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Luai Al Bakour
El Temamy Pharmacy
Akoni Hijyen Teknolojileri Sanayi ve Dış Ticaret LTD. ŞTİ
Britton Chance Center for Biomedical Photonics
Arabian Trade Center - ATC
Medical Facility (32206):
Legality International. (Pvt.) Ltd.
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Carbidopa and Levodopa extended release tablets are indicated in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Nonselective MAO inhibitors are contraindicated for use with Carbidopa and Levodopa extended release tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Carbidopa and Levodopa extended release tablets. Carbidopa and Levodopa extended release tablets may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl). Carbidopa and Levodopa extended release tablets are contraindicated in patients with known hypersensitivity to any component of this drug and in patients with narrow-angle glaucoma. Because levodopa may activate a malignant melanoma, Carbidopa and Levodopa extended release tablets should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.
In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on Carbidopa and Levodopa tablets were randomized to therapy with either Carbidopa and Levodopa tablets or Carbidopa and Levodopa extended release tablets. The adverse experience frequency profile of Carbidopa and Levodopa extended release tablets did not differ substantially from that of Carbidopa and Levodopa tablets Abnormal laboratory findings occurring at a frequency of 1% or greater in approximately 443 patients who received Carbidopa and Levodopa extended release tablets and 475 who received Carbidopa and Levodopa tablets during controlled clinical trials included: decreased hemoglobin and hematocrit; elevated serum glucose; white blood cells, bacteria and blood in the urine. The adverse experiences observed in patients in uncontrolled studies were similar to those seen in controlled clinical studies. Other adverse experiences reported overall in clinical trials in 748 patients treated with Carbidopa and Levodopa extended release tablets, listed by body system in order of decreasing frequency, include: Body as a Whole: Asthenia, fatigue, abdominal pain, orthostatic effects. Cardiovascular: Palpitation, hypertension, hypotension, myocardial infarction. Gastrointestinal: Gastrointestinal pain, dysphagia, heartburn. Metabolic: Weight loss. Musculoskeletal: Leg pain. Nervous System/Psychiatric: Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment. Respiratory: Cough, pharyngeal pain, common cold. Skin: Rash. Special Senses: Blurred vision. Urogenital: Urinary incontinence. Laboratory Tests: Decreased white blood cell count and serum potassium; increased BUN, serum creatinine and serum LDH; protein and glucose in the urine. The following adverse experiences have been reported in post-marketing experience with Carbidopa and Levodopa extended release tablets. Cardiovascular: Cardiac irregularities, syncope. Gastrointestinal: Taste alterations, dark saliva. Hypersensitivity: Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions). Nervous System/Psychiatric: Neuroleptic malignant syndrome, increased tremor, peripheral neuropathy, psychotic episodes including delusions and paranoid ideation, increased libido. Skin: Alopecia, flushing, dark sweat. Urogenital: Dark urine. Other adverse reactions that have been reported with levodopa alone and with various Carbidopa and Levodopa formulations and may occur with Carbidopa and Levodopa extended release tablets are: Cardiovascular: Phlebitis. Gastrointestinal: Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue. Hematologic: Hemolytic and nonhemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis. Hypersensitivity: Henoch-Schonlein purpura. Metabolic: Weight gain, edema. Nervous System/Psychiatric: Ataxia, depression with suicidal tendencies, dementia, euphoria, convulsions (however, a causal relationship has not been established); bradykinetic episodes, numbness, muscle twitching, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, activation of latent Horner’s syndrome, nightmares. Skin: Malignant melanoma, increased sweating. Special Senses: Oculogyric crises, mydriasis, diplopia. Urogenital: Urinary retention, priapism. Miscellaneous: Faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns. Laboratory Tests: Abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), bilirubin, Coombs test, uric acid.
Caution should be exercised when the following drugs are administered concomitantly with Carbidopa and Levodopa extended release tablets. Symptomatic postural hypotension has occurred when Carbidopa and Levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with Carbidopa and Levodopa extended release tablets is started, dosage adjustment of the antihypertensive drug may be required. For patients receiving monoamine oxidase (MAO) inhibitors (Type A or B). Concomitant therapy with selegiline and Carbidopa and Levodopa may be associated with severe orthostatic hypotension not attributable to Carbidopa and Levodopa alone There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and Carbidopa and Levodopa preparations. Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Carbidopa and Levodopa extended release tablets should be carefully observed for loss of therapeutic response. Iron salts may reduce the bioavailability of levodopa and carbidopa. The clinical relevance is unclear. Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
When patients are receiving levodopa without a decarboxylase inhibitor, levodopa must be discontinued at least twelve hours before Carbidopa and Levodopa extended release tablets are started. In order to reduce adverse reactions, it is necessary to individualize therapy. Carbidopa and Levodopa extended release tablets should be substituted at a dosage that will provide approximately 25 percent of the previous levodopa Carbidopa does not decrease adverse reactions due to central effects of levodopa. By permitting more levodopa to reach the brain, particularly when nausea and vomiting is not a dose-limiting factor, certain adverse CNS effects, e.g., dyskinesias, will occur at lower dosages and sooner during therapy with Carbidopa and Levodopa extended release tablets than with levodopa alone. Patients receiving Carbidopa and Levodopa extended release tablets may develop increased dyskinesias compared to Carbidopa and Levodopa tablets. Dyskinesias are a common side effect of Carbidopa and Levodopa treatment. The occurrence of dyskinesias may require dosage reduction. As with levodopa, Carbidopa and Levodopa extended release tablets may cause mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Carbidopa and Levodopa extended release tablets should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease. As with levodopa, care should be exercised in administering Carbidopa and Levodopa extended release tablets to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care. As with levodopa, treatment with Carbidopa and Levodopa extended release tablets may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer. General As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular, and renal function are recommended during extended therapy. Patients with chronic wide-angle glaucoma may be treated cautiously with Carbidopa and Levodopa extended release tablets provided the intraocular pressure is well controlled and the patient is monitored carefully for changes in intraocular pressure during therapy. Information for Patients The patient should be informed that Carbidopa and Levodopa extended release tablet is an extended release formulation of Carbidopa and Levodopa which releases these ingredients over a 4- to 6-hour period. It is important that Carbidopa and Levodopa extended release tablets be taken at regular intervals according to the schedule outlined by the physician. The patient should be cautioned not to change the prescribed dosage regimen and not to add any additional antiparkinson medications, including other carbidopa and levodopa preparations, without first consulting the physician. If abnormal involuntary movements appear or get worse during treatment with Carbidopa and Levodopa extended release tablets, the physician should be notified, as dosage adjustment may be necessary. Patients should be advised that sometimes the onset of effect of the first morning dose of Carbidopa and Levodopa extended release tablets may be delayed for up to 1 hour compared with the response usually obtained from the first morning dose of Carbidopa and Levodopa tablets. The physician should be notified if such delayed responses pose a problem in treatment. Patients should be advised that, occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of Carbidopa and Levodopa extended release tablets. Although the color appears to be clinically insignificant, garments may become discolored. The patient should be informed that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as in multi-vitamin tablets) may also reduce the amount of levodopa available to the body. The above factors may reduce the clinical effectiveness of the levodopa or Carbidopa and Levodopa therapy. Patients must be advised that the whole or half tablet should be swallowed without chewing or crushing. NOTE: The suggested advice to patients being treated with Carbidopa and Levodopa extended release tablets is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
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Samir Moussa M.D.
Dr. Faisal Dibsi
Dr. Hani Najjar
Dr . Dirar Abboud
Dr. Talal Sabouni
Dr. Samer Al-Jneidy
Dr. Tahsin Martini
Yaser Habrawi , F.R.C.S.Ed