Allied Pharma Inc

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Gabapentin is given orally with or without food. Patients should be informed that, should they break the scored 600 mg or 800 tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.

If gabapentin dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

Postherpetic Neuralgia In adults with postherpetic neuralgia, Gabapentin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated. Epilepsy Gabapentin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.Patients >12 years of age The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours. Pediatric PatientsAge 3 to 12 years:  The starting dose should range from 10 to15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatric.) Gabapentin tablets may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.Dosage in Renal Impairment Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:

                for females CCr=(0.85)(140-age)(weight)/[(72)(SCr)]

                for males CCr=(140-age)(weight)/[(72)(SCr)]

in which age is in years, weight is in kilograms, and SCr is serum creatinine in mg/dL.

Dosage adjustment in patients ≥12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).

TABLE 6 Gabapentin Tablets Dosage Based on Renal Function

Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen(mg) ≥60 900–3600 300 TID 400 TID 600 TID 800 TID 1200 TID >30–59 400–1400 200 BID 300 BID 400 BID 500 BID 700 BID >15–29 200–700 200 QD 300 QD 400 QD 500 QD 700 QD 15a 100–300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg)b Hemodialysis   125b 150 b 200b 250b 350b

a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).

b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table

The use of gabapentin in patients <12 years of age with compromised renal function has not been studied.

Dosage in Elderly Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

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Clarithromycin tablets, USP may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR <30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR  of 30 to 60 mL/min, respectively.

ADULT DOSAGE GUIDELINES Infection Clarithromycin tablets   Dosage (q12h) Duration (days) Pharyngitis/Tonsillitis due to     S. pyogenes 250 mg 10 Acute maxillary sinusitis due to 500 mg 14 H. influenzae     M. catarrhalis     S. pneumoniae     Acute exacerbation of chronic bronchitis due to     H. influenzae 500 mg 7-14 H. parainfluenzae 500 mg 7 M. catarrhalis 250 mg 7-14 S. pneumoniae 250 mg 7-14 Community-Acquired Pneumonia due to     H. influenzae 250 mg 7 H. parainfluenzae - - M. catarrhalis - - S. pneumoniae 250 mg 7-14 C. pneumoniae 250 mg 7-14 M. pneumoniae 250 mg 7-14 Uncomplicated skin and skin structure 250 mg 7-14 S. aureus     S. pyogenes    

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple therapy: clarithromycin/lansoprazole/amoxicillin The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) Triple therapy: clarithromycin/omeprazole/amoxicillin The recommended adult dose is 500 mg clarithromycin tablets, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.Dual therapy: clarithromycin /omeprazole The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.Dual therapy: clarithromycin /ranitidine bismuth citrate The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) Children The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.PEDIATRIC DOSAGE GUIDELINES

Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose     Kg lbs (q12h) 125 mg/5 mL 250 mg/5 mL 9 17 25 33 20 37 55 73 62.5 mg 125 mg 187.5 mg 250 mg 2.5 mL q12h 5 mL q12h 7.5 mL q12h 10 mL q12h 1.25 mL q12h 2.5 mL q12h 3.75 mL q12h 5 mL q12h

Mycobacterial Infections Prophylaxis: The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.Treatment: Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.