What happens if I overdose Entrocalm?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include decreased urination; nausea; severe constipation or drowsiness; vomiting.
Proper storage of Entrocalm:
Store Entrocalm at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Entrocalm out of the reach of children and away from pets.
Overdose of Entrocalm in details
In cases of overdosage, (including relative overdose due to hepatic dysfunction), urinary retention, paralytic ileus and CNS depression may occur. Children may be more sensitive to CNS effects than adults. Clinical trials have demonstrated that a slurry of activated charcoal administered promptly after ingestion of Entrocalm can reduce the amount of drug which is absorbed into the systemic circulation by as much as ninefold. If vomiting occurs spontaneously upon ingestion, a slurry of 100 grams of activated charcoal should be administered orally as soon as fluids can be retained.
If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 grams of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours.
If symptoms of overdose occur, naloxone can be given as an antidote. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone.
In view of the prolonged action of Entrocalm and the short duration (one to three hours) of naloxone, the patient must be monitored closely and treated repeatedly with naloxone as indicated. Since relatively little drug is excreted in the urine, forced diuresis is not expected to be effective for Entrocalm overdosage.
In clinical trials an adult who took three 20 mg doses within a 24 hour period was nauseated after the second dose and vomited after the third dose. In studies designed to examine the potential for side effects, intentional ingestion of up to 60 mg of Entrocalm in a single dose to healthy subjects resulted in no significant adverse effects.
What should I avoid while taking Entrocalm?
Entrocalm may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you are taking an antibiotic and you have diarrhea that is watery or has blood in it, call your doctor. Do not use Entrocalm to stop the diarrhea unless your doctor has told you to.
Entrocalm warnings
General
Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported. In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of (Entrocalm) should be discontinued and patients should be advised to consult their physician. Although no pharmacokinetic data are available in patients with hepatic impairment, (Entrocalm) should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity. No pharmacokinetic data are available in patients with renal impairment. Since it has been reported that the majority of the drug is metabolized and metabolites or the unchanged drug is excreted mainly in the feces, dosage adjustments in patients with renal impairment are not required. No formal studies have been conducted to evaluate the pharmacokinetics of Entrocalm in elderly subjects. However, in two studies that enrolled elderly patients, there were no major differences in the drug disposition in elderly patients with diarrhea relative to young patients.
Carcinogenesis, mutagenesis, impairment of fertility
In an 18-month rat study with oral doses up to 40 mg/kg/day (21 times the maximum human dose of 16 mg/day, based on a body surface area comparison), there was no evidence of carcinogenesis.
Entrocalm was not genotoxic in the Ames test, the SOS chromotest in E. coli, the dominant lethal test in female mice, or the mouse embryo cell transformation assay.
Fertility and reproductive performance was evaluated in rats using oral doses of 2.5, 10, and 40 mg/kg/day in one study, and 1, 5, 10, 20, and 40 mg/kg/day (females only) in a second study.
Oral administration of 20 mg/kg/day (approximately 11 times the human dose based on a body surface area comparison) and higher produced strong impairment of female fertility. Treatment of female rats with up to 10 mg/kg/day p.o. (approximately 5 times the human dose based on a body surface area comparison) had no effect on fertility. Treatment of male rats with 40 mg/kg/day p.o. (approximately 21 times the human dose based on a body surface area comparison) produced impairment of male fertility, whereas administration of up to 10 mg/kg/day (approximately 5 times the human dose based on a body surface area comparison) had no effect.
Pregnancy
Teratogenic Effects Pregnancy Category C
Teratology studies have been performed in rats using oral doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with 40 mg/kg/day p.o. (21 times the human dose based on a body surface area comparison) produced marked impairment of fertility. The studies produced no evidence of teratogenic activity. There are no adequate and well-controlled studies in pregnant women. Entrocalm should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Non-teratogenic Effects
In a peri- and post-natal reproduction study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.
Nursing Mothers
Small amounts of Entrocalm may appear in human breast milk. Therefore, (Entrocalm) is not recommended during breast-feeding.
Pediatric Use
See the "WARNINGS" Section for information on the greater variability of response in this age group.
What should I discuss with my healthcare provider before taking Entrocalm?
Some medical conditions may interact with Entrocalm. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have bloody diarrhea; mucus in your stool; fever; bowel problems (eg, inflammation, blockage, enlarged colon); or diarrhea caused by food poisoning, antibiotic use, or bacterial infection.
- if you have AIDS or liver problems
- if you are taking an antibiotic
Some MEDICINES MAY INTERACT with Entrocalm. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Disulfiram, furazolidone, or metronidazole because a severe reaction, including nausea, vomiting, flushing, and fast or irregular heartbeat, may occur
- Quinidine or ritonavir because they may increase the risk of Entrocalm's side effects
- Saquinavir because its effectiveness may be decreased by Entrocalm
This may not be a complete list of all interactions that may occur. Ask your health care provider if Entrocalm may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Entrocalm precautions
General
Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported. In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of Entrocalm should be discontinued and patients should be advised to consult their physician. Although no pharmacokinetic data are available in patients with hepatic impairment, Entrocalm should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity. No pharmacokinetic data are available in patients with renal impairment. Since it has been reported that the majority of the drug is metabolized and metabolites or the unchanged drug is excreted mainly in the feces, dosage adjustments in patients with renal impairment are not required. No formal studies have been conducted to evaluate the pharmacokinetics of Entrocalm in elderly subjects. However, in two studies that enrolled elderly patients, there were no major differences in the drug disposition in elderly patients with diarrhea relative to young patients.
Information for Patients
Patients should be advised to check with their physician if their diarrhea does not improve in 48 hours or if they note blood in their stools, develop a fever or develop abdominal distention.
Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with Entrocalm. Therefore, it is advisable to use caution when driving a car or operating machinery.
Drug Interactions
Nonclinical data have shown that Entrocalm is a P-glycoprotein substrate. Concomitant administration of Entrocalm (16 mg single dose) with a 600 mg single dose of either quinidine or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2 to 3 fold increase in Entrocalm plasma levels. Due to the potential for enhanced central effects when Entrocalm is coadministered with quinidine and with ritonavir, caution should be exercised when Entrocalm is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.
When a single 16 mg dose of Entrocalm is coadministered with a 600 mg single dose of saquinavir, Entrocalm decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on Entrocalm is of less clinical significance. Therefore, when Entrocalm is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In an 18 month rat study with oral doses up to 40 mg/kg/day (21 times the maximum human dose of 16 mg/day, based on a body surface area comparison), there was no evidence of carcinogenesis.
Entrocalm was not genotoxic in the Ames test, the SOS chromotest in E. coli, the dominant lethal test in female mice, or the mouse embryo cell transformation assay.
Fertility and reproductive performance was evaluated in rats using oral doses of 2.5, 10, and 40 mg/kg/day in one study, and 1, 5, 10, 20, and 40 mg/kg/day (females only) in a second study.
Oral administration of 20 mg/kg/day (approximately 11 times the human dose based on a body surface area comparison) and higher produced strong impairment of female fertility. Treatment of female rats with up to 10 mg/kg/day p.o. (approximately 5 times the human dose based on a body surface area comparison) had no effect on fertility. Treatment of male rats with 40 mg/kg/day p.o. (approximately 21 times the human dose based on a body surface area comparison) produced impairment of male fertility, whereas administration of up to 10 mg/kg/day (approximately 5 times the human dose based on a body surface area comparison) had no effect.
Pregnancy
Teratogenic EffectsPregnancy category C
Teratology studies have been performed in rats using oral doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with 40 mg/kg/day p.o. (21 times the human dose based on a body surface area comparison) produced marked impairment of fertility. The studies produced no evidence of teratogenic activity. There are no adequate and well-controlled studies in pregnant women. Entrocalm should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Non-teratogenic Effects
In a peri- and post-natal reproduction study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.
Nursing Mothers
Small amounts of Entrocalm may appear in human breast milk. Therefore, Entrocalm is not recommended during breast-feeding.
Pediatric Use
In case of accidental overdosage of Entrocalm by pediatric patients, see OVERDOSAGE section for suggested treatment.
What happens if I miss a dose of Entrocalm?
Since Entrocalm is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DrugBank. "loperamide". http://www.drugbank.ca/drugs/DB00836 (accessed September 17, 2018).
- MeSH. "Antidiarrheals". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
