Emflam Gel Dosage

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Dosage of Emflam Gel in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Gastro-Resistant Tablet: The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 mg daily is usually sufficient.

The total daily dose should generally be divided into 2 to 3 doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).

In primary dysmenorrhea, the daily dose should be individually adjusted and is generally 50 to 150 mg. A dose of 50 to 100 mg should be given initially and, if necessary, increased over the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.

SR Tablet: The recommended initial daily dose is 100 mg.

In milder cases, as well as for long-term therapy, 100 mg daily is usually sufficient.

Where the symptoms are most pronounced during the night or in the morning, the tablet should preferably be taken in the evening.

Children: Gastro-Resistant Tablet: Children aged 1 year or over and adolescents should be given 0.5 to 2 mg/kg body weight daily in 2 to 3 separate doses, depending on the severity of the disorder. For treatment of juvenile rheumatoid arthritis, the daily dose can be raised up to a maximum of 3 mg/kg daily, given in separate doses.

The maximum daily dose of 150 mg should not be exceeded.

Because of their dosage strength, Emflam Gel 50 mg gastro-resistant tablets are not recommended for use in children and adolescents below 14 years of age; Emflam Gel 25 mg gastro-resistant tablets could be used in these patients.

SR Tablet: Not suitable for children and adolescents because of the dosage strength.

Elderly (Patients aged 65 or above): No adjustment of the starting dose is required for elderly patients.

Established Cardiovascular Disease or Significant Cardiovascular Risk Factors: Treatment with Emflam Gel is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease should be treated with Emflam Gel only after careful consideration and only at doses ≤100 mg daily if treated for more than 4 weeks.

Renal Impairment: Emflam Gel 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 Emflam Gel to patients with mild to moderate renal impairment.

Hepatic Impairment: Emflam Gel 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 Emflam Gel to patients with mild to moderate hepatic impairment.

Administration: SR Tablet: Tablets should be swallowed whole with liquid, preferably before meals and must not be divided or chewed.

Injection: Emflam Gel injection should not be given for >2 days; if necessary, treatment can be continued with Emflam Gel tablets or suppositories.

Injection: IM: The following directions for IM injection must be followed in order to avoid damage to a nerve or other tissue at the injection site.

Dosage is generally 1 75 mg ampoule daily, injected deep intragluteally into the upper outer quadrant. In severe cases (eg, colic), the daily dose can exceptionally be increased to 2 injections, separated by an interval of a few hours (1 into each buttock). Alternatively, it is possible to combine 1 ampoule with other dosage forms of Emflam Gel (eg, tablets) up to a maximum daily dosage of 150 mg.

In migraine attacks, clinical experience is limited to initial use of 1 ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dose should not exceed 175 mg on the 1st day.

IV Infusion: Emflam Gel must not be given as an IV bolus injection.

Immediately before starting an IV infusion, Emflam Gel must be diluted with saline 0.9% or glucose 5% infusion solution buffered with sodium bicarbonate according to the instructions given in Instructions for Use and Handling under Cautions for Usage.

Two (2) alternative dosage regimens of Emflam Gel are recommended.

For the treatment of moderate to severe postoperative pain, 75 mg should be infused continuously over a period of 30 min to 2 hrs. If necessary, treatment may be repeated after a few hours, but the dosage should not exceed 150 mg within any period of 24 hrs.

For the prevention of postoperative pain, a loading dose of 25-50 mg should be infused after surgery over 15 min to 1 hr, followed by a continuous infusion of about 5 mg/hr up to a maximum daily dose of 150 mg.

What other drugs will affect Emflam Gel?

Ask your doctor before using Emflam Gel if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with Emflam Gel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Emflam Gel interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Emflam Gel, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Table 2: Clinically Significant Drug Interactions with Emflam Gel

Drugs That Interfere with Hemostasis
Clinical Impact:
  • Emflam Gel and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of Emflam Gel and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
  • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention: Monitor patients with concomitant use of Emflam Gel with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding.
Aspirin
Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone.
Intervention: Concomitant use of Emflam Gel and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Emflam Gel is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:
  • During concomitant use of Emflam Gel and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of Emflam Gel and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function.
  • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of Emflam Gel with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects
Digoxin
Clinical Impact: The concomitant use of Emflam Gel with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Intervention: During concomitant use of Emflam Gel and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of Emflam Gel and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention: During concomitant use of Emflam Gel and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact: Concomitant use of Emflam Gel and cyclosporine may increase cyclosporine’s’ nephrotoxicity.
Intervention: During concomitant use of Emflam Gel and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact: Concomitant use of Emflam Gel with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.
Intervention: The concomitant use of Emflam Gel with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact: Concomitant use of Emflam Gel and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.
Intervention: During concomitant use of Emflam Gel and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

NSAIDs with short elimination half-lives (e.g., Emflam Gel, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

CYP2C9 Inhibitors or Inducers:
Clinical Impact: Emflam Gel is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of Emflam Gel with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of Emflam Gel whereas coadministration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of Emflam Gel.
Intervention: A dosage adjustment may be warranted when Emflam Gel is administered with CYP2C9 inhibitors or inducers.


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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. FDA/SPL Indexing Data. "144O8QL0L1: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Cyclooxygenase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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