Salagen 5 mg
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Salagen from online pharmacy: Israel
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What is Salagen?
Salagen tablets contain the drug called pilocarpine, and also contain the inactive ingredients: stearic acid, cellulosehydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, polysorbate 80, shellac, ethanol, synthetic black iron oxide, N-butyl alcohol, propylene glycol, ethylene glycol monoethyl ether, lecithin, methyl alcohol, and carnauba wax.
How do Salagen Tablets Work?
Depending on your condition, your doctor has prescribed Salagen tablets to restore comfort to your dry mouth and/or your dry eyes. Salagen tablets cause your salivary glands and your tear glands to make more of your natural saliva and tears. If you have a dry mouth, Salagen tablets will make your mouth feel less dry, you will have less pain in your mouth, it will be easier to talk, chew, swallow, and wear dentures, and you will not need to drink as much water or other liquids that help to keep your mouth wet. If you have dry eyes, Salagen tablets will make your eyes feel less dry, you will have less burning, itching, and redness, and you will not need to use as much artificial tears or other liquids that help keep your eyes moist.
Why Do You Need Saliva?
Saliva is not water. Most of your saliva is produced by 3 major pairs of salivary glands, all located in and around your mouth. Saliva contains many important ingredients such as proteins, enzymes and minerals which protect your teeth, gums and mouth. Each person needs adequate amounts of saliva to:
control the growth of bacteria, viruses, and fungi which lead to infections and tooth decay
clean the mouth of food
continually rinse the teeth with minerals to keep them strong and prevent cavities
lubricate the mouth and throat to make speaking, chewing, and swallowing easier
dissolve foods and let you taste them better
provide enzymes that help you digest your food
Why Do You Need Tears?
Like saliva, tears are not water. Most of your tears are produced by your major tear glands located in the inside upper part of your eyelids. Tears contain many important ingredients such as proteins and enzymes which protect your eye and the surrounding soft tissues. Each person needs adequate amounts of tears to:
prevent and control the growth of bacteria, viruses, and fungi which lead to infections
lubricate and protect the surface of the eye
rinse and clean the eye of foreign objects
What Should Your Doctor Know Before You Start Taking Salagen Tablets?
You doctor needs to know:
If you have ever had any problem with:
allergy to pilocarpine, or any other ingredient in this formulation (see What is Salagen?, above),
heart (e.g., abnormal heartbeat, heart failure)
blood pressure (e.g., high blood pressure, low blood pressure)
lungs (e.g., difficulty breathing, bronchitis, emphysema)
liver (e.g., hepatitis, cirrhosis, liver disease)
eyes or vision (e.g., blurred vision, difficulty seeing at night, glaucoma, iritis)
stomach (e.g., frequent heartburn or indigestion, ulcers)
kidneys (e.g., difficulty urinating, kidney failure, kidney stones)
gallbladder (e.g., gall stones)
nervous system (e.g., confusion, tremors, psychiatric illness)
Some medical problems may get worse while you are taking Salagen tablets. Your doctor will tell you if he or she wants you to take Salagen tablets.
if you are pregnant, if you become pregnant, or if you are breast-feeding your baby. Your doctor will tell you if he or she wants you to take Salagen tablets.
if you are taking, or if you begin taking, any other medicines, even medicines you buy without a prescription. Some medicines may interfere with each other in your body.
How and When Should You Take Salagen Tablets?
Take Salagen tablets exactly as your doctor tells you.
Most people take Salagen 3 or 4 times a day, however, your doctor may recommend a reduced dosage if you suffer from liver or kidney problems. Salagen tablets can be taken with or without food. Usually, you would take 1 tablet about the same time every day with something you do regularly—for example 1 tablet around breakfast, another around lunch, and another around your evening meal or at bedtime. This will help you remember each dose.
Do not chew or bite on the tablet.
Do not take more than 2 tablets at a time or more than 6 tablets/day unless your doctor tells you.
What if You Forget to Take a Dose of Salagen Tablets?
If you miss a dose of Salagen, just take the next dose when you normally would.
How Long Will Salagen Take for Salagen Tablets to Work?
How well and how quickly Salagen tablets work varies from person to person. It depends on your individual condition, and how long you have had a dry mouth and/or dry eyes. You may start to feel relief of your dry mouth and/or dry eyes within a week of starting Salagen tablets, or it could take 3 months or longer.
For best results, you should do the following:
help your doctor find the right dose for you;
give it enough time to work.
If your dry mouth and/or dry eyes do not start to feel better after 1 week, do not stop taking your tablets—tell your doctor. Your doctor may decide to adjust your dose. Take Salagen tablets exactly as your doctor tells you. Ask your doctor when he or she wants to see you for a check-up. If at that time your dry mouth and/or dry eyes is still not starting to feel better, tell your doctor. He or she may decide to adjust your dose again.
How Long Will You Have to Take Salagen Tablets?
This depends on your condition. You may need to take Salagen tablets for a long period of time to keep from having a dry mouth and/or dry eyes.
What Are The Possible Side Effects for Salagen When Taking Salagen?
Some people have unwanted effects from this medicine. Remember, medicines affect different people in different ways. Just because side effects have occurred in other people does not mean you will get them.
Most side effects that could occur have been generally mild or of moderate intensity. The possible side effects are:
mild to moderate sweating,
nausea (feeling sick) and vomiting,
passing urine more often,
problems with digestion,
flushing (redness in face).
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
What Precautions Should You Take?
There are some things you and your doctor need to be aware of so that you can use Salagen safely.
Some people find Salagen tablets affect their vision. Make sure you know how this medicine affects you before you do dangerous activities at night or in low light (example: drive a car or use machines).
Tell your doctor right away if you notice any of the following symptoms where you:
feel weak and have to lie down
feel confused, agitated, or very depressed
get very red, swollen or painful eyes
get chest pain, a rapid heartbeat, or your pulse races
have difficulty breathing
get a skin rash
get severe pain in your stomach or abdomen
find side effects of the following continue, bother you, or are not easily explained. These include: mild to moderate sweating, chills, nausea (feeling sick) and vomiting, diarrhea, passing urine more often, constipation, problems with digestion, vision abnormalities, dizziness, runny eyes, runny nose, headache, flushing (redness in face).
Information for the Patient
Geriatrics: Pharmacokinetics in elderly male volunteers (n=11) were comparable to those in younger men. In 5 healthy elderly female volunteers, the mean Cmax and AUC were approximately twice that of elderly males and young normal male volunteers.
Hepatic Impairment: In (n=12) cirrhotic subjects with mild to moderate hepatic impairment (Child-Pugh Grades A, mild (n=9) & B, moderate (n=3)), administration of a single 5 mg oral dose resulted in decreased apparent plasma clearance. Relative to normal volunteers, subjects with mild and moderate hepatic impairment had 1.4- and 3.3-fold lower apparent plasma clearance, respectively. Compared to normal subjects, Cmax values were 20-40% higher in subjects with mild and moderate hepatic impairment. AUC values were 1.4- and 3.3-fold higher in subjects with mild and moderate impairment, respectively. The plasma elimination half-life of pilocarpine was increased by 30% in subjects with mild hepatic impairment but was at least 2-fold higher in subjects with moderate impairment. Moderate hepatic impairment produced markedly different pharmacokinetic profiles and AUC was positively correlated (r2 = 0.669) with Child-Pugh score. Thus, in patients with mild and moderate hepatic impairment, treatment initiation should employ a reduced daily dosage. No pharmacokinetic data are available for any dose of pilocarpine in patients with severe hepatic impairment (Child-Pugh Grade C; see Precautions and Dosage).
Renal Impairment: There is no reliable data for the pharmacokinetics of orally administered pilocarpine in patients with renal disease (see Precautions and Dosage).
Absorption and Distribution: 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 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.
The results of an in vitro protein binding study indicate 3H-pilocarpine HCl is not bound to plasma proteins as determined in either rat or human plasma.
Biotransformation and Elimination: 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, which include pilocarpic acid, are excreted in the urine.
|Dose|| Tmax |
| Cmax |
| AUCb |
| t1/2 |
|5 mg (n=10)||1.25||14.61||33.04||0.76|
|10 mg (n=9)||0.85||41.35||107.96||1.35|
b. Trapezoidal values.
For the treatment of the symptoms of xerostomia (dry mouth) due to salivary gland hypofunction caused by radiotherapy for cancer of the head and neck.
For the treatment of the symptoms of xerostomia (dry mouth) and xerophthalmia (dry eyes) in patients with Sjögren's syndrome.
The data obtained from a study in rats suggest that pilocarpine may impair the fertility of male and female humans. Therefore, pilocarpine tablets should be administered to individuals who are attempting to conceive a child only if the potential benefit justifies potential impairment of fertility.
Pilocarpine tablets 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 tablets would be expected to result in additive pharmacologic effects. Pilocarpine tablets 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 Sjögren's pivotal studies: acetaminophen, ASA, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole and prednisone. There were no reports of drug toxicities during either trial.
Ocular administration of pilocarpine has been reported to cause visual blurring and impairment of depth perception which may result in decreased visual acuity, especially at night and in patients with central lens changes. Patients should be cautioned about driving at night or performing hazardous activities in reduced lighting while receiving therapy with pilocarpine tablets.
It is not presently 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 tablets, a decision should be made whether to discontinue nursing or to discontinue the drug.
Pilocarpine does not have the potential for addiction; consequently, there have been no reports of addiction with the use of pilocarpine. There are no known withdrawal effects associated with pilocarpine either in animals or in humans. The pharmacologic effects, other than salivation, are not pleasurable, thus, there is no reason to suspect it will be abused.
Safety and effectiveness of pilocarpine tablets have not been studied in children under 18 years of age.
Gastrointestinal Disease: Pilocarpine tablets should be administered with caution to patients with known or suspected cholelithiasis or biliary tract disease. Contractions of the gallbladder and biliary smooth muscle could precipitate complications including cholecystitis, cholangitis, and biliary obstruction.
Cholinergic agonists, like pilocarpine, may cause increased acid secretion. This possibility should be considered when treating patients with active peptic ulcer disease.
Renal Disease: Pilocarpine may increase ureteral smooth muscle tone and could theoretically precipitate renal colic or "ureteral reflux" in patients with renal dysfunction (eg. nephrolithiasis).
There is no reliable data for the pharmacokinetics of orally administered pilocarpine in patients with renal disease. Thus, caution should be observed if pilocarpine is to be administered to patients with renal disease (see Dosage).
Hepatic Impairment: Decreased pilocarpine plasma clearance was observed in patients with mild to moderate hepatic impairment (see Pharmacology). Patients with mild and moderate hepatic impairment should begin treatment at a reduced daily dose, gradually increasing the dosage up to 5 mg three to four times daily as safety and tolerability allow. (See Dosage.) No pharmacokinetic data are available for any dose of pilocarpine in patients with severe hepatic impairment (Childs-Pugh Grade C). Therefore, pilocarpine is not recommended for use in patients with severe hepatic impairment. However, should clinical judgement deem it necessary, the drug should be used with extreme caution (see Dosage).
CNS Disorders: Cholinergic agonists, like pilocarpine HCl, may have dose-related central nervous system effects. This should be considered when treating patients with underlying cognitive or psychiatric disturbances.
Pilocarpine toxicity is characterized by an exaggeration of its parasympathomimetic effects.
The dose-related cardiovascular pharmacologic effects of pilocarpine include hypotension, hypertension, bradycardia, and tachycardia (see also Warnings).
The safety of pilocarpine tablets has not been established in human pregnancy. Therefore, pilocarpine tablets should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus.
Each white, round, biconvex, film-coated unscored tablet, printed with “SAL” on one side and “5” on the other side, contains: pilocarpine HCl 5 mg. Nonmedicinal ingredients: microcrystalline cellulose and stearic acid; coating: hydroxypropyl methylcellulose, polyethylene glycol, polysorbate 80 and titanium dioxide; ink: ethanol, ethylene glycol monoethyl ether, lecithin, methyl alcohol, N-butyl alcohol, propylene glycol, shellac and synthetic black iron oxide. Polish: carnauba wax. Bottles of 100. Store at room temperature (15 to 30°C).
In patients with uncontrolled asthma; when miosis is undesirable (e.g., acute iritis and in narrow-angle [angle closure] glaucoma); in patients with known sensitivity to pilocarpine, or to any of the tablet's excipients.
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. Pilocarpine tablets should be administered with caution and under close medical supervision to patients with significant cardiovascular disease.
Pulmonary Disease: Pilocarpine has been reported to increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Pilocarpine tablets should be administered with caution and under close medical supervision to patients with significant pulmonary disease (e.g., controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease).
Should any adverse changes in the patient's cardiopulmonary condition occur, or be suspected, therapy with pilocarpine tablets should be discontinued immediately.
back pain, myalgia.
The following events were reported by Sjögren's patients at incidences of 1 to 2% at dosages of 10 to 30 mg/day:
constipation, flatulence, glossitis, stomatitis.
urinary incontinence, urinary tract infection, vaginitis.
blurred vision, tinnitus.
edema, face edema.
accidental injury, allergic reaction, fever, abnormal lab test.
cough increased, epistaxis.
The following events were reported by head and neck cancer patients at incidences of 1 to 2% at dosages of 15 to 30 mg/day:
Toxicity from pilocarpine is characterized chiefly by exaggeration of parasympathomimetic effects and resembles “muscarinic poisoning” (e.g., consumption of mushrooms of the genus Inocybe). Dose-dependent symptoms include salivation, sweating, vomiting, respiratory distress, hypotension, diarrhea, nausea and shock. Mental confusion and cardiac arrhythmias can also occur.
A fatal overdose with oral administration of ocular pilocarpine, resulting from poisoning, has been reported in the literature. The symptoms included: salivation, pinpoint pupils, sweating, dyspnea, tachypnea, tachycardia, and pulmonary edema.
There are several reports of pilocarpine overdosage reported with the treatment of angle-closure glaucoma. Cardiovascular decompensation has been noted in patients with acute closed-angle glaucoma who have received intraocular instillation of pilocarpine in excess of 60 to 100 mg over short periods prior to eye surgery. Other reported symptoms occurring in this situation include nausea, vomiting, profuse sweating, tremor, hypotension, sinus bradycardia, AV block, changes in mental state, and shock.
Overdosage with pilocarpine should be treated with atropine titration (0.5 to 1 mg given s.c. or i.v.) and supportive measures to maintain respiration and circulation. Epinephrine (0.3 to 1 mg, s.c. or i.m.) may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if pilocarpine is dialyzable.
The usual dose for initiation of treatment is 5 mg 3 or 4 times daily. Titration up to 10 mg (2 tablets)/dose, not to exceed a total of 30 mg (6 tablets)/day, may be considered for patients who have not responded adequately and who can tolerate the lower doses. The lowest dose that is tolerated and effective should be used for maintenance.
Treatment should begin at the first signs of xerostomia. Clinical experience indicates that the relief of xerostomia and/or xerophthalmia improves over time with the administration of pilocarpine tablets. Administration at the above recommended dosage, for 12 or more weeks may be required before relief can be expected. Onset and degree of relief may vary among patients.
Hepatic impairment: Patients with mild and moderate hepatic impairment should begin treatment at a reduced daily dosage, gradually increasing the dosage up to 5 mg three to four times daily as safety and tolerability allow. No pharmacokinetic data are available for any dose of pilocarpine in patients with severe hepatic impairment (Child-Pugh Grade C). Therefore, pilocarpine is not recommended for use in patients with severe hepatic impairment. However, should clinical judgment deem it necessary, the drug should be used with extreme caution (see Precautions and Pharmacology).
Renal Impairment: There is no reliable data for the pharmacokinetics of orally administered pilocarpine in patients with renal disease. Thus, caution should be observed if pilocarpine is to be administered to patients with renal disease (see Precautions).