Hydrocil

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 psyllium with a full glass (at least 8 ounces) of water or other liquid. Psyllium can swell in your throat and cause choking if you don't take it with enough liquid. Drink plenty of fluids each day to help improve bowel regularity.

Swallow psyllium capsules one at a time. Do not take more than the recommended number of capsules per dose.

Psyllium powder must be mixed with liquid before you take it. Do not swallow the dry powder. Mix the powder with at least 8 ounces of liquid such as water or fruit juice. Stir and drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

The psyllium wafer must be chewed before you swallow it.

Psyllium usually produces a bowel movement within 12 to 72 hours.

It may take up to 3 days before your symptoms improve. Do not take psyllium for longer than 7 days in a row without a doctor's advice. Using a laxative too often or for too long may cause severe medical problems with your intestines.

Call your doctor if your symptoms do not improve, or if they get worse while using psyllium.

Laxatives may be habit-forming if they are used too often or for too long.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

Other drugs may interact with psyllium, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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:

• Belly pain.
• Bloating.
• 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 psyllium: oral capsule, oral powder for reconstitution, oral wafer

Hypersensitivity

Hypersensitivity side effects have been reported rarely. They have included sensitization from inhalation of fine dust particles dispersed into the air as the product is mixed or poured.[Ref]

While hypersensitivity reactions may be severe, they are most frequently reported by workers in the pharmaceutical firms that manufacture the drug. This is because when it is mixed or poured, fine dust particles are readily dispersed into the air and can then be inhaled and cause sensitization. Orally ingested psyllium seems less likely to induce sensitization.[Ref]

Gastrointestinal

Gastrointestinal side effects have included several cases of esophageal impaction and duodenal bezoars in patients receiving a bulk laxative product containing 82% psyllium (the active ingredient contained in Hydrocil) and 18% senna (commercially available as Perdiem Overnight Relief). Other gastrointestinal side effects have included nausea, intestinal gas, cramps, mild diarrhea, rectal pain, constipation, and irritation.[Ref]

Hematologic

The case report of eosinophilia was believed to be a sole manifestation of an allergic reaction to psyllium (the active ingredient contained in Hydrocil) [Ref]

Hematologic side effects have included a case of eosinophilia.[Ref]

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

Obstruction of the esophagus, stomach, small intestine, and colon has occurred when bulk-forming laxatives are administered without adequate fluids or in patients with intestinal stenosis.

Clinical studies have shown that 7 g per day of soluble fiber from psyllium husk may help reduce the risk of heart disease when used as part of a diet low in saturated fat and cholesterol.

Summary of Use during Lactation

Few data are available on psyllium use during breastfeeding; however, it is unabsorbed orally. Most authorities consider psyllium acceptable to use during breastfeeding.[1][2]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Twenty postpartum mothers were given a laxative containing 2.7 grams of plantango (psyllium) and senna equivalent to 15 mg of sennosides a and b daily on days 2 to 4 postpartum. Of the 11 infants who were breastfed (extent notstated), none had any loose stools.[3]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Bisacodyl, Docusate, Magnesium Hydroxide, Senna

References

1. Lewis JH, Weingold AB and the Committee of FDA-Related Matters, American College of Gastroenterology. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80:912-23. PMID: 2864852

2. Hagemann TM. Gastrointestinal medications and breastfeeding. J Hum Lact. 1998;14:259-62. PMID: 10205441

3. Faber P, Strenge-Hesse A. Relevance of rhein excretion into breast milk. Pharmacology. 1988;36 (Suppl 1):212-20. PMID: 336852

Substance Name

Psyllium

CAS Registry Number

8063-16-9

Drug Class

Cathartics