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prorelixcro · 2 years

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The Ultimate Guide to Pharmacovigilance Services: What You Need to Know

What is Pharmacovigilance and How Does It Benefit the Pharmaceutical Industry?

Pharmacovigilance is a valuable tool for the pharmaceutical industry, with its services including drug safety monitoring, adverse event reporting and clinical trial monitoring. It is an essential part of the drug development cycle, enabling companies to detect any potential safety issues with new drugs prior to market launch. By utilizing pharmacovigilance services, pharmaceutical companies can ensure that their products are safe and effective for consumers. This helps to maximize patient safety while also increasing confidence in their products and reducing financial losses due to product recalls or litigation.

What Are The Benefits Of Using Pharmacovigilance Services?

Pharmacovigilance refers to the science of identifying, assessing, understanding and preventing adverse effects of drugs. The use of pharmacovigilance services is essential in order to ensure that drug safety surveillance is carried out properly and patients are protected from any harm or side effects caused by the use of drugs. Pharmacovigilance services also help in minimizing the risks associated with clinical trials and provide valuable insight into how a drug can affect different individuals. It also helps with adverse event analysis so that manufacturers can take necessary actions to reduce such occurrences. In this way, pharmacovigilance services play an important role in protecting people's health by allowing for early detection and prevention of potential drug-related problems.

How Do Pharmacists Monitor Drug Safety?

Pharmacists have an important role to play in monitoring drug safety. Through the use of pharmacy verification (PV) tools and databases, pharmacists are able to identify potential risks associated with certain medications and other products. Furthermore, they are responsible for clinical safety report processing and ensuring that they keep up-to-date with the latest drug safety information. By doing so, pharmacists can help ensure that patients are receiving safe and effective medications that meet their medical needs.

They are responsible for monitoring the use and effects of drugs on patients. To achieve this, they rely on information from clinical research organizations to assess the safety of drugs and monitor any potential side-effects or adverse reactions. Clinical research organization conduct clinical trials and studies to gather data that is then used by pharmacists to make informed decisions about drug safety. Pharmacists rely on data collected by CROs to inform their practice in order to ensure that all medications are safe for use by patients.

What Are The Challenges Faced By Pharmacists In Drug Safety Monitoring?

As pharmacists have a unique and important role in patient care, drug safety monitoring is an essential part of their job. However, there are several challenges that pharmacists face when it comes to data collection for drug safety monitoring and decision making.

Data-driven decision making is one of the main challenges faced by pharmacists and pharmaceutical experts when it comes to drug safety monitoring. This requires the effective collection of patient data which can be a challenge due to privacy laws or system limitations. Furthermore, the accuracy and reliability of data that has been collected needs to be assessed in order for decisions to be made quickly and accurately. Finally, the pharmacist needs to understand how their decisions will affect patients’ health in order to provide safe medication prescribed by doctors.

How Can Technology Help Pharmacists With Drug Safety Monitoring?

As technology advances, the potential of providing safe and effective treatments to patients is only increasing. Pharmacists are now able to use a variety of tools and systems to ensure that their patients receive their medications in a safe manner. By leveraging the power of technology, pharmacists can monitor drug safety and ensure that their patients are receiving appropriate treatments.

Drug safety monitoring is essential to ensure the continued safety of medications and healthcare products. This process involves monitoring a drug's safety profile throughout its life cycle, from pre-market approval to post-market surveillance. It requires the collection and analysis of data from multiple sources including clinical trials, medical records, epidemiological studies and adverse event reports. By understanding the types of drug safety monitoring available, we can ensure that medications are kept safe for everyone who uses them.

The introduction of new technologies has increased the significance of drug safety monitoring even further, making it easier and more effective to track drug use, identify potential side effects, and ensure that medications are taken safely. Effective drug safety monitoring can help prevent serious harm to patients while ensuring compliance with standards and best practices.

Technology has revolutionized the practice of pharmacy, allowing pharmacists to provide drug safety services in the USA as well as in the global marketplace more effectively and efficiently.

We hope that this article will help you gain a better understanding of pharmacovigilance services and the role it plays in our society.

#pharmacovigilanceservices #clinicalresearch

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greatestlcve · 4 years

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Solupred Uses, Dosage, Side Effects, Precautions & Warnings

Drug Online

solupred medicine Generic drug of the therapeutic class: Anti-inflammatory active ingredients: Prednisolone

What is Solupred?

This medication is a corticosteroid.

It is indicated in certain diseases, where it is used for its anti-inflammatory effect.

what is solupred used for and indication ?

what is solupred used for

Conditions or diseases:

Collagenosis, connectivites:

Evolutionary thrusts of systemic diseases, including: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.

Dermatological:

Severe autoimmune bullous dermatoses, especially pemphigus and bullous pemphigoid.

Serious forms of angiomas of the infant.

Some forms of lichen plan.

Some acute urticaria.

Severe forms of neutrophilic dermatoses.

Digestives:

Evolutionary thrusts of ulcerative colitis and Crohn’s disease.

Chronic active autoimmune hepatitis (with or without cirrhosis).

Severe acute alcoholic hepatitis, histologically proven.

Endocrine:

Subacute thyroiditis of severe Quervain.

Some hypercalcemia.

Hematologic:

Severe immunological thrombocytopenic purpura.

Autoimmune haemolytic anemias.

In combination with various chemotherapies in the treatment of lymphoid malignant hemopathies.

Chronic erythroblastopenia, acquired or congenital.

Infectious:

Tuberculous pericarditis and severe forms of life-threatening tuberculosis.

Pneumocystis carinii pneumonia with severe hypoxia.

Neoplasms:

Antiemetic treatment during antineoplastic chemotherapy.

Oedematous and inflammatory thrust associated with antineoplastic treatments (radio and chemotherapy).

Nephrological:

Nephrotic syndrome with minimal glomerular lesions.

Nephrotic syndrome of primitive segmental and focal hyalinoses.

Stages III and IV of lupus nephropathy.

Intrarenal granulomatous sarcoidosis.

Vasculitis with renal involvement.

Primitive extracapillary glomerulonephritis

Neurological:

Gravis.

Cerebral edema of tumoral cause.

Chronic polyradiculoneuropathy, idiopathic, inflammatory.

Infant spasm (West syndrome), Lennox-Gastaut syndrome.

Multiple sclerosis in relapse, in relays of an intravenous corticotherapy.

Ophthalmological:

Uveitis anterior and posterior severe.

Exophthalmos oedematous.

Some optic neuropathies, in reliance on intravenous corticosteroids (in this indication, oral first-line is not recommended).

ENT:

Some serous otitis.

Nasosinus polypsis.

Some acute or chronic sinusitis.

Seasonal allergic rhinitis in short cure.

Stridulous acute laryngitis (subglottic laryngitis) in children.

Respiratory:

Persistent asthma, preferably short-course in case of failure of inhaled treatment in high doses.

Exacerbations of asthma, especially severe acute asthma.

Chronic obstructive pulmonary disease in assessing the reversibility of obstructive syndrome.

Sarcoidosis progressive.

Diffuse interstitial pulmonary fibrosis.

Rheumatologic:

Rheumatoid arthritis and some polyarthritis.

Rhizomelic pseudopolyarthritis and Horton’s disease.

Acute articular rhumatism.

Severe and rebellious cervicobrachial neuralgia.

Organ Transplantation and Hematopoietic Allogeneic Stem Cells:

Prophylaxis or treatment of transplant rejection.

Prophylaxis or treatment of graft-versus-host disease.

Solupred Dosage

Oral way.

Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 5 mg prednisolone.

The tablets will be dissolved in a glass of water during the meal.

If the calculated weight dose is less than 5 mg per day, a more appropriate dosage is available.

solupred dosage adulte

The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient’s response and the tolerance to the treatment.

Attack treatment : 0.35 to 1.2 mg / kg / day. As an indication : 4 to 14 tablets in an adult of 60 kg.

In severe inflammatory diseases , the dosage ranges from 0.75 to 1.2 mg / kg / day. As an indication: 9 to 14 tablets per day for an adult of 60 kg.

The very exceptional situations may require higher doses.

Maintenance treatment: 5 to 15 mg / day, or 1 to 3 tablets a day.

solupred dosage child

The dosage should be appropriate to the condition and weight of the child.

Attack treatment : 0.5 to 2 mg / kg / day. As an indication : 2 to 10 tablets for a child of 25 kg.

Maintenance treatment : 0.25 to 0.5 mg / day. As an indication : 1 to 2 tablets for a child of 25 kg.

The prescription of alternating day corticosteroid therapy (one day without corticosteroid and the second day with a double dosage of the daily dosage that would have been required) is used in children to try to limit stunting.

This alternate day schedule can be considered only after control of inflammatory disease by high doses of corticosteroids, and when during decay no rebound is observed.

IN GENERAL

Treatment at the “attack dose” should be continued until the disease is well controlled. In the case of long-term treatment, the decrease must be slow. Obtaining a weaning is the goal. Maintaining a maintenance dose (minimum effective dose) is a compromise that is sometimes necessary.

For prolonged treatment at high doses, the first doses can be divided into two daily doses. Thereafter, the daily dose may be administered as a single dose preferably in the morning during the meal.

Stop treatment

The rate of withdrawal depends mainly on the duration of treatment, the starting dose and the disease.

The treatment causes resting secretions of ACTH and cortisol with sometimes lasting adrenal insufficiency. When weaning, the stop must be done gradually, in stages, because of the risk of relapse: reduction of 10% every 8 to 15 days on average.

For short courses of less than 10 days, stopping treatment does not require decay.

When decreasing doses (prolonged cure): at the dosage of 5 to 7 mg of prednisone equivalent, when the causal disease no longer requires corticosteroid treatment, it is desirable to replace the synthetic corticoid with 20 mg / day of hydrocortisone until recovery of corticotropic function. If corticosteroid therapy is to be maintained at less than 5 mg prednisone equivalent per day, a small dose of hydrocortisone can be added to achieve a hydrocortisone equivalent of 20 to 30 mg per day. When the patient is only under hydrocortisone, it is possible to test the corticotropic axis by endocrine tests. These tests do not eliminate, alone, the possibility of occurrence of adrenal insufficiency during a stress.

Under hydrocortisone or even at a distance from arrest, the patient should be advised of the need to increase the usual dosage or to resume replacement therapy (eg 100 mg hydrocortisone intramuscularly every 6 to 8 hours) in case stress: surgery, trauma, infection.

How it works Solupred

Pharmacotherapeutic group: GLUCOCORTICOIDES, ATC code: H02AB06.

( H: Non-sexual systemic hormones ).

Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones. Synthetic corticosteroids, including this specialty, are used primarily for their anti-inflammatory effect.

In high doses, they reduce the immune response. Their metabolic and sodium retention effect is less than that of hydrocortisone.

Solupred Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine, essential for your health, is most often well tolerated when you follow the recommendations and especially the diet low in salt, sugar and high protein (see also the paragraph “Warnings and precautions”).

It may nevertheless result, depending on the dose and the duration of the treatment, more or less troublesome effects.

The most common side effects are:

· A modification of some results of your analyzes (salt, sugar, potassium) that may require a diet or a complementary treatment.

· An appearance of bruises.

· Elevated blood pressure, water retention and salt may lead to heart failure.

· Mood disorders (excitement, euphoria), sleep disorders (insomnia).

· A set of disorders called Cushing’s syndrome recognizable by weight gain, swelling and redness of the face, excessive growth of hair.

· Bone fragility (osteoporosis, fractures, vertebral compression in particular).

· Painful disorders of bone at the hip larticulation (osteonecrosis).

Other, much rarer effects have been observed:

· Insufficient production of hormones by the gland located above the kidneys (adrenal gland).

· Stunting in children

· Rule disorders.

· Muscle weakness, tendon rupture especially if SOLUPRED 5 mg, effervescent tablet is associated with certain antibiotics (fluoroquinolones).

· Digestive disorders: digestive ulcer, bleeding and digestive perforations,

· Inflammation of the pancreas especially among child.

· A weakening of the skin, a delay of cicatrization, of lacné.

· Disorientation in time and space (confusion), convulsion, depressive state at the end of treatment.

· Vision problems that may lead to loss of vision: blurred vision, some forms of glaucoma (increased fluid pressure) and cataracts (opacification of the lens), chorioretinopathies (retinal disease).

· Endocrine disorders (hormonal disorders): occurrence of seizures related to the presence of pheochromocytoma (tumor of the adrenal glands) and can put your life in danger.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: https://bit.ly/2XQbWcQ

By reporting side effects, you can help provide more information on the safety of the medicine.

Solupred Interactions

Hypokalaemic drugs

Hypokalemia is a factor favoring the development of cardiac arrhythmias (torsades de pointes, in particular) and increasing the toxicity of certain drugs, for example digoxin. As a result, medications that can lead to hypokalemia are involved in a large number of interactions.

These are hypokalaemic diuretics, alone or in combination, stimulant laxatives, glucocorticoids, tetracosactide and amphotericin B (route IV).

Associations advised against

(See section Warnings and precautions for use )

+ Attenuated live vaccines

Risk of widespread, life-threatening vaccine disease.

+ Acetylsalicylic acid

Increased hemorrhagic risk.

Combination not recommended with anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose and / or ≥ 3 g daily).

Associations subject to precautions for use

+ Oral anticoagulants

Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and that of the coagulation factors. Hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or in prolonged treatment greater than 10 days. When the association is justified, reinforce the monitoring: biological control on the 8th day, then every 15 days during the corticotherapy and after its stop.

+ Other hypokalaemic drugs (diuretics with or without hypokalemia, stimulant laxatives, IV amphotericin B, tetracosactide)

Increased risk of hypokalemia. Monitoring of serum potassium with, if necessary, correction.

+ Enzymatic inducing anticonvulsants: carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone

Decreased plasma concentrations and corticosteroid efficacy by increased hepatic metabolism by the inducer; the consequences are particularly important for addisoners treated with hydrocortisone and for transplantation. Clinical and biological surveillance; adjustment of corticosteroid dosage during treatment with the inducer and after discontinuation.

+ Digital

Hypokalemia favoring the toxic effects of digitalis. Correct any hypokalemia beforehand and perform clinical, electrolytic and electrocardiographic monitoring.

+ Insulin, metformin, sulphonylureas

Increased blood glucose with sometimes ketoacidosis by decreasing glucocorticoid tolerance due to corticosteroids. Prevent the patient and strengthen the self-monitoring glycemic and urinary, especially at the beginning of treatment. If necessary, adjust the dosage of the antidiabetic during treatment with corticosteroids and after discontinuation.

+ Isoniazid

Described for prednisolone: decreased plasma concentrations of isoniazid. Invoked mechanism: increased hepatic metabolism of isoniazid and decreased glucocorticoid. Clinical and biological surveillance.

+ Drugs that may give torsades de pointes: class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide), certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, cyamemazine, sulpiride, sultopride) , amisulpride, tiapride, pimozide, haloperidol, droperidol, veralipride), bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, lumefantrine, methadone, mizolastine, moxifloxacin, pentamidine, spiramycin IV, vincamine IV)

Higher risk of ventricular arrhythmias, especially torsades de pointes. Correct all hypokalemia before administering the product and perform clinical, electrolytic and electrocardiographic monitoring.

+ Rifampicin

Decreased plasma concentrations and efficacy of corticosteroids by increasing their hepatic metabolism with rifampicin; the consequences are particularly important for addisoners treated with hydrocortisone and for transplantation. Clinical and biological surveillance; Adjustment of corticosteroid dosage during rifampicin treatment and after discontinuation.

+ Gastrointestinal Topicals, Antacids and Charcoal (described for prednisolone, dexamethasone)

Decreased digestive absorption of glucocorticoids. Take topical gastrointestinal and antacid drugs away from glucocorticoids (more than 2 hours if possible).

Associations to consider

+ Antihypertensives

Decreased antihypertensive effect (water-soluble retention of corticosteroids).

+ Fluoroquinolones

Possible increase in the risk of tendonopathy or even tendon rupture (exceptional), particularly in patients receiving prolonged corticosteroid therapy.

+ Acetylsalicylic acid

Increased hemorrhagic risk.

To be taken into account with analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day).

+ Nonsteroidal anti-inflammatory drugs

Increased risk of ulceration and gastrointestinal bleeding.

+ Ciclosporin

Increased effects of prednisolone: Cushingoid appearance, reduced carbohydrate tolerance (decreased clearance of prednisolone).

Solupred Warnings and Precautions

Special warnings

In case of peptic ulcer, corticosteroid therapy is not contraindicated if anti-ulcer treatment is associated.

In the case of an ulcerative history, corticosteroid therapy may be prescribed, with clinical monitoring and, if necessary, after fibroscopy.

Corticosteroid therapy can promote the occurrence of various infectious complications due in particular to bacteria, yeasts and parasites. The occurrence of a malignant yellowing is a significant risk. All subjects from an endemic area (tropical, subtropical, southern Europe) should have parasitological examination of the stool and systematic eradication before corticosteroid therapy.

Evidence of an infection may be masked by corticosteroid therapy.

It is important, before the start of treatment, to rule out any possibility of visceral foci, especially tuberculosis, and to monitor, during treatment, the appearance of infectious pathologies.

In case of old tuberculosis, prophylactic anti-tuberculosis treatment is necessary, if there are significant radiological sequelae and if one can not ensure that a good 6-month rifampicin treatment has been given.

The use of corticosteroids requires particularly appropriate monitoring, especially in elderly patients and in cases of ulcerative colitis (risk of perforation), recent intestinal anastomoses, renal failure, hepatic insufficiency, osteoporosis, myasthenia gravis.

Oral or injectable corticosteroids can promote the appearance of tendonopathy, or even tendon rupture (exceptional). This risk is increased when co-prescribed with fluoroquinolones and in dialysis patients with secondary hyperparathyroidism or renal transplantation.

This medicinal product is not recommended in combination with a live attenuated vaccine or with anti-inflammatory doses of acetylsalicylic acid.

This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Precautions for use

In case of long-term corticosteroid treatment:

A diet low in fast-absorbing and high-protein sugars must be associated, because of the hyperglycemic effect and the protein catabolism with negativization of the nitrogen balance.

Hydrosoduced retention is usual, partly responsible for a possible rise in blood pressure. This medicine contains sodium. This medicine contains 1.05 mmol (or 24 mg) of sodium per tablet. To be taken into account in patients on a strict sodium diet.

Sodium intake will be reduced for daily dosages above 15 or 20 mg prednisone equivalent and moderate in long-term low-dose treatments.

Potassium supplementation is warranted only for high-dose, long-term treatment or when there is a risk of rhythm disturbance or combination with hypokalaemic treatment.

The patient must always have a calcium and vitamin D intake.

When corticosteroid therapy is essential, diabetes and high blood pressure are not contraindications, but treatment can lead to imbalance. Their management needs to be re-evaluated.

Patients should avoid contact with individuals with chickenpox or measles.

Attention is drawn to athletes, this specialty containing an active ingredient that can induce a positive reaction tests conducted during anti-doping controls.

Solupred :Drive and use machines

Not applicable.

Solupred and PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

This medication will only be used during pregnancy if necessary. If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue this treatment.

feeding

Breastfeeding should be avoided during treatment because of passage into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

To be effective, this medicine should be used regularly. However, if you miss a dose, continue the treatment normally.

What happens if I overdose from Solupred ?

Not applicable.

What is Forms and Composition Solupred ?

FORMS and PRESENTATIONS

Effervescent tablet 5 mg: Bottle of 30. Effervescent tablet 20 mg: Bottle of 20. Orodispersible 5 mg tablet: Box of 30, in blister packs. Hospital model: Box of 50, in blister packs. 20 mg Orodispersible Tablet: Box of 20, in blister packs. Hospital model: Box of 50, in blister packs. Oral solution 1 mg / ml: 50 ml bottle with child safety cap and dosing syringe (4 graduations: 0.5 ml, 1 ml, 1.5 ml, 2 ml).

COMPOSITION

Effervescent tablet :p cpprednisolone5 mgor20 mg(as metasulfobenzoate sodium: 7.86 mg / cd at 5 mg, 32.416 mg / cp at 20 mg)

Excipients:

5 mg Cp: tartaric acid, citric acid anhydrous, sodium bicarbonate, lithium benzoate, sucrose.

Cp 20 mg: tartaric acid, citric acid anhydrous, sodium bicarbonate, lithium benzoate, lemon natural flavor (maltodextrin, vegetable gum, sorbitol, lemon essential oil, citral, citronellal), sodium saccharin, silicone antifoam emulsion .

Excipients with known effect :

Cp at 5 mg: sodium (24 mg / cp), sucrose.

Cp at 20 mg: sodium (50.8 mg / cp), sorbitol.

Orodispersible tablet:p cpprednisolone5 mgor20 mg(as metasulfobenzoate sodium: 7.86 mg / cp at 5 mg, 31.44 mg / cp at 20 mg)

Excipients (common): dispersion of 30% polyacrylate (Eudragit NE 30 D), hydrophobic colloidal silica (Aerosil R972), mannitol (granule), mannitol (powder), crospovidone, aspartame, magnesium stearate.

Excipient with known effect: aspartame.

Drinkable solution :p mlprednisolone1 mg(as metasulfobenzoate sodium: 1.57 mg / ml)

Excipients: sodium cyclamate, glycerol, sorbic acid, sodium saccharinate, sorbitol (E420), sucrose, ethanol, purified water. Aroma: apricot (ethyl alcohol, vanillin, benzoic aldehyde, isoamyl acetate, diacetyl, ionone, allyl caproate, gamma undelactone, gamma nonalactone, levisticum tincture, essential oils of lemon, orange, bergamot, coriander , neroli, chamomile, cinnamon, nutmeg).

Excipients with known effect: sucrose, sorbitol (E420), ethanol.

1 ml of solution contains 30 mg of alcohol, 200 mg of sucrose and 150 mg of sorbitol (E420).

Alcoholic title: 4% (v / v).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Solupred Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.

from Drug Online https://bit.ly/3df80qo via Edrug Online from Faculty of Medicine https://bit.ly/37HqfDU via Internal Medicine

#medicines #including Allergy Medicines #Anemia #Antibiotic Medicines #Colds & Flu Medicines #Cough Me

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milanrej01-blog · 4 years

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Junkies in the gym Stronger, further, higher. To achieve the Olympic dream more and more people resort to shortcuts despite the serious consequences that they can have for health

01/19/2017 - VALENCIA.- Its consumption spreads almost as fast as its effects on the body. Those who turn to them see the world through a distorted perspective, that of their own physique. An increasingly grim reality that ends up making them slaves of aesthetics .

They profess blind faith in anabolics, the substance on which they deposit everything in hopes of one day achieving the perfect body. acyclovir In the Valencian Community it has been calculated that there are more than 8,000 steroid consumers. An even more worrying figure when compared to the rest of Spain and, more in detail, if the focus is on the age of these consumers.

According to a study by the extinct FEPAD foundation, 3.3% of young people between 14 and 18 years old have already experimented with these substances. Illegal commercialization is established throughout the region. In the last five years, in Valencia, there have been three interventions and seventy-eight arrests, according to data from the National Police. Likewise, the intercepted doses of doping substances during this same period were greater than 20,000 units. A phenomenon that is in line with the figures presented in the annual report prepared each year by the Provincial Prosecutor's Office. As the report says, of the total of more than 800 crimes against public health, almost a hundred are related to this problem.

Illegal commercialization is established throughout the region. In the last five years, in Valencia, there have been three interventions and seventy-eight arrests, according to data from the National Police. Likewise, the intercepted doses of doping substances during this same period were greater than 20,000 units. A phenomenon that is in line with the figures presented in the annual report prepared each year by the Provincial Prosecutor's Office. As the report says, of the total of more than 800 crimes against public health, almost a hundred are related to this problem.

The 'camel' in the pharmacy The Pascual y Genís pharmacy is separated by just over a kilometer from the Escolano Pharmacy. Both have been seized in the past for improperly dispensing anabolics. Like these, in the Valencian Community many establishments have been intervened for the marketing of substances dangerous to the health of athletes. So many that, today, they are a suffocated route in which their access is very restricted.

Long ago, this situation was very different. For years they were the nerve center of this market. Its operations were carried out under an apparent legality that both doctors and pharmacists took advantage of. As of today, "there are doctors who receive daily calls in their private clinics asking for anabolic prescriptions, exposing themselves to sanctions that can lead to professional disqualification," says Juan José Tirado, autonomous secretary of the Nursing Council of the Valencian Community (Cecova).

From this organism - as from others like the College of Pharmaceuticals - only "prevention and awareness treatments" can be carried out. Insufficient action and symptom of the lack of reaction of the public administration. Originally, distribution in pharmacies was closely related to doping. Police actions such as the Puerto , Maza or Dacota operations have had their epicenter in the province of Valencia, while others maintained connection points with other provinces. The intensification of control services, such as the Valencian pharmacovigilance committee, and changes in legislation have displaced the point of sale of these substances until relegating it to secrecy. At the same time, the consumption of steroids began to gain weight in recreational sports and, thus, the black market became the main point of sale. Now, this place of entry and exit emulates drug trafficking in many ways.

The first of these is your turnover. In the United States - the main country in the use of anabolics and where their consumption is normalized - it is estimated that the smuggling of these addictives generates around 60,000 million dollars a year. In Spain, although there are no definitive figures, the Valencia Drug Prosecutor's Office has come to equate this market with that of cocaine. And the fact is that the sale of anabolics does not escape the logic of the market, which has seen prices increase each year and seasonality in its sales has intensified, with peaks in demand in the months leading up to the summer.But the true profitability of this business is in the judicial aspect.

Despite the fact that doping substances figure in most drug addiction prevention plans, the truth is that it is not pursued with the same intensity in the Penal Code. Both prison terms and fines are much higher in drug trafficking. An aspect of which those involved are aware and that has caused the relocation of this blackmarket to this new space. ALMOST ONE IN EIGHT CRIMES AGAINST PUBLIC HEALTH INVOLVES ANABOLICS, BUT THE PENALTIES ARE LIGHTER THAN FOR OTHER DRUGS.

The main gateway to this world is that of gyms. Most of the potential clients are in these sports centers. They are many, but they move in small circles of trust. They share comments and experiences, but only during their training session, as outside the locker room this topic is completely taboo.

For this reason, the route of the forums, in which anonymity is guaranteed, is much more successful. Information is disseminated online and facilities are provided for buying and selling. They do it in full view of any user, without any kind of barrier. Paradoxically, this activity escapes the law if a single rule is respected: not to mention prices

Profiting from the sale is the only motive susceptible to crime, so none of the members of the community ever publicly pronounce in this regard. Here nobody knows what they are sold or who does it, but the obsession surpasses any type of reasoning. Precisely, the origin of these products is one of the most striking aspects. At best these steroids come from China, while they may not even be real. Over time, the sale of counterfeit or underdosed anabolics is becoming more frequent.

Fernando - as he wanted us to name him in this report - knows this world very closely. "Right now 90% of the products available online are not original," he says in relation to this aspect. He has competed in the main fitness championships in Spain and currently owns a supplement brand. He points out that some of the irregularities occur precisely in the bodybuilding competitions themselves. "In Spain there are championships where there is no type of regulation, while in others they make you go through all kinds of controls," he says, referring to the American organizations, which, unlike national organizations, do not check the percentage of testosterone in the blood.

Young and without studies If we looked at Fernando we would see how he complies with some of the statistics that draw the consumer model. The numbers point to young men, with little training, who live in single-parent homes and have an unstable working life. Víctor Agulló , who has compiled some of these figures, is the author of a thesis that addresses the use of steroids in amateur athletes. The professor at the University of Valencia tries to avoid stereotypes. "Every time it is more frequent that consumption occurs in different sectors of the population, regardless of the social group to which they belong" although he affirms that "if there is something that unites them, it is that they prioritize physical well-being over any other option". Among the other generalized behaviors, Agulló highlights "care such as waxing or tanning treatments." Most young people take this shot in "cycles." This rite is a period of time that has accurately marked the hours and amounts of each intake. They are carried out in a pyramidal and progressive way, with increasing doses as time passes. Similarly, a rest period is needed between each cycle. It can be done subcutaneously - the most common - although it is also done orally. Although it sounds contradictory, "polyconsumption is a trend that many of these young people adopt," says Agulló. In their particular anabolic diet they do not hesitate to introduce other narcotic drugs such as alcohol or tobacco and, of course, "an addition of food supplements such as protein, creatine or l-carnitine", he concludes.

The strength gained from consuming steroids is unmatched by the side effects. «Its consumption causes muscle enhancement, increased strength, speed and endurance. It also increases heart rate and reduces fatigue and recovery time » , they assure from the Spanish Agency for Protection against Health in Sport (Aepsad). But this entity also knows the fine print. The side effects of consuming these types of substances without a prescription can be "heart hypertrophy, deficit in oxygen consumption, arrhythmias, cardiac arrest or cardiovascular accidents," they add. A toll that many are willing to pass.

The most obvious sequelae are erectile dysfunction and the reduction of the size of the testicles, as well as the disappearance of sexual appetite and even possible sterility. Something that consumers should already know because a correlation between the consumption of Viagra and that of steroids is beginning to be observed to counteract any adverse effect. Among the other toxic consequences are changes in the nervous system —depression or aggressive attacks as the most common— and, in the worst case, liver failure or liver cancer.

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greatestlcve · 4 years

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Zaldiar Tablets Uses, Dosage, Side Effects, Precautions & Warnings

Drug Online

zaldiar tablets english

Generic drug of the therapeutic class: Analgesics active principles: Tramadol , Paracetamol laboratory: Grunenthal

Is Zaldiar the same as tramadol? and Important to know

ZALDIAR is a combination of 2 analgesics, tramadol and paracetamol, which work together to relieve your pain.

ZALDIAR is indicated for the treatment of moderate to severe pain when your doctor thinks that a combination of tramadol and paracetamol is needed.

ZALDIAR is reserved for adults and adolescents from 12 years old.

What is Zaldiar tablets 37 5mg/325mg used for and indication?

Symptomatic treatment of moderate to severe pain. The use of Zaldiar should be limited to patients with moderate to severe pain requiring treatment with a combination of paracetamol and tramadol ( see Pharmacodynamics ).

zaldiar tablets dosage

RESERVED FOR ADULTS and ADOLESCENT (from 12 years old)

Use of ZALDIAR should be limited to patients with moderate to severe pain requiring treatment with paracetamol and tramadol.

The dose should be individually adjusted according to the intensity of the pain and the individual sensitivity of the patient.

The recommended starting dose is 2 tablets of ZALDIAR. Additional doses may be administered as needed, without exceeding 8 tablets per day (300 mg tramadol and 2600 mg paracetamol).

The catches must be spaced at least 6 hours apart.

ZALDIAR should under no circumstances be administered longer than is strictly necessary (see Warnings and Precautions ). If the nature or severity of the disease requires repeated treatment or prolonged treatment, careful and regular monitoring should be carried out (with treatment breaks if possible) to check whether continuation of treatment is necessary.

zaldiar tablets dosage

children:

The safety and efficacy of ZALDIAR have not been established in children under 12 years of age. Treatment is not recommended in this population.

Elderly

The usual dosage may be used although a 17% increase in the elimination half-life of tramadol has been observed in healthy subjects over 75 years of age after oral administration.

In patients over 75 years of age, a minimum interval of 6 hours between dosages is recommended because of the presence of tramadol.

Renal failure:

Due to the presence of tramadol, the use of ZALDIAR is not recommended in cases of severe renal impairment (creatinine clearance <10 ml / min).

In patients with moderate renal impairment (creatinine clearance between 10 and 30 ml / min), the interval between doses should be 12 hours. Since tramadol is eliminated very slowly by hemodialysis or haemofiltration, post-dialysis is not usually necessary to maintain analgesia.

Hepatic insufficiency:

ZALDIAR should not be used in patients with severe hepatic impairment . In patients with moderate hepatic impairment, an increase in the interval between doses should be carefully considered (see Warnings and Precautions ).

Administration mode:

Oral way.

The tablets should be swallowed as is, with a sufficient amount of liquid. They should not be split or chewed.

How it works Zaldiar Tablets :

Pharmacotherapeutic group: Tramadol in combination , ATC code: N02AX52

ANALGESIC

Tramadol is an opioid analgesic of central action. Tramadol is a nonselective agonist for the μ, δ and κ morphine receptors, with a higher affinity for μ receptors. In addition, the other mechanisms contributing to the analgesic effects of the product are inhibition of neuronal norepinephrine reuptake and increased serotonin release. Tramadol has an antitussive effect. Unlike morphine, a wide range of analgesic doses of tramadol have no respiratory depressant effect. Gastrointestinal motility is not changed either.

The effects on the cardiovascular system are generally weak.

The power of tramadol would be 1/10 to 1/6 of that of morphine.

The exact mechanism of action of the analgesic properties of paracetamol remains to be established; it could involve central and peripheral actions.

ZALDIAR is a level II analgesic in the WHO scale and should be considered as such by the prescriber.

zaldiar tablets side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

zaldiar tablets side effects

Very common: may affect more than 1 in 10 patients;

but first Does Zaldiar make you sleepy?

· Nausea,

· Feeling dizzy, drowsy.

Frequent: may affect up to 1 in 10 patients

· Vomiting, difficult digestion (constipation, bloating, diarrhea), abdominal pain, dry mouth,

· Itching, sweating (hyperhidrosis),

· Headaches, tremors,

· Confusional state, sleep disturbances, mood changes (anxiety, nervousness, euphoria).

Uncommon: may affect up to 1 in 100 patients

· Increased blood pressure, heart rhythm disorders,

· Tingling, numbness, tingling sensation in the limbs, tinnitus, involuntary muscle contractions,

· Depression, nightmares, hallucinations (perception of things that do not exist in reality), amnesia,

· Breathing difficulty.

· Difficulty swallowing, blood in the stool,

· Skin reactions (rashes, urticaria for example),

· Increase in liver enzymes.

· Albumin in urine, difficulty or pain when you urinate,

· Chills, hot flashes, chest pains

Rare: may concern up toto 1 patient in 1000;

· Convulsions, difficulty coordinating movements, transient loss of consciousness (syncope)

· Drug dependence,

· Delirium,

· Blurred vision, narrowing of the pupil (myosis),

· Speech disorders,

· Excessive dilation of the pupil (mydriasis).

Frequency unknown: Frequency can not be estimated from the available data :

· Decreased blood sugar level (hypoglycemia)

The following side effects have been reported in people taking medicines containing only hydrochloride detramadol or paracetamol. Contact your doctor if you experience any of these effects while taking ZALDIAR:

· Feeling weak when you get up after lying down or sitting down, heart rate decrease, appetite change, muscle weakness, slowed or weakened breathing, mood changes, activity changes, changes in mood perception, aggravation of existing asthma.

· Using ZALDIAR with a treatment that thins the blood (eg coumarin derivatives, warfarin) may increase the risk of bleeding. You should immediately report to your doctor any prolonged or unexpected bleeding.

· In rare cases, a rash, a sign of an allergic reaction, may develop with sudden swelling of the face and neck, difficulty breathing or decreased blood pressure and fainting. If you are concerned, stop your treatment and consult your doctor immediately. You must not continue taking this treatment.

In rare cases, taking a drug containing tramadol hydrochloride can cause dependence and make it difficult to stop treatment.

Some people have also had panic attacks, hallucinations, unusual sensations such as itching, tingling or numbness, and a ringing of ears. If you experience this type of symptoms after stopping, contact your doctor.

Exceptionally, blood tests may have revealed abnormalities, such as an abnormally low platelet count, which can cause bleeding from the nose or gums.

Very rare cases of serious skin reactions have been reported with paracetamol.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of side effects

By reporting side effects, you can help provide more information on the safety of the medicine.

Zaldiar Tablets Interactions :

Associations contraindicated

Non-selective MAOIs

Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.

MAOI selective A

By extrapolation from non-selective MAOIs

Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.

Selective MAOI B

Manifestations of central excitement evoking serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion, even coma.

In case of recent treatment by the MAOIs, observe a delay of 2 weeks before starting treatment with tramadol.

Associations advised against

Alcohol

Alcohol enhancement of the sedative effect of opioid analgesics.

Altered alertness can make driving dangerous and the use of machinery dangerous.

Avoid taking alcoholic drinks and drugs containing alcohol.

Carbamazepine and other enzyme inducers

Risk of decreased efficacy and duration of action due to decreased plasma concentrations of tramadol.

Morphine agonist-antagonists (buprenorphine, nalbuphine, pentazocine).

Decrease of the analgesic effect by competitive blocking of the receptors, with the risk of appearance of a withdrawal syndrome.

Associations to consider

Isolated cases of serotonin syndrome with a chronological link to therapeutic doses of tramadol have been reported in association with other serotoninergic drugs such as selective serotonin reuptake inhibitors (SSRIs) and triptans. Signs of serotonin syndrome may include:

Confusion, agitation, fever, sweat, ataxia, hyperreflexia, myoclonus and diarrhea.

Other morphine derivatives (including antitussives and substitution treatments), benzodiazepines, barbiturates.

Increased risk of respiratory depression, which can be fatal in case of overdose.

Other central nervous system depressants, such as other morphine derivatives (including antitussive drugs and substitution treatments), barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, central antihypertensives, thalidomide, baclofen.

These medications may increase the central depression. Altered alertness can make driving dangerous and the use of machinery dangerous.

Depending on the clinical needs, an evaluation of the prothrombin level should be carried out periodically in case of co-administration of ZALDIAR with warfarin-type derivatives, with lengthening of the INR reported.

Other drugs known to inhibit CYP3A4,

Such as ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and probably also the metabolism of the O-demethylated active metabolite. The clinical significance of this interaction has not been studied.

Drugs that lower the epileptogenic threshold, such as bupropion, antidepressants, serotonin reuptake inhibitors, tricyclic antidepressants and neuroleptics.

Concomitant use of tramadol with these drugs may increase the risk of seizures. The rate of absorption of paracetamol can be increased by metoclopramide or domperidone and the absorption rate decreased by cholestyramine.

In a limited number of studies, pre- or post-operative use of the anti-emetic 5HT3 receptor antagonist (ondansetron) necessitated an increase in tramadol doses in patients treated for postoperative pain.

Zaldiar Warnings and Precautions :

Special warnings :

For adults and adolescents from 12 years. The maximum dose of 8 tablets of ZALDIAR should not be exceeded. To avoid the risk of accidental overdose, patients should be advised not to exceed the recommended dose and not to use other medicines containing paracetamol (including over-the-counter medications) or tramadol without the doctor’s advice.

ZALDIAR is not recommended in patients with severe renal impairment (creatinine clearance <10 ml / min).

ZALDIAR should not be administered in patients with severe hepatic impairment . The risks associated with paracetamol overdose are higher in patients with non-cirrhotic alcoholic liver injury. In patients with moderate hepatic impairment, careful consideration should be given to lengthening the dosing interval.

ZALDIAR is not recommended in cases of severe respiratory failure.

Tramadol is not suitable for substitution treatment in patients with opioid dependence. Indeed, although opioid antagonist, tramadol hydrochloride can not correct the withdrawal symptoms of opioids .

Seizures have been reported mainly in predisposed patients treated with tramadol and / or treated with drugs that may lower the seizure threshold, particularly selective serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, central analgesics or local anesthetics. Treatment-experienced epileptic patients or patients who may experience seizures should be treated with ZALDIAR only when absolutely necessary. Seizures have been reported in patients receiving tramadol hydrochloride at the recommended doses. The risk may be increased when doses of tramadol hydrochloride exceed the maximum recommended dose.

Concomitant administration of agonist-antagonist morphines (nalbuphine, buprenorphine, pentazocine) is not recommended .

Precautions for use:

Habituation and physical and / or mental dependence can develop, even at therapeutic doses. The clinical need for analgesic treatment should be reassessed on a regular basis. In patients with opioid dependence and in patients with a history of abuse or dependence, treatment should be short-term and under strict medical supervision.

ZALDIAR should be used with caution in opioid-dependent patients, in patients with head trauma, in patients prone to seizures, in patients with bile duct dysfunction, in a state of shock, with an alteration of the original consciousness. unknown, central or peripheral disorders of the respiratory function or an increase in intracranial pressure.

Overdosage with paracetamol may cause liver toxicity in some patients.

Withdrawal symptoms similar to those seen during opioid withdrawal may occur even at therapeutic doses and for short-term treatment. Withdrawal symptoms can be avoided by gradually decreasing the doses at the end of treatment, especially after long periods of administration. Rare cases of dependence and abuse have been reported .

In one study, the use of tramadol during a general anesthesia with enflurane and nitrous oxide promoted intraoperative memory. In the meantime, new data is needed to prevent tramadol use during shallow anesthesia.

ZALDIAR contains lactose. Patients should not take this medicine for hereditary history such as galactosemia, lactase deficiency or glucose-galactose malabsorption.

Drive and use machines:

Tramadol may cause drowsiness or dizziness, which may be exacerbated by alcohol or other central nervous system depressants. In the event of these symptoms, the patient must not drive or use machines.

Zaldiar and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy :

Since Zaldiar is a fixed combination of tramadol-based active ingredients, this medicine should not be used during pregnancy.

Data on paracetamol:

The results of the epidemiological studies have not revealed the deleterious effect of paracetamol used at the recommended doses.

Tramadol data:

Tramadol should not be used during pregnancy as there are no data of sufficient relevance to evaluate the safety of tramadol in pregnant women.

Administered before or during delivery, tramadol does not affect uterine contractility. In neonates, it can induce changes in respiratory rate usually not clinically significant. Prolonged use during pregnancy may result in withdrawal syndrome in the newborn.

Breastfeeding:

Since Zaldiar is a fixed combination of active ingredients containing tramadol, this medicine should not be administered during breastfeeding.

Data on paracetamol:

Paracetamol is excreted in breast milk in non-clinically significant amounts. To date, published data do not contraindicate breastfeeding in women using drugs containing only paracetamol.

Tramadol data:

Tramadol and its metabolites are found in low amounts in breast milk. During breastfeeding, approximately 0.1% of the dose administered to the mother could be ingested by the newborn. Tramadol should not be administered during breastfeeding.

What should I do if I miss a dose?

If you forget to take the tablets, the pain may reappear. Do not double the dose you forgot to take. Continue your treatment as before.

What happens if I overdose from Zaldiar ?

See your doctor or pharmacist immediately, even if you feel well. There may be a risk of liver injury whose symptoms will appear later.

What is Forms and Composition Zaldiar?

FORMS and PRESENTATIONS

37.5 mg / 325 mg film-coated tablet (light yellow): Box of 20, in blister packs.

Hospital model: Box of 60.

COMPOSITION

p cpTramadol (DCI) hydrochloride37.5 mgParacetamol (INN)325 mg

Excipients: Core: pulverized cellulose, pregelatinized starch, sodium carboxymethyl starch (type A), corn starch, magnesium stearate. Film coating :hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), propylene glycol, talc.

Lactose content: 1.784 mg / cp (as monohydrate: 1.878 mg / cp).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.