 |
AdulaxProducer: Casen Fleet Laborotories
adulax casen‑fleet
Each applicator of 7.5 ml of solution contains:
Glycerol (INN) 6.14 ml Excipient: purified water, q.s. 7.5 ml PHARMACEUTICAL FORM Rectal solution.
For symptomatic local relief of transient, occasional constipation.
Rectal administration.
Children and breast-feeding: do not administer to children under 12 years of age Adults and children over 12 years of age: a single rectal application daily. Elderly: The same dose as recommended for adults. Hepatic and/or kidney failure: in this case an adjustment of doses is not necessary. The product should not be used for more than one week, except on medical criterion.
Each rectal applicator contains a single dose of the product. For an easier application, the applicator is loaded with excess product that remains in it after use. The amount of solution released in the application is therefore the full dose.
Hypersensitivity to the active ingredients or any of the product compounds.
Laxatives are contraindicated in patients with abdominal cramps, colic, nausea, vomiting or other signs of appendicitis, or with any undiagnosed cause of abdominal pain.
Treatment should be discontinued and an assessment should be made by the physician if fecal blood, irritation or pain occur, or if no improvement is seen in intestinal habits.
This drug should not be administered to children aged less than 12 years. This product should not be used for more than one week, except on medical criterion. In patients with severe diseases, particularly cardiovascular, it should only be used under strict medical control.
None reported.
According to medical criterion.
No effects have been reported, and based on the nature of its composition and action, it is not expected to cause such effects.
Local discomfort, irritation, anal itching, and pain may occur.
Abusive and prolonged use of this drug may lead to the occurrence of an "irritable bowel syndrome". Therefore, in cases of long‑term administration, careful use under medical supervision is recommended.
ATC group: A06A4, other laxatives.
Glycerol is a polyhydroxy‑demulcent compound. It is a trihydric alcohol that can be mixed with water and alcohol. It absorbs water, and when used at certain concentrations it can therefore cause dehydration and irritation of the exposed tissues. This irritating action explains its efficacy to promote bowel emptying when used by the rectal route as an enema. After rectal administration, glycerol has a laxative effect due to its capacity to lubricate feces and to the increased intraluminal osmotic pressure, which attracts interstitial water and enhances peristalsis. Glycerol promotes emptying of the colon within 15‑30 minutes to one hour.
Osmotic laxatives such as glycerol, when administered by the rectal route, are hardly absorbed and are resistant to digestion in the small bowel. However, oral glycerol is readily absorbed from the gastrointestinal tract and reaches peak plasma levels in 60‑90 minutes. It is widely distributed in the body, and the majority of the dose administered is incorporated into muscle fat, 80% being metabolized in the liver, while the rest is excreted unchanged in urine. Elimination half‑life is from 30 to 45 minutes.
In order to establish the safety of glycerol, its general toxicity has been studied in mice and rats.
Acute toxicity is very low. The oral LD50 values are higher than 20 ml/kg in both mice and rats; in mice and rats also, the LD50 values are approximately 4.9 and 4.4 ml/kg by the intravenous route, and 7.1 and 6.9 ml/kg by the intraperitoneal route respectively. When administered by the oral route, glycerol is considered by the FDA in category C as regards embryofetal, perinatal and reproductive toxicity. The mutagenicity and carcinogenicity studies performed have shown the total absence of these activities. Rectal administration may cause rectal irritation, burning and discomfort.
Purified water.
Not seen.
Three years from the date of manufacture.
This drug should be stored at a temperature below 25ºC.
The product is packaged in a 7.5 ml applicator fitted with a cannula of low‑density polyethylene and closed with a low‑density polyethylene cap.
At the time selected for administration, and once the cap closing the tip of the cannula has been removed, place the cannula in an upright, upward position and press slightly so that a few drops of the preparation wet the tip of the cannula, in order to achieve an easier insertion in the rectum. After insertion is achieved, squeeze the contents of the applicator and remove it gently once it is empty, with continuous pressure on the applicator walls. Each applicator is loaded with excess product, which remains in the applicator after use. Thus, the amount released in the application is the full dose, and the applicator should not be completely emptied, which facilitates handling.
If resistance is found at the time of application, this should be stopped, since it may be harmful. Each applicator contains a single dose of the product, and should be discarded after use. NAME OR TRADE NAME AND PERMANENT ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING AUTHORIZATION HOLDER
Laboratorios Casen‑Fleet, S.A. Autovía de Logroño, km. 13,300 50180 UTEBO (Zaragoza)
|
