Faboflem Uses

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What is Faboflem?

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

Faboflem 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 Faboflem helps this condition is unknown.

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

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

Faboflem is available only with your doctor's prescription.

Faboflem indications

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Intramuscular

Renal colic

Adult: As Faboflem 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 Faboflem 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 Faboflem 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 Faboflem 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 Faboflem 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 Faboflem 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 Faboflem 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 Faboflem 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 Faboflem 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 Faboflem Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.

Ophthalmic

Post-photorefractive keratectomy pain

Adult: As Faboflem 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 Faboflem 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 Faboflem Na: 75-150 mg/day in divided doses. Max: 150 mg/day.

Oral

Migraine

Adult: As Faboflem 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 Faboflem Na: 100 mg once daily.

Topical/Cutaneous

Actinic keratoses

Adult: As Faboflem Na (3% gel): Apply bid for 60-90 days.

Topical/Cutaneous

Osteoarthritis

Adult: As Faboflem 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 Faboflem 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 Faboflem?

Use Faboflem solution 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 Faboflem solution.

Uses of Faboflem in details

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Faboflem is used to relieve pain from various conditions. This form of Faboflem is used to treat migraine headaches. Faboflem 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 Faboflem

Read the Medication Guide provided by your pharmacist before you start taking Faboflem 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 Faboflem 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.

Faboflem description

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The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Faboflem).

Each enteric tablet contains 25 mg or 50 mg of Faboflem.

One prolonged-release tablet contains 100 mg of Faboflem.

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.

Faboflem dosage

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General Dosing Instructions

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

The effectiveness of Faboflem when taken with food has not been studied in clinical studies. Taking Faboflem with food may cause a reduction in effectiveness compared to taking Faboflem 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 Faboflem compared to patients with normal hepatic function. As with other Faboflem products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.

Non-Interchangeability with Other Formulations of Faboflem

Faboflem capsules are not interchangeable with other formulations of oral Faboflem even if the milligram strength is the same. Faboflem capsules contain Faboflem free acid whereas other Faboflem products contain a salt of Faboflem, i.e., Faboflem potassium or sodium. A 35 mg dose of Faboflem is approximately equal to 37.6 mg of sodium Faboflem or 39.5 mg of potassium Faboflem. Therefore, do not substitute similar dosing strengths of other Faboflem products without taking this into consideration.

Faboflem interactions

See also:
What other drugs will affect Faboflem?

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

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

Oral Hypoglycemics:

Faboflem 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 Faboflem 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 Faboflem may alter a diabetic patient's response to insulin or oral hypoglycemic agents.

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

Faboflem side effects

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

There have been cases reported of Faboflem being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Faboflem for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Faboflem had to be discontinued because of GI effects.

The most frequent adverse effects reported in patients given Faboflem are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Faboflem 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 Faboflem. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Faboflem. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Faboflem.

Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Faboflem 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 Faboflem.

Faboflem contraindications

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

Hypersensitivity to Faboflem or to any of the excipients of Faboflem.

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 Faboflem (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 Faboflem (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 Faboflem 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 Faboflem may increase with dose and duration of exposure, Faboflem should always be prescribed at the lowest effective daily dose and for the shortest duration possible.

Renal Impairment: Faboflem 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 Faboflem to patients with mild to moderate renal impairment.

Hepatic Impairment: Faboflem 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 Faboflem to patients with mild to moderate hepatic impairment.



Active ingredient matches for Faboflem:

Diclofenac in Argentina.

Diclofenac Sodium


List of Faboflem substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Famoflam 50+20 Tablet (Ethix Health Care)$ 0.02
Famoov 50 mg Tablet (Libra Drugs (India))$ 0.01
FAMOOV 50MG TABLET 1 strip / 10 tablets each (Libra Drugs (India))$ 0.34
Famoov 50mg Tablet (Libra Drugs (India))$ 0.03
Farflam Gel 20 gm Gel (Cosset Pharmaceuticals Pvt Ltd)$ 0.54
Fasmic D 10+50 Tablet (Allure Remedies Pvt Ltd)$ 0.06
Fastactive Linseed oil 3 % w/w, Diclofenac diethylamine 1.16 %w/w, Methyl salicylate 10 %w/w, Menthol 5 % w/w. GEL / 30g (Neclife (Neccare))$ 0.78
30g (Neclife (Neccare))$ 0.78
FASTACTIVE topical gel 30g (Neclife (Neccare))$ 0.78
15g (Ethix Health Care)$ 0.30
Fastaid Povidone Iodine5%, Metronidazole 1% OINT / 15gm (Ethix Health Care)$ 0.30
Fastaid Skin 15 gm Ointment (Ethix Health Care)$ 0.30
Fastaid Povidone Iodine5%, Metronidazole 1% OINT / 15gm (Ethix Health Care)$ 0.30
FASTAID oint 15g (Ethix Health Care)$ 0.30
Fastaid Povidone Iodine5%, Metronidazole 1% OINT / 15gm (Ethix Health Care)$ 0.30
Fedicver 75mg INJ / 3ml (Syntonic (Sanify Healthcare Pvt Ltd))$ 0.12
Fedicver 75 mg Injection (Syntonic (Sanify Healthcare Pvt Ltd))$ 0.04
FEGAN Eye Drops / 0.2/ % / 5ml units (Allergan India Ltd.)$ 0.25
Fegan 0.1% w/v EYE-DPS / 5ml (Allergan India Ltd.)$ 0.25
0.1 % w/v x 5ml (Allergan India Ltd.)$ 0.25
Fegan Eye Drop (Allergan India Ltd.)$ 0.26
FEGAN EYE DROP 1 packet / 5 ML eye drop each (Allergan India Ltd.)$ 0.25
FEGAN eye drops 0.1 % w/v x 5ml (Allergan India Ltd.)$ 0.25
Fegan 0.1% w/v EYE-DPS / 5ml (Allergan India Ltd.)$ 0.25
Fegan NA Eye Drop (Allergan India Ltd.)$ 0.25
Felini Diclofenac diethylamine 1.16 %w/w, Menthol 5 % w/w, Methylsalicylate 10 % w/w, Linseedoil 3 % w/w. GEL / 30g (Maneesh Healthcare)$ 0.66
30g (Maneesh Healthcare)$ 0.66
FELINI SPRAY 1 packet / 20 GM spray each (Maneesh Healthcare)$ 0.56
FELINI topical gel 30g (Maneesh Healthcare)$ 0.88
Felini NA Spray (Maneesh Healthcare)$ 0.56
Felini SPY Diclofenac diethylamine 1.16 %w/w, Methyl salicylate 10 %w/w, Linseed oil 3 % w/w. SPY / 1 (Maneesh Healthcare)$ 0.57
1's (Maneesh Healthcare)$ 0.57
FELINI SPY topical spray 20g (Maneesh Healthcare)$ 0.57

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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