Benztropine

Benztropine is not approved for use by anyone younger than 3 years old.

Certain side effects of benztropine may be more likely in older adults.

You should not use benztropine if you are allergic to it.

Benztropine is not approved for use by anyone younger than 3 years old.

To make sure benztropine is safe for you, tell your doctor if you have:

• glaucoma;

• mental illness;

• a nerve-muscle disorder;

• a history of alcoholism;

• a bowel or bladder obstruction;

• urination problems;

• kidney disease; or

• if you are severely ill or otherwise debilitated.

Using benztropine during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

It is not known whether benztropine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Benztropine can decrease sweating and you may be more prone to heat stroke.

If you also take ketoconazole, do not take it within 2 hours before you take benztropine.

Drinking alcohol with benztropine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or pounding heartbeats;

• confusion, hallucinations;

• severe mouth dryness that causes trouble talking or swallowing;

• loss of appetite, weight loss;

• severe constipation;

• little or no urination;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• severe skin rash;

• fever, severe weakness or dizziness; or

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• nausea, vomiting;

• dry mouth;

• blurred vision; or

• your eyes may be more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• Cogentin

Available Dosage Forms:

• Solution
• Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Anticholinergic

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 benztropine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to benztropine 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

Because of benztropine's toxicity, it should be used with caution in children 3 years of age or older. It is not recommended for use in children below 3 years of age.

Geriatric

No information is available on the relationship of age to the effects of benztropine in geriatric patients.

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 benztropine, 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 benztropine 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 benztropine 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.

• Tiotropium

Using benztropine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betel Nut
• Chlorpromazine
• Haloperidol

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 benztropine. Make sure you tell your doctor if you have any other medical problems, especially:

• Enlarged prostate or
• Glaucoma or
• Paralytic ileus (bowel blockage) or
• Psychosis (mental disorder) or
• Tachycardia (fast heartbeat) or
• Urinating problems (e.g., painful or difficult urination, urinary retention)—Use with caution. May make these conditions worse.

• Glaucoma, angle-closure or
• Tardive dyskinesia (movement disorder)—Should not be used in patients with this condition.

Take benztropine every day exactly as ordered by your doctor in order to improve your condition as much as possible. Do not take more of it or less of it, and do not take it more or less often than your doctor ordered.

It is important to take benztropine together with other medicines for Parkinson's disease. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

Dosing

The dose of benztropine 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 benztropine. 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 oral dosage form (tablets):
  • For Idiopathic parkinsonism:
    • Adults—At first, 0.5 to 1 milligram (mg) at bedtime. Your doctor may increase your dose as needed. The dose is usually not more than 6 mg.
    • Children 3 years of age and above—Use and dose must be determined by your doctor.
    • Children below 3 years of age—Use is not recommended.
  • For Parkinson-like symptoms caused by other medicines:
    • Adults—At first, 1 to 4 milligrams (mg) once or twice a day. Your doctor may increase your dose as needed.
    • Children 3 years of age and above—Use and dose must be determined by your doctor.
    • Children below 3 years of age—Use is not recommended.
  • For Postencephalitic parkinsonism:
    • Adults—At first, 0.5 to 2 milligrams (mg) at bedtime. Your doctor may increase your dose as needed. The dose is usually not more than 6 mg.
    • Children 3 years of age and above—Use and dose must be determined by your doctor.
    • Children below 3 years of age—Use is not recommended.

Missed Dose

If you miss a dose of benztropine, 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.

• Benzatropine
• Benztropine Mesylate
• Cogentin

Refer to adult dosing. Start at low end of dosing range and increase only as needed and as tolerated.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Applies to benztropine: compounding powder, injectable solution, oral tablet

General

Adverse reactions are anticholinergic in nature and include dry mouth, constipation, tachycardia, and blurred vision.[Ref]

Nervous system

Frequency not reported: Numbness of fingers[Ref]

Psychiatric

Frequency not reported: Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations, exacerbation of preexisting psychotic symptoms, nervousness, depression[Ref]

Gastrointestinal

Frequency not reported: Constipation, dry mouth, nausea, vomiting, paralytic ileus[Ref]

Ocular

Frequency not reported: Blurred vision, dilated pupils[Ref]

Cardiovascular

Frequency not reported: Tachycardia[Ref]

Genitourinary

Frequency not reported: Urinary retention, dysuria[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction[Ref]

Other

Frequency not reported: Heatstroke, hyperthermia, fever[Ref]

Dermatologic

Frequency not reported: Skin rash[Ref]

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

Initial: 0.5 to 2 mg orally or IM/IV once a day
Usual dose: 1 to 2 mg orally per day
Effective dose range: 0.5 to 6 mg per day
Maximum dose: 6 mg per day

Comments:
-May be given IM or IV, but since there is no significant difference in onset of effect between IM and IV administration; IM injections are preferred; oral therapy should be used as soon as patients are able to take oral medications.
-Dose should be individualized; anticholinergics are poorly tolerated in older patients and therefore use caution with large doses in older patients.
-This drug's long duration of action makes it suitable for once daily administration; however some patients will do better with divided doses.

Use: For use as an adjunct in the therapy of all forms of Parkinsonism.

Elderly patients and those who are thin or underweight generally do not tolerate higher dosages; initial doses should be conservative and titration should be slow and gradual.

• Benztropine may be used in addition to other treatments for Parkinson's disease.
• Benztropine may be used to counteract extrapyramidal side effects caused by antipsychotic drugs. Extrapyramidal side effects are involuntary movement disorders such as akathisia (inability to sit or stand still), dystonia (continuous spasms and muscle contractions), muscle rigidity, and tremor. Benztropine will not alleviate the symptoms of tardive dyskinesia (involuntary movements of the tongue, lips, face, trunk, and extremities).

Use is not recommended unless clearly needed AU TGA pregnancy category: B2 US FDA pregnancy category: Not formally assigned Risk Summary: Safe use in pregnancy has not been established

In a large prospective study of 2323 exposures during the first trimester, atropine-related drugs as a whole were possibly associated with minor fetal malformations. However, only 4 of those exposures were to benztropine. A surveillance study of Michigan Medicaid recipients recorded 84 newborns exposed to benztropine during the first trimester between 1985 and 1992. Four major birth defects were noted (three expected). Three were cardiovascular defects (one expected), suggesting a possible association with benztropine exposure. Paralytic ileus has been reported in 2 newborns exposed to chlorpromazine and benztropine. In one case, other anticholinergic agents had also been administered to the mother. The condition resolved rapidly in both infants following a Gastrografin enema. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.