What happens if I overdose Dicicloverina [Inn-Spanish]?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include convulsions (seizures); difficulty breathing; dilated pupils; disorientation; excessive thirst; flushed, hot, dry skin; hallucinations or unusual behavior; muscle weakness; nausea; rapid heartbeat and breathing; restlessness; severe dizziness or drowsiness; severe dry mouth; vomiting.
Proper storage of Dicicloverina [Inn-Spanish] syrup:
Store at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dicicloverina [Inn-Spanish] syrup out of the reach of children and away from pets.
Overdose of Dicicloverina [Inn-Spanish] in details
In case of an overdose, patients should contact a physician, poison control centre (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 Dicicloverina [Inn-Spanish].
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 Dicicloverina [Inn-Spanish] hydrochloride, the blood concentrations of drug were 200, 220, and 505 ng/mL.
It is not know if Dicicloverina [Inn-Spanish] 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.
What should I avoid while taking Dicicloverina [Inn-Spanish]?
This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Dicicloverina [Inn-Spanish] can cause decreased sweating, which can lead to heat stroke in a hot environment.
Drinking alcohol can increase certain side effects of Dicicloverina [Inn-Spanish].
Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb Dicicloverina [Inn-Spanish].
Dicicloverina [Inn-Spanish] warnings
In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and supportive measures instituted.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
Dicicloverina [Inn-Spanish] hydrochloride oral solution may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.
Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.
These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.
There are reports that administration of Dicicloverina [Inn-Spanish] hydrochloride oral solution to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma. Death has been reported. No causal relationship between these effects observed in infants and Dicicloverina [Inn-Spanish] administration has been established. Dicicloverina [Inn-Spanish] HYDROCHLORIDE ORAL SOLUTION IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS..
Safety and efficacy of Dicicloverina [Inn-Spanish] hydrochloride in pediatric patients have not been established.
What should I discuss with my healthcare provider before taking Dicicloverina [Inn-Spanish]?
Some medical conditions may interact with Dicicloverina [Inn-Spanish] syrup. 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 chronic inflammation or ulcers of the bowel, diarrhea, enlargement of the prostate, hiatal hernia, kidney or liver disease, nerve problems or disease, overactive thyroid, or urinary blockage or retention
- if you have heart disease, heart failure, a history of rapid or irregular heartbeat, or high blood pressure
- if you are at risk for glaucoma
Some MEDICINES MAY INTERACT with Dicicloverina [Inn-Spanish] syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amantadine, antiarrhythmics (eg, quinidine), antihistamines (eg, diphenhydramine), benzodiazepines (eg, diazepam), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic pain medicine (eg, meperidine), nitrates (eg, nitroglycerin, isosorbide), nitrites (eg, sodium nitrite), phenothiazines (eg, chlorpromazine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Dicicloverina [Inn-Spanish] syrup's side effects
- Metoclopramide or phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased by Dicicloverina [Inn-Spanish] syrup
- Digoxin because the risk of its side effects may be increased by Dicicloverina [Inn-Spanish] syrup
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dicicloverina [Inn-Spanish] syrup 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.
Dicicloverina [Inn-Spanish] precautions
Inadvertent
Intravenous Administration
Dicicloverina [Inn-Spanish] 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.
Cardiovascular Conditions
Dicicloverina [Inn-Spanish] 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 Dicicloverina [Inn-Spanish] hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension.
Peripheral And Central Nervous System
The peripheral effects of Dicicloverina [Inn-Spanish] 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.
In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy.
Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.
Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.
Dicicloverina [Inn-Spanish] may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking Dicicloverina [Inn-Spanish].
Myasthenia Gravis
With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase
Intestinal Obstruction
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
Rarely development of Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. Ogilvie's syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction
Toxic Dilatation Of Intestinemegacolon
Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.
Ulcerative Colitis
Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon. Dicicloverina [Inn-Spanish] is contraindicated in patients with severe ulcerative colitis.
Prostatic Hypertrophy
Dicicloverina [Inn-Spanish] should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention
Hepatic And Renal Disease
Dicicloverina [Inn-Spanish] should be used with caution in patients with known hepatic and renal impairment.
Geriatric Population
Dicicloverina [Inn-Spanish] hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been conducted to evaluate the carcinogenic potential of Dicicloverina [Inn-Spanish]. In studies in rats at doses of up to 100 mg/kg/day, Dicicloverina [Inn-Spanish] produced no deleterious effects on breeding, conception, or parturition.
Use In Specific Populations
Pregnancy
Pregnancy Category B
Adequate and well-controlled studies have not been conducted with Dicicloverina [Inn-Spanish] in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations amoung babies born to women who took products containing Dicicloverina [Inn-Spanish] hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.
Reproduction studies have been performed in rats and rabbits at doses of up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to Dicicloverina [Inn-Spanish]. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Dicicloverina [Inn-Spanish] is contraindicated in women who are breastfeeding. Dicicloverina [Inn-Spanish] hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from Dicicloverina [Inn-Spanish], a decision should be made whether to discontine nursing or to discontinue the drug, taking into account the importance of the drug to the mother..
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Dicicloverina [Inn-Spanish] is contraindicated in infants less than 6 months of age. There are published cases reporting that the administration of Dicicloverina [Inn-Spanish] hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.
Geriatric Use
Clinical studies of Dicicloverina [Inn-Spanish] did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Renal Impairment
Effects of renal impairment on PK, safety and efficacy of Dicicloverina [Inn-Spanish] have not been studied. Dicicloverina [Inn-Spanish] drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicicloverina [Inn-Spanish] should be administered with caution in patients with renal impairment.
Hepatic Impairment
Effects of renal impairment on PK, safety and efficacy of Dicicloverina [Inn-Spanish] have not been studied. Dicicloverina [Inn-Spanish] should be administered with caution in patients with hepatic impairment.
What happens if I miss a dose of Dicicloverina [Inn-Spanish]?
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. "dicyclomine". http://www.drugbank.ca/drugs/DB00804 (accessed September 17, 2018).
- MeSH. "Parasympatholytics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
