Gkhair Anti-dandruff
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Side Effects & Adverse Reactions
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Uses
Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.
History
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Other Information
Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist. It is supplied as the hydrochloride salt of ropinirole 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has molecular formula of C16H24N2O•HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water.
Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).
Sources
Gkhair Anti-dandruff Manufacturers
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Van Tibolli Beauty Corp.
![Gkhair Anti-dandruff (Pyrithione Zinc) Shampoo [Van Tibolli Beauty Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gkhair Anti-dandruff | Sandoz Inc
2.1 General Dosing Recommendations • Ropinirole extended-release tablets are taken once daily, with or without food [see CLINICAL PHARMACOLOGY (12.3) ]. • Tablets must be swallowed whole and must not be chewed, crushed, or divided. • If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s DiseaseThe starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, based on therapeutic response and tolerability. The maximum recommended dose of ropinirole extended-release tablets is 24 mg/day.
In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual patient therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Monitor patients during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [seeCLINICAL STUDIES (14.2)]. Due to the flexible dosing design used in clinical trials, specific dose response information could not be determined.
Ropinirole extended-release tablets should be discontinued gradually over a 7–day period.
Renal Impairment
No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole extended-release tablets for patients with end-stage renal disease on hemodialysis is 2 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole extended-release tablets in patients with severe renal impairment without regular dialysis has not been studied.
2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release TabletsPatients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole hydrochloride, as shown in Table 1.
Table 1. Conversion from Immediate-Release Ropinirole to Ropinirole Extended-Release TabletsImmediate-Release Ropinirole Tablets Total Daily Dose (mg)
Ropinirole Extended-Release Tablets
Total Daily Dose (mg)
0.75 to 2.25
2
3 to 4.5
4
6
6
7.5 to 9
8
12
12
15
16
18
18
21
20
24
24
Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [seeDOSAGE AND ADMINISTRATION (2.2)].
2.4 Effect of Gastrointestinal Transit Time on Medication ReleaseRopinirole extended-release tablets are designed to release medication over a 24-hour period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication and medication residue being passed in the stool.
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