Flunisolide

Flunisolide

Nasal Solution USP, 0.025%

Description

Flunisolide Nasal Solution USP, 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of Flunisolide nasal solution, is an anti-inflammatory steroid.

Flunisolide is represented by the following structural formula:

C24H31FO6 • 1/2H2O

Mol. Wt. 443.52

6α-fluoro-11β 16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (USAN).

Flunisolide is a white to creamy white crystalline powder. It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C.

After initial priming (5 to 6 sprays) each spray of the unit delivers a metered droplet spray of 100 mg formulation containing 25 mcg of Flunisolide.

The size of the droplets produced by the unit is in excess of 8 microns to facilitate deposition on the nasal mucosa. The contents of one nasal spray bottle delivers 200 sprays.

Each mL Contains: ACTIVE: Flunisolide 0.25 mg (0.025%); INACTIVES: Propylene Glycol, Polyethylene Glycol 3350, Butylated Hydroxyanisole, Edetate Disodium, Sodium Citrate, Citric Acid and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1 – 5.4). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

Clinical Pharmacology

Flunisolide has demonstrated potent glucocorticoid and weak mineralocorticoid activity in classical animal test systems. As a glucocorticoid it is several hundred times more potent than the cortisol standard. Clinical studies with Flunisolide have shown therapeutic activity on nasal mucous membranes with minimal evidence of systemic activity at the recommended doses.

A study in approximately 100 patients that compared the recommended dose of Flunisolide nasal solution with an oral dose providing equivalent systemic amounts of Flunisolide has shown that the clinical effectiveness of Flunisolide nasal solution, when used topically as recommended, is due to its direct local effect and not to an indirect effect through systemic absorption.

Following administration of Flunisolide to man, approximately half of the administered dose is recovered in the urine and half in the stool: 65 to 70% of the dose recovered in urine is the primary metabolite, which has undergone loss of the 6α fluorine and addition of a 6β hydroxy group. Flunisolide is well absorbed but is rapidly converted by the liver to the much less active primary metabolite and to glucuronate and/or sulfate conjugates. Because of first-pass liver metabolism, only 20% of the Flunisolide reaches the systemic circulation when it is given orally whereas 50% of the Flunisolide administered intranasally reaches the systemic circulation unmetabolized. The plasma half-life of Flunisolide is 1 to 2 hours.

The effects of Flunisolide on hypothalamic-pituitary-adrenal (HPA) axis function have been studied in adult volunteers. Flunisolide was administered intranasally as a spray in total doses over 7 times the recommended dose (2200 mcg, equivalent to 88 sprays/day) in 2 subjects for 4 days, about 3 times the recommended dose (800 mcg, equivalent to 32 sprays/day) in 4 subjects for 4 days, and over twice the recommended dose (700 mcg, equivalent to 28 sprays/day) in 6 subjects for 10 days. Early morning plasma cortisol concentrations and 24-hour urinary 17-ketogenic steroids were measured daily. There was evidence of decreased endogenous cortisol production at all three doses.

In controlled studies, Flunisolide nasal solution was found to be effective in reducing symptoms of stuffy nose, runny nose and sneezing in most patients. These controlled clinical studies have been conducted in 488 adult patients at doses ranging from 8 to 16 sprays (200-400 mcg) per day and 127 pediatric patients at doses ranging from 6 to 8 sprays (150 to 200 mcg) per day for periods as long as 3 months. In 170 patients who had cortisol levels evaluated at baseline and after 3 months or more of Flunisolide treatment, there was no unequivocal Flunisolide-related depression of plasma cortisol levels.

Clinical studies have shown that improvement is usually apparent within a few days after starting Flunisolide nasal solution.

The mechanisms responsible for the anti-inflammatory action of corticosteroids and for the activity of the aerosolized drug on the nasal mucosa are unknown.

Indications and Usage

Flunisolide nasal solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide nasal solution should not be used in the presence of untreated localized infection involving nasal mucosa.

Contraindications

Hypersensitivity to any of the ingredients.

Warnings

The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and/or depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to Flunisolide should be carefully monitored to avoid acute adrenal insufficiency in response to stress.

When transferred to Flunisolide, careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids. This is particularly important in those patients who have associated asthma or other clinical conditions, where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

The use of Flunisolide with alternate-day prednisone systemic treatment could increase the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, Flunisolide treatment should be used with caution in-patients already on alternate-day prednisone regimens for any disease.

Persons who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a nonimmune patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package insert for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Precautions

General

Intranasal corticosteroids may also cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS, Pediatric Use section).

Symptomatic relief may not occur in some patients for as long as 2 weeks. Although systemic effects are minimal at recommended doses, Flunisolide should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. In clinical studies with Flunisolide administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops it may require treatment with appropriate local therapy or discontinuance of treatment with Flunisolide.

Flunisolide is absorbed into the circulation. Use of excessive doses of Flunisolide may suppress hypothalamic-pituitary-adrenal function. Flunisolide should be used with caution, if at all, in-patients with active or quiescent tuberculosis infection of the respiratory tract or in untreated fungal, bacterial or systemic viral infections or ocular herpes simplex.

Because of the inhibitory effect of corticosteroids on wound healing, in patients who have experienced recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, a nasal corticosteroid should be used with caution until healing has occurred.

Although systemic effects have been minimal with recommended doses, this potential increases with excessive dosages. Therefore, larger than recommended doses should be avoided.

Information for patients

Patients should use Flunisolide at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of Flunisolide are fully manifested. One to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, or if the condition worsens, or if sneezing or nasal irritation occurs.

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying Patient Instructions carefully.

Patients should be advised to clear their nasal passages of secretions prior to use.

Carcinogenesis, mutagenesis, impairment of fertility

In mice, Flunisolide at an oral dose of 500 mcg/kg/day (approximately 6 times the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis) for 21 months was negative for carcinogenic effects. In rats, administration of Flunisolide at an oral dose of 2.5 mcg/kg/day (less than the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis) for 24 months resulted in an increased incidence of mammary gland adenoma and islet cell adenoma of the pancreas in females. There were no significant increases in the incidence of any tumor type in rats at an oral dose of 1.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis).

Flunisolide showed no mutagenic activity in in vitro test systems including the Ames Assay and the Rec-Assay, and no clastogenic activity in either the in vitro chromosomal aberration assay in Chinese hamster lung fifibroblast cells or the in vivo mouse bone marrow chromosomal aberration assay.

Flunisolide, at an oral dose of 200 mcg/kg/day (approximately 4 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis) produced impaired fertility in female rats, but was devoid of such effect at oral doses less than or equal to 40 mcg/kg/day (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

Pregnancy

Pregnancy Category C. As with other corticosteroids, Flunisolide has been shown to be teratogenic and fetotoxic in rabbits and rats at oral doses of 40 and 200 mcg/kg/day respectively (approximately 2 and 4 times, respectively, the maximum recommended daily intranasal dose in adults on a mg/m2 basis). There are no adequate and well-controlled studies in pregnant women. Flunisolide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Flunisolide is administered to nursing women.

Pediatric use

Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy, have not been assessed in this age group. Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Flunisolide nasal solution, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Flunisolide nasal solution, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric use

Clinical studies of Flunisolide nasal solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose reduction for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Adverse reactions reported in controlled clinical trials and long-term open studies in 595 patients treated with Flunisolide nasal solution are described below. Of these patients, 409 were treated for 3 months or longer, 323 for 6 months or longer, 259 for 1 year or longer, and 91 for 2 years or longer.

In general, side effects elicited in the clinical studies have been primarily associated with the nasal mucous membranes. The most frequent complaints were those of mild transient nasal burning and stinging, which were reported in approximately 45% of the patients treated with Flunisolide nasal solution in placebo-controlled and long-term studies. These complaints do not usually interfere with treatment; in only 3% of patients was it necessary to decrease dosage or stop treatment because of these symptoms. Approximately the same incidence of mild transient nasal burning and stinging was reported in patients on placebo as was reported in patients treated with Flunisolide nasal solution in controlled studies, implying that these complaints may be related to the vehicle or the delivery system. The incidence of complaints of nasal burning and stinging decreased with increasing duration of treatment.

Other side effects reported at a frequency of 5% or less were: nasal congestion, sneezing, epistaxis and/or bloody mucous, nasal irritation, watery eyes, sore throat, nausea and/or vomiting, and headaches. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of Flunisolide nasal solutions. Temporary or permanent loss of the sense of smell and taste have also been reported with the use of Flunisolide nasal solutions.

Systemic corticosteroid side effects were not reported during the controlled clinical trials. If recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, i.e., Cushing’s syndrome, could occur. Cases of growth suppression have been reported for intranasal corticosteroids (including Flunisolide nasal solution) (see PRECAUTIONS, Pediatric Use section).

Overdosage

Flunisolide, infused intravenously, at doses up to 4 mg/kg in mice, rats and dogs (approximately 45, 300 and 90 times, respectively, the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis) was without lethality.

Dosage and Administration

Adults: The recommended starting dose of Flunisolide nasal solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day). If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day).

Pediatric Patients 6 to 14 years: The recommended starting dose of Flunisolide nasal solution is 1 spray (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day). Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy studies, including possible adverse effects on growth, have not been conducted.

Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day). Since there is no evidence that exceeding the maximum recommended dosage is more effective and increased systemic absorption would occur, higher doses should be avoided.

After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms. Approximately 15% of patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day.

For priming and repriming the nasal spray unit after storage: The patient should remove the dust cover. Put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. Push bottle with thumb FIRMLY and QUICKLY 5-6 times or until fine spray appears. Now your pump is primed. The patient must prime the pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning.

How Supplied

Flunisolide Nasal Solution USP, 0.025% is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size:

25 mL bottles - Prod. No. 34454

Each 25 mL Flunisolide nasal solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 sprays of Flunisolide.

Directions For Use

A patient leaflet of instructions accompanies each package of Flunisolide nasal solution.

Warning

Do not spray in eyes.

Storage

Store between 15°-30°C (59°-86°F).

KEEP OUT OF REACH OF CHILDREN.

Rx only

FOR INTRANASAL USE ONLY

Manufacturer Information

Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

Revised January 2008

9116400

Patient Instructions

PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

Flunisolide Nasal Solution USP, 0.025%

– HOW TO USE YOUR NASAL PUMP UNIT –

Your nasal spray unit with the pump requires no assembly. Just follow the simple instructions below.

IMPORTANT INFORMATION ON Flunisolide NASAL SOLUTION:

1. You should use Flunisolide nasal solution at regular intervals since its effectiveness depends on its regular use (see below).

2. It may take 1-2 weeks before full relief is obtained.

3. You should contact your physician if symptoms do not improve, if the condition worsens, or if sneezing, nasal irritation, or bleeding occurs.

4. You should contact your physician if you know you have been exposed to chickenpox or measles.

TO PRIME:

1. Remove the dust cover. Put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. Push bottle with thumb FIRMLY and QUICKLY 5-6 times or until a fine spray appears. Now your pump is primed. You must prime the pump unit again if you have not used it for 5 days or more, or if you have disassembled it for cleaning.

2. If the solution is delivered in a stream of liquid, it may fail to provide maximum benefit and cause some discomfort. A fine mist can be produced only by a rapid and firm pumping action.

3. Once your pump is primed, it‘s ready to use.

NOTE: Keep dust cover on the pump unit when not in use.

PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

TO USE:

1. Gently blow nose to clear nostrils. If nose is blocked, use medicine your doctor has recommended to open nasal passages.

2. Remove the dust cover. Be sure the pump unit is primed.

3. Place the spray tip into one nostril (tip should not reach far into nose).

Bend head forward so spray will aim toward the back of the nose.

4. Hold pump as shown, resting back of index finger against upper lip.  

BE CAREFUL THAT FINGERS DO NOT SLIP OFF THE PUMP AS YOU SPRAY.

5. Point the tip toward the BACK and OUTER SIDE of the nose. Close other nostril with finger. Pump the spray by pushing bottle with thumb FIRMLY and QUICKLY and sniff gently at the same time. Your doctor will tell you whether to pump once or twice in each nostril.

6. After spraying in nostril, remove unit from nose and bend head back for a few seconds to let spray spread over back of nose.

7. Repeat Steps 5 and 6 in other nostril. You may feel brief burning or stinging after using the spray.

8. Keep dust cover on the pump unit when not in use.

TO CLEAN:

1. If spray nozzle becomes clogged, DO NOT ATTEMPT TO CLEAR IT USING A POINTED OBJECT. Remove the pump unit from bottle.

2. Soak only the pump unit in warm water. Squirt several times while holding under water.

3. Make sure the pump unit is dry. Assemble as before with 5 or 6 sprays before use.

 Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

Revised January 2008

9116400

Principal Display Panel

NDC 24208-344-25

Flunisolide Nasal Solution USP, 0.025%

Rx only

[icon-nose] [icon 0.025%] [icon pump spray] [icon 25 mL]

200 Metered Sprays

Bausch & Lomb

Flunisolide  Flunisolide  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-344 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Flunisolide (Flunisolide) Flunisolide 0.25 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   BUTYLATED HYDROXYANISOLE   CITRIC ACID MONOHYDRATE   EDETATE DISODIUM   HYDROCHLORIC ACID   POLYETHYLENE GLYCOL 3350   PROPYLENE GLYCOL   WATER   SODIUM CITRATE   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-344-25 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 25 mL In 1 BOTTLE, PUMP This package is contained within the CARTON (24208-344-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074805	02/20/2002

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Teva-Sicor SpA		429369713	API MANUFACTURE

Revised: 03/2011Bausch & Lomb Incorporated

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Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid

Pronunciation: FEN-il-EF-rin/kar-bay-ta-PEN-tane/poe-TAS-ee-um GWYE-a-kol-SUL-foe-nate
Generic Name: Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate
Brand Name: Carbatuss-CL

Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels, reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, which makes coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid if:

• you are allergic to any ingredient in Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you take droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid:

Some medical conditions may interact with Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of glaucoma or increased pressure in the eye, heart problems (eg, fast, slow, or irregular heartbeat, heart disease), diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), mental or mood problems (eg, depression), trouble sleeping, an overactive thyroid, seizures, or stroke


• if you have a history of asthma or other breathing problems, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), sleep apnea, or if your cough occurs with large amounts of mucus


• if you have ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate or other prostate problems


• if you are in poor health or are very overweight


• if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid's side effects


• Bromocriptine because the risk of its side effects may be increased by Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid


• Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid:

Use Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


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


• Drink plenty of water while taking Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid.


• If you miss a dose of Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid 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 Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid.

Important safety information:

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


• Do not use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take appetite suppressants while you are taking Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant, cough suppressant, and an expectorant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.


• Do not use Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid 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.


• Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid.


• Tell your doctor or dentist that you take Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid while you are pregnant. It is not known if Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid is found in breast milk. Do not breast-feed while taking Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid.

Possible side effects of Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; trouble sleeping.

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); confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; persistent trouble sleeping; restlessness; seizures; severe or persistent dizziness, drowsiness, headache, or lightheadedness; tremor.

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 blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, headache, or lightheadedness; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid:

Store Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid 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 Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

This information is a summary only. It does not contain all information about Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate resources

• Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Use in Pregnancy & Breastfeeding
• Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Drug Interactions
• Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate Support Group
• 0 Reviews for Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate - Add your own review/rating

Compare Phenylephrine/Carbetapentane/Potassium Guaiacolsulfonate with other medications

• Cough and Nasal Congestion

Amoxil Capsules 250mg

1. Name Of The Medicinal Product

Amoxil® Capsules 250 mg

2. Qualitative And Quantitative Composition

Amoxil Capsules 250 mg contain 250 mg amoxicillin per capsule

The amoxicillin is present as the trihydrate.

3. Pharmaceutical Form

Amoxil Capsules: maroon and gold capsules overprinted 'Amoxil 250'.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

Dental abscess (as an adjunct to surgical management)

Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents. “Susceptibility of the causative organisms to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.

4.2 Posology And Method Of Administration

Treatment of Infection:

Adult dosage (including elderly patients):

Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.

Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.

Renal impairement:

Glomerular filtration rate>30ml/min No adjustment necessary.

Glomerular filtration rate 10-30ml/min: Amoxicillin. max.500mg b.d

Glomerular filtration rate<10ml/min: Amoxicillin. Max. 500mg/day

Helicobacter eradication in peptic (duodenal and gastric) ulcer disease:

Amoxil is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below:

Omeprazole 40 mg daily, Amoxicillin 1G BID, Clarithromycin 500mg BID x 7days

or

Omeprazole 40mg daily, Amoxicillin750mg-1G BID, Metronidazole 400mg TID x 7 days

Children's dosage (up to 10 years of age):

Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.

Renal impairement in children under 40 kg:

Creatnine clearance >30mL/min: No adjustment necessary.

Creatinine clearance 10-30mL/min: 15 mg/kg given b.i.d (maximum 500mg/twice daily).

Creatinine clearance <10mL/min: 15 mg/kg given as a single daily dose (maximum 500mg).

Amoxil Paediatric Suspension is recommended for children under six months of age.

In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.

Prophylaxis of endocarditis: see table on next page.

Administration:

Oral:

Treatment should be continued for 2 to 3 days following the disappearance of symptoms. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci in order to achieve eradication of the organism.

Prophylaxis of endocarditis:

CONDITION		ADULTS' DOSAGE (INCLUDING ELDERLY)	CHILDREN'S DOSAGE	NOTES
Dental procedures : prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. (N.B. Patients with prosthetic heart valves should be referred to hospital - see below).	Patient not having general anaesthetic.	3 g 'Amoxil' orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.	Under 10: half adult dose. Under 5: quarter adult dose.	Note 1. If prophylaxis with 'Amoxil' is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month. Note 2 To minimise pain on injection, 'Amoxil' may be given as two injections of 500 mg dissolved in sterile 1% lidocaime solution (see Administration ).
Patient having general anaesthetic: if oral antibiotics considered to be appropriate.	Initially 3 g 'Amoxil' orally 4 hours prior to anaesthesia, followed by 3 g orally (or 1 g IV or IM if oral dose not tolerated) as soon as possible after the operation.
Patient having general anaesthetic: if oral antibiotics not appropriate.	1 g 'Amoxil' IV or IM immediately before induction; with 500 mg orally, 6 hours later.
Dental procedures : patients for whom referral to hospital is recommended: a) Patients to be given a general anaesthetic who have been given a penicillin in the previous month. b) Patients to be given a general anaesthetic who have a prosthetic heart valve. c) Patients who have had one or more attacks of endocarditis.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure. Followed by (6 hours later): 500 mg 'Amoxil' orally.	Under 10: the doses of 'Amoxil' should be half the adult dose; the dose of gentamicin should be 2 mg/kg. Under 5: the doses of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Note 2. Note 3. 'Amoxil' and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on gentamicin.
Genitourinary Surgery or Instrumentation : prophylaxis for patients who have no urinary tract infection and who are to have genito-urinary surgery or instrumentation under general anaesthesia. In the case of Obstetric and Gynaecological Procedures and Gastrointestinal Procedures– routine prophylaxis is recommended only for patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction. Followed by (6 hours later): 500 mg 'Amoxil' orally or IV or IM according to clinical condition.	See Notes 2, 3 and 4 above.
Surgery or Instrumentation of the Upper Respiratory Tract	Patients other than those with prosthetic heart valves.	1 g 'Amoxil' IV or IM immediately before induction; 500 mg 'Amoxil' IV or IM 6 hours later.	Under 10: half adult dose. Under 5: quarter adult dose.	See Note 2 above. Note 5. The second dose of 'Amoxil' may be administered orally as 'Amoxil' Syrup SF/DF.
Patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg 'Amoxil' IV or IM.	Under 10: the dose of 'Amoxil' should be half the adult dose; the gentamicin dose should be 2 mg/kg. Under 5: the dose of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Notes 2, 3, 4 and 5 above.

4.3 Contraindications

Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

4.4 Special Warnings And Precautions For Use

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose)..

In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly (see section 4.2).

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see sections 4.5 and 4.8).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Concurrent administration of allopurinol during treatment with amoxicillincan increase the likelihood of allergic skin reactions.

In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin (see sections 4.4 and 4.8).

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

Use in pregnancy:

Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillinin breast milk, there are no known detrimental effects for the breast-fed infant.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

The majority of side effects listed below are not unique to amoxicillin and may occur when using other pencillins.

Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Infections and infestations

Very rare:

Mucocutaneous candidiasis

Blood and lymphatic system disorders

Very rare:

Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (see section 4.4 – Special Warnings and Precautions for Use.

Immune system disorders

Very rare:

As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 – Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.

If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).

Nervous system disorders

Very rare:

Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses

.

Gastrointestinal disorders

Clinical Trial Data

*Common :	Diarrhoea and nausea.
*Uncommon :	Vomiting.

Post-marketing Data

Very rare:	Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).
	Black hairy tongue

Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Hepato-biliary disorders

Very rare:

Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT

.

The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

Clinical Trial Data

*Common :	Skin rash
*Uncommon :	Urticaria and pruritus

Post-marketing Data

Very rare :

Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)

(See also Immune system disorders).

Renal and urinary tract disorders

Very rare :	Interstitial nephritis.
Very rare:	Crystalluria (see Section 4.9 Overdose)

*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).

Amoxicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amoxil is a broad spectrum antibiotic.

It is rapidly bactericidal and possesses the safety profile of a penicillin.

The wide range of organisms sensitive to the bactericidal action of Amoxil include:

Aerobes:

Gram-positive	Gram-negative
Streptococcus faecalis	Haemophilus influenzae
Streptococcus pneumoniae	Escherichia coli
Streptococcus pyogenes	Proteus mirabilis
Streptococcus viridans	Salmonella species
Staphylococcus aureus	Shigella species
(penicillin-sensitive strains only)	Bordetella pertussis Brucella species
Corynebacterium species	Neisseria gonorrhoeae
Bacillus anthracis	Neisseria meningitidis
Listeria monocytogenes	Vibrio cholerae Pasteurella septica

Anaerobes:

Clostridium species

5.2 Pharmacokinetic Properties

Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Amoxil Capsules 250 Mg

Each capsule contains magnesium stearate (E572) and erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Capsules

60M

6.4 Special Precautions For Storage

Amoxil Capsules should be stored in a dry place.

6.5 Nature And Contents Of Container

Amoxil Capsules: 250 mg Original Pack of 21 with Patient Information Leaflet; also container of 500. Also packs of 3, 6, 12, 50, 100 and 50,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Beecham Group plc

Great West Road, Brentford, Middlesex TW8 9GS

Trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

And/or

Bencard or SmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Hertfordshire, AL7 1EY.

8. Marketing Authorisation Number(S)

Amoxil Capsules 250 mg

0038/0103

9. Date Of First Authorisation/Renewal Of The Authorisation

19 April 1972 / 13 January 1998

10. Date Of Revision Of The Text

1^st March 2010

11. Legal Category

POM

Tricodene Sugar Free

Generic Name: chlorpheniramine and dextromethorphan (klor feh NEER a meen and DEX troe meh THOR fan)

Brand Names: Coricidin HBP Cough & Cold, Dimetapp Long Acting Cough Plus Cold, Robitussin Cough & Cold Long-Acting, Scot-Tussin Sugar Free DM, Triaminic Cough & Runny Nose, Triaminic Cough & Runny Nose Softchews, Triaminic Night Time Cough & Runny Nose, Tricodene Sugar Free

What is Tricodene Sugar Free (chlorpheniramine and dextromethorphan)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

The combination of chlorpheniramine and dextromethorphan is used to treat sneezing, itching, watery eyes, runny nose, and cough caused by allergies, the common cold, or the flu.

Chlorpheniramine and dextromethorphan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tricodene Sugar Free (chlorpheniramine and dextromethorphan)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or cough suppressant. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Tricodene Sugar Free (chlorpheniramine and dextromethorphan)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  glaucoma;

  
  


• 
  

  kidney disease;

  
  


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  thyroid disease;

  
  


• 
  

  emphysema or chronic bronchitis;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take chlorpheniramine and dextromethorphan.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of this 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 Tricodene Sugar Free (chlorpheniramine and dextromethorphan)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken for only a short time until your symptoms clear up.

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.

The chewable tablet should be chewed before you swallow it.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Tricodene Sugar Free (chlorpheniramine and dextromethorphan)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety).

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or cough suppressant.

Tricodene Sugar Free (chlorpheniramine and dextromethorphan) 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;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  restlessness or excitability (especially in children).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tricodene Sugar Free (chlorpheniramine and dextromethorphan)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  a diuretic (water pill), or blood pressure medication;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others); or

  
  


• 
  

  antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), others.

  
  

This list is not complete and there may be other drugs that can interact with chlorpheniramine and dextromethorphan. 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.

More Tricodene Sugar Free resources

• Tricodene Sugar Free Use in Pregnancy & Breastfeeding
• Tricodene Sugar Free Drug Interactions
• Tricodene Sugar Free Support Group
• 0 Reviews for Tricodene Sugar Free - Add your own review/rating

Compare Tricodene Sugar Free with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and dextromethorphan.

Equimax

Dosage Form: FOR ANIMAL USE ONLY
Equimax®

(ivermectin 1.87% / praziquantel 14.03%)

Paste

Anthelmintic and Boticide

FOR ORAL USE IN HORSES ONLY

Removes worms and bots with a single dose.

Contents will treat up to 1320 lb body weight.

Net Weight: 0.225 oz (6.42 g)

INDICATIONS

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Equimax (ivermectin/praziquantel) Paste is indicated for the treatment and control of the following parasites:

Tapeworms

Anoplocephala perfoliata

Large Strongyles (adults)

Strongylus vulgaris (also early forms in blood vessels)

S. edentatus (also tissue stages)

S. equinus

Triodontophorus spp.

Small Strongyles (adults, including those resistant to some benzimidazole class compounds)

Cyathostomum spp.

Cylicocyclus spp.

Cylicostephanus spp.

Cylicodontophorus spp.

Small Strongyles (fourth-stage larvae)

Pinworms (adults and fourth-stage larvae)

Oxyuris equi

Ascarids (adults and third- and fourth-stage larvae)

Parascaris equorum

Hairworms (adults)

Trichostrongylus axei

Large-mouth Stomach Worms (adults)

Habronema muscae

Bots (oral and gastric stages)

Gasterophilus spp.

Lungworms (adults and fourth-stage larvae)

Dictyocaulus arnfieldi

Intestinal Threadworms (adults)

Strongyloides westeri

Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae

Dermatitis caused by Neck Threadworm microfilariae, Onchocerca sp.

Equimax Dosage and Administration

This syringe contains sufficient paste to treat one 1320-lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) and 0.68 mg praziquantel per lb (1.5 mg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 220 lb (100 kg) of body weight.

1. While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking.


2. Lock the ring in place by making a 1/4 turn to the right.


3. Make sure that the horse's mouth contains no feed.


4. Remove the cover from the tip of the syringe.


5. Insert the syringe tip into the horse's mouth at the space between the teeth.


6. Depress the plunger as far as it will go, depositing paste on the back of the tongue.


7. Immediately raise the horse's head for a few seconds after dosing.

Parasite Control Program

All horses should be included in a regular parasite control program with particular attention being paid to mares, foals, and yearlings. Foals should be treated initially at 4 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Equimax Paste effectively controls gastrointestinal nematodes, cestodes and bots of horses. Regular treatment will reduce the chances of colic caused by Anoplocephala perfoliata and verminous arteritis caused by Strongylus vulgaris.

Product Advantages

Broad-spectrum Control

Equimax Paste kills important internal parasites, including tapeworms, bots and the arterial stages of S. vulgaris, with a single dose. Equimax Paste contains two potent antiparasitic agents that are neither benzimidazoles nor organophosphates.

SAFETY

Equimax Paste may be used in horses 4 weeks of age and older. Stallions and breeding, pregnant or lactating mares may be treated without adverse effects on fertility.

In a tolerance study in which 3- to 4-week-old foals were treated at 10X once, loose watery stools were observed on post-treatment days 1, 2, and 5-9 in one foal. These signs resolved without treatment by day 10, and no other foals were affected.

In a reproductive safety study, eleven mares were treated with a 3X dose of Equimax Paste every two weeks throughout breeding, pregnancy and lactation, up until the foal was three months of age. Ten mares served as controls and were treated with the vehicle paste in a similar manner. An increased incidence of colic was observed in treated mares as compared to control mares. In addition, elevations of GGT and AST were more frequent in the 3X treated mares, and in two mares these enzymes were elevated at the time of colic episodes.

One treated mare was dropped from the study because she did not conceive after three breeding attempts.

Two treated mares had abnormally short diestrous periods of two days and eight days on the first estrous cycle following the birth of the study foal. In addition, one of these two mares failed to ovulate in the second and third estrous cycles.

In the first few weeks of life, foals born to the 3X treated mares had a higher incidence of transient ocular discharge and gastrointestinal disturbances (loose stools, diarrhea) and depression requiring medical intervention as compared to foals born to control mares.

Precautions

Equimax Paste has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Warning

Do not use in horses intended for human consumption.

HUMAN WARNINGS

Not for use in humans. Keep this and all drugs out of the reach of children. Refrain from eating or smoking when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Bimeda Inc. at 1-888-524-6332.

ENVIRONMENTAL WARNINGS

Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

Store at room temperature (25°C/77°F), with excursions permitted between 15°–30°C (59°–86°F).

NOTE TO USER

Swelling and itching reactions after treatment with ivermectin paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Equimax Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

To report adverse reactions, call Bimeda Inc. at 1-888-524-6332.

NADA #141-215, Approved by FDA

Manufactured by:

Virbac AH Inc.

3200 Meacham Blvd

Fort Worth, Texas 76137

U.S. Patent No. 5,824,653

Distributed by:

Bimeda, Inc.

Le Sueur, MN 56058

Made in USA

Equimax is a Registered Trademark of Virbac SA.

301985-01

October 2009

PRINCIPAL DISPLAY PANEL - 6.42 g Syringe Carton

Equimax®

(ivermectin 1.87%/

praziquantel 14.03%)

Paste

Anthelmintic and Boticide

For the treatment and control of roundworms (ascarids,

strongyles and lungworms), tapeworms, and bots in

horses with a single dose.

Contents will treat up to 1320 lb body weight.

FOR ORAL USE IN HORSES ONLY

Net Weight: 0.225 oz (6.42 g)

NADA #141-215, Approved by FDA

Bimeda

Equimax  ivermectin and praziquantel  paste

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 61133-7000 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 200 ug praziquantel (praziquantel) praziquantel 1.5 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor APPLE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61133-7000-1 1 SYRINGE In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141215	01/14/2010

Labeler - Bimeda Inc (043653216)

Registrant - Virbac AH Inc (131568396)

Establishment
Name	Address	ID/FEI	Operations
Virbac Bridgeton		808558100	MANUFACTURE

Revised: 01/2010Bimeda Inc