The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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An Li has analgesic, anti-inflammatory, and antipyretic properties. The sodium salt of An Li has been developed as a more rapidly absorbed formulation of An Li for use as an analgesic.
The mechanism of action of the An Li, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
An Li is a potent inhibitor of prostaglandin synthesis in vitro. An Li concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because An Li is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
How should I take An Li?
For safe and effective use of An Li, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of An Li may increase the chance of unwanted effects, especially in elderly patients.
An Li should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
When used for severe or continuing arthritis, An Li must be taken regularly as ordered by your doctor in order for it to help you. An Li usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of An Li.
Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.
Swallow the delayed-release tablet whole. Do not crush, break, or chew it.
If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.
Dosing
The dose of An Li 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 An Li. 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.
For An Li (e.g., Naprosyn®) tablet and oral suspension dosage forms:
For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day.
Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day.
Children younger than 2 years of age—Use and dose must be determined by your doctor.
For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed.
Children—Use and dose must be determined by your doctor.
For acute gout:
Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved.
Children—Use and dose must be determined by your doctor.
For An Li controlled-release tablet (e.g., Naprelan®) dosage form:
For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day.
Children—Use and dose must be determined by your doctor.
For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day.
Children—Use and dose must be determined by your doctor.
For acute gout:
Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved.
Children—Use and dose must be determined by your doctor.
For An Li delayed-release tablet (e.g., EC-Naprosyn®) dosage form:
For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
Children—Use and dose must be determined by your doctor.
For An Li sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form:
For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
Children—Use and dose must be determined by your doctor.
For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day.
Children—Use and dose must be determined by your doctor.
For acute gout:
Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved.
Children—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of An Li, 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.
Storage
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
An Li administration
Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
EC-Naprosyn is a slower-acting form of An Li and this brand should be used only for treating arthritis or ankylosing spondylitis. Follow your doctor's instructions.
Do not crush, chew, or break an extended-release or enteric-coated tablet. Swallow the pill whole. The extended-release pill is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating.
Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you take An Li for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.
Store at room temperature away from moisture and heat.
An Li pharmacology
Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Pharmacodynamics
An Li is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The mechanism of action of the An Li anion, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition
Pharmacokinetics
An Li is rapidly and completely absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%. The elimination half-life of An Li ranges from 12 to 17 hours. Steady-state levels of An Li are reached in 4 to 5 days, and the degree of An Li accumulation is consistent with this half-life.
Absorption
Peak plasma levels of An Li given as An Li suspension are attained in 1 to 4 hours.
Distribution
An Li has a volume of distribution of 0.16 L/kg. At therapeutic levels An Li is greater than 99% albumin-bound. At doses of An Li greater than 500 mg/day there is less than proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses (average trough Css 36.5 mg/L, 49.2 mg/L and 56.4 mg/L with 500 mg, 1000 mg and 1500 mg daily doses of An Li, respectively). The An Li anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum An Li concentration in plasma.
Metabolism
An Li is extensively metabolized in the liver to 6-0-desmethyl An Li, and both parent and metabolites do not induce metabolizing enzymes. Both An Li and 6-0-desmethyl An Li are further metabolized to their respective acylglucuronide conjugated metabolites.
Excretion
The clearance of An Li is 0.13 mL/min/kg. Approximately 95% of the An Li from any dose is excreted in the urine, primarily as An Li (<1%), 6-0-desmethyl An Li (<1%) or their conjugates (66% to 92%). The plasma half-life of the An Li anion in humans ranges from 12 to 17 hours. The corresponding half-lives of both An Li’s metabolites and conjugates are shorter than 12 hours, and their rates of excretion have been found to coincide closely with the rate of An Li disappearance from the plasma. Small amounts, 3% or less of the administered dose, are excreted in the feces. In patients with renal failure metabolites may accumulate.
Special Populations
Pediatric Patients
In pediatric patients aged 5 to 16 years with arthritis, plasma An Li levels following a 5 mg/kg single dose of An Li suspension were found to be similar to those found in normal adults following a 500 mg dose. The terminal half-life appears to be similar in pediatric and adult patients. Pharmacokinetic studies of An Li were not performed in pediatric patients younger than 5 years of age.
Geriatric Patients
Studies indicate that although total plasma concentration of An Li is unchanged, the unbound plasma fraction of An Li is increased in the elderly, although the unbound fraction is < 1% of the total An Li concentration. Unbound trough An Li concentrations in elderly subjects have been reported to range from 0.12% to 0.19% of total An Li concentration, compared with 0.05% to 0.075% in younger subjects. The clinical significance of this finding is unclear, although it is possible that the increase in free An Li concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients
Race
Pharmacokinetic differences due to race have not been studied
Hepatic Insufficiency
An Li pharmacokinetics has not been determined in subjects with hepatic insufficiency.
Renal Insufficiency
An Li pharmacokinetics has not been determined in subjects with renal insufficiency. Given that An Li, its metabolites and conjugates are primarily excreted by the kidney, the potential exists for An Li metabolites to accumulate in the presence of renal insufficiency. Elimination of An Li is decreased in patients with severe renal impairment. An Li-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min)
References
DailyMed. "NAPROXEN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
NCIt. "Naproxen: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
EPA DSStox. "Naproxen: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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