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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
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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.
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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.