Uro-blue

Uro-blue Manufacturers

• Method Pharmaceuticals, Llc
  

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  Uro-blue | Physicians Total Care, Inc.

  

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  2.1 Dosage

  ZENPEP is not interchangeable with other pancrelipase products.

  ZENPEP is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of ZENPEP should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see Limitations on Dosing below).

  Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1, 2, 3 ZENPEP should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs, with one exception. The Conferences recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months. ZENPEP is available in a 3,000 lipase unit capsule. The recommended dose of ZENPEP in infants up to 12 months is 3,000 lipase units. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

  Infants (up to 12 months)
  Infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or breast-feeding. Do not mix ZENPEP capsule contents directly into formula or breast milk prior to administration [see Dosage and Administration (2.2)].

  Children Older than 12 Months and Younger than 4 Years
  Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

  Children 4 Years and Older and Adults
  Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

  Usually, half of the prescribed ZENPEP dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.

  Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

  Limitations on Dosing
  Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1, 2, 3

  If symptoms and signs of steatorrhea persist, the dosage may be increased by a healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted.

  Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6000 lipase units/kg of body weight per meal have been associated with colonic strictures, indicative of fibrosing colonopathy, in children with cystic fibrosis less than 12 years of age [see Warnings and Precautions (5.1)]. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

  2.2 Administration

  ZENPEP should always be taken as prescribed by a healthcare professional.

  Infants (up to 12 months)
  ZENPEP should be administered to infants immediately prior to each feeding, using a dosage of 3,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Contents of the capsule may be administered with a small amount of applesauce, or other acidic food with a pH of 4.5 or less (e.g., commercially available preparations of bananas, or pears). Contents of the capsule may also be administered directly to the mouth. Administration should be followed by breast milk or formula. Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that ZENPEP is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.

  Children and Adults
  ZENPEP should be taken during meals or snacks, with sufficient fluid. ZENPEP capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.

  For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents sprinkled on small amounts of acidic soft food of pH 4.5 or less (e.g., commercially available preparations of bananas, pears and applesauce).

  The ZENPEP -soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth.

  17.1 Dosing and Administration Instruct patients and caregivers that ZENPEP should only be taken as directed by their healthcare professional. Patients should be advised that the total daily dose should not exceed 10,000 lipase units/kg body weight per day unless clinically indicated. This needs to be especially emphasized for patients eating multiple snacks and meals per day. Patients should be informed that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Doses should not be doubled.[see Dosage and Administration (2)]. Instruct patients and caregivers that ZENPEP should always be taken with food. Patients should be advised that ZENPEP delayed-release capsules must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. If necessary, the capsules contents can also be sprinkled on soft acidic foods. [see Dosage and Administration (2)]. Instruct patients to notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with ZENPEP. [see Use in Specific Populations (8.1).] Instruct patients and caregivers to notify the healthcare professional if the patient has a history of abnormal glucose levels before initiating treatment with ZENPEP. [see Postmarketing Experience (6.2)].

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