|DB00201||Caffeine||For management of fatigue, orthostatic hypotension, and for the short term treatment of apnea of prematurity in infants.|
|DB00363||Clozapine||For use in patients with treatment-resistant schizophrenia.|
|DB04574||Estrone sulfate||Estropipate is used for the treatment of moderate to severe vasomotor symptoms associated with the monopause, and moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. It is also used to treat hypoestrogenism due to hypogonadism, castration or primary ovarian failure, and prevent postmenopausal osteoporosis.|
|DB00420||Promazine||Used as an adjunct for short term treatment of moderate and severe psychomotor agitation. Also used to treat agitation or restlessness in the elderly.|
|DB00458||Imipramine||For the relief of symptoms of depression and as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older [FDA Label].
May also be used off-label to manage panic disorders with or without agoraphobia, as a second line agent for ADHD in children and adolescents, to manage bulimia nervosa, for short-term management of acute depressive episodes in bipolar disorder and schizophrenia, for the treatment of acute stress disorder and posttraumatic stress disorder, and for symptomatic treatment of postherpetic neuralgia and painful diabetic neuropathy [L1349,L1348,A31900,L1351,L1352,L1353,A31904]. |
|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).|
|DB00904||Ondansetron||In the adult patient population:
i) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for:
- the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and
- the prevention and treatment of postoperative nausea and vomiting
ii) intravenously administered ondansetron injection formulations are indicated for:
- the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and
- the prevention and treatment of postoperative nausea and vomiting
In the pediatric (4-18 years of age) patient population:
i) ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting,
ii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for the treatment of children 3 years of age or younger,
iii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting, and
iV) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting
In the geriatric (>65 years of age) patient population:
i) efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting, and
ii) clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population |
|DB00978||Lomefloxacin||For the treatment of bacterial infections of the respiratory tract (chronic bronchitis) and urinary tract, and as a pre-operative prophylactic to prevent urinary tract infection caused by: S.pneumoniae, H.influenzae, S.aureus, P.aeruginosa, E. cloacae, P. mirabilis, C. civersus, S. asprphyticus, E.coli, and K.pneumoniae.|
|DB01137||Levofloxacin||For the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species, Staphylococus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Groups C/F/G), Viridans group streptococci, Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.|
|DB01165||Ofloxacin||For the treatment of infections (respiratory tract, kidney, skin, soft tissue, UTI), urethral and cervical gonorrhoea.|
|DB01182||Propafenone||Used to prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. Also used for the treatment of life-threatening documented ventricular arrhythmias, such as sustained ventricular tachycardia.|
|DB00487||Pefloxacin||For the treatment of uncomplicated gonococcal urethritis in males and for gram-negative-bacterial infections in the gastrointestinal system and the genitourinary tract.|
|DB00730||Thiabendazole||For the treatment of strongyloidiasis (threadworm), cutaneous larva migrans (creeping eruption), visceral larva migrans, and trichinosis.|
|DB01059||Norfloxacin||For the treatment of urinary tract infection|
|DB00468||Quinine||For the treatment of malaria and leg cramps|
|DB00564||Carbamazepine||For the treatment of epilepsy and pain associated with true trigeminal neuralgia. |
|DB00951||Isoniazid||For the treatment of all forms of tuberculosis in which organisms are susceptible.|
|DB01118||Amiodarone||Intravenously, for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Orally, for the treatment of life-threatening recurrent ventricular arrhythmias such as recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia.|
|DB00553||Methoxsalen||For the treatment of psoriasis and vitiligo|
|DB01388||Mibefradil||For the treatment of angina and high blood pressure.|
|DB00338||Omeprazole||Omeprazole, according to the FDA label [FDA label] is a proton pump inhibitor (PPI) used for the following purposes:
• Treatment of active duodenal ulcer in adults
• Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer
recurrence in adults
• Treatment of active benign gastric ulcer in adults
• Treatment of symptomatic gastroesophageal reflux disease (GERD) in
patients 1 year of age and older
• Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 1 month of age and older
• Maintenance of healing of EE due to acid-mediated GERD in patients 1
year of age and older
• Pathologic hypersecretory conditions in adults|
|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.|
|DB00752||Tranylcypromine||For the treatment of major depressive episode without melancholia.|
|DB01087||Primaquine||For the treatment of malaria.|
|DB02709||Resveratrol||Being investigated for the treatment of Herpes labialis infections (cold sores).|
|DB01217||Anastrozole||For adjuvant treatment of hormone receptor positive breast cancer , as well as hormonal treatment of advanced breast cancer in post-menopausal women. Has also been used to treat pubertal gynecomastia and McCune-Albright syndrome; however, manufacturer states that efficacy for these indications have not been established.|
|DB00882||Clomifene||Used mainly in female infertility due to anovulation (e.g. due to polycystic ovary syndrome) to induce ovulation. |
|DB00625||Efavirenz||For use in combination treatment of HIV infection (AIDS)|
|DB00818||Propofol||Used for induction and/or maintenance of anaesthesia and for management of refractory status epilepticus. |
|DB00412||Rosiglitazone||Rosiglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
|DB01037||Selegiline||Monotherapy for initial treatment of Parkinson's disease, as well as an adjunct therapy in patients with a decreased response to levodopa/carbadopa. Also used for the palliative treatment of mild to moderate Alzheimer's disease and at higher doses, for the treatment of depression.|
|DB01079||Tegaserod||Tegaserod is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C) [F4223, F4229]. The safety and effectiveness of tegaserod in men with IBS-C have not been established [F4223, F4229].|
|DB00763||Methimazole||For the treatment of hyperthyroidism, goiter, Graves disease and psoriasis.|
|DB00208||Ticlopidine||Used in patients, who have had a stroke or stroke precursors and who cannot take aspirin or aspirin has not worked, to try to prevent another thrombotic stroke.
|DB00313||Valproic Acid||**Indicated** for:[Label]
1) Use as monotherapy or adjunctive therapy in the management of complex partial seizures and simple or complex absence seizures.
2) Adjunctive therapy in the management of multiple seizure types that include absence seizures.
3) Prophylaxis of migraine headaches.
4) Acute management of mania associated with bipolar disorder.
**Off-label** uses include:
1) Maintenance therapy for bipolar disorder.[A177919]
2) Treatment for acute bipolar depression.[A177928,A177931,A177934]
3) Emergency treatment of status epilepticus.[A177955]|
|DB00549||Zafirlukast||For the prophylaxis and chronic treatment of asthma.|
|DB00633||Dexmedetomidine||For sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting, also used in pain relief; anxiety reduction and analgesia|
|DB06803||Niclosamide||For the treatment of tapeworm and intestinal fluke infections: Taenia saginata (Beef Tapeworm), Taenia solium (Pork Tapeworm), Diphyllobothrium latum (Fish Tapeworm), Fasciolopsis buski (large intestinal fluke). Niclosamide is also used as a molluscicide in the control of schistosomiasis.|
|DB06820||Sulconazole||Sulconazole solution 1.0% is indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete’s foot).|
|DB00105||Interferon alfa-2b||For the treatment of hairy cell leukemia, malignant melanoma, and AIDS-related Kaposi's sarcoma.|
|DB05990||Obeticholic acid||Indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. |
|DB01173||Orphenadrine||Indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.|
|DB00715||Paroxetine||Labeled indications include: major depressive disorder (MDD), panic disorder with or without agoraphobia, obsessive-compulsive disorder (OCD), social anxiety disorder (social phobia), generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Unlabeled indications include: eating disorders, impulse control disorders, vasomotor symptoms of menopause, obsessive-compulsive disorder (OCD) in children, and mild dementia-associated agitation in nonpsychotic individuals. Brisdelle, which consists of paroxetine mesylate is indicated for the treatment of moderate to severe vasomotor symptoms (like hot flashes) associated with menopause. |
|DB00008||Peginterferon alfa-2a||Peginterferon alfa-2a is indicated for the treatment of HCV in combination with other antiviral drugs in patients over 5 years of age with compensated liver disease [FDA Label]. May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.
Peginterferon alfa-2a is also indicated as a monotherapy for adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have
compensated liver disease and evidence of viral replication and liver inflammation [FDA Label].|
|DB00022||Peginterferon alfa-2b||Peginterferon alfa-2b is indicated for the treatment of HCV in combination with [DB00811] and a NS3/4A protease inhibitor for genotype 1 or without a NS3/4A protease inhibitor for genotypes 2-6 [FDA Label]. May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.
|DB13174||Rhein||No approved indication.|
|DB11994||Diacerein||For the treatment of osteoarthritis affecting the hip or knee [L780].|
|DB09118||Stiripentol||Indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate.|
|DB13874||Enasidenib||Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.|
|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.|
|DB13975||Cimicifuga racemosa||Treatment of menopausal symptoms and menstrual dysfunction [L2307].|
|DB11198||Peppermint oil||Indicated for the over-the-counter use for:
-the symptomatic relief of minor spasms of the gastrointestinal tract, flatulence and abdominal pain, especially in patients with irritable bowel syndrome.
-the temporary relief of itching associated with insect bites, eczema, minor burn, sunburn, minor skin irritations, minor cuts, scrapes, atopic dermatitis and other skin disorders.
-the temporary symptomatic relief of mild joint and muscle pain as a local topical analgesic.
-the temporary relief of tension-type headache.|
|DB06654||Safinamide||Safinamide is indicated as an add-on treatment to levodopa with or without other medicines for Parkinson’s disease|
|DB09078||Lenvatinib||Lenvatinib is indicated for the treatment of following conditions.
- Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
- Treatment of advanced renal cell carcinoma (RCC) in combination with everolimus following one prior antiangiogenic therapy.
- First-line treatment of unresectable hepatocellular carcinoma (HCC).|
|DB06771||Besifloxacin||Treatment of bacterial conjunctivitis. Bacterial isolates that are susceptible to besifloxacin include: CDC coryneform group G; Corynebacterium pseudodiphtheriticum; Corynebacterium striatum; Haemophilus influenzae; Moraxella lacunata; Staphylococcus aureus; Staphylococcus epidermidis; Staphylococcus hominis; Staphylococcus lugdunensis; Streptococcus mitis group; Streptococcus oralis; Streptococcus pneumoniae; Streptococcus salivarius* |
|DB00827||Cinoxacin||For the treatment of initial and recurrent urinary tract infections in adults caused by the following susceptible microorganisms: Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella species (including K. pneumoniae), and Enterobacter species.|
|DB06160||Garenoxacin||Investigated for use/treatment in bacterial infection.|
|DB01155||Gemifloxacin||For the treatment of bacterial infection caused by susceptible strains such as S. pneumoniae, H. influenzae, H. parainfluenzae, or M. catarrhalis, S. pneumoniae (including multi-drug resistant strains [MDRSP]), M. pneumoniae, C. pneumoniae, or K. pneumoniae.|
|DB06600||Nemonoxacin||Investigated for use/treatment in bacterial infection and pneumonia.|
|DB13627||Oxolinic acid||Not Available|
|DB00817||Rosoxacin||For the treatment of bacterial infection of respiratory tract, urinary tract, GI, CNS and immuno compromised patients.|
|DB01208||Sparfloxacin||For the treatment of adults with the following infections caused by susceptible strains microorganisms: community-acquired pneumonia (caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, or Streptococcus pneumoniae) and acute bacterial exacerbations of chronic bronchitis (caused by Chlamydia pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus, or Streptococcus pneumoniae).|
|DB04951||Pirfenidone||For the treatment of idiopathic pulmonary fibrosis (IPF).|
|DB00503||Ritonavir||Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.|
|DB04576||Fleroxacin||Fleroxacin is a broad-spectrum antimicrobial fluoroquinolone.|
|DB00435||Nitric Oxide||For the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure|
|DB06292||Dapagliflozin||Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise[Label,A6757,A6758].|
|DB01609||Deferasirox||For the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.|
|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]|
Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below [FDA label]:
**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 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].
**Intestinal amebiasis** caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents [FDA label].
**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].
|DB12245||Triclabendazole||This drug is indicated for the treatment of fascioliasis in patients aged 6 years old and above.[FDA label,L5452]|