Fixed Combinations of Senna leaf and Blonde Psyllium seed husk

Fixed combinations of senna leaf and blonde psyllium seed husk.  

Fixed combinations consisting of:

Senna leaf corresponding to monograph B.  Anz .  133 of July 21, 1993;
Blonde Psyllium seed husk corresponding to monograph B.  Anz .  22a of February 1, 1990;

as well as their preparations in effective dosage.  

A laxative effect is documented for preparations of senna leaf and blonde psyllium seed husk; 1,8-dihydroxy-anthracene derivatives have a laxative effect.  This 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 shortened contact time, a reduction in liquid absorption.  In addition, stimulation of the active chloride secretion increases water and electrolyte content.  

Blonde psyllium seed husk has a laxative effect because of bulk formation due to water absorption resulting in an increased filling pressure.  

The effectiveness of the combination is additive, resulting from the effects of the combination partners.  

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

Clinical Data

Constipation.  

Pathological narrowings in the gastrointestinal tract, intestinal obstructions, difficult-to-control diabetes mellitus, acutely inflamed intestinal diseases, e.g., Crohn's disease, ulcerative colitis, appendicitis, abdominal pain of unknown origin.  Children under 12 years of age.  

In single incidents, allergic reactions may occur.  

Chronic use/abuse:

• loss of electrolytes, especially loss of potassium, albuminuria and hematuria, pigment implantation into the intestinal mucosa ( pseudo melanosis coli ), which is harmless and usually is reversed upon discontinuation of the drug.  

Potassium deficiency can lead to disorders of heart function and muscular weakness, especially with concomitant use of heart 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.  

With 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 increased by simultaneous application of thiazide diuretics, corticoadrenal steroids and licorice root.  

Note:A reduction of the dosage of insulin may be necessary for insulin-dependent diabetics.  

Unless otherwise prescribed:

The individual combination partners must be contained at concentrations of 50 - 75 percent of the daily dosage specified in the respective monographs.  The individually correct dosage is the smallest dosage necessary to maintain a soft stool.  

Solid preparations for oral use.  

Note:Intake of copious amounts of fluid must be observed.  Also, the fixed combination should not be administered until one-half to one hour after intake of other medications.  

Any single dose 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 only be used if no effects can be obtained through change of diet or usage of bulk-forming products.  

None known.