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Fenoprofen Calcium (Fenoprofen Calcium)

Trade Name : Fenoprofen Calcium

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 600 mg/1

FENOPROFEN CALCIUM Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fenoprofen Calcium (Fenoprofen Calcium) which is also known as Fenoprofen Calcium and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 600 mg/1 per ml. Read more

Fenoprofen Calcium (Fenoprofen Calcium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cardiovascular Thrombotic Events
  • Gastrointestinal Risk
  • Fenoprofen calcium is a nonsteroidal, anti-inflammatory, antiarthritic drug. Chemically, fenoprofen calcium is an arylacetic acid derivative. The structural formula is as follows:
  • Fenoprofen calcium, USP is a white crystalline powder, soluble in alcohol (95%) to the extent of approximately 15 mg/mL at 25u00b0C, slightly soluble in water and insoluble in benzene.
  • The pKa of fenoprofen calcium is 4.5 at 25u00b0C.
  • Film-coated fenoprofen calcium tablets for oral administration are available containing fenoprofen calcium as the dihydrate equivalent to 600 mg of fenoprofen and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, titanium dioxide and FD&C Yellow No. 6 Aluminum Lake.
  • Fenoprofen calcium is a nonsteroidal, anti-inflammatory, antiarthritic drug that also possesses analgesic and antipyretic activities. Its exact mode of action is unknown, but it is thought that prostaglandin synthetase inhibition is involved.
  • Results in humans demonstrate that fenoprofen has both anti-inflammatory and analgesic actions. The emergence and degree of erythemic response were measured in adult male volunteers exposed to ultraviolet irradiation. The effects of fenoprofen, aspirin and indomethacin were each compared with those of a placebo. All three drugs demonstrated antierythemic activity.
  • In all patients with rheumatoid arthritis, the anti-inflammatory action of fenoprofen has been evidenced by relief of pain, increase in grip strength and reductions in joint swelling, duration of morning stiffness and disease activity (as assessed by both the investigator and the patient). The anti-inflammatory action of fenoprofen has also been evidenced by increased mobility (i.e., a decrease in the number of joints having limited motion).
  • The use of fenoprofen in combination with gold salts or corticosteroids has been studied in patients with rheumatoid arthritis. The studies, however, were inadequate in demonstrating whether further improvement is obtained by adding fenoprofen to maintenance therapy with gold salts or steroids. Whether or not fenoprofen used in conjunction with partially effective doses of a corticosteroid has a u201csteroid-sparingu201d effect is unknown.
  • In patients with osteoarthritis, the anti-inflammatory and analgesic effects of fenoprofen have been demonstrated by reduction in tenderness as a response to pressure and reductions in night pain, stiffness, swelling and overall disease activity (as assessed by both the patient and the investigator). These effects have also been demonstrated by relief of pain with motion and at rest and increased range of motion in involved joints.
  • In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown fenoprofen to be comparable to aspirin in controlling the aforementioned measures of disease activity, but mild gastrointestinal reactions (nausea, dyspepsia) and tinnitus occurred less frequently in patients treated with fenoprofen than in aspirin-treated patients. It is not known whether fenoprofen calcium causes less peptic ulceration than does aspirin.
  • In patients with pain, the analgesic action of fenoprofen has produced a reduction in pain intensity, an increase in pain relief, improvement in total analgesia scores and a sustained analgesic effect.
  • Under fasting conditions, fenoprofen is rapidly absorbed and peak plasma levels of 50 mcg/mL are achieved within 2 hours after oral administration of 600 mg doses. Good dose proportionality was observed between 200 mg and 600 mg doses in fasting male volunteers. The plasma half-life is approximately 3 hours. About 90% of a single oral dose is eliminated within 24 hours as fenoprofen glucuronide and 4u2019-hydroxy-fenoprofen glucuronide, the major urinary metabolites of fenoprofen. Fenoprofen is highly bound (99%) to albumin.
  • The concomitant administration of antacid (containing both aluminum and magnesium hydroxide) does not interfere with absorption of fenoprofen.
  • There is less suppression of collagen-induced platelet aggregation with single doses of fenoprofen calcium than there is with aspirin.
  • Carefully consider the potential benefits and risks of fenoprofen calcium tablets, USP and other treatment options before deciding to use fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • Fenoprofen calcium tablets are indicated:
  • Fenoprofen calcium tablets are contraindicated in patients who have shown hypersensitivity to fenoprofen calcium.
  • Fenoprofen 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-like reactions to NSAIDs have been reported in such patients (see , and ).
  • Fenoprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
  • Fenoprofen is contraindicated in patients with a history of significantly impaired renal function (see ).
  • No data
  • No data
  • During clinical studies for rheumatoid arthritis, osteoarthritis or mild to moderate pain and studies of pharmacokinetics, complaints were compiled from a checklist of potential adverse reactions, and the following data emerged. These encompass observations in 6,786 patients, including 188 observed for at least 52 weeks. For comparison, data are also presented from complaints received from the 266 patients who received placebo in these same trials. During short-term studies for analgesia, the incidence of adverse reactions was markedly lower than that seen in longer-term studies.
  • No data
  • Carefully consider the potential benefits and risks of fenoprofen calcium tablets and other treatment options before deciding to use fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • After observing the response to initial therapy with fenoprofen calcium tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
  • Fenoprofen Calcium Tablets, USP are available containing fenoprofen calcium, USP equivalent to 600 mg fenoprofen.
  • The 600 mg tablet is an orange film-coated, capsule-shaped tablet debossed with on one side of the tablet and scored on the other side. They are available as follows:
  • NDC 0378-0471-01
  • bottles of 100 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from light.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PHARMACIST:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Mylan Pharmaceuticals Inc.
  • REVISED JULY 2015FENO:R12m
  • NDC 0378-0471-01
  • Fenoprofenn- Calciumn- Tablets, USPn- 600 mg*
  • PHARMACIST: Dispense the accompanying n- Medication Guide to each patient..
  • Rx only 100 Tablets
  • *Each film-coated tablet containsfenoprofen calcium, USP equivalentto 600 mg of fenoprofen.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light.
  • Usual Adult Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM0471A9

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