Benztropine mesylate-injection

Benztropine is an oral and injectable synthetic medication. It is structurally similar to atropine (AtroPen) and diphenhydramine (Benadryl). Benztropine has anticholinergic effects. Anticholinergic drugs block the action of acetylcholine, a neurotransmitter (chemical) that nerves use to communicate with other nerves.

In Parkinson's there is an imbalance between levels of dopamine and acetylcholine neurotransmitters. Benztropine helps restore balance by blocking the action of acetylcholine in the central nervous system (brain and spinal cord). Benztropine may also block the uptake and storage of dopamine in the central nervous system (CNS), resulting in the prolongation of the effects of dopamine. Benztropine was approved by the U.S. Food and Administration (FDA) in 1954.

Yes

: Co-adminstration of benztropine with other anticholinergic agents increases the risk of anticholinergic side effects such as:

• dry mouth,
• dry eyes,
• decreased urination,
• constipation, and
• mental confusion).

Commonly used drugs with moderate to significant anticholinergic effects are:

• amantadine (Symmetral),
• amoxapine, bupropion (Wellbutrin),
• clozapine (Clozaril),
• cyclobenzaprine (Flexeril),
• disopyramide (Norpace),
• maprotiline (Ludiomil),
• olanzapine (Zyprexa),
• orphenadrine (Norflex),
• first generation antihistamines (for example, diphenhydramine),
• phenothiazine, and
• tricyclic anitdepressants.

Benztropine blocks the activity of acetylcholine and can cancel or interfere with the action of drugs that increase gastrointestinal motility (movement of food through the GI tract). Example of such drugs includes:

• metoclopramide (Reglan),
• erythromycin (Erythrocin), and
• tegaserod (Zelnorm).

Umeclidinium (Incruse Ellipta) and tiotropium (Spiriva) may increase the anticholinergic side effects of benztropine. Coadminstration of these agents with benztropine is not recommended.

Benztropine may increase the blood levels of thiazide diuretics. Caution should be used when these agents are used together.

Benztropine may increase the risk of stomach ulcers from using potassium chloride (Klor-Con). Combination treatment with both agents is generally not recommended.

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For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION).

Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).

The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity.

Cardiovascular: Tachycardia.

Digestive: Paralytic ileus, constipation, vomiting, nausea, dry mouth.

If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage, or discontinue the drug temporarily.

Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage.

Nervous System

Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations; exacerbation of pre-existing psychotic symptoms; nervousness; depression; listlessness; numbness of fingers.

Special Senses

Blurred vision, dilated pupils.

Urogenital

Urinary retention, dysuria.

Metabolic/Immune or Skin

Occasionally, an allergic reaction, e.g., skin rash, develops. If this cannot be controlled by dosage reduction, the medication should be discontinued.

Other

Heat stroke, hyperthermia, fever.

To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Benztropine reduces the effects of certain chemicals in the body that may become unbalanced as a result of disease (such as Parkinson's), drug therapy, or other causes.

Benztropine is used to treat the symptoms of Parkinson's disease, such as muscle spasms, stiffness, tremors, sweating, drooling, and poor muscle control.

Benztropine is also used to treat and prevent these symptoms when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.

Benztropine may also be used for purposes not listed in this medication guide.

Since benztropine is sometimes taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.