Juliet-35 ED may be available in the countries listed below.
Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Juliet-35 ED in the following countries:
Ethinylestradiol is reported as an ingredient of Juliet-35 ED in the following countries:
International Drug Name Search
Temporarily relieving pain and itching caused by minor skin irritations, minor cuts and burns, sunburn, insect bites, scrapes, and rashes caused by poison ivy, oak, or sumac.
Pramox Gel is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin, which helps relieve discomfort.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Pramox Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Pramox Gel. Because little, if any, of Pramox Gel is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Pramox Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Pramox Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Pramox Gel.
All medicines may cause side effects, but many people have no, or minor side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Pramox side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Pramox Gel may be harmful if swallowed.
Store in an upright position at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. Keep Pramox Gel out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Pramox Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Macrotec is a sterile, nonpyrogenic, Iyophilized preparation of albumin aggregated. Each 5 mL vial of Macrotec contains 1.5 mg of Albumin Aggregated, 10.0 mg Albumin Human, 0.07 mg (minimum) stannous chloride (SnCl2•2H2O) and 0.19 mg total tin, maximum (as stannous chloride, SnCl2•2H2O), 1.8 mg of sodium chloride with trace amounts of sodium acetate, acetic acid and hydrochloric acid. Macrotec contains no preservatives. The pH of the reconstituted product is between 3.8 and 8.0.
The aggregated particles are formed by denaturation of Albumin Human in a heating and precipitation process. Each vial contains 2–7 million particles, 90% of which are between 10 and 90 microns in size. The average size is 20 to 40 microns; no particles are greater than 150 microns.
Reconstitution of Macrotec with sterile sodium pertechnetate Tc 99m forms an aqueous suspension of Technetium Tc 99m Albumin Aggregated for diagnostic use by intravenous injection. No less than 90% of thepertechnetate Tc 99m added to the reaction vial is bound to the aggregates at preparation time and remains bound throughout the 6-hour lifetime of the suspension.
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1.
| Principal Radiation Emission Data | ||
| Radiation | Mean % per Disintegration | Mean Energy (keV) |
| Gamma-2 | 89.07 | 140.5 |
1 Kocher, David C., "Radioactive Decay Data Tables”, DOE/TIC-11026, (1981) p. 108.>
The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.
| Radiation Attenuation by Lead Shielding | ||
| Shield Thickness (Pb) cm | Coefficient of Attenuation | |
| 0.017 | 0.5 | |
| 0.08 | 10-1 | |
| 0.16 | 10-2 | |
| 0.25 | 10-3 | |
| 0.33 | 10-4 | |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
| Physical Decay Chart: Tc 99m half-life 6.02 hours | ||||
| Hours | Fraction Remaining | Hours | Fraction Remaining | |
| *Calibration time | ||||
| 0* | 1.000 | 8 | 0.398 | |
| 1 | 0.891 | 9 | 0.355 | |
| 2 | 0.794 | 10 | 0.316 | |
| 3 | 0.708 | 11 | 0.282 | |
| 4 | 0.631 | 12 | 0.251 | |
| 5 | 0.562 | 18 | 0.126 | |
| 6 | 0.501 | 24 | 0.063 | |
| 7 | 0.447 | |||
Immediately following intravenous injection, more than 80% of the Albumin Aggregated is trapped in the pulmonary alveolar capillary bed. The imaging procedure can thus be started as soon as the injection is complete. Assuming that a sufficient number of radioactive particles have been used (see DOSAGE AND ADMINISTRATION), the distribution of radioactive aggregated particles in the normally perfused lung is uniform throughout the vascular bed, and will produce a uniform image. Areas of reduced perfusion will be revealed by a correspondingly decreased accumulation of the radioactive particles, and these areas are imaged as areas of decreased photon density.
Following administration of Technetium Tc 99m Albumin Aggregated by intraperitoneal injection, the radiopharmaceutical mixes with the peritoneal fluid. Clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent.
Serial Images should be obtained of both the shunt and lung (target organ). However, an adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases.
Organ selectivity is a direct result of particle size. Below 1–10 microns the material is taken up by the reticuloendothelial system. Above 10 microns the aggregates become lodged in the lung capillaries by a purely mechanical process.
The Albumin Aggregated is sufficiently fragile for the capillary microocclusion to be temporary. Erosion and fragmentation reduce the particle size, allowing passage of the aggregates through the pulmonary alveolar capillary bed. The fragments are then accumulated by the reticuloendothelial system.
Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. Normally, the clearance half-time of the particles from the lungs is 2 to 3 hours.
Studies have shown that when Technetium Tc 99m Albumin Aggregated is injected peripheral to the suspected point of the disease process, the radioactive aggregated particles collect at the sites of endothelial damage and/or clot formation.
Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated) is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and children. It is useful in the early detection of pulmonary emboli and in the evaluation of the status of the pulmonary circulation in such conditions as pulmonary neoplasm, pulmonary tuberculosis and emphysema.
Technetium Tc 99m Albumin Aggregated may be used in adults as an imaging agent to aid in the evaluation of peritoneo-venous (LeVeen) shunt patency.
Macrotec is also indicated for use in isotopic venography as an adjunct in the screening, diagnosis and management of deep vein thrombosis in the lower extremities.
Combined isotopic venography of the lower extremities and the pulmonary vasculature may be performed.
Technetium Tc 99m Albumin Aggregated Injection should not be administered to patients with severe pulmonary hypertension.
The use of Technetium Tc 99m Albumin Aggregated Injection is contraindicated in persons with a history of hypersensitivity reactions to products containing human serum albumin.
The literature contains reports of deaths occurring after the administration of Albumin Aggregated to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to preparations of Technetium Tc 99m Albumin Aggregated have been reported.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
In patients with right to left heart shunts, additional risk may exist due to the rapid entry of Albumin Aggregated into the systemic circulation. The safety of this agent in such patients has not been established.
Hypersensitivity reactions are possible whenever protein-containing materials such as pertechnetate labeled Albumin Aggregated are used in man. Epinephrine, antihistamines and corticosteroids should be kept available for immediate use.
The intravenous administration of any particulate material such as Albumin Aggregated imposes a temporary, small mechanical impediment to blood flow. While this effect is probably physiologically insignificant in most patients, the administration of Albumin Aggregated is possibly hazardous in acute cor pulmonale and other states of severely impaired pulmonary blood flow.
The components of the Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated) are sterile and nonpyrogenic. It is essential to follow directions carefully and adhere to strict aseptic procedures during preparation.
Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Albumin Aggregated Injection and are NOT to be administered directly to the patient.
The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained.
The technetium Tc 99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.
The preparation contains no bacteriostatic preservative. Technetium Tc 99m Albumin Aggregated Injection should be stored refrigerated at 2-8°C and discarded 6 hours after formulation.
Technetium Tc 99m Albumin Aggregated Injection is a physically unstable suspension and consequently the particles settle with time. Failure to agitate the vial adequately before use may result in non-uniform distribution of radioactive particles.
If blood is drawn into the syringe, unnecessary delay prior to injection may result in clot formation.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to clinical personnel.
No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Albumin Aggregated Injection affects fertility in males or females.
Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Albumin Aggregated Injection. It is also not known whether Technetium Tc 99m Albumin Aggregated Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc 99m Albumin Aggregated Injection should be given to a pregnant woman only if clearly needed.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.
Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula-feedings should be substituted for breast-feedings.
The lowest possible number of particles should be used in the right-to-left shunting, in neonates and in severe pulmonary disease.
Although adverse reactions specifically attributable to the Technetium Tc 99m Albumin Aggregated Injection have not been noted, the literature contains reports of deaths occurring after the administration of Albumin Aggregated to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions topreparations of Technetium Tc 99m Albumin Aggregated have been reported.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Mix the contents of the vial by gentle inversion just prior to withdrawing a patient dose. Mix the contents of the syringe just before injection. If blood is drawn into the syringe, any unnecessary delay prior to injection may lead to clot formation. Slow injection is recommended. Imaging may begin immediately after intravenous injection of Technetium Tc 99m Albumin Aggregated; follow-up imaging should be performed as needed.
The recommended intravenous dose range for the average ADULT patient (70 kg) is 37 MBq to 148 MBq (1 to 4 mCi) Technetium Tc 99m Albumin Aggregated after reconstitution with oxidant-free Sodium Pertechnetate Tc 99m Injection. The recommended number of particles per single injection is 200,000-700,000 with suggested number being approximately 350,000.
The number of particles available per megabecquerel (millicurie) dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of the technetium Tc 99m that has occurred. The number of particles available in any specific dose may be estimated by calculating the number of particles per milliliter.
In PEDIATRIC patients, the suggested intravenous doses employed for perfusion lung imaging are in the range of 0.925 MBq to 1.85 MBq per kilogram (25 to 50 μCi/kg) of body weight with a usual dose of 1.11 MBq per kilogram (30 μCi/kg), except in newborns, in whom the administered dose should be 7.4 MBq to 18.5 MBq (200-500 μCi). A minimum dose of 7.4 MBq (200 μCi) should be employed for this procedure. The number of particles administered will vary with age and weight of the child as indicated in Table 4.
| Particle Size and Dose | |||||
| Ages | Newborn | 1 Year | 5 Years | 10 Years | 15 Years |
| Weight (kg) | 3.5 | 12.1 | 20.3 | 33.5 | 55.0 |
| Usual Administered Dose MBq (mCi) | 7.4 (0.2) | 14.8 (0.4) | 22.2 (0.6) | 37 (1.0) | 59.2 (1.6) |
| Range of Particles Administered (in thousands) | 10-50 | 50-150 | 200-300 | 200-300 | 200-700 |
The usual dose for unilateral or bilateral isotopic venography of the lower extremities is 74 to 148 MBq (2-4 mCi) Technetium Tc 99m Albumin Aggregated Injection per limb, injected intravenously peripheral to the suspected areas of venous clot formation.
For isotopic venography of the lower extremities, the patient should be supine and properly positioned under the scintillation camera. For unilateral or bilateral imaging of the lower extremities, a tourniquet should be applied just above the malleolus of each leg to be imaged in order to promote deep vein filling. For simultaneous bilateral imaging, doses should be administered from separate syringes. Rapid sequential scintiphotographs should then be taken along the course of venous flow from the calf to the abdomen. If retention of radioactivity ("hot spots") occurs in the calf region, the patient should be instructed to exercise the lower extremities by flexion and extension of the knees and ankles; reimaging should be performed after about 15 minutes.
Following vein imaging, lung imaging may be performed without need of additional Technetium Tc 99m Albumin Aggregated.
The suggested intraperitoneal dosage range used in the average patient (70 kg) for peritoneo-venous (LeVeen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3 millicuries). Adequate measures should be taken to assure uniform mixing with peritoneal fluid. Serial images of both the shunt and target organ should be obtained and correlated with other clinical findings. Alternatively, the drug may be administered by percutaneous transtubal injection. The suggested percutaneous transtubal (efferent limb) dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0 millicurie) in a volume not to exceed 0.5 mL.
The estimated absorbed radiation doses1 to an average ADULT patient (70 kg) from an intravenous injection of 148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated Injection are shown in Table 5.
| Adult Absorbed Radiation Doses | ||
| Tissue | mGy/148 MBq | rads/4 mCi |
| Total Body | 0.60 | 0.060 |
| Lungs | 8.8 | 0.88 |
| Liver | 0.72 | 0.072 |
| Spleen | 0.68 | 0.068 |
| Kidneys | 0.44 | 0.044 |
| Bladder Wall | ||
| 2-hr void | 1.2 | 0.12 |
| 4.8-hr void | 2.2 | 0.22 |
| Testes | ||
| 2-hr void | 0.24 | 0.024 |
| 4.8-hr void | 0.26 | 0.026 |
| Ovaries | ||
| 2-hr void | 0.30 | 0.030 |
| 4.8-hr void | 0.34 | 0.034 |
1Method of calculation: "S", Absorbed-Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975)
In PEDIATRIC patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 MBq (50 μCi) per kilogram of body weight (except in the newborn where the maximum recommended dose of 18.5 MBq (500 μCi) is used) and are shown in Table 6, which lists the maximum dosage for children up to the age of 15 years. Note the recommendations regarding number of particles to be administered.
| Pediatric Absorbed Radiation Doses | |||||
| *2 hour voiding interval | |||||
| ** 4.8 hour voiding interval | |||||
| Ages | Newborn | 1 year old | 5 year old | 10 year old | 15 year old |
| Weight (kg) | 3.5 | 12.1 | 20.3 | 33.5 | 55.0 |
| Maximum Recommended Dose MBq (mCi) | 18.5 (0.5) | 22.2 (0.6) | 37 (1.0) | 62.9 (1.7) | 103.6 (2.8) |
| Absorbed Dose [mGy (rads)/max dose] | |||||
| Total Body | 0.6 (0.06) | 0.3 (0.03) | 0.31 (0.031) | 0.48 (0.048) | 0.41 (0.041) |
| Lungs | 19 (1.9) | 6.6 (0.66) | 5.8 (0.58) | 8.7 (0.87) | 7.7 (0.77) |
| Liver | 1.4 (0.14) | 0.6 (0.06) | 0.62 (0.062) | 1.8 (0.18) | 1.2 (0.12) |
| Bladder Wall | 2.1 (0.21)* | 1.5 (0.15)* | 3.1 (0.31)** | 3.9 (0.39)** | 4.1 (0.41)* |
| Ovaries | 0.38 (0.038) | 0.2 (0.02) | 0.19 (0.019) | 0.44 (0.044) | 0.41 (0.041) |
| Testes | 0.31 (0.031) | 0.13 (0.013) | 0.19 (0.019) | 0.2 (0.02) | 0.36 (0.036) |
NOTE: DOSES TO TESTES, OVARIES AND BLADDER INCREASE WITH VOIDING INTERVAL.
Method of Calculation:
The following table represents the absorbed radiation dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of Technetium Tc 99m Albumin Aggregated.
| Absorbed Radiation Doses | ||||
| Organ | Shunt Patency (Open) | Shunt Patency (Closed) | ||
| mGy | rads | mGy | rads | |
| Lung | 6.9 | 0.69 | 1.68 | 0.168 |
| Ovaries | 0.18 | 0.018 | 1.68 | 0.168 |
| & Testes | to 0.30 | to 0.030 | ||
| Organs in the | ||||
| Peritoneal Cavity | – | – | 1.68 | 0.168 |
| Total Body | 0.36 | 0.036 | 0.57 | 0.057 |
Calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the peritoneal cavity with no biological clearance.
Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated) is supplied as a kit containing 10 reaction vials (5 mL size), 10 pressure sensitive labels and 1 package insert.
Store the Macrotec kit refrigerated between 2° to 8°C (36° to 46°F). The reconstituted preparation should be refrigerated since the product does not contain a preservative.
When reconstituted with sodium pertechnetate Tc 99m, Macrotec must be used within 6 hours.
The contents of the Macrotec reaction vial are sterile and nonpyrogenic. Aseptic procedures should be used during reconstitution of Macrotec and the withdrawal of doses for intravenous administration. The introduction of air into the vial during the reconstitution step should be avoided. Since the vial contains nitrogen to prevent oxidation of the complex, the vial should not be vented. If repeated withdrawals are made from the vial, the contents should not be replaced with air.
The U.S. Nuclear Regulatory Commission has approved this reagent kit for distribution to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to persons who hold an equivalent license issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.
Manufactured for:
Bracco Diagnostics Inc.
Princeton, NJ 08543
Manufactured by:
Ben Venue Laboratories, Inc.
Bedford, OH 44146
MAC-P01
February 2002
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Treating Cushing syndrome in certain patients. It may also be used for other conditions as determined by your doctor.
Aminoglutethimide is an adrenal steroid inhibitor. It works by blocking the production of a variety of hormones, including glucocorticoids, mineralocorticoids, estrogens, and androgens.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Aminoglutethimide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Aminoglutethimide. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Aminoglutethimide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Aminoglutethimide as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Aminoglutethimide.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; drowsiness; headache; loss of appetite; muscle pain or weakness; nausea; rash; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast heartbeat; fever, chills, or sore throat; severe or prolonged dizziness; unusual tiredness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Aminoglutethimide side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include extreme weakness; increase or decrease in breathing rate; loss of consciousness; severe or prolonged drowsiness or dizziness; severe or prolonged nausea or vomiting; unusual tiredness.
Store Aminoglutethimide below 86 degrees F (30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aminoglutethimide out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Aminoglutethimide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Generic Name: dexamethasone (oral) (dex a METH a sone)
Brand Names: Baycadron, Dexamethasone Intensol, DexPak 10 Day Taperpak, DexPak 13 DayTaperpak, DexPak 6 DayTaperpak, Dexpak Jr. Taperpak, Zema Pak 10-Day, Zema Pak 13-Day, Zema Pak 6-Day
Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
Dexamethasone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
Dexamethasone may also be used for purposes not listed in this medication guide.
Before taking dexamethasone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking dexamethasone. Vaccines may not work as well while you are taking a steroid.
Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.
To make sure you can safely take dexamethasone, tell your doctor if you have any of these other conditions:
liver disease (such as cirrhosis);
kidney disease;
a thyroid disorder;
diabetes;
a history of malaria;
tuberculosis;
osteoporosis;
a muscle disorder such as myasthenia gravis;
glaucoma or cataracts;
herpes infection of the eyes;
stomach ulcers, ulcerative colitis, or diverticulitis;
depression or mental illness;
congestive heart failure; or
high blood pressure
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using dexamethasone.
Call your doctor for instructions if you miss a dose of dexamethasone.
Long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
problems with your vision;
swelling, rapid weight gain, feeling short of breath;
severe depression, unusual thoughts or behavior, seizure (convulsions);
bloody or tarry stools, coughing up blood;
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
sleep problems (insomnia), mood changes;
acne, dry skin, thinning skin, bruising or discoloration;
slow wound healing;
increased sweating;
headache, dizziness, spinning sensation;
nausea, stomach pain, bloating;
muscle weakness; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Many drugs can interact with dexamethasone. Below is just a partial list. Tell your doctor if you are using:
aspirin (taken on a daily basis or at high doses);
a diuretic (water pill);
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
insulin or diabetes medications you take by mouth;
ketoconazole (Nizoral);
rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
This list is not complete and other drugs may interact with dexamethasone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Zema Pak3-Day side effects (in more detail)
Generic Name: procainamide (injection) (proe KANE a mide)
Brand Names: Pronestyl
Procainamide affects the way your heart beats.
Procainamide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart).
Procainamide may also be used for purposes not listed in this medication guide.
In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received this medication.
Procainamide can lower blood cells that help your body fight infections. Tell your doctor if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, sores in your mouth and throat, or unusual weakness.
a serious heart condition such as "AV block" (unless you have a pacemaker);
lupus; or
a history of "Long QT syndrome."
If possible before you receive procainamide, tell your doctor if you have:
congestive heart failure;
circulation problems;
a history of heart attack or stroke (including "mini-stroke");
a weak immune system;
myasthenia gravis;
asthma or sulfite allergy;
if you are allergic to aspirin; or
if you have ever had an allergic reaction to a numbing medicine.
Procainamide is injected into a muscle or into a vein through an IV. You will receive procainamide injection in a hospital setting where your heart can be monitored in case the medication causes serious side effects.
Procainamide can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.
Since procainamide is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Overdose symptoms may include drowsiness, tremors, weak or shallow breathing, and fainting.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
a new or a worsening irregular heartbeat pattern;
chest pain, wheezing, trouble breathing;
feeling like you might pass out;
signs of infection such as fever, chills, sore throat, flu symptoms, pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, sores in your mouth and throat, unusual weakness;
depressed mood, hallucinations, severe dizziness;
upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
joint pain or swelling with fever, swollen glands, muscle pain or weakness, unusual thoughts or behavior, patchy skin color, red spots.
Less serious side effects may include:
mild dizziness or tired feeling;
flushing (warmth, redness, or tingly feeling); or
mild itching or rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
cimetidine (Tagamet, Tagamet HB);
digoxin (digitalis, Lanoxin);
glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin);
dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine).
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
heart rhythm medications such as amiodarone (Cordarone, Pacerone), quinidine (Quin-G), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others.
This list is not complete and other drugs may interact with procainamide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Procanbid side effects (in more detail)
Boots NicAssist Patch
(Nicotine)
Boots NicAssist 15 mg Patch
Boots NicAssist 10 mg Patch
Boots NicAssist 5 mg Patch
This medicine is available without prescription to help you to stop smoking.
However, you still need to use it carefully to get the best results from it.
This medicine contains nicotine which belongs to a group of medicines called nicotine replacement therapy (NRT). It acts to substitute the nicotine that you normally get from cigarettes and can help you stop smoking.
It can be used to relieve the symptoms of nicotine withdrawal and reduce the cravings for nicotine that you get when you try to stop smoking.
To help you quit smoking you should also try to use a behavioural support programme to increase your chances of success.
When you stop smoking, your body misses the nicotine that you have been absorbing from the smoke. You may experience unpleasant feelings and a strong desire to smoke (“craving”).
This shows that you were dependent on nicotine. When you use the patch, nicotine is released and passes into your body through your skin. The nicotine is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop your craving to smoke but will not give you the “buzz” you get from a cigarette.
The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine.
This medicine can be used by adults and children of 12 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.
If you are pregnant: You should try to stop smoking without using medicines. If you still need help you can use this product. The risk to your baby whilst using this product is far less than if you continue to smoke. Talk to your pharmacist or doctor for more advice.
Products that are used intermittently may be preferable to nicotine patches. However if you feel sick or are sick (morning sickness) the patches may be better for you. If you do use nicotine patches they should be taken off before bedtime.
If you are breastfeeding: You should try to stop smoking without using medicines. If you can’t manage this you are best to use an NRT product that is used intermittently (not patches). You should talk to your doctor, nurse or pharmacist for advice.
Breastfeed your baby just before you use the patch to make sure that your baby gets the smallest amount of nicotine possible.
If you need to use this product, the amount of nicotine that your baby may receive is much smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke causes breathing and other health problems in babies and children. If your husband, partner or other family members smoke too, try to get them to give up with you.
Nicotine products and children: Nicotine can be very dangerous to children. The amount of nicotine tolerated by adults and adolescents can make children very ill, and can sometimes be fatal. Do not leave your patches where children may get hold of them.
Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
When you stop smoking your metabolism slows down. This can mean that some medicines may stay in your body longer than usual. If you take any medicine on a regular basis, tell your doctor that you intend to stop smoking and follow his or her advice about these medicines.
Check that the foil pouch is not broken before use. If it is do not use that patch.
Follow the directions which tell you how to use the patches.
1. Before you apply the patch, choose a completely clean, dry area of hairless skin on the front or side of the chest, upper arm or hip
2. Do not place the patch onto any area of skin that is red, cut or irritated
3. Do not apply oil or talcum powder to the skin before putting on the patch as this may prevent it from sticking properly
4. It is important that you do not use the same area on two consecutive days to help avoid irritating that site
1. Each patch comes in a child resistant sachet which can be opened by cutting along the edge with a pair of scissors
2. Remove the patch from its sachet and then remove the clear plastic backing
3. Apply the patch firmly by pressing the sticky side of the patch to the chosen area of skin
4. Run your finger around the edge of the patch to ensure it sticks properly
1. The patch should be removed before you go to bed as it is not designed to be worn when you go to sleep at night or for more than 16 hours each day
2. After removal, the patch should be folded in half, sticky side inwards and placed inside the opened sachet or a piece of aluminium foil
3. The patch should then be disposed of carefully in the household rubbish, out of reach of children and animals
Look at the following information below, which shows the number of patches you should be using, when you should use them and maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for.
Please read this information carefully and then go to the “How to stop smoking “ section which shows you how to give up.
Adults and children of 12 years and over: Apply one new patch (of appropriate strength) to the skin when you wake up (usually in the morning).
Remove the patch 16 hours later, which is usually at bed time.
Children under 12 years
Do not give this product to children under 12 years.
Because smoking is an addiction you may find it difficult to give up. From time to time you may still have strong urges to smoke but if you follow these recommendations, you have a good chance of quitting.
If you find it hard to stop smoking using nicotine patches, you are worried that you will start smoking again without it or you find it difficult to reduce the number of patches you are using, talk to your doctor, nurse or pharmacist.
Remember nicotine patches are not intended as a substitute for smoking, they are an aid to give up.
The idea is to stop smoking immediately and use the patch to relieve the cravings to smoke. After achieving this you then slowly reduce the amount of nicotine that you are getting by switching to lower strength patches. You then stop using the patches. You should aim to do this within 12 weeks (3 months).
Adults aged 18 years and over
The following information shows the basic step by step process. Make sure that you read the instructions for each step in the information which follows.
Step 1:
(15 mg - 8 weeks)
Begin treatment with the highest strength 15 mg patch the day after you stop smoking completely. Use a new 15 mg patch each day for eight weeks.
Step 2:
(10 mg - 2 weeks)
If you are successful and avoid smoking during this eight week period, you should then begin to reduce the amount of nicotine you are getting by switching to a lower strength patch.
You should switch from using the 15 mg patch each day to using the 10 mg patch each day for two weeks.
Step 3:
(5 mg - 2 weeks)
If you are successful and avoid smoking over this two week period, then switch from the 10 mg patch to the 5 mg patch each day for a further two weeks.
You might feel a sudden craving to smoke long after you have given up smoking and stopped using the patch. Remember you can use nicotine replacement therapy again if this should happen.
If you need to use this product for more than 9 months, ask your doctor, nurse or pharmacist for advice.
Children 12 to 17 years
Children can follow the same method as Adults, however they should not use NRT for longer than 12 weeks without asking for help and advice from a doctor, nurse or pharmacist.
If you have used too many patches: If you have used more than the recommended number of patches, left the patch on for too long or have smoked whilst using the patch, you may experience nausea, salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness.
If this happens contact a doctor or hospital casualty department straight away. Take the medicine and this leaflet with you.
If a child under 12 accidentally uses, sucks or chews a patch take them to casualty immediately. Take the medicine and this leaflet with you. Nicotine absorption or ingestion by a child may result in severe poisoning.
Most people can use this medicine without any problems but sometimes you may notice some side effects. Many of these effects are due to nicotine, they may also happen when you smoke.
If you notice any of the following serious side effects, stop using the medicine, do not smoke and see your doctor as soon as possible.
Effects related to stopping smoking (nicotine withdrawal)
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you reduce the size of your patch that you use before you are ready to reduce your nicotine intake.
These effects include:
Effects of too much nicotine
You may also get these effects if you are not used to inhaling tobacco as you smoke. You may be able to relieve these effects by reducing the strength of the patch you are using.
These effects include:
Side effects of the patch
When you use Boots NicAssist patches for the first time they may cause a mild skin reaction. This is usually redness or itching of the skin where the patch has been applied. This will usually disappear after a few days.
Rarely, this reaction may continue for longer, or the reaction may be more severe. If this happens, stop using the patches and talk to your doctor, nurse or pharmacist.
Very common side effects:
(more than 1 in every 10 people are affected)
Common side effects:
(less than 1 in every 10 people are affected)
Uncommon side effects:
(less than 1 in every 100 people are affected)
Very rare side-effects:
(less than 1 in 10,000 people are affected)
If any of the side effects get serious, or you notice any side effect not listed here, please tell your pharmacist or doctor.
When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.
Keep this medicine in a safe place out of the sight and reach of children and animals, preferably in a locked cupboard. Nicotine in high doses can be very dangerous and sometimes fatal if used or swallowed by small children.
Use the medicine by the date on the carton and keep it in the original pack.
Do not store above 30°C.
Store in the original package.
Dispose of the patch as directed by folding it in half and placing inside the empty sachet (or wrapping in a piece of aluminium foil) before throwing away. Always dispose of used patches sensibly, away from the reach of children and animals.
This pack contains 7 patches packed into individual sachets.
Each patch contains nicotine, which is the active ingredient.
As well as the active ingredient, these patches also contain medium molecular weight polyisobutylene, low molecular weight polyisobutylene, polybutylene, polyester non-woven backing film and siliconised polyester release liner.
This product is manufactured for
by
The Marketing Authorisation holder is
Leaflet prepared February 2010
If you would like any further information about this product, please contact
Other formats
To request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference Number
Boots NicAssist 15 mg Patch 15513/0177
Boots NicAssist 10 mg Patch 15513/0176
Boots NicAssist 5 mg Patch 15513/0175
This is a service provided by the Royal National Institute of Blind People.
Helpful tips about giving up smoking
You may have tried to stop smoking before and you know from bitter experience that it’s not easy to give up cigarettes. However, you have now taken the first constructive step towards becoming a non-smoker. In overcoming your tobacco dependence you will have to tackle two problems:
1 Your smoking habit
2 Your addiction to nicotine
Willpower
The overriding success factor in quitting is how determined you are. The first few weeks of quitting will probably be the most difficult because your smoking ritual is still fresh in your mind. However, you will find that as time goes by, your willpower becomes stronger.
Telling friends, family and work colleagues that you are stopping smoking and that you envisage a tough time ahead will encourage them to support you.
1 Pick the right day
There is never a perfect time to give up smoking, but you should plan ahead by choosing a date in the not too distant future on which you are going to give up cigarettes completely. Try to pick a day when you will not be too stressed.
2 Break your routine
For a number of years you will have become accustomed to smoking at certain times, with particular people or circumstances. Think about the times you will miss smoking the most and plan how you will cope on these occasions. Changing your routine will help you break the habit of smoking.
3 Quit with a friend
Quitting with a fellow smoker is a good idea. It will strengthen your resolve and build on your determination. Encourage a friend or family member to quit with you. It will give your morale a boost since there will be another person knowing exactly what you’re feeling and with whom you can share your determination to quit smoking.
4 Remove any temptation
To help yourself succeed, be sure to remove all cigarettes, matches, lighters etc. from the home, the car, and at work. Ask your friends and colleagues not to offer you cigarettes or smoke close by you – but be careful not to offend them. Explain that you have given up. This type of support from friends is of greatest benefit for the first couple of weeks of quitting, as this is your most vulnerable time. The last thing you want is a cigarette close at hand in a moment of weakness.
5 Take one day at a time
When you reach your Quit Day, don’t allow yourself to think that you’re quitting for good. That will make it seem like a superhuman task. Just promise yourself “I won’t have a cigarette today”, and take it one day at a time. You’ll be surprised how much that little thought helps.
6 Keep active
Whenever you feel the urge to smoke coming on, distract yourself by keeping active. Don’t feel sorry for yourself. Get up and DO something. Do that job around the house or garden that you’ve been putting off, or take up a hobby. Remember that the craving only lasts a few minutes.
7 Learn to relax
Once you have stopped smoking, taking exercise regularly will not only help you get fitter but will encourage you to relax. Exercise has the ability to relieve stress and tension. Taken regularly it will benefit you physically and psychologically. If you haven’t exercised for some time, take it slowly to begin with and increase the amount of time spent exercising over the course of a few weeks. Not only will exercising help you relax but also helps to keep your weight under control, which some people find a problem when quitting.
8 Think cash not ash
One of the really noticeable benefits of “stopping” is the extra cash that’s suddenly available. To emphasise the point put the money into a pot marked “cash not ash” and watch it accumulate. But be sure to use the money to treat yourself. You deserve a REWARD for NOT smoking.
9 Dealing with relapses
After you have stopped smoking you might find that in times of stress, reaching for a cigarette is the only thing that will help you through. There may also be certain situations – particularly social situations such as a party – where temptation just gets the better of you, so you smoke one or two cigarettes. You might feel that your only option is to go back to smoking. Don’t think of it as having failed, just think through the reasons why you wanted to quit in the first place and don’t let those couple of cigarettes get the better of you. Refer back to your plan and start again. You can beat it!
10 If you don’t succeed
Giving up is more difficult for some people than others. If you fail to stop first time, don’t be disheartened. Try again at a later date – you can do it! Remember the most successful long term ex-smokers have usually had to try several times to stop smoking… if you don’t succeed – quit again.
