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Important Features of Agiolex:
  1- Composition.
  2- Mechanism of Action.
  3- Indications.
  4- Why Agiolax® (Special features of Agiolax®).
  5- Contraindications.
  6- Directions for use.
  7- Onset of action.
  8- Presentation and pack sizes.
 
     
1- COMPOSITION: Top
 
   
Seeds of Plantago ovata
52.0 g
Isphagula husk
02.2 g
Tinnevelly Senna pods
12.4 g


2- MECHANISM OF ACTION: Top
 

1- Its Fiber: Fiber deficiency is the most common cause of constipation. Agiolax® fiber swells in water to form a mucilaginous mass. This ensures adequate stool hydration, increased fecal volume, reduced intraluminal pressure, which increases peristaltic activity and normalizes the intestinal transit time.
2- It’s a Laxative: The fiber is balanced by natural senna glycosides in order to form an ideal blend. Agiolax® also contains senna which gently stimulates the bowel function, because fiber alone often cannot normalize intestinal transit time.
3- Its granules: Only the right galenical formulation ensures the maximum effect of the active ingredients. Agiolax®’s galenical formulation is a unique protection against early swelling. The coating ensures that Agiolax® exerts its action specifically in the colon, the site of constipation.

3- INDICATIONS: Top
   
 
  • Constipation, particularly the chronic form.
  • Regulation of bowel activity during pregnancy and post partum.
  • In patients confined to bed.
  • Habituation to strong purgatives.
  • Disordered bowel action in patients with colostomies.
4- Why Agiolax® (Special features of Agiolax®) Top
 


12 >> MUSTS << for a good laxative


Fulfilled by
   ....
YES      NO


Fulfilled by   Agiolax®
YES      NO

Colon-specific action

No griping

No bloating

No habituation

No shift in electrolyte balance

Safe during pregnancy

Safe during lactation period

Safe in short and long term use

Easy to take (no mixing required)

Individually adjustable dose

Predictable efficacy

Does not cause watery stools

5- CONTRADICTIONS: Top
 
Lleus, as with all laxatives.
6- DIRECTION FOR USE: Top
 
Agiolax® should be taken after the evening meal and before breakfast. The general dosage is 1 – 2 teaspoonfuls – according to the individual requirement – followed by a glass of liquid. Agiolax® should not be chewed. After the preparation has been effective, the dosage can be individually reduced to ½ to 1 teaspoonful once or twice daily.
7- OUTSET OF ACTION: Top
 

Due to its natural mode of action, Agiolax® ensures the desired response for most people within 12 – 24 hours.

8- PRESENTATION AND PACK SIZES: Top
   
 

Manufacturer’s pack of 12 sachets of 5g of granules.
Manufacturer’s pack of 100g of granules.
Manufacturer’s pack of 250g of granules.
Manufacturer’s pack of 1000g of granules.
Hospital pack of 10 kg of granules

   
9- CLINICAL RESULTS: Top
   
 
Agiolax® in chronic habitual constipation Top
   
 
Two placebo-controlled randomized double blind trails comprising a total of 115 patients with chronic habitual constipation show that Agiolax® significantly improves frequency of defaecation and stool consistency.

• Thirty patients suffering from constipation, some of them for 2 years, and a further 25 patients due to confinement to bed, were treated for 7 days with Agiolax® (2 teaspoonfuls) or placebo. In the Agiolax® group the frequency of bowel motions was significantly higher and there was a significant change in the direction of normal stool consistency.

• In another trail comprising 60 patients with chronic habitual constipation Agiolax® (2 teaspoonfuls daily) was compared with placebo over a 7 day period.There was a significant increase in frequency of defaecation from the first day of treatment onwards, and this improvement continued with only minor fluctuations during the subsequent days of treatment.

Agiolax® in chronic & acute constipation Top

The efficacy of Agiolax® has been investigated in several clinical follow up trails ranging from 1 to 8 weeks in duration and comprising over 200 patients of constipation of various kinds.

Normal defaecation rhythm with painless evacuation of faeces or adequate bulk and soft consistency was achieved in some 90 % of the patients.

Constipation in geriatric patients Top
  • In a group of geriatric patients (n=57), some of whom had suffered from constipation for as long as 10-30 years and had a history of laxative abuse, treatment with Agiolax® (3 teaspoonfuls daily) produced regular bowel motions with adequate faecal bulk in 82.5 % of cases. Fundamental improvement was achieved in 86 % of those patients who had previously been taking drastic purgatives.
  • In another series of patients (n=78) good therapeutic results were achieved in 90 % of those with secondary constipation and 100 % of those with chronic habitual constipation, the criterion of success being painless evacuation of stools of adequate bulk and soft consistency.
Constipation as an incidental symptom of various underlying diseases Top

Agiolax® has also been tested in cases of constipation resulting from conditions such as cholelithiasis, cholecystitis, gastritis and duodenal ulcer. The objective of treatment was the painless evacuation of stools of soft consistency in a 24 hour rhythm; this was achieved in all patients 48 hours after starting Agiolax® therapy.

Constipation of varied aetiology Top
  • Assessed in terms of reinstatement of normal defaecation rhythm, treatment with Agiolax® in an average dose of 2.5 teaspoonful daily for a mean of 23 days (maximum 61 days) achieved good results in 75.5 % of a total of 40 patients with chronic constipation.
  • In a multicentre trail in 403 patients with constipation of various aetiological types, Agiolax® was successful in normalizing stool consistency and frequency of defaecation.

During treatment with Agiolax® 0.5 – 3 teaspoonfuls daily the proportion of patients reporting stools of semisolid or adequately soft consistency rose from 79.6 % to 92.8 %. Tab. 2

   
 

Stool consistency

No. of patients

Before Agiolax® (n %)

After Agiolax® (n %)

Hard

350 (86.8)

24 (6.0)

Semisolid or adequately soft

53 (13.2)

374 (92.8)

Watery

-

5 (1.2)

   
 
Tab. 2 :Changes in stool consistency produced by Agiolax®
 
  • Changes in frequency of defaecation were documented in 339 patients. Frequency of defaecation was defined as normal if it was within the range of between two evacuations per day and two evacuations per week. Treatment with Agiolax® in variable doses between 0.5 – 3 teaspoonfuls daily produced the results outlined in Tab. 3
   
 

Frequency of defaecation

No. of patients

Before Agiolax® (n %)

After Agiolax® (n %)

3-2 / 1 day

1 (0.3)

2 (0.6)

2 -1 / 1 - 2 days

19 (5.6)

264 (77.9)

1 / 2 - 3 days

119 (35.1)

52 (15.3)

1 / 3 - 6 days

182 (53.7)

21 (6.2)

1 / 6 - 10 days

18 (5.3)

-

   
 
Tab. 3 : Frequency of defaecation before and after Agiolax®
  • Agiolax® in doses of 1.5 teaspoonfuls daily also gave good results in 94.1 % of patients suffering from constipation due to anal conditions such as haemorrhoids and anal fissures.
   
 
Agiolax® in constipation during and after pregnancy Top
   
 
The efficacy and tolerability of Agiolax® have been tested in several follow up trails in pregnant women, most of whom were suffering from constipation during the first trimester, and also in women with constipation following pregnancy.
  • After 4 – 6 weeks treatment bowel function had improved to such an extend that 50 % of the pregnant women in the trail (n=327) were able to manage with one or two doses weekly or even discontinue the product altogether.
  • An initial dose of not less than 3 teaspoonfuls of Agiolax® daily, reduced once its effect had apparent, achieved regular bowel motion in 95 % of patients with mild constipation during and after pregnancy, and 84 % of patients with severe constipation.
  • A variable dosage of 1 – 2 teaspoonfuls of Agiolax® daily gave good results in 96.4 % in pregnant women who were suffering either from chronic constipation (n=62) or from changes in bowel habit since the commencement of pregnancy (n=31). After taking Agiolax® regularly for four weeks 13 out of 93 patients (14 %) reported that normal bowel function had been restored and that they were able to discontinue its use.
  • In another series of pregnant women suffering from constipation (n=52) treatment with Agiolax® 6 gm daily raised the number of patients reporting one evacuation every 1 – 3 days to 74.5 %. Fig.5
   
 
 
Fig. 5 :Change in frequency of bowel action in pregnant women produced by Agiolax®

The changes in stool consistency produced by Agiolax® are shown in Fig. 6

   
 
 
Fig. 6 : Changes in stool consistency in pregnant women produced by Agiolax®
   
 
Monitoring electrolyte balance during treatment with Agiolax® Top
   
 

The safety and tolerability of Agiolax® have been tested during long – term administration

• Determination carried out after 1 year’s treatment (n=84) and 2 year’s treatment (n=20) with Agiolax® in daily doses of 1-2 teaspoonfuls did not show any changes in serum electrolytes, in particular potassium levels.

• A farther trail was carried out in 35 patients who had taken Agiolax® in daily doses 1-3 teaspoonfuls over an average period of 34 months (minimum 24, maximum 72 months). Monitoring of serum electrolytes again showed levels within the normal range.