What is Sildec Plus Gel?
Sildec Plus Gel 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, Sildec Plus Gel does not cure osteoarthritis and will help you only as long as you continue to use it.
Sildec Plus Gel 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 Sildec Plus Gel helps this condition is unknown.
Sildec Plus Gel topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Sildec Plus Gel topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Sildec Plus Gel is available only with your doctor's prescription.
Sildec Plus Gel indications
Carefully consider the potential benefits and risks of Sildec Plus Gel delayed-release tablets and other treatment options before deciding to use Sildec Plus Gel delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Sildec Plus Gel 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 Sildec Plus Gel?
Use Sildec Plus Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sildec Plus Gel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sildec Plus Gel refilled.
- Do not apply Sildec Plus Gel to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Sildec Plus Gel.
- Wash the affected area and dry completely before using Sildec Plus Gel.
- To apply Sildec Plus Gel, dispense 10 drops at a time onto the knee or into your hand. Spread Sildec Plus Gel 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 Sildec Plus Gel. 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 Sildec Plus Gel.
- If you miss a dose of Sildec Plus Gel, 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 Sildec Plus Gel.
Uses of Sildec Plus Gel in details
Use: Labeled Indications
Ankylosing spondylitis (delayed-release tablets only): Acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.
Dysmenorrhea (immediate-release tablets only): Treatment of primary dysmenorrhea.
Migraine (powder for oral solution only): Acute treatment of migraine attacks with or without aura in adults.
Osteoarthritis (immediate-release, extended-release, and delayed-release tablets; capsules [Zorvolex]; and suppositories [Canadian product] only): Relief of signs and symptoms of osteoarthritis.
Pain
Capsules/immediate-release tablets only: Relief of mild to moderate acute pain.
Injection only: Management of mild to moderate pain and moderate to severe pain (alone or in combination with opioid analgesics) in adults.
Rheumatoid arthritis (immediate-release, extended-release, and delayed-release tablets; and suppositories [Canadian product] only): Relief of signs and symptoms of rheumatoid arthritis.
Off Label Uses
Gout, treatment (acute flares)
Data from a limited number of trials support the efficacy of Sildec Plus Gel in the treatment of acute gout flares.
Based on the 2012 American College of Rheumatology guidelines for management of gout, nonsteroidal anti-inflammatory drugs are effective and recommended agents in the treatment of acute gout flares.
Sildec Plus Gel description
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
Sildec Plus Gel dosage
Carefully consider the potential benefits and risks of Sildec Plus Gel extended-release tablets, and other treatment options before deciding to use Sildec Plus Gel 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 Sildec Plus Gel 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 Sildec Plus Gel 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 Sildec Plus Gel (Sildec Plus Gel enteric-coated tablets; Sildec Plus Gel extended-release tablets; Sildec Plus Gel potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
Sildec Plus Gel interactions
See also:
What other drugs will affect Sildec Plus Gel?
Aspirin: Concomitant administration of Sildec Plus Gel and aspirin is not recommended because Sildec Plus Gel 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 Sildec Plus Gel 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 Sildec Plus Gel, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Sildec Plus Gel, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Sildec Plus Gel may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Sildec Plus Gel or who increase their Sildec Plus Gel 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: Sildec Plus Gel decreases lithium renal clearance and increases lithium plasma levels. In patients taking Sildec Plus Gel and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Sildec Plus Gel 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 Sildec Plus Gel 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 Sildec Plus Gel may alter a diabetic patientís response to insulin or oral hypoglycemic agents.
Diuretics: Sildec Plus Gel 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 Sildec Plus Gel. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Sildec Plus Gel therapy.
Protein Binding
In vitro, Sildec Plus Gel 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 Sildec Plus Gel in human serum.
Drug/Laboratory Test Interactions
Effect on Blood Coagulation: Sildec Plus Gel 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. Sildec Plus Gel 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.
Sildec Plus Gel side effects
See also:
What are the possible side effects of Sildec Plus Gel?
Ocular
Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Sildec Plus Gel ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Sildec Plus Gel 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.
Systemic
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.
Clinical Practice
The following reactions have been identified during postmarketing use of topical Sildec Plus Gel 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 Sildec Plus Gel 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.
Sildec Plus Gel contraindications
See also:
What is the most important information I should know about Sildec Plus Gel?
Sildec Plus Gel in all formulations, Cataflam, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Sildec Plus Gel and Sildec Plus Gel-containing products. Sildec Plus Gel 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 Sildec Plus Gel have been reported in such patients.
Active ingredient matches for Sildec Plus Gel:
| Unit description / dosage (Manufacturer) | Price, USD |
| Sildec Plus Gel 30 gm Gel | $ 0.54 |
List of Sildec Plus Gel substitutes (brand and generic names): | |
| Sidaze D | |
| Sidaze D 50+10 Tablet (Symet Drugs Ltd.) | $ 0.06 |
| Siodase D | |
| Siodase D 50+10 Tablet (Savoy Biotech) | $ 0.08 |
| Siodic MR | |
| Siodic MR 250+50 Tablet (Siochem Pharma Pvt Ltd) | $ 0.08 |
| Slanac | |
| Slanac 50 mg Tablet (Slaney Healthcare Pvt. Ltd.) | $ 0.03 |
| Slanac Inj Injection | |
| Slanac Inj Injection (Slaney Healthcare Pvt. Ltd.) | $ 0.18 |
| Solof (Mexico) | |
| Solopar | |
| Solopar 50+650 Tablet (New Gayzel Pharmaceuticals) | $ 0.02 |
| Spadic | |
| Spadic 75 mg Injection (Sparkles Exim Pvt Ltd) | $ 0.03 |
| Spado | |
| Spado 10+25 Injection (Comed Chemicals Pvt Ltd) | $ 0.18 |
| Spasmo Proxyvon Forte | |
| Spasmo Proxyvon Forte 2 ml Injection (Wockhardt Ltd.) | $ 0.12 |
| SPASMO PROXYVON FORTE INJECTION 1 vial / 2 ML injection each (Wockhardt Ltd.) | $ 0.17 |
| Spasmo Proxyvon Forte Injection (Wockhardt Ltd.) | $ 0.10 |
| Spasriv 2 | |
| Spasriv 2 250+50+32.5 Tablet (East African (I) Remedies Pvt Ltd) | $ 0.03 |
| Speedex | |
| Speedex 20 gm Gel (V.S. Healthcare Limited.) | $ 0.46 |
| SUBSYDE - CR | |
| SUBSYDE - CR Modified Release Capsule/ Tablet / 100mg / 10 units (Raptakos Brett & Co.) | $ 0.36 |
| Surgicare D | |
| Surgicare D 50+10 Tablet (Sun Rise International Labs Ltd.) | $ 0.05 |
| SURGICARE D TABLET 1 strip / 10 tablets each (Sun Rise International Labs Ltd.) | $ 0.17 |
| Surgicare D Tablet (Sun Rise International Labs Ltd.) | $ 0.02 |
| Suzox Forte | |
| Suzox Forte 500+100+10 Tablet (Focus Healthcare Pvt Ltd) | $ 0.08 |
| Svsera D | |
| Svsera D 50+10 Tablet (Ecocare) | $ 0.06 |
| Swenac SR | |
| Swenac SR 50 mg Tablet (Mascot Lifesciences Pvt. Ltd.) | $ 0.02 |
| Synotrip D | |
| Synotrip D 50+10 Tablet (Syntro Health Care (Synokem Pharmaceuticals Ltd)) | $ 0.04 |
| Synovial MR | |
| Synovial MR 325+250+50 Tablet (Synokem Pharmaceuticals Ltd) | $ 0.06 |
| SYNOVIAL MR 50MG/325MG/250MG TABLET 1 strip / 10 tablet mrs each (Synokem Pharmaceuticals Ltd) | $ 0.72 |
| Synovial MR 250 mg/50 mg/325 mg Tablet (Synokem Pharmaceuticals Ltd) | $ 0.07 |
| Tab Serrodase D | |
| Tab Serrodase D 50+10 Tablet (Siesta Pharmaceuticals) | $ 0.07 |
| Taldic | |
| Taldic 50 mg Tablet (Talent Laboratories) | $ 0.01 |
| Tifenac | |
| Tifenac 75 mg Injection (Trigenesis Lifesciences Pvt. Ltd.) | $ 0.03 |
| Tizidal D | |
| Tizidal D 50+2 Tablet (Adley Formulation) | $ 0.06 |
| Tromadac | |
| Tromadac 50 mg Tablet (Hamax Pharmaceuticals) | $ 0.01 |
| Tromadac 75 mg Injection (Hamax Pharmaceuticals) | $ 0.01 |
| Udec | |
| Udec 100 mg Tablet (Ubit Pharmaceuticals Pvt Ltd) | $ 0.03 |
| UNIDIC INJ. | |
| UNIDIC INJ. Injection / 25mg per ml / 3ml units (Unimarck Pharma) | $ 0.08 |
| Uniflam X | |
| Uniflam X 50 mg Tablet (Alpha Drugs & Pharmaceuticals) | $ 0.01 |
| Validay SR | |
| Validay SR 100+20 Capsule (Mankind Pharmaceuticals Pvt. Ltd.) | $ 0.04 |
| VALIDAY SR 100MG/20MG TABLET 1 strip / 10 tablets each (Mankind Pharmaceuticals Pvt. Ltd.) | $ 0.42 |
| VERUB (India) | |
| 1 % x 30g (Cipla Limited) | $ 0.45 |
| Verub 1% GEL / 30g (Cipla Limited) | $ 0.45 |
| Verub 30 gm Gel (Cipla Limited) | $ 0.45 |
| VERUB topical gel 1 % x 30g (Cipla Limited) | $ 0.45 |
| Verub 1% GEL / 30g (Cipla Limited) | $ 0.45 |
| VINDEC (India) | |
| VINDEC inj 75 mg x 3 mL x 3ml (Vinca) | $ 0.11 |
See 919 substitutes for Sildec Plus Gel | |
References
- 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).
- PubChem. "diclofenac". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "diclofenac". http://www.drugbank.ca/drugs/DB00586 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Sildec Plus Gel 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 Sildec Plus Gel. 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
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology
