Robinul Forte

Name: Robinul Forte

What is Robinul Forte (glycopyrrolate)?

Glycopyrrolate reduces the secretions of certain organs in the body.

Glycopyrrolate helps to control conditions such as peptic ulcers that involve excessive stomach acid production.

Glycopyrrolate is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

Glycopyrrolate may also be used for purposes not listed in this medication guide.

Before Using Robinul Forte

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glycopyrrolate in children 3 to 16 years of age. However, safety and efficacy have not been established in children younger than 3 years of age.

Geriatric

No information is available on whether the risk of glycopyrrolate-induced adverse effects are increased in the elderly; however, it should be used with caution because elderly patients are more likely to have age related liver disease, kidney disease, heart disease, or prostate problems. This may require a dosage adjustment or careful monitoring in elderly patients receiving glycopyrrolate.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Potassium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion
  • Donepezil
  • Tiotropium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Colostomy (bowel surgical procedure) or
  • Congestive heart failure or
  • Heart disease or
  • Heart rhythm problems or
  • Hiatal hernia with gastroesophageal reflux disease (GERD) or
  • Hypertension (high blood pressure) or
  • Hyperthyroidism (overactive thyroid) or
  • Ileostomy (bowel surgical procedure) or
  • Liver disease or
  • Nerve problems (e.g., neuropathy) or
  • Prostatic hypertrophy (enlarged prostate) or
  • Ulcerative colitis—Use with caution. May make these conditions worse.
  • Glaucoma or
  • Myasthenia gravis (severe muscle weakness) or
  • Obstructive uropathy (urinary blockage due to enlarged prostate or other condition) or
  • Paralytic ileus (bowel blockage) or
  • Stomach or intestinal problems (e.g., ulcerative colitis, toxic megacolon, bowel obstruction), severe or
  • Trouble urinating—Should not be used in patients with these conditions.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

What do I need to tell my doctor BEFORE I take Robinul Forte?

  • If you have an allergy to Robinul Forte (glycopyrrolate tablets) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Heart problems due to bleeding, enlarged colon, glaucoma, bowel block, myasthenia gravis, slow-moving GI (gastrointestinal) tract, ulcerative colitis, or trouble passing urine.
  • If you are taking potassium tablets.

This is not a list of all drugs or health problems that interact with Robinul Forte.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Robinul Forte) best taken?

Use Robinul Forte as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Robinul Forte, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Robinul Forte (glycopyrrolate tablets). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Robinul Forte.

Review Date: October 4, 2017

For Healthcare Professionals

Applies to glycopyrrolate: inhalation capsule, injectable solution, oral solution, oral tablet

Nervous system

Nervous system side effects have included headache, nervousness, drowsiness, dizziness, insomnia, and mental confusion. The elderly appear to be more prone to the anticholinergic effects of glycopyrrolate (the active ingredient contained in Robinul Forte) on the CNS. Seizures have been reported from postmarketing experience.[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia and palpitations. In addition, cardiac arrhythmias, cardiac arrest, hypertension, and hypotension have been reported from postmarketing experience.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, vomiting, constipation, and feeling bloated.[Ref]

Genitourinary

Genitourinary side effects have included urinary hesitancy, urinary retention, and impotence.[Ref]

Ocular

Ocular side effects have included blurred vision, increased ocular tension, cycloplegia, and dilatation of the pupil.[Ref]

Endocrine

Endocrine side effects have included suppression of lactation.[Ref]

Dermatologic

Dermatologic side effects have included dry mucous membranes and decreased sweating.[Ref]

General

General side effects have included weakness, hyperpyrexia, and a loss of taste.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria and other dermal manifestations.[Ref]

Immunologic

Immunologic side effects have included anaphylaxis.[Ref]

Local

Local side effects have included pruritus, edema, erythema, and pain at the injection site.[Ref]

Respiratory

Respiratory side effects have included nasal congestion, nasal dryness, and sinusitis.[Ref]

Some side effects of Robinul Forte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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