Drug Catalog - Product Detail
CARBIDOPA W/LEVODOPA ORAL DISINTEGRATING TABLETS TB 25/250MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-5053-01 | MYLAN | 100 | 25-250MG | TABLET |
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Description
DESCRIPTION Carbidopa and levodopa orally disintegrating tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa and levodopa orally disintegrating tablets are an orally administered formulation of carbidopa and levodopa which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.2. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and levodopa orally disintegrating tablets, USP are supplied as tablets in three strengths: Carbidopa and Levodopa Orally Disintegrating Tablets 10 mg /100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and Levodopa Orally Disintegrating Tablets 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and Levodopa Orally Disintegrating Tablets 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint flavor, silica, sodium stearyl fumarate and sorbitol. In addition, the 25 mg/100 mg tablets contain FD&C Blue No. 1 Aluminum Lake and the 10 mg/100 mg and 25 mg/250 mg tablets contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Carbidopa Structural Formula Levodopa Structural Formula
How Supplied
HOW SUPPLIED Carbidopa and Levodopa Orally Disintegrating Tablets, USP are available containing 10 mg or 25 mg of carbidopa, USP, with 100 mg or 250 mg of levodopa, USP providing the following available combinations: 10 mg/100 mg, 25 mg/100 mg or 25 mg/250 mg. The 10 mg/100 mg orally disintegrating tablets are green, round, scored and debossed with M above the score and C51 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5051-01 bottles of 100 tablets The 25 mg/100 mg orally disintegrating tablets are blue, round, scored and debossed with M above the score and C52 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5052-01 bottles of 100 tablets The 25 mg/250 mg orally disintegrating tablets are green, round, scored and debossed with M above the score and C53 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5053-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Revised: 9/2016 CLODT:R3
Indications & Usage
INDICATIONS AND USAGE Carbidopa and levodopa orally disintegrating 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. Carbidopa and levodopa orally disintegrating tablets are indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B 6 ). In some patients, a somewhat smoother antiparkinsonian effect results from therapy with carbidopa and levodopa than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from carbidopa and levodopa therapy. Although the administration of carbidopa permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa. Certain patients who responded poorly to levodopa have improved when carbidopa and levodopa was substituted. This is most likely due to decreased peripheral decarboxylation of levodopa which results from administration of carbidopa rather than to a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in parkinsonian syndromes. In considering whether to give carbidopa and levodopa orally disintegrating tablets to patients already on levodopa who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa, about half of the patients with nausea and/or vomiting on levodopa improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.
Dosage and Administration
DOSAGE AND ADMINISTRATION Instructions for Use/Handling Carbidopa and Levodopa Orally Disintegrating Tablets Just prior to administration, GENTLY remove the tablet from the bottle with dry hands. IMMEDIATELY place the carbidopa and levodopa orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary. The optimum daily dosage of carbidopa and levodopa orally disintegrating tablets must be determined by careful titration in each patient. Carbidopa and levodopa orally disintegrating tablets are available in a 1:4 ratio of carbidopa to levodopa (carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg) as well as 1:10 ratio (carbidopa and levodopa orally disintegrating tablets 25 mg/250 mg and carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage. Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 mg to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. Usual Initial Dosage Dosage is best initiated with one carbidopa and levodopa orally disintegrating tablet 25 mg/100 mg 3 times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg a day is reached. If carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg are used, dosage may be initiated with one tablet 3 or 4 times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (two tablets q.i.d.) is reached. How to Transfer Patients from Levodopa Levodopa must be discontinued at least twelve hours before starting carbidopa and levodopa orally disintegrating tablets. A daily dosage of carbidopa and levodopa orally disintegrating tablets should be chosen that will provide approximately 25% of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on one carbidopa and levodopa orally disintegrating tablet 25 mg/100 mg 3 or 4 times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one carbidopa and levodopa orally disintegrating tablet 25 mg/250 mg 3 or 4 times a day. Maintenance Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 mg to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one carbidopa and levodopa orally disintegrating tablet 25 mg/100 mg may be substituted for each carbidopa and levodopa orally disintegrating tablet 10 mg/100 mg. When more levodopa is required, carbidopa and levodopa orally disintegrating 25 mg/250 mg tablets should be substituted for carbidopa and levodopa orally disintegrating 25 mg/100 mg tablets or carbidopa and levodopa orally disintegrating 10 mg/100 mg tablets. If necessary, the dosage of carbidopa and levodopa orally disintegrating tablet 25 mg/250 mg tablets may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited. Because both therapeutic and adverse responses occur more rapidly with carbidopa and levodopa orally disintegrating tablets than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with carbidopa and levodopa orally disintegrating tablets than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients. Addition of Other Antiparkinsonian Medications Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa orally disintegrating tablets are being administered, although dosage adjustments may be required. Interruption of Therapy Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of carbidopa and levodopa. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa orally disintegrating tablets is required, especially if the patient is receiving neuroleptics (See WARNINGS ). If general anesthesia is required, carbidopa and levodopa orally disintegrating tablets may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.