Product Details

PILOCARPINE HCL 5 MG TAB 100

Manufacturer: AMICI PHARMACEUTICALS LLC

MFG#: 69292-0265-01

NDC: 69292-0265-01

PID: 233613

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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AB
DESI2 Drug Ind AB
Drug Category -
Drug Category -
Drug Type Code N
Drug Type Code N
FDA Approval Date 12/14/2018
FDA Approval Date 12/14/2018
FDA Therap Equiv TAB
FDA Therap Equiv TAB
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date 1
Unit 100
Unit 100
Units Per Pkg 12/22/2004
Units Per Pkg 12/22/2004
Active Ingredients 1694 pilocarpine HCl 54717
Active Ingredients 1694 pilocarpine HCl 54717
AHFS Class 12040000 PARASYMPATHOMIMETIC (CHOLINERGIC AGENTS)
AHFS Class 12040000 PARASYMPATHOMIMETIC (CHOLINERGIC AGENTS)
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 21731 pilocarpine HCl ORAL TABLET 5 MG
Gen Code and Des 21731 pilocarpine HCl ORAL TABLET 5 MG
Inactive Ingredients 915 dextrose 5996101
Inactive Ingredients 915 dextrose 5996101
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 5MG
Strength 5MG
Common Brand Name COMMON BRAND NAME(S): Salagen
Common Brand Name COMMON BRAND NAME(S): Salagen
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: beta blockers (such as propranolol, metoprolol).
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: beta blockers (such as propranolol, metoprolol).
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 100
Drug Form Pack Size 100
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 100
Unit Size 100
How to Use HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 to 4 times daily. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Dosage is based on your medical condition and response to treatment. If you have liver problems, your doctor may direct you to start taking this drug only twice daily. The usual maximum adult dose is 30 milligrams each day. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. You may continue to drink water or use saliva substitutes as needed for moisture in your mouth. You may start to feel some benefit in 1 to 2 weeks. However, it may take up to 3 months to feel the full benefit. Tell your doctor if your condition lasts or gets worse.
How to Use HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 to 4 times daily. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Dosage is based on your medical condition and response to treatment. If you have liver problems, your doctor may direct you to start taking this drug only twice daily. The usual maximum adult dose is 30 milligrams each day. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. You may continue to drink water or use saliva substitutes as needed for moisture in your mouth. You may start to feel some benefit in 1 to 2 weeks. However, it may take up to 3 months to feel the full benefit. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others.
Notes NOTES: Do not share this medication with others.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: diarrhea that doesn't stop, heavy sweating, severe trouble breathing, severe wheezing, stomach cramps, vomiting, very slow/fast heartbeat, severe confusion.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: diarrhea that doesn't stop, heavy sweating, severe trouble breathing, severe wheezing, stomach cramps, vomiting, very slow/fast heartbeat, severe confusion.
Phonetic Pronunciation (PYE-loe-KAR-peen)
Phonetic Pronunciation (PYE-loe-KAR-peen)
Precautions PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic bronchitis, chronic obstructive pulmonary disease-COPD), certain eye conditions (such as night blindness, acute iritis, narrow-angle glaucoma), heart disease (such as chest pain, heart failure, heart attack, slow heartbeat), low or high blood pressure, liver problems, gallbladder disease (such as gallstones), kidney stones, mental/mood disorders (such as depression, psychoses, thinking/understanding problems like dementia, Alzheimer's), stomach problems (such as chronic heartburn, ulcer). This drug may make you dizzy or cause vision problems, especially at night. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision, especially at night, until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If pilocarpine makes you sweat heavily, drink plenty of fluids so that you do not become dehydrated. If you are unable to drink enough fluids, talk with your doctor right away. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially dizziness, diarrhea, and increased urge to urinate. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic bronchitis, chronic obstructive pulmonary disease-COPD), certain eye conditions (such as night blindness, acute iritis, narrow-angle glaucoma), heart disease (such as chest pain, heart failure, heart attack, slow heartbeat), low or high blood pressure, liver problems, gallbladder disease (such as gallstones), kidney stones, mental/mood disorders (such as depression, psychoses, thinking/understanding problems like dementia, Alzheimer's), stomach problems (such as chronic heartburn, ulcer). This drug may make you dizzy or cause vision problems, especially at night. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision, especially at night, until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If pilocarpine makes you sweat heavily, drink plenty of fluids so that you do not become dehydrated. If you are unable to drink enough fluids, talk with your doctor right away. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially dizziness, diarrhea, and increased urge to urinate. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Sweating, nausea, runny nose, chills, flushing, frequent urge to urinate, dizziness, weakness, diarrhea, and blurred vision may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. This medication may cause an increase in tears. This can be helpful if you have dry eyes (such as with Sjogren's syndrome). Tell your doctor if runny eyes become a problem. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: slow/fast heartbeat, shakiness (tremor), fainting, lung problems (such as increased wheezing/cough/phlegm), mental/mood changes (such as confusion, agitation), severe stomach/abdominal pain. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Sweating, nausea, runny nose, chills, flushing, frequent urge to urinate, dizziness, weakness, diarrhea, and blurred vision may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. This medication may cause an increase in tears. This can be helpful if you have dry eyes (such as with Sjogren's syndrome). Tell your doctor if runny eyes become a problem. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: slow/fast heartbeat, shakiness (tremor), fainting, lung problems (such as increased wheezing/cough/phlegm), mental/mood changes (such as confusion, agitation), severe stomach/abdominal pain. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat symptoms of dry mouth due to a certain immune disease (Sjogren's syndrome) or from saliva gland damage due to radiation treatments of the head/neck for cancer. Pilocarpine belongs to a class of drugs known as cholinergic agonists. It works by stimulating certain nerves to increase the amount of saliva you produce, making it easier and more comfortable to speak and swallow.
Uses USES: This medication is used to treat symptoms of dry mouth due to a certain immune disease (Sjogren's syndrome) or from saliva gland damage due to radiation treatments of the head/neck for cancer. Pilocarpine belongs to a class of drugs known as cholinergic agonists. It works by stimulating certain nerves to increase the amount of saliva you produce, making it easier and more comfortable to speak and swallow.

Frequently Asked Questions (FAQs)

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PILOCARPINE HCL 5 MG TAB 100 is manufactured by AMICI PHARMACEUTICALS LLC.

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