ACTION AND MECHANISM

- Laxative. Bisacodyl is a stimulant laxative derived from diphenylmethane. It works by stimulating colonic peristalsis, either through direct action on the mucosa or on the myenteric plexuses of Auerbach. This leads to an accumulation of fluids and electrolytes in the intestinal lumen. Its effects begin within 6-10 hours when administered orally, or within 15-60 minutes when administered rectally.

SPECIAL WARNINGS

- Perform a differential diagnosis in patients suspected of having intestinal obstruction.

Before starting treatment, the patient must be properly hydrated and have normal electrolyte levels. Treatment should not be started if these levels are abnormal.

- In elderly or debilitated patients, it is recommended to monitor electrolyte levels periodically.

PATIENT ADVICE

Before starting any treatment for constipation, lifestyle habits should be modified. Adequate daily intake of fluids and fiber is recommended, as well as responding promptly to the urge to defecate and engaging in physical exercise.

- This medicine should not be used by patients with intestinal obstructions.

- Continued use may lead to habituation.

- If after 1 week of use, constipation does not improve, persists or worsens, you should consult your doctor or pharmacist.

- Consult your doctor and/or pharmacist if constipation worsens, or if symptoms such as nausea or vomiting, abdominal bloating or fever appear.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication.

- Conditions that could be aggravated by the laxative effect include intestinal obstruction, intestinal perforation, chronic inflammatory bowel disease, appendicitis, or toxic megacolon. Naturally, it should not be used in patients with diarrhea.

- [GASTROINTESTINAL BLEEDING]. Bisacodyl should not be administered to patients with gastrointestinal bleeding due to its irritant effects on the intestinal mucosa.

ADVANCED AGE

Peristalsis stimulants can exacerbate weakness, incoordination, and orthostatic hypotension in geriatric patients, as a result of large electrolyte loss, when used repeatedly.

PREGNANCY

Animal safety : no data available.

Safety in humans : There are insufficient data on the use of bisacodyl in pregnant women. The possible effects of bisacodyl on the fetus are unknown; therefore, bisacodyl should not be administered during pregnancy except when the physician believes the benefits outweigh the possible risks, because bisacodyl is absorbed in small amounts.

Effects on fertility : no specific studies have been conducted in humans.

PHARMACOKINETICS

It is a prodrug that is metabolized in the colon by the action of the bacterial flora, giving rise to the active metabolite, bis-(para-hydroxyphenyl)-2-pyridylmethane.

- Absorption. It is absorbed in very small quantities.

Food: Milk can increase the absorption of bisacodyl, so it is recommended to separate the intake of milk and bisacodyl by at least two hours.

- Metabolism. The absorbed portion is metabolized in the liver by conjugation reactions.

- Excretion. Unabsorbed bisacodyl is excreted in the feces, while the small absorbed fraction is eliminated in the urine.

INDICATIONS

- Symptomatic treatment of occasional [CONSTIPATION].

INTERACTIONS

- Digoxin. Prolonged use of laxatives can lead to potassium depletion, increasing digoxin toxicity. Monitoring electrolyte levels is recommended in patients treated with digoxin.

LACTATION

Animal safety: no data available.

Safety in humans: neither the active fraction of bisacodyl (bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted in breast milk. Use is acceptable during breastfeeding.

CHILDREN

As a general rule, laxatives are not recommended for children under 6 years of age, as they are often unable to accurately describe their symptoms. A proper diagnosis should be made before using a laxative, as it could mask more serious conditions. The product information indicates that the tablets are approved for use in children over 2 years of age.

GUIDELINES FOR PROPER ADMINISTRATION

The suppositories should be administered first thing in the morning.

POSOLOGY

" RECTAL ADMINISTRATION":

- Adults: 1 suppository (10 mg)/24 h.

- Children and adolescents < 18 years:

* Children > 10 years: same as adults.

* Children < 10 years: not recommended.

PRECAUTIONS

- Symptoms of intestinal obstruction. Before starting treatment with a laxative, it is advisable to perform a differential diagnosis of intestinal obstruction in patients with symptoms such as [NAUSEA], [VOMITING] or [ABDOMINAL PAIN] of unknown origin, or [ABDOMINAL DISTENSION].

- [ELECTROLYTE IMBALANCE]. The use of laxatives for long periods of time can lead to electrolyte imbalances. Patients should be properly hydrated and have normal electrolyte levels before starting treatment with a laxative.

- Dependence. Continued use of laxatives can lead to dependence, as they may cause electrolyte imbalances that lead to intestinal atony.

- Dizziness/syncope: Dizziness and/or syncope have been reported, seemingly attributable to distension caused by stool or as a vasovagal response to abdominal pain related to constipation and not necessarily to the administration of bisacodyl itself.

ADVERSE REACTIONS

The adverse effects of bisacodyl are generally mild and transient. The most common adverse reactions are:

- Digestive. After continued use, abdominal pain and abdominal distension may occur. Rectal forms may also cause irritation, pain, and bleeding of the rectal mucosa, and in more severe cases, proctitis.

Hematochezia (evacuation of bloody stools) has been observed, which is usually mild and resolves spontaneously.

- Allergic/dermatological: The presence of [SKIN ERUPTIONS] and hypersensitivity reactions including [ANGIOEDEMA] and [ANAPHYLAXIS] is very rare.

- Metabolism and nutrition: [DEHYDRATION].

OVERDOSE

Symptoms: After excessive administration, a condition may appear characterized by gastrointestinal spasms, mucous and diarrheal stools, and loss of potassium and other electrolytes.

Treatment: The laxative should be discontinued. Supportive treatment should be initiated, including rehydration with saline solution and administration of mineral salts if necessary. Antispasmodics may be administered to relieve intestinal spasms.