Vergentan may be available in the countries listed below.
Alizapride hydrochloride (a derivative of Alizapride) is reported as an ingredient of Vergentan in the following countries:
International Drug Name Search
Class: Local Anti-infectives, Miscellaneous
Chemical Name: N,N′′-Bis(4-chlorophenyl)-3,12-diimino- 2,4,11,13-tetraazatetradecanediimidamide di-d-gluconate
Molecular Formula: C22H30Cl2N10•2C6H12O7
CAS Number: 18472-51-0
Brands: Avagard, Betasept, Biopatch, Chlorostat, Hibiclens, Hibistat
Cationic bisbiguanide; a topical anti-infective agent.1 4 5
Preoperative hand antisepsis in health-care personnel1 18 105 107 108 to inactivate microorganisms (normal and transient flora) present on the hands and forearms.5 18 104
Chlorhexidine gluconate 2 or 4% skin cleanser solutions have more persistent anti-infective activity compared with other available anti-infective cleansers.105
Anti-infective skin cleanser for preoperative skin preparation at the surgical site.1 15 18 107
Anti-infective skin cleanser for patient preoperative showering and bathing†5 18 35 36 37 39 44 to decrease bacterial flora on the skin.18
Routine hand hygiene in health-care personnel1 2 18 105 107 to prevent transmission of nosocomial infection.5 17 25 83 105
Considered an alternative for decontaminating hands; alcohol-based preparations are recommended instead for decontaminating hands (if they are not visibly soiled) since alcohol-based preparations are most effective for standard hand antisepsis by health-care personnel.105
Used as a cleanser of superficial skin wounds and for general cleansing of skin.1 53 54 78
Should not be used routinely in wounds that involve more than the superficial layers of the skin.1 78
Advantage over alcohol because of a duration of action of 5–6 hours and retention of the drug’s activity in the presence of blood and organic material.1 5 54
Skin disinfection prior to insertion of intravascular, central venous, or arterial catheters† and for postinsertion site care to prevent catheter-related infections in patients with vascular and nonvascular percutaneous devices.47 51 55 100 11
Chlorhexidine gluconate 2% solution is the preferred agent for such antisepsis.106
Management of burns† to clean the affected area and prevent wound infection.4 5 56
Skin disinfection prior to collection of venous blood cultures†7 or blood donations.116
Periurethral cleansing prior to urinary catheterization.103
Topical lubricant on urinary catheters.3 5
Bladder irrigation†5 57 104 in an attempt to decrease the incidence of bacteriuria and bacteremia associated with the use of indwelling catheters.3 5 103 (See Hypersensitivity Reactions under Cautions.)
Prevent maternal-fetal transmission of vaginal bacteria, including Streptococcus agalactiae (group B streptococci), to reduce maternal and neonatal infections.95 96 97 98 115
Preparations are for external use only; avoid contact with the eyes, ears, or mouth.1 2 78 107 108
Apply solutions in a sudsing base (skin cleanser) and solutions in an alcohol base with emollients (hand rub) topically to the skin and hands.1 2 78 107 108
Do not use solutions in sudsing base on the face or head for preoperative skin preparation.1 78 107
Apply chlorhexidine containing dressings at the site of vascular and nonvascular percutaneous devices.111
Wet hands and forearms with water.1 78 107 Apply approximately 5 mL of the skin cleanser onto the hands and rub into a copious lather by adding small amounts of water.1 78 107
Spread suds over the hands and forearms and scrub well with a wet brush for the time interval recommended by the manufacturer (e.g., 3 minutes).1 78 107
Pay particular attention to the nails, cuticles, and interdigital spaces; a separate nail cleaner may be used.1 78 107
After scrubbing, rinse the hands and forearms thoroughly under running water.1 78 107
Apply a second application (5 mL) and scrub the hands and forearms for an additional 3 minutes.1 78 107 Then rinse thoroughly with running water and dry with a sterile towel.1 18 78 107
Prolonged scrub times (e.g., 10 minutes) not necessary and may increase incidence of skin damage.105
Sponge/brush containing 4% skin cleanser: open package and remove nail cleaner.1 Wet hands with water and use nail cleaner under fingernails and to clean cuticles.1 Wet hands and forearms to elbows with warm water (avoid use of very cold or very warm water).1 Wet sponge side of sponge/brush; squeeze and pump immediately to work up adequate lather.1 Apply lather to hands and forearms using only sponge side of product; then start 3-minute scrub using brush side of product to scrub only nails, cuticles, and interdigital areas.1 Rinse hands and forearms thoroughly with warm water, then scrub for an additional 3 minutes using sponge side only.1 Rinse hands and forearms thoroughly with running water and dry with sterile towel.1
Wash hands, forearms, and nails with an unmedicated soap (without an anti-infective) and dry completely.105 108 Apply 2 mL of solution onto palm of one hand; dip fingertips of other hand into solution and massage under nails.108
Spread remaining solution over hand and forearms, up to just above the elbow, making certain to cover all surfaces.108
Repeat procedure using another 2 mL of solution using opposite hand.108
Finally, apply additional 2 mL of solution onto palm of either hand and reapply to both hands, up to wrists.108
Rub hands together briskly until all solution is rubbed into hands and forearms and dries completely; do not use towels to dry since this decreases solution efficacy.108
Hands and forearms should be completely dry prior to donning surgical gloves.105 108
Never use water in conjunction with the alcohol-based solution.108
Apply liberally to the incision site and swab for at least 2 minutes; dry with a sterile towel.1 78 107
Repeat procedure for an additional 2 minutes and dry area again with a sterile towel.1 78 107
Wet hands with warm water (avoid use of very cold or very hot water); dispense approximately 5 mL of the skin cleanser into cupped hands.1 78 107 Work up a lather (do not use excessive pressure to produce additional lather) and wash hands for 15 seconds.1 78 Rinse hands thoroughly with warm water, then dry.1 78 107
Hands must first be physically clean and dry before application of solution.2 108 Dispense approximately 5 mL of the 0.5% solution or 2 mL of 1% solution into cupped hands and rub vigorously until dry (about 15 seconds); pay particular attention to nails and interdigital spaces.2 108 Solution dries rapidly while hands are rubbed; do not use water or other toweling.2 108
Pledgets: vigorously rub hands with a hand wipe for approximately 15 seconds, paying particular attention to nails and interdigital spaces.2 Solution dries rapidly while hands are rubbed; do not use water or other toweling.2
Rinse the area thoroughly with water before application of the solution.1 78 107 Apply the minimum amount of skin cleanser to cover the skin or wound area.1 78 107 Wash the area gently with the skin cleanser, then thoroughly rinse again.1 78 107
Apply solution and air dry before catheter insertion.106
Dressing: Apply to the site using aseptic technique.111 Dressing may be left in place for up to 7 days.111 Consult manufacturer’s information for details.111
Contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.1 2 78 107 108
Skin cleanser and alcohol-based solutions are for external use only; do not use in eyes, ears, or mouth.1 2 78 107 108 Skin cleanser should not be used for preoperative skin preparation of the face or head.1
Skin cleanser and alcohol-based chlorhexidine solutions should not be used routinely on individuals who have wounds involving more than the superficial layers of the skin.1 78 107 108
Use with caution on mucous membranes and apply on wound surfaces at the lowest bactericidal concentration (0.05%) (not commercially available in the US) to decrease the risk of anaphylactic reactions.63
Avoid direct contact of the drug with brain tissue or meninges.1 105 107
Possible irreversible corneal damage after accidental ocular exposure.60
Do not touch eyes with hands that have been treated with chlorhexidine.108 If ocular contact occurs, rinse eye promptly and thoroughly with water.1 2 78 107 108
Possible sensorineural deafness after direct application for perioperative disinfection of the ear prior to vascular myringoplasty.1 5
Alcohol-based preparations (Hibistat, Avagard) should not be exposed to excessive heat (i.e., temperatures exceeding 40°C); keep away from flames or devices that may generate an electric spark.2 108 These preparations dry rapidly as the hands are rubbed together2 108 and are no longer flammable after drying.108
Serious, systemic hypersensitivity reactions, including hypotension, tachycardia, shortness of breath, skin erythema, and anaphylaxis, have been reported with preparations applied topically to the skin3 4 63 64 66 or given intraurethrally,3 4 64 65 intranasally,67 or on central venous catheter (CVCs) impregnated with the drug.3 4 68 69
Local contact dermatitis reported when chlorhexidine-impregnated dressings were used to cover CVC insertion site in neonates.3 62 100 May be severe, may require discontinuance of the chlorhexidine dressing, and have occurred most frequently in low birthweight neonates.62 100
Binds to many fabrics, particularly cotton, and may not be removed by washing.79 Permanent brown stain may occur if sufficient chlorine is present during washing.79 Consult manufacturer’s recommendations for laundering advice.79
Category B.b
Unlikely to be distributed into human milk following topical or intravaginal application.71
Multiple episodes of bradycardia and cyanosis reported in a neonate when chlorhexidine was applied to the nursing mother’s breasts for prevention of mastitis.74 Wash nipples thoroughly with water prior to nursing if used for skin cleansing.71
Keep preparations out of the reach of children.1 2 107 108
Irritation, sensitization, generalized allergic reactions,1 2 4 5 100 107 108 118 especially when used in the genital area.1 2 78 107 108
No formal drug interaction studies to date.1 2 3
Poorly absorbed from GI tract4 or percutaneously following topical application to skin.1 4 5
Low concentrations appear to be absorbed systemically following intravaginal† administration.71
Adsorbed onto outer layers of skin following topical application to intact skin, resulting in a persistent (residual) antimicrobial effect.1 5 6 14
In pregnant women who received a 2% solution intravaginally† as a vaginal wash during labor, concentrations ranging from 0.01–0.083 mcg/mL were detected in the blood (limits of detection 0.01 mcg/mL) of approximately 33% of these women.71
Serum concentrations of 11 ng/mL reported in a neonate after oral exposure when chlorhexidine gluconate was used on the nursing mother's nipples to prevent mastitis.74
Possible systemic absorption when topical preparations used as skin cleansers in neonates or infants.4 5 12 13
Not known whether chlorhexidine crosses the placenta or is distributed into milk.a
If absorbed percutaneously following topical application to the skin, appears to be mainly excreted unchanged in feces.5
Tight, light resistant containers; protect from excessive heat (i.e., >40°C).1 2 11
Keep alcohol-based preparations (Hibistat and Avagard) away from flames or devices that may generate an electric spark.2 108
Bacteriostatic or bactericidal in action, depending on concentration attained at site and susceptibility of organism.5 15
Cationic compound;5 6 adsorbed onto negatively charged cell surfaces of susceptible organisms, with specific and strong adsorption to certain phosphate-containing compounds.5 6 Integrity of the cell membrane is disrupted, resulting in increased permeability.5 6
Active against some aerobic and anaerobic gram-positive and gram-negative bacteria.1 2 4 5 6 102 Also has some activity against Chlamydia trachomatis,77 certain fungi,4 5 6 and certain viruses,4 5 52 but inactive against mycobacteria48 and generally inactive against bacterial spores.15
Importance of avoiding contact with eyes, ears, and mouth.1 2 78 107 108 If ocular contact occurs, rinse eye promptly and thoroughly with water to prevent irreversible injury.1 2 60 78 107 108
Avoid exposure to excessive heat (i.e., >40°C) with alcohol-based preparations (Hibistat, Avagard); keep away from flames or devices that may generate an electric spark.2 108
Importance of discontinuing drug and informing clinician if an allergic or hypersensitivity reaction occurs.1 2 108
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.71 93
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2 108
Importance of informing patients of other important precautionary information. (See Cautions.)1 2 108
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Dressing | 20% w/w | Biopatch | J & J |
Pledgets (saturated with solution) | 0.5% w/w with isopropyl alcohol 70% | Hibistat Hand Wipe | Regent Medical | |
Solution | 0.5% w/w with isopropyl alcohol 70% | Hibistat Hand Rinse | Regent Medical | |
1% w/w with alcohol 61% | Avagard Hand Antiseptic | 3M | ||
2% w/w | Chlorostat Skin Cleaner and Surgical Scrub | King | ||
4% w/v | Betasept Surgical Scrub | Purdue Frederick | ||
Hibiclens Skin Cleanser | Regent Medical | |||
Sponge/Brush | 4% w/v | Hibiclens Skin Cleanser | Regent Medical |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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84. Knight BA, Puy R, Douglass J et al. Chlorhexidine anaphylaxis: a case report and review of the literature. Intern Med J. 2001; 31:436-7. [PubMed 11584911]
85. Baqui AAMA, Kelley JI, Jabra-Rizk MA et al. In vitro effect of oral antiseptics on human immunodeficiency virus-1 and herpes simplex virus type 1. J Clin Periodontol. 2001; 28:610-16. [PubMed 11422581]
86. Block C, Robenshtok E, Simhon A et al. Evaluation of chlorhexidine and povidone iodine activity against methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecalis using a surface test. J Hosp Infect. 2000; 46:147-52. [PubMed 11049709]
87. Suller MTE, Russell AD. Antibiotic and biocide resistance in methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus. J Hosp Infect. 1999; 43:281-91. [PubMed 10658804]
88. Kampf G, Hofer M, Wendt C. Efficacy of hand disinfectants against vancomycin-resistant enterococci in vitro. J Hosp Infect. 1999; 42:143-50. [PubMed 10389064]
89. Kampf G, Jarosch R, Ruden H. Limited effectiveness of chlorhexidine based hand disinfectants against methicillin-resistant Staphylococcus aureus (MRSA). J Hosp Infect. 1998; 38:297-303. [PubMed 9602978]
Generic Name: nystatin (Topical route)
nye-STAT-in
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antifungal
Chemical Class: Polyene
Nystatin belongs to the group of medicines called antifungals. Topical nystatin is used to treat some types of fungus infections of the skin.
Nystatin is available in the U.S. only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Although there is no specific information comparing use of topical nystatin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical nystatin in the elderly with use in other age groups.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
This section provides information on the proper use of a number of products that contain nystatin. It may not be specific to Pedi-Dri. Please read with care.
Topical nystatin should not be used in the eyes.
Apply enough nystatin to cover the affected area.
For patients using the powder form of this medicine on the feet:
The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over this medicine unless directed to do so by your doctor. When using this medicine on the diaper area of children, avoid tight-fitting diapers and plastic pants.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Pedi-Dri Topical side effects (in more detail)
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Naproxen AL may be available in the countries listed below.
Naproxen is reported as an ingredient of Naproxen AL in the following countries:
International Drug Name Search
Therapeutic – intraperitoneal or intracavitary injection only for treatment of peritoneal or pleural effusions caused by metastatic disease.
Phosphocol® P 32 is supplied as a sterile, nonpyrogenic aqueous suspension in a 30% dextrose solution with 2% benzyl alcohol added as preservative. Each milliliter contains 1 mg sodium acetate. Sodium hydroxide or hydrochloric acid may be present for pH adjustment.
Local irradiation by beta emission.
Phosphocol P 32 is employed by intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease, and may be injected interstitially for the treatment of cancer.
Chromic phosphate P 32 therapy should not be used in the presence of ulcerative tumors.
Administration should not be made in exposed cavities or where there is evidence of loculation unless the extent of loculation is determined.
Not for intravascular use.
This radiopharmaceutical should not be administered to patients who are pregnant or during lactation unless the therapeutic benefits outweigh the potential hazards.
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). Phosphocol P 32 is not indicated in the intra-articular treatment of hemarthroses.
As in the use of any other radioactive material care should be taken to insure minimum radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers.
Careful intracavitary instillation is required to avoid placing the dose of chromic phosphate P 32 into intrapleural or intraperitoneal loculations, bowel lumen or into the body wall. Intestinal fibrosis or necrosis and chronic fibrosis of the body wall have been reported to result from unrecognized misplacement of the therapeutic agent.
The presence of large tumor masses indicates the need for other forms of treatment. However, when other forms of treatment fail to control the effusion, chromic phosphate P 32 may be useful. In bloody effusion, treatment may be less effective.
Safety and effectiveness in pediatric patients has not been established.
Risk of Malignancy
Acute lymphocytic leukemia has been reported in children following the intra-articular administration of Phosphocol P 32 (see WARNINGS).
Untoward effects may be associated with use of chromic phosphate P 32. These include transitory radiation sickness, bone marrow depression, pleuritis, peritonitis, nausea and abdominal cramping. Radiation damage may occur if accidentally injected interstitially or into a loculation.
The following adverse reactions associated with the use of Phosphocol P 32 have been identified during post approval use:
Leukemia in Children (see WARNINGS)
Radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity.
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.
The suggested dose range employed in the average patient (70 kg) is:
Doses for interstitial use should be based on estimated gram weight of tumor, about 3.7 to 18.5 MBq/gm (0.1 to 0.5 mCi/gm).
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Phosphorus P 32 decays by beta emission with a physical half-life of 14.3 days.1 The mean energy of the beta particle is 695 keV.
| Radiation | Mean Percent/ Disintegration | Mean Energy (keV) |
| Beta-1 | 100.0 | 694.9 |
The range of the phosphorus P 32 beta particle, which has a maximum energy of 1.71 MeV, is 2.9 mm of aluminum.
To correct for physical decay of this radionuclide, the percentages that remain at selected time intervals before and after the day of calibration are shown in Table 2.
| Days | Fraction Remaining | Days | Fraction Remaining | Days | Fraction Remaining |
*Calibration Day | |||||
| -15 -10 -5 -2 -1 0* 1 | 2.07 1.62 1.27 1.10 1.05 1.00 0.953 | 2 5 10 15 20 25 30 | 0.908 0.785 0.616 0.483 0.379 0.298 0.234 | 35 40 45 50 55 60 65 | 0.183 0.144 0.113 0.089 0.070 0.055 0.043 |
The effective half-life of phosphorus P 32 is considered to be equal to its physical half-life, with a residence time of 495 hours.
The radiation dose from a uniformly distributed concentration of 37 kilobecquerels (1 microcurie) per gram within a 16-gram prostate is estimated to be equivalent to about 7.3 grays (730 rads)2. Table 3 shows the estimated radiation doses to the prostate and the pleural or peritoneal surfaces3 of an average patient (70 kg) from a dose of 740 megabecquerels (20 millicuries) of phosphorus P 32.
In comparison to the distribution in the prostate, the distribution of phosphorus P 32 on the pleural and peritoneal surfaces is non-uniform, with great extremes in local doses. To obtain an estimate of the average dose, the surface area of the pleural and peritoneal cavities can be assumed to amount to 4,000 and 5,000 cm2, respectively. The estimated radiation doses to an average patient (70 kg) with 90% retention of a dose of 740 megabecquerels (20 millicuries) of phosphorus P 32 distributed uniformly over these areas are shown in Table 3. The decreases of the averaged radiation doses at various tissue depths away from the surfaces of the pleural and peritoneal cavities are also tabulated.
| Surface/Organ | Pleural | Peritoneal | Prostate | |||||
| % Retention Area/wt | 90 4000 cm2 | 90 5000 cm2 | 100 16 gm | |||||
| Depth in tissue (cm) | Dose Rate | Tissue Dose / 740 MBq (20 mCi) | ||||||
| mGy-cm2 MBq-s | rad-cm2 μCi-h | grays | rads | grays | rads | grays | rads | |
| 0.006 | 0.75 | 10 | 178 | 17800 | 134 | 13400 | 9180 | 918000 |
| 0.018 | 0.53 | 7 | 125 | 12500 | 94 | 9360 | ||
| 0.03 | 0.42 | 5.6 | 100 | 10000 | 74.9 | 7490 | ||
| 0.12 | 0.15 | 2 | 36 | 3570 | 26.7 | 2670 | ||
| 0.21 | 0.064 | 0.85 | 15 | 1520 | 11.4 | 1140 | ||
| 0.3 | 0.023 | 0.31 | 5.5 | 550 | 4.1 | 410 | ||
| 0.4 | 0.0047 | 0.062 | 1 | 110 | 0.83 | 83 | ||
Catalog Number 470
Phosphocol P 32 - Chromic Phosphate P 32 Suspension (NDC No. 0019-N470-P0) is available in 10 milliliter vials containing 555 megabecquerels (15 millicuries) with a concentration of 185 megabecquerels (5 millicuries) per milliter. The radiopharmaceutical is manufactured with a specific activity of 122 megabecquerels (3.3 millicuries) per milligram Chromic Phosphate at the time of standardization.
The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.300, and to persons who hold an equivalent license issued by an Agreement State.
Store at controlled room temperature 20 to 25°C (68 to 77°F).
Revised 020308
Mallinckrodt Inc.
Hazelwood, MO 63042 U.S.A.
Mallinckrodt
A470I0
| PHOSPHOCOL P 32 chromic phosphate, p-32 injection, suspension | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017084 | 09/23/1974 | 09/21/2009 |
| Labeler - Mallinckrodt, Inc. (047021092) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mallinckrodt, Inc. | 557570652 | analysis, manufacture | |
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.
Each 5 mg Pilocarpine Hydrochloride Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet's film coating is: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.
Each 7.5 mg Pilocarpine Hydrochloride Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet's film coating is: FD&C Blue #2/Indigo Carmine aluminum lake, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.
Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal, gastric, pancreatic, and intestinal glands and the mucous cells of the respiratory tract may be stimulated. When applied topically to the eye as a single dose it causes miosis, spasm of accommodation, and may cause a transitory rise in intraocular pressure followed by a more persistent fall. Dose-related smooth muscle stimulation of the intestinal tract may cause increased tone, increased motility, spasm, and tenesmus. Bronchial smooth muscle tone may increase. The tone and motility of urinary tract, gallbladder, and biliary duct smooth muscle may be enhanced. Pilocarpine may have paradoxical effects on the cardiovascular system. The expected effect of a muscarinic agonist is vasodepression, but administration of pilocarpine may produce hypertension after a brief episode of hypotension. Bradycardia and tachycardia have both been reported with use of pilocarpine.
In a study of 12 healthy male volunteers there was a dose-related increase in unstimulated salivary flow following single 5 and 10 mg oral doses of pilocarpine hydrochloride tablets. This effect of pilocarpine on salivary flow was time-related with an onset at 20 minutes and a peak effect at 1 hour with a duration of 3 to 5 hours (See Pharmacokinetics section).
In a 12 week randomized, double-blind, placebo-controlled study in 207 patients (placebo, N=65; 5 mg, N=73; 10 mg, N=69), increases from baseline (means 0.072 and 0.112 mL/min, ranges −0.690 to 0.728 and −0.380 to 1.689) of whole saliva flow for the 5 mg (63%) and 10 mg (90%) tablet, respectively, were seen 1 hour after the first dose of pilocarpine hydrochloride tablets. Increases in unstimulated parotid flow were seen following the first dose (means 0.025 and 0.046 mL/min, ranges 0 to 0.414 and −0.070 to 1.002 mL/min for the 5 and 10 mg dose, respectively). In this study, no correlation existed between the amount of increase in salivary flow and the degree of symptomatic relief.
In two 12 week randomized, double-blind, placebo-controlled studies in 629 patients (placebo, N=253; 2.5 mg, N=121; 5 mg, N=255; 5-7.5 mg, N=114), the ability of pilocarpine hydrochloride tablets to stimulate saliva production was assessed. In these trials using varying doses of pilocarpine hydrochloride tablets (2.5-7.5 mg), the rate of saliva production was plotted against time. An Area Under the Curve (AUC) representing the total amount of saliva produced during the observation interval was calculated. Relative to placebo, an increase in the amount of saliva being produced was observed following the first dose of pilocarpine hydrochloride tablets and was maintained throughout the duration (12 weeks) of the trials in an approximate dose response fashion (See Clinical Studies section).
In a multiple-dose pharmacokinetic study in male volunteers following 2 days of 5 or 10 mg of oral pilocarpine hydrochloride tablets given at 8 a.m., noontime, and 6 p.m., the mean elimination half-life was 0.76 hours for the 5 mg dose and 1.35 hours for the 10 mg dose. Tmax values were 1.25 hours and 0.85 hours. Cmax values were 15 ng/mL and 41 ng/mL. The AUC trapezoidal values were 33 h(ng/mL) and 108 h(ng/mL), respectively, for the 5 and 10 mg doses following the last 6 hour dose.
Pharmacokinetics in elderly male volunteers (N = 11) were comparable to those in younger men. In five healthy elderly female volunteers, the mean Cmax and AUC were approximately twice that of elderly males and young normal male volunteers.
When taken with a high fat meal by 12 healthy male volunteers, there was a decrease in the rate of absorption of pilocarpine from pilocarpine hydrochloride tablets. Mean Tmax's were 1.47 and 0.87 hours, and mean Cmax's were 51.8 and 59.2 ng/mL for fed and fasted, respectively.
Limited information is available about the metabolism and elimination of pilocarpine in humans. Inactivation of pilocarpine is thought to occur at neuronal synapses and probably in plasma. Pilocarpine and its minimally active or inactive degradation products, including pilocarpic acid, are excreted in the urine. Pilocarpine does not bind to human or rat plasma proteins over a concentration range of 5 to 25,000 ng/mL. The effect of pilocarpine on plasma protein binding of other drugs has not been evaluated.
In patients with mild to moderate hepatic impairment (N=12), administration of a single 5 mg dose resulted in a 30% decrease in total plasma clearance and a doubling of exposure (as measured by AUC). Peak plasma levels were also increased by about 30% and half-life was increased to 2.1 hrs.
There were no significant differences in the pharmacokinetics of oral pilocarpine in volunteer subjects (N=8) with renal insufficiency (mean creatinine clearances 25.4 mL/min; range 9.8 – 40.8 mL/min) compared to the pharmacokinetics previously observed in normal volunteers.
A 12 week randomized, double-blind, placebo-controlled study in 207 patients (142 men, 65 women) was conducted in patients whose mean age was 58.5 years with a range of 19 to 77; the racial distribution was Caucasian 95%, Black 4%, and other 1%. In this population, a statistically significant improvement in mouth dryness occurred in the 5 and 10 mg pilocarpine hydrochloride tablet treated patients compared to placebo treated patients. The 5 and 10 mg treated patients could not be distinguished. (See Pharmacodynamics section for flow study details.)
Another 12 week, double-blind, randomized, placebo-controlled study was conducted in 162 patients whose mean age was 57.8 years with a range of 27 to 80; the racial distribution was Caucasian 88%, Black 10%, and other 2%. The effects of placebo were compared to 2.5 mg three times a day of pilocarpine hydrochloride tablets for 4 weeks followed by adjustment to 5 mg three times a day and 10 mg three times a day. Lowering of the dose was necessary because of adverse events in 3 of 67 patients treated with 5 mg of pilocarpine hydrochloride tablets and in 7 of 66 patients treated with 10 mg of pilocarpine hydrochloride tablets. After 4 weeks of treatment, 2.5 mg of pilocarpine hydrochloride tablets three times a day was comparable to placebo in relieving dryness. In patients treated with 5 mg and 10 mg of pilocarpine hydrochloride tablets, the greatest improvement in dryness was noted in patients with no measurable salivary flow at baseline.
In both studies, some patients noted improvement in the global assessment of their dry mouth, speaking without liquids, and a reduced need for supplemental oral comfort agents.
In the two placebo-controlled clinical trials, the most common adverse events related to drug, and increasing in rate as dose increases, were sweating, nausea, rhinitis, diarrhea, chills, flushing, urinary frequency, dizziness, and asthenia. The most common adverse experience causing withdrawal from treatment was sweating (5 mg t.i.d. ≤1%; 10 mg t.i.d. =12%).
Two separate studies were conducted in patients with primary or secondary Sjogren's Syndrome. In both studies, the majority of patients best fit the European criteria for having primary Sjogren's Syndrome. ["Criteria for the Classification of Sjogren's Syndrome" (Vitali C, Bombardieri S, Moutsopoulos HM, et al: Preliminary criteria for the classification of Sjogren's syndrome. Arthritis Rheum 36:340-347, 1993.)]
A twelve week, randomized, double-blind, parallel-group, placebo-controlled study was conducted in 256 patients (14 men, 242 women) whose mean age was 57 years with a range of 24 to 85 years. The racial distribution was as follows: Caucasian 91%, Black 6%, and other 3%.
The effects of placebo were compared with those of pilocarpine hydrochloride tablets 5 mg four times a day (20 mg/day) for 6 weeks. At 6 weeks, the patients' dosage was increased from 5 mg pilocarpine hydrochloride tablets q.i.d. to 7.5 mg q.i.d. The data collected during the first 6 weeks of the trial were evaluated for safety and efficacy, and the data of the second 6 weeks of the trial were used to provide additional evidence of safety.
After 6 weeks of treatment, statistically significant global improvement of dry mouth was observed compared to placebo. "Global improvement" is defined as a score of 55 mm or more on a 100 mm visual analogue scale in response to the question, "Please rate your present condition of dry mouth (xerostomia) compared with your condition at the start of this study. Consider the changes to your dry mouth and other symptoms related to your dry mouth that have occurred since you have taken this medication." Patients' assessments of specific dry mouth symptoms such as severity of dry mouth, mouth discomfort, ability to speak without water, ability to sleep without drinking water, ability to swallow food without drinking, and a decreased use of saliva substitutes were found to be consistent with the significant global improvement described.
Another 12 week randomized, double-blind, parallel-group, placebo-controlled study was conducted in 373 patients (16 men, 357 women) whose mean age was 55 years with a range of 21 to 84. The racial distribution was Caucasian 80%, Oriental 14%, Black 2%, and 4% of other origin. The treatment groups were 2.5 mg Pilocarpine Tablets, 5 mg pilocarpine hydrochloride tablets, and placebo. All treatments were administered on a four times a day regimen.
After 12 weeks of treatment, statistically significant global improvement of dry mouth was observed at a dose of 5 mg compared with placebo. The 2.5 mg (10mg/day) group was not significantly different than placebo. However, a subgroup of patients with rheumatoid arthritis tended to improve in global assessments at both the 2.5 mg q.i.d. (9 patients) and 5 mg q.i.d. (16 patients) dose (10-20 mg/day). The clinical significance of this finding is unknown.
Patients' assessments of specific dry mouth symptoms such as severity of dry mouth, mouth discomfort, ability to sleep without drinking water, and decreased use of saliva substitutes were also found to be consistent with the significant global improvement described when measured after 6 weeks and 12 weeks of pilocarpine hydrochloride tablets use.
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.
Pilocarpine hydrochloride tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
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.
Pilocarpine toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may include: headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, and tremors.
The dose-related cardiovascular pharmacologic effects of pilocarpine include hypotension, hypertension, bradycardia, and tachycardia.
Pilocarpine should be administered with caution to patients with known or suspected cholelithiasis or biliary tract disease. Contractions of the gallbladder or biliary smooth muscle could precipitate complications including cholecystitis, cholangitis, and biliary obstruction.
Pilocarpine may increase ureteral smooth muscle tone and could theoretically precipitate renal colic (or "ureteral reflux"), particularly in patients with nephrolithiasis.
Cholinergic agonists may have dose-related central nervous system effects. This should be considered when treating patients with underlying cognitive or psychiatric disturbances.
Based on decreased plasma clearance observed in patients with moderate hepatic impairment, the starting dose in these patients should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency (Child-Pugh score of 5-6) do not require dosage reductions. To date, pharmacokinetic studies in subjects with severe hepatic impairment (Child-Pugh score of 10-15) have not been carried out. The use of pilocarpine in these patients is not recommended.
| Clinical and Biochemical Measurements | Points Scored for Increasing Abnormality | ||
|---|---|---|---|
| 1 | 2 | 3 | |
| |||
| Encephalopathy (grade)* | None | 1 and 2 | 3 and 4 |
| Ascites | Absent | Slight | Moderate |
| Bilirubin (mg. Per 100 ml.) | 1-2 | 2-3 | >3 |
| Albumin (g. per 100 ml.) | 3-5 | 2.8-3.5 | <2.8 |
| Prothrombin time (sec. Prolonged) | 1-4 | 4-6 | >6 |
| For primary biliary cirrhosis:- Bilirubin (mg. Per 100 ml.) | 1-4 | 4-10 | >10 |
Reference: Pugh, RNH, Murray-Lyon, IM, Dawson, JL Pietroni, MC, Williams, R. Transection of the oesophagus for bleeding oesophageal varices, Brit. J. Surg. 1973;60:646-9.
Patients should be informed that pilocarpine may cause visual disturbances, especially at night, that could impair their ability to drive safely.
If a patient sweats excessively while taking pilocarpine hydrochloride and cannot drink enough liquid, the patient should consult a physician. Dehydration may develop.
Pilocarpine should be administered with caution to patients taking beta adrenergic antagonists because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered concurrently with pilocarpine would be expected to result in additive pharmacologic effects.
Pilocarpine might antagonize the anticholinergic effects of drugs used concomitantly. These effects should be considered when anticholinergic properties may be contributing to the therapeutic effect of concomitant medication (e.g., atropine, inhaled ipratropium).
While no formal drug interaction studies have been performed, the following concomitant drugs were used in at least 10% of patients in either or both Sjogren's efficacy studies: acetylsalicylic acid, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol, and prednisone.
Lifetime oral carcinogenicity studies were conducted in CD-1 mice and Sprague-Dawley rats. Pilocarpine did not induce tumors in mice at any dosage studied (up to 30 mg/kg/day, which yielded a systemic exposure approximately 50 times larger than the maximum systemic exposure observed clinically). In rats, a dosage of 18 mg/kg/day, which yielded a systemic exposure approximately 100 times larger than the maximum systemic exposure observed clinically, resulted in a statistically significant increase in the incidence of benign pheochromocytomas in both males and females, and a statistically significant increase in the incidence of hepatocellular adenomas in female rats. The tumorigenicity observed in rats was observed only at a large multiple of the maximum labeled clinical dose, and may not be relevant to clinical use.
No evidence that pilocarpine has the potential to cause genetic toxicity was obtained in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations; 2) an in vitro chromosome aberration assay in a Chinese hamster ovary cell line; 3) an in vivo chromosome aberration assay (micronucleus test) in mice; and 4) a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures.
Oral administration of pilocarpine to male and female rats at a dosage of 18 mg/kg/day, which yielded a systemic exposure approximately 100 times larger than the maximum systemic exposure observed clinically, resulted in impaired reproductive function, including reduced fertility, decreased sperm motility, and morphologic evidence of abnormal sperm. It is unclear whether the reduction in fertility was due to effects on male animals, female animals, or both males and females. In dogs, exposure to pilocarpine at a dosage of 3 mg/kg/day (approximately 3 times the maximum recommended human dose when compared on the basis of body surface area (mg/m2) estimates) for six months resulted in evidence of impaired spermatogenesis. The data obtained in these studies suggest that pilocarpine may impair the fertility of male and female humans. Pilocarpine hydrochloride tablets should be administered to individuals who are attempting to conceive a child only if the potential benefit justifies potential impairment of fertility.
Pregnancy Category C
Pilocarpine was associated with a reduction in the mean fetal body weight and an increase in the incidence of skeletal variations when given to pregnant rats at a dosage of 90 mg/kg/day (approximately 26 times the maximum recommended dose for a 50 kg human when compared on the basis of body surface area (mg/m2) estimates). These effects may have been secondary to maternal toxicity. In another study, oral administration of pilocarpine to female rats during gestation and lactation at a dosage of 36 mg/kg/day (approximately 10 times the maximum recommended dose for a 50 kg human when compared on the basis of body surface area (mg/m2) estimates) resulted in an increased incidence of stillbirths; decreased neonatal survival and reduced mean body weight of pups were observed at dosages of 18 mg/kg/day (approximately 5 times the maximum recommended dose for a 50 kg human when compared on the basis of body surface area (mg/m2) estimates) and above. There are no adequate and well-controlled studies in pregnant women. Pilocarpine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from pilocarpine hydrochloride tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
In the placebo-controlled clinical trials (see Clinical Studies section) the mean age of patients was approximately 58 years (range 19 to 80). Of these patients, 97/369 (61/217 receiving pilocarpine) were over the age of 65 years. In the healthy volunteer studies, 15/150 subjects were over the age of 65 years. In both study populations, the adverse events reported by those over 65 years and those 65 years and younger were comparable. Of the 15 elderly volunteers (5 women, 10 men), the 5 women had higher Cmax's and AUC's than the men. (See Pharmacokinetics section.)
In the placebo-controlled clinical trials (see Clinical Studies section), the mean age of patients was approximately 55 years (range 21 to 85). The adverse events reported by those over 65 years and those 65 years and younger were comparable except for notable trends for urinary frequency, diarrhea, and dizziness (see ADVERSE REACTIONS section).
In controlled studies, 217 patients received pilocarpine, of whom 68% were men and 32% were women. Race distribution was 91% Caucasian, 8% Black, and 1% of other origin. Mean age was approximately 58 years. The majority of patients were between 50 and 64 years (51%), 33% were 65 years and older and 16% were younger than 50 years of age.
The most frequent adverse experiences associated with pilocarpine hydrochloride tablets were a consequence of the expected pharmacologic effects of pilocarpine.
| Adverse Event | Pilocarpine HCl | Placebo | |
|---|---|---|---|
| 10 mg t.i.d. (30 mg/day) | 5 mg t.i.d. (15 mg/day) | (t.i.d.) | |
| N=121 | N=141 | N=152 | |
| Sweating | 68% | 29% | 9% |
| Nausea | 15 | 6 | 4 |
| Rhinitis | 14 | 5 | 7 |
| Diarrhea | 7 | 4 | 5 |
| Chills | 15 | 3 | <1 |
| Flushing | 13 | 8 | 3 |
| Urinary Frequency | 12 | 9 | 7 |
| Dizziness | 12 | 5 | 4 |
| Asthenia | 12 | 6 | 3 |
In addition, the following adverse events (≥3% incidence) were reported at dosages of 15-30 mg/day in the controlled clinical trials:
| Adverse Event | Pilocarpine HCl | Placebo |
|---|---|---|
| 5-10 mg t.i.d. (15-30 mg/day) | (t.i.d.) | |
| N=212 | N=152 | |
| Headache | 11% | 8% |
| Dyspepsia | 7 | 5 |
| Lacrimation | 6 | 8 |
| Edema | 5 | 4 |
| Abdominal Pain | 4 | 4 |
| Amblyopia | 4 | 2 |
| Vomiting | 4 | 1 |
| Pharyngitis | 3 | 8 |
| Hypertension | 3 | 1 |
The following events were reported with treated head and neck cancer patients at incidences of 1% to 2% at dosages of 7.5 to 30 mg/day: abnormal vision, conjunctivitis, dysphagia, epistaxis, myalgias, pruritus, rash, sinusitis, tachycardia, taste perversion, tremor, voice alteration.
The following events were reported rarely in treated head and neck cancer patients (<1%): Causal relation is unknown.
Body as a whole: body odor, hypothermia, mucous membrane abnormality
Cardiovascular: bradycardia, ECG abnormality, palpitations, syncope
Digestive: anorexia, increased appetite, esophagitis, gastrointestinal disorder, tongue disorder
Hematologic: leukopenia, lymphadenopathy
Nervous: anxiety, confusion, depression, abnormal dreams, hyperkinesia, hypesthesia, nervousness, parethesias, speech disorder, twitching
Respiratory: increased sputum, stridor, yawning
Skin: seborrhea
Special senses: deafness, eye pain, glaucoma
Urogenital: dysuria, metrorrhagia, urinary impairment
In long-term treatment were two patients with underlying cardiovascular disease of whom one experienced a myocardial infarct and another episode of syncope. The association with drug is uncertain.
In controlled studies, 376 patients received pilocarpine, of whom 5% were men and 95% were women. Race distribution was 84% Caucasian, 9% Oriental, 3% Black, and 4% of other origin. Mean age was 55 years. The majority of patients were between 40 and 69 years (70%), 16% were 70 years and older and 14% were younger than 40 years of age. Of these patients, 161/629 (89/376 receiving pilocarpine) were over the age of 65 years. The adverse events reported by those over 65 years and those 65 years and younger were comparable except for notable trends for urinary frequency, diarrhea, and dizziness. The incidences of urinary frequency and diarrhea in the elderly were about double those in the non-elderly. The incidence of dizziness was about three times as high in the elderly as in the non-elderly. These adverse experiences were not considered to be serious. In the 2 placebo-controlled studies, the most common adverse events related to drug use were sweating, urinary frequency, chills, and vasodilatation (flushing). The most commonly reported reason for patient discontinuation of treatment was sweating. Expected pharmacologic effects of pilocarpine include the following adverse experiences associated with pilocarpine hydrochloride tablets:
| Adverse Event | Pilocarpine HCl | Placebo |
|---|---|---|
| 5 mg q.i.d. (20 mg/day) | (q.i.d.) | |
| N=255 | N=253 | |
| Sweating | 40% | 7% |
| Urinary Frequency | 10 | 4 |
| Nausea | 9 | 9 |
| Flushing | 9 | 2 |
| Rhinitis | 7 | 8 |
| Diarrhea | 6 | 7 |
| Chills | 4 | 2 |
| Increased Salivation | 3 | 0 |
| Asthenia | 2 | 2 |
In addition, the following adverse events (≥3% incidence) were reported at dosages of 20 mg/day in the controlled clinical trials:
| Adverse Event | Pilocarpine HCl | Placebo |
|---|---|---|
| 5 mg q.i.d. (20 mg/day) | (q.i.d.) | |
| N=255 | N=253 | |
| Headache | 13% | 19% |
| Flu Syndrome | 9 | 9 |
| Dyspepsia | 7 | 7 |
| Dizziness | 6 | 7 |
| Pain | 4 | 2 |
| Sinusitis | 4 | 5 |
| Abdominal Pain | 3 | 4 |
| Vomiting | 3 | 1 |
| Pharyngitis | 2 | 5 |
| Rash | 2 | 3 |
| Infection | 2 | 6 |
The following events were reported in Sjogren's patients at incidences of 1% to 2% at dosing of 20 mg/day: accidental injury, allergic reaction, back pain, blurred vision, constipation, increased cough, edema, epistaxis, face edema, fever, flatulence, glossitis, lab test abnormalities, including chemistry, hematology, and urinalysis, myalgia, palpitation, pruritus, somnolence, stomatitis, tachycardia, tinnitus, urinary incontinence, urinary tract infection, vaginitis.
The following events were reported rarely in treated Sjogren's patients (<1%) at dosing of 10-30 mg/day: Causal relation is unknown.
Body as a whole: chest pain, cyst, death, moniliasis, neck pain, neck rigidity, photosensitivity reaction
Cardiovascular: angina pectoris, arrhythmia, ECG abnormality, hypotension, hypertension, intracranial hemorrhage, migraine, myocardial infarction
Digestive: anorexia, bilirubinemia, cholelithiasis, colitis, dry mouth, eructation, gastritis, gastroenteritis, gastrointestinal disorder, gingivitis, hepatitis, abnormal liver function tests, melena, nausea & vomiting, pancreatitis, parotid gland enlargement, salivary gland enlargement, sputum increased, taste loss, tongue disorder, tooth disorder
Hematologic: hematuria, lymphadenopathy, abnormal platelets, thrombocythemia, thrombocytopenia, thrombosis, abnormal WBC
Metabolic and Nutritional: peripheral edema, Hypoglycemia
Musculoskeletal: arthralgia, arthritis, bone disorder, spontaneous bone fracture, pathological fracture, myasthenia, tendon disorder, tenosynovitis
Nervous: aphasia, confusion, depression, abnormal dreams, emotional lability, hyperkinesia, hypesthesia, insomnia, leg cramps, nervousness, parethesias, abnormal thinking, tremor
Respiratory: bronchitis, dyspnea, hiccup, laryngismus, laryngitis, pneumonia, viral infection, voice alteration
Skin: alopecia, contact dermatitis, dry skin, eczema, erythema nodosum, exfoliative dermatitis, herpes simplex, skin ulcer, vesiculobullous rash
Special senses: cataract, conjunctivitis, dry eyes, ear disorder, ear pain, eye disorder, eye hemorrhage, glaucoma, lacrimation disorder, retinal disorder, taste perversion, abnormal vision
Urogenital: breast pain, dysuria, mastitis, menorrhagia, metrorrhagia, ovarian disorder, pyuria, salpingitis, urethral pain, urinary urgency, vaginal hemorrhage, vaginal moniliasis
The following adverse experiences have been reported rarely with ocular pilocarpine: A-V block, agitation, ciliary congestion, confusion, delusion, depression, dermatitis, middle ear disturbance, eyelid twitching, malignant glaucoma, iris cysts, macular hole, shock, and visual hallucination.
Fatal overdosage with pilocarpine has been reported in the scientific literature at doses presumed to be greater than 100 mg in two hospitalized patients. 100 mg of pilocarpine is considered potentially fatal. Overdosage should be treated with atropine titration (0.5 mg to 1.0 mg given subcutaneously or intravenously) and supportive measures to maintain respiration and circulation. Epinephrine (0.3 mg to 1.0 mg, subcutaneously or intramuscularly) may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if pilocarpine is dialyzable.
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.
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.
The recommended dose of pilocarpine hydrochloride tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.
Pilocarpine hydrochloride tablets, 5 mg are white, film coated, round tablets, debossed LAN on one side and 1313 on the other side. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows:
Bottles of 100; NDC 0527-1313-01
Store at 20°- 25°C(68°-77°F) [see USP Controlled Room Temperature].
Pilocarpine hydrochloride tablets, 7.5 mg are blue, film coated, round tablets, debossed LCI on one side and 1407 on the other side. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows:
Bottles of 100; NDC 0527-1407-01
Store at 20°- 25°C(68°-77°F) [see USP Controlled Room Temperature].
Manufactured by:
Lannett Company, Inc.
Philadelphia, PA 19136
Revised 06/09
NDC 0527-1313-01
LANNETT
PILOCARPINE
HYDROCHLORIDE
TABLETS
5 mg
Rx Only
100 TABLETS
NDC 0527-1407-01
LANNETT
PILOCARPINE
HYDROCHLORIDE
TABLETS
7.5 mg
Rx Only
100 TABLETS
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