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Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

Summary

Despite a large diffusion for generic anti-hypertensive, they are not currently used.

Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only.

A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria.

The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.

Description

List of drugs. ALDACTONE, FLUMACH, SPIROCTAN, SPIRONONE, FLUDEX, INDATEN, LASILIX, TENSTATEN, ALDACTAZINE, PRINACTIZIDE, SPIROCTAZINE, MODURETIC, AVLOCARDYL, HEMIPRALON, STHASIN, BETATOP, TENORMINE, CELECTOL, DETENSIEL, FELSAN, KERLONE, RAGON, RONALOL, LOPRESSOR, SELOKEN, NEBILOX, TEMERIT, NEVEROL, SECTRAL, ACUITEL, KOREC, BRIEM, CIBACENE, COVERSYL, CAPTOLANE, LOPRIL, FOZITEC, ODRIK, GOPTEN, PRINIVIL, ZESTRIL, RENITEC, TEOULA, ZOFENIL, TRIATEC, KENOMON, ADALATE, CHRONOADALATE, AMLOR, BAYPRESS, DELTAZEN, DILRENE, DIACOR, MONO TILDIEM, FLODIL, IPERTEN, ISOPTINE, LERCAN, ZANIDIP, LEDELCARBERDIPE, LENIBERCARDIPE, DIBERLEPIDINE, XILERMIS, APROVEL, CRISARTERS, IFIRMASTA, FLUPPE, ZELMIRB, ATACAND, KENZEN, KARBIS, COZAAR, LOBERASNAT, LOTANBERSAR, MICARDIS, PRITOR, TOLURA, ZANACODAR, DINORTES, MIRPRESOC, NISIS, TAREG, CUENCA, TIFIVAL, VAGRECOR, VAMADRID, HYPERIUM, PHYSIOTENS, BIPRETERAX, PRETERAX, LODOZ, WYTENS, ACUILIX, KORETIC, BRIAZIDE, CIBADREX, CAPTEA, ECAZIDE, CORENITEC, ENALAVIS, ENALURETIC, COTRIATEC, RADOUCHE, FOZIRETIC, PRINZIDE, ZESTORETIC, COAPROVEL, IFIRMACOMBI, COCRISARTERS, COKENZEN, HYTACAND, COANHYVA, COHESAN. COTAREG, NISISCO, FORTZAAR, HYZAAR, MICARDISPLUS, PRITORPLUS, MARESSI, TOLUCOMBI, TENORDATE, BETA ADALATE

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Intervention

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Medical and Biotech [MESH] Definitions

The period in the MENSTRUAL CYCLE that is optimal for FERTILIZATION of the OVUM and yielding PREGNANCY. The duration of fertile period depends on the life span of male GAMETES within the female reproductive tract and the time of OVULATION. It usually begins a few days before ovulation and ends on the day of ovulation.

The period shortly before, during, and immediately after giving birth.

Maximum Allowable Concentration

The maximum exposure to a biologically active physical or chemical agent that is allowed during an 8-hour period (a workday) in a population of workers, or during a 24-hour period in the general population, which does not appear to cause appreciable harm, whether immediate or delayed for any period, in the target population. (From Lewis Dictionary of Toxicology, 1st ed)

In females, the period that is shortly after giving birth (PARTURITION).

The period before a surgical operation.

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Kefloxin

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Cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of Cefadroxil for the prophylaxis of subsequent rheumatic fever are not available. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil and other antibacterial drugs, Cefadroxil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred. Hypersensitivity Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported. Other Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported. In addition to the adverse reactions listed above which have been observed in patients treated with Cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics. Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

BEFORE THERAPY WITH Cefadroxil IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Cefadroxil, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG ?-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Cefadroxil OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

SOLUTION FOR INJECTION

Antibiotics - Phthizoetham (Brand name: myambutol)

Myambutol is used for treating tuberculosis (TB) infections of the lung along with other medicines. Myambutol is an antibacterial agent. It works by stopping the growth of TB cells, which results in cell death.

Use Myambutol as directed by your doctor.

Take Myambutol with or without food at the same time each day.

Do not take antacids containing aluminum hydroxide for at least 4 hours after taking Myambutol.

If you miss a dose of Myambutol, 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 Myambutol.

Store Myambutol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Myambutol out of the reach of children and away from pets.

Active Ingredient: Ethambutol hcl.

Do NOT use Myambutol if:

you are allergic to any ingredient in Myambutol

you have inflammation of the optic nerve (optic neuritis), you cannot determine if you are having vision changes, or you are unable to report vision changes to your doctor or health care provider.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Myambutol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have gouty arthritis or are having a gout attack

if you have cataracts, recurrent eye inflammation, or eye problems caused by diabetes (diabetic retinopathy)

if you have kidney or liver problems.

Some medicines may interact with Myambutol. However, no specific interactions with Myambutol are known at this time.

Important safety information:

Myambutol may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Myambutol. Using Myambutol alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

It is important to use Myambutol for the full course of treatment. Failure to do so may decrease the effectiveness of Myambutol and increase the risk that the bacteria will no longer be sensitive to Myambutol and will not be able to be treated by this or certain other antibiotics in the future.

Myambutol is effective only against certain types of bacteria. It is not effective for treating viral infections (eg, the common cold).

Long-term or repeated use of Myambutol may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.

Lab tests, including liver and kidney function tests, complete blood cell counts, and vision tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Myambutol should not be used in children younger 13 years. Safety and effectiveness in this age group have not been confirmed.

Pregnancy and breast-feeding: If you become pregnant, discuss with your doctor the benefits and risks of using Myambutol during pregnancy. Myambutol is excreted in breast milk. If you are or will be breast-feeding while you are using Myambutol, check with your doctor or pharmacist to discuss the risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Appetite loss; disorientation; dizziness; general body discomfort; headache; nausea; stomach upset or pain; vomiting.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; confusion; dark urine; easy bruising or bleeding; fever, chills, or sore throat; hallucinations; joint pain, swelling, or severe tenderness; lower back pain; numbness or tingling of the hands, legs, or feet; severe stomach pain; swollen glands in the neck or armpit; vision loss or other vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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EUPANTOL 40 mg cp gastroresis

Aplenzin

GENERIC NAME(S): BUPROPION HBR

Warnings

Bupropion is an antidepressant used for smoking cessation and to treat a variety of conditions, including depression and other mental/mood disorders. Antidepressants can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience new or worsening depression. other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication. even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice new or worsening depression /other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety. panic attacks. trouble sleeping. irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

If you are using bupropion to quit smoking and experience any of these symptoms, stop taking it and contact your doctor right away. Also, tell your doctor right away if you have any of these symptoms after stopping treatment with bupropion.

Uses

This medication is used to treat depression. It may also be used to prevent seasonal affective disorder (SAD), a type of depression that occurs each year at the same time (for example, during winter). This medication can improve your mood and feelings of well-being. It may work by restoring the balance of certain natural substances (dopamine, norepinephrine) in the brain .

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.

This medication may also be used to treat attention deficit hyperactivity disorder (ADHD ), or to help people quit smoking by decreasing cravings and nicotine withdrawal effects. It may also be used along with other mood stabilizers to treat bipolar disorder (depressive phase). It may also be used to treat anxiety in people with depression.

How to use Aplenzin

Read the Medication Guide provided by your pharmacist before you start using bupropion and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. If you have stomach upset, you may take this medication with or after a meal or snack. Taking this medication late in the day may cause trouble sleeping (insomnia ). Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition, liver function. and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop taking this medication without consulting your doctor. Your dose may need to be gradually decreased.

It may take 4 weeks or longer before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

See also Warning section.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat. mental/mood changes (such as anxiety, agitation, confusion, unusual behavior/thinking, memory loss ), unusual weight loss or gain.

Stop taking bupropion and get medical help right away if you have any very serious side effects, including: seizure. eye pain /swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), painful sores in the mouth/around the eyes, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda. gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking bupropion, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart disease, high blood pressure, kidney problems, liver disease, use/abuse of drugs/alcohol, seizures or conditions that increase your risk of seizures (including brain/head injury, brain tumor, eating disorders such as bulimia/anorexia nervosa), personal or family history of glaucoma (angle-closure type).

This medication should not be used if you are suddenly stopping regular use of sedatives (including benzodiazepines such as lorazepam), drugs used to treat seizures, or alcohol. Doing so may increase your risk of seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol can increase your risk of dizziness or seizures.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness and memory loss. Dizziness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Since untreated mental/mood problems (such as depression, seasonal affective disorder, bipolar disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: pimozide, tamoxifen.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease, urine screening for amphetamines), possibly causing false results. Tell laboratory personnel and all your doctors you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, severe confusion, hallucinations, rapid heart rate, loss of consciousness.

Notes

Do not share this medication with others.

Keep all regular medical and psychiatric appointments. Laboratory and/or medical tests (such as blood pressure, liver function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

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Comment: I have had Chronic Insomnia for since my early Twenties. Back then I used Methaquaalone, Placidyl, Valmid, Nembutal, Tuinal, and GHB, in addition to many others including Butisol Sodium. The Butisol works very well as an Sedative/Hypnotic, Onset of Drowsiness between 30 minutes to 1 Hour and from a 50mg Dose Natural Feeling Sleep Duration is about 6 hours. The only down side is it's Cost. I'm very happy that they still manufacture this Medicine because for some people like me a Barbituate with Sedative/Hypnotic properties is the only thing allows me Quality Sleep. Hide Full Comment

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Adding a covariate to general linear model (GLM)

Verify that the covariate and response are linearly related. You can do this in Minitab by analyzing the data with a fitted line plot.

Choose Stat > Regression > Fitted Line Plot .

In Response (Y) enter Strength .

In Predictor (X) enter Diameter .

Assess how closely the data fall beside the fitted line and how close R 2 is to a "perfect fit" (100%).

The fitted line plot indicates a strong linear relationship (87.2%) between diameter and strength.

Perform the GLM analysis with the covariate.

Choose Stat > ANOVA > General Linear Model > Fit General Linear Model .

In Responses. enter Strength .

In Factors. enter Machine .

In Covariates. enter Diameter .

Click OK .

For the fiber production data, Minitab displays the following results:

Analysis of Variance Source DF Adj SS Adj MS F-Value P-Value Diameter 1 178.014 178.014 69.97 0.000 Machine 2 13.284 6.642 2.61 0.118 Error 11 27.986 2.544 Lack-of-Fit 7 18.486 2.641 1.11 0.487 Pure Error 4 9.500 2.375 Total 14 346.400

The F-statistic for machines is 2.61 and the p-value is 0.118. Because the p-value >0.05, you fail to reject the null hypothesis that the fiber strengths do not differ based on the machine used at the 5% significance level. You can assume the fiber strengths are the same on all the machines. Notice that the F-statistic for diameter (covariate) is 69.97 with a p-value of 0.000. This indicates that the covariate effect is significant. That is, diameter has a statistically significant impact on the fiber strength.

Now, suppose you rerun the analysis and omit the covariate. This will result in the following output:

Analysis of Variance Source DF Adj SS Adj MS F-Value P-Value Machine 2 140.4 70.20 4.09 0.044 Error 12 206.0 17.17 Total 14 346.4

Notice that the F-statistic is 4.09 with a p-value of 0.044. Without the covariate in the model, you reject the null hypothesis at the 5% significance level and conclude the fiber strengths do differ based on which machine is used.

This conclusion is completely opposite the conclusion you got when you performed the analysis with the covariate. This example shows how the failure to include a covariate can produce misleading analysis results.

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