Indicus Pharma Llc

Indicus Pharma Llc Drugs

• Minocycline Hydrochlori...
  

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  Minocycline Hydrochloride

  

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  THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

  Minocycline hydrochloride tablets should be taken at least one hour before meals or 2 hours after meals (see CLINICAL PHARMACOLOGY).

  For Pediatric Patients Above 8 Years of Age

  Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours.

  Adults

  The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg tablet four times daily.

  Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of four days, with post-therapy cultures within 2 to 3 days.

  In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended.

  For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.

  In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for five days.

  Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.

  Uncomplicated urethra, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least seven days.

  Ingestion of adequate amounts of fluids along with tablet form of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.

  In patients with renal impairment (see WARNINGS), the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time interval between doses.

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• Donepezil Hydrochloride...
  

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  Donepezil Hydrochloride

  

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  Donepezil hydrochloride tablet should be taken in the evening, just prior to retiring.

  Donepezil hydrochloride tablet can be taken with or without food.

  2.1 Mild to Moderate Alzheimer’s Disease

  The dosages of donepezil hydrochloride tablets shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day.

  The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride tablets might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference.

  2.2 Severe Alzheimer’s Disease

  Donepezil hydrochloride tablets have been shown to be effective in controlled clinical trials at a dose of 10 mg administered once daily.

  2.3. Titration

  The recommended starting dose of donepezil hydrochloride tablets is 5 mg once daily. Evidence from the controlled trials in mild to moderate Alzheimer’s disease indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events compared to the 5 mg dose. In open-label trials using a 6 week titration, the type and frequency of these same adverse events were similar between the 5 mg and 10 mg dose groups. Therefore, because donepezil hydrochloride tablets steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

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• Letrozole
  

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  Letrozole

  

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  2.1 Recommended Dose

  The recommended dose of letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals.

  2.2 Use in Adjuvant Treatment of Early Breast Cancer

  In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies (14.1)].

  2.3 Use in Extended Adjuvant Treatment of Early Breast Cancer

  In the extended adjuvant setting, the optimal treatment duration with letrozole tablets are not known. The planned duration of treatment in the study was 5 years. In the final updated analysis at a median follow-up of 62 months, the median treatment duration was 60 months. Seventy-one percent of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies (14.2)].

  2.4 Use in First and Second-Line Treatment of Advanced Breast Cancer

  In patients with advanced disease, treatment with letrozole tablets should continue until tumor progression is evident. [see Clinical Studies (14.4, 14.5)]

  2.5 Use in Hepatic Impairment

  No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole tablets blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3)]. The recommended dose of letrozole tablets for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole tablets exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.

  2.6 Use in Renal Impairment

  No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥10 mL/min. [see Clinical Pharmacology (12.3)].

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