Validay SR is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, Validay SR does not cure osteoarthritis and will help you only as long as you continue to use it.
Validay SR topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical Validay SR helps this condition is unknown.
Validay SR topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Validay SR topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Validay SR is available only with your doctor's prescription.
Validay SR indications
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 Validay SR delayed-release tablets and other treatment options before deciding to use Validay SR delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Validay SR delayed-release tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
How should I use Validay SR?
Use Validay SR as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Validay SR comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Validay SR refilled.
Do not apply Validay SR to infected skin; open wounds; or red, swollen, or peeling skin.
Wash your hands immediately before and after using Validay SR.
Wash the affected area and dry completely before using Validay SR.
To apply Validay SR, dispense 10 drops at a time onto the knee or into your hand. Spread Validay SR evenly around the front, back, and sides of the knee. Repeat until you have used the whole dose.
Be sure that you cover your entire knee with your dose of Validay SR. Do not use more than the recommended amount.
Do not apply sunscreens, cosmetics, insect repellants, other topical medicines, or any other substance to the treated area until it is completely dry.
Do not put on clothes over the treated area until it is completely dry.
Do not wrap, bandage, or apply heat to the treated area.
Let the treated skin dry before touching it or letting it touch anyone else's skin.
Do not shower, bathe, or wash the treated area for at least 30 minutes after you use Validay SR.
If you miss a dose of Validay SR, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Validay SR.
Uses of Validay SR in details
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.
Validay SR is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).
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.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks.
How to use Validay SR
Read the Medication Guide provided by your pharmacist before you start using Validay SR and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth 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. To prevent stomach upset, take this medication with food, milk, or an antacid.
There are different brands and forms of this medication available. Because different brands deliver different amounts of medication, do not switch brands of Validay SR without your doctor's permission and directions.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To minimize side effect risks (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For chronic conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.
For certain conditions (such as arthritis), it may take up to 2 weeks of regular use before the full benefits of this drug take effect.
If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
Tell your doctor if your condition worsens.
Validay SR description
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
Validay SR dosage
Carefully consider the potential benefits and risks of Validay SR extended-release tablets, and other treatment options before deciding to use Validay SR 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 Validay SR extended-release tablets the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg daily.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg daily. In the rare patient where Validay SR extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day if the benefits outweigh the clinical risks of increased side effects.
Different formulations of Validay SR (Validay SR enteric-coated tablets; Validay SR extended-release tablets; Validay SR potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
Aspirin: Concomitant administration of Validay SR and aspirin is not recommended because Validay SR is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.
Anticoagulants: While studies have not shown Validay SR to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Validay SR, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Validay SR, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Validay SR may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Validay SR or who increase their Validay SR dose or any other NSAID while taking digoxin, methotrexate, or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.
Lithium: Validay SR decreases lithium renal clearance and increases lithium plasma levels. In patients taking Validay SR and lithium concomitantly, lithium toxicity may develop.
Validay SR does not alter glucose metabolism in normal subjects nor does it alter the effects of oral hypoglycemic agents. There are rare reports, however, from marketing experiences, of changes in effects of insulin or oral hypoglycemic agents in the presence of Validay SR that necessitated changes in the doses of such agents. Both hypo- and hyperglycemic effects have been reported. A direct causal relationship has not been established, but physicians should consider the possibility that Validay SR may alter a diabetic patientís response to insulin or oral hypoglycemic agents.
Diuretics: Validay SR and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.
Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect the peak levels and AUC values of Validay SR. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Validay SR therapy.
In vitro, Validay SR interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of Validay SR in human serum.
Drug/Laboratory Test Interactions
Effect on Blood Coagulation: Validay SR increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. Validay SR is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.
Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Validay SR ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Validay SR ophthalmic solution, 0.1%, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.
The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection and vomiting.
The following reactions have been identified during postmarketing use of topical Validay SR ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical Validay SR ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration and epithelilal breakdown.
TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Validay SR in all formulations, Validay SR, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Validay SR and Validay SR-containing products. Validay SR should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to Validay SR have been reported in such patients.
DailyMed. "DICLOFENAC EPOLAMINE: 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).
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