Bandaríkin - enska - NLM (National Library of Medicine)

cronus pharma llc - carprofen (unii: ffl0d546ho) (carprofen - unii:ffl0d546ho) - carprofen chewable tablets are indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. carprofen chewable tablets should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Bandaríkin - enska - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafilfororal suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [ see clinical studies (14)] .  pediatric use information is approved for viatris specialty llc's, revatio (sildenafil) for oral suspension. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. sildenafil for oral suspension is contraindicated in patients with:  - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [ see warnings and precautions (5.1)]. - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the oral suspension. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary  limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations) . animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (see data) .  the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations  disease-associated maternal and/or embryo/fetal risk  pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.  data  animal data   no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2 basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m 2 basis). risk summary  limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc's, revatio (sildenafil) for oral suspension. however, due to viatris  specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [ see clinical pharmacology (12.3)]. no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [ see clinical pharmacology (12.3)]. no dose adjustment is required (including severe impairment clcr <30 ml/min) [ see clinical pharmacology (12.3)].  sildenafil for oral suspension  (sil den' a fil) read this instructions for use before you start taking sildenafil for oral suspension 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 treatment. important information:   - ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension. - your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you.  do not  take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. - always use the oral dosing syringe that comes with sildenafil for oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. - do not  take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. if the bottle adaptor is not in the bottle, contact your pharmacist. - sildenafil for oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil oral suspension (see figure a):  - 1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor - 1 oral dosing syringe (provided in the carton)   step 1. shake the bottle of sildenafil for oral suspension for 10 seconds before each use. (see figure b)    step 2. remove the cap. open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (see figure c)  step 3. fully push down (depress) the plunger of the oral dosing syringe. then insert the tip of the oral dosing syringe into the bottle adaptor while  holding the bottle upright, on a flat surface. (see figure d)   step 4. turn the bottle upside down while holding the oral dosing syringe in place. slowly pull back the plunger of the oral dosing syringe until the  bottom of the plunger is even with the ml marking on the syringe for your prescribed dose. (see figure e)            if your dose of sildenafil for oral suspension is 1 ml (10 mg), measure 0.5 ml two times for a total of 1 ml of sildenafil for oral                                     suspension. if your dose of sildenafil for oral suspension is more than 2 ml (20 mg), you will need to divide the dose. follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. if you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat step 4. step 5. turn the bottle back upright with the oral dosing syringe still in place. place the bottle on a flat surface. remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (see figure f)  do not press on the plunger of the  oral  dosing  syringe at this time.       step 6. put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. slowly push the plunger of  the oral dosing syringe all the way down to give the entire dose. do not squirt the medicine out quickly. (see figure g) if you are giving sildenafil for oral suspension, make sure they are in an upright position before giving the medicine. step 7. replace the cap on the bottle, leaving the bottle adaptor in place. turn the cap in the direction of the arrow (clockwise) to close the bottle. (see figure h)  step 8. wash the oral dosing syringe after each use. pull the plunger out of the barrel and rinse both parts with water. (see figure i) step 9. dry all parts with a clean paper towel. push the plunger back into the barrel. store the oral dosing syringe with the sildenafil oral suspension bottle. how should i store sildenafil for oral suspension?  - store mixed (reconstituted) sildenafil oral suspension below 86°f (30°c) or in a refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze mixed sildenafil for oral suspension.  - throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. see the “discard after” date written on the bottle label. keep sildenafil for oral suspension and all medicines out of the reach of children.  pediatric use information is approved for viatris specialty llc's, revatio (sildenafil) for oral suspension. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. this instructions for use has been approved by the u.s. food and drug administration.   manufactured for: camber pharmaceuticals, inc. piscataway, nj 08854 by: annora pharma pvt. ltd. sangareddy - 502313, telangana, india. revised: 02/2024

Bandaríkin - enska - NLM (National Library of Medicine)

bryant ranch prepack - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - 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 tablets and carbamazepine tablets (chewable) (see precautions , general ). carbamazepine tablets and carbamazepine tablets (chewable) 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

Bandaríkin - enska - NLM (National Library of Medicine)

bryant ranch prepack - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - 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 tablets and carbamazepine tablets (chewable) (see precautions , general ). carbamazepine tablets and carbamazepine tablets (chewable) 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

Bandaríkin - enska - NLM (National Library of Medicine)

remedyrepack inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - tegretol is indicated for use as an anticonvulsant drug. evidence supporting efficacy of tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by tegretol (see precautions, general). tegretol is 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. tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug,

Bandaríkin - enska - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a. inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies (14)] . pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. sildenafil for oral suspension is contraindicated in patients with: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions (5.1)] . - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations). animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2 basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m 2 basis). risk summary limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil for oral suspension did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [see clinical pharmacology (12.3)] . no dose adjustment is required (including severe impairment clcr <30 ml/min) [see clinical pharmacology (12.3)] . instructions for use sildenafil (sil den⸍ a fil) oral suspension read this instructions for use before you start taking sildenafil oral suspension 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 treatment. important information: - ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension. - your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you. do not take or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. - always use the oral dosing syringe that comes with sildenafil oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. - do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. if the bottle adaptor is not in the bottle, contact your pharmacist. - sildenafil oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil oral suspension (see figure a): - 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor - 1 oral dosing syringe (provided in the carton) how should i store sildenafil oral suspension? - store mixed (reconstituted) sildenafil oral suspension below 86°f (30°c) or in a refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze mixed sildenafil oral suspension - throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil oral suspension and all medicines out of the reach of children. pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. mfd. by: taro pharmaceutical industries ltd. haifa bay, israel 2624761 dist. by: taro pharmaceuticals u.s.a., inc . hawthorne, ny 10532 this instruction for use has been approved by the u.s. food and drug administration. revised: december 2023

Malta - enska - Medicines Authority

pharmexon consulting s.r.o. pitterova 2855/7, zizkov, prague, 130 00, czech republic - granules for oral solution - ketoprofen 50 mg - antiinflammatory and antirheumatic products

Bandaríkin - enska - NLM (National Library of Medicine)

bryant ranch prepack - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - 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 tablets and carbamazepine tablets (chewable) (see precautions , general ). carbamazepine tablets and carbamazepine tablets (chewable) 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.

Bandaríkin - enska - NLM (National Library of Medicine)

zydus lifesciences limited - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies (14)] . pediatric use information is approved for viatris specialty llc's, revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information . sildenafil for oral suspension is contraindicated in patients with: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions (5.1)]. - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations). animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data no evidence of teratogenicity, embryo toxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m2 basis). risk summary limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc's, revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)]. no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [see clinical pharmacology (12.3)]. no dose adjustment is required (including severe impairment clcr <30 ml/min) [see clinical pharmacology (12.3)]. sildenafil (sil den' a fil) for oral suspension read this instructions for use before you start taking sildenafil for oral suspension 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 treatment. important information: •    ask your healthcare provider or pharmacist to show you how to measure and take prescribed dose of sildenafil for oral suspension. •   your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. do not take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. •   always use the oral dosing syringe that comes with sildenafil for oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. •   if the bottle adaptor is not in the bottle, contact your pharmacist. •   sildenafil for oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil for oral suspension (see figure a): •   1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor •   1 oral dosing syringe (provided in the carton) step 1. shake the bottle of sildenafil for oral suspension for 10 seconds before each use. (see figure b)             step 2. remove the cap. open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (see figure c) step 3. fully push down (depress) the plunger of the oral dosing syringe. then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. (see figure d) step 4. turn the bottle upside down while holding the oral dosing syringe in place. slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the ml marking on the syringe for your prescribed dose. (see figure e) if your dose of sildenafil for oral suspension is 1 ml (10 mg), measure 0.5 ml two times for a total of 1 ml of sildenafil for oral suspension. if your dose of sildenafil for oral suspension is more than 2 ml (20 mg), you will need to divide the dose. follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. if you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat step 4. step 5. turn the bottle back upright with the oral dosing syringe still in place. place the bottle on a flat surface. remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (see figure f) do not press on the plunger of the oral dosing syringe at this time. step 6. put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. do not squirt the medicine out quickly. (see figure g) if you are giving sildenafil for oral suspension to a child, make sure they are in an upright position before giving the medicine. step 7. replace the cap on the bottle, leaving the bottle adaptor in place. turn the cap in the direction of the arrow (clockwise) to close the bottle. (see figure h) step 8. wash the oral dosing syringe after each use. pull the plunger out of the barrel and rinse both parts with water. (see figure i) step 9. dry all parts with a clean paper towel. push the plunger back into the barrel. store the oral dosing syringe with the sildenafil for oral suspension bottle. how should i store sildenafil for oral suspension? •    store mixed (reconstituted) sildenafil for oral suspension below 30°c (86°f) or in a refrigerator between 2°c to 8°c (36°f to 46°f). •    do not freeze mixed sildenafil for oral suspension •    throw away (discard) sildenafil for oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil for oral suspension and all drugs out of the reach of children. pediatric use information is approved for viatris specialty llc's, revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. this instruction for use has been approved by the u.s. food and drug administration. manufactured by: zydus lifesciences ltd., baddi, india. rev.: 12/2023

Bandaríkin - enska - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies (14)] . pediatric use information is approved for viatris specialty llc's, revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. sildenafil for oral suspension is contraindicated in patients with: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions (5.1)]. - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations). animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data no evidence of teratogenicity, embryo toxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m2 basis). risk summary limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc's, revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information . clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)]. no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [see clinical pharmacology (12.3)]. no dose adjustment is required (including severe impairment clcr <30 ml/min) [see clinical pharmacology (12.3)]. sildenafil (sil den' a fil) for oral suspension read this instructions for use before you start taking sildenafil for oral suspension 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 treatment. important information: •    ask your healthcare provider or pharmacist to show you how to measure and take prescribed dose of sildenafil for oral suspension. •   your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. do not take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. •   always use the oral dosing syringe that comes with sildenafil for oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. •   if the bottle adaptor is not in the bottle, contact your pharmacist. •   sildenafil for oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil for oral suspension (see figure a): •   1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor •   1 oral dosing syringe (provided in the carton) step 1. shake the bottle of sildenafil for oral suspension for 10 seconds before each use. (see figure b)             step 2. remove the cap. open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (see figure c) step 3. fully push down (depress) the plunger of the oral dosing syringe. then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. (see figure d) step 4. turn the bottle upside down while holding the oral dosing syringe in place. slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the ml marking on the syringe for your prescribed dose. (see figure e) if your dose of sildenafil for oral suspension is 1 ml (10 mg), measure 0.5 ml two times for a total of 1 ml of sildenafil for oral suspension. if your dose of sildenafil for oral suspension is more than 2 ml (20 mg), you will need to divide the dose. follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. if you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat step 4. step 5. turn the bottle back upright with the oral dosing syringe still in place. place the bottle on a flat surface. remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (see figure f) do not press on the plunger of the oral dosing syringe at this time. step 6. put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. do not squirt the medicine out quickly. (see figure g) if you are giving sildenafil for oral suspension to a child, make sure they are in an upright position before giving the medicine. step 7. replace the cap on the bottle, leaving the bottle adaptor in place. turn the cap in the direction of the arrow (clockwise) to close the bottle. (see figure h) step 8. wash the oral dosing syringe after each use. pull the plunger out of the barrel and rinse both parts with water. (see figure i) step 9. dry all parts with a clean paper towel. push the plunger back into the barrel. store the oral dosing syringe with the sildenafil for oral suspension bottle. how should i store sildenafil for oral suspension? •    store mixed (reconstituted) sildenafil for oral suspension below 30°c (86°f) or in a refrigerator between 2°c to 8°c (36°f to 46°f). •    do not freeze mixed sildenafil for oral suspension. •    throw away (discard) sildenafil for oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil for oral suspension and all drugs out of the reach of children. pediatric use information is approved for viatris specialty llc's, revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. this instruction for use has been approved by the u.s. food and drug administration. manufactured by: zydus lifesciences ltd., baddi, india. distributed by: zydus pharmaceuticals (usa) inc. pennington, nj 08534 rev.: 12/2023