Dolphin Uses

• Dolphin indications
• Uses of Dolphin in details
• Dolphin description
• Dolphin dosage
• Dolphin interactions
• Dolphin side effects
• Dolphin contraindications

What is Dolphin?

Dolphin is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Dolphin is used to treat mild to moderate pain, osteoarthritis, or rheumatoid arthritis.

Dolphin may also be used for other purposes not listed in this medication guide.

Dolphin indications

Carefully consider the potential benefits and risks of Dolphin (Dolphin) and other treatment options before deciding to use Dolphin (Dolphin). Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Dolphin (Dolphin) is indicated for acute or long-term use for symptomatic treatment of the following:

1. Mild to moderate pain
2. Osteoarthritis
3. Rheumatoid arthritis

How should I use Dolphin?

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

• Dolphin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dolphin refilled.
• Take Dolphin 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.
• Swallow Dolphin whole. Do not break, crush, or chew before swallowing.
• Take Dolphin with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Dolphin 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 the proper use of Dolphin.

Uses of Dolphin in details

Use: Labeled Indications

Osteoarthritis/Rheumatoid arthritis (RA): Treatment of osteoarthritis and RA

Pain, mild to moderate: Treatment of mild to moderate pain

Dolphin description

Dolphin, a salicylate derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with pharmacologic actions similar to other prototypical NSAIAs. Dolphin possesses anti-inflammatory, analgesic and antipyretic activity. Though its mechanism of action has not been clearly established, most of its actions appear to be associated with inhibition of prostaglandin synthesis via the arachidonic acid pathway. Dolphin is used to relieve pain accompanied with inflammation and in the symptomatic treatment of rheumatoid arthritis and osteoarthritis.

Dolphin dosage

Carefully consider the potential benefits and risks of Dolphin (Dolphin) and other treatment options before deciding to use Dolphin (Dolphin). Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Dolphin (Dolphin), the dose and frequency should be adjusted to suit an individual patient's needs.

Concentration-dependent pharmacokinetics prevail when Dolphin (Dolphin) is administered; a doubling of dosage produces a greater than doubling of drug accumulation. The effect becomes more apparent with repetitive doses.

For mild to moderate pain, an initial dose of 1000 mg followed by 500 mg every 12 hours is recommended for most patients. Following the initial dose, some patients may require 500 mg every 8 hours.

A lower dosage may be appropriate depending on such factors as pain severity, patient response, weight, or advanced age; for example, 500 mg initially, followed by 250 mg every 8-12 hours.

For osteoarthritis and rheumatoid arthritis, the suggested dosage range is 500 mg to 1000 mg daily in two divided doses. The dosage of Dolphin (Dolphin) may be increased or decreased according to patient response.

Maintenance doses higher than 1500 mg a day are not recommended.

Tablets should be swallowed whole, not crushed or chewed.

How supplied

Tablets Dolphin (Dolphin) are capsule-shaped, film-coated tablets supplied as follows:

No. 3390 250 mg peach colored, coded Dolphin (Dolphin) on one side and MSD 675 on the other.

NDC 0006-0675-61 unit of use bottles of 60

(6505-01-164-0501, 250 mg 60's).

No. 3392 500 mg orange colored, coded Dolphin (Dolphin) on one side and MSD 697 on the other.

NDC 0006-0697-61 unit of use bottles of 60

(6505-01-144-9724, 500 mg 60's).

Distributed by: MERCK & Co. Inc, Whitehouse Station, NJ 08889, USA, Issued January 2007. FDA revision date: 3/16/2007

Dolphin interactions

See also:
What other drugs will affect Dolphin?

ACE-Inhibitors and Angiotensin II Antagonists

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors and angiotensin II antagonists. These interactions should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors or angiotensin II antagonists. In some patients with compromised renal function, the co-administration of an NSAID and an ACE-inhibitor or an angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.

Acetaminophen

In normal volunteers, concomitant administration of Dolphin (Dolphin) and acetaminophen resulted in an approximate 50% increase in plasma levels of acetaminophen. Acetaminophen had no effect on plasma levels of Dolphin (Dolphin). Since acetaminophen in high doses has been associated with hepatotoxicity, concomitant administration of Dolphin (Dolphin) and acetaminophen should be used cautiously, with careful monitoring of patients. Concomitant administration of Dolphin (Dolphin) and acetaminophen in dogs, but not in rats, at approximately 2 times the recommended maximum human therapeutic dose of each (40-52 mg/kg/day of Dolphin (Dolphin) /acetaminophen), resulted in greater gastrointestinal toxicity than when either drug was administered alone. The clinical significance of these findings has not been established.

Antacids

Concomitant administration of antacids may reduce plasma levels of Dolphin (Dolphin). This effect is small with occasional doses of antacids, but may be clinically significant when antacids are used on a continuous schedule.

Aspirin

When Dolphin (Dolphin) is administered with aspirin, its protein binding is reduced, although the clearance of free Dolphin (Dolphin) is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Dolphin and aspirin is not generally recommended because of the potential of increased adverse effects.

In normal volunteers, a small decrease in Dolphin levels was observed when multiple doses of Dolphin (Dolphin) and aspirin were administered concomitantly.

Cyclosporine

Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. NSAIDs should be used with caution in patients taking cyclosporine, and renal function should be carefully monitored.

Diuretics

Clinical studies, as well as post marketing observations, have shown that Dolphin (Dolphin) can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

In normal volunteers, concomitant administration of Dolphin (Dolphin) and hydrochlorothiazide resulted in significantly increased plasma levels of hydrochlorothiazide. Dolphin (Dolphin) decreased the hyperuricemic effect of hydrochlorothiazide. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

NSAIDs

The administration of Dolphin to normal volunteers receiving indomethacin decreased the renal clearance and significantly increased the plasma levels of indomethacin. In some patients the combined use of indomethacin and Dolphin (Dolphin) has been associated with fatal gastrointestinal hemorrhage. Therefore, indomethacin and Dolphin (Dolphin) should not be used concomitantly.

The concomitant use of Dolphin (Dolphin) and other NSAIDs is not recommended due to the increased possibility of gastrointestinal toxicity, with little or no increase in efficacy. The following information was obtained from studies in normal volunteers.

Sulindac: The concomitant administration of Dolphin (Dolphin) and sulindac in normal volunteers resulted in lowering of the plasma levels of the active sulindac sulfide metabolite by approximately one-third.

Naproxen: The concomitant administration of Dolphin (Dolphin) and naproxen in normal volunteers had no effect on the plasma levels of naproxen, but significantly decreased the urinary excretion of naproxen and its glucuronide metabolite. Naproxen had no effect on plasma levels of Dolphin (Dolphin).

Oral Anticoagulants

In some normal volunteers, the concomitant administration of Dolphin (Dolphin) and warfarin, acenocoumarol, or phenprocoumon resulted in prolongation of prothrombin time. This may occur because Dolphin competitively displaces coumarins from protein binding sites. Accordingly, when Dolphin (Dolphin) is administered with oral anticoagulants, the prothrombin time should be closely monitored during and for several days after concomitant drug administration. Adjustment of dosage of oral anticoagulants may be required. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Tolbutamide

In diabetic patients receiving Dolphin (Dolphin) and tolbutamide, no significant effects were seen on tolbutamide plasma levels or fasting blood glucose.

Drug/Laboratory Test Interactions

Serum Salicylate Assays: Caution should be used in interpreting the results of serum salicylate assays when Dolphin is present. Salicylate levels have been found to be falsely elevated with some assay methods.

Dolphin side effects

See also:
What are the possible side effects of Dolphin?

The adverse reactions observed in controlled clinical trials encompass observations in 2,427 patients.

Listed below are the adverse reactions reported in the 1,314 of these patients who received treatment in studies of two weeks or longer. Five hundred thirteen patients were treated for at least 24 weeks, 255 patients were treated for at least 48 weeks, and 46 patients were treated for 96 weeks. In general, the adverse reactions listed below were 2 to 14 times less frequent in the 1,113 patients who received short-term treatment for mild to moderate pain.

Incidence Greater Than 1%

Gastrointestinal

The most frequent types of adverse reactions occurring with Dolphin (Dolphin) are gastrointestinal: these include nausea, fatigue/tiredness.

Incidence Less Than 1 in 100

The following adverse reactions, occurring less frequently than 1 in 100, were reported in clinical trials or since the drug was marketed. The probability exists of a causal relationship between Dolphin (Dolphin) and these adverse reactions.

Dermatologic

Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, pruritus, sweating, dry mucous membranes, stomatitis, photosensitivity.

Gastrointestinal

Peptic ulcer, gastrointestinal bleeding, anorexia, eructation, gastrointestinal perforation, gastritis.

Liver function abnormalities; jaundice, sometimes with fever; cholestasis; hepatitis.

Hematologic

Thrombocytopenia; agranulocytosis; hemolytic anemia.

Genitourinary

Dysuria; renal impairment, including renal failure; interstitial nephritis; hematuria; proteinuria.

Psychiatric

Nervousness, depression, hallucinations, confusion, disorientation.

Central Nervous System

Vertigo; light-headedness; paresthesias.

Special Senses

Transient visual disturbances including blurred vision.

Hypersensitivity Reactions

Acute anaphylactic reaction with bronchospasm; angioedema; flushing.

Hypersensitivity vasculitis.

Hypersensitivity syndrome.

Miscellaneous

Asthenia, edema.

Causal Relationship Unknown

Other reactions have been reported in clinical trials or since the drug was marketed, but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

Respiratory

Dyspnea.

Cardiovascular

Palpitation, syncope.

Musculoskeletal

Muscle cramps.

Genitourinary

Nephrotic syndrome.

Special Senses

Hearing loss.

Miscellaneous

Chest pain.

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group A α-hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including Dolphin, sometimes with fatal outcome.

Potential Adverse Effects

In addition, a variety of adverse effects not observed with Dolphin (Dolphin) in clinical trials or in marketing experience, but reported with other non-steroidal analgesic/anti-inflammatory agents, should be considered potential adverse effects of Dolphin (Dolphin).

**Incidence between 3% and 9%. Those reactions occurring in 1% to 3% are not marked with an asterisk.

Dolphin contraindications

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

Dolphin (Dolphin) is contraindicated in patients with known hypersensitivity to Dolphin or the excipients.

Dolphin (Dolphin) 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/anaphylactoid reactions to NSAIDS have been reported in such patients.

Dolphin (Dolphin) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Active ingredient matches for Dolphin:

Diflunisal in Turkey.

References

1. DailyMed. "DIFLUNISAL: 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. "diflunisal". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "diflunisal". http://www.drugbank.ca/drugs/DB00861 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology