Components:
Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 14.03.2022
Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Top 20 medicines with the same components:
Dyspeptic symptom complex often associated with delayed gastric emptying, gastroesophageal reflux disease (GERD) or esophagitis: Epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain, flatulence (gassiness), eructation (belching), and heartburn.
Short-term treatment of nausea and vomiting of various origins including functional, organic, infectious, diabetic origin, or induced by radiotherapy or medicine therapy. (It is not considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of postoperative vomiting.)
Treatment of nausea and vomiting induced by dopamine agonists ie, L-dopa and bromocriptine used in Parkinson's disease.
Domperidone (Pacinac-NP) may also be given as needed, together with paracetamol for the symptomatic treatment of nausea and vomiting associated with migraine.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Carefully consider the potential benefits and risks of Naproxen sodium (Pacinac-NP) tablets and other treatment options before deciding to use Naproxen sodium (Pacinac-NP) tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Naproxen sodium (Pacinac-NP) tablets are indicated:
Naproxen sodium (Pacinac-NP) as Naproxen sodium (Pacinac-NP) suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.
Naproxen sodium (Pacinac-NP) tablets are also indicated:
Domperidone (Pacinac-NP) is a medicine that increases the movements or contractions of the stomach and bowel. Domperidone (Pacinac-NP) is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.
Domperidone (Pacinac-NP) is to be given only by or under the immediate supervision of your doctor.
Naproxen sodium (Pacinac-NP) contain Naproxen sodium (Pacinac-NP). Naproxen sodium (Pacinac-NP) is a nonsteroidal anti-inflammatory drug (NSAID).
Flanax is used to treat minor aches and pains such as headache, backache or toothache.
Naproxen sodium (Pacinac-NP) can also be used to treat pain associated with a common cold and certain symptoms of arthritis and menstrual cramps.
Domperidone (Pacinac-NP) is injected submucosally in the urinary bladder in close proximity to the ureteral orifice. The injection of Domperidone (Pacinac-NP) creates increased tissue bulk thereby providing coaptation of the distal ureter during filling and contraction of the bladder. The dextranomer microspheres are gradually surrounded by host connective tissue.
Directions For Use
Domperidone (Pacinac-NP) is to be administered only by qualified surgeons experienced in the use of a cystoscope and trained in the technique of subureteric and/or intraureteric injections injections (with Domperidone (Pacinac-NP) or other materials).
It is recommended to use the Domperidone (Pacinac-NP) metal needle (3.7F x 23G tip x 350 mm) for safe and accurate administration of Domperidone (Pacinac-NP). To assist the physician in positioning the needle, the Domperidone (Pacinac-NP) metal needle has a circular mark 6 mm from the needle tip. To show the position of the needle bevel, there is a square mark 8 mm from the needle tip. The marks are for reference only.
Domperidone (Pacinac-NP) can be injected with any common pediatric cystoscope with a minimum 4 French working channel. A type of cystoscope witha straight working channel is also well adapted for this type of procedure. The child is placed in a lithotomy position under general anesthesia and cystoscopy is performed to localize the ureteral orifices.
Before injecting Domperidone (Pacinac-NP) the following is recommended:
- Flush physiological saline solution through the needle.
- Fasten the needle tightly to the syringe.
- Remove the air from the needle by injecting the gel into the needle up to a point where a droplet is visible at the tip.
Please note that the luer lock adapter is snapped onto the syringe and held in place with friction only. It can rotate freely or be pulled off should enough force be applied. Because of this, it is recommended that the thumb and forefinger are held firmly around both the glass syringe barrel and the luer lock adapter when assembling the needle and syringe. To facilitate proper threading/fastening of needle hub and luer lock adapter, please both push and rotate them firmly together.
To avoid any interruption in patient treatment or the need to repeat a procedure because of leakage or breakage of a syringe, it is recommended that extra syringes be kept in inventory.
Domperidone (Pacinac-NP) is easily injected by finger pressure on a normal syringe with any commonly used pediatric cystoscope. Due to its viscoelastic properties, Domperidone (Pacinac-NP) can be injected through a fine needle – no special injection device is necessary.
Injection Techniques
Several techniques have been described for the endoscopic treatment of VUR including a subureteric injection (STING procedure), a single intra-ureteric injection (HIT procedure) and a double (proximal and distal) intra-ureteric injection (Double-HIT procedure). The Double-HIT procedure is a refinement of the original STING and HIT procedures and has been reported to result in greater clinical success rates.
In general, the bladder is semi-filled to allow for good visualization of the ureteral orifice(s) and to avoid tension within the submucosal layer of the ureter secondary to overdistension. For the HIT procedure, hydrodistention of the ureteral orifice is initiated to define the site of injection within the submucosa of the intramural ureter. The needle is inserted approximately 4 mm in the submucosa of the mid- to distal ureteral tunnel at the 6 o
Carefully consider the potential benefits and risks of Naproxen sodium (Pacinac-NP) extended-release tablets and other treatment options before deciding to use Naproxen sodium (Pacinac-NP) extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Naproxen sodium (Pacinac-NP) extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of:
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
The recommended starting dose of Naproxen sodium (Pacinac-NP) extended-release tablets in adults is two Naproxen sodium (Pacinac-NP) extended-release 375 mg tablets (750 mg) once daily, or two Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1000 mg) once daily. Patients already taking Naproxen sodium (Pacinac-NP) 250 mg, 375 mg or 500 mg twice daily (morning and evening) may have their total daily dose replaced with Naproxen sodium (Pacinac-NP) extended-release tablets as a single daily dose.
During long-term administration, the dose of Naproxen sodium (Pacinac-NP) extended-release tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of Naproxen sodium (Pacinac-NP) extended-release tablets well, the dose may be increased to three Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk.. The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit.
A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients. Studies indicate that although total plasma concentration of Naproxen sodium (Pacinac-NP) is unchanged, the unbound plasma fraction of Naproxen sodium (Pacinac-NP) is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose.
Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and Bursitis
The recommended starting dose is two Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1000 mg) once daily. For patients requiring greater analgesic benefit, three Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1000 mg).
Acute Gout
The recommended dose on the first day is two to three Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1000 - 1500 mg) once daily, followed by two Naproxen sodium (Pacinac-NP) extended-release 500 mg tablets (1000 mg) once daily, until the attack has subsided.
Hypersensitivity to Domperidone (Pacinac-NP) or any ingredient of Domperidone (Pacinac-NP).
If patients are taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists which can increase plasma concentrations of Domperidone (Pacinac-NP), leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Domperidone (Pacinac-NP) leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.
Gastrointestinal hemorrhage (bleeding), obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.
Prolactin-releasing pituitary tumor (prolactinoma).
See also:
What is the most important information I should know about Naproxen sodium (Pacinac-NP)?
Naproxen sodium (Pacinac-NP) extended-release tablets are contraindicated in patients with known hypersensitivity to Naproxen sodium (Pacinac-NP).
Naproxen sodium (Pacinac-NP) extended-release tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Naproxen sodium (Pacinac-NP) extended-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Use Naproxen sodium (Pacinac-NP) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Naproxen sodium (Pacinac-NP) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen sodium (Pacinac-NP) refilled.
- Swallow Naproxen sodium (Pacinac-NP) whole. Do not break, crush, or chew before swallowing.
- Take Naproxen sodium (Pacinac-NP) by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- Take Naproxen sodium (Pacinac-NP) with a full glass of water (8 oz [240 mL]) as directed by your doctor.
- If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Naproxen sodium (Pacinac-NP).
- If you miss a dose of Naproxen sodium (Pacinac-NP) and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Naproxen sodium (Pacinac-NP).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Domperidone (Pacinac-NP) is used to treat vomiting or nausea caused due to indigestion, diseases or drugs. It is also used to relieve fullness of stomach, belching and heavy bloating, gas and heartburn for a longer period up to 2 weeks.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Naproxen sodium (Pacinac-NP) is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation.
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
Some brands of sustained-release Naproxen sodium (Pacinac-NP) take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.
How to use Naproxen sodium (Pacinac-NP)
Read the Medication Guide provided by your pharmacist before you start using Naproxen sodium (Pacinac-NP) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily with a full glass of water (8 ounces/240 milliliters). Do not lie down for at least 10 minutes after taking this drug. To prevent stomach upset, take this medication with food, milk, or an antacid.
Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
The dosage is based on your medical condition and response to treatment. Your doctor will usually start you on the short-acting form of this medication and switch you over to this form if it provides the proper dose and if your pain/condition lasts for a long time. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit.
Tell your doctor if your condition does not improve or if it worsens.
Concomitant administration of anticholinergic drugs may antagonise the antidyspeptic effect of Domperidone (Pacinac-NP).
Antacids and antisecretory drugs should not be given simultaneously with oral formulations of Domperidone (Pacinac-NP) as they lower its oral bioavailability.
The main metabolic pathway of Domperidone (Pacinac-NP) is through CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of Domperidone (Pacinac-NP). Examples of potent CYP3A4 inhibitors include: Azole antifungals eg, fluconazole*, itraconazole, ketoconazole* and voriconazole*; macrolide antibiotics eg, clarithromycin* and erythromycin*; HIV protease inhibitors eg, amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists eg, diltiazem and verapamil; amiodarone*; aprepitant; nefazodone; telithromycin*.
(*Also prolong the QTc interval; see Contraindications.)
Separate pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of Domperidone (Pacinac-NP)'s CYP3A4 mediated first-pass metabolism by these drugs.
With the combination of Domperidone (Pacinac-NP) 10 mg 4 times daily and ketoconazole 200 mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2-17.5 msec. With the combination of Domperidone (Pacinac-NP) 10 mg 4 times daily and erythromycin 500 mg 3 times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6-14.3 msec. Both the Cmax and AUC of Domperidone (Pacinac-NP) at steady-state were increased approximately 3-fold in each of these interaction studies.
The contribution of increased plasma concentrations of Domperidone (Pacinac-NP) to the observed effect on QTc is not known.
In these studies, Domperidone (Pacinac-NP) monotherapy at 10 mg 4 times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while ketoconazole monotherapy (200 mg twice daily) and erythromycin monotherapy (500 mg 3 times daily) led to increases in mean QTc of 3.8 and 4.9 msec, respectively, over the observation period.
In another multiple-dose study in healthy subjects, no significant increases in QTc were noted during steady-state treatment with Domperidone (Pacinac-NP) monotherapy at 40 mg 4 times daily (total daily dose of 160 mg, which is double the maximum daily dose) at plasma concentrations of Domperidone (Pacinac-NP) that were at least similar to those found in the combination arms of the interaction studies.
Theoretically, since Domperidone (Pacinac-NP) has gastrokinetic effects, it could influence the absorption of concomitantly orally administered drugs, particularly those with sustained release or enteric-coated formulations. However, in patients already stabilised on digoxin or paracetamol, concomitant administration of Domperidone (Pacinac-NP) did not influence the blood levels of these drugs.
Domperidone (Pacinac-NP) may also be given with neuroleptics, the action of which it does not potentiate; dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects eg, digestive disorders, nausea and vomiting, it suppresses without counteracting their central properties.
See also:
What other drugs will affect Naproxen sodium (Pacinac-NP)?
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (such as prednisone), lithium, "water pills" (diuretics such as furosemide).
This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to Naproxen sodium (Pacinac-NP) and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of Naproxen sodium (Pacinac-NP) may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must take Naproxen sodium (Pacinac-NP), talk to your doctor about possibly taking immediate-release aspirin (not enteric-coated/EC) and then taking your Naproxen sodium (Pacinac-NP) at a different time after your aspirin. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.
This medication can affect the results of certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
See also:
What are the possible side effects of Domperidone (Pacinac-NP)?
Adverse Events
The safety of Domperidone (Pacinac-NP) in the treatment of VUR is based on a pivotal randomized study in which 39 children were treated with Domperidone (Pacinac-NP), two nonrandomized supportive studies in which 170 children were treated with Domperidone (Pacinac-NP), and a nonrandomized post-approval study in which 165 children were treated with Domperidone (Pacinac-NP). Follow-up for the pivotal and supportive studies was 12 months; follow-up for the post-approval study was 5 years (5-year data available for 31 of the 165 enrolled subjects (18.8%) ). No patients died during the course of these studies.
A list of the treatment -related adverse events occurring in > 1% of patients in all four studies is presented in Table 1.
Table 1: List of Treatment-Related Adverse Events Occurring in > 1% of Patients in the Pivitol, Supportive and Post-Approval Studies
Adverse Event Category | pivotal Study (n=39 Domperidone (Pacinac-NP) patients) | Supportive Studies (n=170 Domperidone (Pacinac-NP) patients) | post-Approval Study (n=165 Domperidone (Pacinac-NP) patients) |
Urinary tract infection (UTI)(i) | 6 (I5.4%)(ii, iii) | 13 (7.6%)(ii, iii) | 3 (1.8%) |
Ureteral dilatation(iv) | 1 (2.6%) | 6 (3.5%) | 0 (0%) |
Nausea/Vomiting/Abdominal pain(v) | 0 (0%) | 2 (1.2%) | 0 (0%) |
Abdominal discomfort | 0 (0%) | 0 (0%) | 2 (1.2%) |
Dysuria | 0 (0%) | 0 (0%) | 2 (1.2%) |
Micturition urgency | 0 (0%) | 0 (0%) | 2 (1.2%) |
Pollakiuria | 0 (0%) | 0 (0%) | 2 (1.2%) |
Urinary incontinence | 0 (0%) | 0 (0%) | 2 (1.2%) |
Vesicoureteric reflux | 0 (0%) | 0 (0%) | 2 (1.2%) |
(i) Cases of UTI typically occurred in patients with persistent reflux. (ii) Patients in the nonrandomized studies received antibiotic prophylaxis until the 3-month voiding cystourethrogram (VCUG). After that only those patients whose treatment had failed received further antibiotic prophylaxis. The patients in the randomized study received antibiotic prophylaxis 1 month post-treatment. (iii) All UTI cases were successfully treated with antibiotics. (iv) No case of ureteral dilatation required intervention and most cases resolved spontaneously. (v) Both cases of nausea/vomiting/abdominal pain were resolved. |
The following adverse events were associated with the use of Domperidone (Pacinac-NP) from spontaneous post-marketing surveillance reporting or from clinical studies (occurring ≤ 1%) and include but are not limited to: ureteral obstruction with or without hydronephrosis (some cases requiring temporary placement of a ureteric stent, and rare cases of ureteral re-implant procedures), hematuria, urgency, frequency, pyelonephritis, foreign body reaction, calcification, pyrexia, hypertonic bladder, bladder irritation, and Henoch-Schonlein purpura.
Adverse events should be reported to:
Salix Product Information Call Center, Phone: 1-800-508-0024, Fax: 1-510-595-8183, E-mail: Salix@medcomsol.com
See also:
What are the possible side effects of Naproxen sodium (Pacinac-NP)?
As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose of the drug and duration of treatment; the age, the sex, physical condition of the patient; any concurrent medical diagnoses or individual risk factors.
The following adverse reactions are divided into three parts based on frequency and whether or not the possibility exists of a causal relationship between drug usage and these adverse events. In those reactions listed as “Probable Causal Relationship” there is at least one case for each adverse reaction where there is evidence to suggest that there is a causal relationship between drug usage and the reported event. The adverse reactions reported were based on the results from two double-blind controlled clinical trials of three months duration with an additional nine month open-label extension. A total of 542 patients received Naproxen sodium (Pacinac-NP) extended-release tablets either in the double-blind period or in the nine month open-label extension. Of these 542 patients, 232 received Naproxen sodium (Pacinac-NP) extended-release tablets, 167 were initially treated with Naproxen sodium (Pacinac-NP) and 143 were initially treated with placebo. Adverse reactions reported by patients who received Naproxen sodium (Pacinac-NP) extended-release tablets are shown by body system. Those adverse reactions observed with Naproxen sodium (Pacinac-NP) but not reported in controlled trials with Naproxen sodium (Pacinac-NP) extended-release tablets are italicized.
The most frequent adverse events from the double-blind and open-label clinical trials were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%). The incidence of other adverse events occurring in 3%-9% of the patients are marked with an asterisk.
Those reactions occurring in less than 3% of the patients are unmarked.
Incidence Greater Than 1% (Probable Causal Relationship)
Body as a Whole — Pain (back)*, pain*, infection*, fever, injury (accident), asthenia, pain chest, headache (15%), flu syndrome (10%).
Gastrointestinal — Nausea*, diarrhea*, constipation*, abdominal pain*, flatulence, gastritis, vomiting, dysphagia, dyspepsia (14%), heartburn*, stomatitis.
Hematologic — Anemia, ecchymosis.
Respiratory — Pharyngitis*, rhinitis*, sinusitis*, bronchitis, cough increased.
Renal — Urinary tract infection*, cystitis.
Dermatologic — Skin rash*, skin eruptions*, ecchymoses*, purpura.
Metabolic and Nutrition — Peripheral edema, hyperglycemia.
Central Nervous System — Dizziness, paresthesia, insomnia, drowsiness*, lightheadedness.
Cardiovascular — Hypertension, edema*, dyspnea*, palpitations.
Musculoskeletal — Cramps (leg), myalgia, arthralgia, joint disorder, tendon disorder.
Special Senses — Tinnitus*, hearing disturbances, visual disturbances.
General — Thirst.
Incidence Less Than 1% (Probable Causal Relationship)
Body as a Whole — Abscess, monilia, neck rigid, pain neck, abdomen enlarged, carcinoma, cellulitis, edema general, LE syndrome, malaise, mucous membrane disorder, allergic reaction, pain pelvic.
Gastrointestinal — Anorexia, cholecystitis, cholelithiasis, eructation, GI hemorrhage, rectal hemorrhage, stomatitis aphthous, stomatitis ulcer, ulcer mouth, ulcer stomach, periodontal abscess, cardiospasm, colitis, esophagitis, gastroenteritis, GI disorder, rectal disorder, tooth disorder, hepatosplenomegaly, liver function abnormality, melena, ulcer esophagus, hematemesis, jaundice, pancreatitis, necrosis.
Renal — Dysmenorrhea, dysuria, kidney function abnormality, nocturia, prostate disorder, pyelonephritis, carcinoma breast, urinary incontinence, kidney calculus, kidney failure, menorrhagia, metrorrhagia, neoplasm breast, nephrosclerosis, hematuria, pain kidney, pyuria, urine abnormal, urinary frequency, urinary retention, uterine spasm, vaginitis, glomerular nephritis, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis.
Hematologic — Leukopenia, bleeding time increased, eosinophilia, abnormal RBC, abnormal WBC, thrombocytopenia, agranulocytosis, granulocytopenia.
Central Nervous System — Depression, anxiety, hypertonia, nervousness, neuralgia, neuritis, vertigo, amnesia, confusion, co-ordination, abnormal diplopia, emotional lability, hematoma subdural, paralysis, dream abnormalities, inability to concentrate, muscle weakness.
Dermatologic — Angiodermatitis, herpes simplex, dry skin, sweating, ulcer skin, acne, alopecia, dermatitis contact, eczema, herpes zoster, nail disorder, skin necrosis, subcutaneous nodule, pruritus, urticaria, neoplasm skin, photosensitive dermatitis, photosensitivity reactions resembling porphyria cutaneous tarda, epidermolysis bullosa.
Special Senses — Amblyopia scleritis, cataract, conjunctivitis, deaf, ear disorder, keratoconjunctivitis, lacrimation disorder, otitis media, pain eye.
Cardiovascular — Angina pectoris, coronary artery disease, myocardial infarction, deep thrombophlebitis, vasodilation, vascular anomaly, arrhythmia, bundle branch block, abnormal ECG, heart failure right, hemorrhage, migraine, aortic stenosis, syncope, tachycardia, congestive heart failure.
Respiratory — Asthma, dyspnea, lung edema, laryngitis, lung disorder, epistaxis, pneumonia, respiratory distress, respiratory disorder, eosinophilic pneumonitis.
Musculoskeletal — Myasthenia, bone disorder, spontaneous bone fracture, fibrotendinitis, bone pain, ptosis, spasm general, bursitis.
Metabolic and Nutrition — Creatinine increase, glucosuria, hypercholesteremia, albuminuria, alkalosis, BUN increased, dehydration,
edema, glucose tolerance decrease, hyperuricemia, hypokalemia, SGOT increase, SGPT increase, weight decrease.
General — Anaphylactoid reactions, angioneurotic edema, menstrual disorders, hypoglycemia, pyrexia (chills and fevers).
Incidence Less Than 1% (Causal Relationship Unknown)
Other adverse reactions listed in the Naproxen sodium (Pacinac-NP) package label, but not reported by those who received Naproxen sodium (Pacinac-NP) extended-release tablets are shown in italics. These observations are being listed as alerting information to the physician.
Hematologic — Aplastic anemia, hemolytic anemia.
Central Nervous System — Aseptic meningitis, cognitive dysfunction.
Dermatologic — Epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
Gastrointestinal — Non-peptic GI ulceration, ulcerative stomatitis.
Cardiovascular — Vasculitis.
Domperidone (Pacinac-NP) is a synthetic anticoagulant and an indanedione derivative. It prevents the formation of active procoagulation factors II, VII, IX, and X, as well as the anticoagulant proteins C and S, in the liver by inhibiting the vitamin K mediated gamma-carboxylation of precursor proteins.
Generally refers to the 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Naproxen sodium (Pacinac-NP)-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the placenta. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of estradiol binds weakly to estrogen receptors (receptors, estrogen) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.