Fixed Combinations of Senna leaf, Peppermint oil, and Caraway oil

Fixed combinations of senna leaf, peppermint oil, and caraway oil.  

Fixed combinations consisting of:

Senna leaf, corresponding to monograph B.  Anz. 133 of July 21, 1993;
Peppermint oil corresponding to monograph B.  Anz. 50 of March 13, 1986;
Caraway oil corresponding to monograph in the B.  Anz .  22a of February 1, 1990;

as well as their preparations in effective dosage.  

1,8-dihydroxy-anthracene derivatives have a laxative effect.  This laxative effect is based on the sennosides, i.e., on their active metabolite in the colon, rheinanthrone.  The effect is primarily caused by the influence on the motility of the colon as an inhibition of stationary and stimulation of propulsive contractions.  This results in an accelerated intestinal passage and, because of the contact time, a reduction in liquid absorption.  In addition, stimulation of the active chloride secretion increases the water and electrolyte content.  

An antispasmodic action is documented for preparations of peppermint oil and caraway oil.  

The effect of the combination is additive-synergistic.  

Pharmacological studies concerning the effectiveness of the fixed combination are not available.  

Clinical Data

Constipation, especially with spastic-like discomforts.  

Intestinal obstructions, acutely inflamed intestinal diseases, e.g., Crohn's disease, ulcerative colitis, appendicitis, abdominal pain of unknown origin.  Children under 12 years of age.  In case of gallstones, to be used only after consultation with a physician.  

In single incidents, spastic gastrointestinal discomforts.  In these cases, a dosage reduction is required.  

Chronic use/abuse:

• loss of electrolytes, especially loss of potassium, albuminuria and hematuria, pigment implantation into the intestinal mucosa ( pseudomelanosis coli ), which is harmless and usually reverses upon discontinuation of the drug.  Potassium deficiency can lead to disorders of heart function and muscular weakness, especially with concurrent use of cardiac glycosides, diuretics and corticoadrenal steroids.  

Stimulating laxatives must not be used over an extended period of time (1 - 2 weeks) without medical advice.  

Because of insufficient toxicological investigations, this drug should not be used during pregnancy and lactation.  

By chronic use/abuse, due to loss in potassium, an increase in effectiveness of cardiac glycosides and an effect on antiarrhythmic drugs is possible.  Potassium deficiency can be aggravated by simultaneous administration of the fixed combination and thiazide diuretics, corticoadrenal steroids, or licorice root.  

Unless otherwise prescribed:

Senna leaf must be contained in the amount specified in the monograph.  The essential oils must be present at concentrations of 50 - 70 percent of the daily dosage specified in the respective individual monographs.  

A deviating dosage of the essential oils must be specifically determined for each preparation.  

The individually correct dosage is the smallest dosage necessary to maintain a soft stool.  

Liquid and solid preparations for oral use.  

Note:A single administration should be less than the common daily dosage.  

Actions influencing electrolyte and water balance.  

Usage of a stimulating laxative for longer than the recommended short-term application can cause an increase in intestinal sluggishness.  The preparation should be used only if no effects can be obtained through change of diet or usage of bulk-forming products.  

None known.