The most common adverse reactions reported with CUVPOSA
are dry mouth, vomiting, constipation, flushing, and nasal congestion.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

The data described below reflect exposure to CUVPOSA in
151 subjects, including 20 subjects who participated in a 8-week
placebo-controlled study (Study 1) and 137 subjects who participated in a
24-week open-label study (six subjects who received CUVPOSA in the
placebo-controlled study and 131 new subjects).

Postmarketing Experience

The following adverse reactions
have been identified during postapproval use of other formulations of
glycopyrrolate for other indications. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.

Additional adverse reactions
identified during postapproval use of glycopyrrolate tablets include: loss of
taste and suppression of lactation.

DRUG INTERACTIONS

Drugs Affected by Reduced GI
Transit Time

Glycopyrrolate reduces GI
transit time, which may result in altered release of certain drugs when
formulated in delayed- or controlled-release dosage forms.

The passage of potassium
chloride tablets through the GI tract may be arrested or delayed with
coadministration of glycopyrrolate. Solid dosage forms of potassium chloride are
contraindicated [see CONTRAINDICATIONS].

Digoxin administered as slow
dissolution oral tablets may have increased serum levels and enhanced action
when administered with glycopyrrolate. Monitor patients receiving slow
dissolution digoxin for increased action if glycopyrrolate is coadministered
regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir
or capsules).

Amantadine

The anticholinergic effects of
glycopyrrolate may be increased with concomitant administration of amantadine.
Consider decreasing the dose of glycopyrrolate during coadministration of
amantadine.

Drugs Whose Plasma Levels May
be Increased by Glycopyrrolate

Coadministration of
glycopyrrolate may result in increased levels of certain drugs.

Atenolol's bioavailability may
be increased with coadministration of glycopyrrolate. A reduction in the
atenolol dose may be needed.

Metformin plasma levels may be
elevated with coadministration of glycopyrrolate, increasing metformin's
pharmacologic and toxic effects. Monitor clinical response to metformin with
concomitant glycopyrrolate administration; consider a dose reduction of
metformin if warranted.

Drugs Whose Plasma Levels May be Decreased by
Glycopyrrolate

Coadministration of glycopyrrolate may result in
decreased levels of certain drugs.

Haloperidol's serum levels may be decreased when
coadministered with glycopyrrolate, resulting in worsening of schizophrenic
symptoms, and development of tardive dyskinesia. Closely monitor patients if
coadministration cannot be avoided.

Levodopa's therapeutic effect may be reduced with
glycopyrrolate administration. Consider increasing the dose of levodopa.