Ticlid is a product of Roche Pharmaceuticals.

The founder of Roche, Fritz Hoffmann-La Roche, was a pioneering entrepreneur who was convinced that the future belonged to branded pharmaceutical products. He was among the first to recognize that the industrial manufacture of standardized medicines would be a major advance in the fight against disease.

This led him to found F. Hoffmann-La Roche & Co. on October 1st 1896. From the very beginning, Fritz Hoffmann attached great importance to product information as the link between the pharmaceutical manufacturer and doctors, pharmacists and patients. Shortly after the foundation of the company, affiliates were opened in Germany, Italy, France, the US, Great Britain and Russia.

Since then, Roche has grown into one of the world's leading healthcare companies and one of the most important in Europe. 

2.TICLID FACTS

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, one of the world's leading research-oriented health care groups with core businesses in pharmaceuticals and diagnostics. The company provides innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. 

3.ABOUT TICLID MEDICATION

What are platelets?

Platelets are active agents of inflammation when damage occurs to a blood vessel. They are not actually cells, but fragments released by megakaryocyte cells. A megakaryocyte is a large cell in the bone marrow whose function is to produce Platelets. When vascular damage (i.e, damage to blood vessels) occurs, the Platelets stick to the vascular walls, forming clots to prevent the loss of blood. Thus, it is important to have adequate numbers of normally functioning Platelets to maintain effective coagulation (clotting) of the blood. There are drugs that can potentially alter the platelet count, making it necessary to monitor the count.

What is Platelet aggregation?

Platelet aggregation refers to Platelets arriving to and sticking to the site of injury in a vessel. However, in terms of heart health, Platelets aggregate at the site of plaque formations along blood vessel walls. This leads to the development of localized blood clots, which further block the flow of blood in the artery.

What are antiplatelets?

Antiplatelet drugs are a group of powerful medications that prevent the formation of Blood clots.

Antiplatelet drugs protect against myocardial infarction, stroke, cardiovascular death and other serious vascular events in patients with a history of previous vascular events or known risk factors for cardiovascular disease.

Plavix is the most common Antiplatelet drug. Other Antiplatelet drugs commonly used to treat heart disease include Aspirin and Ticlid.

Antiplatelets are used to treat:

• Coronary artery disease (Coronary artery disease is atherosclerosis of the coronary arteries. Atherosclerosis is when the arteries become clogged and narrowed, restricting blood flow to the heart. Without adequate blood, the heart becomes starved of oxygen and vital nutrients it needs to work properly).
• heart attack (If taken while an attack is in progress or within 30 minutes of symptoms, Antiplatelets may reduce heart damage.)
• Angina (chest pain)
• stroke and mini-strokes
• Peripheral artery disease

Antiplatelets are also used:

• After angioplasty
• After heart bypass surgery
• To prevent the formation of Blood clots in people with atrial fibrillation  

How does Ticlid work?

Ticlid works by preventing a natural substance called ADP from binding to its receptors on Platelets. ADP is one of the chemicals in the body that cause Platelets to clump together and start the process of blood clotting. As Ticlid stops ADP from binding to Platelets, it reduces the likelihood of clots forming in the blood.

A blood clot that forms inside the blood vessels is known as a thrombosis and can be dangerous, as it can cause a blockage that cuts off the blood supply to an organ. A blockage in the arteries supplying blood to the heart or brain can cause a heart attack or stroke. A blockage in the blood vessels in the extremities, eg legs, may result in gangrene.

Blood clots and blockages mainly result from a build up of atherosclerosis on the inside of blood vessels. Atherosclerosis is a build up of cholesterol and fat cells that narrows the blood vessels and makes their interiors rough and bumpy. This makes it more difficult for blood to flow through the vessels, and increases the likelihood of clots forming in the vessels.

People who have already suffered a heart attack or stroke are at risk of having another because of the atherosclerosis in their arteries. People with unstable angina are also at risk of a heart attack because of the atherosclerosis in their arteries. Similarly, people who have narrowed arteries in their extremities, eg legs, (peripheral arterial disease) are also at risk of Blood clots. These events are known as atherothrombotic events.

Ticlid is used to prevent blood clots forming within blood vessels, and therefore reduce the risk of further atherothrombotic events in these groups of people.

4.TICLID EFFECTIVENESS
(When is Ticlid best taken?)

After oral administration of a single 250-mg dose of Ticlid, it is rapidly absorbed with peak plasma levels occurring at approximately 2 hours after Ticlid dosing and is extensively metabolized. Absorption is greater than 80%. Administration after meals results in a 20% increase in the AUC of Ticlid.

Ticlid displays nonlinear pharmacokinetics and clearance decreases markedly on repeated dosing. In older volunteers the apparent half-life of Ticlid after a single 250-mg dose of Ticlid is about 12.6 hours; with repeat dosing at 250 mg bid, the terminal elimination half-life rises to 4 to 5 days and steady-state levels of Ticlid in plasma are obtained after approximately 14 to 21 days.

Ticlid binds reversibly (98%) to plasma proteins, mainly to serum albumin and lipoproteins. The binding to albumin and lipoproteins is nonsaturable over a wide concentration range. Ticlid also binds to alpha-1 acid glycoprotein. At concentrations attained with the recommended dose, only 15% or less ticlopidine in plasma is bound to this protein.

Ticlid is metabolized extensively by the liver; only trace amounts of intact drug are detected in the urine. Following an oral dose of radioactive ticlopidine hydrochloride administered in solution, 60% of the radioactivity is recovered in the urine and 23% in the feces. Approximately 1/3 of the dose excreted in the feces is intact Ticlid, possibly excreted in the bile. Ticlid is a minor component in plasma (5%) after a single dose, but at steady-state is the major component (15%). Approximately 40% to 50% of the radioactive metabolites circulating in plasma are covalently bound to plasma proteins, probably by acylation.

Clearance of Ticlid decreases with age. Steady-state trough values in elderly patients (mean age 70 years) are about twice those in younger volunteer populations.

5.TICLID EFFECTS ON SPECIAL POPULATION
(How do different people react to Ticlid?)

Pregnancy

Teratology studies have been conducted in mice (doses of Ticlid up to 200 mg/kg/day), rats (doses of Ticlid up to 400 mg/kg/day) and rabbits (doses of Ticlid up to 200 mg/kg/day). Doses of Ticlid of 400 mg/kg in rats, 200 mg/kg/day in mice and 100 mg/kg in rabbits produced maternal toxicity, as well as fetal toxicity, but there was no evidence of a teratogenic potential of Ticlid. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Studies in rats have shown Ticlid is excreted in the milk. It is not known whether Ticlid is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Ticlid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clearance of Ticlid is somewhat lower in elderly patients and trough levels are increased. The major clinical trials with Ticlid in stroke patients were conducted in an elderly population with an average age of 64 years. Of the total number of patients in the therapeutic trials, 45% of patients were over 65 years old and 12% were over 75 years old. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

6.TICLID EFFECTS ON MEDICAL CONDITIONS
(How does Ticlid affect your existing condition/ailment?)

Hepatically Impaired Patients

The effect of decreased hepatic function on the pharmacokinetics of Ticlid was studied in 17 patients with advanced cirrhosis. The average plasma concentration of Ticlid in these subjects was slightly higher than that seen in older subjects in a separate trial.

Renally Impaired Patients

Patients with mildly or moderately impaired renal function were compared to normal subjects in a study of the pharmacokinetic and platelet pharmacodynamic effects of Ticlid (250 mg bid) for 11 days. Concentrations of unchanged Ticlid were measured after a single 250-mg dose and after the final 250-mg dose on Day 11.

AUC values of ticlopidine increased by 28% and 60% in mild and moderately impaired patients, respectively, and plasma clearance decreased by 37% and 52%, respectively, but there were no statistically significant differences in ADP-induced platelet aggregation. In this small study (26 patients), bleeding times showed significant prolongation only in the moderately impaired patients.

7.OTHER/ALTERNATE USES OF TICLID
(What else does Ticlid treat?)

Ticlid is used to reduce risk of atherothrombotic events (eg further heart attacks) in people who have had a heart attack or an Ischemic stroke and in people with unstable angina.

A stroke occurs when a clot forms in a blood vessel in the brain (thrombus) or forms in another part of the body and breaks off, then travels to the brain (an embolus). In both cases the blood supply to part of the brain is blocked and that part of the brain is damaged. Ticlid works by making the blood less likely to clot, thus, less likely to have a stroke.

8.ADVERSE/SIDE EFFECTS of TICLID
(What are the side effects of Ticlid?)

Adverse reactions in stroke patients were relatively frequent with over 50% of patients reporting at least one. Most (30% to 40%) involved the gastrointestinal tract. Most adverse effects are mild, but 21% of patients discontinued therapy because of an adverse event, principally diarrhea, rash, nausea, vomiting, GI pain and neutropenia. Most adverse effects occur early in the course of treatment, but a new onset of adverse effects can occur after several months.

The incidence rates of adverse events listed in the following table were derived from multicenter, controlled clinical trials in stroke patients described above comparing Ticlid, placebo and aspirin over study periods of up to 5.8 years. Adverse events considered by the investigator to be probably drug-related that occurred in at least 1% of patients treated with Ticlid are shown in the following table:

PERCENT OF PATIENTS WITH ADVERSE EVENTS IN CONTROLLED CLINICAL STUDIES

Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.

Hematological: Neutropenia/thrombocytopenia, TTP, aplastic anemia, leukemia, agranulocytosis, eosinophilia, pancytopenia, thrombocytosis and bone-marrow depression have been reported.

Gastrointestinal: Ticlid therapy has been associated with a variety of gastrointestinal complaints including diarrhea and nausea. The majority of cases are mild, but about 13% of patients discontinued therapy because of these. They usually occur within 3 months of initiation of therapy and typically are resolved within 1 to 2 weeks without discontinuation of therapy. If the effect is severe or persistent, therapy should be discontinued. In some cases of severe or bloody diarrhea, colitis was later diagnosed.

Hemorrhagic: Ticlid has been associated with increased bleeding, spontaneous posttraumatic bleeding and perioperative bleeding including, but not limited to, gastrointestinal bleeding. It has also been associated with a number of bleeding complications such as ecchymosis, epistaxis, hematuria and conjunctival hemorrhage.

Intracerebral bleeding was rare in clinical trials in stroke patients with Ticlid, with an incidence no greater than that seen with comparator agents (ticlopidine 0.5%, aspirin 0.6%, placebo 0.75%). It has also been reported postmarketing.

Rash: Ticlid has been associated with a maculopapular or urticarial rash (often with pruritus). Rash usually occurs within 3 months of initiation of therapy with a mean onset time of 11 days. If drug is discontinued, recovery occurs within several days. Many rashes do not recur on drug rechallenge. There have been rare reports of severe rashes, including Stevens-Johnson syndrome, erythema multiforme and exfoliative dermatitis.

Less Frequent Adverse Reactions (Probably Related): Clinical adverse experiences occurring in 0.5% to 1.0% of stroke patients in controlled trials include:

Digestive System: GI fullness

Skin and Appendages : urticaria

Nervous System : headache

Body as a Whole : asthenia, pain

Hemostatic System : epistaxis

Special Senses : tinnitus

In addition, rarer, relatively serious and potentially fatal events associated with the use of Ticlid have also been reported from postmarketing experience: Hemolytic anemia with reticulocytosis, immune thrombocytopenia, hepatitis, hepatocellular jaundice, cholestatic jaundice, hepatic necrosis, hepatic failure, peptic ulcer, renal failure, nephrotic syndrome, hyponatremia, vasculitis, sepsis, allergic reactions (including angioedema, allergic pneumonitis, and anaphylaxis), systemic lupus (positive ANA), peripheral neuropathy, serum sickness, arthropathy and myositis.

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