Resflor Gold

Dosage Form: FOR ANIMAL USE ONLY
Resflor

GOLD®

(Florfenicol and Flunixin Meglumine)

Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

For subcutaneous use in beef and non-lactating dairy cattle only.

Not for use in female dairy cattle 20 months of age or older or in calves to be processed for veal.

PRODUCT INFORMATION

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Resflor Gold Description

Resflor Gold® is an injectable solution of the synthetic antibiotic florfenicol and the non-steroidal anti-inflammatory drug (NSAID) flunixin. Each milliliter of sterile Resflor Gold® contains 300 mg florfenicol, 16.5 mg flunixin as flunixin meglumine, 300 mg 2-pyrrolidone, 35 mg malic acid, and triacetin qs.

INDICATION

Resflor Gold® is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

Resflor Gold Dosage and Administration

Resflor Gold® should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated. For the 500mL vial, do not puncture the stopper more than 10 times.

* Do not administer more than 10 mL at each site.
Resflor Gold® Dosage Guide*
ANIMAL WEIGHT (lb)	DOSAGE (mL)
100	6.0	Recommended Injection Location
200	12.0
300	18.0
400	24.0
500	30.0
600	36.0
700	42.0
800	48.0
900	54.0
1000	60.0

Contraindications

Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.

Warnings

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains material that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.

For customer service or to obtain a copy of the MSDS, call 1-800-211-3573. For technical assistance or to report suspected adverse reactions, call 1-800-219-9286.

Precautions

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully monitored. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that have not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concominant use of Resflor Gold® with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.

Flunixin is a cyclo-oxygenase inhibitory NSAID, and as with others in this class, adverse effects may occur with its use. The most frequently reported adverse effects have been gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported for other drugs in this class.

Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. NSAIDs are known to have potential effects on both parturition and the estrous cycle. There may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of the estrous cycle. The effects of flunixin on imminent parturition have not been evaluated in a controlled study. NSAIDs are known to have the potential to delay parturition through a tocolytic effect.

Resflor Gold®, when administered as directed, may induce a transient reaction at the site of injection and underlying tissues that may result in trim loss of edible tissue at slaughter.

RESIDUE WARNINGS

Animals intended for human consumption must not be slaughtered within 38 days of treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

Adverse Reactions

Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle. In cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use of flunixin meglumine.

Resflor Gold - Clinical Pharmacology

The pharmacokinetics (PK) of florfenicol (Table 1) and flunixin (Table 2) after subcutaneous injection of Resflor Gold® is described below:

Table 1. Mean (n=28) pharmacokinetic parameters for florfenicol in cattle after a single subcutaneous administration of Resflor Gold (florfenicol dose of 40 mg/kg BW).

Mean Florfenicol PK parameters in Cattle
PK Parameter	AUC 0-t * (ng*hr/mL)	AUC0-inf † (ng*hr/mL)	Cmax‡ (ng/mL)	Tmax§ (hr)	T½¶ (hr)	MRT0-inf # (hr)
Mean	242527	247577	11151	6.25	28.5	27.3
SDß	42741	41391	4194	3.87	9.91	11.6

Table 2. Mean (n=28) pharmacokinetic parameters for flunixin in cattle after a single subcutaneous administration of Resflor Gold (flunixin dose of 2.2 mg/kg BW).

Mean Flunixin PK parameters in Cattle
PK Parameter	AUC 0-t * (ng*hr/mL)	AUC0-inf † (ng*hr/mL)	Cmax‡ (ng/mL)	Tmax§ (hr)	T½¶ (hr)	MRT0-inf # (hr)
* AUC 0-t = Area under the plasma-concentration-time curve (AUC) from time zero to the last quantifiable concentrations † AUC0-inf = AUC from time zero to infinity ‡ Cmax = Maximum plasma concentration § Tmax = Time at which Cmax was observed ¶ T½ = Terminal elimination half-life # MRT0-inf = Mean residence time from time zero to infinity Þ n=27 ß SD = Standard deviation
Mean	13370	14448Þ	1913	1.14	9.5Þ	11.4
SD ß	4964	5116	791	0.97	3.27	4.41

MICROBIOLOGY

Florfenicol is a synthetic, broad-spectrum antibiotic active against many Gram-negative and Gram-positive bacteria isolated from domestic animals. It acts by binding to the 50S ribosomal subunit and inhibiting bacterial protein synthesis. Florfenicol is generally considered a bacteriostatic drug, but exhibits bactericidal activity against certain bacterial species. In vitro studies demonstrate that florfenicol is active against the BRD pathogens M. haemolytica, P. multocida, and H. somni, and that florfenicol exhibits bactericidal activity against strains of M. haemolytica and H. somni.

The minimum inhibitory concentrations (MICs) of florfenicol were determined for BRD isolates obtained from calves enrolled in BRD field studies in the U.S. in 2006 using methods recommended by the Clinical and Laboratory Standards Institute (M31-A2). Isolates were obtained from pre-treatment nasal swabs from all calves enrolled at all four sites, post-treatment nasal swabs from treatment failures in the Resflor Gold and saline control treatment groups at three sites, and lung tissue from one calf that died in the saline control treatment group. The results are shown in Table 3.

Table 3. Florfenicol MIC values* of indicated pathogens isolated from cattle with naturally-ocurring BRD.

Indicated pathogens	Year of isolation	Number of isolates	MIC50† (μg/mL)	MIC90† (μg/mL)	MIC range (μg/mL)
* The correlation between in vitro susceptibility data and clinical effectiveness is unknown. † The lowest MIC to encompass 50% and 90% of the most susceptible isolates, respectively.
Mannheimia haemolytica	2006	183	1.0	1.0	0.5 to 32
Pasteurella multocida	2006	139	0.5	0.5	≤ 0.125 to 16
Histophilus somni	2006	84	≤ 0.125	≤ 0.125	≤ 0.125 to 0.25

EFFECTIVENESS

In a multi-site field study, calves with naturally-occurring BRD were treated with Resflor Gold®, Nuflor Gold® (NADA 141-265), or saline. A treatment success was defined as a calf with normal respiration to mild respiratory distress, normal attitude to mildly depressed, and a rectal temperature < 104.0 °F on Day 11. The treatment success rate for BRD for the Resflor Gold® treatment group (68.4%) was statistically significantly greater (p = 0.0255) compared to the saline control treatment group (42.9%). Resflor Gold® was non-inferior to Nuflor Gold® for the treatment of BRD, with a one-sided 95% lower confidence bound for the difference between the two treatments equal to -13.2%.

In the same study, the change in rectal temperature from pre-treatment to six hours post-treatment was evaluated to determine the effectiveness of Resflor Gold® for the control of BRD-associated pyrexia. The proportion of calves whose rectal temperatures decreased by ≥ 2.0 °F from pre-treatment to six hours post-treatment was statistically significantly greater (p = 0.0019) in the Resflor Gold® treatment group compared to the saline control treatment group. The mean decrease in rectal temperature from pre-treatment to six hours post-treatment was statistically significantly greater in the Resflor Gold® treatment group compared to the Nuflor Gold® and saline control treatment groups (p = 0.0031 and 0.0002, respectively).

ANIMAL SAFETY

A target animal safety study was conducted to evaluate the effects of Resflor Gold® when administered to cattle subcutaneously at 1X, 3X, or 5X the labeled dose for three consecutive days (3X the labeled duration). Decreased feed and water consumption, and decreased body weights (secondary to decreased feed consumption) were observed in the 1X, 3X, and 5X groups. Injection site swellings were noted in the 1X, 3X, and 5X groups.

A separate injection site study was conducted in cattle. The study demonstrated that Resflor Gold®, when administered according to the label directions, may induce a transient local reaction in the subcutaneous and underlying muscle tissue.

STORAGE INFORMATION

Do not store above 30°C (86°F). Use within 28 days of first use.

How is Resflor Gold Supplied

Resflor Gold® is available in 100, 250, and 500 mL sterile, multiple-dose, glass vials.

Made in Germany

Intervet Inc. Roseland, NJ 07068

©2009, Intervet Inc. All rights reserved.

May 2009

US 3448 V

NADA 141-299, Approved by FDA.

US 3448 R

PRINCIPAL DISPLAY PANEL - 100 mL Carton

100 mL

Multiple Dose Vial

300mg/16.5mg/mL

Sterile

Resflor

GOLD®

Florfenicol and

Flunixin Meglumine

(Florfenicol and Flunixin Meglumine)

Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

For subcutaneous use in beef and

non-lactating dairy cattle only.

Not for use in female dairy cattle

20 months of age or older or in calves

to be processed for veal.

CAUTION: Federal law restricts

this drug to use by or on the order of

a licensed veterinarian.

NADA 141-299, Approved by FDA.

Intervet

Schering-Plough Animal Health

Resflor Gold  florfenicol and flunixin meglumine  injection

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0061-4305 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Florfenicol (Florfenicol) Florfenicol 300 mg  in 1 mL Flunixin Meglumine (Flunixin) Flunixin Meglumine 16.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength malic acid   triacetin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0061-4305-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE 1 100 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0061-4305-01) 2 0061-4305-02 250 mL In 1 VIAL, MULTI-DOSE None 3 0061-4305-03 500 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141299	12/15/2009

Labeler - Schering Corporation (001317601)

Establishment
Name	Address	ID/FEI	Operations
Essex Animal Health Friesoythe		330363511	ANALYSIS, MANUFACTURE

Revised: 12/2009Schering Corporation

Didronel

Generic Name: etidronate (e ti DROE nate)

Brand Names: Didronel

What is etidronate?

Etidronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body.

Etidronate is used to treat Paget's disease, and to treat conditions of irregular bone growth due to hip fracture or spinal cord injury.

Etidronate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about etidronate?

Take etidronate with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an etidronate tablet. For at least the first 2 hours after taking etidronate, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins or mineral supplements.

Especially avoid drinking milk or eating dairy products within 2 hours after taking etidronate. Also avoid taking supplements that contain calcium, magnesium, iron, or aluminum (such as in multivitamins with iron, and in many types of antacids).

Some people using medicines similar to etidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using etidronate. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before taking etidronate?

Do not take etidronate if you have a condition called osteomalacia (softening of the bones), or a problem with the movement of muscles in your esophagus.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  diarrhea;

  
  


• 
  

  a bone fracture;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  a stomach or esophageal ulcer or disease; or

  
  


• kidney disease.

Some people using medicines similar to etidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether etidronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether etidronate 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 etidronate?

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.

Do not crush, chew, or suck the pill. Swallow it whole. Take each etidronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an etidronate tablet. For at least the first 2 hours after taking etidronate, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins or mineral supplements.

It is important to take etidronate regularly to get the most benefit.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using etidronate. You may need to stop using the medicine for a short time.

After you stop taking etidronate, you must stay off the medication for at least 90 days before starting etidronate therapy again.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Etidronate is only part of a complete program of treatment that may also include taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

See also: Didronel dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes.

What should I avoid while taking etidronate?

Avoid drinking milk or eating dairy products within 2 hours after taking etidronate. Also avoid taking supplements that contain calcium, magnesium, iron, or aluminum (such as in multivitamins with iron, and in many types of antacids).

Etidronate 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 etidronate and call your doctor at once if you have any of these serious side effects:

• 
  

  painful or difficult swallowing;

  
  


• 
  

  severe heartburn, burning pain in your upper stomach, or coughing up blood;

  
  


• 
  

  severe joint, bone, or muscle pain;

  
  


• 
  

  jaw pain, numbness, or swelling;

  
  


• 
  

  severe diarrhea;

  
  


• 
  

  bone fracture; or

  
  


• 
  

  a red, blistering, peeling skin rash.

  
  

Less serious side effects may include:

• 
  

  mild diarrhea;

  
  


• 
  

  headache, confusion;

  
  


• 
  

  muscle cramps, joint pain; or

  
  


• 
  

  numbness or tingly feeling.

  
  

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 etidronate?

Before taking etidronate, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete and other drugs may interact with etidronate. 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.

More Didronel resources

• Didronel Side Effects (in more detail)
• Didronel Dosage
• Didronel Use in Pregnancy & Breastfeeding
• Drug Images
• Didronel Drug Interactions
• Didronel Support Group
• 0 Reviews for Didronel - Add your own review/rating

• Didronel Prescribing Information (FDA)


• Didronel Monograph (AHFS DI)


• Didronel Advanced Consumer (Micromedex) - Includes Dosage Information


• Didronel Consumer Overview


• Didronel MedFacts Consumer Leaflet (Wolters Kluwer)


• Etidronate Prescribing Information (FDA)

Compare Didronel with other medications

• Heterotopic Ossification, Spinal Cord Injury
• Heterotopic Ossification, Total Hip Arthroplasty
• Hypercalcemia of Malignancy
• Osteoporosis
• Paget's Disease

Where can I get more information?

• Your pharmacist can provide more information about etidronate.

See also: Didronel side effects (in more detail)

Buprenorphine and naloxone Sublingual

bue-pre-NOR-feen hye-droe-KLOR-ide, nal-OX-one hye-droe-KLOR-ide

Commonly used brand name(s)

In the U.S.

• Suboxone

Available Dosage Forms:

• Tablet


• Film

Therapeutic Class: Opioid Dependency

Pharmacologic Class: Buprenorphine

Chemical Class: Buprenorphine

Uses For buprenorphine and naloxone

Buprenorphine and naloxone sublingual tablet is used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxonesublingual film is used for maintenance treatment of opioid (narcotic) dependence. It should be used in patients who have already been treated with buprenorphine sublingual tablets.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine and naloxone combination. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.

buprenorphine and naloxone is available only with your doctor's prescription.

Before Using buprenorphine and naloxone

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 buprenorphine and naloxone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to buprenorphine and naloxone 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 buprenorphine and naloxone sublingual tablet or sublingual film in children younger than 18 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 buprenorphine and naloxone combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking buprenorphine and naloxone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using buprenorphine and naloxone 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.

• Alfentanil


• Alphaprodine


• Atazanavir


• Codeine


• Diazepam


• Dihydrocodeine


• Fentanyl


• Hydrocodone


• Hydromorphone


• Levorphanol


• Meperidine


• Methadone


• Morphine


• Morphine Sulfate Liposome


• Oxycodone


• Oxymorphone


• Propoxyphene


• Sufentanil


• Tapentadol

Using buprenorphine and naloxone 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.

• Clonidine


• Darunavir


• Etravirine


• Yohimbine

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 buprenorphine and naloxone. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, or history of or


• Asthma, severe or


• Brain tumor, history of or


• Breathing problems, severe (e.g., hypoxia, hypercapnia) or


• Chronic obstructive pulmonary disease (COPD) or


• CNS depression or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Gallbladder disease or gallstones or


• Head injuries, history of or


• Heart disease or


• Hepatitis B or C, history of or


• Hypothyroidism (an underactive thyroid) or


• Hypovolemia (low blood volume) or


• Kyphoscoliosis (curvature of the spine with breathing problems) or


• Mental illness or


• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Hypotension (low blood pressure) or


• Respiratory depression (very slow breathing)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of buprenorphine and naloxone

Take buprenorphine and naloxone exactly 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.

If you are using the sublingual tablet: Do not crush or swallow it. Place the tablet under the tongue until it is dissolved. If you take 2 or more tablets at a time, place all of the tablets under the tongue together. If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all tablets have been taken.

If you are using the sublingual film:

• Place the film under the tongue until it is dissolved.


• If you need to take an additional film, place the new film on the opposite side from the first film.


• Do not chew, swallow, or move the film after placing it under the tongue.

buprenorphine and naloxone should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of buprenorphine and naloxone 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 buprenorphine and naloxone. 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 sublingual dosage form (film):
  
  • For maintenance treatment of opioid dependence:
    
    • Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For sublingual dosage form (tablets):
  
  • For treatment of opioid dependence:
    
    • Adults—12 to 16 milligrams (mg) as a single dose once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of buprenorphine and naloxone, 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.

To dispose any unneeded buprenorphine and naloxone films: remove the film from its foil package and flush down the toilet. Do not flush the foil packages or cartons down the toilet.

Precautions While Using buprenorphine and naloxone

It is very important that your doctor check your progress while you are using buprenorphine and naloxone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused films in a safe and secure place. People who are addicted to drugs might want to steal buprenorphine and naloxone.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using buprenorphine and naloxone. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.

buprenorphine and naloxone will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using buprenorphine and naloxone.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

buprenorphine and naloxone may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to buprenorphine and naloxone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

buprenorphine and naloxone may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using buprenorphine and naloxone.

If you have been using buprenorphine and naloxone regularly for several weeks or longer, do not suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using buprenorphine and naloxone while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using buprenorphine and naloxone.

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.

buprenorphine and naloxone 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

• Cough or hoarseness


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• fever or chills


• flushing or redness of the skin, especially on the face and neck


• headache


• lower back or side pain


• painful or difficult urination


• sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision


• confusion


• difficult or troubled breathing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drowsiness


• irregular, fast, slow, or shallow breathing


• pale or blue lips, fingernails, or skin


• pinpoint pupils


• relaxed and calm feeling


• shortness of breath


• sleepiness


• unusual tiredness or weakness

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

• Abdominal or stomach pain


• difficulty having a bowel movement (stool)


• lack or loss of strength


• nausea


• pain


• sleeplessness


• trouble sleeping


• unable to sleep


• vomiting

Less common

• Back pain


• diarrhea


• runny nose


• sneezing


• stuffy nose

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.

See also: buprenorphine and naloxone Sublingual side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More buprenorphine and naloxone Sublingual resources

• Buprenorphine and naloxone Sublingual Side Effects (in more detail)
• Buprenorphine and naloxone Sublingual Use in Pregnancy & Breastfeeding
• Buprenorphine and naloxone Sublingual Drug Interactions
• Buprenorphine and naloxone Sublingual Support Group
• 303 Reviews for Buprenorphine and naloxone Sublingual - Add your own review/rating

Compare buprenorphine and naloxone Sublingual with other medications

• Opiate Dependence

Rolaids Soft Chew

Generic Name: calcium carbonate (KAL see um KAR boe nate)

Brand Names: Alka-Mints, Cal-Gest, Calcarb, Calci Mix, Calci-Chew, Calci-Mix, Calcium Concentrate, Calcium Liquid Softgel, Calcium Oyster Shell, Caltrate, Chooz, Extra Strength Mylanta Calci Tabs, Icar Prenatal Chewable Calcium, Maalox Antacid Barrier, Maalox Childrens', Maalox Quick Dissolve, Maalox Quick Dissolve Maximum Strength, Maalox Regular Strength, Mylanta Child, Nephro Calci, Os-Cal 500, Oysco 500, Oyst Cal 500, Oyster Cal, Oyster Calcium, Oyster Shell, Pepto Children's, Rolaids Sodium Free, Rolaids Soft Chew, Titralac, Tums, Tums 500, Tums E-X, Tums Kids, Tums QuikPak, Tums Ultra

What is Rolaids Soft Chew (calcium carbonate)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Rolaids Soft Chew (calcium carbonate)?

Do not take calcium carbonate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines. Calcium carbonate works best if you take it with food.

What should I discuss with my healthcare provider before taking Rolaids Soft Chew (calcium carbonate)?

To make sure you can safely take calcium carbonate, tell your doctor if you have any of these other conditions:

• 
  

  a history of kidney stones; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium carbonate if you are pregnant. Talk to your doctor before taking calcium carbonate if you are breast-feeding a baby.

How should I take Rolaids Soft Chew (calcium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Calcium carbonate works best if you take it with food. Swallow the calcium carbonate tablet or capsule with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Use the calcium carbonate powder as directed. Allow the powder to dissolve completely, then consume the mixture.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-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. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.

What should I avoid while taking Rolaids Soft Chew (calcium carbonate)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Rolaids Soft Chew (calcium carbonate) 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 may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  decreased appetite;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth or increased thirst; or

  
  


• 
  

  urinating more than usual.

  
  

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 can affect Rolaids Soft Chew (calcium carbonate)?

Calcium carbonate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids or other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or vitamin D supplements; or

  
  


• 
  

  doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium carbonate. 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.

More Rolaids Soft Chew resources

• Rolaids Soft Chew Side Effects (in more detail)
• Rolaids Soft Chew Use in Pregnancy & Breastfeeding
• Rolaids Soft Chew Drug Interactions
• 0 Reviews for Rolaids Soft Chew - Add your own review/rating

• Calcium Carbonate MedFacts Consumer Leaflet (Wolters Kluwer)


• Titralac Consumer Overview


• Titralac MedFacts Consumer Leaflet (Wolters Kluwer)


• Tums Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Rolaids Soft Chew with other medications

• Indigestion

Where can I get more information?

• Your doctor or pharmacist can provide more information about calcium carbonate.

See also: Rolaids Soft Chew side effects (in more detail)

Diphenhydramine Elixir

Pronunciation: DYE-fen-HYE-dra-meen
Generic Name: Diphenhydramine
Brand Name: Examples include Benadryl Allergy and Dytuss

Diphenhydramine Elixir is used for:

Preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough. It may also be used for other conditions as determined by your doctor.

Diphenhydramine Elixir is an antihistamine and anticholinergic. It works by blocking the action of histamine, reducing the symptoms of an allergic reaction. It also works in the brain to cause sedation.

Do NOT use Diphenhydramine Elixir if:

• you are allergic to any ingredient in Diphenhydramine Elixir or other similar medicines


• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Diphenhydramine Elixir:

Some medical conditions may interact with Diphenhydramine Elixir. 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 fast, slow, or irregular heartbeat


• if you have a history of asthma; chronic obstructive pulmonary disease (COPD); chronic bronchitis; lung problems (eg, emphysema); shortness of breath; sleep apnea; heart blood vessel problems; stroke; seizures; a blockage of your stomach, intestine, or bladder; difficulty urinating; diabetes; ulcers; an enlarged prostate or other prostate problems; glaucoma; heart problems; high blood pressure; the blood disease porphyria; phenylketonuria; or an overactive thyroid

Some MEDICINES MAY INTERACT with Diphenhydramine Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diphenhydramine Elixir 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 Diphenhydramine Elixir:

Use Diphenhydramine Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Diphenhydramine Elixir by mouth with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Use Diphenhydramine Elixir exactly as directed on the package, unless instructed differently by your doctor. If you are taking Diphenhydramine Elixir without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of Diphenhydramine Elixir and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose 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 Diphenhydramine Elixir.

Important safety information:

• Diphenhydramine Elixir may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Diphenhydramine Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Diphenhydramine Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Diphenhydramine Elixir may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Diphenhydramine Elixir may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Diphenhydramine Elixir for a few days before the tests.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Diphenhydramine Elixir may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Diphenhydramine Elixir. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Diphenhydramine Elixir has diphenhydramine in it. Before you start any new medicine, check the label to see if it has diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• If your symptoms persist for more than 1 week or if you develop a fever, contact your health care provider.


• Do not use Diphenhydramine Elixir for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Use Diphenhydramine Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.


• Different brands of Diphenhydramine Elixir may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diphenhydramine Elixir while you are pregnant. Diphenhydramine Elixir is found in breast milk. If you are or will be breast-feeding while you use Diphenhydramine Elixir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Diphenhydramine Elixir:

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; dry mouth, throat, and nose; excitability; thickening of mucus in nose or throat.

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); convulsions; fast heartbeat or pounding in the chest; decreased alertness; hallucinations; tremor; wheezing.

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.

Proper storage of Diphenhydramine Elixir:

Store Diphenhydramine Elixir 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 Diphenhydramine Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Diphenhydramine Elixir, please talk with your doctor, pharmacist, or other health care provider.


• Diphenhydramine Elixir 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.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Diphenhydramine Elixir. 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Diphenhydramine resources

• Diphenhydramine Use in Pregnancy & Breastfeeding
• Drug Images
• Diphenhydramine Drug Interactions
• Diphenhydramine Support Group
• 58 Reviews for Diphenhydramine - Add your own review/rating

Compare Diphenhydramine with other medications

• Allergic Reactions
• Cold Symptoms
• Cough
• Extrapyramidal Reaction
• Hay Fever
• Insomnia
• Motion Sickness
• Nausea/Vomiting
• Pruritus
• Urticaria

Brompheniramine

Generic Name: brompheniramine (brome feh NEER a meen)

Brand names: BroveX, BroveX CT, Dimetane, Dimetane Extentab, Dimetapp Allergy, Dimetapp Allergy Liquigel, Lodrane 12 Hour, ...show all 28 brand names.Cophene B, Nasahist B, Rohist, ND-Stat, Codimal A, Histaject, Prop-A-Tane, Siltane, VaZol, Bidhist, Lodrane XR, B-Vex, Lodrane 24, P-Tex, Bromaphen, J-Tan, J-Tan PD, Tanacof-XR, LoHist-12, Respa-BR, Bromax

What is brompheniramine?

Brompheniramine is an antihistamine. Brompheniramine blocks the effects of the naturally occurring chemical histamine in the body.

Brompheniramine is used to sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Brompheniramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about brompheniramine?

Use caution when driving, operating machinery, or performing other hazardous activities. Brompheniramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine. Do not crush, chew, or break the extended- or timed-release forms of brompheniramine. Swallow them whole. They are specially formulated to release the medication slowly in the body.

What should I discuss with my healthcare provider before taking brompheniramine?

Do not take brompheniramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking brompheniramine, talk to your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

You may not be able to take brompheniramine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Brompheniramine is in the FDA pregnancy category C. This means that it is not known whether brompheniramine will be harmful to an unborn baby. Do not take brompheniramine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Brompheniramine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing infant. Do not take brompheniramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from brompheniramine. You may require a lower dose of this medication.

How should I take brompheniramine?

Take brompheniramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Brompheniramine can be taken with or without food.

Do not crush, chew, or break the extended- or timed-release forms of brompheniramine. Swallow them whole. They are specially formulated to release the medication slowly in the body.

To ensure that you get a correct dose, measure the liquid form of brompheniramine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is prescribed or is recommended on the package. The maximum amount of brompheniramine that you should take in 1 day is 24 mg. The regular-release tablets and the syrup are usually taken every 4 to 6 hours as needed (four to six times a day). The sustained-release tablets and capsules are usually taken every 8 to 12 hours as needed (two or three times a day). If your symptoms do not improve, or if they worsen, contact your healthcare provider. Store brompheniramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a brompheniramine overdose may include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking brompheniramine?

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.

Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine.

Brompheniramine side effects

Stop taking brompheniramine and seek emergency medical attention if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take brompheniramine and talk to your doctor if you experience

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Brompheniramine Dosing Information

Usual Adult Dose for Cold Symptoms:

Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.

Extended Release: 6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

Usual Adult Dose for Allergic Rhinitis:

Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.

Extended Release: 6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

Usual Adult Dose for Urticaria:

Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.

Extended Release: 6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

Usual Adult Dose for Allergic Reaction:

Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.

Extended Release: 6 mg to mg 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

IV, IM, subcutaneous: 5 mg to 20 mg every 6 to 12 hours. Duration of action is 3 to 12 hours.
Maximum parenteral dose 40 mg/day.

Usual Pediatric Dose for Allergic Rhinitis:

Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.

2 to 6 years:
Extended Release suspension:
2 mg orally twice daily, not to exceed 2 doses in 24 hours.

6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release suspension:
4 mg orally twice daily, not to exceed 2 doses in 24 hours.

> 12 years:
Immediate Release:
4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg sustained release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

Usual Pediatric Dose for Cold Symptoms:

Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.

2 to 6 years:
Extended Release suspension:
2 mg orally twice daily, not to exceed 2 doses in 24 hours.

6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release suspension:
4 mg orally twice daily, not to exceed 2 doses in 24 hours.

> 12 years:
Immediate Release:
4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg sustained release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

Usual Pediatric Dose for Urticaria:

Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.

2 to 6 years:
Extended Release suspension:
2 mg orally twice daily, not to exceed 2 doses in 24 hours.

6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release suspension:
4 mg orally twice daily, not to exceed 2 doses in 24 hours.

> 12 years:
Immediate Release:
4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg sustained release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

Usual Pediatric Dose for Allergic Reaction:

Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.

2 to 6 yrs:
Extended Release Suspension:
2.5 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release Suspension:
5 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.


> 12 years:
Immediate Release:
4 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.

Maximum oral dose 24 mg/day.

IM, IV, subcutaneous :
0.5 mg/kg/day divided every 6 to 8 hours.

> 12 years:
5 mg to 20 mg every 6 to 12 hours. Duration of action is 3 to 12 hours.
Maximum parenteral dose 40 mg/day.

What other drugs will affect brompheniramine?

Do not take brompheniramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.

Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.

Drugs other than those listed here may also interact with brompheniramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More brompheniramine resources

• Brompheniramine Side Effects (in more detail)
• Brompheniramine Use in Pregnancy & Breastfeeding
• Drug Images
• Brompheniramine Drug Interactions
• Brompheniramine Support Group
• 6 Reviews for Brompheniramine - Add your own review/rating

• Brompheniramine 12-Hour Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Brompheniramine Professional Patient Advice (Wolters Kluwer)


• Brompheniramine Maleate, Dexbrompheniramine Maleate Monograph (AHFS DI)


• Brovex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Brovex CT Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lodrane 24 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• VaZol Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare brompheniramine with other medications

• Allergic Reactions
• Cold Symptoms
• Hay Fever
• Urticaria

Where can I get more information?

• Your pharmacist has more information about brompheniramine written for health professionals that you may read.

See also: brompheniramine side effects (in more detail)

Rifapentine

Generic Name: rifapentine (RIF a PEN teen)

Brand Names: Priftin

What is rifapentine?

Rifapentine is an antibiotic. It prevents bacteria from multiplying in your body.

Rifapentine is used together with other antibiotics to treat tuberculosis.

Rifapentine must always be used in combination with other antibiotics.

Rifapentine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about rifapentine?

You should not take this medication if you are allergic to rifapentine, rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Before taking rifapentine, tell your doctor if you have porphyria.

Rifapentine should not be used without other antibiotics. Be sure to take all your medications as prescribed by your doctor.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Rifapentine can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifapentine.

Do not wear dentures or contact lenses while taking rifapentine. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain a pair of contact lenses.

What should I discuss with my healthcare provider before taking rifapentine?

You should not take this medication if you are allergic to rifapentine, rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Before taking rifapentine, tell your doctor if you have porphyria.

Rifapentine should not be used without other antibiotics. Be sure to take all your medications as prescribed by your doctor.

Before using rifapentine, tell your doctor if you are allergic to any drugs, or if you have liver disease. You may need a dose adjustment or special tests to safely take rifapentine. Your doctor will tell you if any of your medication doses need to be changed.

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. Rifapentine can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifapentine. It is not known whether rifapentine 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. Rifapentine may cause a red-orange discoloration of breast milk.

How should I take rifapentine?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

You may take rifapentine with or without food. Take the medication with food if it causes stomach upset, nausea, or vomiting.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Store rifapentine at room temperature away from moisture and heat. Keep the bottle tightly closed.

See also: Rifapentine dosage (in more detail)

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, wait until then to take the medicine and skip the missed dose. 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 headache, heartburn, nausea, or urinating more than usual.

What should I avoid while taking rifapentine?

Do not wear dentures or contact lenses while taking rifapentine. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain a pair of contact lenses.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Rifapentine 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  blood in your urine;

  
  


• 
  

  pale skin, weakness, easy bruising or bleeding; or

  
  


• 
  

  fever, chills, body aches, flu symptoms.

  
  

Less serious side effects may include:

• 
  

  red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;

  
  


• 
  

  nausea, vomiting, diarrhea, loss of appetite;

  
  


• 
  

  stomach pain;

  
  


• 
  

  headache;

  
  


• 
  

  joint pain; or

  
  


• 
  

  mild 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.

Rifapentine Dosing Information

Usual Adult Dose for Tuberculosis -- Active:

Initial intensive phase dose: 600 mg orally two times a week with at least 72 hours between doses for 2 months

Rifapentine should be administered by direct observation of therapy in combination with daily companion drugs (such as ethambutol, pyrazinamide, and streptomycin) during the initial treatment phase. The determination of the companion drugs should be made by the treating physician and depends on susceptibility testing results as well as treatment phase.

Continuation phase dose: Following the 2 month intensive phase, 600 mg orally once a week for at least 4 months

The continuation treatment phase may consist of rifapentine with isoniazid or an appropriate antituberculosis agent for susceptible organisms by direct observation therapy. The treating physician should consult current guidelines for additional direction on other possible components of the continuation phase as well as for directions on extending this phase.

Usual Pediatric Dose for Tuberculosis -- Active:

15 years or older:
Initial intensive phase dose: 600 mg orally two times a week with at least 72 hours between doses for 2 months

Rifapentine should be administered by direct observation of therapy in combination with daily companion drugs (such as ethambutol, pyrazinamide, and streptomycin) during the initial treatment phase. The determination of the companion drugs should be made by the treating physician and depends on susceptibility testing results as well as treatment phase.

Continuation phase dose: Following the 2 month intensive phase, 600 mg orally once a week for at least 4 months

The continuation treatment phase may consist of rifapentine with isoniazid or an appropriate antituberculosis agent for susceptible organisms by direct observation therapy. The treating physician should consult current guidelines for additional direction on other possible components of the continuation phase as well as for directions on extending this phase.

Pharmacokinetics study (n=2)
12 years to less than 15 years weighing less than 45 kg:
Initial intensive phase dose: 450 mg orally two times a week with at least 72 hours between doses for 2 months

Continuation phase dose: 450 mg orally once a week for at least 4 months following the initial phase

Pharmacokinetics study (n=10)
12 years to less than 15 years weighing 45 kg or more:
Initial intensive phase dose: 600 mg orally two times a week with at least 72 hours between doses for 2 months

Continuation phase dose: 600 mg orally once a week for at least 4 months following the initial phase

What other drugs will affect rifapentine?

Before taking rifapentine, tell your doctor if you are using any of these HIV or AIDS medications:

• 
  

  abacavir (Ziagen);

  
  


• 
  

  amprenavir (Agenerase);

  
  


• 
  

  delavirdine (Rescriptor);

  
  


• 
  

  didanosine (Videx);

  
  


• 
  

  efavirenz (Sustiva);

  
  


• 
  

  indinavir (Crixivan);

  
  


• 
  

  lamivudine (Combivir, Epivir);

  
  


• 
  

  nelfinavir (Viracept);

  
  


• 
  

  nevirapine (Viramune);

  
  


• 
  

  ritonavir (Norvir);

  
  


• 
  

  saquinavir (Invirase, Fortovase);

  
  


• 
  

  stavudine (Zerit);

  
  


• 
  

  zalcitabine (Hivid); or

  
  


• 
  

  zidovudine (Retrovir).

  
  

There are many other medicines that can interact with rifapentine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More rifapentine resources

• Rifapentine Side Effects (in more detail)
• Rifapentine Dosage
• Rifapentine Use in Pregnancy & Breastfeeding
• Rifapentine Drug Interactions
• Rifapentine Support Group
• 0 Reviews for Rifapentine - Add your own review/rating

• rifapentine Advanced Consumer (Micromedex) - Includes Dosage Information


• Rifapentine Professional Patient Advice (Wolters Kluwer)


• Rifapentine Monograph (AHFS DI)


• Rifapentine MedFacts Consumer Leaflet (Wolters Kluwer)


• Priftin Prescribing Information (FDA)

Compare rifapentine with other medications

• Tuberculosis, Active

Where can I get more information?

• Your pharmacist can provide more information about rifapentine.

See also: rifapentine side effects (in more detail)