Silace oral / rectal

Docusate is a stool softener. It makes bowel movements softer and easier to pass.

Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.

Docusate may also be used for purposes not listed in this medication guide.

You should not use docusate if you are allergic to it, or if you have:

• nausea, vomiting, or severe stomach pain;

• a blockage in your intestines; or

• chronic stomach pain that has not been checked by a doctor.

You should not take mineral oil while using docusate.

Ask a doctor or pharmacist if it is safe for you to take docusate:

• if you are on a low-salt diet; or

• if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.

FDA pregnancy category C. It is not known whether docusate will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether docusate passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not give this medicine to a child younger than 6 years old without the advice of a doctor.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. Drink plenty of liquids while you are taking docusate.

Do not crush, chew, break, or open a docusate capsule or tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.

After taking docusate by mouth (tablets, capsules, liquid), you should have a bowel movement within 12 to 72 hours.

Do not take docusate rectal enema by mouth. It is for use only in your rectum.

Wash your hands before and after using docusate enema.

Try to empty your bowel and bladder just before using the enema. Remove the cap from the enema applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it. For best results, hold in the enema for as long as possible, or until you have a bowel movement.

The rectal enema should produce a bowel movement within 2 to 15 minutes.

Do not use docusate for longer than 7 days unless your doctor has told you to. Call your doctor if your symptoms do not improve, or if you have not had a bowel movement within 1 to 3 days. Overuse of a stool softener can lead to serious medical problems.

Store at room temperature away from moisture and heat.

Avoid using laxatives or other stool softeners unless your doctor has told you to.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to docusate: compounding powder, oral capsule, oral liquid, oral syrup, oral tablet, rectal enema

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal cramping. Reports of bitter taste and throat irritation have been reported with administration of primarily the syrup and liquid formulations.[Ref]

Dermatologic

Dermatologic side effects have included rash.[Ref]

Metabolic

Metabolic side effects have included at least one case report of hypomagnesemia.[Ref]

Metabolic abnormalities reported include hypomagnesemia in one woman who took docusate chronically throughout her pregnancy. Magnesium levels returned to normal following discontinuation of docusate.[Ref]

Some side effects of Silace may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.