Naxdom

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 (Naxdom) may also be given as needed, together with paracetamol for the symptomatic treatment of nausea and vomiting associated with migraine.

Carefully consider the potential benefits and risks of Naproxen (Naxdom), Naproxen (Naxdom), ANAPROX, ANAPROX DS or Naproxen (Naxdom) Suspension and other treatment options before deciding to use Naproxen (Naxdom), Naproxen (Naxdom), ANAPROX, ANAPROX DS or Naproxen (Naxdom) Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Naproxen (Naxdom) as Naproxen (Naxdom), Naproxen (Naxdom), ANAPROX, ANAPROX DS or Naproxen (Naxdom) Suspension is indicated:

• For the relief of the signs and symptoms of rheumatoid arthritis
• For the relief of the signs and symptoms of osteoarthritis
• For the relief of the signs and symptoms of ankylosing spondylitis
• For the relief of the signs and symptoms of juvenile arthritis

Naproxen (Naxdom) as Naproxen (Naxdom) Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Naproxen (Naxdom) as Naproxen (Naxdom) and Naproxen (Naxdom) Suspension is also indicated:

• For relief of the signs and symptoms of tendonitis
• For relief of the signs and symptoms of bursitis
• For relief of the signs and symptoms of acute gout
• For the management of pain
• For the management of primary dysmenorrhea

Naproxen (Naxdom) is not recommended for initial treatment of acute pain because the absorption of Naproxen (Naxdom) is delayed compared to absorption from other Naproxen (Naxdom)-containing products.

Domperidone (Naxdom) is a medicine that increases the movements or contractions of the stomach and bowel. Domperidone (Naxdom) is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.

Domperidone (Naxdom) is to be given only by or under the immediate supervision of your doctor.

Naproxen (Naxdom) is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen (Naxdom) works by reducing hormones that cause inflammation and pain in the body.

Naproxen (Naxdom) is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

The delayed-release or extended-release tablets are slower-acting forms of Naproxen (Naxdom) that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of Naproxen (Naxdom) will not work fast enough to treat acute pain.

Naproxen (Naxdom) may also be used for purposes not listed in this medication guide.

Domperidone (Naxdom) is injected submucosally in the urinary bladder in close proximity to the ureteral orifice. The injection of Domperidone (Naxdom) 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 (Naxdom) 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 (Naxdom) or other materials).

It is recommended to use the Domperidone (Naxdom) metal needle (3.7F x 23G tip x 350 mm) for safe and accurate administration of Domperidone (Naxdom). To assist the physician in positioning the needle, the Domperidone (Naxdom) 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 (Naxdom) 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 (Naxdom) 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 (Naxdom) is easily injected by finger pressure on a normal syringe with any commonly used pediatric cystoscope. Due to its viscoelastic properties, Domperidone (Naxdom) 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

Usual Adult Dose for Ankylosing Spondylitis:

Initial: 250 mg to 500 mg (Naproxen (Naxdom)) or 275 mg to 550 mg (Naproxen (Naxdom) sodium) orally twice a day. The initial dose for Naproxen (Naxdom) sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naproxen (Naxdom)) or 1650 mg (Naproxen (Naxdom) sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naproxen (Naxdom) sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Osteoarthritis:

Initial: 250 mg to 500 mg (Naproxen (Naxdom)) or 275 mg to 550 mg (Naproxen (Naxdom) sodium) orally twice a day. The initial dose for Naproxen (Naxdom) sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naproxen (Naxdom)) or 1650 mg (Naproxen (Naxdom) sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naproxen (Naxdom) sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 250 mg to 500 mg (Naproxen (Naxdom)) or 275 mg to 550 mg (Naproxen (Naxdom) sodium) orally twice a day. The initial dose for Naproxen (Naxdom) sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naproxen (Naxdom)) or 1650 mg (Naproxen (Naxdom) sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naproxen (Naxdom) sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Acute Gout:

750 mg (Naproxen (Naxdom)) or 825 mg (Naproxen (Naxdom) sodium) orally one time, followed by 250 mg (Naproxen (Naxdom)) or 275 mg (Naproxen (Naxdom) sodium) every 8 hours until the gouty attack has resolved, usually 2 to 3 days. The recommended dose of Naproxen (Naxdom) sodium controlled-release is two to three 500 mg tablets (1000 to 1500 mg) orally on the first day, followed by two 500 mg tablets (1000 mg) orally daily until the attack has subsided.

Usual Adult Dose for Bursitis:

550 mg Naproxen (Naxdom) sodium orally once, followed by 550 mg Naproxen (Naxdom) sodium every 12 hours, or 275 mg (Naproxen (Naxdom) sodium)/250 mg (Naproxen (Naxdom)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Naxdom) sodium or 1000 mg Naproxen (Naxdom). The recommended initial dose of Naproxen (Naxdom) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Tendonitis:

550 mg Naproxen (Naxdom) sodium orally once, followed by 550 mg Naproxen (Naxdom) sodium every 12 hours, or 275 mg (Naproxen (Naxdom) sodium)/250 mg (Naproxen (Naxdom)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Naxdom) sodium or 1000 mg Naproxen (Naxdom). The recommended initial dose of Naproxen (Naxdom) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Dysmenorrhea:

550 mg Naproxen (Naxdom) sodium orally once, followed by 550 mg Naproxen (Naxdom) sodium every 12 hours, or 275 mg (Naproxen (Naxdom) sodium)/250 mg (Naproxen (Naxdom)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Naxdom) sodium or 1000 mg Naproxen (Naxdom).

Over-the-counter preparation: Naproxen (Naxdom) sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Naproxen (Naxdom) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Pain:

550 mg Naproxen (Naxdom) sodium orally once, followed by 550 mg Naproxen (Naxdom) sodium every 12 hours, or 275 mg (Naproxen (Naxdom) sodium)/250 mg (Naproxen (Naxdom)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Naxdom) sodium or 1000 mg Naproxen (Naxdom).

Over-the-counter preparation: Naproxen (Naxdom) sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Naproxen (Naxdom) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Geriatric Dose for Pain:

Over-the-counter preparation - 220 mg (Naproxen (Naxdom) sodium) orally every 12 hours or 250 mg (Naproxen (Naxdom)) orally every 8 hours as needed.

Usual Pediatric Dose for Fever:

Dosage guidelines are based on Naproxen (Naxdom):

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Pain:

Dosage guidelines are based on Naproxen (Naxdom):

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Dosage guidelines are based on Naproxen (Naxdom):

Greater than or equal to 2 years: 5 mg/kg orally twice a day. Maximum dose: 1000 mg/day.

Hypersensitivity to Domperidone (Naxdom) or any ingredient of Domperidone (Naxdom).

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 (Naxdom), leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Domperidone (Naxdom) 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 (Naxdom)?

Naproxen (Naxdom), Naproxen (Naxdom), ANAPROX, ANAPROX DS and Naproxen (Naxdom) Suspension are contraindicated in patients with known hypersensitivity to Naproxen (Naxdom) and Naproxen (Naxdom) sodium.

Naproxen (Naxdom), Naproxen (Naxdom), ANAPROX, ANAPROX DS and Naproxen (Naxdom) Suspension 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 (Naxdom), Naproxen (Naxdom), ANAPROX, ANAPROX DS and Naproxen (Naxdom) Suspension are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Use Naproxen (Naxdom) sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Naproxen (Naxdom) sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen (Naxdom) sustained-release tablets refilled.
• Swallow Naproxen (Naxdom) sustained-release tablets whole. Do not break, crush, or chew before swallowing.
• Take Naproxen (Naxdom) sustained-release tablets 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 (Naxdom) sustained-release tablets 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 (Naxdom) sustained-release tablets.
• If you miss a dose of Naproxen (Naxdom) sustained-release tablets 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 (Naxdom) sustained-release tablets.

Domperidone (Naxdom) 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.

Naproxen (Naxdom) is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. 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.

This form of Naproxen (Naxdom) is absorbed slowly and should not be used for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist about using a different form of this drug or other medications for quick relief of pain.

How to use Naproxen (Naxdom)

Read the Medication Guide provided by your pharmacist before you start using Naproxen (Naxdom) 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 twice daily with or without food. Swallow this medication whole. Do not break, crush, or chew the tablets. Doing so can release the drug too quickly, increasing the risk of side effects. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.

The dosage is based on your medical condition and response to treatment. 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.

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 (Naxdom).

Antacids and antisecretory drugs should not be given simultaneously with oral formulations of Domperidone (Naxdom) as they lower its oral bioavailability.

The main metabolic pathway of Domperidone (Naxdom) 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 (Naxdom). 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 (Naxdom)'s CYP3A4 mediated first-pass metabolism by these drugs.

With the combination of Domperidone (Naxdom) 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 (Naxdom) 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 C_max and AUC of Domperidone (Naxdom) at steady-state were increased approximately 3-fold in each of these interaction studies.

The contribution of increased plasma concentrations of Domperidone (Naxdom) to the observed effect on QTc is not known.

In these studies, Domperidone (Naxdom) 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 (Naxdom) 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 (Naxdom) that were at least similar to those found in the combination arms of the interaction studies.

Theoretically, since Domperidone (Naxdom) 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 (Naxdom) did not influence the blood levels of these drugs.

Domperidone (Naxdom) 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 (Naxdom)?

The use of NSAIDs in patients who are receiving ACE inhibitors may potentiate renal disease states.

In vitro studies have shown that Naproxen (Naxdom) anion, because of its affinity for protein, may displace from their binding sites other drugs which are also albumin-bound.

Theoretically, the Naproxen (Naxdom) anion itself could likewise be displaced. Short-term controlled studies failed to show that taking the drug significantly affects prothrombin times when administered to individuals on coumarin-type anticoagulants. Caution is advised nonetheless, since interactions have been seen with other nonsteroidal agents of this class. Similarly, patients receiving the drug and a hydantoin, sulfonamide or sulfonylurea should be observed for signs of toxicity to these drugs.

Concomitant administration of Naproxen (Naxdom) and aspirin is not recommended because Naproxen (Naxdom) is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations and peak plasma levels.

The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class. Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has also been reported. Naproxen (Naxdom) and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers.

Probenecid given concurrently increases Naproxen (Naxdom) anion plasma levels and extends its plasma half-life significantly.

Caution should be used if Naproxen (Naxdom) is administered concomitantly with methotrexate. Naproxen (Naxdom), Naproxen (Naxdom) sodium and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, possibly increasing the toxicity of methotrexate.

Drug/Laboratory Test Interactions

Naproxen (Naxdom) may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined. The administration of Naproxen (Naxdom) may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-dinitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with Naproxen (Naxdom) be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.

Naproxen (Naxdom) may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).

See also:
What are the possible side effects of Domperidone (Naxdom)?

Adverse Events

The safety of Domperidone (Naxdom) in the treatment of VUR is based on a pivotal randomized study in which 39 children were treated with Domperidone (Naxdom), two nonrandomized supportive studies in which 170 children were treated with Domperidone (Naxdom), and a nonrandomized post-approval study in which 165 children were treated with Domperidone (Naxdom). 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

The following adverse events were associated with the use of Domperidone (Naxdom) 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: [email protected]

See also:
What are the possible side effects of Naproxen (Naxdom)?

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg Naproxen (Naxdom) compared to those taking 750 mg Naproxen (Naxdom).

In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with Naproxen (Naxdom), the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking Naproxen (Naxdom) in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo

Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura

Special Senses: tinnitus*, visual disturbances, hearing disturbances

Cardiovascular: edema*, palpitations

General: dyspnea*, thirst

*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in <1% of patients taking Naproxen (Naxdom) during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper and lower gatrointestinal tract. Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some causes have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (Female): infertility

In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuri

Domperidone (Naxdom) 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.

Each tablet contains Naproxen (Naxdom) 200 mg and sodium 20 mg. It also contains the following inactive ingredients: Povidone, microcrystalline cellulose, talc, magnesium stearate, purified water and Opadry (blue) in the coating. It is lactose- and gluten-free.

The sodium content of Naproxen (Naxdom) is low, similar to a slice of wheat bread.