| DB04348 | Taurocholic Acid | Not Available |
| DB02659 | Cholic Acid | Oral cholic acid is indicated for: treatment of bile acid synthesis disorders due to single enzyme defects; and as adjunctive treatment of peroxisomal disorders including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption. |
| DB01045 | Rifampicin | For the treatment of Tuberculosis and Tuberculosis-related mycobacterial infections. |
| DB00286 | Conjugated estrogens | The conjugated estrogens are indicated for several different conditions including:
- Treatment of moderate to severe vasomotor symptoms due to menopause.
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
- Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
- Palliative treatment of breast cancer in appropriately selected patients with metastatic disease.
- Palliative treatment of androgen-dependent carcinoma of the prostate.
- Preventive therapy of postmenopausal osteoporosis.[A38238] |
| DB00655 | Estrone | For management of perimenopausal and postmenopausal symptoms. |
| DB00783 | Estradiol | Estradiol is indicated for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause, for the treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and for the prevention of post-menopausal osteoarthritis. It is also used for the treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease, and for the treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). |
| DB01232 | Saquinavir | For the treatment of HIV-1 with advanced immunodeficiency together with antiretroviral nucleoside analogues. |
| DB00503 | Ritonavir | Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| DB00220 | Nelfinavir | Used in combination with other antiviral drugs in the treatment of HIV in both adults and children. |
| DB00224 | Indinavir | Indinavir is an antiretroviral drug for the treatment of HIV infection. |
| DB01892 | Hyperforin | Not Available |
| DB00091 | Ciclosporin | Cyclosporine is officially approved for different conditions listed below:
* Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. For this indication, it can be used concomitantly with azathioprine and corticosteroids.
* Treatment of patients with severe active, rheumatoid arthritis when the patient no longer responds to methotrexate.
* Concomitantly with methotrexate for the treatment of patients with severe active rheumatoid arthritis when patients do not respond to methotrexate treatment alone.
* Treatment of adult nonimmunocompromised patients with severe, recalcitrant, plaque psoriasis that have failed to respond to at least one systemic therapy or when systemic therapies are not tolerated or contraindicated.[FDA label]
* Its ophthalmic solution is indicated to increase tear production in patients with keratoconjunctivitis sicca in patients from 4 years old.[L5158]
* Prevention of graft rejection following bone marrow transplantation and in the treatment of graft-versus-host disease (GVHD).
* Treatment of steroid dependent and steroid-resistant nephrotic syndrome due to glomerular diseases such as minimal change nephropathy, focal and segmental glomerulosclerosis or membranous glomerulonephritis in adults and children.[F3091]
Away from all this approved and reviewed indications, cyclosporine is commonly used on dermatology for the treatment of various inflammatory skin conditions such as atopic dermatitis, blistering disorders, and connective tissue diseases.[A174085] |
| DB00908 | Quinidine | For the treatment of ventricular pre-excitation and cardiac dysrhythmias |
| DB00345 | Aminohippuric acid | Used to measure effective renal plasma flow (ERPF) and to determine the functional capacity of the tubular excretory mechanism. |
| DB00583 | Levocarnitine | For treatment of primary systemic carnitine deficiency, a genetic impairment of normal biosynthesis or utilization of levocarnitine from dietary sources, or for the treatment of secondary carnitine deficiency resulting from an inborn error of metabolism such as glutaric aciduria II, methyl malonic aciduria, propionic acidemia, and medium chain fatty acylCoA dehydrogenase deficiency. Used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias. Parenteral levocarnitine is indicated for the prevention and treatment of carnitine deficiency in patients with end-stage renal disease. |
| DB00877 | Sirolimus | For the prophylaxis of organ rejection in patients receiving renal transplants. |
| DB00641 | Simvastatin | For the treatment of hypercholesterolemia and for the reduction in the risk of cardiac heart disease mortality and cardiovascular events. It can also be used in adolescent patients for the treatment of heterozygous familial hypercholesterolemia. |
| DB00227 | Lovastatin | Lovastatin is indicated as an intervention alternative in individuals presenting dyslipidemia at risk of atherosclerotic vascular disease. The administration of this agent should be accompanied by the implementation of a fat and cholesterol-restricted diet.[FDA label]
In individuals with risk factors related to elevated total cholesterol, elevated LDL cholesterol and below average HDL cholesterol, lovastatin can be used to reduce the risk of myocardial infarction, unstable angina and coronary revascularization procedures.[FDA label]
As well, lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease.[FDA label]
Lovastatin is used as part of the multiple risk factor intervention with a saturated fat-restricted diet in patients with significantly increased risk of atherosclerotic vascular disease due to hypercholesterolemia. The administration of lovastatin is restricted to patients to whom the administration of a diet restricted in saturated fat and cholesterol or the application of nonpharmaceutical measures are inadequate or irresponsive.[FDA label]
Lovastatin is indicated as an adjunct therapy to diet to reduce total cholesterol, LDL cholesterol and apolipoprotein B level in adolescents between 10-17 years. The administration of lovastatin is restricted to patients in which adequate diet has been unresponsive as seen by LDL cholesterol higher than 189 mg/dL or LDL cholesterol higher than 160 mg/dL and history of family cardiovascular disease or with two or more cardiovascular disease risk factors.[FDA label]
Before administering lovastatin, it is important to rule out the presence of secondary causes of hypercholesterolemia and a lipid profile should be performed.[FDA label]
Lovastatin is used off-label for the treatment and management of peripheral artery disease.[T415] |
| DB01076 | Atorvastatin | Atorvastatin is approved for the treatment of several types of dyslipidemias including:
- Primary hyperlipidemia and mixed dyslipidemia in adults.
- Hypertriglyceridemia.
- Primary dysbetalipoproteinemia.
- Homozygous familial hypercholesterolemia.
- Heterozygous familial hypercholesterolemia in adolescent patients with failed dietary modifications.[A177397]
Dyslipidemia is defined as an elevation of plasma cholesterol, triglycerides or both as well as to the presence of low levels of high-density lipoprotein. This condition represents an increased risk for the development of atherosclerosis.[L6025]
Atorvastatin is indicated, in combination with dietary modifications, to prevent cardiovascular events in patients with cardiac risk factors and/or abnormal lipid profiles.[A177397]
Atorvastatin can be used as a preventive agent for myocardial infarction, stroke, revascularization, and angina, in patients without coronary heart disease but with multiple risk factors, and in patients with type 2 diabetes without coronary heart disease but multiple risk factors.[A177397]
Atorvastatin can also be used as a preventive agent for non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure and angina in patients with coronary heart disease.[A177397]
The term cardiovascular events correspond to all the incidents that can produce damage to the heart muscle including the interruption of blood flow.[L6028] |
| DB00197 | Troglitazone | For the treatment of Type II diabetes mellitus. It is used alone or in combination with a sulfonylurea, metformin, or insulin as an adjunct to diet and exercise. |
| DB00412 | Rosiglitazone | Rosiglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
| DB01132 | Pioglitazone | Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [FDA Label]. |
| DB00762 | Irinotecan | For the treatment of metastatic colorectal cancer (first-line therapy when administered with 5-fluorouracil and leucovorin). Also used in combination with cisplatin for the treatment of extensive small cell lung cancer. Irinotecan is currently under investigation for the treatment of metastatic or recurrent cervical cancer. Also used in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. |
| DB00520 | Caspofungin | For the treatment of esophageal candidiasis and invasive aspergillosis in patients who are refractory to or intolerant of other therapies. |
| DB01393 | Bezafibrate | For the treatment of primary hyperlipidaemia types IIa, IIb, III, IV and V (Fredrickson classification) corresponding to groups I, II and III of the European Atherosclerosis Society guidelines - when diet alone or improvements in lifestyle such as increased exercise or weight reduction do not lead to an adequate response. Also for the treatment of secondary hyperlipidaemias, e.g. severe hypertriglyceridemias, when sufficient improvement does not occur after correction of the underlying disorder (e.g. diabetes mellitus). |
| DB01241 | Gemfibrozil | For treatment of adult patients with very high elevations of serum triglyceride levels (types IV and V hyperlipidemia) who are at risk of developing pancreatitis (inflammation of the pancreas) and who do not respond adequately to a strict diet. |
| DB06151 | Acetylcysteine | Acetylcysteine is used mainly as a mucolytic and in the management of paracetamol (acetaminophen) overdose. |
| DB04881 | Elacridar | For the treatment of solid tumors. |
| DB06191 | Zosuquidar | Investigated for use/treatment in leukemia (myeloid) and myelodysplastic syndrome. |
| DB00661 | Verapamil | For the treatment of hypertension, angina, and cluster headache prophylaxis. |
| DB00213 | Pantoprazole |
**Pantoprazole Injection**:
**Treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis**
Pantoprazole for injection is indicated for short-term treatment (7-10 days) of patients having gastroesophageal reflux disease (GERD) with a history of erosive esophagitis, as an alternative to oral medication in patients who are unable to continue taking pantoprazole delayed-release tablets. _Safety and efficacy of pantoprazole injection as the initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated at this time_ [FDA label].
**Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome**
Pantoprazole for injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions [FDA label].
**Pantoprazole delayed-release oral suspension**:
**Short-Term Treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD)**
Indicated in adults and pediatric patients five years of age and above for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been determined [F3202].
**Maintenance of healing of erosive esophagitis**
Indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD [F3202].
**Pathological hypersecretory conditions including Zollinger-Ellison syndrome**
Indicated for the long-term treatment of the above conditions [F3202]. |
| DB00390 | Digoxin | Digoxin is indicated in the following conditions:
1) For the treatment of mild to moderate heart failure in adult patients.[FDA label]
2) To increase myocardial contraction in children diagnosed with heart failure.[FDA label]
3) To maintain control ventricular rate in adult patients diagnosed with chronic atrial fibrillation.[FDA label]
In adults with heart failure, when it is clinically possible, digoxin should be administered in conjunction with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor for optimum effects.[FDA label]
|
| DB06210 | Eltrombopag | Thrombopoietin receptor agonists are pharmaceutical agents that stimulate platelet production in the bone marrow. In this, they differ from the previously discussed agents that act by attempting to curtail platelet destruction. |
| DB06589 | Pazopanib | Treatment of advanced renal cell cancer and advanced soft tissue sarcoma (in patients previously treated with chemotherapy) |
| DB06772 | Cabazitaxel | For treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. |
| DB08864 | Rilpivirine | Rilpivirine, in combination with other agents, is indicated for the treatment of HIV-1 infections in antiretroviral treatment-naive patients with HIV-1 RNA ≤100,000 copies/mL and CD4+ cell count >200 cells/mm3.[L1030] The FDA combination therapy approval of rilpivirine and dolutegravir is indicated for adults with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy.[L1031] |
| DB08912 | Dabrafenib | Tafinlar is a kinase inhibitor that was initially indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test [FDA label].
Tafinlar in combination with [DB08911] is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for Tafinlar in combination with trametinib [FDA label].
In May 2018, Tafinlar (dabrafenib) and Mekinist ([DB08911]) have been approved in combination to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene [L2712]. |
| DB06290 | Simeprevir | Indicated for the treatment of adults with chronic hepatitis C virus (HCV) infection: typically in combination with sofosbuvir in patients with HCV genotype 1 without cirrhosis or with compensated cirrhosis and in combination with peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) in patients with HCV genotype 1 or 4 without cirrhosis or with compensated cirrhosis.
Resistance: Reduced susceptibility to simeprevir was most commonly associated with the viral NS3 Q80K polymorphism. Amino acid substitutions at NS3 positions S122, R155 and/or D168 are also shown to reduce susceptibility to simeprevir in genotype 1a/b patients.
|
| DB04850 | Posizolid | For the treatment of gram-positive infections, including multiresistant strains. |
| DB09054 | Idelalisib | Idelalisib is indicated in the treatment of chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). For the treatment of relapsed CLL, it is currently indicated as a second-line agent in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities, while in the treatment of FL and SLL it is intended to be used in patients who have received at least two prior systemic therapies. |
| DB09272 | Eluxadoline | For the treatment of irritable bowel syndrome with diarrhea (IBS-D). |
| DB09292 | Sacubitril | Used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB. |
| DB09102 | Daclatasvir | Indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1a/b or 3 infection. The dosing regimen of 60mg daclatasvir 60 mg with 400mg sofosbuvir once a day is recommended for both genontypes.
Resistance: Reduced susceptibility to daclatasvir was associated with the polymorphisms at NS5A amino acid positions M28, Q30, L31, and Y93 in genotypes 1a, 1b, and 3a patients. NS5A Resistance Testing is recommended for HCV genotype 1a-infected patients with cirrhosis prior to the initiaition of the treatment, as the risk of resistance development is higher in genotype 1a patients. |
| DB11613 | Velpatasvir | Velpatasvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients. Depending on the level of cirrhosis or decompensation, combination therapy can also include therapy with [DB00811].
When used in combination with [DB08934] as the combination product Epclusa, Velpatasvir is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or in combination with [DB00811] if associated with decompensated cirrhosis [FDA Label]. |
| DB05521 | Telaprevir | Telaprevir, when used in combination with [DB00811], [DB00008], and [DB00022] is indicated for use in the treatment of chronic HCV genotype 1 infection in adults [FDA Label]. |
| DB09198 | Lobeglitazone | Lobeglitazone was approved by the Ministry of Food and Drug Safety (South Korea) in 2013, and is being monitored by postmarketing surveillance until 2019. Lobeglitazone is not approved for use by either the Food and Drug Administration (USA), Health Canada, or by the European Medicines Agency for use in the management of diabetes. |
| DB12026 | Voxilaprevir | Vosevi (Voxilaprevir/[DB08934]/[DB11613]) is approved for use in patients with genotypes 1-6 who have been previously treated with an NS5A inhibitor, or patients with genotypes 1a or 3 infection who have previously been treated with an HCV regimen containing [DB08934] without an NS5A inhibitor [L935]. |
| DB13874 | Enasidenib | Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. |
| DB13878 | Pibrentasvir | Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh
A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor
or an NS3/4A protease inhibitor (PI), but not both [FDA Label]. |
| DB13879 | Glecaprevir | Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh
A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor
or an NS3/4A protease inhibitor (PI), but not both [FDA Label]. |
| DB12332 | Rucaparib | Indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for rucaparib. |
| DB13928 | Semaglutide | Semaglutide is indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct of diet and exercise. The approved therapeutic doses are 0.5 mg and 1 mg.[L1068] Diabetes mellitus type 2 is a long-term metabolic disorder characterized by high blood sugar, insulin resistance and lack of insulin. Its onset is determined by the loss ability of beta cells to respond to an increased plasma glucose. This disease is predominantly caused by lifestyle factors like overweight and obesity. The key feature on type 2 diabetes is the presence of insulin resistance which reduced the capacity of insulin to exert its functions at normal at any given concentration. The secretion of insulin is stimulated by the action of incretins in the gut like glucagon-like peptide 1, which also delays gastric emptying and induces satiety, and glucose-dependent insulinotropic polypeptide.[T59] |
| DB13952 | Estradiol acetate | Femring is indicated for the treatment of vasomotor and urogenital symptoms associated with menopause. Use of Femring (estradiol acetate) has been shown to improve symptoms caused by atrophy of the vagina (such as dryness, burning, pruritus and dyspareunia) and/or the lower urinary tract (urinary urgency and dysuria). |
| DB13953 | Estradiol benzoate | Estradiol benzoate is not currently available in any FDA or Health Canada approved products. |
| DB13954 | Estradiol cypionate | Depo-Estradiol intramuscular depot injection is indicated for the treatment of moderate to severe vasomotor symptoms and hypoestrogenism due to hypogonadism. |
| DB13955 | Estradiol dienanthate | Estradiol dienanthate is not currently available in any FDA or Health Canada approved products. |
| DB13956 | Estradiol valerate | Estradiol valerate is commercially available as an intramuscular injection as the product Delestrogen and is indicated for the treatment of moderate to severe vasomotor symptoms and vulvovaginal atrophy due to menopause, for the treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure, and for the treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Estradiol valerate is also available in combination with [DB09123] as the commercially available product Natazia used for the prevention of pregnancy and for the treatment of heavy menstrual bleeding. |
| DB01072 | Atazanavir | Used in combination with other antiretroviral agents for the treatment of HIV-1 infection, as well as postexposure prophylaxis of HIV infection in individuals who have had occupational or nonoccupational exposure to potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission. |
| DB00199 | Erythromycin |
Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below [FDA label]:
_Respiratory infections_
**Upper respiratory tract infections** of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) [FDA label].
**Lower-respiratory tract infections** of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.
Listeriosis caused by Listeria monocytogenes [FDA label].
**Pertussis (whooping cough)** caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals [FDA label].
**Respiratory tract infections** due to Mycoplasma pneumoniae [FDA label].
**Legionnaires’ Disease** caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease [FDA label].
**Diphtheria**: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers [FDA label].
_Skin infections_
**Skin and skin structure infections** of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment) [FDA label].
**Erythrasma**: In the treatment of infections due to Corynebacterium minutissimum [FDA label].
_Gastrointestinal infections_
**Intestinal amebiasis** caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents [FDA label].
_Genital infections/STIs_
**Acute pelvic inflammatory disease** caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months [FDA label].
**Syphilis** caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy [FDA label].
**Chlamydia trachomatis**: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis [FDA label].
**Nongonnoconnal urethritis**: When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum [FDA label].
|
| DB00439 | Cerivastatin | Used as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate. |
| DB01092 | Ouabain | For the treatment of atrial fibrillation and flutter and heart failure |
| DB00177 | Valsartan | **Monotherapy**
Valsartan may be used alone for the management of hypertension [FDA label]
**Combination therapy**
Valsartan is indicated for the management of hypertension in patients for whom combination therapy is deemed appropriate [F3139]. It is combined with other anthypertensive agents such as hydrochlorothiazide, amlodipine, nevibolol and sacubitril [F3139], [F3136], [F3145], [F3148].
**Heart Failure**
Valsartan is indicated for the treatment of heart failure (NYHA class II-IV) in patients who are intolerant to angiotensin-converting enzyme inhibitors (ACE inhibitors) for various reasons, including those who experience ACE inhibitor adverse effects. In a clinical study of 5010 patients, hospitalizations due to heart failure were markedly decreased when valsartan was taken regularly over a 2-year span [FDA label].
|
| DB00451 | Levothyroxine | For use alone or in combination with antithyroid agents to treat hypothyroidism, goiter, chronic lymphocytic thyroiditis, myxedema coma, and stupor. |
| DB01095 | Fluvastatin | To be used as an adjunct to dietary therapy to prevent cardiovascular events. May be used as secondary prevention in patients with coronary heart disease (CHD) to reduce the risk of requiring coronary revascularization procedures, for reducing progression of coronary atherosclerosis in hypercholesterolemic patients with CHD, and for the treatment of primary hypercholesterolemia and mixed dyslidipidemia. |
| DB08860 | Pitavastatin | Pitavastatin is used to lower serum levels of total cholesterol, LDL-C, apolipoprotein B, and triglycerides, and raise levels of HDL-C for the treatment of dyslipidemia. |
| DB06626 | Axitinib | Used in kidney cell cancer and investigated for use/treatment in pancreatic and thyroid cancer. |
| DB01098 | Rosuvastatin | Used as an adjunct to dietary therapy to treat primary hyperlipidemia (heterozygous familial and nonfamilial), mixed dyslipidemia and hypertriglyceridemia. Also indicated for homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering therapies or when other such therapies are not available. Furthermore, it is used to slow the progression of atherosclerosis and for primary prevention of cardiovascular disease. |
| DB09297 | Paritaprevir | When used within the fixed-dose combination product with [DB09296], [DB09183], and [DB00503] as the FDA-approved product Viekira Pak, paritaprevir is indicated for the treatment of HCV genotype 1b without cirrhosis or with compensated cirrhosis, and when combined with [DB00811] for the treatment of HCV genotype 1a without cirrhosis or with compensated cirrhosis.
When used within the fixed-dose combination product with [DB09296] and [DB00503] as the FDA- and Health Canada-approved product Technivie, paritaprevir is indicated in combination with [DB00811] for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.
When used within the fixed-dose combination product with [DB09296], [DB09183], and [DB00503] as the Health Canada-approved, commercially available product Holkira Pak, paritaprevir is indicated for the treatment of HCV genotype 1b with or without cirrhosis, and when combined with [DB00811] for the treatment of HCV genotype 1a with or without cirrhosis. |
| DB00975 | Dipyridamole | For as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement and also used in prevention of angina. |
| DB00541 | Vincristine | Treatment of acute lymphocytic leukemia (ALL), Hodgkin lymphoma, non-Hodgkin lymphomas, Wilms' tumor, neuroblastoma, rhabdomyosarcoma. Liposomal vincristine is indicated for the treatment of relapsed Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). |
| DB12319 | Benzbromarone | Not Available |
| DB08862 | Cholecystokinin | For use as a diagnostic aid for evaluation of gallbladder disorders. It is also used in conjunction with secretin in pancreatic insufficiency [L1634]. |
| DB00255 | Diethylstilbestrol | Used in the treatment of prostate cancer. Previously used in the prevention of miscarriage or premature delivery in pregnant women prone to miscarriage or premature delivery. |
| DB01645 | Genistein | Currently Genistein is being studied in clinical trials as a treatment for prostate cancer. |
| DB00602 | Ivermectin | For the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. Also for the treatment of onchocerciasis (river blindness) due to the nematode parasite Onchocerca volvulus. Can be used to treat scabies caused by Sarcoptes scabiei. |
| DB01115 | Nifedipine | For the management of vasospastic angina, chronic stable angina, hypertension, and Raynaud's phenomenon. May be used as a first line agent for left ventricular hypertrophy and isolated systolic hypertension (long-acting agents). |
| DB01051 | Novobiocin | For the treatment of infections due to staphylococci and other susceptible organisms |
| DB00646 | Nystatin | For treatment of cutaneous or mucocutaneous mycotic infections caused by Candida species |
| DB11869 | Valspodar | Not Available |
| DB00206 | Reserpine | Foe the treatment of hypertension |
| DB09298 | Silibinin | Currently being tested as a treatment of severe intoxications with hepatotoxic substances, such as death cap (Amanita phalloides) poisoning. |
| DB00795 | Sulfasalazine | For the treatment of Crohn's disease and rheumatoid arthritis as a second-line agent. |
| DB00932 | Tipranavir | For combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors. |
| DB01601 | Lopinavir | Indicated in combination with other antiretroviral agents for the treatment of HIV-infection. |
| DB01264 | Darunavir | Darunavir, co-administered with ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. |
| DB00328 | Indometacin | Oral indometacin is indicated for symptomatic management of moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.[A177871,Label]
Intravenous indometacin is indicated to induce closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.[F4600] |
| DB00701 | Amprenavir | For the treatment of HIV-1 infection in combination with other antiretroviral agents. |
| DB00586 | Diclofenac | For the acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis. |
| DB04216 | Quercetin | Not Available |
| DB00622 | Nicardipine | Used for the management of patients with chronic stable angina and for the treatment of hypertension. |
| DB00396 | Progesterone | **Gelatinized capsules**
The gelatinized capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea [FDA label].
**Vaginal gel**
Progesterone gel (8%) is indicated as progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. The lower concentration progesterone gel (4%) is used in the treatment of secondary amenorrhea, with the use of the 8% concentration if there is no therapeutic response to the 4% gel [F3898].
**Vaginal insert**
This form is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women [F3901].
**Injection (intramuscular)**
This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer [F3907].
**Tablets, contraceptive**
The tablet form of progesterone in contraceptive formulations is indicated for the prevention of pregnancy [F3904]. |
| DB00570 | Vinblastine | For treatment of breast cancer, testicular cancer, lymphomas, neuroblastoma, Hodgkin's and non-Hodgkin's lymphomas, mycosis fungoides, histiocytosis, and Kaposi's sarcoma. |
| DB00468 | Quinine | For the treatment of malaria and leg cramps |
| DB01026 | Ketoconazole | For the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. |
| DB13919 | Candesartan | Not Available |
| DB09065 | Cobicistat | Cobicistat is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. It is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. The use of cobicistat is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir or tipranavir. Complex or unknown mechanisms of drug interactions preclude extrapolation of ritonavir drug interactions to certain cobicistat interactions. Cobicistat and ritonavir when administered with either atazanavir or darunavir may result in different drug interactions when used with concomitant medications. |
| DB00976 | Telithromycin | For the treatment of Pneumococcal infection, acute sinusitis, acute bacterial tonsillitis, acute bronchitis and bronchiolitis, lower respiratory tract infection and lobar (pneumococcal) pneumonia. |
| DB01590 | Everolimus | Everolimus is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.
Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.
Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
Indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. |
| DB00203 | Sildenafil | Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor that is predominantly employed for two primary indications:
(1) the treatment of erectile dysfunction [A175582, L5611, F3853, F3856, F3886]; and
(2) treatment of pulmonary hypertension, where:
a) the US FDA specifically indicates sildenafil for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening [F3850]. The delay in clinical worsening was demonstrated when sildenafil was added to background epoprostenol therapy [F3850]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%) [F3850];
b) the Canadian product monograph specifically indicates sildenafil for the treatment of primary pulmonary arterial hypertension (PPH) or pulmonary hypertension secondary to connective tissue disease (CTD) in adult patients with WHO functional class II or III who have not responded to conventional therapy [F3859]. In addition, improvement in exercise ability and delay in clinical worsening was demonstrated in adult patients who were already stabilized on background epoprostenol therapy [F3859]; and
c) the EMA product information specifically indicates sildenafil for the treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity [F3883]. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease [F3883]. The EMA label also indicates sildenafil for the treatment of pediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension [F3883]. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease [F3883]. |
| DB00864 | Tacrolimus | For use after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It was given FDA approval in 1994 for use in liver transplantation. Since then, this indication has expanded to kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis. |
| DB00398 | Sorafenib | Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. |
| DB04868 | Nilotinib | For the potential treatment of various leukemias, including chronic myeloid leukemia (CML). |
| DB11586 | Asunaprevir | Asunaprevir is indicated in combination with other agents for the treatment of chronic hepatitis C in adult patients with hepatitis C virus genotypes 1 or 4 and compensated liver cirrhosis.[L2278]
Hepatitis C is a liver disease caused by the hepatitis C virus. The chronic state of this condition accounts for 60-80% of the cases from which the risk of cirrhosis of the liver within 20 years is of around 15-30%.[L2281] The genotype 1 is the most common type of hepatitis C in the United States and the most difficult to treat.[L2282] |
| DB13867 | Fluticasone | Fluticasone's 2 esters are indicated as inhalers for the treatment and management of asthma by prophylaxis[FDA Label][F4364]as well as inflammatory and pruritic dermatoses[F4355]. A [DB00588] nasal spray is indicated for managing nonallergic rhinitis[F4358] while the [DB08906] nasal spray is indicated for treating season and perennial allergic rhinitis[F4361,A177130]. |
| DB08906 | Fluticasone furoate | Fluticasone furoate is indicated as an inhaler for the treatment and management of asthma by prophylaxis[FDA Label][F4364]. The fluticasone furoate nasal spray is indicated for treating season and perennial allergic rhinitis[FDA Label][A177130]. |
| DB00588 | Fluticasone propionate | Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxis[FDA Label]as well as inflammatory and pruritic dermatoses[F4355]. A fluticasone propionate nasal spray is indicated for managing nonallergic rhinitis[F4358]. |
| DB09078 | Lenvatinib | Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. |
| DB05928 | Dovitinib | Investigated for use/treatment in multiple myeloma and solid tumors. |
| DB08880 | Teriflunomide | Used in the treatment of relapsing forms of multiple sclerosis (MS). |
| DB02703 | Fusidic Acid | For the treatment of bacterial infections. |
| DB00778 | Roxithromycin | Used to treat respiratory tract, urinary and soft tissue infections. |
| DB11753 | Rifamycin | Rifamycin is indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of _E. coli_. The status of the disease should not be complicated by fever or blood in the stool. To prevent drug-resistant bacteria, it is important to mention that the use of rifamycin for this indication should be only done in cases where the infection is proven or strongly suspected to be caused by bacteria.[L4802]
Travallers' diarrhea is very common problem affecting 20-60% of the travellers and it is defined as an increase in frequency of bowel movements to three or more loose stools per day during a trip abroad. This condition is rarely life threatening but in severe cases it can produce dehydration and sepsis. The most common cause of travellers' diarrhea is a pathogen and from the pathogens identified, bacteria is the most common cause followed by norovirus, rotavirus and similar viruses.[A39995] |
| DB11581 | Venetoclax | A BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label]. |
| DB00834 | Mifepristone | For the medical termination of intrauterine pregnancy through 49 days' pregnancy. Also indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and are not candidates for surgery or have had unsuccessful surgery. |
| DB00257 | Clotrimazole | **Topical preparations**
Clotrimazole topical cream is indicated for the topical treatment of the following dermal infections [F3088], [F3121]:
Tinea pedis, tinea cruris, and tinea corporis due to _Trichophyton rubrum_, _Trichophyton mentagrophytes_, _Epidermophyton floccosum_
Candidiasis due to _Candida albicans_
Tinea versicolor due to _Malassezia furfur_
Diaper rash infected by _Candida albicans_
In some preparations, clotrimazole may be combined with betamethasone dipropionate, a corticosteroid [F3121].
**Oral preparations**
The oral troche preparation is indicated for the local treatment of oropharyngeal candidiasis [FDA label]. It is also indicated as a prophylactic drug to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions such as chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation [FDA label]. Troche preparations are not indicated for the treatment of any systemic mycoses [FDA label]. |