Clominal

A muscarinic antagonist used as an antispasmodic and in urinary incontinence. It has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms. [PubChem]

For the treatment of functional disturbances of gastrointestinal motility eg, irritable bowel syndrome and renal and biliary colic. As with other antispasmodics, Clominal has limited efficacy in the treatment of these disorders and should be used only if other measures (eg, diet) have been of little or no benefit.

Clominal has been used alone or in combination with phenobarbital in the treatment of infant colic and acute enterocolitis but lacks substantial evidence of efficacy in these conditions. Infant colic is considered a benign and self-limiting condition.

Clominal relieves spasms of the muscles in the stomach and intestines.

Clominal is used to treat functional bowel or irritable bowel syndrome.

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

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule,

Oral, as hydrochloride:

Bentyl: 10 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), corn starch, fd&c red #40]

Generic: 10 mg

Solution,

Intramuscular, as hydrochloride:

Bentyl: 10 mg/mL (2 mL) [pyrogen free]

Generic: 10 mg/mL (2 mL)

Solution,

Intramuscular, as hydrochloride [preservative free]:

Generic: 10 mg/mL (2 mL)

Solution,

Oral, as hydrochloride:

Generic: 10 mg/5 mL (473 mL)

Tablet,

Oral, as hydrochloride:

Bentyl: 20 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), corn starch]

Generic: 20 mg

Dosing: Adult

Irritable bowel syndrome-associated abdominal pain:

Oral: Initial: 20 mg up to 4 times daily; some experts recommend only administering as needed or in anticipation of a stressor that triggers abdominal pain (Wald 2019); intended for short-term use; scheduled dosing for >2 weeks has not been studied (Ford 2014; manufacturer's labeling)

Note: According to the manufacturer's labeling, may titrate dose after 1 week, based on response and tolerability, up to 40 mg 4 times daily; however, some experts do not recommend doses >20 mg due to anticholinergic adverse effects (Wald 2019).

Dosing: Geriatric

Avoid use (Beers Criteria [AGS 2019]).

Dosing: Pediatric

Gastrointestinal motility disorders/irritable bowel: Limited data available (Bentylol Canadian prescribing information 2012):

Infants ≥6 months and Children <2 years:

Oral: 5 to 10 mg 3 to 4 times daily administered 15 minutes before feeding

Children ≥2 years

Oral: 10 mg 3 to 4 times daily

Adolescents:

Oral: 10 to 20 mg 3 to 4 times daily. If efficacy not achieved in 2 weeks, therapy should be discontinued.

See also:
What is the most important information I should know about Clominal?

1. Obstructive uropathy
2. Obstructive disease of the gastrointestinal tract
3. Severe ulcerative colitis
4. Reflux esophagitis
5. Unstable cardiovascular status in acute hemorrhage
6. Glaucoma
7. Myasthenia gravis
8. Evidence of prior hypersensitivity to Clominal hydrochloride or other ingredients in this formulation
9. Infants less than 6 months of age
10. Nursing Mothers

Use Clominal as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clominal is usually given as an injection at your doctors office, hospital, or clinic. If you will be using Clominal at home, a health care provider will teach you how to use it. Be sure you understand how to use Clominal. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Clominal is for intramuscular (IM) injection only. It is NOT for intravenous (IV) use.
• Do not use Clominal if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• The injection form of Clominal is only given short-term when the oral form cannot be taken. Your health care provider will prescribe the oral form of Clominal as soon as you are able to take it.
• Use Clominal on a regular schedule around the clock, unless your doctor tells you otherwise.
• If you miss a dose of Clominal, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Clominal.

Clominal is used to treat periodic spasms and pain in abdomen and stomach, intestinal cramps, irritable bowel syndrome (disorder of the intestines that leads to cramps in the abdomen, gas, bloating and changes in bowel habits) and inability to control urine (urinary incontinence).

See also:
What other drugs will affect Clominal?

As an anticholinergic drug Clominal is likely to interact additively with other drugs acting on muscarinic cholinergic receptors. However there seems to be no evidence.

See also:
What are the possible side effects of Clominal?

Controlled clinical trials have provided frequency information for reported adverse effects of Clominal hydrochloride listed in a decreasing order of frequency.

Not all of the following adverse reactions have been reported with Clominal hydrochloride. Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.

Gastrointestinal: dry mouth, nausea, vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia.

Central Nervous System: dizziness, lightheadedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia.

Ophthalmologic: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension

Dermatologic/Allergic: rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis.

Genitourinary: urinary hesitancy, urinary retention

Cardiovascular: tachycardia, palpitations

Respiratory: Dyspnea, apnea, asphyxia

Other: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation