Generic Name: monensin
Dosage Form: FOR ANIMAL USE ONLY
Rumensin® 90
Monensin, USP
Granulated
Net Weight: 25 kg
(55 lbs)
Elanco® AF0647
For Animal Feed Only
HIGHER
CONCENTRATION
Observe Directions
for Use
Type A Medicated Article
Do Not Feed Undiluted
Cattle fed in confinement for slaughter:
For improved feed efficiency.
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Dairy Cows: A. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake).
Growing cattle on pasture or in dry lot (stocker and feeder and dairy and beef replacement heifers):
For increased rate of weight gain.
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Mature Reproducing Beef Cows:
For improved feed efficiency when receiving supplemental feed.
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Goats: A. For the prevention of coccidiosis caused by Eimeria crandallis, Eimeria christenseni, and Eimeria ninakohlyakimovae in goats maintained in confinement.
Calves (excluding veal calves):
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
CAUTION: Do not allow horses or other equines access to feeds containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions as reduced average daily gains may result. Do not feed to lactating goats. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.
YOU MAY NOTICE:
Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment.
Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed.
Increased incidence and treatment of cystic ovaries and metritis in dairy cows fed monensin.
Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin.
Have a comprehensive and ongoing nutritional, reproductive and herd health program in place when feeding monensin to dairy cows.
NOT FOR HUMAN USE
WARNING: When mixing and handling Rumensin 90, use protective clothing, impervious gloves and a dust mask.
Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse with water.
Store at controlled room temperature (25° C). Excursions permitted to 37° C. Not to be used after date printed at top of bag.
Restricted Drug (California) – Use Only as Directed
NADA # 95-735, Approved by FDA
Elanco®, Rumensin®, and the diagonal bar are trademarks of Eli Lilly and Company.
Elanco Animal Health, A Division of Eli Lilly and Company, Indianapolis, IN 46285, USA
To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Directions for use Read All Directions Carefully Before Mixing and Feeding
Active Drug Ingredients: Monensin USP, 90 g per pound.
Cattle fed in confinement for slaughter:
For improved feed efficiency. Feeding Directions: Thoroughly mix Rumensin 90 to make one ton of complete feed that provides 5 to 40 g/ton monensin on a 90% dry matter basis (Table 1). Feed complete feed (5 to 40 g/ton) continuously to growing finishing beef cattle to provide not less than 50 nor more than 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin per head per day).
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Feeding Directions: Feed continuously (10 to 40 g/ton) to provide 0.14 to 0.42 mg per pound of body weight per day, depending upon severity of challenge, up to a maximum of 480 mg of monensin per head per day.
Dairy Cows:
For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake).
Feeding Directions:
Total Mixed Rations (“complete feed”): Feed continuously to dry and lactating dairy cows a total mixed ration (“complete feed”) containing 11 to 22 g/ton monensin on a 100% dry matter basis (Table 2).
Component Feeding Systems (including top dress): Feed continuously to dry and lactating dairy cows a Type C Medicated Feed containing 11 to 400 g/ton monensin (Table 3). The Type C Medicated Feed must be fed in a minimum of 1 pound of feed per cow per day to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. This provides cows with similar amounts of monensin they would receive by consuming total mixed rations containing 11 to 22 g/ton monensin on a 100% dry matter basis.
Growing cattle on pasture or in dry lot (stocker and feeder and dairy and beef replacement heifers):
For increased rate of weight gain. Feeding Directions: Feed at the rate of not less than 50 nor more than 200 mg per head per day in not less than one pound of Type C Medicated Feed; or after the 5th day, feed at the rate of 400 mg per head per day every other day in not less than 2 pounds of Type C Medicated Feed. The monensin concentration in the Type C Medicated Feed must be between 25 and 400 grams per ton. During the first 5 days, cattle should receive no more than 100 mg per day contained in not less than 1 pound of feed. Do not self feed.
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Feeding Directions: Feed at a rate to provide 0.14 to 0.42 mg per pound body weight per day, depending upon severity of challenge, up to a maximum of 200 mg per head per day. The monensin concentration in Type C Medicated Feed must be between 25 and 400 g/ton (Table 1). During the first 5 days, cattle should receive no more than 100 mg per day contained in not less than 1 pound of feed.
Free-Choice (Self-Fed) Medicated Feeds.
All Free-choice medicated feeds must provide not less than 50 nor more than 200 mg monensin per head per day. (1) Free-choice medicated feeds manufactured from a published formula and/or specifications do not require a Medicated Feed Mill License. (2) Other manufacturers of Type C free choice feeds with a proprietary formula and/or specifications require an FDA approved Medicated Feed Mill License.
Mature Reproducing Beef Cows (on pasture or in dry lot):
For improved feed efficiency when receiving supplemental feed. Feeding Directions: Feed continuously at a rate of 50 to 200 mg per head per day. Blend into a minimum of 1 pound of Type C Medicated Feed and either hand feed or mix into the total ration. Feed (other than the Type C Medicated Feed containing Rumensin) can be restricted to 95% (of normal requirements) when 50 mg of monensin activity is fed, and to 90% at 200 mg. Cows on pasture or in dry lot must receive a minimum of 1 pound of Type C Medicated Feed per head per day. Additionally, a minimum of 16 pounds (air-dry basis) of roughage such as silage, haylage, ammoniated straw, hay or equivalent feedstuffs should be fed in order to meet NRC recommendations for mature reproducing beef cows to gain 0.25 to 0.75 pounds per head per day. Standing, dried winter range forage may not be of adequate quality to result in improved efficiency when supplemented with Rumensin. During the first 5 days, pastured cattle should receive no more than 100 mg per day contained in not less than 1 pound of feed. Do not self feed.
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Feeding Directions: Feed at a rate of 0.14 to 0.42 mg per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 mg per head per day. During the first 5 days, pastured cattle should receive no more than 100 mg per day contained in not less than 1 pound of feed.
Goats:
A. For prevention of coccidiosis caused by Eimeria crandallis, Eimeria christenseni and Eimeria ninakohlyakimovae.
Feeding Directions: Feed complete feed (20 g/ton) continuously to goats as the sole ration (Table 1). Feed only to goats maintained in confinement.
Calves (excluding veal calves):
For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Feed at a rate of 0.14 to 1.00 mg per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 mg of monensin per head per day. The monensin concentration in Type C Medicated Feed must be between 10 and 200 g/ton (Table 1).
Type B or C Medicated Feed Mixing Directions (Dry and Liquid):
Dry or Liquid
Thoroughly mix the following amounts of Rumensin 90 to make one ton of Type B or C Medicated Feed to provide the levels shown in Table 1. Dry Only – An Intermediate blending step should be performed to ensure an adequate mix.
Liquid Limitations
The supplement pH must be between 4.3 – 7.1.
Stored liquid Type B Medicated Feeds containing Rumensin: For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
CAUTION: Inadequate mixing (recirculation or agitation) of monensin Liquid Type B or C Medicated Feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats. • If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing.
Directions for Use: Read All Directions Carefully Before Mixing and Feeding
Table 1: Mixing Directions for Cattle (excluding Dairy Cows), Goat and Calf Feeds
a 90% dry matter basis
Desired Monensin Concentration in
Amount of Rumensin 90
Medicated Feeda
Needed per ton
grams/ton
mg/lb feed
lbs.
grams
5
2.5
0.05
24
20
10
0.22
100
30
15
0.33
149
40
20
0.44
202
400
200
4.4
2016
1200
600
13.3
6048
Table 2: Mixing Directions for Dairy Cow Total Mixed Rations (TMR)a
Desired monensin concentration in Type B Feed, g/ton; as-fed basisb
Amount of Rumensin 90 needed per ton of Type B, lbc
Dry matter of TMR, %
Desired monensin concentration, g/ton in TMRd
11
15
22
lb of Type B (as-fed) needed per ton of TMR
a Amount of Type B (as-fed basis) needed to produce the TMR with desired level of monensin is as follows: ((Desired level of monensin in TMR g/ton) X (% dry matter of TMR)/g/ton of monensin in Type B) X 2000 Example Diet: Desire 11 g/ton monensin in TMR (dry matter basis), TMR contains 50% dry matter, & Type B contains 500 g/ton of monensin. Example Solution: ((11 g/ton) X (0.50 dry matter of TMR) / 500 g/ton monensin in Type B) X 2000 = 22 lb of Type B needed per ton of TMR
b It is recommended that Type B feeds containing more than 1440 g/ton be further diluted before mixing into the TMR. An example of further dilution would be a ratio of 1:10 of Type B Medicated Feed:Unmedicated Feed.
c (Desired concentration of monensin in Type B feed, g/ton)/ 90 g/lb. Example: 500 g/ton / 90 g/lb = 5.56 lb Rumensin 90 per ton of Type B
d 100% dry matter basis
500
5.56
50
60
22.00
26.40
30.00
36.00
44.00
52.80
1440
16
50
60
7.64
9.17
10.42
12.50
15.28
18.33
8,000
89
50
60
1.5
1.7
2.1
2.3
3.0
3.3
Table 3: Mixing Directions for Dairy Cows in Component Feeding Systems (Including Top Dress)a
Desired monensin concentration in Type B Feed, g/ton; as-fed basisb
Amount of Rumensin 90 needed per ton of Type B, lbc
Desired monensin concentration, g/ton in Component Feed
50
200
400
lb of Type B (as-fed) needed per ton of component feed
a Amount of Type B (as-fed basis) needed to produce the component portion of the ration with desired level of monensin is as follows: (Desired level of monensin in component, g/ton / g/ton of monensin in Type B) X 2000 Example Top Dress: Desire 50 g/ton monensin in component, & Type B contains 500 g/ton of monensin. Example Solution: (50 g/ton / 500 g/ton monensin in Type B) X 2000 = 200 lb of Type B needed per ton of Top Dress
b It is recommended that Type B feeds containing more than 1440 g/ton be further diluted before mixing into Top Dress. An example of further dilution would be a ratio of 1:10 of Type B Medicated Feed: Unmedicated Feed.
c (Desired concentration of monensin in Type B feed, g/ton)/ 90 g/lb. Example: 500 g/ton / 90 g/lb = 5.56 lb Rumensin 90 per ton of Type B
Generic Name: bioflavonoids (BYE oh FLAV oh noids)
Brand Names: Amino-Opti-C, Limbrel, P-1000, Pan C 500, Peridin-C, Rutin, Span C
What are Rutin (bioflavonoids)?
Bioflavonoids are found in the rind of green citrus fruits and in rose hips and black currants.
Bioflavonoids have been used in alternative medicine as an aid to enhance the action of vitamin C, to support blood circulation, as an antioxidant, and to treat allergies, viruses, or arthritis and other inflammatory conditions.
Not all uses for bioflavonoids have been approved by the FDA. Bioflavonoids should not be used in place of medication prescribed for you by your doctor.
Bioflavonoids is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Bioflavonoids may also be used for other purposes not listed in this product guide.
What is the most important information I should know about Rutin (bioflavonoids)?
Not all uses for bioflavonoids have been approved by the FDA. Bioflavonoids should not be used in place of medication prescribed for you by your doctor.
Bioflavonoids is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Use bioflavonoids as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.
What should I discuss with my healthcare provider before taking Rutin (bioflavonoids)?
Do not use this product if you are allergic to bioflavonoids or if you have:
Before using bioflavonoids, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use bioflavonoids if you have certain medical conditions.
Do not take bioflavonoids without first talking to your doctor if you are pregnant or planning a pregnancy. It is not known whether bioflavonoids will be harmful to an unborn baby. Do not take bioflavonoids without first talking to your doctor if you are breast-feeding a baby. It is not known whether bioflavonoids will be harmful to a nursing infant. Do not give any herbal/health supplement to a child without the advice of a doctor.
How should I take Rutin (bioflavonoids)?
When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.
If you choose to take bioflavonoids, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.
Take this medicine with a full glass of water.
Do not use different formulations of bioflavonoids at the same time without first talking to your doctor. Using different formulations together increases the risk of an bioflavonoids overdose.
If your condition does not improve, or if it appears to get worse, contact your doctor.
Store bioflavonoids at room temperature away from moisture and heat.
What happens if I miss a dose?
Consult your doctor, pharmacist, herbalist, or other healthcare provider for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Rutin (bioflavonoids)?
There are no known restrictions on food, beverages, or activities while you are taking bioflavonoids unless otherwise directed by your health care provider.
Rutin (bioflavonoids) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects are more likely to occur, and you may have none at all.
Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Rutin (bioflavonoids)?
There may be other drugs that can interact with bioflavonoids. Tell your healthcare provider about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your healthcare provider.
Where can I get more information?
Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.
Consultation with a licensed health care professional is advisable before using any herbal/health supplement. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial and coordination of treatment among all health care providers involved may be advantageous. Remember, keep this and all other prescription drug products, over-the-counter drug products, and herbal/health supplements out of the reach of children.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Zinc oxide topical (applied to the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.
Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.
Zinc oxide topical may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about RVPaque (zinc oxide (topical))?
Do not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.
Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.
Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.
Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment.
Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.
Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.
What should I discuss with my health care provider before using RVPaque (zinc oxide (topical))?
Do not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.
Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while you are using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use RVPaque (zinc oxide (topical))?
Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.
To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.
To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.
Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.
When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.
Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Wash your hands before and after inserting a rectal suppository.
Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.
Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.
For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.
Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment.
Store this medication at room temperature away from moisture and heat. Keep the lid or cap tightly closed. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting.
What happens if I miss a dose?
Since zinc oxide topical is used as needed, it is not likely that you will be on a dosing schedule. Using extra zinc oxide to make up a missed dose will not make the medication more effective.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.
An overdose of zinc oxide applied to the skin is unlikely to occur.
What should I avoid while using RVPaque (zinc oxide (topical))?
Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.
RVPaque (zinc oxide (topical)) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.
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.
What other drugs will affect RVPaque (zinc oxide (topical))?
Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.
It is not likely that other drugs you take orally or inject will have any effect on topically applied zinc oxide. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about zinc oxide topical.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Supplementing the diet to treat or prevent vitamin deficiency. It may also be used for other conditions as determined by your doctor.
Rx Support Heartburn and Acid Reflux is a vitamin combination. It works by increasing the amounts of folic acid, vitamins B6 and B12, vitamin D, and calcium in the body.
Do NOT use Rx Support Heartburn and Acid Reflux if:
you are allergic to any ingredient in Rx Support Heartburn and Acid Reflux
you are taking fluorouracil or levodopa (without carbidopa)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Rx Support Heartburn and Acid Reflux:
Some medical conditions may interact with Rx Support Heartburn and Acid Reflux. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have anemia or a condition known as Leber hereditary optic atrophy
Some MEDICINES MAY INTERACT with Rx Support Heartburn and Acid Reflux. Tell your health care provider if you are taking any other medicines, especially any of the following:
Fluorouracil because it may increase the actions and the risk of Rx Support Heartburn and Acid Reflux’s side effects
Hydantoins (eg, phenytoin) or levodopa because their effectiveness may be decreased by Rx Support Heartburn and Acid Reflux
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rx Support Heartburn and Acid Reflux 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.
How to use Rx Support Heartburn and Acid Reflux:
Use Rx Support Heartburn and Acid Reflux as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Rx Support Heartburn and Acid Reflux by mouth with food.
If you miss taking a dose of Rx Support Heartburn and Acid Reflux for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.
Ask your health care provider any questions you may have about how to use Rx Support Heartburn and Acid Reflux.
Important safety information:
Do not take large doses of vitamins while you use Rx Support Heartburn and Acid Reflux unless your doctor tells you to.
Rx Support Heartburn and Acid Reflux should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Rx Support Heartburn and Acid Reflux can cause harm to the fetus. If you become pregnant while taking Rx Support Heartburn and Acid Reflux, contact your doctor. You will need to discuss the benefits and risks of using Rx Support Heartburn and Acid Reflux while you are pregnant. If you are or will be breast-feeding while you are using Rx Support Heartburn and Acid Reflux, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Rx Support Heartburn and Acid Reflux:
All medicines may cause side effects, but many people have no, or minor side effects. 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); difficulty grasping with your hands; difficulty walking; itching, tingling, or numbness of fingers or toes; loss of muscle coordination.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.
Proper storage of Rx Support Heartburn and Acid Reflux:
Store Rx Support Heartburn and Acid Reflux at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rx Support Heartburn and Acid Reflux out of the reach of children and away from pets.
General information:
If you have any questions about Rx Support Heartburn and Acid Reflux, please talk with your doctor, pharmacist, or other health care provider.
Rx Support Heartburn and Acid Reflux is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Rx Support Heartburn and Acid Reflux. 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.
The combination of antipyrine and benzocaine is used to treat pain, and swelling caused by ear infections.
Antipyrine and benzocaine otic may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Rx-Otic (antipyrine and benzocaine otic)?
Antipyrine and benzocaine otic is for use only in your ears. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Stop using this medication and call your doctor if you have ear drainage or discharge, or worsening pain, irritation, or rash.
Talk with your doctor if your symptoms do not improve after using this medication.
What should I discuss with my healthcare provider before using Rx-Otic (antipyrine and benzocaine otic)?
You should not use antipyrine and benzocaine otic if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using antipyrine and benzocaine otic, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether antipyrine and benzocaine otic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use Rx-Otic (antipyrine and benzocaine otic)?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.
Do not use the medication in your eyes or take it by mouth. Antipyrine and benzocaine otic is for use only in the ears.
For best results, remove any ear wax or other debris before using the ear drops. Ask your doctor about safe methods of ear wax removal.
To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and place enough drops of the medicine in your ear to fill the ear canal.
Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.
After using the ear drops, keep the ear tilted upward for about 5 minutes. Ask your doctor about using a small piece of cotton to plug the ear and keep the medicine from draining out.
Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.
Talk with your doctor if your symptoms do not improve after using this medication.
Store antipyrine and benzocaine otic at room temperature away from moisture and heat. Keep the bottle properly capped.
What happens if I miss a dose?
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
An overdose of antipyrine and benzocaine applied into the ear is not likely to cause life-threatening symptoms.
What should I avoid while using this medication?
Do not use other ear drops during treatment with antipyrine and benzocaine otic without first talking to your doctor. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Antipyrine and benzocaine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.
Rx-Otic (antipyrine and benzocaine otic) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
ear drainage or discharge; or
worsening pain, irritation, 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.
What other drugs will affect Rx-Otic (antipyrine and benzocaine otic)?
It is not likely that other drugs you take orally or inject will have an effect on antipyrine and benzocaine used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about antipyrine and benzocaine otic.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Generic Name: phenylephrine and pyrilamine (FEN il EFF rin and pir IL a meen)
Brand Names: Aldex D, Deconsal CT Tannate, K-Tan, Pyril Tann-12, Pyrlex PD, Ry-T-12, Ryna-12, Ryna-12S, Rynesa 12S, V-Tann, Viravan-S, Viravan-T
What is this drug?
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
The combination of phenylephrine and pyrilamine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.
Phenylephrine and pyrilamine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about this drug?
Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine.
What should I discuss with my health care provider before taking this drug?
Do not use this medication if you are allergic to phenylephrine or pyrilamine, or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.
Before taking phenylephrine and pyrilamine, tell your doctor if you are allergic to any drugs, or if you have:
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma;
kidney disease;
an enlarged prostate; or
problems with urination.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
How should I take this drug?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.
Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.
The chewable tablet must be chewed before you swallow it.
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store this medicine at room temperature, away from heat, light, and moisture.
What happens if I miss a dose?
Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
What should I avoid while taking this drug?
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pyrilamine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.
This drug side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;
easy bruising or bleeding, fever, chills, body aches, flu symptoms;
urinating less than usual or not at all; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
nausea, stomach pain, constipation, mild loss of appetite;
dry mouth;
warmth, tingling, or redness under your skin;
blurred vision;
dizziness, drowsiness;
problems with memory or concentration;
restless or excitability (especially in children);
sleep problems (insomnia); or
skin rash or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect this drug?
Before taking phenylephrine and pyrilamine, tell your doctor if you are also taking:
a diuretic (water pill);
salicylates such as aspirin, Novasal, Doan’s Extra Strength, Salflex, Tricosal, and others;
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).
This list is not complete and there may be other drugs that can interact with phenylephrine and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about phenylephrine and pyrilamine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Rufinamide is used to control seizures (convulsions) that occur with Lennox-Gastaut syndrome (LGS). rufinamide will not cure LGS and will only work to control seizures for as long as you continue to take it.
rufinamide is available only with your doctor’s prescription.
Before Using rufinamide
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rufinamide, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to rufinamide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rufinamide in children below 4 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rufinamide in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose in patients receiving rufinamide.
Pregnancy
Pregnancy Category
Explanation
All Trimesters
C
Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using rufinamide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Carbamazepine
Estradiol Cypionate
Ethinyl Estradiol
Etonogestrel
Lamotrigine
Levonorgestrel
Medroxyprogesterone
Mestranol
Norethindrone
Norgestrel
Phenobarbital
Phenytoin
Primidone
Triazolam
Valproic Acid
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of rufinamide. Make sure you tell your doctor if you have any other medical problems, especially:
Familial Short QT syndrome (heart rhythm problem)—Should not be used in patients with this condition.
Heart rhythm problems (e.g., shortened QT interval)—Use with caution. May make this condition worse.
Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of rufinamide
Take rufinamide only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
rufinamide should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
It is best to take rufinamide with food.
Dosing
The dose of rufinamide will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of rufinamide. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
For seizures:
Adults—At first, 400 to 800 milligrams (mg) per day taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 3,200 mg per day.
Children 4 years of age and older—Dose is based on body weight. The usual dose is 10 milligrams (mg) per kilogram (kg) of body weight per day taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 45 mg/kg/day or 3,200 mg per day.
Children below 4 years of age—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of rufinamide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using rufinamide
It is very important that your doctor check your progress at regular visits to make sure rufinamide is working properly.
If you develop any unusual or strange thoughts and behavior while taking rufinamide, be sure to discuss it with your doctor. Some changes that have occurred in people taking rufinamide are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
rufinamide may cause some people to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to rufinamide before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.
Rufinamide may cause serious allergic reactions that may affect several parts of the body (e.g., liver or kidney). Check with your doctor right away if you have the following symptoms: fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, unusual tiredness, or yellow eyes or skin.
Do not stop taking rufinamide without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Avoid drinking alcohol while taking rufinamide.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
rufinamide Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Dizziness
shakiness in the legs, arms, hands, or feet
sleepiness or unusual drowsiness
trembling or shaking of the hands or feet
uncontrolled eye movements
Less common
Attack, assault, or force
chills
cough producing mucus
diarrhea
difficulty breathing
dizziness or lightheadedness
fear or nervousness
feeling of constant movement of self or surroundings
fever
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pains
nausea
pain or tenderness around the eyes and cheekbones
rash
restlessness
runny nose
sensation of spinning
shakiness and unsteady walk
shivering
shortness of breath or troubled breathing
sore throat
stuffy or runny nose
sweating
tightness in the chest
trouble in walking
trouble sitting still
trouble sleeping
unsteadiness, trembling, or other problems with muscle control or coordination
unusual tiredness or weakness
vomiting
wheezing
Rare
Black, tarry stools
bleeding gums
blood in urine or stools
burning while urinating
chest pain
difficult or painful urination
fainting
frequent urination
inability to hold urine
increased urge to urinate during the night
increased volume of pale, dilute urine
lower back or side pain
pale skin
pinpoint red spots on the skin
pounding, slow heartbeat
sore tongue
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
swollen, painful, or tender lymph glands in the neck, armpit, or groin
troubled breathing with exertion
unusual bleeding or bruising
waking to urinate at night
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Blurred vision
double vision
seeing double
Less common
Acid or sour stomach
back pain
belching
change in hearing
decreased appetite
difficulty having a bowel movement (stool)
ear drainage
earache or pain in the ear
heartburn
indigestion
itching skin
stomach discomfort, upset, or pain
upper abdominal pain
Rare
Increased appetite
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.
Potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.
Potassium chloride may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Rum-K (potassium chloride)?
You should not use this medication if you have kidney failure, Addison’s disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia). Do not crush, chew, break, or suck on an extended-release tablet or capsule. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time. Sucking on a potassium tablet can irritate your mouth or throat. Take this medication with food or just after a meal.
To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.
Serious side effects of potassium include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or mouth.
Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.
What should I discuss with my healthcare provider before taking Rum-K (potassium chloride)?
You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:
high levels of potassium in your blood (hyperkalemia);
kidney failure;
Addison’s disease (an adrenal gland disorder);
a large tissue injury such as a severe burn;
if you are severely dehydrated; or
if you are taking a “potassium-sparing” diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).
Before using potassium chloride, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease;
heart disease or high blood pressure;
a blockage in your stomach or intestines; or
chronic diarrhea (such as ulcerative colitis, Crohn’s disease).
If you have any of these conditions, you may need a dose adjustment or special tests to safely take potassium chloride.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether potassium chloride passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Rum-K (potassium chloride)?
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.
Mix the powder, granule, or liquid form of this medicine with at least 4 ounces (one-half cup) of cold water or fruit juice before taking. Drink the mixture slowly, over 5 to 10 minutes in all. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Do not crush, chew, break, or suck on an extended-release tablet or capsule. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time. Sucking on a potassium tablet can irritate your mouth or throat.
Take this medication with food or just after a meal.
Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.
Potassium-rich foods include: squash, baked potatoes (skin on), spinach, lentils, broccoli, brussels sprouts, zucchini, kidney or navy beans, raisins, watermelon, orange juice, bananas, cantaloupe, and low-fat milk or yogurt. Consume only the daily amounts recommended by your doctor or nutrition counselor.
To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.
Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store potassium chloride at room temperature away from moisture and heat. Keep the medication in a closed container.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include heavy feeling in your arms or legs, confusion, weak or shallow breathing, slow or uneven heartbeat, seizure (convulsions), or feeling like you might pass out.
What should I avoid while taking Rum-K (potassium chloride)?
Avoid taking potassium supplements or using other products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.
Rum-K (potassium chloride) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
confusion, anxiety, feeling like you might pass out;
uneven heartbeat;
extreme thirst, increased urination;
leg discomfort;
muscle weakness or limp feeling;
numbness or tingly feeling in your hands or feet, or around your mouth;
severe stomach pain, ongoing diarrhea or vomiting;
black, bloody, or tarry stools; or
coughing up blood or vomit that looks like coffee grounds.
Less serious side effects may include:
mild nausea or upset stomach;
mild or occasional diarrhea;
slight tingling in your hands or feet; or
appearance of a potassium chloride tablet in your stool.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Rum-K (potassium chloride)?
The following drugs can interact with potassium chloride. Tell your doctor if you are using any of these:
eplerenone (Inspra);
digoxin (digitalis, Lanoxin);
quinidine (Quinaglute, Quinidex, Quin-Release);
a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or
any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).
This list is not complete and there may be other drugs that can interact with potassium chloride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about potassium chloride.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Generic Name:Potassium Chloride (po-TAS-ee-um KLOR-ide) Brand Name: Examples include Kaon and Rum-K
Rum-K Liquid is used for:
Treating or preventing low potassium blood levels when the amount of potassium in the diet is inadequate. Low potassium levels may also be caused by some diseases, severe or prolonged vomiting or diarrhea, or certain medicines (eg, diuretics). Symptoms of low potassium levels include weakness, fatigue, or weakening of reflexes.
Rum-K Liquid is an electrolyte that is needed for normal functioning of cells, nerve conduction, muscle contraction, kidney function, and acid-base balance.
Do NOT use Rum-K Liquid if:
you are allergic to any ingredient in Rum-K Liquid
you have a high potassium level
you are taking a potassium-sparing diuretic (eg, triamterene)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Rum-K Liquid:
Some medical conditions may interact with Rum-K Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a high acidity of your body fluids (acidosis), adrenal gland problems, diarrhea, kidney problems, or severe burns
if you are dehydrated
Some MEDICINES MAY INTERACT with Rum-K Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:
Aldosterone blockers (eg, spironolactone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or potassium-sparing diuretics (eg, triamterene) because the risk of high blood potassium levels may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rum-K Liquid 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.
How to use Rum-K Liquid:
Use Rum-K Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Rum-K Liquid may cause stomach upset. Take Rum-K Liquid by mouth with food or after meals.
The liquid must be diluted before using. The package label will advise the minimum amount (eg, 4 oz) of cold water, juice, or other beverage to mix with the liquid. After thoroughly mixing, drink slowly over a 5- to 10-minute period.
Do not lie down for 30 minutes after taking Rum-K Liquid.
If you miss a dose of Rum-K Liquid, take it if you remember within 2 hours. If it is more than 2 hours since your missed dose, skip it and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Rum-K Liquid.
Important safety information:
Check with your doctor before you use a salt substitute or a product that has potassium in it.
Too much or too little potassium can adversely affect the heart. Be sure that your doctor and pharmacist are aware of any heart medications you are taking.
This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
Lab tests, including blood electrolytes and kidney function, may be performed while you use Rum-K Liquid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Rum-K Liquid with caution in the ELDERLY; they may be more sensitive to its effects.
Rum-K Liquid should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rum-K Liquid while you are pregnant. It is not known if Rum-K Liquid is found in breast milk. If you are or will be breast-feeding while you use Rum-K Liquid, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Rum-K Liquid:
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:
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); abnormal heartbeat; black, tarry stools; chest pain; heaviness in the legs; indigestion; irregular heartbeat; severe vomiting; stomach pain; tingling in the hands and feet; unusual tiredness or weakness; vomit that looks like coffee grounds.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fast, slow, or irregular heartbeat; limp muscles; listlessness; muscle weakness or paralysis; slow or difficult breathing.
Proper storage of Rum-K Liquid:
Store Rum-K Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rum-K Liquid out of the reach of children and away from pets.
General information:
If you have any questions about Rum-K Liquid, please talk with your doctor, pharmacist, or other health care provider.
Rum-K Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Rum-K Liquid. 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.
Rubella virus vaccine live is an active immunizing agent used to prevent infection by the rubella virus. It works by causing your body to produce its own protection (antibodies) against the virus infection.
Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease. While immunization against rubella is recommended for everyone, it is especially important for women of child-bearing age.
Immunization against rubella is also important for employees in medical facilities, adolescents and adult men, persons traveling outside the U.S., and all children 12 months of age and older, including school-aged children.
Immunization against rubella is not recommended for infants less than 12 months of age, because antibodies they received from their mothers before birth may interfere with the effectiveness of the vaccine. Children who were immunized against rubella before 12 months of age should be immunized again.
You can be considered immune to rubella only if you received rubella vaccine on or after your first birthday and have the medical record to prove it, or if you have had a blood test showing immunity to rubella. A past history of having a rubella infection does not prove immunity, because the signs of rubella infection are not reliable enough to be certain that you have had the disease.
Since vaccination with rubella vaccine may not provide protection for everyone, you may want to ask your doctor to check your immunity to the rubella virus 6 to 8 weeks following your vaccination. This may be especially important if you are a woman of child-bearing age who is likely to become pregnant in the future.
This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.
Before Using rubella virus vaccine, live
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to rubella virus vaccine, live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use is not recommended for infants less than 12 months of age. rubella virus vaccine, live has been tested in older infants and children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
Pregnancy
Pregnancy Category
Explanation
All Trimesters
C
Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Aclarubicin
Adalimumab
Aldesleukin
Alemtuzumab
Altretamine
Amonafide
Amsacrine
Asparaginase
Azacitidine
Azathioprine
Bleomycin
Broxuridine
Busulfan
Capecitabine
Carboplatin
Carmustine
Certolizumab Pegol
Chlorambucil
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Cytarabine Liposome
Dacarbazine
Dactinomycin
Daunorubicin
Daunorubicin Citrate Liposome
Decitabine
Docetaxel
Doxifluridine
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride Liposome
Edatrexate
Eflornithine
Epirubicin
Estramustine
Etanercept
Etoposide
Floxuridine
Fludarabine
Fluorouracil
Fotemustine
Gallium Nitrate
Gemcitabine
Golimumab
Hydroxyurea
Idarubicin
Ifosfamide
Irinotecan
Lomustine
Mechlorethamine
Melphalan
Mercaptopurine
Methotrexate
Mitolactol
Mitomycin
Mitotane
Mitoxantrone
Mycophenolic Acid
Oxaliplatin
Paclitaxel
Pegaspargase
Pentostatin
Pipobroman
Pirarubicin
Plicamycin
Procarbazine
Raltitrexed
Rilonacept
Rituximab
Sirolimus
Streptozocin
Tacrolimus
Teceleukin
Tegafur
Temsirolimus
Teniposide
Thioguanine
Thiotepa
Topotecan
Treosulfan
Trimetrexate
Trofosfamide
Uracil Mustard
Vinblastine
Vincristine
Vincristine Liposome
Vindesine
Vinorelbine
Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Abatacept
Leflunomide
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine
Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine
Proper Use of rubella virus vaccine, live
Dosing
The dose of rubella virus vaccine, live will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of rubella virus vaccine, live. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For injection dosage form:
For prevention of rubella:
Adults and children 12 months of age and older—One dose injected under the skin.
Children up to 12 months of age—Use is not recommended.
Precautions While Using rubella virus vaccine, live
Do not become pregnant for 3 months after receiving rubella vaccine without first checking with your doctor. There is a chance that this vaccine may cause birth defects.
Tell your doctor that you have received this vaccine:
if you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.
if you are to receive blood transfusions or other blood products within 2 weeks after receiving this vaccine.
if you are to receive gamma globulin or other immune globulins within 2 weeks after receiving this vaccine.
rubella virus vaccine, live Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Symptoms of allergic reaction
Difficulty in breathing or swallowing
hives
itching, especially of feet or hands
reddening of skin, especially around ears
swelling of eyes, face, or inside of nose
unusual tiredness or weakness (sudden and severe)
Check with your doctor as soon as possible if any of the following side effects occur:
Less common
Pain or tenderness of eyes
Rare
Bruising or purple spots on skin
confusion
convulsions (seizures)
headache (severe or continuing)
pain, numbness, or tingling of hands, arms, legs, or feet
stiff neck
unusual irritability
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Burning or stinging at place of injection
skin rash
swelling of glands in neck
Less common
Aches or pain in joints
headache (mild), sore throat, runny nose, or fever
itching, swelling, redness, tenderness, or hard lump at place of injection
nausea
vague feeling of bodily discomfort
The above side effects (especially aches or pain in joints) are more likely to occur in adults, particularly women.
Some of the above side effects may not occur until 1 to 4 weeks after immunization and usually last less than 1 week. Aches or pain in joints may not occur until 1 to 10 weeks after immunization, and usually lasts less than 1 week. Check with your doctor if this side effect continues or is bothersome.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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