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Orchidpharma Inc Drugs

Cefprozil

Cefprozil

Cefprozil is administered orally.
Population/Infection Dosage (mg) Duration(days) ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10a Acute Sinusitis(For moderate to severe infections, the higher dose should be used)
250 q12h or

500 q12h
10 LOWER RESPIRATORY TRACT Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or500 q24h or500 q12h 10 CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACTb Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10a SKIN AND SKIN STRUCTUREb Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES) 15 mg/kg q12h 10 Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10
aIn the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.bNot to exceed recommended adult doses.

Renal Impairment: Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min) Dosage(mg) Dosing Interval 30 to 120 standard standard 0 to 20* 50% of standard standard
*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.

Hepatic Impairment: No dosage adjustment is necessary for patients with impaired hepatic function.
Mucus Relief Severe Con...

Mucus Relief Severe Congestion And Cough Maximum Strength

(see INDICATIONS AND USAGE for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals.
Pediatric Patients (Age 6 Months Through 12 Years) Type of Infection Dosage Duration Acute Bacterial Otitis Media 7 mg/kg q12h or 14 mg/kg q24h 5 to 10 days10 days Acute Maxillary Sinusitis 7 mg/kg q12h or14 mg/kg q24h 10 days10 days Pharyngitis/Tonsillitis 7 mg/kg q12h or14 mg/kg q24h 5 to 10 days10 days Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART * Pediatric patients who weigh ≥43 kg should receive the maximum daily dose of 600 mg. Weight 125 mg/5 mL 250 mg/5 mL 9 kg/20 lbs 2.5 mL q12h or 5 mL q24h Use 125 mg/5 mL product 18 kg/40 lbs 5 mL q12h or 10 mL q24h 2.5 mL q12h or 5 mL q24h 27 kg/60 lbs 7.5 mL q12h or 15 mL q24h 3.75 mL q12h or 7.5 mL q24h 36 kg/80 lbs 10 mL q12h or 20 mL q24h 5 mL q12h or 10 mL q24h ≥43 kg*/95 lbs 12 mL q12h or 24 mL q24h 6 mL q12h or 12 mL q24h
Patients With Renal Insufficiency

For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:                                CLcr = (weight) (140 – age)

                                                       (72) (serum creatinine)

Females:                            CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.

The following formula may be used to estimate creatinine clearance in pediatric patients:

                                    CLcr = K x body length or height

                                                  serum creatinine

where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.

In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54.
Patients on Hemodialysis

Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.
Directions for Mixing Cefdinir for Oral Suspension Final Concentration Final Volume(mL) Amount of Water Directions 125 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. 100 63 mL 250 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. 100 63 mL
After mixing, the suspension can be stored at room temperature (25°C/77°F). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.
Multi-symptom Cold Reli...

Multi-symptom Cold Relief

2.1 Recommended Dosing Schedule

Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once Daily*** Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily**
* For adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered.

** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

*** Controlled studies did not extend beyond 12 months

2.2 Administration Instructions

Directions for method of administration for each dosage form are presented in Table 2.

Formulation
Route Instructions* Delayed-Release Tablets Oral Swallowed whole, with or without food
* Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.

Pantoprazole Sodium Delayed-Release Tablets Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
Cephalexin

Cephalexin

Cephalexin capsules are administered orally.

Adults

The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients

The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Cephalexin

Cephalexin

Cephalexin for Oral Suspension, USP is administered orally.

Adults :

The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin for Oral Suspension, USP greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients :

The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin Suspension Weight 125 mg/5 mL 10 kg (22 lb) 1/2 to 1 tsp q.i.d. 20 kg (44 lb) 1 to 2 tsp q.i.d. 40 kg (88 lb) 2 to 4 tsp q.i.d. Weight 250 mg/5 mL 10 kg (22 lb) 1/4 to 1/2 tsp q.i.d. 20 kg (44 lb) 1/2 to 1 tsp q.i.d. 40 kg (88 lb) 1 to 2 tsp q.i.d. or Weight 125 mg/5 mL 10 kg (22 lb) 1 to 2 tsp b.i.d. 20 kg (44 lb) 2 to 4 tsp b.i.d. 40 kg (88 lb) 4 to 8 tsp b.i.d. Weight 250 mg/5 mL 10 kg (22 lb) 1/2 to 1 tsp b.i.d. 20 kg (44 lb) 1 to 2 tsp b.i.d. 40 kg (88 lb) 2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin for Oral Suspension, USP should be administered for at least 10 days.
Direction for Mixing: Cephalexin for Oral Suspension, USP Bottle Size Directions for Reconstitution 125 mg/5 mL 100 mL Add 68 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition. 200 mL Add 136 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition. 250 mg/5 mL 100 mL Add 68 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition. 200 mL Add 136 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
Naratriptan

Naratriptan

2.1 Dosing Information

The recommended dose of naratriptan tablets is 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24 hour period.

The safety of treating an average of more than 4 migraine attacks in a 30 day period has not been established.

2.2 Dosage Adjustment in Patients With Renal Impairment

Naratriptan tablets are contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24‑hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.3 Dosage Adjustment in Patients With Hepatic Impairment

Naratriptan tablets are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24 hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
Modafinil

Modafinil

2.1 Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA)

The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.

Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].

2.2 Dosage in Shift Work Disorder (SWD)

The recommended dosage of modafinil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

2.3 Dosage Modifications in Patients with Severe Hepatic Impairment

In patients with severe hepatic impairment, the dosage of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.4 Use in Geriatric Patients

Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
Cefdinir

Cefdinir

(see INDICATIONS AND USAGE for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir Capsules should be administered twice daily in these infections. Cefdinir Capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration Community-Acquired Pneumonia 300 mg q12h 10 days Acute Exacerbations of Chronic Bronchitis 300 mg q12h or600 mg q24h 5 to 10 days10 days Acute Maxillary Sinusitis 300 mg q12h or600 mg q24h 10 days10 days Pharyngitis/Tonsillitis 300 mg q12h or600 mg q24h 5 to 10 days10 days Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days
Patients With Renal Insufficiency

For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:                    CLcr = (weight) (140 – age)

                                          (72) (serum creatinine)

Females:                CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.

The following formula may be used to estimate creatinine clearance in pediatric patients:

                            CLcr = K x body length or height

                                          serum creatinine

where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.

In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54.
Patients on Hemodialysis

Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.
Cephalexin

Cephalexin

Cephalexin for Oral Suspension is administered orally.

Adults :

The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin for Oral Suspension greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients:

The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin Suspension Weight 125 mg/5 mL 10 kg (22 lb) 1/2 to 1 tsp q.i.d. 20 kg (44 lb) 1 to 2 tsp q.i.d. 40 kg (88 lb) 2 to 4 tsp q.i.d. Weight 250 mg/5 mL 10 kg (22 lb) 1/4 to 1/2 tsp q.i.d. 20 kg (44 lb) 1/2 to 1 tsp q.i.d. 40 kg (88 lb) 1 to 2 tsp q.i.d. or Weight 125 mg/5 mL 10 kg (22 lb) 1 to 2 tsp b.i.d. 20 kg (44 lb) 2 to 4 tsp b.i.d. 40 kg (88 lb) 4 to 8 tsp b.i.d. Weight 250 mg/5 mL 10 kg (22 lb) 1/2 to 1 tsp b.i.d. 20 kg (44 lb) 1 to 2 tsp b.i.d. 40 kg (88 lb) 2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin for Oral Suspension should be administered for at least 10 days.
Direction for Mixing: Cephalexin for Oral Suspension Bottle Size Directions for Reconstitution 125 mg/5 mL
100 mL

Add 68 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.

200 mL

Add 136 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
250 mg/5 mL 100 mL Add 68 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition. 200 mL Add 136 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
Eszopiclone

Eszopiclone

Use the lowest effective dose for the patient.

2.1 Dosage in Adults

The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].

2.2 Geriatric or Debilitated Patients

The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.

2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors

In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].

2.4 Use with CNS Depressants

Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

2.5 Administration with Food

Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

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