Pilocarpine Hydrochloride label

Pilocarpine Hydrochloride

Pilocarpine Hydrochloride Recall

Get an alert when a recall is issued.

Add Info

Side Effects & Adverse Reactions

Cardiovascular Disease: Patients with significant cardiovascular disease may be unable to compensate for transient changes in hemodynamics or rhythm induced by pilocarpine. Pulmonary edema has been reported as a complication of pilocarpine toxicity from high ocular doses given for acute angle-closure glaucoma. Pilocarpine should be administered with caution in and under close medical supervision of patients with significant cardiovascular disease.

Ocular: Ocular formulations of pilocarpine have been reported to cause visual blurring which may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause impairment of depth perception. Caution should be advised while driving at night or performing hazardous activities in reduced lighting.

Pulmonary Disease: Pilocarpine has been reported to increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Pilocarpine hydrochloride should be administered with caution to and under close medical supervision in patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease requiring pharmacotherapy.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome.

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

Pilocarpine Hydrochloride Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S–cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1 -methyl-1H-imidazol-5-yl) methyl] monohydrochloride, has a molecular weight of 244.72.

Pilocarpine hydrochloride structural formula

Each 5 mg Pilocarpine Hydrochloride Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients.

Each 7.5 mg Pilocarpine Hydrochloride Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet’s film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&C blue # 2 aluminum lake, and other ingredients.

Add Info
Add to My Alerts
Report Side Effect
Leave a Review
Navigate to :
Pilocarpine Hydrochloride Recall
Side Effects & Adverse Reactions
Legal Issues
FDA Safety Alerts
Manufacturer Warnings
FDA Labeling Changes
Uses
History
Other Information
Manufacturers
Trending Topics

Pilocarpine Hydrochloride Manufacturers

  • American Health Packaging
    Pilocarpine Hydrochloride | American Health Packaging
    No Recall

    Pilocarpine Hydrochloride | American Health Packaging

    Pilocarpine Hydrochloride | American Health Packaging

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients: 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.

    Sjogren's Syndrome Patients: The recommended dose of Pilocarpine Hydrochloride Tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.

  • Marlex Pharmaceuticals Inc
    Pilocarpine Hydrochloride | Marlex Pharmaceuticals Inc
    No Recall

    Pilocarpine Hydrochloride | Marlex Pharmaceuticals Inc

    Pilocarpine Hydrochloride | Marlex Pharmaceuticals Inc

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    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.

    Sjogren’s Syndrome Patients

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

  • Rebel Distributors Corp
    Pilocarpine Hydrochloride | Rebel Distributors Corp
    No Recall

    Pilocarpine Hydrochloride | Rebel Distributors Corp

    Pilocarpine Hydrochloride | Rebel Distributors Corp

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    The recommended initial dose of Pilocarpine HCl Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerability. The usual dosage range is 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 HCl 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.

    Sjogren's Syndrome Patients

    The recommended dose of Pilocarpine HCl Tablets is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.

  • Physicians Total Care, Inc.
    Pilocarpine Hydrochloride | Physicians Total Care, Inc.
    No Recall

    Pilocarpine Hydrochloride | Physicians Total Care, Inc.

    Pilocarpine Hydrochloride | Physicians Total Care, Inc.

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    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.

    Sjogren's Syndrome Patients

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

  • Global Pharmaceuticals, Division Of Impax Laboratories, Inc.
    Pilocarpine Hydrochloride | Global Pharmaceuticals, Division Of Impax Laboratories, Inc.
    No Recall

    Pilocarpine Hydrochloride | Global Pharmaceuticals, Division Of Impax Laboratories, Inc.

    Pilocarpine Hydrochloride | Global Pharmaceuticals, Division Of Impax Laboratories, Inc.

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    The recommended initial dose of Pilocarpine HCl Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerability. The usual dosage range is 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 HCl 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.

    Sjogren's Syndrome Patients

    The recommended dose of Pilocarpine HCl Tablets is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.

  • Corepharma, Llc
    Pilocarpine Hydrochloride | Corepharma, Llc
    No Recall

    Pilocarpine Hydrochloride | Corepharma, Llc

    Pilocarpine Hydrochloride | Corepharma, Llc

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head and Neck Cancer Patients: 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 tolerability. The usual dosage range is up to 15 to 30 mg per day. (Not to exceed10 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.

    Sjogren"s Syndrome Patients: The recommended dose of pilocarpine hydrochloride tablets is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.

  • Actavis Elizabeth Llc
    Pilocarpine Hydrochloride | Target Corporation
    No Recall

    Pilocarpine Hydrochloride | Target Corporation

    Pilocarpine Hydrochloride | Target Corporation
    • this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours   Weight (lb)   Age (yr)   Dose (mL or tsp)*   under 24   under 2 years   ask a doctor   24-35   2-3 years   5 mL (1 tsp)   36-47   4-5 years   7.5 mL (1 ½ tsp)   48-59   6-8 years   10 mL (2 tsp)   60-71   9-10 years   12.5 mL (2 ½ tsp)   72-95   11 years   15 mL (3 tsp)

    *or as directed by a doctor

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Roxane Laboratories, Inc
    Pilocarpine Hydrochloride | Roxane Laboratories, Inc
    No Recall

    Pilocarpine Hydrochloride | Roxane Laboratories, Inc

    Pilocarpine Hydrochloride | Roxane Laboratories, Inc

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the PRECAUTIONS section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    The recommended initial dose of pilocarpine hydrochloride tablets USP is one tablet (5 mg) taken three times a day. Dosage should be adjusted according to therapeutic response and tolerability. The usual dosage range is 15 to 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 USP 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.

    Sjogren's Syndrome Patients

    The recommended dose of pilocarpine hydrochloride tablets USP is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.

  • Kaiser Foundation Hospitals
    Pilocarpine Hydrochloride | Kaiser Foundation Hospitals
    No Recall

    Pilocarpine Hydrochloride | Kaiser Foundation Hospitals

    Pilocarpine Hydrochloride | Kaiser Foundation Hospitals

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the  Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    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.

    Sjogren's Syndrome Patients

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

  • Lannett Company, Inc.
    Pilocarpine Hydrochloride | Lannett Company, Inc.
    No Recall

    Pilocarpine Hydrochloride | Lannett Company, Inc.

    Pilocarpine Hydrochloride | Lannett Company, Inc.

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients

    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.

    Sjogren's Syndrome Patients

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

  • American Health Packaging
    Pilocarpine Hydrochloride | American Health Packaging
    No Recall

    Pilocarpine Hydrochloride | American Health Packaging

    Pilocarpine Hydrochloride | American Health Packaging

    Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

    Head & Neck Cancer Patients: 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.

    Sjogren's Syndrome Patients: The recommended dose of Pilocarpine Hydrochloride Tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.

Login To Your Free Account