E.E.S. 100

Generic Name: erythromycin (Oral route, Parenteral route)

e-rith-roe-MYE-sin

Commonly used brand name(s)

In the U.S.

• E.E.S. 200


• E.E.S. 400


• E.E.S. Granules


• Eryped


• Eryped 200


• Eryped 400


• Erythrocin


• Erythrocin Stearate


• Ilosone

In Canada

• E.E.S. 100


• Ees 200


• Novo-Rythro Estolate Suspension


• Novo-Rythro Ethyl Succinate Suspension


• Novo-Rythro Stearate

Available Dosage Forms:

• Suspension


• Powder for Suspension


• Tablet


• Tablet, Chewable


• Capsule

Uses For E.E.S. 100

Erythromycins are used to treat many kinds of infections. Erythromycins are also used to prevent "strep" infections in patients with a history of rheumatic heart disease who may be allergic to penicillin.

These medicines may also be used to treat Legionnaires' disease and for other problems as determined by your doctor. They will not work for colds, flu, or other virus infections.

Erythromycins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, erythromycins are used in certain patients with the following medical conditions:

• Acne


• Actinomycosis


• Anthrax


• Chancroid


• Gastroparesis


• Lyme disease


• Lymphogranuloma venereum


• Relapsing fever

Before Using E.E.S. 100

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older adults may be at increased risk of hearing loss, especially if they are taking high doses of erythromycin and/or have kidney or liver disease.

Pregnancy

Erythromycin estolate has caused side effects involving the liver in some pregnant women. However, none of the erythromycins has been shown to cause birth defects or other problems in human babies.

Breast Feeding

Erythromycins pass into the breast milk. However, erythromycins have not been shown to cause problems in nursing babies.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease—High doses of erythromycin may increase the chance of side effects in patients with a history of an irregular heartbeat.

• Liver disease—Erythromycins, especially erythromycin estolate, may increase the chance of side effects involving the liver.

• Loss of hearing—High doses of erythromycins may, on rare occasion, cause hearing loss, especially if you have kidney or liver disease.

Proper Use of erythromycin

This section provides information on the proper use of a number of products that contain erythromycin. It may not be specific to E.E.S. 100. Please read with care.

Generally, erythromycins are best taken with a full glass (8 ounces) of water on an empty stomach (at least 1 hour before or 2 hours after meals). If stomach upset occurs, these medicines may be taken with food. If you have questions about the erythromycin medicine you are taking, check with your health care professional.

For patients taking the oral liquid form of this medicine:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid


• Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

For patients taking the chewable tablet form of this medicine:

• Tablets must be chewed or crushed before they are swallowed.

For patients taking the delayed-release capsule form (with enteric-coated pellets) or the delayed-release tablet form of this medicine:

• Swallow capsules or tablets whole. Do not break or crush. If you are not sure about which type of capsule or tablet you are taking, check with your pharmacist.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a "strep" infection, you should keep taking this medicine for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose medicines in this class 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 these medicines. 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 erythromycin base


• For oral dosage forms (capsules, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

• For erythromycin estolate


• For oral dosage forms (capsules, oral suspension, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

• For erythromycin ethylsuccinate


• For oral dosage forms (oral suspension, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—400 to 800 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1.6 grams two hours before your dental appointment or surgery, then 800 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

• For erythromycin gluceptate


• For injection dosage forms:
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
    • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
  
  

• For erythromycin lactobionate


• For injection dosage forms:
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
    • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
  
  

• For erythromycin stearate


• For oral dosage forms (oral suspension, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day; or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using E.E.S. 100

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

E.E.S. 100 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:

Less common

• Fever


• nausea


• skin rash, redness, or itching


• stomach pain (severe)


• unusual tiredness or weakness


• vomiting


• yellow eyes or skin–with erythromycin estolate (rare with other erythromycins)

Less common - with erythromycin injection only

• Pain, swelling, or redness at place of injection

Rare

• Fainting (repeated)


• irregular or slow heartbeat


• loss of hearing (temporary)

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 cramping and discomfort


• diarrhea


• nausea or vomiting

Less common

• Sore mouth or tongue


• vaginal itching and discharge

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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More E.E.S. 100 resources

• E.E.S. 100 Use in Pregnancy & Breastfeeding
• Drug Images
• E.E.S. 100 Drug Interactions
• E.E.S. 100 Support Group
• 13 Reviews for E.E.S.00 - Add your own review/rating

Compare E.E.S. 100 with other medications

• Bacterial Endocarditis Prevention
• Bartonellosis
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• Bronchitis
• Bullous Pemphigoid
• Campylobacter Gastroenteritis
• Chancroid
• Chlamydia Infection
• Dental Abscess
• Legionella Pneumonia
• Lyme Disease
• Lymphogranuloma Venereum
• Mycoplasma Pneumonia
• Nongonococcal Urethritis
• Ocular Rosacea
• Otitis Media
• Pemphigoid
• Pertussis
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• Skin Infection
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• Upper Respiratory Tract Infection

Rhinolast Allergy 0.1% w / v Nasal Spray

1. Name Of The Medicinal Product

Rhinolast Allergy 0.1 w/v Nasal Spray

2. Qualitative And Quantitative Composition

Azelastine Hydrochloride 0.1% w/v

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Nasal spray

Clear, colourless to almost colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of both seasonal allergic rhinitis (e.g. hay fever) and perennial allergic rhinitis.

4.2 Posology And Method Of Administration

Route of application is topical - nasal mucosa.

Adults

One application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride).

Children

For children aged 5 years and older, one application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride).

Duration

Rhinolast Allergy 0.1 w/v Nasal Spray should not be used continuously for longer than 4 weeks without a consultation with a doctor.

4.3 Contraindications

Proven allergy against azelastine hydrochloride.

4.4 Special Warnings And Precautions For Use

Not to be used to relieve the symptoms of Upper Respiratory Tract Infection.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interactions have been studied.

4.6 Pregnancy And Lactation

At high oral doses in animals, 500 times the proposed oral human daily dose, foetal death, growth retardation and an increased incidence of skeletal abnormalities occurred during reproduction toxicity testing. Due to the nasal route of administration and the low dose administered, minimal systemic exposure can be expected. However as with all medicines caution should be exercised with use during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

In rare cases, a mild, transient irritation of the inflamed nasal mucosa may occur, with symptoms such as stinging, itching, sneezing, and epistaxis.

More frequently a substance-specific bitter taste may be experienced after administration (often due to incorrect method of application, namely tilting the head too far backwards during administration) which, in rare cases, may lead to nausea.

4.9 Overdose

The results of animal studies show that toxic doses can produce CNS symptoms, e.g. excitation, tremor, convulsions. Should these occur in humans symptomatic and supportive treatment should be instigated as there is no specific antidote. Gastric lavage is recommended if the overdose is recent.

With the nasal route of administration overdosage reactions are not anticipated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Azelastine, a phthalazinone derivative of novel structure, is classified as a potent long acting anti-allergic compound with particularly strong H1 antagonist properties.

Data from animal studies show that where high levels of azelastine are achieved both inhibition and release of chemical mediators (e.g. leukotriene, histamine, serotonin) involved in allergic reaction occurs.

5.2 Pharmacokinetic Properties

After repeated nasal application (0.14 mg) into each nostril twice daily, the plasma levels of azelastine were about 0.26 ng/ml. The levels of the active metabolite desmethylazelastine were detected at or below the lower limit of quantification (0.12 ng/ml).

After repeated oral administration, the mean Cmax steady state plasma levels were determined giving 3.9 ng/ml for azelastine and 1.86 ng/ml for desmethylazelastine after 2.2 mg b.i.d. azelastine which represents the therapeutic oral dose for the treatment of allergic rhinitis.

Following oral administration azelastine is rapidly absorbed showing an absolute bioavailability of 81%. Food has no influence on absorption. The volume of distribution is high indicating distribution predominantly to the peripheral tissues. The level of protein binding is low, (80-95% a level too low to give concern over drug displacement reactions).

Plasma elimination half lives after a single dose of azelastine are approximately 20 hours for azelastine and about 45 hours for N desmethylazelastine (a therapeutically active metabolite). Excretion occurs mainly via the faeces. The sustained excretion of small amounts of the dose in the faeces suggest that some enterohepatic circulation may take place.

5.3 Preclinical Safety Data

Nothing relevant.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hypromellose, disodium edetate, citric acid anhydrous, disodium phosphate dodecahydrate, sodium chloride, purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

Three years unopened, six months after opening.

6.4 Special Precautions For Storage

Do not refrigerate.

6.5 Nature And Contents Of Container

Either a 10 ml polyethylene bottle with polypropylene and polyethylene seals (containing 5ml solution), or a brown glass bottle with attached Valois pump containing 5 ml Rhinolast Allergy 0.1 w/v Nasal Spray solution (36 doses).

6.6 Special Precautions For Disposal And Other Handling

Remove the protective cap. Before first using, squeeze down the collar several times until an even spray emerges. The spray is now ready to use.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishops Stortford

CM22 6PU

8. Marketing Authorisation Number(S)

PL 15142/0034

9. Date Of First Authorisation/Renewal Of The Authorisation

31 May 2002

10. Date Of Revision Of The Text

24 January 2010

Antizol Vet

Dosage Form: FOR ANIMAL USE ONLY

Rx only Pr



Sterile for use in dogs only Dilute 1:19 in sterile 0.9% sodium chloride injection prior to intravenous injection

CAUTION

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

ACTIVE INGREDIENT

One single use vial (1.5 mL) of Antizol-Vet® (fomepizole) for injection contains 1.5 grams of fomepizole without excipients. When one vial is diluted with 28.5 mL of sterile 0.9% sodium chloride, the final diluted concentration is 50 mg/mL fomepizole.

PHARMACOLOGY

Antizol-Vet® is a synthetic alcohol dehydrogenase inhibitor. It is a 4-methyl-substituted five-membered ring structure with the molecular formula C4H6N2 and a molecular weight of 82.1 grams per mole. The chemical name is 4-methylpyrazole. Antizol-Vet® acts as a competitive inhibitor of the liver enzyme alcohol dehydrogenase. The oxidation of ethylene glycol to glycoaldehyde by alcohol dehydrogenase is a critical step in the metabolism of this compound. Alcohol dehydrogenase is also involved in the metabolism of ethanol, methanol, and other hydrocarbon alcohols. Glycolic, glyoxalic, and oxalic acids, the metabolites of ethylene glycol, are the substances responsible for the severe metabolic acidosis and renal tubular epithelial damage present in poisoned dogs. Once inhibition of alcohol dehydrogenase has been achieved by treatment with Antizol-Vet®, the remaining unchanged ethylene glycol and its metabolites are excreted in the urine.

INDICATIONS

Antizol-Vet® is indicated as an antidote for ethylene glycol (antifreeze) poisoning in dogs that have ingested or are suspected of having ingested ethylene glycol.

PROGNOSIS

Antizol-Vet® is only effective if administered prior to complete metabolism of ethylene glycol. To evaluate whether ethylene glycol has been completely metabolized, it is advisable to measure serum BUN and creatinine, and to monitor urine output. Correction of dehydration is essential to obtain accurate serum BUN and creatinine values. Serum concentrations of blood urea nitrogen >40 mg/dl and creatinine >1.8 mg/dl that do not resolve after dehydration is corrected indicate that ethylene glycol has been fully metabolized and significant renal damage may exist. However, if urine flow is maintained, benefit-to-risk considerations suggest that treatment with Antizol-Vet® is warranted.

Contraindications

There are no known contraindicatlons to Antizol-Vet®. However, Antizol-Vet® can cause central nervous system depression at doses much higher than recommended. For this reason, additional monitoring of the dog may be necessary when concomitantly administering drugs that cause central nervous system depression.

Warnings

For use in dogs only. Safety for use in breeding animals and lactating or pregnant bitches has not been demonstrated.

HUMAN WARNINGS

Not for use in humans. Keep out of reach of children. Irritant. Avoid ocular, dermal or inhalation exposures. In case of eye or skin exposure, flush immediately with copious amounts of water. Seek medical attention if irritation persists. Use product only in a well-ventilated area. If accidental inhalation occurs, move to fresh air. The material safety data sheet (MSDS) contains additional information regarding the safe use of this product.

For emergency medical assistance, to report adverse effects in users and/or to obtain a copy of the MSDS, call 1-888-867-7426.

Precautions

Antizol-Vet® (fomepizole) for injection should only be administered after dilution with sodium chloride. Any competitive substrate (such as ethanol) given concurrently with Antizol-Vet® may contribute to central nervous system depression and respiratory difficulties.

Such use should be avoided. Other pyrazoles may be toxic to the liver and bone marrow and should not be substituted for fomepizole. Overdosage of Antlzol-Vet® may cause additional central nervous system depression. Follow the dosing regimen carefully.

SAFETY

A subacute toxicity study was conducted in dogs for 14 days with doses of 10, 20, and 30 mg/kg of Antizol-Vet® administered intravenously twice daily in 0.9% sodium chloride injection, USP. Dogs dosed at 30 mg/kg showed increased hypoactivity, decreased food consumption, decreased serum potassium, increased sodium and bicarbonate levels, increased urinary output, increased alkaline phosphatase and alanine amino transferase (ALT) values, decreased triglycerides and increased liver weights. These effects in liver were not life-threatening and most (all except alkaline phosphatase and ALT values) were reversible following a 28-day recovery period. A two phase toxicity study was conducted in dogs for 14 days. Dose levels of 75 and 150 (phase I) and 25 and 50 (phase II) mg/kg of Antizol-Vet® were administered intravenously twice per day in 0.9% sodium chloride injection. Antizol-Vet® administered at 25 mg/kg resulted in decreased food consumption, body weight loss, and breaths with sweet odors. At 50 mg/kg or greater, Antizol-Vet® resulted in ataxia, hypoactivity, hypothermia, tremors and/or prostration, injected sclera, ptosis, decreased defecation, and protruding tongues. Chronic daily oral administration of fomepizole (110 mg/kg) to rats for 40-42 days resulted in decreased testicular mass (approximately 8%).

Mutagenesis studies of fomepizole revealed a positive Ames test involving Escherichia coli tester strain WP2uvrA and the Salmonella typhimurium tester strain TA102 in the absence of S9 mix. However, the use of in vivo mouse micronucleus assay did not indicate bone marrow cytotoxicity and is considered negative for mutagenicity. No long-term studies have been conducted in laboratory animals to evaluate the carcinogenicity of this drug.

Adverse Reactions

In a clinical field study, one of 105 dogs experienced an anaphylactic type reaction following the second dose of Antizol-Vet®. Clinical signs included tachypnea, gagging, excessive salivation and trembling. Dosing with Antizol-Vet® was discontinued and the animal survived.

PHARMACOKINETICS

Results from a 14-day intravenous study evaluating twice daily doses of 10, 20, and 30 mg/kg in dogs showed a dose proportional increase in plasma concentrations of fomepizole after a single (first) dose. In this same study, it was noted that there was a non-linear increase in plasma concentrations of fomepizole after the fourteenth day of dosing that was particularly evident in the 30 mg/kg dose group. The non-linear accumulation in plasma is assumed to be a result of a saturable elimination process. At 10 mg/kg there was no plasma accumulation and no fomepizole detectable in plasma prior to the last (28th) dose. Fifty percent of the dogs dosed at 20 mg/kg showed some plasma accumulation after 14 days of dosing. In general, dogs dosed below 20 mg/kg should have no detectable fomepizole in their plasma by 12 hours following intravenous dose administration.

Antizol Vet Dosage and Administration

Directions for Dilution

Antizol-Vet® is supplied as a sterile concentrate. If the Antizol-Vet® solution has solidified in the vial, the solution should be liquefied by running the vial under warm water or holding it in the hand. Solidification does not affect the efficacy, safely, or stability of Antizol-Vet®. The intravenous dose should be prepared aseptically by withdrawing the entire contents of the Antizol-Vet® (fomepizole) for injection vial into a syringe containing 28.5 mL of sterile 0.9% sodium chloride. Shake the solution very well to mix. Inspect visually for particulate matter prior to administration. Store the diluted solution at room temperature. DISCARD ANY UNUSED SOLUTION 72 HOURS FOLLOWING DILUTION.

Directions for Dosing

Following dilution, Antizol-Vet® should be administered intravenously over five to ten minutes. An initial loading dose of 20 mg/kg should be administered intravenously (IV) as soon as practical upon suspicion of ethylene glycol poisoning (use Table 1 below to determine the number of mL to inject). At 12, 24, and 36 hours following the initial loading dose of Antizol-Vet®, doses of 15, 15, and 5 mg/kg, respectively, should be administered. If the animal has not recovered following this regimen and there is a suspicion or documentation of remaining ethylene glycol in the bloodstream of the affected animal, the practitioner should continue to dose the animal with 5 mg/kg every 12 hours until ethylene glycol is undetectable in the bloostream or the animal has visibly recovered.

TABLE 1 Volume of diluted (50 mg/kg) Antizol-Vet® needed to dose a dog of the following body weights at the indicated dose

Animal body weight (kg)	Inject IV at:
	Initial loading dose	12 and 24 hours after initial dose	36 hours after initial dose
1 Kg = 2.2 Lbs.	Milliliters of diluted Antizol-Vet® needed for a dose of 20 mg/kg	Milliliters of diluted Antizol-Vet® needed for a dose of 15 mg/kg	Milliliters of diluted Antizol-Vet® needed for a dose of 5 g/kg
5	2.0 mL	1.5 mL	0.5 mL
10	4.0 mL	3.0 mL	1.0 mL
15	6.0 mL	4.5 mL	1.5 mL
20	8.0 mL	6.0 mL	2.0 mL
25	10.0 mL	7.5 mL	2.5 mL
30	12.0 mL	9.0 mL	3.0 mL
35	14.0 mL	10.5 mL	3.5 mL
40	16.0mL	12.0 mL	4.0 mL
45	18.0 mL	13.5 mL	4.5 mL
50	20.0 mL	15.0 mL	5.0 mL
55	22.0 mL	16.5 mL	5.5 mL
60	24.0 mL	18.0mL	6.0 mL
65	26.0 mL	19.5 mL	6.5 mL
70	28.0 mL	21.0 mL	7.0 mL

Example calculation: Use the 50 mg/mL solution of diluted Antizol-Vet® for the 20 mg/kg dose. The number of milliliters of the reconstituted Antizol-Vet® needed for an animal weighting 7.6 kg =

 20 mg/kg (dose required) x 7.6 kg (body weight in kg)

————————————————————— - ———    =    3.04 mL

50 mg/mL (Antizol-Vet® concentration)

Additional Therapy

Supportive care to correct fluid, acid-base, and electrolyte imbalances may also be necessary. If ingestion of antifreeze is witnessed, vomiting should be induced. Gastric lavage with activated charcoal is indicated within 1 to 2 hours of ingestion; beyond this time, the procedure is of little benefit.

How is Antizol Vet Supplied

Antizol-Vet® (fomepizole) for injection is supplied as a sterile single-use vial containing 1.5 mL (1.5 g) of Antizol-Vet® without excipients. Store at room temperature 15° to 30°C (59° to 86°F).

NDC: 46129-300-01

Distributed in the U.S. by:

Paladin Labs (USA) Inc.

Dover, Kent County,

Delaware, 19904

Antizol-Vet® can be ordered by calling Paladin Labs (USA) Inc. Customer Service at

1-888-678-7840 or by contacting your local wholesaler.

ANV PI-FOLD1 04/09

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL - 1.5 mL vial

NDC 46129-300-01

Antizol-Vet®

(fomepizole)

for injection

for use in dogs only

1.5 mL (1g / mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1.5 mL Box

NDC 46129-300-01

 

Rx only

Antizol-Vet®

(fomepizole)

for injection

ANTIZOL-VET  fomepizole  injection

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 46129-300 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOMEPIZOLE (FOMEPIZOLE) FOMEPIZOLE 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46129-300-01 1.5 mL In 1 VIAL, SINGLE-USE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141075	07/31/2009

Labeler - PALADIN LABORATORIES (USA) INC (831011775)

Registrant - Ben Venue Laboratories (004327953)

Establishment
Name	Address	ID/FEI	Operations
Ben Venue Laboratories		004327953	manufacture

Revised: 07/2009PALADIN LABORATORIES (USA) INC

Equate Children's Ibuprofen - Berry - Dye Free

Generic Name: ibuprofen (Oral route)

eye-bue-PROE-fen

Oral route(Tablet;Suspension;Capsule, Liquid Filled;Tablet, Chewable)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Addaprin


• Advil


• A-G Profen


• Bufen


• Genpril


• Haltran


• I-Prin


• Midol


• Motrin


• Nuprin


• Proprinal


• Q-Profen

In Canada

• Actiprofen


• Advil Children's


• Advil Pediatric


• Children's Motrin


• Children's Motrin Berry Flavor


• Children's Motrin Bubble Gum Flavor


• Children's Motrin Grape Flavor


• Equate Children's Ibuprofen - Berry - Dye Free


• Infants' Motrin


• Teddy's Choice Children's Ibuprofen - Berry


• Teddy's Choice Children's Ibuprofen - Bubble Gum


• Teddy's Choice Children's Ibuprofen - Grape

Available Dosage Forms:

• Suspension


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Equate Children's Ibuprofen - Berry - Dye Free

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .

This medicine is available both over-the-counter (OTC) and with your doctor's prescription .

Before Using Equate Children's Ibuprofen - Berry - Dye Free

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 ibuprofen in children below 6 months of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibuprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ibuprofen .

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	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.
2nd Trimester	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.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine 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.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine 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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amikacin


• Amiloride


• Arotinolol


• Aspirin


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desipramine


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenytoin


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Tacrine


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Voriconazole


• Xipamide


• Zofenopril

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

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• High blood pressure or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding or


• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

• Diabetes—Use with caution. The suspension form of this medicine contains sugar .

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to Equate Children's Ibuprofen - Berry - Dye Free. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .

To lessen stomach upset, you may take this medicine with food or milk .

Dosing

The dose of this medicine 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 this medicine. 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 and suspension):
  
  • For fever:
    
    • Children over 2 years of age—Use and dose must be determined by your doctor.
    
    
    • Children 6 months of age up to 2 years—Dose is based on body weight and body temperature, and must be determined by your doctor. For fever lower than 102.5 °F (39.2 °C), the dose usually is 5 milligrams (mg) per kilogram (kg) (about 2.2 mg per pound) of body weight. For higher fever, the dose usually is 10 mg per kg (about 4.5 mg per pound) of body weight. The medicine may be given every six to eight hours, as needed, up to 40 mg per kg per day.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For menstrual cramps:
    
    • Adults—400 milligrams (mg) every four hours, as needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For mild to moderate pain:
    
    • Adults and teenagers—400 milligrams (mg) every four to six hours, as needed.
    
    
    • Children over 6 months of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 10 milligrams (mg) per kilogram (kg) of body weight every six to eight hours, as needed, up to 40 mg per kg per day.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults and teenagers—1200 milligrams (mg) up to 3200 mg per day divided into three or four equal doses.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose usually is 30 milligrams (mg) to 40 mg per kilogram (kg) of body weight per day, divided into three or four doses.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Equate Children's Ibuprofen - Berry - Dye Free

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

Equate Children's Ibuprofen - Berry - Dye Free 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

• Abdominal pain


• acid or sour stomach


• belching


• bloating


• cloudy urine


• decrease in amount of urine


• decrease in urine output or decrease in urine-concentrating ability


• diarrhea


• difficulty having a bowel movement (stool)


• excess air or gas in stomach or intestines


• full feeling


• heartburn


• indigestion


• itching skin


• pain or discomfort in chest, upper stomach, or throat


• pale skin


• passing gas


• nausea


• noisy, rattling breathing


• rash with flat lesions or small raised lesions on the skin


• shortness of breath


• swelling of face, fingers, hands, feet, lower legs, or ankles


• troubled breathing at rest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Abdominal cramps


• stomach soreness or discomfort

Rare

• Agitation


• back, leg, or stomach pains


• bleeding gums


• blistering, peeling, loosening of skin


• blood in urine or stools


• bloody, black, or tarry stools


• blurred vision


• burning feeling in chest or stomach


• change in vision


• chest pain


• chills


• clay-colored stools


• coma


• confusion


• constipation


• cough or hoarseness


• dark urine


• decreased urine output


• depression


• difficulty breathing


• difficulty swallowing


• dilated neck veins


• dizziness


• dry mouth


• extreme fatigue


• fast, irregular, pounding, or racing heartbeat or pulse


• fever with or without chills


• frequent urination


• general body swelling


• general feeling of tiredness or weakness


• hair loss, thinning of hair


• headache


• hives or welts


• hostility


• impaired vision


• increased blood pressure


• increased volume of pale, dilute urine


• irregular breathing


• irritability


• itching


• joint or muscle pain


• lab results that show problems with liver


• lethargy


• light-colored stools


• loss of appetite


• lower back or side pain


• muscle twitching


• nosebleeds


• painful or difficult urination


• pains in stomach, side, or abdomen, possibly radiating to the back


• pinpoint red spots on skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• redness of skin


• seizures


• severe abdominal pain, cramping, burning


• severe and continuing nausea


• sore throat


• sores, ulcers, or white spots in mouth or on lips


• stiff neck or back


• stomach upset


• stupor


• swollen or painful glands


• tenderness in stomach area


• thirst


• tightness in chest


• unpleasant breath odor


• upper right abdominal pain


• vomiting of blood


• vomiting of material that looks like coffee grounds


• wheezing


• yellow eyes and skin

Symptoms of overdose

• Bluish lips or skin


• difficulty sleeping


• disorientation


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


• drowsiness to profound coma


• hallucination


• lightheadedness or fainting


• mood or other mental changes


• muscle tremors


• not breathing


• rapid, deep breathing


• restlessness


• slow or irregular heartbeat


• stomach cramps


• sudden fainting


• sweating

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

• Continuing ringing or buzzing or other unexplained noise in ears


• hearing loss


• nervousness

Rare

• Crying


• depersonalization


• discouragement


• dry eyes


• dysphoria


• euphoria


• feeling sad or empty


• lack of appetite


• loss of interest or pleasure


• mental depression


• paranoia


• quick to react or overreact


• rapidly changing moods


• runny nose


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• stuffy nose


• trouble concentrating


• trouble sleeping


• unable to sleep

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: Equate Children's Ibuprofen - Berry - Dye Free side effects (in more detail)

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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 Equate Children's Ibuprofen - Berry - Dye Free resources

• Equate Children's Ibuprofen - Berry - Dye Free Side Effects (in more detail)
• Equate Children's Ibuprofen - Berry - Dye Free Use in Pregnancy & Breastfeeding
• Drug Images
• Equate Children's Ibuprofen - Berry - Dye Free Drug Interactions
• Equate Children's Ibuprofen - Berry - Dye Free Support Group
• 51 Reviews for Equate Children's Ibuprofen - Berry - Dye Free - Add your own review/rating

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Guaifed Caps

Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX

What is Guaifed Caps (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Guaifed Caps (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 4 years old. 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. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Guaifed Caps (guaifenesin and phenylephrine)?

You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  circulation problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  enlarged prostate or problems with urination.

  
  

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes 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 Guaifed Caps (guaifenesin and phenylephrine)?

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. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. 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. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is taken 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. 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, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Guaifed Caps (guaifenesin and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with 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.

Guaifed Caps (guaifenesin and phenylephrine) 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;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); 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:

• 
  

  vomiting, upset stomach;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  headache; or

  
  


• 
  

  dizziness.

  
  

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 Guaifed Caps (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with guaifenesin and phenylephrine. 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 Guaifed Caps resources

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

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• Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


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


• Guiatex PE Prescribing Information (FDA)


• Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Guaifed Caps with other medications

• Cough and Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Guaifed Caps side effects (in more detail)

Lipantil Micro 267

1. Name Of The Medicinal Product

Lipantil^® Micro 267 mg, capsules.

2. Qualitative And Quantitative Composition

Each capsule contains 267 mg fenofibrate.

For excipients, see 6.1

3. Pharmaceutical Form

Orange/ivory, hard gelatin capsule.

4. Clinical Particulars

4.1 Therapeutic Indications

Lipantil® Micro 267 mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

4.2 Posology And Method Of Administration

Adults

The initial recommended dose is one capsule of Lipantil Micro 200 taken daily with food. However, in patients with severe dyslipidaemia, an increased dose of 267mg (Lipantil Micro 267), is recommended. Lipantil Micro 267 should always be taken with food, because it is less well absorbed from an empty stomach. Dietary measures instituted before therapy should be continued.

Children

This dosage is not recommended in children.

Elderly

In elderly patients without renal impairment, the normal adult dose is recommended.

Renal impairment

In renal dysfunction, the dosage may need to be reduced depending on the rate of creatinine clearance, for example:

Creatinine clearance (ml/min)	Dosage
< 60	One Lipantil Micro 140 mg capsule
< 20	One Lipantil Micro 67 mg capsule

4.3 Contraindications

Lipantil Micro 267 is contra-indicated in children, in patients with severe liver or renal dysfunction, gallbladder disease, biliary cirrhosis and in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.

Use during pregnancy and lactation (see section 4.6).

4.4 Special Warnings And Precautions For Use

Secondary causes of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is initiated.

Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-C, triglycerides). If an adequate response has not been achieved after several months (e.g. 3 months) complementary or different therapeutic measures should be considered.

Renal function

In renal dysfunction the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance, (see section 4.2). Dose reduction should be considered in elderly patients with impaired renal function.

It is recommended that creatinine is measured during the first three months after initiation of treatment and thereafter periodically. Treatment should be interrupted in case of an increase in creatinine levels > 50% of (upper limit of normal).

Liver function abnormalities

Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment. However, it is recommended that serum transaminases should be monitored every three months during the first twelve months of treatment. Treatment should be interrupted in the event of ALAT (SGPT) or ASAT (SGOT) elevations to more than 3 times the upper limit of the normal range or more than one hundred international units.

Pancreatitis

Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.

Myopathy

Muscle toxicity, including rare cases of rhabdomyolysis, has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency. Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up.

Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in CPK (levels exceeding 5 times the normal range). In such cases treatment with fenofibrate should be stopped.

The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in cases of pre-existing muscular disease. Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity.

For hyperlipidaemic patients taking oestrogens or contraceptives containing oestrogen it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by oral oestrogen).

For patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption: although the amount of lactose contained in Lipantil Micro 267 mg is low, caution should be exercised in these patients (as no study has been formally conducted in this special population).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Oral anti-coagulants

Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. In patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by about one-third at the commencement of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.

HMG-CoA reductase inhibitors or Other Fibrates

The risk of serious muscle toxicity is increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity (see section 4.4).

There is currently no evidence to suggest that fenofibrate affects the pharmacokinetics of simvastatin.

Cyclosporin

Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and cyclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.

Other

No proven clinical interactions of fenofibrate with other drugs have been reported, although in vitro interaction studies suggest displacement of phenylbutazone from plasma protein binding sites. In common with other fibrates, fenofibrate induces microsomal mixed-function oxidases involved in fatty acid metabolism in rodents and may interact with drugs metabolised by these enzymes.

4.6 Pregnancy And Lactation

There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity (see section 5.3). The potential risk for humans is unknown.

There are no data on the excretion of fenofibrate and/or its metabolites into breast milk. It is therefore recommended that Lipantil Micro 267 should not be administered to women who are pregnant or are breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No effect noted to date.

4.8 Undesirable Effects

Fenofibrate is generally well tolerated. Adverse reactions observed during fenofibrate treatment are not very frequent; they are generally minor, transient and do not interfere with treatment.

The most commonly reported adverse reactions include:

Gastrointestinal: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, and flatulence) moderate in severity.

Uncommon: Pancreatitis*

Cardiovascular system

Uncommon: Thromboembolism (pulmonary embolism, deep vein thrombosis)*

Skin: Reactions such as rashes, pruritus, urticaria or photosensitivity reactions; in individual cases (even after many months of uncomplicated use) cutaneous photosensitivity may occur with erythema, vesiculation or nodulation on parts of the skin exposed to sunlight or artificial UV light (e.g. sun lamp).

Neurological disorders: Headache

General disorders: Fatigue

Disorders of the ear: Vertigo

Less frequently reported adverse reactions:

Liver: Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment (see also section 4.4). Episodes of hepatitis have been reported very rarely. When symptoms (e.g. jaundice, pruritus) indicative of hepatitis occur, laboratory tests are to be conducted for verification and fenofibrate discontinued, if applicable (see Special Warnings). Development of gallstones has been reported.

Muscle: As with other lipid lowering agents, cases of muscle toxicity (diffuse myalgia, myositis, muscular cramps and weakness) and very rare cases of rhabdomyolysis have been reported. These effects are usually reversible when the drug is withdrawn (see Special Warnings).

In rare cases, the following effects are reported: Sexual asthenia and alopecia. Increases in serum creatinine and urea, which are generally slight, and also a slight decrease in haemoglobin and leukocytes may be observed.

Very rare cases of interstitial pneumopathies have been reported.

* In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p = 0.074).

4.9 Overdose

No case of overdosage has been reported. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates.

ATC code: C10 AB 05

Lipantil Micro 267 is a formulation containing 267 mg of micronised fenofibrate.

The lipid lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I, A-II and of HDL cholesterol.

Epidemiological studies have demonstrated a positive correlation between increased serum lipid levels and an increased risk of coronary heart disease. The control of such dyslipidaemias forms the rationale for treatment with fenofibrate. However, the possible beneficial and adverse long-term consequences of drugs used in the management of dyslipidaemias are still the subject of scientific discussion. Therefore the presumptive beneficial effect of Lipantil Micro 267 on cardiovascular morbidity and mortality is as yet unproven.

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

Studies with fenofibrate consistently show decreases in levels of LDL-cholesterol. HDL-cholesterol levels are frequently increased. Triglyceride levels are also reduced. This results in a decrease in the ratio of low and very low density lipoproteins to high density lipoproteins, which has been correlated with a decrease in atherogenic risk in epidemiological studies. Apolipoprotein-A and apolipoprotein-B levels are altered in parallel with HDL and LDL and VLDL levels respectively.

Regression of xanthomata has been observed during fenofibrate therapy.

Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV phenotype. Lipantil Micro 267 has a uricosuric effect and is therefore of additional benefit in such patients.

Patients with raised levels of fibrinogen and Lp(a) have shown significant reductions in these measurements during clinical trials with fenofibrate.

5.2 Pharmacokinetic Properties

Absorption

The unchanged compound is not recovered in the plasma. Fenofibric acid is the major plasma metabolite. Peak plasma concentration occurs after a mean period of 5 hours following dosing.

Mean plasma concentration is 15 μg/ml for a daily dosage of 200 mg of micronised fenofibrate.

Steady state levels are observed throughout continuous treatments.

Fenofibric acid is highly bound to plasma albumin: it can displace antivitamin K compounds from the protein binding sites and potentiate their anti-coagulant effect.

Plasma half-life

The plasma half-life of elimination of fenofibric acid is approximately 20 hours.

Metabolism and excretion

The product is mainly excreted in the urine: 70% in 24 hours and 88% in 6 days, at which time total excretion in urine and faeces reaches 93%. Fenofibrate is mainly excreted as fenofibric acid and its derived glucuroconjugate.

Kinetic studies after administration of repeated doses show the absence of accumulation of the product.

Fenofibric acid is not eliminated during haemodialysis.

5.3 Preclinical Safety Data

Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.

Studies on mutagenicity of fenofibrate have been negative.

In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation. These changes are specific to small rodents and have not been observed in other animal species. This is of no relevance to therapeutic use in man.

Studies in mice, rats and rabbits did not reveal any teratogenic effect. Embryotoxic effects were observed at doses in the range of maternal toxicity. Prolongation of the gestation period and difficulties during delivery were observed at high doses. No sign of any effect on fertility has been detected.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Excipients: lactose monohydrate, magnesium stearate, pregelatinised starch, sodium laurilsulfate, crospovidone.

Composition of the capsule shell: gelatin, titanium dioxide (E 171), yellow and red ferrous oxide (E 172).

6.2 Incompatibilities

No effect noted to date.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in the original package. Do not store above 30^oC.

6.5 Nature And Contents Of Container

Pack of 28, 30 capsules in blisters (PVC/Aluminium).

*Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Capsules should be swallowed whole with water.

7. Marketing Authorisation Holder

Abbott Healthcare Products Ltd

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

PL 00512/0391

9. Date Of First Authorisation/Renewal Of The Authorisation

3 February 1999/February 2004

10. Date Of Revision Of The Text

June 2011

11. LEGAL CATEGORY

POM