Pilocarpine (oral)

Pilocarpine (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Pilocarpine (oral) is a cholinergic agent that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Angle-closure glaucoma, acute

• Dosing Information

• Usual dose: Instill 1 drop of 1% or 2% solution topically into affected eye(s) up to 3 times over 30 minutes; pretreatment with a secretory suppressant and hyperosmotic agent may be required to lower pressure below 50 mmHg
• Use with laser iridoplasty or iridomy: Instill 1 drop of 4% solution topically into affected eye(s) prior to procedure; afterwards, instill 1 drop of 1% solution topically 4 times daily until iridotomy

Head and neck cancer - Radiation-induced xerostomia

• Dosing Information

• The recommended initial dose of pilocarpine hydrochloride tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15-30 mg per day. (Not to exceed 10 mg per dose.) Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with pilocarpine hydrochloride tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.

Miosis induction

• Dosing Information

• Usual dose: Instill 1 drop (or 2 drops 5 minutes apart) topically into eye(s)

Raised intraocular pressure

• Dosing Information

• Usual dose: Apply a 0.5-inch ribbon of the 4% gel topically in the lower conjunctival sac of the affected eye(s) once daily at bedtime

Raised intraocular pressure, Associated with laser surgery; Prophylaxis

• Dosing Information

• Usual dose: Instill 1 drop (or 2 drops 5 minutes apart) topically into eye(s) 15 to 60 minutes prior to surgery

Raised intraocular pressure, Associated with open-angle glaucoma or ocular hypertension

• Dosing Information

• Usual dose: 1 drop topically into affected eye(s) up to 4 times daily depending on degree of intraocular pressure elevation and miotic response; initiate using 1% solution in pilocarpine-naive patients.
• Limiting systemic exposure: Advise punctal occlusion for 2 minutes following instillation.
• Study dosage: The 1% and 2% pilocarpine solutions were effective with nasolacrimal occlusion (N=6), which may allow for twice-daily (every 12 hours) dosage.
• Effects of eye color: Blue-eyed patients demonstrated near maximal ocular hypotensive effects with 1% pilocarpine, while brown-eyed patients required 4% pilocarpine to produce a therapeutic response. Black patients with dark brown irides required 8% pilocarpine for a similar response.

Sjögren's syndrome - Xerostomia

• Dosing Information

• The recommended dose of pilocarpine hydrochloride tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Pilocarpine (oral) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pilocarpine (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Miosis induction

• Dosing Information

• Dosage

Raised intraocular pressure, Associated with open-angle glaucoma or ocular hypertension

• Dosing Information

• Dosage

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Pilocarpine (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pilocarpine (oral) in pediatric patients.

Contraindications

• Condition1

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Pilocarpine (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Pilocarpine (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pilocarpine (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pilocarpine (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pilocarpine (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Pilocarpine (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Pilocarpine (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Pilocarpine (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pilocarpine (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pilocarpine (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pilocarpine (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pilocarpine (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pilocarpine (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Pilocarpine (oral) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Pilocarpine (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Pilocarpine (oral) in the drug label.

Pharmacology

There is limited information regarding Pilocarpine (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Pilocarpine (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Pilocarpine (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Pilocarpine (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Pilocarpine (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Pilocarpine (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Pilocarpine (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Pilocarpine (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Pilocarpine (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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