"The US Food and Drug Administration (FDA) is investigating the "rare but serious" risk for slowed or difficult breathing in children 17 and younger treated with the opioid analgesic tramadol.
"This risk may be increased in children tr"...
(Glycopyrrolate) Injection, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
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:
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 (24°C).
What are the possible side effects of glycopyrrolate (Cuvposa, Robinul, Robinul Forte)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using glycopyrrolate and call your doctor at once if you have a serious side effect such as:
- severe constipation, severe stomach pain and bloating;
- diarrhea (especially if you have a colostomy or ileostomy);
- feeling like you might pass out;
- feeling very thirsty or hot, being unable to urinate, heavy sweating, weak pulse, or hot and dry skin; or
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: personal or family history of glaucoma (angle-closure type), 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...
Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Robinul Information
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