Drug information of glycopyrrolate topical

glycopyrrolate topical

Drug group:

Glycopyrrolate topical (glycopyrronium cloth) is used on underarm skin to treat excessive sweating (hyperhidrosis) in adults and children who are at least 9 years old.

Mechanism of effect

Competitive inhibitor of acetylcholine receptors located on certain peripheral tissues, including sweat glands; reduces sweating by inhibiting the action of acetylcholine on sweat glands.

Pharmacokinetics

Absorption

Topical: No evidence of accumulation after repeated daily dosing for 5 days.

Excretion

IV: Urine: ~85% (>80% as unchanged drug); bile: <5% (>80% as unchanged drug)

Time to Peak

Topical: 1 to 1.5 hours

Drug indications

Primary axillary hyperhidrosis: For topical treatment of primary axillary hyperhidrosis in adult and pediatric patients ≥9 years.

Dosage

Usual Adult Dose for Hyperhidrosis

Use one cloth to wipe the entire underarm once, use the same cloth to wipe the other entire underarm once
Maximum frequency: Once every 24 hours

Usual Pediatric Dose for Hyperhidrosis

Dosing: Pediatric

Hyperhidrosis, primary axillary: Children ≥9 years and Adolescents: Topical: Apply once daily to clean dry skin on the underarm areas only; do not use more often than every 24 hours.

Drug contraindications

Medical conditions that can be exacerbated by the anticholinergic effect of glycopyrronium (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome)

Side effects

Side effects requiring immediate medical attention

Along with its needed effects, glycopyrronium topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking glycopyrronium topical:

Less common

  • Blurred vision
  • trouble in urinating

Side effects not requiring immediate medical attention

Some side effects of glycopyrronium topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • dry mouth
  • fever
  • headache
  • increased sensitivity of the eyes to light
  • muscle aches
  • pain in the mouth or throat
  • redness, burning, stinging, or itching of the skin
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness

Less common

  • Constipation
  • dry eye
  • dry skin
  • dry throat
  • nasal dryness

acetylcholine ophthalmic ,clidinium  , demecarium bromide ophthalmic ,  doxepin topical ,ipratropium nasal , isoflurophate ophthalmic ,umeclidinium ,revefenacin

Alerts

You should not use glycopyrrolate topical if you have:
-ulcerative colitis or other serious bowel problems;
- glaucoma;
- myasthenia gravis; or
- Sjogren's syndrome.

Tell your doctor if you have ever had:
- bladder obstruction or other urination problems,
- kidney disease; or
- an enlarged prostate.

Tell your doctor if you are pregnant or breast-feeding.

Concerns related to adverse effects:

  • Heat illness: May occur in the presence of increased environmental temperature; advise patients to avoid use if not sweating in hot or very warm environmental temperatures.
  • Visual disturbances: May cause transient blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

  • Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction; discontinue therapy if indicated.

Concurrent drug therapy issues:

  • Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Points of recommendation

- Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

- Apply only to clean, dry underarm skin. Do not use on open wounds or broken skin.

- Do not cover treated skin with a bandage or with plastic.

- Use a single glycopyrrolate topical cloth on both underarms once every 24 hours. Then throw the cloth away.

- Wash your hands after handling a glycopyrrolate topical cloth. Any medicine left on your hands could cause blurred vision if you later touch your eyes.

- Store at room temperature away from moisture and heat.

- Keep each cloth in the sealed pouch until it is time for you to apply the medicine.

- Glycopyrrolate cloths are flammable. Do not use near high heat or open flame.

- Avoid becoming overheated or dehydrated during exercise and in hot weather. - - - Glycopyrrolate topical decreases sweating, and you may be more prone to heat stroke.

- glycopyrrolate topical may cause blurred vision and may impair your reactions. - - - Avoid driving or hazardous activity until you know how this medicine will affect you.

- Avoid getting this medicine in your eyes.

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), Protect from heat or flame.

Pregnancy level

HAVE NOT BEEN ESTABLISHED

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:

-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

-The available animal data does not support relevant comparisons of those systemic exposures to human exposure after topical use.

Breast feeding warning

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown

Excreted into animal milk: Data not available

Drug forms

Qbrexza

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