United States - English - NLM (National Library of Medicine)

apotex corp. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 200 mg - carbamazepine tablets are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types.   2. generalized tonic-clonic seizures (grand mal).   3. mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general). carbamazepine tablets are indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. likewise, on theoretical grounds its use with monoamine oxidase (mao) inhibitors is not recommended. before administration of carbamazepine, mao inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. coadministration of carbamazepine with nefazodone is contraindicated. no evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

United States - English - NLM (National Library of Medicine)

apotex corp. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. ipratropium bromide nasal solution, 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution, 0.03% nasal spray (ip" ra troe' pee um broe' mide) rx only read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing or postnasal drip associated with allergic or nonallergic perennial rhinitis. read complete instructions carefully and use only as directed. to use: 1. remove the clear plastic dust cap and the green safety clip from the nasal spray pump ( figure 1). the safety clip prevents the accidental discharge of the spray in your pocket or purse. figure 1 2. the nasal spray pump must be primed before ipratropium bromide nasal solution, 0.03% is used for the first time. to prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. make sure the bottle points upright and away from your eyes. press your thumb firmly and quickly against the bottle seven times ( figure 2). the pump is now primed and can be used. your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays. if you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays. figure 2 3. before using ipratropium bromide nasal solution, 0.03%, blow your nose gently to clear your nostrils if necessary. 4. close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril ( figure 3). point the tip toward the back and outer side of the nose.          figure 3 5. press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. following each spray, sniff deeply and breathe out through your mouth. 6. after spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose. 7. repeat steps 4 through 6 in the same nostril. 8. repeat steps 4 through 7 in the other nostril (i.e., two sprays per nostril). 9. replace the clear plastic dust cap and safety clip. 10. at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. you should not take extra doses or stop using ipratropium bromide nasal solution, 0.03% without consulting your physician. to clean:   figure 4 if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water ( figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip.                                           ipratropium bromide nasal solution, 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution, 0.03% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent during the first full day of treatment with ipratropium bromide nasal solution, 0.03%. some patients may require up to two weeks of treatment to obtain maximum benefit. do not spray ipratropium bromide nasal solution, 0.03% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution, 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding, contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.03%. . if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.03%. address medical inquiries to apotex corp: (800) 706-5575. storage store tightly closed at 20°-25°c (68°-77°f) [see usp controlled room temperature]. avoid freezing. keep out of reach of children. manufactured by:                            manufactured for: apotex inc.                                    apotex corp. toronto, ontario                             weston, fl canada m9l 1t9                            33326 may 2014

United States - English - NLM (National Library of Medicine)

apotex corp. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide nasal solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. the safety and effectiveness of the use of ipratropium bromide nasal solution, 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established. ipratropium bromide nasal solution, 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution, 0.06% nasal spray (ip" ra troe' pee um broe' mide) rx only read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide nasal solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. do not use ipratropium bromide nasal solution, 0.06% for longer than four days for a common cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. read complete instructions carefully and use only as directed. to use - remove the clear plastic dust cap and the green safety clip from the nasal spray pump (figure 1). the safety clip prevents the accidental discharge of the spray in your pocket or purse.           figure 1                                                                               figure 1 - the nasal spray pump must be primed before ipratropium bromide nasal solution, 0.06% is used for the first time. to prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. make sure the bottle points upright and away from your eyes. press your thumb firmly and quickly against the bottle seven times (figure 2). the pump is now primed and can be used. your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays. if you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays.  figure 2                                         figure 2 - before using  ipratropium bromide nasal solution, 0.06%, blow your nose gently to clear your nostrils if necessary. - close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril (figure 3). point the tip toward the back and outer side of the nose.  figure 3                                                                                 figure 3 - press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. following each spray, sniff deeply and breathe out through your mouth. - after spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose. - repeat steps 4 through 6 in the same nostril. - repeat steps 4 through 7 in the other nostril (i.e., two sprays per nostril). - replace the clear plastic dust cap and safety clip. - at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. you should not take extra doses or stop using ipratropium bromide nasal solution, 0.06% without consulting your physician. to clean if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip.                                                             figure 4                                                       caution     ipratropium bromide nasal solution, 0.06% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution, 0.06% as prescribed by your physician. for most patients, some improvement in runny nose is apparent following the first dose of treatment with ipratropium bromide nasal solution, 0.06%. do not use ipratropium bromide nasal solution, 0.06% for longer than four days for your cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. do not spray ipratropium bromide nasal solution, 0.06% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution, 0.06% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding, contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.06%. if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.06%. address medical inquiries to apotex corp: (800) 706-5575. storage store tightly closed at 20°to  25°c (68° to  77°f) [see usp controlled room temperature]. avoid freezing. keep out of reach of children. manufactured by:                              manufactured for: apotex inc.                                      apotex corp. toronto, ontario                               weston, fl canada m9l 1t9                              33326 may 2014

United States - English - NLM (National Library of Medicine)

apotex corp. - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 200 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 capsules are indicated: • for acute and long-term use in the management of signs and symptoms of the following: - osteoarthritis - rheumatoid arthritis • for the management of acute pain etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. 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 ). - in the setting of coronary artery bypass graft (cabg) surgery (see warnings )

United States - English - NLM (National Library of Medicine)

apotex corp. - 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: - for acute and long-term use in the management of signs and symptoms of the following: osteoarthritis rheumatoid arthritis - osteoarthritis - rheumatoid arthritis - for the management of acute pain 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 ). - etodolac tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

United States - English - NLM (National Library of Medicine)

apotex corp. - teriparatide (unii: 10t9csu89i) (teriparatide - unii:10t9csu89i) - teriparatide injection is indicated. - for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures. - to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. - for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. hypersensitivity reactions have included angioedema and anaphylaxis [see adverse reactions (6.3)]. risk summary there are no available data on teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing teriparatide injection when pregnancy is recognized. in animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the us general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m2 ). at subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). when pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. in a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. there were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively. risk summary it is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. avoid teriparatide use in women who are breastfeeding. the safety and effectiveness of teriparatide injection have not been established in pediatric patients. pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see warnings and precautions (5.1)]. of the patients who received teriparatide injection in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. of the patients who received teriparatide injection in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. of the 214 patients who received teriparatide injection in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older. no overall differences in safety or effectiveness of teriparatide injection have been observed between patients 65 years of age and older and younger adult patients. no studies have been performed in patients with hepatic impairment. [see clinical pharmacology (12.3)] . in 5 patients with severe renal impairment (crcl<30 ml/minute), the auc and t1/2  of teriparatide were increased by 73% and 77%, respectively. maximum serum concentration of teriparatide was not increased. it is unknown whether teriparatide injection alters the underlying metabolic bone disease seen in chronic renal impairment  [see clinical pharmacology (12.3)]. teriparatide injection, usp user manual important: first read the medication guide that comes inside your teriparatide injection carton . before you use your new teriparatide injection delivery device, please read the entire front and back of this user manual completely. follow the directions carefully when using the teriparatide injection delivery device. do not share your delivery device or needles because infection or disease can be spread from one person to another. the teriparatide injection delivery device contains 28 days of medicine. throw away the teriparatide injection delivery device after 28 days, even if it is not completely empty. do not inject more than one dose of teriparatide injection in the same day. do not transfer teriparatide injection to a syringe. wash your hands before every injection. prepare the injection site as your healthcare provider instructed. for more information, or if you have any questions, turn to the back of this page. a. the yellow shaft is still showing after i push in the black injection button. how do i reset my teriparatide injection delivery device? - if you have already injected, do not inject yourself a second time on the same day. - remove the needle. - attach a new needle, pull off the large needle cover and save it. - pull out the black injection button until it stops. check to make sure the red stripe shows. - pull off the small needle protector and throw away. - point the needle down into an empty container. push in the black injection button until it stops. hold it in and slowly count to five. you may see a small stream or drop of fluid. when you have finished, the black injection button should be all the way in. - if you still see the yellow shaft showing, contact apotex corp (see contact information below) or your healthcare provider. - put the large needle cover on the needle. unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. pull off the covered needle and throw away as instructed by your healthcare provider. push the white cap back on, and put your teriparatide injection delivery device in the refrigerator. - put the large needle cover on the needle. - use the large needle cover to unscrew the needle. - unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. - if you still cannot get the needle off, ask someone to help you. e. what should i do if i have difficulty pulling out the black injection button? - wipe the outside of the teriparatide delivery device with a damp cloth. - do not place the teriparatide delivery device in water, or wash or clean with any liquid. storing your teriparatide delivery device - after each use, refrigerate the teriparatide delivery device right away. read and follow the instructions in the medication guide section “how should i store teriparatide injection?”. - do not store the teriparatide delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the teriparatide delivery device with the white cap on. - do not freeze teriparatide injection. if the teriparatide delivery device has been frozen, throw the device away and use a new teriparatide delivery device. - if the teriparatide delivery device has been left out of the refrigerator, do not throw the delivery device away. place the delivery device back in the refrigerator and call apotex at 1-800-706-5575. - the teriparatide delivery device contains 28 days of medicine. - do not transfer teriparatide injection to a syringe. this may result in you taking the wrong dose of medicine. - read and follow the instructions in the user manual so that you use your teriparatide delivery device the right way. - check the teriparatide delivery device label to make sure you have the right medicine and that it has not expired. - do not use the teriparatide delivery device if it looks damaged. look at the teriparatide medicine in the cartridge. if the medicine is not clear and colorless, or if it has particles, do not use it. call apotex if you notice any of these (see contact information ). - use a new needle for each injection. - during injection, you may hear one or more clicks – this is normal. - the teriparatide delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device. - keep your teriparatide delivery device and needles out of the reach of children. - before throwing away the teriparatide delivery device, be sure to remove the pen needle. - throw away your teriparatide delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. contact information

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - pantoprazole sodium sesquihydrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - pantoprazole sodium sesquihydrate -

United States - English - NLM (National Library of Medicine)

apotex corp. - risedronate sodium (unii: ofg5exg60l) (risedronic acid - unii:km2z91756z) - risedronate sodium 35 mg - risedronate sodium tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, risedronate sodium tablets, usp reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1, 14.2) ]. risedronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis. risedronate sodium tablets, usp are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d. risedronate sodium tablets, usp are indicated for treatment of paget’s disease of bone in men and women. the optimal duration of use has not been determined. the safety and effectiveness of risedronate sodium tablets, usp for the treatment of osteoporosis are based on clinical data of three years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. risedronate sodium tablets are contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see warnings and precautions (5.1)] - inability to stand or sit upright for at least 30 minutes [see dosage and administration (2), warnings and precautions (5.1)] - hypocalcemia [see warnings and precautions (5.2)] - known hypersensitivity to risedronate sodium tablets or any of its excipients. angioedema, generalized rash, bullous skin reactions, stevens-johnson syndrome and toxic epidermal necrolysis have been reported [see adverse reactions (6.2)] risk summary available data on the use of risedronate sodium tablets in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. discontinue risedronate sodium tablets when pregnancy is recognized. in animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m2 ). a low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose. bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. the amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. the impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal studies, pregnant rats received risedronate sodium during organogenesis at doses equivalent to 1 to 26 times the 30 mg human daily dose (based on body surface area, mg/m2 ). survival of neonates was decreased in dams treated during gestation with oral doses approximately 5 times the human dose, and body weight was decreased in neonates of dams treated with approximately 26 times the human dose. a low incidence of cleft palate was observed in fetuses of dams treated with oral doses approximately equal to the human dose. the number of fetuses exhibiting incomplete ossification of sternebrae or skull of dams treated with approximately 2.5 times the human dose was significantly increased compared to controls. both incomplete ossification and unossified sternebrae were increased in fetuses of dams treated with oral doses approximately 5 times the human dose. no significant ossification effects were seen in fetuses of rabbits treated with oral doses approximately 7 times the human dose (the highest dose tested). however, 1 of 14 litters were aborted and 1 of 14 litters were delivered prematurely. periparturient mortality due to maternal hypocalcemia occurred in dams and neonates when pregnant rats were treated daily during mating and/or gestation with oral doses equivalent to the human dose or higher. risk summary there are no data on the presence of risedronate in human milk, the effects on the breastfed infant, or the effects on milk production. a small degree of lacteal transfer occurred in nursing rats. the concentration of the drug in animal milk does not necessarily predict the concentration of drug in human milk. however, when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for risedronate sodium and any potential adverse effects on the breast-fed child from risedronate sodium or from the underlying maternal condition. data animal data risedronate was detected in neonates of lactating rats given a single oral dose of risedronate at 24-hours post-dosing, indicating a small degree of lacteal transfer.  risedronate sodium tablets are not indicated for use in pediatric patients.  the safety and effectiveness of risedronate was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143 pediatric patients (94 received risedronate) with osteogenesis imperfecta (oi). the enrolled population was predominantly patients with mild osteogenesis imperfecta (85% type-i), aged 4 to less than 16 years, 50% male and 82% caucasian, with a mean lumbar spine bmd z-score of -2.08 (2.08 standard deviations below the mean for age-matched controls). patients received either a 2.5 mg (less than or equal to 30 kg body weight) or 5 mg (greater than 30 kg body weight) daily oral dose. after one year, an increase in lumbar spine bmd in the risedronate group compared to the placebo group was observed. however, treatment with risedronate did not result in a reduction in the risk of fracture in pediatric patients with osteogenesis imperfecta. in risedronate sodium-treated subjects, no mineralization defects were noted in paired bone biopsy specimens obtained at baseline and month 12. the overall safety profile of risedronate in oi patients treated for up to 12 months was generally similar to that of adults with osteoporosis. however, there was an increased incidence of vomiting compared to placebo. in this study, vomiting was observed in 15% of children treated with risedronate and 6% of patients treated with placebo. other adverse events reported in greater than or equal to 10% of patients treated with risedronate and with a higher frequency than placebo were: pain in the extremity (21% with risedronate versus 16% with placebo), headache (20% versus 8%), back pain (17% versus 10%), pain (15% versus 10%), upper abdominal pain (11% versus 8%), and bone pain (10% versus 4%). of the patients receiving risedronate sodium tablets in postmenopausal osteoporosis studies [see clinical studies (14)], 47% were between 65 and 75 years of age, and 17% were over 75. the corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in paget’s disease trials.  no overall differences in efficacy between geriatric and younger patients were observed in these studies. in the male osteoporosis trial, 28% of patients receiving risedronate sodium tablets were between 65 and 75 years of age and 9% were over 75. the lumbar spine bmd response for risedronate sodium tablets compared to placebo was 5.6% for subjects less than 65 years and 2.9% for subjects greater than or equal to 65 years. no overall differences in safety between geriatric and younger patients were observed in the risedronate sodium trials, but greater sensitivity of some older individuals cannot be ruled out. risedronate sodium tablets are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 ml/min) because of lack of clinical experience. no dosage adjustment is necessary in patients with a creatinine clearance  greater than or equal to 30 ml/min. no studies have been performed to assess risedronate's safety or efficacy in patients with hepatic impairment. risedronate is not metabolized in human liver preparations. dosage adjustment is unlikely to be needed in patients with hepatic impairment.

United States - English - NLM (National Library of Medicine)

apotex corp. - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma. controlled substance clorazepate dipot