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par pharmaceutical, inc - diazoxide (unii: o5cb12l4fn) (diazoxide - unii:o5cb12l4fn) - diazoxide oral suspension is useful in the management of hypoglycemia due to hyperinsulinism associated with the following conditions: adults: inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. infants and children: leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. diazoxide oral suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. diazoxide oral suspension should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. when other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with diazoxide oral suspension should be considered. the use of diazoxide oral suspension for functional hypoglycemia is contraindicated. the drug should not be used in patients hypersensitive to diazoxide or to other thiazides unless the potential benefits outweigh

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vistapharm, llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus oral solution is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that sirolimus oral solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2) ]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level > 80%]), it is recommended that sirolimus oral solution be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3), clinical studies (14.3) ]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine > 4.5 mg/dl, black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies [see clinical studies (14.2) ]. in patients at high-immunologic risk , the safety and efficacy of sirolimus oral solution used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient [see clinical studies (14.3) ]. in pediatric patients , the safety and efficacy of sirolimus oral solution have not been established in patients < 13 years old, or in pediatric (< 18 years) renal transplant patients considered at high-immunologic risk [see adverse reactions (6.5), clinical studies (14.6) ]. the safety and efficacy of de novo use of sirolimus oral solution without cyclosporine have not been established in renal transplant patients [see warnings and precautions (5.12) ]. the safety and efficacy of conversion from calcineurin inhibitors to sirolimus oral solution  in maintenance renal transplantpatients have not been established [see clinical studies (14.4) ]. sirolimus oral solution is contraindicated in patients with a hypersensitivity to sirolimus [see warnings and precautions (5.4) ]. risk summary based on animal studies and the mechanism of action, sirolimus can cause fetal harm when administered to a pregnant woman [see data, clinical pharmacology (12.1) ]. there are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal studies, sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses [see data ]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data sirolimus crossed the placenta and was toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered sirolimus orally during the period of organogenesis (gestational day 6-15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) and reduced fetal weight at 1 mg/kg (5-fold the clinical dose of 2 mg). the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg). maternal toxicity (weight loss) was observed at 2 mg/kg (10-fold the clinical dose of 2 mg). the noael for maternal toxicity was 1 mg/kg. in combination with cyclosporine, rats had increased embryo-fetal mortality compared with sirolimus alone. in rabbit embryo-fetal development studies, pregnant rabbits were administered sirolimus orally during the period of organogenesis (gestational day 6-18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg (0.5-fold the clinical dose of 2 mg, on a body surface area basis); however, at doses of 0.05 mg/kg and above, the ability to sustain a successful pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg (0.25-fold the clinical dose of 2 mg). in a pre-and post-natal development study in rats, pregnant females were dosed during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups, resulting in reduced live litter size, occurred at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg/kg on a body surface area basis). at 0.1 mg/kg (0.5-fold the clinical dose of 2 mg), there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest dose tested. risk summary it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology (12.1) ]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sirolimus and any potential adverse effects on the breastfed child from sirolimus. contraception females should not be pregnant or become pregnant while receiving sirolimus. advise females of reproductive potential that animal studies have been shown sirolimus to be harmful to the developing fetus. females of reproductive potential are recommended to use highly effective contraceptive method. effective contraception must be initiated before sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has been stopped [see warnings and precautions (5.15), use in specific populations (8.1) ]. infertility based on clinical findings and findings in animals, male and female fertility may be compromised by the treatment with sirolimus [see adverse reactions (6.7), nonclinical toxicology (13.1) ]. ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of sirolimus. azoospermia has been reported in males with the use of sirolimus and has been reversible upon discontinuation of sirolimus in most cases. renal transplant the safety and efficacy of sirolimus in pediatric patients < 13 years have not been established. the safety and efficacy of sirolimus oral solution have been established for prophylaxis of organ rejection in renal transplantation in children ≥ 13 years judged to be at low- to moderate-immunologic risk. use of sirolimus oral solution in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of sirolimus oral solution in adults with additional pharmacokinetic data in pediatric renal transplantation patients [see clinical pharmacology (12.3) ]. safety and efficacy information from a controlled clinical trial in pediatric and adolescent (< 18 years of age) renal transplant patients judged to be at high-immunologic risk, defined as a history of one or more acute rejection episodes and/or the presence of chronic allograft nephropathy, do not support the chronic use of sirolimus oral solution in combination with calcineurin inhibitors and corticosteroids, due to the higher incidence of lipid abnormalities and deterioration of renal function associated with these immunosuppressive regimens compared to calcineurin inhibitors, without increased benefit with respect to acute rejection, graft survival, or patient survival [see clinical studies (14.6) ]. clinical studies of sirolimus oral solution did not include sufficient numbers of patients ≥ 65 years to determine whether they respond differently from younger patients. data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. differences in responses between the elderly and younger patients have not been identified. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, or cardiac function, and of concomitant disease or other drug therapy. the maintenance dose of sirolimus should be reduced in patients with hepatic impairment [see dosage and administration (2.7), clinical pharmacology (12.3) ]. dosage adjustment is not required in patients with renal impairment [see dosage and administration (2.8), clinical pharmacology (12.3) ]. sirolimus (sir-oh-li-mus) oral solution be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. ask your pharmacist or doctor if you are not sure. important: - always keep the bottle in an upright position. - you may store sirolimus oral solution that is in a syringe at room temperature up to 77°f (25°c) or in the refrigerator at 36°f to 46°f (2°c to 8°c) for up to 24 hours. see “how should i store sirolimus oral solution?” at the end of these instructions for use. - sirolimus oral solution can develop a slight haze when it is refrigerated. if this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away. - only use a glass or plastic cup to dilute sirolimus oral solution. - if you are a caregiver, do not let sirolimus oral solution come in contact with your skin or eyes. if you get the oral solution on your skin, wash the area well with soap and water. if you get the oral solution in your eyes, rinse with plain water. - if you spill sirolimus oral solution, dry the area with a dry paper towel and then wipe the area with a wet paper towel. throw away the paper towels in the trash and wash your hands well with soap and water. each sirolimus oral solution carton contains: a) a 2 oz. (60 ml fill) amber glass bottle of sirolimus (concentration of 1 mg/ml) b) 1 oral syringe adapter for fitting into the neck of the bottle c) enough disposable amber oral syringes and caps for daily dosing d) 1 carrying case you will also need: - glass or plastic cup - 6 oz. of water or orange juice only. 1. opening the solution bottle. - remove the safety cap by pushing down and turning counterclockwise (figure 1). 2. the first time you use a bottle of sirolimus oral solution: - insert the oral syringe adapter (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle (figure 2). - do not remove the oral syringe adapter from the bottle once inserted.  3. use a new disposable amber oral syringe for each dose of sirolimus oral solution. - fully push down (depress) on the plunger of the disposable amber oral syringe. - then, tightly insert the oral syringe into the opening in the adapter (figure 3). 4. withdraw the prescribed amount of sirolimus oral solution: - gently pull back the plunger of the syringe until the level of the oral solution is even with the marking on the syringe for your prescribed dose. - always keep the bottle in an upright position. - if bubbles form within the oral solution in the syringe, empty the syringe into the bottle and repeat step 4 (figure 4). - you may need to repeat step 4 more than once to draw up your prescribed dose. 5. if your doctor tells you to carry your medicine with you: - each dose of sirolimus oral solution should be placed in an oral syringe. place a cap securely on each syringe. the cap should snap into place (figure 5). figure 6: placing syringe in carrying case - place the capped syringe in the enclosed carrying case (figure 6). if you need more than 1 carrying case, talk with your doctor or pharmacist. - see `how should i store sirolimus oral solution? ' for storage instructions. figure 7: emptying syringe into glass 6. taking a dose of sirolimus oral solution: - choose a clean flat work surface. place a clean paper towel on the work surface. wash and dry your hands. - empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup, 60 ml) of water or orange juice, stir vigorously for 1 minute and drink right away (figure 7). - if more than 1 syringe is needed for your prescribed dose, empty the oral solution from each syringe into the same glass or plastic cup of water or orange juice. - refill the container with at least 4 ounces (1/2 cup, 120 ml) of water or orange juice, stir vigorously again and drink the rinse solution.do not mix sirolimus oral solution with apple juice, grapefruit juice, or other liquids. only glass or plastic cups should be used to mix sirolimus oral solution. - the syringe and cap should be used only one time and then thrown away. - throw away the paper towel and clean the work surface. wash your hands. 7. always store the bottles of medication in the refrigerator. how should i store sirolimus oral solution? - store bottles of sirolimus oral solution in the refrigerator at 36°f to 46°f (2°c to 8°c) - protect from light - store sirolimus oral solution that is in a syringe at room temperature up to 77°f (25°c) or in the refrigerator at 36°f to 46°f (2°c to 8°c) for up to 24 hours - if necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°f (25°c) for up to 15 days - when a bottle of sirolimus oral solution is opened, it should be used within 1 month - use any diluted sirolimus oral solution right away keep sirolimus oral solution and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: novitium pharma llc 70 lake drive, east windsor new jersey 08520 distributed by: vistapharm, inc. largo, fl 33771 usa trademarks are the property of their respective owners. revised: april, 2022 lb4062-05

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oakrum pharma, llc - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. included within the category of homocystinuria are - cystathionine beta-synthase (cbs) deficiency - 5,10-methylenetetrahydrofolate reductase (mthfr) deficiency - cobalamin cofactor metabolism (cbl) defect none. risk summary available data from a limited number of published case reports and post marketing experience with betaine anhydrous for oral solution use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with betaine. 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

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ani pharmaceuticals, inc. - atenolol (unii: 50vv3vw0ti) (atenolol - unii:50vv3vw0ti), chlorthalidone (unii: q0mqd1073q) (chlorthalidone - unii:q0mqd1073q) - atenolol and chlorthalidone tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol and chlorthalidone. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. this fixed dose combination drug is not indicated for initial therapy of hypertension. if the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components. atenolol and chlorthalidone is contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see warnings ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.

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northwind pharmaceuticals, llc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin is indicated for the treatment of mild to moderate heart failure in adults. digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin increases myocardial contractility in pediatric patients with heart failure. digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication

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oakrum pharma, llc - pyrimethamine (unii: z3614qox8w) (pyrimethamine - unii:z3614qox8w) - treatment of toxoplasmosis: pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. use of pyrimethamine is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.

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eton pharmaceuticals, inc. - carglumic acid (unii: 5l0hb4v1ew) (carglumic acid - unii:5l0hb4v1ew) - carglumic acid tablets for oral suspension are indicated in adult and pediatric patients as: - adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to nags deficiency. - maintenance therapy for the treatment of chronic hyperammonemia due to nags deficiency. none risk summary although rare case reports of carglumic acid tablets for oral suspension use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, untreated nags deficiency can result in irreversible neurologic damage and death in pregnant women [see clinical considerations]. in an animal reproduction study, decreased survival and growth occurred in offspring born to rats that received carglumic acid at a dose approximately 38 times the maximum reported human maintenance dose. 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, miscarriage, 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 urea cycle disorders may experience an increase in catabolic stress which can trigger a hyperammonemic crisis both in the intrapartum and in the post-partum (3-14 days post-partum) periods. maternal complications related to hyperammonemic crisis can include neurological impairment, coma and in some cases death. data animal data no effects on embryo-fetal development were observed in pregnant rats treated with up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on auc [area under the plasma concentration-time curve]) from two weeks prior to mating through organogenesis or in pregnant rabbits treated with up to 1000 mg/kg/day (approximately 6 times the maximum reported human maintenance dose [100 mg/kg/day] based on auc) during organogenesis. in a pre-and post-natal developmental study, female rats received oral carglumic acid from organogenesis through lactation at doses of 500 mg/kg/day and 2000 mg/kg/day. decreased growth of offspring was observed at 500 mg/kg/day and higher (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on auc), and reduction in offspring survival during lactation was observed at 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on auc). no effects on physical and sexual development, learning and memory, or reproductive performance were observed through maturation of the surviving offspring at maternal doses up to 2000 mg/kg/day. the high dose (2000 mg/kg/day) produced maternal toxicity (impaired weight gain and approximately 10% mortality). risk summary it is not known whether carglumic acid is present in human milk. there are no available data on the effects of carglumic acid on the breastfed infant or the effects on milk production. carglumic acid is present in milk from treated rats. 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 breastfeeding should be considered along with the mother’s clinical need for carglumic acid tablets for oral suspension and any potential adverse effects on the breastfed child from carglumic acid tablets for oral suspension or from the underlying maternal condition. the safety and effectiveness of carglumic acid tablets for oral suspension for the treatment of pediatric patients (birth to 17 years of age) with acute or chronic hyperammonemia due to nags deficiency have been established, and the information on these uses are discussed throughout the labeling. there are insufficient data to determine if there is a difference in clinical or biochemical responses between adult and pediatric patients treated with carglumic acid tablets for oral suspension. clinical studies of carglumic acid tablets for oral suspension did not include patients 65 years of age and older to determine whether they respond differently from younger patients. plasma concentrations of carglumic acid increased in patients with renal impairment [see clinical pharmacology (12.3)] . reduce the carglumic acid tablets for oral suspension dosage in patients with moderate or severe renal impairment [see dosage and administration (2.4)] . the pharmacokinetics of carglumic acid have not been evaluated in patients with end stage renal disease. carglumic acid tablets for oral suspension important information: - carglumic acid tablets for oral suspension must be mixed in water before taking . carglumic acid tablets for oral suspension should not be mixed in any other food or liquid. - do not swallow carglumic acid tablets for oral suspension whole. - do not crush carglumic acid tablets for oral suspension. - take carglumic acid tablets for oral suspension right before meals or feedings. - the carglumic acid tablet for oral suspension and water mixture has a slightly sour taste. you may need to ask your healthcare provider or pharmacist for a medicine cup to measure the correct amount of water you will need to prepare the dose of carglumic acid tablets for oral suspension. the carglumic acid tablet for oral suspension tablet has 3 lines used for splitting the tablet into 4 equal parts in order to get the prescribed dose. ask your healthcare provider if you have any questions about how to split the tablet the right way or have any questions about the prescribed dose. taking carglumic acid tablets for oral suspension by mouth using a cup: children and adults 1. add a minimum of 2.5 ml of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose. for example: - if the prescribed dose is 2 carglumic acid tablets for oral suspension, add a minimum of 5 ml of water into the cup. - if the prescribed dose is 2 and a ¼ carglumic acid tablets for oral suspension, add a minimum of 7.5 ml of water into the cup.        - if the prescribed dose is 2 and a ½ carglumic acid tablets for oral suspension, add a minimum of 7.5 ml of water into the cup. - ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of carglumic acid tablets for oral suspension. 2. place the prescribed number of carglumic acid tablets for oral suspension into the water in the cup. 3. carefully stir the carglumic acid tablet for oral suspension and water mixture in the cup to avoid spilling the mixture. carglumic acid tablets for oral suspension do not dissolve completely in water. 4.swallow the carglumic acid tablets for oral suspension and water mixture right away . 5. pieces of the tablet may remain in the cup. add more water to the cup to rinse the cup and swallow the mixture right away . 6. repeat step 5 until there are no pieces of the tablet left in the cup. taking carglumic acid tablets for oral suspension by mouth using an oral syringe: children 1. add a minimum of 2.5 ml of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose. for example: - if the prescribed dose is 2 carglumic acid tablets for oral suspension, add a minimum of 5 ml of water into the cup.   - if the prescribed dose is 2 and a ¼ carglumic acid tablets for oral suspension, add a minimum of 7.5 ml of water into the cup. - if the prescribed dose is 2 and a ½ carglumic acid tablets for oral suspension, add a minimum of 7.5 ml of water into the cup. - ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of carglumic acid tablets for oral suspension. 2. place the prescribed number of carglumic acid tablets for oral suspension into the water in the cup. 3. carefully stir the carglumic acid tablets for oral suspension and water mixture in the cup to avoid spilling the mixture. carglumic acid tablets for oral suspension do not dissolve completely in water. 4. draw up all of the carglumic acid tablets for oral suspension and water mixture in the cup into an oral syringe. 5. give your child the carglumic acid tablets for oral suspension and water mixture right away by placing the tip of the oral syringe along the inner cheek of their mouth, on either the right or left side. slowly push all the way down on the plunger to give the medicine. 6. pieces of the tablet may remain in the oral syringe. refill the oral syringe with a minimum of 1 ml to 2 ml of water, and give your child the mixture right away . 7. repeat step 6 until there are no pieces of the tablet left in the oral syringe. giving carglumic acid tablets for oral suspension through a nasogastric (ng) or gastrostomy tube (g-tube): children and adults 1.add a minimum of 2.5 ml of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose. for example: - if the prescribed dose is 2 carglumic acid tablets for oral suspension, add a minimum of 5 ml of water into the cup. - if the prescribed dose is 2 and a ¼ carglumic acid tablets for oral suspension, add a minimum of 7.5 ml of water into the cup.       - if the prescribed dose is 2 and a ½ carglumic acid tablets for oral suspension, add a minimum of 7.5 ml of water into the cup. - ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of carglumic acid tablets for oral suspension. 2. place the prescribed number of carglumic acid tablets for oral suspension into the water in the cup. 3. carefully stir the carglumic acid tablets for oral suspension and water mixture in the cup to avoid spilling the mixture. carglumic acid tablets for oral suspension do not dissolve completely in water. 4. draw up all of the carglumic acid tablets for oral suspension and water mixture in the cup into a catheter-tip syringe. 5. connect the catheter-tip syringe to the ng tube or g-tube. 6. give the carglumic acid tablet for oral suspension and water mixture through the ng tube or g-tube right away . 7. pieces of the tablet may remain in the catheter-tip syringe or ng tube or g-tube. 8. refill the catheter-tip syringe with 1 ml to 2 ml of water and flush the ng tube or g-tube right away . 9. repeat step 8 until there are no pieces of the tablet left in the catheter-tip syringe or ng tube or g-tube. how should i store carglumic acid tablets for oral suspension? - before opening , store carglumic acid tablets for oral suspension at 20° to 25°c (68° to 77°f) in the bottle it comes in. - after opening , store carglumic acid tablets for oral suspension at room temperature between 20° to 25°c (68° to 77°f). do not store carglumic acid tablets for oral suspension in a refrigerator after opening.         keep carglumic acid tablets for oral suspension in a tightly closed bottle to protect the tablets from moisture.       write the date the carglumic acid tablets for oral suspension bottle is opened on the bottle label. throw away any unused tablets after 90       days from first opening the bottle. - do not use carglumic acid tablets for oral suspension after the expiration date on the bottle. - keep carglumic acid tablets for oral suspension and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. all trademarks are the property of their respective owners. manufactured by: novitium pharma llc 70 lake drive, east windsor new jersey 08520 distributed by: eton pharmaceuticals, inc. deer park, il 60010 usa issued:  01/2024 lb4191-04

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vyera pharmaceuticals llc - pyrimethamine (unii: z3614qox8w) (pyrimethamine - unii:z3614qox8w) - pyrimethamine 25 mg - treatment of toxoplasmosis: daraprim is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. use of daraprim is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.

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denton pharma, inc. dba northwind pharmaceuticals - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride tablets, usp are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria). oxybutynin chloride tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. oxybutynin chloride tablets are  also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

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golden state medical supply inc. - trihexyphenidyl hydrochloride (unii: ao61g82577) (trihexyphenidyl - unii:6rc5v8b7po) - this drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). it is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.