Oxytocin
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Questions & Answers
Side Effects & Adverse Reactions
Oxytocin, when given for induction or stimulation of labor, must be administered only by intravenous infusion (drip method) and with adequate medical supervision in a hospital.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
IMPORTANT NOTICE
Oxytocin is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits-to-risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.
Oxytocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve early vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.
Oxytocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
History
There is currently no drug history available for this drug.
Other Information
Each mL of Oxytocin Injection sterile solution contains an oxytocic activity equivalent to 10 USP Posterior Pituitary Units, Chlorobutanol (a chloroform derivative), 0.5%, as a preservative, and acetic acid to adjust pH (3.0 to 5.0). Oxytocin is intended for IM or IV use. Oxytocin is a synthetic polypeptide; it occurs as a white powder and is soluble in water. It may be designated chemically as:
Oxytocin
Sources
Oxytocin Manufacturers
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Baxter Healthcare Corporation
![Oxytocin Injection [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Oxytocin | Baxter Healthcare Corporation
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage of oxytocin is determined by the uterine response. The following dosage information is based upon various regimens and indications in general use.
A. Induction or Stimulation of LaborIntravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of nonoxytocin-containing solution should be started. Physiologic electrolyte solution should be used except under unusual circumstances. To prepare the usual solution for infusion, 1-mL Oxytocin Injection, 10 USP Units/mL is combined aseptically with 1,000 mL of nonhydrating diluent (physiologic electrolyte solution). The combined solution, rotated in the infusion bottle to ensure thorough mixing, containing 10 mU/mL. Add the container with dilute oxytocic solution to the system through use of a constant infusion pump or other such device, to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 mU/min. the dose may be gradually increased in increments of no more than 1 to 2 mU/min. until a contraction pattern has been established which is similar to normal labor. The fetal heart rate, resting uterine tone, and the frequency, duration, and the force of contractions should be monitored. The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and the fetus must be evaluated by the responsible physician. B. Control of Postpartum Uterine Bleeding Intravenous Infusion (Drip Method):To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent (physiologic electrolyte solution) and run a rate necessary to control uterine atony.
Intramuscular Administration:1 mL (10 units) of oxytocin can be given after the delivery of the placenta.
C. Treatment of Incomplete or Inevitable AbortionIntravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops per minutes.
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Vettek
Oxytocin | Vettek
Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:
EWES, SOWS:
1.5 to 2.5 mL..30 to 50 USP Units
COWS, HORSES:
5.0 mL...........100 USP Units
These dosages are recommended, and may be repeated as indicated.
Milk Let-down:
Inject aseptically by the intravenous, intramuscular or subcutaneous route.
COWS:
0.5 to 1.0 mL.....10 to 20 USP Units
SOWS:
0.25 to 1.0 mL....5 to 20 USP Units
These dosages are recommended and may be repeated as necessary.
Note: Oxytocin will not induce milk let-down unless the udder is in the proper physiological state.
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App Pharmaceuticals, Llc
Oxytocin | App Pharmaceuticals, Llc
Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use.
Induction or Stimulation of Labor
Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine Bleeding
Intravenous Infusion (Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration—1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Induction or Stimulation of Labor
Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine Bleeding
Intravenous Infusion (Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration—1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cantrell Drug Company
Oxytocin | Jazz Pharmaceuticals, Inc.
The patient dose of the radiolabel must be measured in a dose calibrator prior to administration.
The recommended dose of ProstaScint® (capromab pendetide) is 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride. Each dose is administered intravenously over 5 minutes and should not be mixed with any other medication during its administration. Indium In 111 ProstaScint® may be readministered following infiltration or a technically inadequate scan; however, it is not indicated for readministration for the purpose of assessment of response to treatment (see INDICATIONS AND USAGE).
Each ProstaScint® kit is a unit dose package. After radiolabeling with Indium In 111, the entire Indium In 111 ProstaScint® dose should be administered to the patient. Reducing the dose of Indium In 111, unlabeled ProstaScint®, or Indium In 111 ProstaScint® may adversely impact imaging results and is, therefore, not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Radiation DosimetryThe estimated absorbed radiation doses to an average adult patient from an intravenous injection of ProstaScint® labeled with 5 mCi of Indium In 111 are shown in TABLE 6. Total dose estimates include absorbed radiation doses from both Indium In 111 and the Indium In 114m radiocontaminant. A level of 0.06% of Indium In 114m was utilized for the dose estimates presented in TABLE 6.
TABLE 6 - ESTIMATED AVERAGE
ABSORBED RADIATION DOSE
IN ADULT PATIENTS FROM INTRAVENOUS
ADMINISTRATION OF PROSTASCINT®
LABELED WITH 5 mCi (185 MBq) OF
INDIUM IN 111 CHLORIDEa a Based on data from 21 patients who received doses of ProstaScint® labeled with a mean (± SD) Indium In 111 dose of 4.6 ± 1.0 mCi.Organ
Average
Dose
(rad/5 mCi)Average
Dose
(mGy/185 MBq)Total body
2.7
27
Brain
1.1
11
Liver
18.5
185
Spleen
16.3
163
Kidneys
12.4
124
Lungs
5.6
56
Heart wall
7.8
78
Red marrow
4.3
43
Adrenals
5.2
52
Urine Bladder wall
2.2
22
Bone Surfaces
4.0
40
Stomach
3.1
31
Gall Bladder Wall
7.3
73
Small Intestine
3.3
33
Upper Large Intestine Wall
5.0
50
Lower Large Intestine Wall
7.6
76
Pancreas
5.1
51
Skin
1.1
11
Testes
5.6
56
Prostate
8.2
82
Thymus
2.6
26
Thyroid
1.4
14
Other Tissues
2.0
20
Directions for Radiolabeling ProstaScint® (capromab pendetide) with Indium In 111 ChlorideProper aseptic techniques and precautions for handling radioactive materials should be employed. Waterproof gloves should be worn during the radiolabeling procedure. The preparation of the product should be done by the following procedure.
1. Required materials, not supplied: A. Indium In 111 Chloride from GE Healthcare, Inc. or Covidien, Inc. B. One sterile 1 mL syringe, one sterile 3 mL syringe C. Vial shield D. Dose calibrator set for Indium In 111 E. Biodex Dark Green Chromatography strips F. Developing chamber for chromatography (e.g. scintillation vial) G. 21-23 gauge sterile needles H. Shield for 10 mL syringe I. Waterproof gloves J. Alcohol wipe K. Water-soluble marker L. 0.9% sodium chloride solution M. 0.05 M solution of diethylenetriamine pentaacetic acid (DTPA) N. Gamma ray detector 2. Sterile, pyrogen-free Indium In 111 Chloride solution must be utilized in the preparation of the Indium In 111 ProstaScint ®. The use of high purity Indium In 111 Chloride manufactured by GE Healthcare, Inc. or by Covidien, Inc. is required. The Indium In 111 Chloride should be used only to radiolabel ProstaScint ® and should not be injected directly into the patient. The Indium In 111 Chloride should not be utilized after its expiration date. 3. Before radiolabeling, bring the refrigerated ProstaScint ® to room temperature. Note: ProstaScint ® is a protein solution which may develop translucent particulates. These particulates will be removed by filtration. 4. Clean the rubber stopper of each vial with an alcohol wipe. With a sterile 1 mL syringe add 0.1 mL of sodium acetate solution to the shielded vial of Indium In 111 chloride and mix. Retain remaining sodium acetate for use in Step 7. 5. With the same 1 mL syringe, withdraw between 6 and 7 mCi of the buffered Indium In 111 chloride and add to the ProstaScint ® vial. Flush the syringe to mix the preparation. Swirl gently to mix, and assay contents in a dose calibrator. On one of the labels provided, record the patient's identification, the date, time of preparation, and activity in the vial. Affix the label to the vial shield. 6. Allow the labeling reaction to proceed at room temperature for 30 minutes. 7. With a 3 mL syringe, add the remaining sodium acetate to the ProstaScint ® reaction vial. To normalize pressure, withdraw an equal volume of air. 8. Aseptically attach the 0.22 μm Millex ® GV sterile filter (provided) and a sterile hypodermic needle to a 10 mL sterile disposable syringe and withdraw the contents of the reaction vial through the filter into the syringe. Keep the needle immersed in the solution to avoid creating an air-lock in the filter. 9. Remove the filter and needle. Aseptically attach a fresh sterile hypodermic needle to the syringe. Assay syringe and contents in a dose calibrator. The syringe should contain not less than 4 mCi (148 MBq) of Indium In 111 ProstaScint ®. 10. Radiochemical purity (RCP) by Instant Thin Layer Chromatography (ITLC) can be determined by the following procedure: A. Mix equal parts (several drops of each) of Indium In 111 ProstaScint ® (capromab penditide) with DTPA solution. Allow the mixture to stand at room temperature for one minute. Spot a small drop of the mixture onto an ITLC strip at its origin. B. Add 0.9% sodium chloride solution to the developing chamber to a depth of about 0.5 cm. Place the strip in a chromatography chamber with the origin at the bottom (ensure the strip does not bend or touch the walls of the chamber) and allow the solvent to migrate to about 0.5 cm from the end of the strip. A small dot made with a felt tip pen at this distance can help indicate the arrival of the solvent front. Remove from the chamber and cut the strip in half and measure the counts per minute (CPM) of both halves with a gamma ray detector. C. Calculate the percent RCP as follows:
%RCP = CPM bottom half x 100
CPM bottom half + CPM top half D. If the radiochemical purity is <90%, the ITLC procedure should be repeated. If repeat testing remains <90%, the preparation should not be administered. 11. On the second label provided in the kit, record the patient's identification, the date, time of assay, and activity in the syringe. Affix this label to the syringe shield. 12. Indium In 111 ProstaScint ® should be used within 8 hours of radiolabeling. 13. Discard vials, needles, and syringes in accordance with local, state, and federal regulations governing radioactive and biohazardous waste. Image Acquisition and InterpretationImages should be acquired using a large field of view gamma camera equipped with a parallel hole medium energy collimator. The gamma camera should be calibrated using the 172 and 247 keV photopeaks for Indium In 111 with a 15-20% symmetric window.
Whole body or spot planar views of the pelvis, abdomen, and thorax should be performed between 72 and 120 hours following Indium In 111 ProstaScint® (capromab penditide) infusion. A cathartic is required the evening before imaging and a cleansing enema should be administered within an hour prior to each 72-120 hour imaging session. In addition, the bladder should be catheterized and irrigated.
Whole body acquisition should be carried out from skull through mid-femur. The total scan time over this area should be no less than 35 minutes using a 128x512 or 256x1024 matrix.
Planar images should be acquired in anterior and posterior views for 7.5 minutes per view using a 128x128 or 256x256 matrix. Due to uptake of Indium In 111 ProstaScint® by the liver, planar images obtained with the liver in the field of view must be acquired with adequate counts to allow the detection of lesions in the adjacent extrahepatic abdomen and pelvis. This may result in pixel overflow with image degradation in the region of the liver.
Two SPECT imaging sessions are necessary. The first SPECT session should be of the pelvis and be performed approximately 30 minutes after infusion to obtain a blood pool image. The second SPECT session should include both the pelvis and abdomen, including the lower liver margin through the prostatic fossa and be performed between 72 and 120 hours after infusion for detection of benign and malignant prostate tissue sites. Depending upon the capability of the camera field of view to include both pelvis and abdomen, either one or two separate acquisitions may be necessary during the second session.
To resolve imaging ambiguities possibly resulting from activity in blood pool, stool or urinary bladder, follow-up imaging sessions with full patient preparation should be performed.
The SPECT Images should be acquired using a 64x64 or 128x128 matrix for a minimum of 60 or 120 stops, respectively, over 360 degrees rotation for approximately 25 seconds per view at the first session and 50 seconds per view at the second session. Reconstruction should be performed using a Butterworth filter or equivalent in the transverse, coronal and sagittal views. An order of 5 and cut off of 0.5 may be used as a starting point. Slice thickness should be in the range of 6 to 12 mm.
Following Indium In 111 ProstaScint® (capromab penditide) administration, some of the radiolabel localizes in normal liver, spleen, bone marrow and genitalia.
It has been reported that Indium In 111 labeled antibodies may localize non-specifically in colostomy sites, degenerative joint disease, abdominal aneurysms, post-operative bowel adhesions, and local inflammatory lesions, including those typically associated with inflammatory bowel disease or secondary to surgery or radiation. Indium In 111 ProstaScint® can demonstrate apparent localization to sites of tortuous blood vessels. Careful review of the patient's medical history and other diagnostic information should aid in the interpretation of the images.
The diagnostic images acquired with Indium In 111 ProstaScint® should be interpreted in conjunction with other appropriate diagnostic tests.
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cardinal Health
Oxytocin | Cardinal Health
Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use.
Induction or Stimulation of Labor
Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine Bleeding
Intravenous Infusion (Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration—1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Induction or Stimulation of Labor
Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine Bleeding
Intravenous Infusion (Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration—1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Cantrell Drug Company
Oxytocin | Mckesson
• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctorTo spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.
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West-ward Pharmaceutical Corp.
Oxytocin | West-ward Pharmaceutical Corp.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage of oxytocin is determined by the uterine response. The following dosage information is based upon various regimens and indications in general use.
A. Induction or Stimulation of LaborIntravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of nonoxytocin-containing solution should be started. Physiologic electrolyte solution should be used except under unusual circumstances. To prepare the usual solution for infusion, 1-mL Oxytocin Injection, 10 USP Units/mL is combined aseptically with 1,000 mL of nonhydrating diluent (physiologic electrolyte solution). The combined solution, rotated in the infusion bottle to ensure thorough mixing, containing 10 mU/mL. Add the container with dilute oxytocic solution to the system through use of a constant infusion pump or other such device, to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 mU/min. the dose may be gradually increased in increments of no more than 1 to 2 mU/min. until a contraction pattern has been established which is similar to normal labor. The fetal heart rate, resting uterine tone, and the frequency, duration, and the force of contractions should be monitored. The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and the fetus must be evaluated by the responsible physician. B. Control of Postpartum Uterine Bleeding Intravenous Infusion (Drip Method):To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent (physiologic electrolyte solution) and run a rate necessary to control uterine atony.
Intramuscular Administration:1 mL (10 units) of oxytocin can be given after the delivery of the placenta.
C. Treatment of Incomplete or Inevitable AbortionIntravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops per minutes.
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Bimeda Inc., Division Of Cross Vetpharm Group
Oxytocin | Air Liquide America L.p.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cantrell Drug Company
Oxytocin | Target Corporation
adults and children 6 years & older: rinse for 30 seconds with 20mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushing, rinse mouth with water first children under 6 years of age: do not use -
Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Jhp Pharmaceuticals, Llc
Oxytocin | Jhp Pharmaceuticals, Llc
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The dosage of oxytocin is determined by the uterine response and must therefore be individualized and initiated at a very low level. The following dosage information is based upon various regimens and indications in general use.
A. Induction or Stimulation of LaborIntravenous infusion (drip method) is the only acceptable method of parenteral administration of oxytocin injection for the induction or stimulation of labor. Accurate control of the rate of infusion is essential and is best accomplished by an infusion pump. It is convenient to piggyback the oxytocin infusion on a physiologic electrolyte solution, permitting the oxytocin infusion to be stopped abruptly without interrupting the electrolyte infusion. This is done in the following way.
1. Preparation a. The standard solution for infusion of oxytocin injection is prepared by adding the contents of one 1 mL vial containing 10 units of oxytocin to 1000 mL of 0.9% aqueous sodium chloride or Ringer's lactate. The combined solution containing 10 milliunits (mU) of oxytocin/mL is rotated in the infusion bottle for thorough mixing. b. Establish the infusion with a separate bottle of physiologic electrolyte solution not containing oxytocin. c. Attach (piggyback) the oxytocin-containing bottle with the infusion pump to the infusion line as close to the infusion site as possible.
2. AdministrationThe initial dose should be 0.5–1 mU/min (equal to 3–6 mL of the dilute oxytocin solution per hour). At 30–60 minute intervals the dose should be gradually increased in increments of 1–2 mU/min until the desired contraction pattern has been established. Once the desired frequency of contractions has been reached and labor has progressed to 5–6 cm dilation, the dose may be reduced by similar increments.
Studies of the concentrations of oxytocin in the maternal plasma during oxytocin infusion have shown that infusion rates up to 6 mU/min give the same oxytocin levels that are found in spontaneous labor. At term, higher infusion rates should be given with great care, and rates exceeding 9–10 mU/min are rarely required. Before term, when the sensitivity of the uterus is lower because of a lower concentration of oxytocin receptors, a higher infusion rate may be required.
3. Monitoring a. Electronically monitor the uterine activity and the fetal heart rate throughout the infusion of oxytocin. Attention should be given to tonus, amplitude and frequency of contractions, and to the fetal heart rate in relation to uterine contractions. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane (see PRECAUTIONS section). b. Discontinue the infusion of oxytocin immediately in the event of uterine hyperactivity and/or fetal distress. Administer oxygen to the mother, who preferably should be put in a lateral position. The condition of mother and fetus should immediately be evaluated by the responsible physician and appropriate steps taken. B. Control of Postpartum Uterine Bleeding Intravenous infusion (drip method). If the patient has an intravenous infusion running, 10 to 40 units of oxytocin may be added to the bottle, depending on the amount of electrolyte or dextrose solution remaining (maximum 40 units to 1000 mL). Adjust the infusion rate to sustain uterine contraction and control uterine atony. Intramuscular administration. (One mL) Ten (10) units of oxytocin injection can be given after the delivery of the placenta. C. Treatment of Incomplete, Inevitable, or Elective Abortion
Intravenous infusion of 10 units of oxytocin injection added to 500 mL of a physiologic saline solution or 5% dextrose-in-water solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable, or elective abortion.
Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea, etc., for midtrimester elective abortion, the injection-to-abortion time may be shortened by infusion of oxytocin at the rate of 10 to 20 milliunits (20 to 40 drops) per minute. The total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication.
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West-ward Pharmaceutical Corp
Oxytocin | West-ward Pharmaceutical Corp
Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use.
Induction or Stimulation of LaborIntravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion - one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min, until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine BleedingIntravenous Infusion (Drip Method) – To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration – 1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable AbortionIntravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Mwi/vetone
Oxytocin | Dr.reddy's Laboratories Inc
2.1 SchizophreniaAdults
Dose Selection— Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should 4 generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine is not indicated for use in doses above 20 mg/day.
Dosing in Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Maintenance Treatment —The effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies (14.1)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Adolescents
Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.1)].
Maintenance Treatment — The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Bipolar I Disorder (Manic or Mixed Episodes)Adults
Dose Selection for Monotherapy — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2)].
Maintenance Monotherapy — The benefit of maintaining bipolar I patients on monotherapy with oral olanzapine at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [see Clinical Studies (14.2)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Dose Selection for Adjunctive Treatment — When administered as adjunctive treatment to lithium or valproate, oral olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals.
Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2)]. The safety of doses above 20 mg/day has not been evaluated in clinical trials.
Adolescents
Dose Selection— Oral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.2)].
Maintenance Treatment— The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I DisorderWhen using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adults
Oral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.
Children and Adolescents (10 to 17 years of age)
Dosage and Administration information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Safety and efficacy of olanzapine and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Symbyaxa and the Combination of Olanzapine and Fluoxetine
Use in Combination For Symbyax(mg/day) Olanzapine (mg/day) Fluoxetine(mg/day) 3 mg olanzapine/25 mg fluoxetine 2.5 20 6 mg olanzapine/25 mg fluoxetine 5 20 12 mg olanzapine/25 mg fluoxetine 10+2.5 20 6 mg olanzapine/50 mg fluoxetine 5 40+10 12 mg olanzapine/50 mg fluoxetine 10+2.5 40+10a Symbyax (olanzapine/fluoxetine HCl) is a fixed-dose combination of olanzapine and fluoxetine.
While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.
2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special PopulationsThe starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under < 10 years of age. [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)].
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Bayer Healthcare Llc
Oxytocin | Bayer Healthcare Llc
(INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS
For obstetrical use: U.S.P Units
Horses and Cows.........................100 (5 mL)
Sows and Ewes.........................30-50 (1½ to 2½ mL)
For milk letdown: U.S.P. Units
Cows............................................10-20 (½ to 1 mL)
Sows..............................................5-20 (¼ to 1 mL)
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Cantrell Drug Company
Oxytocin | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Fresenius Kabi Usa, Llc
Oxytocin | Fresenius Kabi Usa, Llc
Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use.
Induction or Stimulation of Labor
Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine Bleeding
Intravenous Infusion (Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration—1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Induction or Stimulation of Labor
Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.
Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.
To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.
The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.
The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor.
The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician.
Control of Postpartum Uterine Bleeding
Intravenous Infusion (Drip Method)—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.
Intramuscular Administration—1 mL (10 units) of oxytocin can be given after delivery of the placenta.
Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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