Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone and ethinyl estradiol tablets for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

teligent pharma, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate topical solution is indicated in the treatment of acne vulgaris. in view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (see contraindications, warnings and adverse reactions.) clindamycin phosphate topical solution is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

teligent pharma, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate  lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate lotion is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate lotion use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate lotion may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion on the smallest area of skin and for the shortest duration possible.

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baxter healthcare corporation - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - 0.9% sodium chloride irrigation, usp is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints. none known.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

bluepoint laboratories - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - in anesthesia glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate injection or any of its inactive ingredients. in addition, in the management of

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

avkare - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. known hypersensitivity to any of the listed ingredients.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - hailey fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table 1 lowest expected and typical failure rates during the first year of continuous use of a method % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected* typical** (no contraception) (85) (85) oral contraceptives 3 combined 0.1 n/a*** progestin only 0.5 n/a*** diaphragm with spermicidal cream or jelly 6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 vaginal sponge nulliparous 9 20 parous 20 40 implant 0.05 0.05 inj

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hikma pharmaceuticals usa inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate is indicated in the treatment of manic episodes of bipolar disorder. bipolar disorder, manic (dsm-iv) is equivalent to manic depressive illness, manic, in the older dsm-ii terminology. lithium carbonate is also indicated as a maintenance treatment for individuals with a diagnosis of bipolar disorder. maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. when given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

egalet us inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - tivorbex is indicated for treatment of mild to moderate acute pain in adults. tivorbex is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1 )] pregnancy category c in the first and second trimesters of pregnancy; category d in the third trimester. risk summary use of nsaids, including tivorbex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including tivorbex, in pregnant women starting at 30 weeks of gestation (third trim

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encube ethicals private limited - 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 has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions ( 5.7, 5.9 )] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8 )] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1 )] pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation  risk summary use of nsaids, incl