Spado Uses

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What is Spado?

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

Spado 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 Spado helps this condition is unknown.

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

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

Spado is available only with your doctor's prescription.

Spado indications

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

Spado 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 Spado?

Use Spado 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 Spado.

Uses of Spado 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 Spado 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.

Spado 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.

Spado dosage

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

Spado interactions

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What other drugs will affect Spado?

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

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

Oral Hypoglycemics:

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

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

Protein Binding

In vitro, Spado 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 Spado in human serum.

Drug/Laboratory Test Interactions

Effect on Blood Coagulation: Spado 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. Spado 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.

Spado side effects

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What are the possible side effects of Spado?

Ocular

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

Spado contraindications

See also:
What is the most important information I should know about Spado?

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

Active ingredient matches for Spado:

Diclofenac Sodium


Unit description / dosage (Manufacturer)Price, USD
Spado 10+25 Injection$ 0.18

List of Spado substitutes (brand and generic names):

Spadic 75 mg Injection (Sparkles Exim Pvt Ltd)$ 0.03
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 2 250+50+32.5 Tablet (East African (I) Remedies Pvt Ltd)$ 0.03
Speedex 20 gm Gel (V.S. Healthcare Limited.)$ 0.46
SUBSYDE - CR Modified Release Capsule/ Tablet / 100mg / 10 units (Raptakos Brett & Co.)$ 0.36
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 500+100+10 Tablet (Focus Healthcare Pvt Ltd)$ 0.08
Svsera D 50+10 Tablet (Ecocare)$ 0.06
Swenac SR 50 mg Tablet (Mascot Lifesciences Pvt. Ltd.)$ 0.02
Synotrip D 50+10 Tablet (Syntro Health Care (Synokem Pharmaceuticals Ltd))$ 0.04
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 50+10 Tablet (Siesta Pharmaceuticals)$ 0.07
Taldic 50 mg Tablet (Talent Laboratories)$ 0.01
Tifenac 75 mg Injection (Trigenesis Lifesciences Pvt. Ltd.)$ 0.03
Tizidal D 50+2 Tablet (Adley Formulation)$ 0.06
Tromadac 50 mg Tablet (Hamax Pharmaceuticals)$ 0.01
Tromadac 75 mg Injection (Hamax Pharmaceuticals)$ 0.01
Udec 100 mg Tablet (Ubit Pharmaceuticals Pvt Ltd)$ 0.03
UNIDIC INJ. Injection / 25mg per ml / 3ml units (Unimarck Pharma)$ 0.08
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

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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