Robinul

DRUG DESCRIPTION

Robinul (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:


Glycopyrrolate, USP 0.2 mg
Water for Injection, USP q.s.
Benzyl Alcohol, NF 0.9% (preservative)
pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.

For Intramuscular (IM) or Intravenous (IV) administration.

Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formulas is C19H28BrNO3 and the molecular weight is 398.33.

Its structural formula is as follows:

Robinul (glycopyrrolate)  structural formula illustration

Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.

Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Robinul (glycopyrrolate) Injection is a clear, colorless, sterile liquid; pH 2.0 - 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24C).

What are the possible side effects of glycopyrrolate (Robinul, Robinul Forte)?

If you experience any of the following serious side effects, stop taking glycopyrrolate and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular or fast heart rate;
  • rash or flushing; or
  • eye pain.

Other, less serious side effects may be more likely to occur. Continue to take glycopyrrolate and talk to your doctor if you experience

    ...

Read All Potential Side Effects and See Pictures of Robinul

What are the precautions when taking glycopyrrolate (Robinul)?

Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due to severe bleeding), high blood pressure, heartburn...

Read All Potential Precautions of Robinul


Robinul Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, weakness, blurred vision, dry eyes, dry mouth, constipation, or abdominal bloating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), eye pain, vision changes, difficulty urinating, decreased sexual ability.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due to severe bleeding), high blood pressure, heartburn problems (such as acid reflux, hiatal hernia, esophagus problems), certain nervous system problem (autonomic neuropathy), myasthenia gravis, liver problems, kidney problems.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you sweat less which can increase your risk for heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids, and dress lightly while in hot weather or when exercising. If you become overheated, stop exercising and promptly seek cooler shelter. Seek immediate medical attention if you develop a fever, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, constipation, and urination problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Robinul Patient Information Including Side Effects

Brand Names: Robinul, Robinul Forte

Generic Name: glycopyrrolate (Pronunciation: glye koe PIE roe late)

  • What is glycopyrrolate (Robinul)?
  • What are the possible side effects of glycopyrrolate (Robinul)?
  • What is the most important information I should know about glycopyrrolate (Robinul)?
  • Who should not take glycopyrrolate (Robinul)?
  • How should I take glycopyrrolate (Robinul)?
  • What happens if I miss a dose (Robinul)?
  • What happens if I overdose (Robinul)?
  • What should I avoid while taking glycopyrrolate (Robinul)?
  • What other drugs will affect glycopyrrolate (Robinul)?
  • Where can I get more information?

What is glycopyrrolate (Robinul)?

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.

The injectable form of glycopyrrolate is also used to reduce saliva, nasal, lung, and stomach secretions and to help control heart rate during surgery.

Glycopyrrolate may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of glycopyrrolate (Robinul)?

If you experience any of the following serious side effects, stop taking glycopyrrolate and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular or fast heart rate;
  • rash or flushing; or
  • eye pain.

Other, less serious side effects may be more likely to occur. Continue to take glycopyrrolate and talk to your doctor if you experience

  • headache, dizziness, or lightheadedness;
  • weakness or nervousness;
  • blurred vision, large pupils, or sensitivity of the eyes to bright light;
  • nausea, bloating, heartburn, or constipation;
  • changes in taste;
  • difficulty urinating;
  • decreased sweating; or
  • nasal congestion, stuffiness, or a dry mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about glycopyrrolate (Robinul)?

Use caution when driving, operating machinery, or performing other hazardous activities. Glycopyrrolate may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking glycopyrrolate.

Avoid becoming overheated in hot weather. Glycopyrrolate increases the risk of heat stroke because it causes decreased sweating.

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