Rohto Hydra

Rohto Hydra Manufacturers

• Rohto Pharmaceutical Co Ltd
  

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  Rohto Hydra | Rohto Pharmaceutical Co. Ltd.

  

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  put 1 or 2 drops in the affected eye(s) as needed

  tightly snap on cap to seal

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• Rohto-mentholatum (Vietnam) Co. Ltd.
  

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  Rohto Hydra | Rohto-mentholatum (vietnam) Co. Ltd.

  

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  • put 1 or 2 drops in the affected eye(s) as needed

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• The Mentholatum Company
  

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  Rohto Hydra | Dava Pharmaceuticals Inc

  

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children

  > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses

  every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, uncomplicated

  ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  55 mL

  100 mL

  68 mL

  150 mL

  102 mL

  Oral Suspension 200 mg/5 mL

  50 mL

  34 mL

  75 mL

  51 mL

  100 mL

  68 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  55 mL

  100 mL

  68 mL

  150 mL

  102 mL

  Oral Suspension 400 mg/5 mL

  50 mL

  34 mL

  75 mL

  51 mL

  100 mL

  68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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