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 Forte tablets are contraindicated in those patients with a hypersensitivity to Robinul Forte.
WARNINGS
In the presence of a high environmental temperature, heat prostration can occur with use of Robinul Forte.
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 Forte 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 Forte; 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 Forte. 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.
PRECAUTIONS
Use Robinul Forte 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 Forte 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.
OVERDOSAGE
The symptoms of overdosage of Robinul Forte 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 Forte 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 Forte is 8 mg.
Robinul Forte Tablets 1 mg. The recommended initial dosage of Robinul Forte 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 Forte Tablets 2 mg. The recommended dosage of Robinul Forte for adults is one tablet two or three times daily at equally spaced intervals.
Robinul Forte tablets are not recommended for use in pediatric patients under the age of 12 years.
DRUG INTERACTIONS
There are no known drug interactions.
HOW SUPPLIED
Robinul Forte 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 Forte 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 Forte 2mg Tablet
Robinul Forte pharmaceutical active ingredients containing related brand and generic drugs:
Can i drive or operate heavy machine after consuming Robinul Forte?
Depending on the reaction of the Robinul Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Robinul Forte 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 Forte 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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