What is Penta-Diclofenac?
Penta-Diclofenac 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, Penta-Diclofenac does not cure osteoarthritis and will help you only as long as you continue to use it.
Penta-Diclofenac 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 Penta-Diclofenac helps this condition is unknown.
Penta-Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Penta-Diclofenac topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Penta-Diclofenac is available only with your doctor's prescription.
Penta-Diclofenac indications
Intramuscular
Renal colic
Adult: As Penta-Diclofenac Na: 75 mg, may repeat once after 30 min if needed. Max: 150 mg/day. Max period: 2 days.
Intramuscular
Bursitis, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Acute gout, Dysmenorrhoea
Adult: As Penta-Diclofenac Na: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions. Max period: 2 days.
Intravenous
Postoperative pain
Adult: As Penta-Diclofenac Na: 75 mg infusion in glucose 5% or NaCl 0.9% (previously buffered w/ Na bicarbonate) given over 30-120 min or as bolus inj, may repeat after 4-6 hr if necessary. Max period: 2 days.
Intravenous
Prophylaxis of postoperative pain
Adult: As Penta-Diclofenac Na: Initially, 25-50 mg infusion given after surgery over 15-60 min followed by 5 mg/hr. Alternatively, initial dose may be given as bolus inj over 5-60 sec followed by additional inj, may repeat after 4-6 hr if necessary. Max: 150 mg/day. Max period: 2 days.
Ophthalmic
Postoperative ocular inflammation
Adult: As Penta-Diclofenac Na (0.1% soln): Instill into the appropriate eye 4 times daily starting 24 hr after surgery for up to 28 days.
Ophthalmic
Inflammation and discomfort after strabismus surgery
Adult: As Penta-Diclofenac Na (0.1% soln): Instill 1 drop 4 times daily for the 1st wk; then tid in the 2nd wk, bid in the 3rd wk, and as required for the 4th wk.
Ophthalmic
Pain and discomfort after radial keratotomy
Adult: As Penta-Diclofenac Na (0.1% soln): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
Ophthalmic
Pain after accidental trauma
Adult: As Penta-Diclofenac Na (0.1% soln): Instill 1 drop 4 times daily for up to 2 days.
Ophthalmic
Control of inflammation after argon laser trabeculoplasty
Adult: As Penta-Diclofenac Na (0.1% soln): Instill 1 drop 4 times during the 2 hr before procedure followed by 1 drop 4 times daily, up to 7 days after procedure.
Ophthalmic
Prophylaxis of intra-operative miosis
Adult: As Penta-Diclofenac Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As Penta-Diclofenac Na (0.1% soln): Instill into the affected eye twice, an hr before surgery, then 1 drop twice at 5-min intervals immediately after surgery, then every 2-5 hr while awake for up to 24 hr.
Ophthalmic
Seasonal allergic conjunctivitis
Adult: As Penta-Diclofenac Na (0.1% soln): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
Oral
Bursitis, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Acute gout, Dysmenorrhoea
Adult: As Penta-Diclofenac Na: 75-150 mg/day in divided doses. Max: 150 mg/day.
Oral
Migraine
Adult: As Penta-Diclofenac K: Initially, 50 mg taken at the 1st sign of an attack, an additional dose of 50 mg may be taken after 2 hr if symptoms persist. If needed, further doses of 50 mg may be taken 4-6 hrly. Max: 200 mg/day.
Rectal
Acute gout, Bursitis, Dysmenorrhoea, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis
Adult: As Penta-Diclofenac Na: 100 mg once daily.
Topical/Cutaneous
Actinic keratoses
Adult: As Penta-Diclofenac Na (3% gel): Apply bid for 60-90 days.
Topical/Cutaneous
Osteoarthritis
Adult: As Penta-Diclofenac Na (1.6% soln): Apply in small amounts (20 or 40 drops) onto affected area 4 times daily. As Na: (1% gel): Apply to the affected area 4 times daily. Max: 32 g/day over the affected area.
Topical/Cutaneous
Local symptomatic relief of pain and inflammation
Adult: As Penta-Diclofenac Na (1% gel): Apply onto affected area 3 or 4 times daily.
Transdermal
Acute pain
Adult: Sprains, strains, contusions: 1 patch bid.
How should I use Penta-Diclofenac?
Use Penta-Diclofenac solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Penta-Diclofenac solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Penta-Diclofenac solution refilled.
- Do not apply Penta-Diclofenac solution to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Penta-Diclofenac solution.
- Wash the affected area and dry completely before using Penta-Diclofenac solution.
- To apply Penta-Diclofenac solution, dispense 10 drops at a time onto the knee or into your hand. Spread Penta-Diclofenac solution 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 Penta-Diclofenac solution. 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 Penta-Diclofenac solution.
- If you miss a dose of Penta-Diclofenac solution, 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 Penta-Diclofenac solution.
Uses of Penta-Diclofenac in details
Penta-Diclofenac is used to relieve pain from various conditions. This form of Penta-Diclofenac is used to treat migraine headaches. Penta-Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
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 Penta-Diclofenac
Read the Medication Guide provided by your pharmacist before you start taking Penta-Diclofenac and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 milliliters) of water. Mix well and drink all of it right away. Do not mix with any liquid other than water. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. However, if you take this medication with a meal high in fat, it may not work as well.
There are different brands and forms of this medication available. Because different forms do not have the same effects at equal strengths, do not switch forms of Penta-Diclofenac unless your doctor tells you to.
To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose. Do not increase your dose or take it more often than prescribed.
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 persists or worsens.
Penta-Diclofenac description
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Penta-Diclofenac sodium).
Each enteric tablet contains 25 mg or 50 mg of Penta-Diclofenac sodium.
One prolonged-release tablet contains 100 mg of Penta-Diclofenac sodium.
Excipients/Inactive Ingredients: Gastro-Resistant Tablet: Core for 25 mg and 50 mg: Cellulose microcrystalline; lactose monohydrate; magnesium stearate; maize starch; povidone; silica, colloidal anhydrous; sodium starch glycolate (type A).
Coating for 25 mg and 50 mg: Hypromellose; iron oxide yellow (E172); macrogoglycerol hydroxystearate; methacrylic acid-ethyl acrylate copolymer; macrogol 8000; talc; titanium dioxide (E171); simeticone; alpha-octadecyl-omega-hydroxy-polyglykolether; sorbic acid.
Coating for 50 mg: Iron oxide red (E172).
SR Tablet: Tablet Core: Cetyl alcohol; magnesium stearate; povidone; silica; colloidal anhydrous; sucrose.
Tablet Coating: Hypromellose; iron oxide red (E172); macrogol 8000; polysorbate 80; sucrose; talc; titanium dioxide (E171). Printing Ink: Carbon black, shellac, ammonium hydroxide, simethicone.
Injection: Each ampoule also contains the following excipients: Mannitol, sodium metabisulfite (E223), benzyl alcohol, propylene glycol, water for injection, sodium hydroxide.
Penta-Diclofenac dosage
General Dosing Instructions
Carefully consider the potential benefits and risks of Penta-Diclofenac and other treatment options before deciding to use Penta-Diclofenac. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The effectiveness of Penta-Diclofenac when taken with food has not been studied in clinical studies. Taking Penta-Diclofenac with food may cause a reduction in effectiveness compared to taking Penta-Diclofenac on an empty stomach.
Acute Pain
For management of mild to moderate acute pain, the dosage is 18 mg or 35 mg orally three times daily.
Osteoarthritis Pain
For management of osteoarthritis pain, the dosage is 35 mg orally three times daily.
Dosage Adjustments in Patients with Hepatic Impairment
Patients with hepatic disease may require reduced doses of Penta-Diclofenac compared to patients with normal hepatic function. As with other Penta-Diclofenac products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Non-Interchangeability with Other Formulations of Penta-Diclofenac
Penta-Diclofenac capsules are not interchangeable with other formulations of oral Penta-Diclofenac even if the milligram strength is the same. Penta-Diclofenac capsules contain Penta-Diclofenac free acid whereas other Penta-Diclofenac products contain a salt of Penta-Diclofenac, i.e., Penta-Diclofenac potassium or sodium. A 35 mg dose of Penta-Diclofenac is approximately equal to 37.6 mg of sodium Penta-Diclofenac or 39.5 mg of potassium Penta-Diclofenac. Therefore, do not substitute similar dosing strengths of other Penta-Diclofenac products without taking this into consideration.
Penta-Diclofenac interactions
See also:
What other drugs will affect Penta-Diclofenac?
Aspirin: Concomitant administration of Penta-Diclofenac and aspirin is not recommended because Penta-Diclofenac 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 Penta-Diclofenac 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 Penta-Diclofenac and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Penta-Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Penta-Diclofenac may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Penta-Diclofenac or who increase their Penta-Diclofenac 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: Penta-Diclofenac decreases lithium renal clearance and increases lithium plasma levels. In patients taking Penta-Diclofenac and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Penta-Diclofenac 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 Penta-Diclofenac 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 Penta-Diclofenac may alter a diabetic patient's response to insulin or oral hypoglycemic agents.Diuretics: Penta-Diclofenac 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 Penta-Diclofenac. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Penta-Diclofenac therapy.
Penta-Diclofenac side effects
See also:
What are the possible side effects of Penta-Diclofenac?
There have been cases reported of Penta-Diclofenac being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Penta-Diclofenac for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Penta-Diclofenac had to be discontinued because of GI effects.
The most frequent adverse effects reported in patients given Penta-Diclofenac are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Penta-Diclofenac has also been implicated as the causative agent in colonic ulceration, small bowel perforation and pseudomembranous colitis.
Renal papillary necrosis and nephritic syndrome have been reported in patients taking Penta-Diclofenac. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Penta-Diclofenac. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Penta-Diclofenac.
Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Penta-Diclofenac in doses of 10-25 mg and the CMS in the UK have received a report of 1 aspirin-sensitive patient who died from acute asthma 4 hrs after a single 25-mg dose of Penta-Diclofenac.
Penta-Diclofenac contraindications
See also:
What is the most important information I should know about Penta-Diclofenac?
Hypersensitivity to Penta-Diclofenac sodium or to any of the excipients of Penta-Diclofenac.
Active gastric or intestinal ulcer, bleeding or perforation.
Last trimester of pregnancy.
Hepatic, renal and severe cardiac failure.
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid and/or other drugs with prostaglandin-synthetase inhibitory activity.
Treatment of peri-operative pain in setting of coronary artery bypass graft (CABG) surgery.
The use of high dose Penta-Diclofenac (150 mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.
Established Cardiovascular Disease or Significant Cardiovascular Risk Factors: The use of high dose Penta-Diclofenac (150mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If Penta-Diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (eg, hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for >4 weeks. As the cardiovascular risks of Penta-Diclofenac may increase with dose and duration of exposure, Penta-Diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Penta-Diclofenac is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Penta-Diclofenac to patients with mild to moderate renal impairment.
Hepatic Impairment: Penta-Diclofenac is contraindicated in patients with hepatic failure. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Penta-Diclofenac to patients with mild to moderate hepatic impairment.
Active ingredient matches for Penta-Diclofenac:
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet, Enteric Coated; Oral; Diclofenac Sodium 25 mg | |
| Tablet, Enteric Coated; Oral; Diclofenac Sodium 50 mg | |
| Tablets, Enteric Coated; Oral; Diclofenac Sodium 25 mg | |
| Tablets, Enteric Coated; Oral; Diclofenac Sodium 50 mg | |
List of Penta-Diclofenac substitutes (brand and generic names): | |
| Pennsaid Topical | |
| Pepdic (India) | |
| Pepdic Diclofenac potassium 50 mg, serratiopeptidase 10 mg. TAB / 10 (Mediez) | $ 0.59 |
| 10's (Mediez) | $ 0.59 |
| PEPDIC 50MG/10MG TABLET 1 strip / 10 tablets each (Mediez) | $ 0.18 |
| PEPDIC tab 10's (Mediez) | $ 0.59 |
| Pepdic 50 mg/10 mg Tablet (Mediez) | $ 0.02 |
| Pepsun-D (India) | |
| Pepsun-D Serratiopeptidase 10 mg, Diclofenac potassium 50 mg. TAB / 100 (Laksun) | |
| 100's (Laksun) | |
| PEPSUN-D tab 10's (Laksun) | |
| Peptinim-D (India) | |
| Peptinim-D Diclofenac potassium 50 mg, Serrapeptase 10 mg. TAB / 10 (Neiss) | $ 0.66 |
| 10's (Neiss) | $ 0.66 |
| Peptinim-D Diclofenac potassium 50 mg, Serrapeptase 10 mg TAB / 10 (Neiss) | $ 0.66 |
| PEPTINIM-D tab 10's (Neiss) | $ 0.66 |
| Pevoran (Chile) | |
| PGI GEL (India) | |
| PGI GEL oint 30 mg x 30g (Vanguard) | $ 0.34 |
| Pharma-Q Diclofenac (South Africa) | |
| Pharmacor Diclofenac 50 (Australia) | |
| Pharmaflam (South Africa) | |
| Pharofen (Egypt) | |
| Phil Pharmawealth/Standard Chem Diclofenac (Philippines) | |
| Phil Pharmawealth/Standard Chem Diclofenac / amp 25 mg/1 mL x 3 mL x 10's | |
| Phil Pharmawealth/Standard Chem Diclofenac 25 mg/1 mL x 3 mL x 100's | |
| Physicare (Israel) | |
| Pinanac (Japan) | |
| Pirafen (Paraguay) | |
| Pirexyl (Chile) | |
| Drops; Oral; Diclofenac Sodium 15 mg / ml (Pasteur) | |
| Suppositories; Rectal; Diclofenac Sodium 12.5 mg (Pasteur) | |
| Suppositories; Rectal; Diclofenac Sodium 50 mg (Pasteur) | |
| Piroflam (Chile, Germany) | |
| Drops; Oral; Diclofenac Resinate 46.44 mg / ml (Lichtenstein) | |
| Gel; Topical; Diclofenac Diethylamine 1% (Lichtenstein) | |
| Suppositories; Rectal; Diclofenac Sodium 12.5 mg (Lichtenstein) | |
| Suppositories; Rectal; Diclofenac Sodium 50 mg (Lichtenstein) | |
| Tablet, Enteric Coated; Oral; Diclofenac Sodium 50 mg (Lichtenstein) | |
| Tablet; Oral; Piroxicam 10 mg (Lichtenstein) | |
| Tablet; Oral; Piroxicam 20 mg (Lichtenstein) | |
| Tablets, Enteric Coated; Oral; Diclofenac Sodium 50 mg (Lichtenstein) | |
| Tablets; Oral; Piroxicam 10 mg (Lichtenstein) | |
| Tablets; Oral; Piroxicam 20 mg (Lichtenstein) | |
| Piroflam L.P. | |
| Capsule, Prolonged Release; Oral; Diclofenac Sodium 100 mg | |
| Capsules, Prolonged Release; Oral; Diclofenac Sodium 100 mg | |
| PMS-Diclofenac (Canada) | |
| Suppositories; Rectal; Diclofenac Sodium 100 mg | |
| Suppositories; Rectal; Diclofenac Sodium 50 mg | |
| Tablet, Delayed Release; Oral; Diclofenac Sodium 25 mg | |
See 7735 substitutes for Penta-Diclofenac | |
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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
