Unidic INJ. Uses

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What is Unidic INJ.?

Unidic INJ. 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, Unidic INJ. does not cure osteoarthritis and will help you only as long as you continue to use it.

Unidic INJ. 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 Unidic INJ. helps this condition is unknown.

Unidic INJ. topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.

Unidic INJ. topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

Unidic INJ. is available only with your doctor's prescription.

Unidic INJ. indications

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Carefully consider the potential benefits and risks of Unidic INJ. delayed-release tablets and other treatment options before deciding to use Unidic INJ. delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Unidic INJ. 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 Unidic INJ.?

Use Unidic INJ. as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Unidic INJ..

Uses of Unidic INJ. in details

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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 Unidic INJ. 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.

Unidic INJ. description

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A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

Unidic INJ. dosage

Carefully consider the potential benefits and risks of Unidic INJ. extended-release tablets, and other treatment options before deciding to use Unidic INJ. 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 Unidic INJ. 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 Unidic INJ. 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 Unidic INJ. (Unidic INJ. enteric-coated tablets; Unidic INJ. extended-release tablets; Unidic INJ. potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

Unidic INJ. interactions

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What other drugs will affect Unidic INJ.?

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Aspirin: Concomitant administration of Unidic INJ. and aspirin is not recommended because Unidic INJ. 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 Unidic INJ. 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 Unidic INJ., and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Unidic INJ., like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Unidic INJ. may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Unidic INJ. or who increase their Unidic INJ. 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: Unidic INJ. decreases lithium renal clearance and increases lithium plasma levels. In patients taking Unidic INJ. and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics:

Unidic INJ. 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 Unidic INJ. 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 Unidic INJ. may alter a diabetic patientís response to insulin or oral hypoglycemic agents.

Diuretics: Unidic INJ. 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 Unidic INJ.. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Unidic INJ. therapy.

Protein Binding

In vitro, Unidic INJ. 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 Unidic INJ. in human serum.

Drug/Laboratory Test Interactions

Effect on Blood Coagulation: Unidic INJ. 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. Unidic INJ. 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.

Unidic INJ. side effects

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What are the possible side effects of Unidic INJ.?

Ocular

Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Unidic INJ. ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Unidic INJ. 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 Unidic INJ. 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 Unidic INJ. 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.

Unidic INJ. contraindications

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What is the most important information I should know about Unidic INJ.?

Unidic INJ. in all formulations, Cataflam, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Unidic INJ. and Unidic INJ.-containing products. Unidic INJ. 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 Unidic INJ. have been reported in such patients.

Active ingredient matches for Unidic INJ.:

Diclofenac Sodium


Unit description / dosage (Manufacturer)Price, USD
UNIDIC INJ. Injection / 25mg per ml / 3ml units (Unimarck Pharma)$ 0.08

List of Unidic INJ. substitutes (brand and generic names):

Udec 100 mg Tablet (Ubit Pharmaceuticals Pvt Ltd)$ 0.03
Uniflam X 50 mg Tablet (Alpha Drugs & Pharmaceuticals)$ 0.01
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
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 inj 75 mg x 3 mL x 3ml (Vinca)$ 0.11
VIRON - SR Modified Release Capsule/ Tablet / 100mg / 10 units (Intra Labs)$ 0.18
25 mg x 1 mL x 30ml (Lincoln Pharmaceuticals Ltd)$ 0.41
25 mg x 1 mL x 3ml (Lincoln Pharmaceuticals Ltd)$ 0.14
75 mg x 1 mL x 1ml (Lincoln Pharmaceuticals Ltd)$ 0.14
100 mg x 10's (Lincoln Pharmaceuticals Ltd)$ 0.24
Vivian 25mg x 1mL INJ / 30ml (Lincoln Pharmaceuticals Ltd)$ 0.41
Vivian 25mg x 1mL INJ / 3ml (Lincoln Pharmaceuticals Ltd)$ 0.14
Vivian 75mg x 1mL INJ / 1ml (Lincoln Pharmaceuticals Ltd)$ 0.14
Vivian 100mg SR-TAB / 10 (Lincoln Pharmaceuticals Ltd)$ 0.24
Vivian 50 mg Tablet (Lincoln Pharmaceuticals Ltd)$ 0.01
VIVIAN 1.16% GEL 1 tube / 30 GM gel each (Lincoln Pharmaceuticals Ltd)$ 0.85
VIVIAN 100 MG TABLET SR 1 strip / 10 tablet srs each (Lincoln Pharmaceuticals Ltd)$ 0.27
VIVIAN 25 MG INJECTION 1 vial / 3 ML injection each (Lincoln Pharmaceuticals Ltd)$ 0.19
VIVIAN 50 MG TABLET 1 strip / 10 tablets each (Lincoln Pharmaceuticals Ltd)$ 0.10
VIVIAN 75 MG INJECTION 1 vial / 3 ML injection each (Lincoln Pharmaceuticals Ltd)$ 0.19
VIVIAN ROLL ON GEL 1 tube / 40 GM gel each (Lincoln Pharmaceuticals Ltd)$ 1.06
VIVIAN inj 25 mg x 1 mL x 30ml (Lincoln Pharmaceuticals Ltd)$ 0.41
VIVIAN inj 25 mg x 1 mL x 3ml (Lincoln Pharmaceuticals Ltd)$ 0.14
VIVIAN inj 75 mg x 1 mL x 1ml (Lincoln Pharmaceuticals Ltd)$ 0.14
VIVIAN SR tab 100 mg x 10's (Lincoln Pharmaceuticals Ltd)$ 0.24
Vivian 25mg x 1mL INJ / 30ml (Lincoln Pharmaceuticals Ltd)$ 0.41
Vivian 25mg x 1mL INJ / 3ml (Lincoln Pharmaceuticals Ltd)$ 0.14
Vivian 75mg x 1mL INJ / 1ml (Lincoln Pharmaceuticals Ltd)$ 0.14
Vivian 100mg SR-TAB / 10 (Lincoln Pharmaceuticals Ltd)$ 0.24
Vivian 1.16% Gel (Lincoln Pharmaceuticals Ltd)$ 0.85
Vivian 100mg Tablet SR (Lincoln Pharmaceuticals Ltd)$ 0.03
Vivian 25mg Injection (Lincoln Pharmaceuticals Ltd)$ 0.06
Vivian 50mg Tablet (Lincoln Pharmaceuticals Ltd)$ 0.01
Vivian 75mg Injection (Lincoln Pharmaceuticals Ltd)$ 0.06
Vivian Spray (Lincoln Pharmaceuticals Ltd)$ 1.31
Volffin Gel 30 gm Gel (Boffin Biotech Pvt Ltd)$ 0.52
VOLFLAM - SR Modified Release Capsule/ Tablet / 100mg / 10 units (Psychotropics India)$ 0.16

References

  1. 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).
  2. PubChem. "diclofenac". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "diclofenac". http://www.drugbank.ca/drugs/DB00586 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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