Dicyclomine

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Dicyclomine, commonly sold under the brand name Bentyl, is an anti-cholinergic drug used to treat symptoms of irritable bowel syndrome (IBS).

It works by relieving spasms of the muscles in your stomach and intestines by blocking a certain substance that your body produces naturally.

Dicyclomine was approved by the Food and Drug Administration (FDA) in 1950.

Dicyclomine Warnings

Dicyclomine can impair your thinking or reactions. You should be careful when you drive or doing anything that requires you to be alert if you are taking dicyclomine.

Dicyclomine may also make you dizzy or cause you to have blurred vision.

You should stop using dicyclomine and call your doctor right away if you have serious side effects such as confusion, hallucinations, unusual thoughts or behavior, fast or uneven heart rate, or if you urinate less than usual or not at all.

Dicyclomine reduces your body's ability to cool off by sweating. You should be careful if you live in an area where there are high temperatures because dicyclomine can cause fever and heat stroke.

Care is also required in patients with coronary heart disease and in patients with known high blood pressure.

Dicyclomine and Pregnancy

If you are pregnant, you should only use dicyclomine when it is clearly needed. You should discuss all the risk and benefits with your doctor before taking.

It is known that dicyclomine passes into breast milk and may have serious side effects on a nursing infant. The manufacturer recommends that you do not breastfeed while using this drug.

This medication must not be used in children younger than 6 months old because of the risk of serious side effects.

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Dosage Forms And Strengths

• BENTYL 10 mg capsules: blue, imprinted BENTYL 10
• BENTYL 20 mg tablets: compressed, light blue, round, debossed BENTYL 20
• BENTYL injection 20 mg/2 mL (10 mg/mL)

Storage And Handling

10 mg blue capsules, imprinted BENTYL 10, supplied in bottles of 100. Store at room temperature, preferably below 86°F (30°C).

NDC number: 58914-012-10.

20 mg compressed, light blue, round tablets, debossed BENTYL 20, supplied in bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).

NDC 58914-013-10.

20 mg/2 mL (10 mg/mL) injection supplied in boxes of five 20 mg/2 mL ampules (10 mg/mL). Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

NDC 58914-080-52.

Manufactured for: Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807 USA. Revised: June 2013

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antiglaucoma agents
• Antacids
• other anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

This is not a complete list of dicyclomine drug interactions. Ask your doctor or pharmacist for more information.

Before taking dicyclomine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to dicyclomine or to any of its ingredients
• are a nursing mother
• have acid reflux disease
• have problems urinating
• have heart problems
• have myasthenia gravis
• have glaucoma
• have severe ulcerative colitis
• have an enlarged prostate
• have liver problems
• have kidney problems
• have mental health problems

​Dicyclomine is not for infants younger than 6 months.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed. Dicyclomine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from dicyclomine, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of dicyclomine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Dicyclomine can decrease your sweating, which can lead to heat stroke in a hot environment.

Stop using dicyclomine and call your doctor right away if you have serious side effects such as confusion, hallucinations, unusual thoughts or behavior, fast or uneven heart rate, or if you urinate less than usual or not at all.

There are many other medicines that can interact with dicyclomine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dilated pupils, weakness or loss of movement in any part of your body, trouble swallowing, fainting, or seizure (convulsions).

Antiglaucoma Agents

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of Dicyclomine hydrochloride in patients with glaucoma is not recommended [see Contraindications (4)].

Other Drugs with Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including Dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.

Other Gastrointestinal Motility Drugs

Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

Effect of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including dicycolomine hydrochloride, simultaneous use of these drugs should be avoided.

Effect on Absorption of Other Drugs

Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

Effect on Gastric Acid Secretion

The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

Data not available

Administration advice:
-Dicyclomine injection is for IM administration only.
-Inspect parenteral products visually for particulate matter and discoloration prior administration.
-Aspirate the syringe before injecting to avoid intravascular injection (thrombosis may occur if the drug is inadvertently injected intravascularly).

Patient advice: This drug may cause drowsiness or blurred vision; avoid activities that require mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

• Side effects are usually transient and eventually resolve although some people may require dosage reduction. 9% of people discontinue dicyclomine because of side effects.
• May cause drowsiness or blurred vision and affect your ability to drive or operate machinery. Avoid alcohol.
• Dicyclomine may increase your risk of developing heat stroke in hot weather because it decreases your ability to sweat. If symptoms of heat stroke occur (symptoms include fever, nausea, and dizziness after sun exposure), discontinue dicyclomine and seek urgent medical attention.
• May affect the absorption of other medications. Take other medications at least an hour or two before taking dicyclomine. Talk to your doctor or pharmacist before taking any other medications, including those bought over the counter, to check if they are compatible with dicyclomine.
• Talk to your doctor if you experience any unexplained diarrhea, severe constipation, hallucinations, loss of muscle control or other worrisome side effects.