Actions of Apo-Naproxen in details
Apo-Naproxen has analgesic, anti-inflammatory, and antipyretic properties. The sodium salt of Apo-Naproxen has been developed as a more rapidly absorbed formulation of Apo-Naproxen for use as an analgesic.
The mechanism of action of the Apo-Naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Apo-Naproxen is a potent inhibitor of prostaglandin synthesis in vitro. Apo-Naproxen 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 Apo-Naproxen 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 Apo-Naproxen?
Use Apo-Naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.
Do not crush, chew, or break a Apo-Naproxen tablet. Swallow it whole.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
If you change brands, strengths, or forms of Apo-Naproxen, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of Apo-Naproxen you are using.
If a child is using this medicine, tell your doctor if the child has any changes in weight. Apo-Naproxen doses are based on weight in children, and any changes may affect your child's dose.
If you use Apo-Naproxen long-term, you may need frequent medical tests.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Apo-Naproxen.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Apo-Naproxen administration
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-Apo-Naproxen is a slower-acting form of Apo-Naproxen 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 Apo-Naproxen 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.
Apo-Naproxen pharmacology
Pharmacodynamics
Apo-Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The mechanism of action of the Apo-Naproxen anion, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition
Pharmacokinetics
Apo-Naproxen is rapidly and completely absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%. The elimination half-life of Apo-Naproxen ranges from 12 to 17 hours. Steady-state levels of Apo-Naproxen are reached in 4 to 5 days, and the degree of Apo-Naproxen accumulation is consistent with this half-life.
Absorption
Peak plasma levels of Apo-Naproxen given as Apo-Naproxen suspension are attained in 1 to 4 hours.
Distribution
Apo-Naproxen has a volume of distribution of 0.16 L/kg. At therapeutic levels Apo-Naproxen is greater than 99% albumin-bound. At doses of Apo-Naproxen 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 Apo-Naproxen, respectively). The Apo-Naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum Apo-Naproxen concentration in plasma.
Metabolism
Apo-Naproxen is extensively metabolized in the liver to 6-0-desmethyl Apo-Naproxen, and both parent and metabolites do not induce metabolizing enzymes. Both Apo-Naproxen and 6-0-desmethyl Apo-Naproxen are further metabolized to their respective acylglucuronide conjugated metabolites.
Excretion
The clearance of Apo-Naproxen is 0.13 mL/min/kg. Approximately 95% of the Apo-Naproxen from any dose is excreted in the urine, primarily as Apo-Naproxen (<1%), 6-0-desmethyl Apo-Naproxen (<1%) or their conjugates (66% to 92%). The plasma half-life of the Apo-Naproxen anion in humans ranges from 12 to 17 hours. The corresponding half-lives of both Apo-Naproxen’s metabolites and conjugates are shorter than 12 hours, and their rates of excretion have been found to coincide closely with the rate of Apo-Naproxen 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 Apo-Naproxen levels following a 5 mg/kg single dose of Apo-Naproxen 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 Apo-Naproxen were not performed in pediatric patients younger than 5 years of age.
Geriatric Patients
Studies indicate that although total plasma concentration of Apo-Naproxen is unchanged, the unbound plasma fraction of Apo-Naproxen is increased in the elderly, although the unbound fraction is < 1% of the total Apo-Naproxen concentration. Unbound trough Apo-Naproxen concentrations in elderly subjects have been reported to range from 0.12% to 0.19% of total Apo-Naproxen 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 Apo-Naproxen 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
Apo-Naproxen pharmacokinetics has not been determined in subjects with hepatic insufficiency.
Renal Insufficiency
Apo-Naproxen pharmacokinetics has not been determined in subjects with renal insufficiency. Given that Apo-Naproxen, its metabolites and conjugates are primarily excreted by the kidney, the potential exists for Apo-Naproxen metabolites to accumulate in the presence of renal insufficiency. Elimination of Apo-Naproxen is decreased in patients with severe renal impairment. Apo-Naproxen-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
The results of a survey conducted on ndrugs.com for Apo-Naproxen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Apo-Naproxen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
1 consumer reported administration
When best can I take Apo-Naproxen, on an empty stomach, before or after food?ndrugs.com website users have also released a report stating that Apo-Naproxen should be taken With a meal. In any case, this may not be the right description on how you ought to take this Apo-Naproxen. Kindly visit your doctor for more medical advice in this regard. Click here to see other users view on when best the Apo-Naproxen can be taken.
| Users | % | ||
|---|---|---|---|
| With a meal | 1 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
