Tadlis Uses

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What is Tadlis?

Tadlis is used to treat men who have erectile dysfunction (also called sexual impotence). Tadlis belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, Tadlis helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, Tadlis will not work to cause an erection.

Tadlis is also used to treat men who have signs and symptoms of benign prostatic hyperplasia (BPH). BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Tadlis will make these symptoms less severe and reduce the chance that prostate surgery will be needed. Tadlis is also used to treat erectile dysfunction and signs and symptoms of BPH.

Tadlis is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadlis works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

Tadlis is available only with your doctor's prescription..

Tadlis indications

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Erectile Dysfunction

Tadlis tablets are indicated for the treatment of erectile dysfunction (ED).

Benign Prostatic Hyperplasia

Tadlis tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Erectile Dysfunction and Benign Prostatic Hyperplasia

Tadlis tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

Limitation of Use

If Tadlis tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of Tadlis tablets decrease from 4 weeks until 26 weeks, and the incremental benefit of Tadlis tablets beyond 26 weeks is unknown.

How should I use Tadlis?

Use Tadlis as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Tadlis.

Uses of Tadlis in details

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Tadlis is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Tadlis is also available in another brand for treating erectile dysfunction-ED in men. It may also be used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH).

How to use Tadlis

Read the Patient Information Leaflet provided by your pharmacist before you start taking Tadlis and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

To treat high blood pressure in the lungs, take this medication by mouth as directed by your doctor, with or without food, usually once daily.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

Tadlis description

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Tadlis is an orally adminstered drug used to treat male erectile dysfunction (impotence). It is marketed worldwide under the brand name Tadlis. It is a phosphodiesterase 5 (PDE5) inhibitor. Tadlis's distinguishing pharmacologic feature is its longer half-life (17.5 hours) compared with Viagra and Levitra (4-5 hours). This longer half-life results in a longer duration of action and is, in part, responsible for the Tadlis nickname of the "weekend pill." This longer half-life also is the basis of current investigation for Tadlis's use in pulmonary arterial hypertension as a once-daily therapy. [Wikipedia]

Tadlis dosage

Tadlis Dosage

Generic name: Tadlis 2.5mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Do not split Tadlis tablets; entire dose should be taken.

Tadlis for Use as Needed for Erectile Dysfunction

Tadlis for Once Daily Use for Erectile Dysfunction

Tadlis for Once Daily Use for Benign Prostatic Hyperplasia

Tadlis for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose of Tadlis for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Use with Food

Tadlis may be taken without regard to food.

Use in Specific Populations

Renal Impairment

Tadlis for Use as Needed

Tadlis for Once Daily Use

Erectile Dysfunction

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

Hepatic Impairment

Tadlis for Use as Needed

Tadlis for Once Daily Use

Concomitant Medications

Nitrates

Concomitant use of nitrates in any form is contraindicated.

Alpha-Blockers

ED — When Tadlis is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and Tadlis should be initiated at the lowest recommended dose.

BPH — Tadlis is not recommended for use in combination with alpha-blockers for the treatment of BPH.

CYP3A4 Inhibitors

Tadlis for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadlis is 10 mg, not to exceed once every 72 hours.

Tadlis for Once Daily Use — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose is 2.5 mg.

More about Tadlis (Tadlis)

Consumer resources

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Related treatment guides

Tadlis interactions

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What other drugs will affect Tadlis?

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Potential For Pharmacodynamic Interactions With Tadlis

Nitrates

Administration of Tadlis to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, Tadlis was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken Tadlis, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of Tadlis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring.

Alpha-Blockers

Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including Tadlis, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of Tadlis with doxazosin, tamsulosin or alfuzosin..

Antihypertensives

PDE5 inhibitors, including Tadlis, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of Tadlis on the potentiation of the bloodpressure- lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of Tadlis with these agents compared with placebo..

Alcohol

Both alcohol and Tadlis, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with Tadlis can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadlis did not affect alcohol plasma concentrations and alcohol did not affect Tadlis plasma concentrations..

Potential For Other Drugs To Affect Tadlis

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Antacids

Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and Tadlis reduced the apparent rate of absorption of Tadlis without altering exposure (AUC) to Tadlis.

H2 Antagonists (e.g. Nizatidine)

An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.

Cytochrome P450 Inhibitors

Tadlis is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase Tadlis exposure.

CYP3A4 (e.g., Ketoconazole)

Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased Tadlis 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for Tadlis 20 mg alone. Ketoconazole (200 mg daily) increased Tadlis 10-mg singledose exposure (AUC) by 107% and Cmax by 15%, relative to the values for Tadlis 10 mg alone.

Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase Tadlis exposure.

HIV Protease inhibitor

Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased Tadlis 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for Tadlis 20 mg alone. Ritonavir (200 mg twice daily), increased Tadlis 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for Tadlis 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase Tadlis exposure.

Cytochrome P450 Inducers

Studies have shown that drugs that induce CYP3A4 can decrease Tadlis exposure.

CYP3A4 (e.g., Rifampin)

Tadlis side effects

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What are the possible side effects of Tadlis?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadlis was administered to over 9000 men during clinical trials worldwide. In trials of Tadlis for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For Tadlis for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

Tadlis For Use As Needed For ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with Tadlis 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported for Tadlis for use as needed:

Table 1: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadlis (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo- Controlled Clinical Studies (Including a Study in Patients with Diabetes ) for Tadlis for Us e as Needed for ED

Adverse Reaction Placebo

(N=476)

Tadlis 5 mg

(N=151)

Tadlis 10 mg

(N=394)

Tadlis 20 mg

(N=635)

Headache 5% 11% 11% 15%
Dyspepsia 1% 4% 8% 10%
Back pain 3% 3% 5% 6%
Myalgia 1% 1% 4% 3%
Nasal congestion 1% 2% 3% 3%
FlushingThe term flushing includes: facial flushing and flushing

Tadlis For Once Daily Use For ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with Tadlis was 4.1%, compared to 2.8% in placebo-treated patients.

The following adverse reactions were reported in clinical trials of 12 weeks duration:

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadlis for Once Daily Us e (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes ) for Tadlis for Once Daily Us e for ED

Adverse Reaction Placebo

(N=248)

Tadlis 2.5 mg

(N=196)

Tadlis 5 mg

(N=304)

Headache 5% 3% 6%
Dyspepsia 2% 4% 5%
Naso pharyngitis 4% 4% 3%
Back pain 1% 3% 3%
Upper respiratory tract infection 1% 3% 3%
Flushing 1% 1% 3%
Myalgia 1% 2% 2%
Cough 0% 4% 2%
Diarrhea 0% 1% 2%
Nasal congestion 0% 2% 2%
Pain in extremity 0% 1% 2%
Urinary tract infection 0% 2% 0%
Gastroesophageal reflux disease 0% 2% 1%
Abdominal pain 0% 2% 1%

The following adverse reactions were reported over 24 weeks treatment duration in one placebo-controlled clinical study:

Table 3: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadlis for Once Daily Us e (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for Tadlis for Once Daily Use for ED

Adverse Reaction Placebo

(N=94)

Tadlis 2.5 mg

(N=96)

Tadlis 5 mg

(N=97)

Naso pharyngitis 5% 6% 6%
Gastroenteritis 2% 3% 5%
Back pain 3% 5% 2%
Upper respiratory tract infection 0% 3% 4%
Dyspepsia 1% 4% 1%
Gastroesophageal reflux disease 0% 3% 2%
Myalgia 2% 4% 1%
Hypertension 0% 1% 3%
Nasal congestion 0% 0% 4%

Tadlis For Once Daily Use For BPH And For ED And BPH

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with Tadlis was 3.6% compared to 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with Tadlis included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported.

Table 4: Treatment-Emergent Adverse Reactions Reported by ≥ 1% of Patients Treated with Tadlis for Once Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo- Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for Tadlis for Once Daily Us e for BPH and One Study for ED and BPH

Adverse Reaction Placebo

(N=576)

Tadlis 5 mg

(N=581)

Headache 2.3% 4.1%
Dyspepsia 0.2% 2.4%
Back pain 1.4% 2.4%
Naso pharyngitis 1.6% 2.1%
Diarrhea 1.0% 1.4%
Pain in extremity 0.0% 1.4%
Myalgia 0.3% 1.2%
Dizziness 0.5% 1.0%

Additional, less frequent adverse reactions ( < 1%) reported in the controlled clinical trials of Tadlis for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In Tadlis clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with Tadlis treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency ( < 5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with Tadlis for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for Tadlis for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of Tadlis for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of < 1% across all indications.

Across placebo-controlled studies with Tadlis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Tadlis (2.5% of patients).

Across all studies with any Tadlis dose, reports of changes in color vision were rare ( < 0.1% of patients).

The following section identifies additional, less frequent events ( < 2%) reported in controlled clinical trials of Tadlis for once daily use or use as needed. A causal relationship of these events to Tadlis is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a Whole - asthenia, face edema, fatigue, pain, peripheral edema

Cardiovascular - angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive - abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal - arthralgia, neck pain

Nervous - dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo Renal and Urinary

Tadlis contraindications

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What is the most important information I should know about Tadlis?

Do not take Tadlis if you are allergic to it, or if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Tadlis with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Tadlis.

Do not take Tadlis more than once a day. Allow 24 hours to pass between doses.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Tadlis can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Tadlis, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether Tadlis is the actual cause of vision loss.

Stop using Tadlis and get emergency medical help if you have sudden vision loss.



Active ingredient matches for Tadlis:

Tadalafil in Turkey.


List of Tadlis substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tadityl 10 mg x 25 Blister x 4 Tablet
Tadora 20 mg Tablet (German Remedies (Zydus Cadila Healthcare Ltd.))$ 0.29
TADORA 20 MG TABLET 1 strip / 4 tablets each (German Remedies (Zydus Cadila Healthcare Ltd.))$ 0.23
TADOVAS 20MG TABLET 1 strip / 10 tablets each (MSN Laboratories Ltd)$ 2.87
Tagil 10mg TAB / 10 (Asclepius Pharmaceuticals Pvt. Ltd.)$ 2.29
Tagil 20mg TAB / 10 (Asclepius Pharmaceuticals Pvt. Ltd.)$ 4.34
Tagil 20 mg Tablet (Asclepius Pharmaceuticals Pvt. Ltd.)$ 0.43
Tagil 10 mg Tablet (Asclepius Pharmaceuticals Pvt. Ltd.)$ 0.23
TAGIL tab 10 mg x 10's (Asclepius Pharmaceuticals Pvt. Ltd.)$ 2.29
TAGIL tab 20 mg x 10's (Asclepius Pharmaceuticals Pvt. Ltd.)$ 4.34
TAGIL 10MG TABLET 1 strip / 10 tablets each (Asclepius Pharmaceuticals Pvt Ltd)$ 2.29
Talefil 20 mg x 1 Blister x 1 Tablet, 1 Blister x 2 Tablet, 2 Blister x 2 Tablet
Talefil 20 mg x 1 Blister x 1 Tablet
Talefil 20 mg x 1 Blister x 2 Tablet
Talefil 20 mg x 2 Blister x 2 Tablet
Talis 20 mg x 1 Blister x 1 Tablet (Kali)
Talis 20 mg x 2 Blister x 2 Tablet (Kali)
TAZZLE Capsule/ Tablet / 10mg / 4 units (Dr Reddy Laboratories Ltd)$ 0.87
TAZZLE Capsule/ Tablet / 20mg / 4 units (Dr Reddy Laboratories Ltd)$ 1.54
Tazzle 10mg TAB / 4 (Dr Reddy Laboratories Ltd)$ 0.90
Tazzle 20mg TAB / 4 (Dr Reddy Laboratories Ltd)$ 1.64
10 mg x 4's (Dr Reddy Laboratories Ltd)$ 0.90
20 mg x 4's (Dr Reddy Laboratories Ltd)$ 1.64
Tazzle 10 mg Tablet (Dr Reddy Laboratories Ltd)$ 0.25
Tazzle 20 mg Tablet (Dr Reddy Laboratories Ltd)$ 0.45
TAZZLE 10 MG TABLET 1 strip / 30 tablets each (Dr Reddy Laboratories Ltd)$ 9.06
TAZZLE 20 MG TABLET 1 strip / 30 tablets each (Dr Reddy Laboratories Ltd)$ 16.13
TAZZLE film-coated tab 10 mg x 4's (Dr Reddy Laboratories Ltd)$ 0.90
TAZZLE film-coated tab 20 mg x 4's (Dr Reddy Laboratories Ltd)$ 1.64
TAZZLE 10 MG TABLET 1 strip / 15 tablets each (Dr Reddy Laboratories Ltd)$ 4.53
Tazzle 10mg TAB / 4 (Dr Reddy Laboratories Ltd)$ 0.90
Tazzle 20mg TAB / 4 (Dr Reddy Laboratories Ltd)$ 1.64
Tazzle 10mg Disintegrating Strip (Dr Reddy Laboratories Ltd)$ 0.39

References

  1. DailyMed. "TADALAFIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Tadalafil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Tadalafil". http://www.drugbank.ca/drugs/DB00820 (accessed September 17, 2018).

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