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Side Effects & Adverse Reactions
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- with any other product containing diphenhydramine, even one used on skin
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- to make a child sleepy
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
taking sedatives or tranquilizers
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- excitability may occur, especially in children
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- alcohol, sedatives and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
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- with any other product containing diphenhydramine, even one used on skin
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- to make a child sleepy
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
taking sedatives or tranquilizers
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itchy nose or throat
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- temporarily relieves these symptoms of the common cold:
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- runny nose
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- sneezing
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Dg Health Allergy Manufacturers
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Dolgencorp, Llc
Dg Health Allergy | Dolgencorp, Llc
• take every 4 to 6 hours, not more than 6 doses in 24 hoursadults and children 12 years of age and over
1 or 2 tablets
children 6 to under 12 years of age
1 tablet
children 4 to under 6 years of age
do not use unless directed by a doctor
children under 4 years of age
do not use
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Dolgencorp, Llc
Dg Health Allergy | The University Of Utah Dba Cyclotron Radiochemistry Lab / Huntsman Cancer Institute
Fludeoxyglucose F-18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description(11.2)].
2.1 Recommended Dose for AdultsWithin the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.
2.2 Recommended Dose for Pediatric PatientsWithin the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations (8.4)].
2.3 Patient Preparation To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study.Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour.
Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F-18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection.
In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F-18 Injection facilitates localization of cardiac ischemia.
2.4 Radiation DosimetryThe estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F-18 Injection are shown in Table 1. These estimates were calculated based on human 2 data and using the data published by the InternationalCommission on Radiological Protection 4 for Fludeoxyglucose 18F. The dosimetry data show thatthere are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.
Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injection* Organ Newborn (3.4 kg) 1-year old (9.8 kg) 5-year old (19 kg) 10-year old (32 kg) 15-year old (57 kg) Adult
(70 kg) Bladder wall† 4.3 1.7 0.93 0.60 0.40 0.32 Heart wall 2.4 1.2 0.70 0.44 0.29 0.22 Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19 0.14 Lungs 0.96 0.38 0.20 0.13 0.092 0.064 Kidneys 0.81 0.34 0.19 0.13 0.089 0.074 Ovaries 0.80 0.8 0.19 0.11 0.058 0.053 Uterus 0.79 0.35 0.19 0.12 0.076 0.062 LLI wall‡ 0.69 0.28 0.15 0.097 0.060 0.051 Liver 0.69 0.31 0.17 0.11 0.076 0.058 Gallbladder wall 0.69 0.26 0.14 0.093 0.059 0.049 Small intestine 0.68 0.29 0.15 0.096 0.060 0.047 ULI wall₴ 0.67 0.27 0.15 0.090 0.057 0.046 Stomach wall 0.65 0.27 0.14 0.089 0.057 0.047 Adrenals 0.65 0.28 0.15 0.095 0.061 0.048 Testes 0.64 0.27 0.14 0.085 0.052 0.041 Red marrow 0.62 0.26 0.14 0.089 0.057 0.047 Thymus 0.61 0.26 0.14 0.086 0.056 0.044 Thyroid 0.61 0.26 0.13 0.080 0.049 0.039 Muscle 0.58 0.25 0.13 0.078 0.049 0.039 Bone surface 0.57 0.24 0.12 0.079 0.052 0.041 Breast 0.54 0.22 0.11 0.068 0.043 0.034 Skin 0.49 0.20 0.10 0.060 0.037 0.030 Brain 0.29 0.13 0.09 0.078 0.072 0.070 Other tissues 0.59 0.25 0.13 0.083 0.052 0.042* MIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the biodistribution based on data from Gallagher et al.1 and Jones et al.2
† The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used.
‡ LLI = lower large intestine;
₴ ULI = upper large intestine
2.5 Radiation Safety – Drug Handling Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F-18 Injection to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons. Radiopharmaceuticals should be used by or under the control of physicians who arequalified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Calculate the final dose from the end of synthesis (EOS) time using proper radioactivedecay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)]. The dose of Fludeoxyglucose F-18 used in a given patient should be minimizedconsistent with the objectives of the procedure, and the nature of the radiation detection devices employed. 2.6 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F-18 Injection from its container. Inspect Fludeoxyglucose F-18 Injection visually for particulate matter and discolorationbefore administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose ofthese unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Use Fludeoxyglucose F-18 Injection within 12 hours from the EOS 2.7 Imaging Guidelines Initiate imaging within 40 minutes following Fludeoxyglucose F-18 Injection administration. Acquire static emission images 30 – 100 minutes from the time of injection.
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