Bedwetting
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Questions & Answers
Side Effects & Adverse Reactions
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. See DOSAGE AND ADMINISTRATION section before initiating therapy.
Carbidopa and levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage (see DOSAGE AND ADMINISTRATION).
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 central nervous system (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-levodopa treatment. The occurrence of dyskinesias may require dosage reduction.
All patients should be observed carefully for the development of depression with concomitant suicidal tendencies.
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.
Falling Asleep During Activities of Daily Living and Somnolence
Patients taking carbidopa and levodopa extended-release tablets alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living (includes operation of motor vehicles). Road traffic accidents attributed to sudden sleep onset have been reported. Although many patients reported somnolence while on dopaminergic medications, there have been reports of road traffic accidents attributed to sudden onset of sleep in which the patient did not perceive any warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Sudden onset of sleep has been reported to occur as long as one year after the initiation of treatment.
Falling asleep while engaged in activities of daily living usually occurs in patients experiencing pre- existing somnolence, although some patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness especially since some of the events occur well after the start of treatment. Prescribers should be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Patients should be advised to exercise caution while driving or operating machines during treatment with carbidopa and levodopa extended-release tablets. Patients who have already experienced somnolence or an episode of sudden sleep onset should not participate in these activities during treatment with carbidopa and levodopa extended-release tablets.
Before initiating treatment with carbidopa and levodopa extended-release tablets, advise patients about the potential to develop drowsiness and ask specifically about factors that may increase the risk for somnolence with carbidopa and levodopa extended-release tablets such as the use of concomitant sedating medications and the presence of sleep disorders. Consider discontinuing carbidopa and levodopa extended-release tablets in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If treatment with carbidopa and levodopa extended-release tablets continues, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
Hyperpyrexia and Confusion
Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported in association with dose reductions or withdrawal of certain antiparkinsonian agents such as levodopa, carbidopa levodopa and carbidopa levodopa extended-release tablets. Therefore, patients should be observed carefully when the dosage of levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin have been reported.
The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.
The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
History
There is currently no drug history available for this drug.
Other Information
Carbidopa and levodopa extended-release tablets are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.
Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-a-hydrazino-a-methyl-b-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4•H2O and its structural formula is:
Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.
Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-a-amino-b-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4 and its structural formula is:
Carbidopa and levodopa extended-release tablets are supplied as tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate and red ferric oxide. Carbidopa and levodopa extended-release tablets 50/200 mg also contains yellow ferric oxide.
The 50/200 mg tablet is supplied as a buff to light brown, round, scored tablet. The 25/100 mg tablet is supplied as a reddish-brown, round, unscored tablet. The carbidopa and levodopa extended-release tablet is a polymeric based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25/100 mg are available to facilitate titration and as an alternative to the half-tablet of carbidopa and levodopa extended-release tablets 50/200 mg.
Sources
Bedwetting Manufacturers
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Liddell Laboratories, Inc.
![Bedwetting (Belladonna, Cantharis, Causticum, Cina, Equisetum Hyemale, Ingatia Amara, Physalis Alkekengi, Sepia, Uranium Nitricum, Verbascum Thapsus,) Liquid [Liddell Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bedwetting | Apotex Corp.
Carbidopa and levodopa extended-release tablets contain carbidopa and levodopa in a 1:4 ratio as either the 50/200 mg tablet or the 25/100 mg tablet. The daily dosage of carbidopa and levodopa extended-release tablets must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea. Carbidopa and levodopa extended-release tablets should not be chewed or crushed.
Standard drugs for Parkinson’s disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa extended-release tablets are being administered, although their dosage may have to be adjusted.
Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, carbidopa and levodopa extended-release tablets can be given to patients receiving supplemental pyridoxine (vitamin B6).
Initial Dosage Patients currently treated with conventional carbidopa-levodopa preparationsStudies show that peripheral dopa-decarboxylase is saturated by the bioavailable carbidopa at doses of 70 mg a day and greater. Because the bioavailabilities of carbidopa and levodopa in carbidopa and levodopa tablets and carbidopa and levodopa extended-release tablets are different, appropriate adjustments should be made, as shown in Table 2.
Table 2. Approximate Bioavailabilities at Steady State† Tablet Amount of
Levodopa (mg)
in Each Tablet Approximate
Bioavailability Approximate Amount
of Bioavailable
Levodopa (mg) in
Each Tablet † This table is only a guide to bioavailabilities since other factors such as food, drugs, and inter-patient variabilities may affect the bioavailability of carbidopa and levodopa. †† The extent of availability of levodopa from carbidopa and levodopa extended-release tablets was about 70-75% relative to intravenous levodopa or standard carbidopa and levodopa tablets in the elderly. †††The extent of availability of levodopa from carbidopa and levodopa tablets was 99% relative to intravenous levodopa in the healthy elderly. Carbidopa and Levodopa Extended-Release Tablets
50-200
200
0.70-0.75††
140-150 Carbidopa and Levodopa Tablets
25-100
100
0.99†††
99Dosage with carbidopa and levodopa extended-release tablets should be substituted at an amount that provides approximately 10% more levodopa per day, although this may need to be increased to a dosage that provides up to 30% more levodopa per day depending on clinical response (see DOSAGE AND ADMINISTRATION, Titration with Carbidopa and Levodopa Extended-Release Tablets). The interval between doses of carbidopa and levodopa extended-release tablets should be 4 to 8 hours during the waking day (see CLINICAL PHARMACOLOGY, Pharmacodynamics).
A guideline for initiation of carbidopa and levodopa extended-release tablets is shown in Table 3.
Table 3. Guidelines for Initial Conversion from Carbidopa and Levodopa and Levodopa Tablets to Carbidopa and Levodopa Extended-Release Tablets *For dosing ranges not shown in the table see DOSAGE AND ADMINISTRATION, Initial Dosage — Patients Currently treated with conventional Carbidopa-Levodopa Preparations. Carbidopa and Levodopa Tablets
Total Daily Dose*
Levodopa (mg) Carbidopa and Levodopa Extended-Release Tablets
Suggested
Dosage Regimen 300-400 200 mg b.i.d. 500-600 300 mg b.i.d. or 200 mg t.i.d. 700-800 A total of 800 mg in 3 or more divided doses (e.g., 300 mg a.m., 300 mg early p.m., and 200 mg later p.m.) 900-1000 A total of 1000 mg in 3 or more divided doses (e.g., 400 mg a.m., 400 mg early p.m., and 200 mg later p.m.) Patients currently treated with levodopa without a decarboxylase inhibitorLevodopa must be discontinued at least twelve hours before therapy with carbidopa and levodopa extended-release tablets is started. Carbidopa and levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually 1 tablet of carbidopa and levodopa extended-release tablets 50/200 mg b.i.d.
Patients not receiving levodopaIn patients with mild to moderate disease, the initial recommended dose is 1 tablet of carbidopa and levodopa extended-release tablets 50/200 mg b.i.d. Initial dosage should not be given at intervals of less than 6 hours.
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Newton Laboratories, Inc.
Bedwetting | Newton Laboratories, Inc.
Directions: ORAL USE ONLY - SHAKE WELL. Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
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Newton Laboratories, Inc.
Bedwetting | Newton Laboratories, Inc.
Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
![Bedwetting (Belladonna, Cantharis, Causticum, Equisetum Hyemale, Ferrum Metallicum, Gelsemium, Humulus, Kali Phos., Lycopodium, Nat.mur., Plantago, Pulsatilla, Rhus Aromatica, Sabal, Thyroidinum, Verbascum, Echinacea, Hydrastis, Passiflora, Valeriana) Liquid [Newton Laboratories, Inc.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
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