BENTYL functions as both an antispasmodic and an anticholinergic (antimuscarinic) agent and is accessible in the subsequent form:
BENTYL injection is a sterile aqueous solution, devoid of pyrogens, intended for intramuscular administration (NOT SUITABLE FOR INTRAVENOUS USAGE). It is supplied in an ampoule containing 20 mg/2 mL (10 mg/mL) dicyclomine hydrochloride USP dissolved in sterile water for injection, rendered isotonic with sodium chloride.
BENTYL, known chemically as dicyclomine hydrochloride, is represented by the subsequent molecular structure:
[Bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with the molecular formula C19H35NO2•HCl.
Its molecular weight is 345.95. Dicyclomine hydrochloride materializes as a fine, white, crystalline powder, essentially lacking any discernible odor and exhibiting a bitter flavor. It possesses solubility in water, higher solubility in alcohol and chloroform, and a very limited solubility in ether.
How long does bentyl stay in your system?
The duration that Bentyl (dicyclomine) remains in your system can vary based on factors such as your individual metabolism, dosage, frequency of use, and overall health. Generally, the half-life of Bentyl, which is the time it takes for half of the drug to be eliminated from the body, is around 1 to 2 hours.
However, it's important to note that the effects of the medication might not directly correlate with its presence in the bloodstream. The therapeutic effects of Bentyl might last longer than the time it takes for the drug to be eliminated from the body, due to its mechanism of action and potential interactions with receptors and tissues.
If you're concerned about how long Bentyl might affect you or have questions about its presence in your system, it's advisable to consult a healthcare professional who can provide personalized information based on your specific situation.
Usage Indications:
BENTYL® (dicyclomine hydrochloride) is prescribed to address functional bowel/irritable bowel syndrome in patients.
Dosage and Application:
Dosage should be individualized to match each patient's requirements.
Intramuscular Dosage and Application in Adults:
BENTYL Intramuscular Injection must exclusively be administered through intramuscular means and should not be administered by any other method.
The suggested intramuscular dose ranges from 10 mg to 20 mg, taken four times daily [refer to CLINICAL PHARMACOLOGY].
The use of intramuscular injection should be confined to 1 or 2 days, typically when oral medication is not feasible.
Intramuscular injection exhibits approximately double the bioavailability of oral forms.
Preparation for Intramuscular Administration:
Parenteral drug products should be visually inspected for any particles or discoloration prior to administration, whenever the solution and container allow.
Before injecting, it's advisable to withdraw the syringe to prevent inadvertent intravascular injection, as thrombosis could occur if the drug is mistakenly injected intravascularly.
Presentation and Potency:
BENTYL injection is available in a strength of 20 mg/2 mL (10 mg/mL).
Storage and Handling:
BENTYL Injection is supplied in packs of five 20 mg/2 mL ampules (10 mg/mL). It is recommended to store it at room temperature, preferably below 86°F (30°C). Protection from freezing is essential.
Read Also: How Long does Contrave Stay in Your System
Side Effects:
The pattern of unwanted effects associated with dicyclomine is primarily linked to its interactions with muscarinic receptors [refer to CLINICAL PHARMACOLOGY]. These effects arise from the inhibitory impact on muscarinic receptors within the autonomic nervous system. Generally, these effects are proportional to the dosage and tend to reverse upon discontinuation of treatment.
Experience from Clinical Trials:
Due to the wide range of conditions under which clinical trials are conducted, the rates of adverse reactions observed in the trials of one drug cannot be directly compared to those of another drug's trials, and these rates might not accurately reflect real-world observations.
The data below pertain to controlled clinical trials that involved more than 100 patients treated for functional bowel/irritable bowel syndrome using dicyclomine hydrochloride at initial doses of 160 mg per day (40 mg taken four times daily).
In these trials, the majority of side effects were commonly associated with anticholinergic properties and were reported by 61% of the patients.
Table 1 displays adverse reactions (MedDRA 13.0 preferred terms) ranked by frequency, presented alongside placebo in a side-by-side comparison.
| MEDDRA PREFERRED TERM | DICYCLOMINE HYDROCHLORIDE (40 MG FOUR TIMES A DAY) % | PLACEBO % |
| Dry Mouth | 33 | 5 |
| Dizziness | 40 | 5 |
| Vision Blurred | 27 | 2 |
| Nausea | 14 | 6 |
| Somnolence | 9 | 1 |
| Asthenia | 7 | 1 |
| Nervousness | 6 | 2 |
Interactions with Other Medications:
Antiglaucoma Agents
The effects of antiglaucoma agents can be countered by anticholinergic activity. Concurrent use of anticholinergic drugs, especially in the presence of elevated intraocular pressure, could pose risks, particularly when taken alongside substances like corticosteroids. It is not advisable to employ BENTYL in individuals with glaucoma [refer to CONTRAINDICATIONS].
Other Drugs Exhibiting Anticholinergic Activity:
Certain agents can enhance specific actions or potential side effects associated with anticholinergic drugs, including BENTYL. These agents encompass amantadine, antiarrhythmic agents from Class I (such as quinidine), antihistamines, antipsychotic agents (like phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, as well as other drugs possessing anticholinergic properties.
Other Medications Affecting Gastrointestinal Motility:
Interaction with other gastrointestinal motility-altering drugs may counteract the effects of substances that influence gastrointestinal motility, like metoclopramide.
Impact of Antacids:
Given that antacids can impede the absorption of anticholinergic agents, including BENTYL, simultaneous usage of these drugs should be avoided.
Effects on the Absorption of Other Medications:
Anticholinergic agents have the potential to influence the gastrointestinal absorption of various drugs by affecting gastrointestinal motility. For instance, they may impact the absorption of slowly dissolving forms of digoxin, potentially leading to elevated serum digoxin concentrations.
Effects on Gastric Acid Secretion:
The inhibition of gastric hydrochloric acid secretion by anticholinergic drugs is counteracted by substances used to treat achlorhydria, as well as those used to evaluate gastric secretion.
Unintentional Intravenous 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 [see ADVERSE REACTIONS].
Cardiovascular Conditions
Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see ADVERSE REACTIONS].
Peripheral And Central Nervous System
The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see ADVERSE REACTIONS].
In High Environmental Temperature
In elevated environmental temperatures, heat-related issues like fever and heat stroke due to reduced sweating could occur with drug usage. Caution should also be exercised in patients with fever. Should symptoms manifest, discontinuation of the drug and provision of supportive measures is advised. Due to the inhibitory effect on muscarinic receptors within the autonomic nervous system, extra care should be taken in patients with autonomic neuropathy.
Central Nervous System Effects
Signs and symptoms within the central nervous system (CNS) encompass a confused state, disorientation, memory loss, hallucinations, difficulty in speech, lack of coordination, coma, feelings of euphoria, fatigue, sleeplessness, restlessness, and inappropriate emotional expressions. In sensitive individuals (e.g., elderly patients or those with mental illness), anticholinergic drugs can lead to psychosis and delirium. These CNS effects typically resolve within 12 to 24 hours following discontinuation of the drug.
Potential Impairment
BENTYL may induce drowsiness, dizziness, or blurred vision. Patients should be cautioned against engaging in activities requiring mental alertness, such as operating vehicles or machinery, or performing hazardous tasks while using BENTYL.
Myasthenia Gravis
An action similar to curare-like neuromuscular blockade, leading to muscular weakness and possible paralysis, can occur in cases of overdosage. Except for mitigating adverse muscarinic effects of an anticholinesterase, BENTYL should not be administered to patients with myasthenia gravis [refer to CONTRAINDICATIONS].
Intestinal Conditions
Diarrhea might indicate incomplete intestinal obstruction, particularly in individuals with ileostomy or colostomy. In such cases, usage of this drug would be inappropriate and potentially harmful [refer to CONTRAINDICATIONS]. Rarely, Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. This syndrome mirrors the appearance of acute large bowel obstruction on imaging, but without evidence of distal colonic obstruction.
Toxic Intestinal Dilatation (Megacolon)
In patients with Salmonella dysentery, administration of anticholinergic agents could result in toxic dilatation of the intestine and intestinal perforation.
Ulcerative Colitis
Patients with ulcerative colitis should exercise caution. Large doses could potentially suppress intestinal motility to the point of causing a paralytic ileus. Usage of this drug might also trigger or exacerbate the serious complication of toxic megacolon [refer to ADVERSE REACTIONS]. BENTYL is contraindicated in cases of severe ulcerative colitis [refer to CONTRAINDICATIONS].
Prostatic Enlargement
Care should be taken in patients with known or suspected prostatic enlargement, as such enlargement might lead to urinary retention [refer to ADVERSE REACTIONS].
Hepatic And Renal Impairment
Caution is advised when using BENTYL in patients with known hepatic and renal impairment.
Elderly Population
Elderly individuals might be more susceptible to adverse effects and should use dicyclomine hydrochloride with caution.
Nonclinical Safety
Long-term animal studies have not been conducted to evaluate the potential carcinogenicity of dicyclomine. Rats exposed to doses of up to 100 mg/kg/day showed no detrimental effects on reproduction. Additionally, studies on rats and rabbits at doses of up to 33 times the maximum human dose showed no harm to the fetus. However, as animal studies don't always predict human responses, the use of this drug during pregnancy should only occur if absolutely necessary.
Nursing Mothers
BENTYL should not be used by breastfeeding women, as dicyclomine hydrochloride is excreted in human milk. Given the potential for serious adverse reactions in breastfed infants, a decision should be made to either discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of BENTYL in pediatric patients have not been established. It is contraindicated in infants less than 6 months old [refer to CONTRAINDICATIONS]. Though cases of serious respiratory symptoms, seizures, and other reactions have been reported after administering dicyclomine hydrochloride to infants, no causal relationship has been established.
Geriatric Use
Clinical trials did not involve a substantial number of individuals aged 65 and older to determine potential differences in response. While responses between elderly and younger patients do not appear to differ significantly, caution is advised when dosing elderly patients, typically starting at the lower end of the adult dosing range due to the higher likelihood of decreased hepatic, renal, or cardiac function, as well as concurrent conditions or other medications.
Renal Impairment
The impact of renal impairment on PK, safety, and efficacy of BENTYL hasn't been studied. Since the drug is significantly excreted by the kidney, patients with impaired renal function might be at greater risk of toxic reactions. BENTYL should be used cautiously in patients with renal impairment.
Hepatic Impairment
Similarly, the effects of hepatic impairment on PK, safety, and efficacy of BENTYL haven't been studied. Caution should be exercised when administering BENTYL to patients with hepatic impairment.
