Dartisla ODT (Oral)

Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by some neurologic disorders (for example, cerebral palsy) in children aged 3 to 16 years. This medicine is an anticholinergic.

This medicine is available only with your doctor's prescription.

It is very important that your doctor or your child's doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check for unwanted effects.

You should not take potassium chloride tablets or other potassium supplements (in tablet or capsule forms) while using this medicine. Using these medicines together may cause delayed movement of the potassium supplement through the esophagus and stomach.

This medicine may cause constipation or diarrhea. Constipation or diarrhea can be an early symptom of a serious bowel problem. Check with your doctor if you or your child has constipation, diarrhea, stomach distention (swelling), pain, nausea, or vomiting.

Check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has irritability, crying, decrease in the frequency of urine, or difficult or painful urination.

If you or your child develops a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

This medicine may make you or your child sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may make you or your child dizzy, confused, drowsy, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be balanced against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of glycopyrrolate in children aged 3 to 16 years. However, safety and effectiveness have not been established in children younger than 3 years.

Studies have not been conducted to determine how age affects the use of glycopyrrolate in children. Safety and effectiveness have not been established.

Geriatric

There is no information on whether the risk of adverse effects from glycopyrrolate is higher in older adults. However, it should be used cautiously because older patients are more likely to have age-related liver disease, kidney disease, heart disease, or prostate issues. This may require adjusting the dosage or careful monitoring for older patients taking glycopyrrolate.

Studies have not shown any specific problems that would limit the use of the chlordiazepoxide and clidinium combination in older adults. However, older patients may be more sensitive to the effects (such as stomach or bowel issues, urination problems, heart rhythm issues, falls, or fractures) of this medicine compared to younger adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In such cases, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

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

• Potassium Chloride
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dosage or how often you take one or both medicines.

• Aclidinium
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Brompheniramine
• Buprenorphine
• Bupropion
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Donepezil
• Doxepin
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glucagon
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Loxapine
• Meclizine
• Mepenzolate
• Methacholine
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Paroxetine
• Perphenazine
• Pimozide
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Solifenacin
• Stramonium
• Tapentadol
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical conditions may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, 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
• Ulcerative colitis—Use with caution. May worsen these conditions.

• Enlarged prostate or
• Glaucoma or
• Myasthenia gravis (severe muscle weakness) or
• Paralytic ileus (bowel blockage) or
• Severe stomach or intestinal problems (e.g., ulcerative colitis, toxic megacolon, bowel obstruction) or
• Urinary bladder blockage (trouble urinating)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. Effects may be stronger due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine can also cause some unwanted effects. While not everyone experiences these side effects, if they do happen, they may require medical attention.

Contact your doctor right away if you notice any of the following side effects:

More common

• Body aches or pain
• chills
• constipation
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• difficulty with breathing
• ear congestion
• feeling of warmth
• fever
• headache
• loss of voice
• painful urination
• redness of the face, neck, arms, and sometimes, upper chest
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Chest pain or tightness
• confusion
• dizziness
• dry heaves
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• pain or tenderness around the eyes and cheekbones
• rapid breathing
• stomach pain or discomfort
• stuffy nose
• sunken eyes
• thirst
• trouble breathing
• vomiting
• wrinkled skin

Incidence not known

• Change in taste
• difficulty swallowing
• fast heartbeat
• hives, itching, skin rash
• loss of taste
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Seek emergency help immediately if you experience any of the following symptoms of overdose:

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when standing up quickly from a lying or sitting position
• muscle weakness
• sweating
• trouble breathing
• unusual tiredness or weakness

Some side effects may occur that usually do not require medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional might also be able to suggest ways to prevent or lessen some of these side effects. Consult your healthcare professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

Less common

• Altered mood
• anxiety
• attack, assault, or force
• bloated
• chapped lips
• crying
• dry skin
• dry tongue
• excess air or gas in the stomach or intestines
• full feeling
• hyperventilation
• irregular heartbeats
• irritability
• moaning
• nervousness
• pain
• paleness of the skin
• passing gas
• rash
• restlessness
• shaking
• trouble with sleeping
• uncontrolled eye movements

Incidence not known

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Cuvposa
• Dartisla ODT
• Glycate
• Robinul
• Robinul Forte

Available Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antimuscarinic

Take this medicine only as directed by your doctor. Your doctor may change your dose several times in order to find out what works best for you. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Take this medicine at least one hour before or two hours after meals.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Make sure your hands are dry before you handle the orally disintegrating tablet. Do not open the blister pack until you are ready to take it. Peel back the foil from the blister pack, then remove the tablet. Do not push the tablet through the foil. Do not break or cut the tablet. Place the tablet in your mouth. After it has melted, swallow without water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For peptic ulcers: For oral dosage form (tablet): Adults and children 12 years of age and older—The initial dose is 1 milligram (mg) 3 times a day. Your doctor will adjust the dose as needed. However, the dose is usually not more than 8 mg per day. Children younger than 12 years of age—Use is not recommended. For oral dosage form (disintegrating tablet): Adults—1.7 milligrams (mg) 2 to 3 times a day. Your doctor will adjust the dose as needed. However, the dose is usually not more than 6.8 mg per day. Children—Use and dose must be determined by your doctor.
• For severe drooling:For oral dosage form (solution): Children 3 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The dose is 0.02 milligram (mg) per kilogram (kg) of body weight 3 times a day. Your child's doctor may increase your child's dose as needed. However, the dose is usually not more than 1.5 to 3 mg per dose. Children younger than 3 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.