What is Loortan Plus 50/12.5?
Loortan Plus 50/12.5 contains a combination of Loortan Plus 50/12.5. Hydrochlorothiazide (Loortan Plus 50/12.5) is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Losartan (Loortan Plus 50/12.5) is an angiotensin II receptor antagonist. Losartan (Loortan Plus 50/12.5) keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.
Loortan Plus 50/12.5 is used to treat high blood pressure (hypertension). It is also used to lower the risk of stroke in certain people with heart disease.
Loortan Plus 50/12.5 may also be used for purposes not listed in this medication guide.
Loortan Plus 50/12.5 indications
Hypertension
Loortan Plus 50/12.5® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Losartan (Loortan Plus 50/12.5) and Hydrochlorothiazide (Loortan Plus 50/12.5).
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients.
Loortan Plus 50/12.5 may be administered with other antihypertensive agents.
Hypertensive Patients With Left Ventricular Hypertrophy
Loortan Plus 50/12.5 is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients.
How should I use Loortan Plus 50/12.5?
Use Loortan Plus 50/12.5 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Loortan Plus 50/12.5. Talk to your pharmacist if you have questions about this information.
- Take Loortan Plus 50/12.5 by mouth with or without food.
- Drinking extra fluids while you are taking Loortan Plus 50/12.5 is recommended. Check with your doctor for instructions.
- Loortan Plus 50/12.5 may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
- If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Loortan Plus 50/12.5.
- Continue to take Loortan Plus 50/12.5 even if you feel well. Do not miss any doses.
- If you miss a dose of Loortan Plus 50/12.5, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Loortan Plus 50/12.5.
Uses of Loortan Plus 50/12.5 in details
Use: Labeled Indications
Hypertension: Management of hypertension.
Hypertension with left ventricular hypertrophy: To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH). Evidence suggests that this benefit does not apply to black patients.
Loortan Plus 50/12.5 description
Each tablet contains Losartan (Loortan Plus 50/12.5) potassium 50 or 100 mg and Hydrochlorothiazide (Loortan Plus 50/12.5) 12.5 mg.
Losartan (Loortan Plus 50/12.5) Potassium: Losartan (Loortan Plus 50/12.5) potassium, a nonpeptide molecule, is chemically described as 2-butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium salt.
Its empirical formula is C22H22ClKN6O.
Losartan (Loortan Plus 50/12.5) potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents eg, acetonitrile and methyl ethyl ketone.
Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of Losartan (Loortan Plus 50/12.5).
Hydrochlorothiazide (Loortan Plus 50/12.5): Hydrochlorothiazide (Loortan Plus 50/12.5) is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Its empirical formula is C7H8ClN3O4S2.
It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
Loortan Plus 50/12.5 dosage
Hypertension
The usual starting dose of Loortan Plus 50/12.5 is 50/12.5 (Losartan (Loortan Plus 50/12.5) 50 mg/Hydrochlorothiazide (Loortan Plus 50/12.5) 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (Losartan (Loortan Plus 50/12.5) 100 mg/Hydrochlorothiazide (Loortan Plus 50/12.5) 25 mg) once daily as needed to control blood pressure.
Initiate a patient whose blood pressure is not adequately controlled with Losartan (Loortan Plus 50/12.5) 50 mg monotherapy with Loortan Plus 50/12.5 50/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of Loortan Plus 50/12.5 50/12.5 once daily or one tablet of Loortan Plus 50/12.5 100/25 once daily.
Initiate a patient whose blood pressure is not adequately controlled with Losartan (Loortan Plus 50/12.5) 100 mg monotherapy with Loortan Plus 50/12.5 100/12.5 (Losartan (Loortan Plus 50/12.5) 100 mg/Hydrochlorothiazide (Loortan Plus 50/12.5) 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of Loortan Plus 50/12.5 50/12.5 once daily or one tablet of Loortan Plus 50/12.5 100/25 once daily.
Initiate a patient whose blood pressure is inadequately controlled with Hydrochlorothiazide (Loortan Plus 50/12.5) 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen, on Loortan Plus 50/12.5 50/12.5 once daily, reducing the dose of Hydrochlorothiazide (Loortan Plus 50/12.5) without reducing the overall expected antihypertensive response. Evaluate the clinical response to Loortan Plus 50/12.5 50/12.5 and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of Loortan Plus 50/12.5 50/12.5 once daily or one tablet of Loortan Plus 50/12.5 100/25 once daily.
Hypertensive Patients with Left Ventricular Hypertrophy
In patients whose blood pressure is not adequately controlled on 50 mg Losartan (Loortan Plus 50/12.5) potassium, initiate treatment with Loortan Plus 50/12.5 50/12.5. If additional blood pressure reduction is needed, increase the dose to Loortan Plus 50/12.5 100/12.5, followed by Loortan Plus 50/12.5 100/25. For further blood pressure reduction add other antihypertensives.
Loortan Plus 50/12.5 interactions
See also:
What other drugs will affect Loortan Plus 50/12.5?
Agents Increasing Serum Potassium
Coadministration of Losartan (Loortan Plus 50/12.5) with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.
Lithium
Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving Loortan Plus 50/12.5 and lithium.
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors
Losartan (Loortan Plus 50/12.5) Potassium
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including Losartan (Loortan Plus 50/12.5)) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Losartan (Loortan Plus 50/12.5) and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Losartan (Loortan Plus 50/12.5), may be attenuated by NSAIDs, including selective COX-2 inhibitors.
Hydrochlorothiazide (Loortan Plus 50/12.5)
The administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Loortan Plus 50/12.5 and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.
In patients receiving diuretic therapy, coadministration of NSAIDs with angiotensin receptor blockers, including Losartan (Loortan Plus 50/12.5), may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Hydrochlorothiazide (Loortan Plus 50/12.5), Losartan (Loortan Plus 50/12.5), and NSAID therapy.
Dual Blockade Of The Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of Losartan (Loortan Plus 50/12.5) therapy and followed them for a median of 2.2 years. Patients receiving the combination of Losartan (Loortan Plus 50/12.5) and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end-stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.
Closely monitor blood pressure, renal function, and electrolytes in patients on Loortan Plus 50/12.5 and other agents that affect the RAS.
Do not coadminister aliskiren with Loortan Plus 50/12.5 in patients with diabetes. Avoid use of aliskiren with Loortan Plus 50/12.5 in patients with renal impairment (GFR < 60 mL/min).
The Use Of Hydrochlorothiazide (Loortan Plus 50/12.5) With Other Drugs
When administered concurrently, the following drugs may interact with thiazide diuretics :
Antidiabetic drugs (oral agents and insulin) — dosage adjustment of the antidiabetic drug may be required.
Cholestyramine and colestipol resins — Absorption of Hydrochlorothiazide (Loortan Plus 50/12.5) is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the Hydrochlorothiazide (Loortan Plus 50/12.5) and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Stagger the dosage of Hydrochlorothiazide (Loortan Plus 50/12.5) and the resin such that Hydrochlorothiazide (Loortan Plus 50/12.5) is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.
Loortan Plus 50/12.5 side effects
See also:
What are the possible side effects of Loortan Plus 50/12.5?
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.
Losartan (Loortan Plus 50/12.5) potassium-Hydrochlorothiazide (Loortan Plus 50/12.5) has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively.
In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% of subjects treated with Losartan (Loortan Plus 50/12.5)-Hydrochlorothiazide (Loortan Plus 50/12.5) and at a greater rate than placebo were: back pain (2.1% vs 0.6%), dizziness (5.7% vs 2.9%), and upper respiratory infection (6.1% vs 4.6%).
The following additional adverse reactions have been reported in clinical trials with Loortan Plus 50/12.5 and/or the individual components:
Blood and the lymphatic system disorders: Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.
Metabolism and nutrition disorders: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia.
Psychiatric disorders: Insomnia, restlessness.
Nervous system disorders: Dysgeusia, headache, migraine, paraesthesias.
Eye disorders: Xanthopsia, transient blurred vision.
Cardiac disorders: Palpitation, tachycardia.
Vascular disorders: Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).
Respiratory, thoracic and mediastinal disorders: Nasal congestion, pharyngitis, sinus disorder, respiratory distress (including pneumonitis and pulmonary edema).
Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, diarrhea, constipation, nausea, vomiting, pancreatitis, sialoadenitis.
Hepato-biliary disorders: Jaundice (intrahepatic cholestatic jaundice).
Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus.
Musculoskeletal and connective tissue disorders: Muscle cramps, muscle spasm, myalgia, arthralgia.
Renal and urinary disorders: Glycosuria, renal dysfunction, interstitial nephritis, renal failure.
Reproductive system and breast disorders: Erectile dysfunction/impotence.
General disorders and administration site conditions: Chest pain, edema/swelling, malaise, fever, weakness.
Investigations: Liver function abnormalities.
Cough
Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of Losartan (Loortan Plus 50/12.5) on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to Losartan (Loortan Plus 50/12.5) 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg Hydrochlorothiazide (Loortan Plus 50/12.5) (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.
| |||
| Study 1* | HCTZ | Losartan (Loortan Plus 50/12.5) | Lisinopril |
| Cough | 25% | 17% | 69% |
| Study 2† | Placebo | Losartan (Loortan Plus 50/12.5) | Lisinopril |
| Cough | 35% | 29% | 62% |
These studies demonstrate that the incidence of cough associated with Losartan (Loortan Plus 50/12.5) therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with Hydrochlorothiazide (Loortan Plus 50/12.5) or placebo therapy.
Cases of cough, including positive re-challenges, have been reported with the use of Losartan (Loortan Plus 50/12.5) in postmarketing experience.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Loortan Plus 50/12.5. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Digestive: Hepatitis has been reported rarely in patients treated with Losartan (Loortan Plus 50/12.5).
Hematologic: Thrombocytopenia.
Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with Losartan (Loortan Plus 50/12.5); some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with Losartan (Loortan Plus 50/12.5). Anaphylactic reactions have been reported.
Musculoskeletal: rhabdomyolysis
Skin: Erythroderma
Loortan Plus 50/12.5 contraindications
See also:
What is the most important information I should know about Loortan Plus 50/12.5?
Hypersensitivity to Losartan (Loortan Plus 50/12.5), sulphonamide-derived substances (as Hydrochlorothiazide (Loortan Plus 50/12.5)) or to any of the excipients of Loortan Plus 50/12.5.
Therapy resistant hypokalemia or hypercalcemia; severe hepatic impairment; cholestasis and biliary obstructive disorders; refractory hyponatremia; symptomatic hyperuricemia/gout; 2nd and 3rd trimester of pregnancy; lactation; severe renal impairment (ie, creatinine clearance <30 mL/min); anuria.
Excipient: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Loortan Plus 50/12.5.
Use in lactation: It is not known whether Losartan (Loortan Plus 50/12.5) is excreted in human milk. However, Losartan (Loortan Plus 50/12.5) is excreted in the milk of lactating rats. Because no information is available regarding the use of Losartan (Loortan Plus 50/12.5) during breastfeeding, Losartan (Loortan Plus 50/12.5) is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Thiazides pass into human milk and may inhibit lactation. Because of the potential for adverse effects on the nursing infant, Losartan (Loortan Plus 50/12.5)/HCTZ is contraindicated during breastfeeding.
Active ingredient matches for Loortan Plus 50/12.5:
Hydrochlorothiazide/Losartan in Luxembourg.
List of Loortan Plus 50/12.5 substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Loortan Plus Forte 100/25 (Luxembourg) | |
| LOP-H (India) | |
| LOP-H tab 10's (Syn Labs) | $ 0.78 |
| Lopar-H (India) | |
| Lopar-H Losartan K 50mg, Hydrochlorothiazide 12.5mg TAB / 100 (Psycorem) | $ 7.83 |
| 100's (Psycorem) | $ 7.83 |
| LOPAR-H tab 10's (Psycorem) | $ 0.78 |
| LOPASSIUM-H (India) | |
| 10's (ABS) | $ 0.43 |
| Lopassium-H Losartan potassium 50 mg, Hydrochlorothiazide 12.5 mg. TAB / 10 (ABS) | $ 0.43 |
| LOPASSIUM-H tab 10's (ABS) | $ 0.43 |
| Lopassium-H Losartan potassium 50 mg, Hydrochlorothiazide 12.5 mg. TAB / 10 (ABS) | $ 0.43 |
| Lopernal (Greece) | |
| Lopizide (Pakistan) | |
| Loplac-D (Argentina) | |
| Loplac-D 100 (Argentina) | |
| Loplus (Pakistan) | |
| Lopo Plus (Bangladesh) | |
| Lopos Plus (Bangladesh) | |
| Lopren-D (Chile) | |
| Lopress comp (Iceland) | |
| LOPT-H (India) | |
| 10's (Rhine Biogenics) | $ 0.37 |
| Lopt-H losartan potassium 50 mg, hydrochlorothiazide 12.5 mg. TAB / 10 (Rhine Biogenics) | $ 0.37 |
| LOPT-H tab 10's (Rhine Biogenics) | $ 0.53 |
| Lopt-H losartan potassium 50 mg, hydrochlorothiazide 12.5 mg. TAB / 10 (Rhine Biogenics) | $ 0.37 |
| LOPULSE H | |
| LOPULSE H 50MG/12.5MG TABLET 1 strip / 10 tablets each (Hamps India Pvt Ltd) | $ 0.67 |
| Loratus HZ | |
| Loratus HZ 50mg/12.5mg Tablet (Tusker Pharma Pvt Ltd) | $ 0.03 |
| Loraz (Egypt) | |
| Tablet; Oral; Lorazepam 0.5 mg (Gentech HC) | |
| Tablet; Oral; Lorazepam 1 mg (Gentech HC) | |
| Tablet; Oral; Lorazepam 2 mg (Gentech HC) | |
| 1 mg x 10's (Gentech HC) | $ 0.15 |
| 2 mg x 10's (Gentech HC) | $ 0.20 |
| 1's (Gentech HC) | $ 0.20 |
| Loraz 1mg TAB / 10 (Gentech HC) | $ 0.15 |
| Loraz 2mg TAB / 10 (Gentech HC) | $ 0.20 |
| Loraz - INJ / 1 (Gentech HC) | $ 0.20 |
| LORAZ 2MG TABLET 1 strip / 10 tablets each (Gentech HC) | $ 0.21 |
| LORAZ tab 1 mg x 10's (Gentech HC) | $ 0.15 |
| LORAZ tab 2 mg x 10's (Gentech HC) | $ 0.20 |
| LORAZ inj 2 mg x 1 mL x 2ml (Gentech HC) | $ 0.20 |
| Loraz 2mg Tablet (Gentech HC) | $ 0.02 |
| Lorcombi (Italy) | |
| Loreblok HCT (Poland) | |
| Loril-HT (India) | |
| Loril-HT Losartan K 50mg, Hydrochlorothiazide 12.5mg TAB / 100 (Essweil) | |
| 100's (Essweil) | |
See 1294 substitutes for Loortan Plus 50/12.5 | |
References
- DailyMed. "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: 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).
- DailyMed. "LOSARTAN POTASSIUM: 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).
- PubChem. "losartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Loortan Plus 50/12.5 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Loortan Plus 50/12.5. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
