Fixed Combinations of Belladonna with other drugs

Published July 14, 1993.
List of German Commission E Monographs (Phytotherapy)

Name of Drug

Fixed Combinations of Belladonna [Atropa belladonna] with other drugs.

Components of Drug

Fixed combinations of Belladonna are available with the following drugs:

Pheasant's Eye Herb (B. Anz. No. 85 of May 5, 1988)
Aloe (B. Anz. No. 154 of August 21, 1985)
Horehound herb (B. Anz. No. 22a of February 1, 1990)
Arnica flower (B. Anz. No. 228 of December 5, 1984)
Valerian root (B. Anz. No. 90 of May 15, 1985)
Pimpinella root (B. Anz. No. 101 of June 1, 1990)
Monkshood (B. Anz. No. 193a of October 15, 1987)
Stinging Nettle root (B. Anz. No. 173 of September 18, 1986)
Nux Vomica (B. Anz. No. 173 of September 18, 1986)
Camphor (B. Anz. No. 228 of December 5, 1984)
Turmeric root (B. Anz. No. 223 of November 30, 1985)
Ivy leaf (B. Anz. No. 122 of July 6, 1988)
Gentian root (B. Anz. No. 223 of November 30, 1985)
Eucalyptus leaf (B. Anz. No. 177a of September 24, 1986)
Eucalyptus oil (B. Anz. No. 177a of September 24, 1986)
Buckthorn Bark (B. Anz. No. 228 of December 5, 1984)
Witch Hazel leaf and bark (B. Anz. No. 154 of August 21, 1985)
Henbane leaf (B. Anz. No. 85 of May 5, 1988)
St. John's Wort (B. Anz. No. 228 of December 5, 1984)
Coffee Charcoal (B. Anz. No. 85 of May 5, 1988)
Chamomile flower, German (B. Anz. No. 228 of December 5, 1984)
Caraway seed (B. Anz. No. 22a of February 1, 1990)
Blessed Thistle fruit (B. Anz. No. 50 of March 13,1986)
Mistletoe herb (B. Anz. No. 228 of December 5, 1984)
Agrimony (B. Anz. No. 50 of March 13,1986)
Paprika (Cayenne) (B. Anz. No. 22a of February 1, 1990)
Peppermint leaf (B. Anz. No. 223 of November 30, 1985)
Pepermint oil (B. Anz. No. 50 of March 30,1986)
Bitter Orange peel (B. Anz. No. 193a of October 15, 1987)
Primrose root (B. Anz. No. 122 of July 6, 1988)
Rhubarb root (B. Anz. No. 228 of December 5, 1984)
Horse Chestnut seed (B. Anz. No. 228 of December 5, 1984)
Sandy Everlasting (B. Anz.No. 122 of July 6, 1988)
Saw Palmetto berry (B. Anz. No. 43 of March 2, 1989)
Sage leaf (B. Anz. No. 90 of May 15, 1985)
Yarrow (B. Anz. No. 22a of February 1, 1990)
Celandine herb (B. Anz. No. 90 of May 15, 1985)
Senna leaf (B. Anz. No. 228 of December 5, 1984)
Jimsonweed leaf and seed (B. Anz. No. 22a of February 1, 1990)
Plantain (B. Anz. No. 223 of November 5, 1985)
Licorice root (B. Anz. No. 90 of May 15, 1985)
Thyme (B. Anz. No. 228 of December 5, 1984)
Uzara root (B. Anz. No. 164 of September 1, 1990)
Hawthorn (B. Anz. No. 1 of January 3, 1984)
Soapwort root, White (B. Anz. No. 101 of June 1, 1990)
Wormwood (B. Anz. No. 228 of December 5, 1984)

This list of components will be supplemented according to the development of preparations.

Pharmacological Properties, Pharmacokinetics, Toxicology

For Belladonna and the other herbs, refer to the respective monographs.

Clinical Data 1. Uses The following indications are claimed for the combination preparations:

Bronchitis, asthma, acute and chronic diseases of the respiratory tract and lung, emphysema of the lung, tuberculosis of the lung, influenza-like infections, dust lung, whooping cough, smoker's cough, fever with eruptive children's diseases, and as an antitussive and expectorant Hemorrhoids, anal fissures, spasms of the anal sphincter, cryptitis, muscosal prolapse, and for pre- and post-operative treatment of surgery in the anal area Disturbances of gall production and gall secretion, disturbances of liver functions, icterus, spasms in the area of the bile ducts, cholangiitis, cholelithiasis, dyspepsia, hyperacidity of the stomach, severe spasms of acute and chronic gastric disorders, gastritis, duodenitis, supportive in the treatment of ulcus ventriculi et duodeni, gastroenteritis, colitis, digestive disorders, bloating and feeling of fullness, especially constipation caused by liver insufficiency, loss of appetite, acute and chronic constipation, reconstruction of damaged intestinal flora with concurrently desired laxative effect, colic, and gastrocardiac sympomatic complex Angina, stomatitis, periarthritis, conservative treatment and pre-treatment of abscesses, panaritium, furuncles, and as an adjuvant for pleurisy Sleeping disorders, vegetative dystonia, psychosexual disturbances, discomforts due to foehn, neurovegetative misregulations of all origins, especially disorders of the cardiovascular system and the digestive organs, hormonal based difficulties during puberty, menopause, for hyperfunction of the thyroid during the course of infectious diseases, conditions of anxiety and stress, depression, thyrotoxicosis, neurasthenia, migrane, as a day-time sedative, in preparation for surgey, for hyperhydrosis, enuresis nocturna, vegetative neuroses, cardiac and vascular neuroses, Meniere's disease, dizziness, nausea and vomiting of various origins, headaches, and difficulty in concentrating Tachycardia, over-excitability of the conduction system, extrasystole, vascular spasms, functional problems at hypertonia, angina pectoris, geriatric heart Arteriosclerosis Prostate edema, prostatitis, nervous bladder, residual urine, difficulties in urination, increased frequency in urination, cystitis, tenesmus, parametritis, adnexitis Rheumatic ailments, sciatica, lumbago, gout, neuralgia, muscle strain, sprains, pain in the limbs and joints, hallux valgus, swelling of the big toe joint. The effectiveness of the combinations for the claimed uses has not been documented. 2. Risks The safety of these combination products is specified by the data given in the individual monographs.

The following risks are valid for Belladonna:

Do not use in case of tachycardiac arrhythmia, prostate edema with residual urine, narrow-angle glaucoma, acute edema of the lungs, mechanical stenoses of the gastrointestinal tract, and megacolon. 3. Side Effects Dry mouth, decrease of perspiratory gland function, accommodation disturbances, reddening and dryness of the skin, hyperthermia, tachycardia, difficulties in urination, hallucinations and spastic conditions, especially when overdosed.

The anticholinergic action of the drug can be enhanced by tricyclic anti-depressants, amantadine and quinidine.

Evaluation

The uses of the individual components are listed in their respective monographs. Concerning the combinations of Belladonna with other drugs, no data are available from which a positive contribution to the effectiveness of these drug combinations can be deduced. According to the evaluation results of the other mentioned drugs, these neither contribute to the effectiveness nor to the tolerance of deadly nightshade-containing medicines.

The combination of Belladonna, an alkaloid drug with narrow dosage limitations and high toxicity, with other compounds is not recommended. Poisonings with this herb have been reported. There is no rationale for the additions in the fixed combinations. The risks of side effects and overdosing must be rated higher than the usefulness. Some of the combinations claim uses such as tachycardia and prostate edema with residual urine, which are contraindications for Belladonna. There are neither clinical nor pharmacological data available for the evaluation of fixed combinations with Belladonna for spasms and colic-like pain in the area of the gastrointestinal tract and bile ducts. Furthermore, there are respective mono-preparations of Belladonna available as therapy for these symptoms.

Approval for such combination products cannot be recommended.