Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - ketoprofen (unii: 90y4qc304k) (ketoprofen - unii:90y4qc304k) - ketoprofen 50 mg - carefully consider the potential benefits and risks of ketoprofen capsules usp and other treatment options before deciding to use ketoprofen capsules usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketoprofen capsules usp are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ketoprofen capsules usp are indicated for the management of pain. ketoprofen capsules usp are also indicated for treatment of primary dysmenorrhea. ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. ketoprofen capsules 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 reactions to ketoprofen have been reported in such patients (see warnings , anaphylactoid reactions and precautions , preexisting asthma ). ketoprofen capsules are contraindicate

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - ketoprofen (unii: 90y4qc304k) (ketoprofen - unii:90y4qc304k) - ketoprofen 75 mg - carefully consider the potential benefits and risks of ketoprofen capsules usp and other treatment options before deciding to use ketoprofen capsules usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketoprofen capsules usp are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ketoprofen capsules usp are indicated for the management of pain. ketoprofen capsules usp are also indicated for treatment of primary dysmenorrhea. ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. ketoprofen capsules 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 reactions to ketoprofen have been reported in such patients (see warnings , anaphylactoid reactions and precautions , preexisting asthma ). ketoprofen capsules are contraindicate

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets are indicated: etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings , anaphylactoid reactions and precautions , preexisting asthma). etodolac tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation) . naproxen as naproxen tablets are indicated: naproxen tablets are contraindicated in the following patients:

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 600 mg - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets 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 warnings, anaphylactoid reac

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets 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 warnings, anaphylactoid reac

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets 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 warnings, anaphylactoid reac

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - nabumetone (unii: lw0tiw155z) (nabumetone - unii:lw0tiw155z) - carefully consider the potential benefits and risks of nabumetone tablets usp and other treatment options before deciding to use nabumetone tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). nabumetone tablets usp are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or product excipients. nabumetone tablets 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 warnings , anaphylactoid reactions and precautions , general , preexisting asthma ). nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. diclofenac sodium topical gel is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation  risk summary use of nsaids, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women. human and animal studies indicate that diclofenac crosses the placenta.  data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. in animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 5, 5, and 10 times, respectively, the maximum recommended topical dose of diclofenac sodium topical gel, despite the presence of maternal and fetal toxicity at these doses [see data] . based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. clinical considerations labor or delivery there are no studies on the effects of diclofenac sodium topical gel during labor or delivery. in animal studies, nsaids, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data animal data reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose (mrhd) of diclofenac sodium topical gel based on bioavailability and body surface area (bsa) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 5 and 10 times the mrhd based on bioavailability and bsa comparison).  in a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (approximately 1 and 2 times the mrhd based on bioavailability and bsa comparison) from gestation day 15 through lactation day 21, significant maternal toxicity (peritonitis, mortality) was noted.  these maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. risk summary based on available data, diclofenac may be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cataflam and any potential adverse effects on the breastfed infant from the cataflam or from the underlying maternal condition.          data one woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/l, equivalent to an infant dose of about 0.03 mg/kg/day.  diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period). infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including diclofenac sodium topical gel, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin- mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including diclofenac sodium topical gel, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients have not been established. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see warnings and precautions(5.1, 5.2, 5.3, 5.6, 5.13) ].  of the total number of subjects treated with diclofenac sodium topical gel in clinical studies, 498 were 65 years of age and over. no overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity to the effect of nsaids in some older individuals cannot be ruled out. diclofenac, as with any nsaid, is known to be substantially excreted by the kidney, and the risk of toxic reactions to diclofenac sodium topical gel may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken when using diclofenac sodium topical gel in the elderly, and it may be useful to monitor renal function. diclofenac sodium topical gel, 1% important: use the dosing card that is inside the diclofenac sodium topical gel carton to correctly measure each dose. the dosing card is re-usable. do not throw the dosing card away. before you use diclofenac sodium topical gel for the first time, your healthcare provider or pharmacist should show you how to correctly measure your dose using the dosing card. read this instructions for use before you start using diclofenac sodium topical gel and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider has prescribed diclofenac sodium topical gel to help relieve arthritis pain in some of your joints. diclofenac sodium topical gel may be used to treat arthritis pain in the arms (hands, wrists, and elbows) and in the legs (feet, ankles, and knees). it is not known if diclofenac sodium topical gel is safe and effective if used on your spine, hips, or shoulders. the dose for your hands, wrists, or elbows is 2 grams of diclofenac sodium topical gel each time you apply it. the dose for your feet, ankles, or knees is 4 grams of diclofenac sodium topical gel each time you apply it. some examples of diclofenac sodium topical gel application include : figure a what if i miss a dose? applying 2 grams (2 g) of diclofenac sodium topical gel to hands, wrists, or elbows: step 1.   remove the dosing card that is attached inside the diclofenac sodium topical gel carton. use the dosing card to correctly measure each dose of diclofenac sodium topical gel. to measure the correct amount of diclofenac sodium topical gel, place the dosing card on a flat surface so that you can read the print. if the print is backwards, flip dosing card over (see figure a). if you lose or misplace your dosing card, you can ask your pharmacist for a new one or call. 1-833-285-4151. ask your healthcare provider or pharmacist to show you how to correctly measure your dose of diclofenac sodium topical gel while you are waiting to receive your new dosing card.                         figure b                                                figure c                                         figure d step 2 .  squeeze diclofenac sodium topical gel onto the dosing card evenly, up to the 2 g line (a 2.25 inch length of gel). make sure that the gel covers the 2 g area of the dosing card (see figure b). put the cap back on the tube of diclofenac sodium topical gel. ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of diclofenac sodium topical gel. step 3.   apply the gel to your hand, wrist, or elbow. you can use the dosing card to apply the gel (see figure c). then, use your hands to gently rub the gel into the skin (see figure d).  do not share your dosing card with another person. make sure to cover the entire affected hand, wrist, or elbow with the gel. remember that the hand includes the palm of your hand, the top of your hand, and your fingers. step 4.  after using the dosing card, hold end with fingertips, rinse and dry. store the dosing card until next use. do not shower or bathe for at least 1 hour after applying diclofenac sodium topical gel. do not wash your treated hands for at least 1 hour after applying the diclofenac sodium topical gel. step 5. after applying diclofenac sodium topical gel, wait 10 minutes before covering the treated skin with gloves or clothing. applying 4 grams (4 g) of diclofenac sodium topical gel to feet, ankles, or knees: step 1.  refer to step 1 above. step 2.  squeeze diclofenac sodium topical gel onto the dosing card evenly up to the 4 g line (a 4.5 inch length of gel), making sure the gel covers the 4 g area of the dosing card (see figure e). put the cap back on the tube of diclofenac sodium topical gel. ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of diclofenac sodium topical gel. step 3.   apply diclofenac sodium topical gel to your foot, ankle, or knee.  you can use the dosing card to apply the gel (see figure f).  then, use your hands to gently rub the gel into the skin (see figure g).  do not share your dosing card with another person. make sure to cover your entire foot, ankle, or knee area with the gel. for example, cover the skin above, below, inside and outside the knee cap. remember that the foot includes the sole of your foot, the top of your foot, and your toes.                             figure e                                     figure f                                    figure g refer to steps 4 and 5 above . wash your hands after applying diclofenac sodium topical gel to your foot, ankle, or knee. what are the ingredients in diclofenac sodium topical gel? active ingredient : diclofenac sodium inactive ingredients: carbomer homopolymer type c, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution. how should i store diclofenac sodium topical gel?   keep diclofenac sodium topical gel, the dosing card, and all medicines out of the reach of children . this medication guide and instructions for use have been approved by the u.s. food and drug administration. manufactured by: encube ethicals pvt. ltd. plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa – 403404, india distributed by : encube ethicals inc. 200 meredith avenue, suite 101a, durham, nc 27713 usa rev:02 december 2019 relabeled by preferred pharmaceuticals, inc.

Marekani - Kiingereza - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 400 mg - carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets, usp are indicated: etodolac is contraindicated in patients with known hypersensitivity to etodolac. etodolac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions and precautions, pre-existing asthma ).