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Interactions between Gastrosed and Mitotane

1 drug interaction and 29 additional warnings found for the following 2 drugs:

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Drug interactions

Moderate drug interactions

Moderate:

hyoscyamine mitotane

Applies to: Gastrosed (hyoscyamine) and mitotane
Monitor

Coadministration with alcohol or other central nervous system (CNS) depressants may enhance the sedative effects of mitotane and increase the likelihood and/or severity of central nervous system (CNS) side effects. In clinical studies and post marketing reports, CNS side effects occurred in 40% of patients, primarily consisting of depression as manifested by lethargy and somnolence (25%), and dizziness or vertigo (15%). Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of severe neurologic toxicity. Clinical data are not available for the concomitant use of mitotane with other CNS depressants.

Management

Caution and clinical monitoring for increased CNS adverse effects is advised if mitotane is coadministered with alcohol, other CNS depressants, or agents that cause dizziness or vertigo. Patients should not drive, operate machinery, or engage in hazardous activities requiring mental alertness and motor coordination until they know how the medications affect them. In addition, more frequent monitoring of serum mitotane levels may be considered.

References (3)
  1. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma America
  2. (2023) "Product Information. Lysodren (mitotane)." Medunik Canada
  3. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma UK & Ireland Ltd

Food/lifestyle interactions

Moderate food/lifestyle interactions

Moderate:

mitotane Food/Lifestyle

Applies to: mitotane
Adjust dosing interval

Fat-rich food enhances the absorption of mitotane. One study evaluated blood levels of mitotane (o,p'-DDD) after subjects ingested a single dose of 2 g administered using various delivery vehicles (e.g., tablets, granules, milk, chocolate or oil emulsion). Mitotane plasma levels were significantly higher for milk, chocolate, and oil emulsion when compared to those who received tablets or granules alone. In the same study, mitotane levels were evaluated in subjects following long-term treatment (total dose of 200 g over 30 to 60 days) in tablet, oil emulsion, or milk formulations. Significantly higher mean plasma levels were recorded in subjects who received mitotane as an oil emulsion or mixed in milk, when compared to tablets alone. Additionally, the recovery of o,p'-DDD from the feces was about 5 times higher in subjects who received tablets alone, suggesting absorption was reduced when compared to subjects who received mitotane mixed with a fat-rich vehicle (e.g., oil emulsion or milk).

Generally avoid

Concomitant use of mitotane with central nervous system (CNS) depressants, including alcohol, may potentiate adverse effects such as somnolence and sedation.

Management

According to product labeling, mitotane tablets should be taken during meals containing fat-rich food (e.g., milk, chocolate, or oil) and with a full glass of water. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them.

References (4)
  1. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma America
  2. (2023) "Product Information. Lysodren (mitotane)." Medunik Canada
  3. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma UK & Ireland Ltd
  4. Moolenaar AJ, van Slooten H, van Seters AP, Smeenk D (2023) Blood levels of o,p-DDD following administration in various vehicles after a single dose and during long-term treatment https://link.springer.com/article/10.1007/BF00258213
Moderate:

hyoscyamine Alcohol (Ethanol)

Applies to: Gastrosed (hyoscyamine)
Generally avoid

Use of anticholinergic agents with alcohol may result in sufficient impairment of attention so as to render driving and operating machinery more hazardous. In addition, the potential for abuse may be increased with the combination. The mechanism of interaction is not established but may involve additive depressant effects on the central nervous system. No effect of oral propantheline or atropine on blood alcohol levels was observed in healthy volunteers when administered before ingestion of a standard ethanol load. However, one study found impairment of attention in subjects given atropine 0.5 mg or glycopyrrolate 1 mg in combination with alcohol.

Management

Alcohol should generally be avoided during therapy with anticholinergic agents. Patients should be counseled to avoid activities requiring mental alertness until they know how these agents affect them.

References (1)
  1. Linnoila M (1973) "Drug effects on psychomotor skills related to driving: interaction of atropine, glycopyrrhonium and alcohol." Eur J Clin Pharmacol, 6, p. 107-12

Disease interactions

27 potential interactions Applies to: 25 conditions, including High Blood Pressure, Depression, GERD, Asthma, and Diarrhea.

Arrhythmia

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Arrhythmia.

Anticholinergics block vagal inhibition of the SA nodal pacemaker. Therapy with anticholinergics should be administered cautiously in patients with tachycardia, congestive heart failure, or coronary artery disease. Premature ventricular depolarization or ventricular tachycardia or fibrillation associated with anticholinergics is rare.

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Arrhythmia.

Antimuscarinic agents block vagal inhibition of the SA nodal pacemaker. These agents should be administered cautiously in patients with tachycardia, congestive heart failure, or coronary artery disease. Premature ventricular depolarization or ventricular tachycardia or fibrillation associated with antimuscarinic drugs is rare.

Asthma

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Asthma.

The use of systemic anticholinergics is contraindicated in the treatment of lower respiratory tract symptoms including asthma. Muscarinic receptor antagonists reduce bronchial secretions, which can result in decreased fluidity and increased thickening of secretions. However, ipratropium does not produce these effects and can be used safely in treating asthma.

Autonomic Neuropathy

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Autonomic Neuropathy.

Agents with anticholinergic activity can exacerbate many of the manifestations of autonomic neuropathy, including tachycardia, anhidrosis, bladder atony, obstipation, dry mouth and eyes, cycloplegia and blurring of vision, and sexual impotence in males. Therapy with antimuscarinic agents and higher dosages of antispasmodic agents (e.g., dicyclomine or oxybutynin) should be administered cautiously in patients with autonomic neuropathy.

Bleeding Disorder

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Bleeding Disorder.

Antimuscarinic agents may cause a delay in gastric emptying and possibly antral stasis in patients with gastric ulcer. Therapy with antimuscarinic agents should be administered cautiously to patients with gastric ulcer.

Cardiovascular Conditions and Disorders

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Cardiovascular Conditions and Disorders.

Anticholinergics block vagal inhibition of the SA nodal pacemaker. Therapy with anticholinergics should be administered cautiously to patients with tachycardia, congestive heart failure, or coronary artery disease. Premature ventricular depolarization, ventricular tachycardia, and fibrillation associated with anticholinergics are rare.

Depression

Moderate:

mitotane

Mitotane has a moderate potential interaction with Depression.

Symptoms of depression consisting of lethargy and somnolence have been reported during mitotane therapy. Therapy with mitotane should be administered cautiously to patients with or predisposed to depression. Clinical monitoring of psychological behavior is recommended.

Diarrhea

Minor:

Gastrosed

The hyoscyamine in Gastrosed has a minor potential interaction with Diarrhea.

Diarrhea may be a symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Antimuscarinic agents may further aggravate the diarrhea. Therefore, these drugs should be administered cautiously in patients with diarrhea.

Esophageal Obstruction

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Esophageal Obstruction.

Anticholinergics are contraindicated in patients with obstructive diseases such as achalasia, esophageal stricture or stenosis, pyloroduodenal stenosis, stenosing peptic ulcer, pyloric obstruction, and paralytic ileus. Anticholinergics may further suppress intestinal motility with resultant precipitation or aggravation of toxic megacolon.

Fever

Minor:

Gastrosed

The hyoscyamine in Gastrosed has a minor potential interaction with Fever.

Atropine-like agents may increase the risk of hyperthermia in patients with fever by producing anhidrosis. Therapy with atropine-like agents should be administered cautiously in febrile patients.

Gastrointestinal Obstruction

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Gastrointestinal Obstruction.

Anticholinergics are contraindicated in patients with obstructive diseases such as achalasia, esophageal stricture or stenosis, pyloroduodenal stenosis, stenosing peptic ulcer, pyloric obstruction, and paralytic ileus. Anticholinergics may further suppress intestinal motility with resultant precipitation or aggravation of toxic megacolon.

GERD

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with GERD.

Antimuscarinic agents decrease gastric motility and relax the lower esophageal sphincter which promotes gastric retention and can aggravate reflux. These drugs should be administered cautiously in patients with gastroesophageal reflux or hiatal hernia associated with reflux esophagitis.

Glaucoma/Intraocular Hypertension

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Glaucoma/Intraocular Hypertension.

Anticholinergic agents are contraindicated in patients with primary glaucoma, a tendency toward glaucoma (narrow anterior chamber angle), or adhesions (synechiae) between the iris and lens, as well as for the elderly and others in whom undiagnosed glaucoma or excessive pressure in the eye may be present. Because anticholinergics cause mydriasis, they may exacerbate these conditions.

High Blood Pressure

Minor:

Gastrosed

The hyoscyamine in Gastrosed has a minor potential interaction with High Blood Pressure.

Cardiovascular effects of anticholinergics may exacerbate hypertension. Therapy with anticholinergic agents should be administered cautiously in patients with hypertension.

Hyperthyroidism

Minor:

Gastrosed

The hyoscyamine in Gastrosed has a minor potential interaction with Hyperthyroidism.

In general, agents with anticholinergic activity may exacerbate hyperthyroidism. Therapy with anticholinergics should be administered cautiously in patients with hyperthyroidism. Thyroid levels should be monitored if usage is prolonged.

Infection

Major:

mitotane

Mitotane has a major potential interaction with Infection.

Mitotane inhibits production of corticosteroids and alters extra-adrenal metabolism of endogenous and exogenous steroids. All patients treated with mitotane should be instructed to immediately report signs and symptoms of infection or other illnesses. Therapy with mitotane should be withheld immediately following shock or severe trauma or infection. Exogenous steroids should be administered since the suppressed adrenal may not immediately begin to secrete steroids.

Infectious Gastroenteritis

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Infectious Gastroenteritis.

The use of drugs with antiperistaltic activity (primarily antidiarrheal and antimuscarinic agents, but also antispasmodic agents such as dicyclomine or oxybutynin at high dosages) is contraindicated in patients with diarrhea due to pseudomembranous enterocolitis or enterotoxin-producing bacteria. These drugs may prolong and/or worsen diarrhea associated with organisms that invade the intestinal mucosa, such as toxigenic E. coli, Salmonella and Shigella, and pseudomembranous colitis due to broad-spectrum antibiotics. Other symptoms and complications such as fever, shedding of organisms and extraintestinal illness may also be increased or prolonged. In general, because antiperistaltic agents decrease gastrointestinal motility, they may delay the excretion of infective gastroenteric organisms or toxins and should be used cautiously in patients with any infectious diarrhea, particularly if accompanied by high fever or pus or blood in the stool. Some cough and cold and other combination products may occasionally include antimuscarinic agents for their drying effects and may, therefore, require careful selection when necessary.

Ischemic Heart Disease

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Ischemic Heart Disease.

Antimuscarinic agents block vagal inhibition of the SA nodal pacemaker. These agents should be administered cautiously in patients with tachycardia, congestive heart failure, or coronary artery disease. Premature ventricular depolarization or ventricular tachycardia or fibrillation associated with antimuscarinic drugs is rare.

Liver Disease

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Liver Disease.

Atropine-like agents undergo significant hepatic metabolism. Therapy with atropine-like agents should be administered cautiously to patients with liver disease.

Moderate:

mitotane

Mitotane has a moderate potential interaction with Liver Disease.

Mitotane is primarily metabolized by the liver. Metabolism and therapeutic activity may be altered in patients with hepatic impairment. Therapy with mitotane should be administered cautiously in patients with hepatic impairment. Clinical monitoring of hepatic function is recommended.

Menopause

Moderate:

mitotane

Mitotane has a moderate potential interaction with Menopause.

Ovarian macrocysts, often bilateral and multiple, have been reported in premenopausal patients receiving mitotane which might lead to adnexal torsion and hemorrhagic cyst rupture. It is recommended to use care when using this agent in premenopausal patients and to seek medical care if they experience gynecological symptoms such as vaginal bleeding and/or pelvic pain.

Myasthenia Gravis

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Myasthenia Gravis.

Because antimuscarinic agents have anticholinergic effects, they are contraindicated in patients with myasthenia gravis. Their use may be appropriate to reduce adverse muscarinic effects caused by an anticholinesterase agent.

Neurological Disorders

Moderate:

mitotane

Mitotane has a moderate potential interaction with Neurological Disorders.

Unspecified brain damage and impairment of function have been reported during prolonged mitotane therapy. Therapy with mitotane should be administered cautiously to patients with neurologic impairment. Clinical monitoring of behavior and neurological function is recommended when continuous mitotane therapy exceeds two years.

Renal Dysfunction

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Renal Dysfunction.

Atropine-like agents are primarily eliminated by the kidney. Therapy with atropine-like agents should be administered cautiously to patients with renal disease.

Shock

Major:

mitotane

Mitotane has a major potential interaction with Shock.

Mitotane inhibits production of corticosteroids and alters extra-adrenal metabolism of endogenous and exogenous steroids. All patients treated with mitotane should be instructed to immediately report signs and symptoms of infection or other illnesses. Therapy with mitotane should be withheld immediately following shock or severe trauma or infection. Exogenous steroids should be administered since the suppressed adrenal may not immediately begin to secrete steroids.

Ulcerative Colitis

Moderate:

Gastrosed

The hyoscyamine in Gastrosed has a moderate potential interaction with Ulcerative Colitis.

Antimuscarinic agents may suppress intestinal motility and produce paralytic ileus with resultant precipitation of toxic megacolon. These drugs should be administered cautiously to patients with ulcerative colitis.

Urinary Retention

Major:

Gastrosed

The hyoscyamine in Gastrosed has a major potential interaction with Urinary Retention.

In general, the use of anticholinergic agents is contraindicated in patients with urinary retention and bladder neck obstruction caused by prostatic hypertrophy. Dysuria may occur and may require catheterization. Also, anticholinergic drugs may aggravate partial obstructive uropathy. Caution is advised even when using agents with mild to moderate anticholinergic activity, particularly in elderly patients.

More resources

Gastrosed

A total of 223 drugs are known to interact with Gastrosed.

mitotane

A total of 661 drugs are known to interact with mitotane.

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.