For use as adjunctive therapy in the treatment of peptic ulcer.
CONTRAINDICATIONS
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Robinul tablets are contraindicated in those patients with a hypersensitivity to Robinul.
WARNINGS
In the presence of a high environmental temperature, heat prostration can occur with use of Robinul.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomyor colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
Robinul may produce drowsiness and blurred vision. In this event, 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.
Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.
Pregnancy
The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from Robinul; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of Robinul. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
Pediatric Use
Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.
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PRECAUTIONS
Use Robinul with caution in the elderly and in all patients with:
Autonomic neuropathy.
Hepatic or renal disease.
Ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate “toxic megacolon,” a serious complication of the disease.
Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.
ADVERSE REACTIONS
Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.
Robinul is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.
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OVERDOSAGE
The symptoms of overdosage of Robinul are peripheral in nature rather than central.
To guard against further absorption of the drug-use gastric lavage, cathartics and/or enemas.
To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.
To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.
To combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as Dopram®* i.v.; artificial respiration.
DOSAGE AND ADMINISTRATION
The dosage of Robinul should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of Robinul is 8 mg.
Robinul Tablets 1 mg. The recommended initial dosage of Robinul for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate.
Robinul Tablets 2 mg. The recommended dosage of Robinul for adults is one tablet two or three times daily at equally spaced intervals.
Robinul tablets are not recommended for use in pediatric patients under the age of 12 years.
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DRUG INTERACTIONS
There are no known drug interactions.
HOW SUPPLIED
Robinul tablets 1 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “400” below the bisect on one side of the tablet, and plain on the other side.
Available in bottles of 100 (NDC 49884-065-01).
Robinul tablets 2 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “401” below the bisect on one side of the tablet, and plain on the other side.
Available in bottles of 100 (NDC 49884-066-01).
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
Dispense in tight container.
Rx only
* Dopram® is a registered trademark of Baxter Healthcare Corporation.
Manufactured by:
Par Pharmaceutical Companies, Inc.
Spring Valley, NY 10977
Rev: 07/2010
OS065-01-1-02
Robinul 2mg Tablet
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Robinul pharmaceutical active ingredients containing related brand and generic drugs:
Can i drive or operate heavy machine after consuming Robinul?
Depending on the reaction of the Robinul after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Robinul not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Robinul addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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Review
sdrugs.com conducted a study on Robinul, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Robinul consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reports
Visitor reported useful
No survey data has been collected yet
Visitor reported side effects
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Visitor reported price estimates
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Visitor reported frequency of use
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One visitor reported doses
What is the dose of Robinul drug you are taking? According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors
%
1-5mg
1
100.0%
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