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SecreFlo

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SecreFlo

Indications
Dosage
How Supplied

INDICATIONS

SecreFlo™ (secretin) is indicated for use in secretin stimulation testing for:

  1. Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
  2. Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma.
  3. Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).

DOSAGE AND ADMINISTRATION

Dissolve the contents of the vial of SecreFlo™ (secretin) in 8 mL of Sodium Chloride Injection USP, to yield a concentration of 2 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution. Discard any unused portion after reconstitution. The reconstituted drug product should be inspected visually prior to administration. If particulate matter or discoloration is seen, the product should be discarded.

Dosage: SECRETIN STIMULATION TESTING:

  1. TO STIMULATE PANCREATIC SECRETIONS, INCLUDING BICARBONATE, TO AID IN THE DIAGNOSIS OF EXOCRINE PANCREAS DYSFUNCTION: 0.2 mcg/kg body weight by intravenous injection over 1 minute.
  2. STIMULATION OF GASTRIN SECRETION TO AID IN THE DIAGNOSIS OF GASTRINOMA: 0.4 mcg/kg body weight by intravenous injection over 1 minute.
  3. FACILITATION OF THE IDENTIFICATION OF THE AMPULLA OF VATER AND ACCESSORY PAPILLA DURING ERCP to aid in the cannulation of the pancreatic ducts: 0.2 mcg/kg body weight by intravenous injection over 1 minute.

Administration: SECRETIN STIMULATION TESTING:

  1. TO STIMULATE PANCREATIC SECRETIONS, INCLUDING BICARBONATE, TO AID IN THE DIAGNOSIS OF EXOCRINE PANCREAS DYSFUNCTION: A radiopaque, double-lumen tube is passed through the mouth following a 12-15 hour fast. Under fluoroscopic control, the opening of the proximal lumen of the tube is placed in the gastric antrum and the opening of the distal lumen just beyond the papilla of Vater. The positioning of the tube must be confirmed and the tube secured prior to secretin testing. Intermittent negative pressure of 25-40 mmHg is applied to both lumens and maintained throughout the test. When duodenal contents have a pH of ≥ 6.0, a baseline sample of duodenal fluids is collected for a 10 minute period. A test dose of SecreFlo™ (secretin) 0.2 mcg (0.1 mL) is injected intravenously to test of possible allergies. After one minute, if there are no untoward reactions, SecreFlo™ (secretin) at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. Duodenal fluid is collected for 60 minutes thereafter. The aspirate is divided into four collection periods of fifteen minutes each. The duodenal lumen of the tube is cleared with an injection of air after collection of each sample. Wide variation in volume of the aspirate is indicative of incomplete aspiration. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample is < 80 mEq/L.
  2. STIMULATON OF GASTRIN TO AID IN THE DIAGNOSIS OF GASTRINOMA: The patient should have fasted for at least 12 hours prior to beginning the test. Before injecting SecreFlo™ (secretin) , two blood samples are drawn for determination of fasting serum gastrin levels (baseline values). Subsequently, a test dose of SecreFlo™ (secretin) 0.2 mcg (0.1 mL) is injected intravenously, to test for possible allergies. If no untoward reactions, 0.4 mcg/kg of SecreFlo™ (secretin) is administered intravenously over 1 minute; post-injection blood samples are collected after 1, 2, 5, 10, and 30 minutes for determination of serum gastrin concentrations. Gastrinoma is strongly suspected in patients who show an increase in serum gastrin concentration of more than 110 pg per mL over basal levels on any of the post injection samples.
  3. FACILITATION OF THE IDENTIFICATION OF THE AMPULLA OF VATER AND ACCESSORY PAPILLA DURING ERCP: When difficulty is encountered by the endoscopist in identifying the ampulla of Vater or in identifying the accessory papilla in patients with pancreas divisum, administration of secretin at a does of 0.2 mcg/kg of body weight intravenously over 1 minute will result in visible excretion of pancreatic fluids from the orifices of these papillae enabling their identification and facilitating cannulation.

HOW SUPPLIED

SecreFlo™ (secretin) is supplied as a lyophilized sterile powder in vials containing 16 mcg secretin.

Storage

The unreconstituted product should be stored at -20C (freezer).

Manufactured for: ChiRhoClin, Inc. Silver Spring, MD 20905. Manufactured by: Chesapeake Biological Laboratories, Baltimore, MD 21230. November 2002. FDA Rev date: 4/4/2002

Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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