Isoproterenol Clorhidrato

Isoproterenol Clorhidrato may be available in the countries listed below.

Ingredient matches for Isoproterenol Clorhidrato

Isoprenaline

Isoprenaline hydrochloride (a derivative of Isoprenaline) is reported as an ingredient of Isoproterenol Clorhidrato in the following countries:

• Chile

International Drug Name Search

Privigen 100mg / ml solution for infusion

1. Name Of The Medicinal Product

Privigen^®

2. Qualitative And Quantitative Composition

Human normal immunoglobulin (IVIg).

One ml contains:

human plasma protein…………………………………………………………...100 mg

(purity of at least 98% IgG)

One vial of 25 ml contains: 2.5 g

One vial of 50 ml contains: 5 g

One vial of 100 ml contains: 10 g

One vial of 200 ml contains: 20 g

Distribution of the IgG subclasses (average values):

IgG₁........... . 67.8%

IgG₂........... . 28.7%

IgG₃........... . 2.3%

IgG₄........... . 1.2%

The maximum IgA content is 0.025 mg/ml.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

The solution is clear or slightly opalescent and colourless to pale yellow.

Privigen is isotonic, with an osmolality of 320 mOsmol/kg.

4. Clinical Particulars

4.1 Therapeutic Indications

Replacement therapy in

• Primary immunodeficiency (PID) syndromes such as:

– congenital agammaglobulinaemia and hypogammaglobulinaemia

– common variable immunodeficiency

– severe combined immunodeficiency

– Wiskott Aldrich syndrome

• Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

• Children with congenital AIDS and recurrent infections.

Immunomodulation

• Immune thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

• Guillain-Barré syndrome.

• Kawasaki disease.

Allogeneic bone marrow transplantation

4.2 Posology And Method Of Administration

Posology

The dose and dosage regimen is dependent on the indication.

In replacement therapy the dosage may need to be individualised for each patient depending on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.

Replacement therapy in primary immunodeficiency syndromes

The dosage regimen should achieve a trough IgG level (measured before the next infusion) of at least 4 to 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur.

The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) followed by at least 0.2 g/kg bw every three weeks.

The dose required to achieve a trough level of 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month. The dosage interval when steady state has been reached varies from two to four weeks.

Trough levels should be measured in order to adjust the dose and dosage interval.

Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections

The recommended dose is 0.2 to 0.4 g/kg bw every three to four weeks.

Immune thrombocytopenic purpura

For the treatment of an acute episode, 0.8 to 1 g/kg bw on day one, which may be repeated once within three days, or 0.4 g/kg bw daily for two to five days. The treatment can be repeated if relapse occurs.

Guillain-Barré syndrome

0.4 g/kg bw/day for three to seven days.

Experience in children is limited.

Kawasaki disease

1.6 to 2.0 g/kg bw should be administered in divided doses over two to five days or 2.0 g/kg bw as a single dose.

Patients should receive concomitant treatment with acetylsalicylic acid.

Allogeneic bone marrow transplantation:

Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplantation.

For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg bw/week, starting seven days before transplantation and continued for up to three months after the transplantation.

In case of persistent lack of antibody production, a dose of 0.5 g/kg bw/month is recommended until antibody levels return to normal.

The dosage recommendations are summarised in the following table:

Indication	Dose	Frequency of injections
Replacement therapy
–in primary immunodeficiency	starting dose: 0.4–0.8 g/kg bw
	thereafter: 0.2–0.8 g/kg bw	every two to four weeks to obtain IgG trough levels of at least 4–6 g/l
–in secondary immunodeficiency	0.2–0.4 g/kg bw	every three to four weeks to obtain IgG trough levels of at least 4–6 g/l
–Children with AIDS	0.2–0.4 g/kg bw	every three to four weeks
Immunomodulation
–Immune thrombocytopenic purpura	0.8–1 g/kg bw	on day one, possibly repeated once within three days
	or 0.4 g/kg bw/d	for two to five days
–Guillain-Barré syndrome	0.4 g/kg bw/d	for three to seven days
–Kawasaki disease	1.6–2 g/kg bw	in divided doses over two to five days in association with acetylsalicylic acid
	or 2 g/kg bw	in one dose in association with acetylsalicylic acid
Allogeneic bone marrow transplantation
–treatment of infections and prophylaxis of graft versus host disease	0.5 g/kg bw	every week from seven days before up to three months after transplantation
–persistent lack of antibody production	0.5 g/kg bw	every month until antibody levels return to normal

Method of administration

Human normal immunoglobulin should be infused intravenously. The initial infusion rate is 0.3 ml/kg bw/hr. If well tolerated, the rate of administration may gradually be increased to 4.8 ml/kg bw/hr.

In PID patients who have tolerated the infusion rate of 4.8ml/kg bw/hr well, the rate may be further increased gradually to 7.2 ml/kg bw/hr.

If dilution prior to infusion is desired, Privigen may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5%). For instruction, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Hypersensitivity to homologous immunoglobulins, especially in the very rare cases of IgA deficiency when the patient has antibodies against IgA.

Patients with hyperprolinaemia.

4.4 Special Warnings And Precautions For Use

Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under section 4.2 "Method of administration" must be followed closely. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently:

– in case of high rate of infusion,

– in patients with hypo- or agammaglobulinaemia with or without IgA deficiency,

– in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.

True hypersensitivity reactions are rare. They can occur in the very rare cases of IgA deficiency with anti-IgA antibodies.

Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.

Potential complications can often be avoided by ensuring that patients:

– are not sensitive to human normal immunoglobulin by initially infusing the product slowly (0.3 ml/kg bw/hr);

– are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for one hour after, in order to detect potential adverse signs. All other patients should be observed for at least twenty minutes after administration.

Haemolytic anaemia

IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction (Coomb's test) and, rarely, haemolysis. Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration. IVIg recipients should be monitored for clinical signs and symptoms of haemolysis (see also Section 4.8).

There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients. Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients and patients with diseases which increase blood viscosity).

Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, being overweight, concomitant nephrotoxic medicinal products or age over 65.

In case of renal impairment, IVIg discontinuation should be considered.

While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. In patients at risk, the use of IVIg products that do not contain sucrose may be considered. Privigen does not contain sucrose or other sugars.

In patients at risk of acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.

In all patients, IVIg administration requires:

– adequate hydration prior to the initiation of the infusion of IVIg

– monitoring of urine output

– monitoring of serum creatinine levels

– avoidance of concomitant use of loop diuretics.

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the side effect.

In case of shock, standard medical treatment for shock should be implemented.

For patients suffering from diabetes mellitus and requiring dilution of Privigen to lower concentrations, the presence of glucose in the recommended diluent should be taken into account.

Information on safety with respect to transmissible agents

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV, and HCV, and for the non-enveloped viruses HAV and B19V.

There is reassuring clinical experience regarding the lack of hepatitis A or B19V transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

It is strongly recommended that every time Privigen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Live attenuated virus vaccines

Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella and varicella for a period of at least six weeks and up to three months. After administration of this product, an interval of three months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to one year. Therefore patients receiving measles vaccine should have their antibody status checked.

Interference with serological testing

After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test).

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

With human normal immunoglobulin for intravenous administration, adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin. Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see also Section 4.4).

Increase in serum creatinine level and/or acute renal failure have been observed.

Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.

Three clinical studies with Privigen were performed, two in patients with primary immunodeficiency (PID) and one in patients with immune thrombocytopenic purpura (ITP). In the pivotal PID study 80 subjects were enrolled and treated with Privigen. Of these, 72 completed the twelve months of treatment. In the PID extension study 55 subjects were enrolled and treated with Privigen. The ITP study was performed in 57 patients.

Most adverse drug reactions (ADRs) observed in the three clinical studies were mild to moderate in nature.

The ADRs reported in the three studies are summarised and categorised according to the MedDRA System organ class and frequency below. Frequency per infusion has been evaluated using the following criteria: very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing severity.

Frequency of Adverse Drug Reactions (ADRs) in clinical studies with Privigen

MedDRA System Organ Class	MedDRA preferred term	ADR frequency category
Investigations	Bilirubin conjugated increased, blood bilirubin unconjugated increased, Coombs direct test positive, Coombs test positive, blood lactate dehydrogenase increased, haematocrit decreased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood pressure decreased, blood pressure increased, body temperature increased, haemoglobin decreased	Uncommon
Cardiac disorders	Palpitations	Uncommon
Blood and lymphatic system disorders	Anaemia, anisocytosis	Uncommon
Nervous system disorders	Headache	Very common
Dizziness, head discomfort, somnolence, tremor, sinus headache	Uncommon
Respiratory, thoracic and mediastinal disorders	Dyspnoea, oropharyngeal blistering, painful respiration, throat tightness	Uncommon
Gastrointestinal disorders	Vomiting, nausea	Common
Diarrhoea, abdominal pain upper	Uncommon
Renal and urinary disorders	Proteinuria	Uncommon
Skin and subcutaneous tissue disorders	Pruritus, skin disorder, night sweats, urticaria	Uncommon
Musculoskeletal and connective tissue disorders	Back pain	Common
Neck pain, pain in extremity, musculoskeletal stiffness, muscle spasms, musculoskeletal pain, myalgia	Uncommon
Vascular disorders	Flushing, hypertension, hypotension	Uncommon
General disorders and administration site conditions	Chills, fatigue, pyrexia	Common
Chest pain, general symptom, asthenia, influenza like illness, hyperthermia, pain, injection site pain	Uncommon
Hepatobiliary disorders	Hyperbilirubinaemia	Uncommon

For safety with respect to transmissible agents, see section 4.4.

4.9 Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.

Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1,000 donors. It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.

The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

The safety and efficacy of Privigen was evaluated in three prospective, open-label, single-arm, multicenter studies performed in Europe (ITP and PID studies) and the USA (PID study).

5.2 Pharmacokinetic Properties

Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid, equilibrium between the intra- and extravascular compartments is reached after approximately three to five days.

The pharmacokinetic parameters for Privigen were determined in a clinical study in PID patients (see section 5.1). Twenty-five patients (aged 13 to 69 years) participated in the pharmacokinetic (PK) assessment. In this study, the median half-life of Privigen in primary immunodeficiency patients was 36.6 days. In an extension of this study, thirteen PID patients (aged 3 to 65 years) participated in a PK sub-study. The results of this study show the median half-life of Privigen to be 31.1 days (see table below). The half-life may vary from patient to patient, particularly in primary immunodeficiency.

Pharmacokinetic parameters of Privigen in PID patients

Parameter	Pivotal Study (N=25) ZLB03_002CR Median (Range)	Extension Study (N=13) ZLB05_006CR Median (Range)
Cmax (peak, g/l)	23.4 (10.4-34.6)	26.3 (20.9-32.9)
Cmin (trough, g/l)	10.2 (5.8-14.7)	12.3 (10.4-18.8) (3-week schedule) 9.4 (7.3-13.2) (4-week schedule)
t½ (days)	36.6 (20.6-96.6)	31.1 (14.6-43.6)

C_max, maximum serum concentration; C_{min ,} trough (minimum level) serum concentration; t_½, elimination half-life

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

Immunoglobulins are a normal constituent of the human body. L-proline is a physiological, non-essential amino acid.

The safety of Privigen has been assessed in several preclinical studies, with particular reference to the excipient L-proline. Some published studies pertaining to hyperprolinaemia have shown that long-term, high doses of L-proline have effects on brain development in very young rats. However, in studies where the dosing was designed to reflect the clinical indications for Privigen, no effects on brain development were observed. Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.

6. Pharmaceutical Particulars

6.1 List Of Excipients

L-proline

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

3 years

If the product is diluted to lower concentrations (see section 6.6), immediate use after dilution is recommended. The in-use stability of Privigen after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) has been demonstrated for 10 days at 30°C; however, the microbial contamination aspect was not studied.

6.4 Special Precautions For Storage

Do not store above 25 °C.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

25 ml of solution in a single vial (type I glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.

50 or 100 ml of solution in a single vial (type I or II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.

200 ml of solution in a single vial (type II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.

Pack sizes:

1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml),

3 vials (10 g/100 ml, 20 g/200 ml).

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Privigen comes as a ready-for-use solution in single-use vials. The product should be at room or body temperature before use. A vented infusion line should be used for the administration of Privigen. Always pierce the stopper at its centre, within the marked area.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have particulate matter.

If dilution is desired, 5 % glucose solution should be used. For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the 5% glucose solution. Aseptic technique must be strictly observed during the dilution of Privigen.

Once the vial has been entered under aseptic conditions, its contents should be used promptly. Because the solution contains no preservative, Privigen should be infused as soon as possible.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

CSL Behring GmbH

Emil-von-Behring-Strasse 76

D-35041 Marburg

Germany

8. Marketing Authorisation Number(S)

2.5g: EU/1/08/446/004

5g: EU/1/08/446/001

10g: EU/1/08/446/002

20g: EU/1/08/446/003

10g x 3: EU/1/08/446/005

20g x 3: EU/1/08/446/006

9. Date Of First Authorisation/Renewal Of The Authorisation

001-003: 25 April 2008

004: 07 May 2009

005-006: 30 June 2009

10. Date Of Revision Of The Text

26 August 2010

Detailed information on this product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Icaz

Icaz may be available in the countries listed below.

Ingredient matches for Icaz

Isradipine

Isradipine is reported as an ingredient of Icaz in the following countries:

• France


• Tunisia

International Drug Name Search

Heart Disease Medications

Definition of Heart Disease:

Heart disease is any disorder that affects the heart's ability to function normally. The most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart itself. This happens slowly over time. (See coronary artery disease.)

Some heart diseases can be present at birth (congenital heart diseases).

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The following drugs and medications are in some way related to, or used in the treatment of Heart Disease. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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Micromedex Care Notes:

• Atrial Septal Defect
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Medical Encyclopedia:

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• Heart palpitations
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Depocyt

Phenylephrine Chewable Tablets

Pronunciation: fehn-ihl-EFF-rihn
Generic Name: Phenylephrine
Brand Name: AH-Chew D and Gilchew IR

Phenylephrine Chewable Tablets are used for:

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

Phenylephrine Chewable Tablets are a decongestant. It works by shrinking swollen and congested nasal tissues (mucous membranes) by constricting blood vessels. This results in relief of congestion (stuffy feeling) and improved drainage of mucus and improved breathing through the nose.

Do NOT use Phenylephrine Chewable Tablets if:

• you are allergic to any ingredient in Phenylephrine Chewable Tablets


• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days


• you have high blood pressure or an abnormally fast heartbeat

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

Before using Phenylephrine Chewable Tablets:

Some medical conditions may interact with Phenylephrine Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 heart disease, diabetes, phenylketonuria (PKU), tumors on your adrenal gland, or thyroid disease

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

• Rauwolfia derivatives (eg, reserpine) or tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Phenylephrine Chewable Tablets may be decreased


• Cocaine, furazolidone, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Phenylephrine Chewable Tablets may be increased


• Bromocriptine, COMT inhibitors (eg, entacapone), cocaine, or droxidopa because the actions and side effects of these medicines may be increased


• Guanethidine because its effectiveness may be decreased by Phenylephrine Chewable Tablets

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

Use Phenylephrine Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Phenylephrine Chewable Tablets with food, water, or milk to minimize stomach irritation.


• Chew thoroughly before swallowing. Tablets may be broken in half to make them easier to take.


• If you miss a dose of Phenylephrine Chewable Tablets and 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 Chewable Tablets.

Important safety information:

• Phenylephrine Chewable Tablets may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenylephrine Chewable Tablets. Using Phenylephrine Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Phenylephrine Chewable Tablets.


• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Phenylephrine Chewable Tablets


• Phenylketonuria patients - Phenylephrine Chewable Tablets contains phenylalanine.


• Diabetes patients - Phenylephrine Chewable Tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• Use Phenylephrine Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Phenylephrine Chewable Tablets during pregnancy. It is unknown if Phenylephrine Chewable Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Phenylephrine Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Phenylephrine Chewable Tablets. This is known as DEPENDENCE or "addiction." If you are addicted and you suddenly stop taking Phenylephrine Chewable Tablets, you may experience WITHDRAWAL symptoms, including depression.

Possible side effects of Phenylephrine Chewable Tablets:

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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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 confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Phenylephrine Chewable Tablets:

Store Phenylephrine Chewable Tablets 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 Chewable Tablets out of the reach of children and away from pets.

General information:

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


• Phenylephrine Chewable Tablets are 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 Chewable Tablets. 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.

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• Hypotension
• Nasal Congestion
• Shock
• Supraventricular Tachycardia

Zileuton

Pronunciation: zye-LOO-ton
Generic Name: Zileuton
Brand Name: Zyflo

Zileuton is used for:

Preventing and treating asthma in patients 12 years old and older. It may also be used for other conditions as determined by your doctor.

Zileuton is a leukotriene synthesis inhibitor. It works by blocking the formation of a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.

Do NOT use Zileuton if:

• you are allergic to any ingredient in Zileuton


• you have liver disease or abnormal liver function tests


• you are taking astemizole, pimozide, or terfenadine

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

Before using Zileuton:

Some medical conditions may interact with Zileuton. 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 liver problems (eg, hepatitis) or symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine)


• if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions


• if you drink alcohol

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

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased


• Azole antifungals (eg, ketoconazole) because they may increase the risk of Zileuton's side effects


• Astemizole, beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine), cisapride, cyclosporine, pimozide, terfenadine, or theophylline because the risk of their side effects may be increased by Zileuton

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

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

• An extra patient leaflet is available with Zileuton. Talk to your pharmacist if you have questions about this information.


• Take Zileuton by mouth with or without food.


• Take Zileuton on a regular schedule to get the most benefit from it. Taking Zileuton at the same times each day will help you remember to take it.


• Continue to take Zileuton even if you feel well. Do not miss any doses.


• If you miss a dose of Zileuton, 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 Zileuton.

Important safety information:

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


• It may take a few weeks before you get the full benefit of Zileuton. Do not stop using Zileuton without checking with your doctor.


• Zileuton will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Zileuton (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.


• Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it more often, or if you have a decrease in your peak flow meter results.


• Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.


• Talk with your doctor or pharmacist about all your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.


• Some patients taking Zileuton have developed mental or mood changes, including sleep problems and behavior changes. Contact your doctor immediately if you experience any unusual symptoms while taking Zileuton.


• Lab tests, including liver function, may be performed while you take Zileuton. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Zileuton with caution in the ELDERLY; they may be more sensitive to its effects, especially liver problems.


• Zileuton should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Zileuton:

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:

Mild stomach pain or upset; nausea.

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); chest pain; fever, chills, or persistent sore throat; mental or mood changes; sleep problems; symptoms of liver problems (eg, dark urine; flu-like symptoms; pale stools; persistent loss of appetite; right upper stomach pain; unusual nausea, sluggishness, or tiredness; yellowing of the skin or eyes); unusual changes in behavior.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zileuton side effects (in more detail)

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.

Proper storage of Zileuton:

Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zileuton out of the reach of children and away from pets.

General information:

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


• Zileuton 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 Zileuton. 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 Zileuton resources

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

• Zileuton Monograph (AHFS DI)


• Zileuton Professional Patient Advice (Wolters Kluwer)


• zileuton Concise Consumer Information (Cerner Multum)


• zileuton Advanced Consumer (Micromedex) - Includes Dosage Information


• Zyflo Prescribing Information (FDA)


• Zyflo CR Prescribing Information (FDA)

Compare Zileuton with other medications

• Asthma, Maintenance

Lannett Company, Inc

Address Lannett Company, Inc, 9000 State Rd, Philadelphia, PA 19136-1615 Contact Details Phone: (215) 333-9000 Website: http://www.lannett.com/ Careers: http://tbe.taleo.net/NA11/ats/careers...

Glucagen Diagnostic Kit

Generic Name: glucagon (Injection route)

GLOO-ka-gon

Commonly used brand name(s)

In the U.S.

• Glucagen


• Glucagen Diagnostic Kit


• Glucagon


• Glucagon Diagnostic Kit


• Glucagon Emergency Kit

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Glucose Regulation, Antihypoglycemic

Uses For Glucagen Diagnostic Kit

Glucagon belongs to the group of medicines called hormones. It is an emergency medicine used to treat severe hypoglycemia (low blood sugar) in patients with diabetes who have passed out or cannot take some form of sugar by mouth.

Glucagon is also used during x-ray tests of the stomach and bowels to improve test results by relaxing the muscles of the stomach and bowels. This also makes the testing more comfortable for the patient.

Glucagon also may be used for other conditions as determined by your doctor.

Glucagon is 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, glucagon is used in certain patients with the following medical conditions or undergoing certain medical procedures:

• Overdose of beta-adrenergic blocking medicines


• Overdose of calcium channel blocking medicines


• Removing food or an object stuck in the esophagus


• Hysterosalpingography (x-ray examination of the uterus and fallopian tubes)

Before Using Glucagen Diagnostic Kit

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

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

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of glucagon in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking 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 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.

• Acenocoumarol


• Anisindione


• Dicumarol


• Phenindione


• Phenprocoumon


• Warfarin

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:

• Diabetes mellitus—When glucagon is used for test or x-ray procedures in patients with diabetes that is well-controlled, a rise in blood sugar may occur; otherwise, glucagon is an important part of the management of diabetes because it is used to treat hypoglycemia (low blood sugar)

• Insulinoma (tumors of the pancreas gland that make too much insulin) (or history of)—Blood sugar concentrations may decrease

• Pheochromocytoma—Glucagon can cause high blood pressure

Proper Use of glucagon

This section provides information on the proper use of a number of products that contain glucagon. It may not be specific to Glucagen Diagnostic Kit. Please read with care.

Glucagon is an emergency medicine and must be used only as directed by your doctor. Make sure that you and a member of your family or a friend understand exactly when and how to use this medicine before it is needed .

Glucagon is packaged in a kit with a vial of powder containing the medicine and a syringe filled with liquid to mix with the medicine. Directions for mixing and injecting the medicine are in the package. Read the directions carefully and ask your health care professional for additional explanation, if necessary.

Glucagon should not be mixed after the expiration date printed on the kit and on one vial. Check the date regularly and replace the medicine before it expires. The printed expiration date does not apply after mixing, when any unused portion must be discarded.

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.

• As an emergency treatment for hypoglycemia:
  
  • Adults and children weighing 20 kilograms (kg) (44 pounds) or more: 1 milligram (mg). The dose may be repeated after fifteen minutes if necessary.
  
  
  • Children weighing up to 20 kg (44 pounds): 0.5 mg or 20 to 30 micrograms (mcg) per kg (9.1 to 13.6 mcg per pound) of body weight. The dose may be repeated after fifteen minutes if necessary.
  
  

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Glucagen Diagnostic Kit

Patients with diabetes should be aware of the symptoms of hypoglycemia (low blood sugar). These symptoms may develop in a very short time and may result from:

• using too much insulin (“insulin reaction”) or as a side effect from oral antidiabetic medicines.


• delaying or missing a scheduled snack or meal.


• sickness (especially with vomiting or diarrhea).


• exercising more than usual.

Unless corrected, hypoglycemia will lead to unconsciousness, convulsions (seizures), and possibly death. Early symptoms of hypoglycemia include: anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.

Symptoms of hypoglycemia can differ from person to person. It is important that you learn your own signs of low blood sugar so that you can treat it quickly. It is a good idea also to check your blood sugar to confirm that it is low.

You should know what to do if symptoms of low blood sugar occur. Eating or drinking something containing sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse, and will probably make the use of glucagon unnecessary. Good sources of sugar include glucose tablets or gel, corn syrup, honey, sugar cubes or table sugar (dissolved in water), fruit juice, or nondiet soft drinks. If a meal is not scheduled soon (1 hour or less), you should also eat a light snack, such as crackers and cheese or half a sandwich or drink a glass of milk to keep your blood sugar from going down again. You should not eat hard candy or mints because the sugar will not get into your blood stream quickly enough. You also should not eat foods high in fat such as chocolate because the fat slows down the sugar entering the blood stream. After 10 to 20 minutes, check your blood sugar again to make sure it is not still too low.

Tell someone to take you to your doctor or to a hospital right away if the symptoms do not improve after eating or drinking a sweet food. Do not try to drive yourself.

If severe symptoms such as convulsions (seizures) or unconsciousness occur, the patient with diabetes should not be given anything to eat or drink. There is a chance that he or she could choke from not swallowing correctly. Glucagon should be administered and the patient's doctor should be called at once.

If it becomes necessary to inject glucagon, a family member or friend should know the following:

• After the injection, turn the patient on his or her left side. Glucagon may cause some patients to vomit and this position will reduce the possibility of choking.


• The patient should become conscious in less than 15 minutes after glucagon is injected, but if not, a second dose may be given. Get the patient to a doctor or to hospital emergency care as soon as possible because being unconscious too long can be harmful.


• When the patient is conscious and can swallow, give him or her some form of sugar. Glucagon is not effective for much longer than 1½ hours and is used only until the patient is able to swallow. Fruit juice, corn syrup, honey, and sugar cubes or table sugar (dissolved in water) all work quickly. Then, if a snack or meal is not scheduled for an hour or more, the patient should also eat some crackers and cheese or half a sandwich, or drink a glass of milk. This will prevent hypoglycemia from occurring again before the next meal or snack.


• The patient or caregiver should continue to monitor the patient's blood sugar. For about 3 to 4 hours after the patient regains consciousness, the blood sugar should be checked every hour.


• If nausea and vomiting prevent the patient from swallowing some form of sugar for an hour after glucagon is given, medical help should be obtained.

Keep your doctor informed of any hypoglycemic episodes or use of glucagon even if the symptoms are successfully controlled and there seem to be no continuing problems. Complete information is necessary for the doctor to provide the best possible treatment of any condition.

Replace your supply of glucagon as soon as possible, in case another hypoglycemic episode occurs.

You should wear a medical identification (I.D.) bracelet or chain at all times. In addition, you should carry an I.D. card that lists your medical condition and medicines.

Glucagen Diagnostic Kit 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

• Dizziness


• lightheadedness


• trouble in breathing

Symptoms of overdose

• Diarrhea


• irregular heartbeat


• loss of appetite


• muscle cramps or pain


• nausea (continuing)


• vomiting (continuing)


• weakness of arms, legs, and trunk (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Skin rash

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:

Less common or rare

• Fast heartbeat


• nausea


• vomiting

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: Glucagen side effects (in more detail)

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

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

More Glucagen Diagnostic Kit resources

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

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• Diagnosis and Investigation
• Hypoglycemia

Isofra

Isofra may be available in the countries listed below.

Ingredient matches for Isofra

Framycetin

Framycetin sulfate (a derivative of Framycetin) is reported as an ingredient of Isofra in the following countries:

• Benin


• Burkina Faso


• Cameroon


• Central African Republic


• Chad


• Congo


• Cote D'ivoire


• Gabon


• Georgia


• Guinea


• Luxembourg


• Madagascar


• Mali


• Mauritania


• Mauritius


• Niger


• Russian Federation


• Senegal


• Togo


• Zaire

International Drug Name Search

Exall Liquid

carbetapentane citrate and guaifenesin

Dosage Form: liquid
Exall Liquid

Exall Liquid

Rx Only

Antitussive / Expectorant


DESCRIPTION: ExallTM Liquid is alcohol-free, dye-free, sugar-free, colorless liquid for oral administration having a cherry odor and flavor.


Each teaspoonful (5 mL) for oral administration contains:

Carbetapentane Citrate........................ 10 mg

Guaifenesin.......................................100 mg


Inactive ingredients: Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.


Carbetapentane Citrate (1-Phenylcyclopentanecarboxylic acid 2-(2-diethylaminoethoxy) ethyl ester citrate) is a white crystalline powder.

It is freely soluble in water and chloroform. Its structure is as follows:

Guaifenesin (1,2-Propanediol, 3-(2-methoxyphenoxy)-, (±)-) is a white to slightly gray, crystalline powder, having a bitter taste.

It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. Its structure is as follows:

CLINICAL PHARMACOLOGY:

Antitussive and expectorant actions.

Carbetapentane Citrate is a centrally acting non-narcotic antitussive. Carbetapentane citrate has atropine-like and local anesthetic actions,

as well as temporarily controls and suppresses the cough reflex by selective depression of the medullary cough center. It has no significant

analgesic or sedative properties, does not depress respiration or predispose to addiction with usual doses.

Guaifenesin has an expectorant action, which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension.

By increasing respiratory tract fluid, guaifenesin reduces the viscosity of secretions, and facilitates expectoration of retained secretions.

Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and renally excreted. Guaifenesin has a plasma

half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid. Sinus and bronchial drainage is improved and dry,

non-productive coughs become more productive and less frequent. Guaifenesin helps loosen phlegm (mucus) and thin bronchial secretions

to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

INDICATIONS AND USAGE:

For temporary relief of productive and non-productive cough accompanying respiratory tract congestion associated with the common

cold, influenza, sinusitis, and bronchitis.

CONTRAINDICATIONS:

ExallTM Liquid is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the ingredients

and in patients receiving monoamine oxidase inhibitor (MAOI) therapy, including 14 days after stopping.

WARNINGS:

General: Before prescribing any medication to suppress or modify cough, it is important that the underlying cause of the cough is identified.

Information for Patients:

Patients should be instructed to take ExallTM Liquid only as prescribed. Do not exceed the recommended dose. If nervousness,

dizziness, or sleeplessness occur, discontinue use and consult a physician.

Drug/Laboratory Test Interactions:

Carbetapentane citrate should not be used in patients receiving MAO inhibitors, including 14 days after stopping the MAOI drug.

The use of carbetapentane citrate may result in additive CNS depressant effects when coadministered with alcohol, antihistamines,

psychotropics or other drugs that produce CNS depression.

Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of

this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this

drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No adequate and well-controlled studies have been conducted to determine whether the components of ExallTM  Liquid

have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is also not known whether it can

cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should not be administered

to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Pediatric use:

Safety and effectiveness in pediatric patients below the age of six have not been established. Product not intended for administration

for children 6 years of age and under.

ADVERSE REACTIONS:

Adverse effects associated with carbetapentane citrate are rare, but nausea and/or other gastrointestinal disturbances sometimes occur.

Guaifenesin is well tolerated and has a wide margin of safety. Adverse effects associated with guaifenesin usually result from doses larger

than those required for expectoration.

OVERDOSAGE:

Signs and Symptoms: Overdosage with carbetapentane citrate may produce central excitement and mental confusion. Guaifenesin is

unlikely to produce toxic effects since its toxicity is low. When laboratory animals were administered guaifenesin in doses up to 5 g/kg

by stomach tube, no toxicity resulted.

Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the

administration of ipecac liquid is a preferred method, however, vomiting should not be induced in patients with impaired consciousness.

Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach

may be absorbed by activated charcoal administered as a slurry with water.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older:

1-2 teaspoonfuls (5-10 mL) every 4-6 hours, not to exceed 12 teaspoonfuls in a 24 hour period.

Children 6 to 12 years of age:

1 teaspoonful (5 ml) every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.

Children under 6 years of age:

Consult a physician.

HOW SUPPLIED:

ExallTM Liquid is a colorless, cherry flavored liquid and supplied in bottles of 16 fl oz (473 mL), NDC 63717-554-16, or samples

of 1/2 fl oz (15 mL), NDC 63717-554-99.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE,

CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx Only

Manufactured for:

Hawthorn Pharmaceuticals, Inc.

Madison, MS 39110

HI255   08/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

NDC 63717-554-16

ExallTM Liquid

Antitussive / Expectorant

Each teaspoonful (5 mL) for oral administration contains:

Carbetapentane Citrate..... 10 mg

Guaifenesin.................... 100 mg

Rx Only

Dye Free/Sugar Free/Alcohol Free

Hawthorn Pharmaceuticals, Inc.

16 fl oz (473 mL)

Side Panel:

USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON

CONTROL CENTER IMMEDIATELY.

Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to the consumer. Dispense in a tight, light-resistant container with a child-resistant closure.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (Toll Free).

Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110

HL209   08/09

Exall Liquid  carbetapentane citrate, guaifenesin   liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63717-554 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbetapentane Citrate (Carbetapentane) Carbetapentane Citrate 10 mg  in 5 mL Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63717-554-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		08/24/2009

Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 08/2009Hawthorn Pharmaceuticals, Inc.

More Exall Liquid resources

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

Compare Exall Liquid with other medications

• Cough