-effective indication requires further investigation.
CONTRAINDICATIONS:
Belladonna; tablets are contraindicated in patients with glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflex esophagitis.
WARNINGS:
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with belladonna; butabarbital sodium would be inappropriate and possibly harmful.
PRECAUTIONS:
General
Use of belladonna in the treatment of gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis). Do not rely on the use of belladonna in the presence of complication of biliary tract disease.
Use with caution in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, and hypertension.
Information for the Patient
Belladonna may produce blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, or perform hazardous work while taking this drug.
In the presence of a high environmental temperature, heat prostration can occur (fever and heatstroke due to decreased sweating).
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Adequate long-term studies in animals to determine the carcinogenic potential of belladonna have not been performed. Also, adequate studies of mutagenicity or effects on fertility are not available on belladonna.
Pregnancy, Teratogenic Effects, Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Belladonna should be used during pregnancy only if the potential benefits outweigh the potential risk to the fetus (see WARNINGS).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS:
The following adverse reactions may occur with anticholinergic.
Gastrointestinal: Nausea, vomiting, constipation, bloated feeling.
Cardiovascular: Tachycardia and palpitation.
Ocular: Blurred vision, increased intraocular pressure, mydriasis, and cycloplegia.
Musculoskeletal: Pain.
Genitourinary: Urinary hesitancy and retention.
Central Nervous System: Headache, nervousness, drowsiness, weakness, dizziness, insomnia, impotence.
Nasopharyngeal: Xerostomia, loss of taste.
Other: Decreased sweating, suppression of lactation.
OVERDOSAGE:
Signs and Symptoms: The manifestations of belladonna overdose are extensions of the pharmacologic actions of the individual components. A curare-like action may occur. The signs and symptoms of overdosage include headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, CNS stimulation.
Treatment: When an overdosage of belladonna has been taken, measures to reduce intestinal absorption (gastric lavage, administration of emetics or activated charcoal) should be initiated immediately. A patent airway should be maintained and specific therapy instituted based upon signs and symptoms. If indicated, parenteral cholinergic agents such as bethanechol chloride should be administered to counteract the effects of the belladonna alkaloids.
Uses and Administration
Belladonna has the actions of atropine . Belladonna
herb and its preparations have been used for their antimus-
carinic actions in a wide range of conditions, including the
relief of gastro-intestinal and urinary-tract disorders associat-
ed with smooth muscle spasm, but they are generally regarded
as an outmoded form of treatment.
Belladonna liniments and plasters have been used as counter-
irriiants for the relief of pain but [here is little evidence that
they have a beneficial effect and side-effects have occurred.
Belladonna is used in homoeopathic medicine.