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Bentyl
Overview
What is Bentyl?
BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms:
BENTYL (dicyclomine hydrochloride) is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of CHNO•HCl and the following structural formula:
Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.
What does Bentyl look like?
What are the available doses of Bentyl?
What should I talk to my health care provider before I take Bentyl?
How should I use Bentyl?
BENTYL (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dosage must be adjusted to individual patient needs.
What interacts with Bentyl?
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What are the warnings of Bentyl?
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What are the precautions of Bentyl?
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What are the side effects of Bentyl?
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What should I look out for while using Bentyl?
BENTYL is contraindicated in infants less than 6 months of age , nursing mothers , and in patients with:
What might happen if I take too much Bentyl?
In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room.
The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily). These events resolved after discontinuing the dicyclomine.
The acute oral LD of the drug is 625 mg/kg in mice.
The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride
, the blood concentrations of drug were 200, 220, and 505 ng/mL.
It is not known if BENTYL is dialyzable.
Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.
How should I store and handle Bentyl?
Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature. Protect from light. Do not freeze.Available asPhentermine hydrochloride capsules USP, 15 and 30 mg are supplied as:15 mg capsules, gray/yellow; imprinted "EL600" in black ink on cap and body, filled with white to off-white powder. They are available in bottles of;Bottle of 7 - 68788-9534-1Bottle of 30 - 68788-9534-3Available asPhentermine hydrochloride capsules USP, 15 and 30 mg are supplied as:15 mg capsules, gray/yellow; imprinted "EL600" in black ink on cap and body, filled with white to off-white powder. They are available in bottles of;Bottle of 7 - 68788-9534-1Bottle of 30 - 68788-9534-3Available asPhentermine hydrochloride capsules USP, 15 and 30 mg are supplied as:15 mg capsules, gray/yellow; imprinted "EL600" in black ink on cap and body, filled with white to off-white powder. They are available in bottles of;Bottle of 7 - 68788-9534-1Bottle of 30 - 68788-9534-3Available asPhentermine hydrochloride capsules USP, 15 and 30 mg are supplied as:15 mg capsules, gray/yellow; imprinted "EL600" in black ink on cap and body, filled with white to off-white powder. They are available in bottles of;Bottle of 7 - 68788-9534-1Bottle of 30 - 68788-9534-3Available asPhentermine hydrochloride capsules USP, 15 and 30 mg are supplied as:15 mg capsules, gray/yellow; imprinted "EL600" in black ink on cap and body, filled with white to off-white powder. They are available in bottles of;Bottle of 7 - 68788-9534-1Bottle of 30 - 68788-9534-3
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism:
Atropine did not affect responses to these two agonists. studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.
Non-Clinical Toxicology
BENTYL is contraindicated in infants less than 6 months of age , nursing mothers , and in patients with:Inhibitors of CYP3A4 and CYP2D6
The concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone hydrochloride and ibuprofen, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone Hydrochloride and Ibuprofen Tablets is achieved
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone hydrochloride and ibuprofen plasma concentration will decrease , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone Hydrochloride and Ibuprofen Tablets.
If concomitant use is necessary, consider dosage reduction of Oxycodone Hydrochloride and Ibuprofen Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone Hydrochloride and Ibuprofen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Inducers of CYP3A4
The concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone hydrochloride , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Oxycodone Hydrochloride and Ibuprofen Tablets
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone hydrochloride plasma concentration will increase , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the Oxycodone Hydrochloride and Ibuprofen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride and Ibuprofen Tablets dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome .
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone Hydrochloride and Ibuprofen Tablets if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma)
The use of Oxycodone Hydrochloride and Ibuprofen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Agonist/antagonist analgesics such as pentazocine, nalbuphine, butorphanol and buprenorphine may reduce the analgesic effect of Oxycodone Hydrochloride and Ibuprofen Tablets and/or precipitate withdrawal symptoms in these patients.
Avoid concomitant use of these drugs.
Muscle Relaxants
Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Oxycodone Hydrochloride and Ibuprofen Tablets and/or the muscle relaxant as necessary.
Anticholinergics
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone Hydrochloride and Ibuprofen Tablets are used concomitantly with anticholinergic drugs.
Neuromuscular Blocking Agents
Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Drugs That Interfere With Hemostasis
Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Monitor patients with concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding
Aspirin
Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone
Concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding
ACE-Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and ACE-inhibitors, ARBs, or beta-blockers, in who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function
When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects
Digoxin
The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and digoxin, monitor serum digoxin levels.
Lithium
NSAIDs have produced elevations in plasma lithium concentration and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. This effect has been attributed to inhibition of renal prostaglandin synthesis.
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and cyclosporine may increase cyclosporine’s nephrotoxicity.
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy
The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended.
Pemetrexed
Concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
During concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.
In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
BENTYL solution is for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, thrombophlebitis, and injection site reactions such as pain, edema, skin color change, and reflex sympathetic dystrophy syndrome .
The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.
The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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