Drugs Details

Drugs Info of Intal, Intal Inhaler
Drugs Details
  • Drugs Type  : Multum
  • Date : 18th Feb 2015 01:14 am
  • Brand Name : Intal, Intal Inhaler
  • Generic Name :  cromolyn sodium (inhalation) (Pronunciation: KROE moe lin SOE dee um)
Descriptions

The active ingredient of INTAL Nebulizer Solution is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn

sodium is disodium 5,5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2- carboxylate]. The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Cromolyn sodium is a water soluble, odorless, white, hydrated crystalline powder. It is tasteless at first, but leaves a slightly bitter aftertaste. INTAL Nebulizer Solution (cromolyn sodium inhalation solution) is clear, colorless, sterile, and has a target pH of 5.5. The molecular structure is:

Intal (cromolyn sodium) structural formula illustration

Each 2 mL ampule of INTAL Nebulizer Solution (cromolyn sodium inhalation solution, USP) contains 20 mg cromolyn sodium, USP, in purified water.

What are the possible side effects of cromolyn sodium inhalation (Intal, Intal Inhaler)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe wheezing or chest tightness just after inhaling the medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • fever, swollen glands, rash or itching, joint pain, and a general ill feeling.

Less serious side effects may include:

  • dry or irritated...

Read All Potential Side Effects and See Pictures of Intal Nebulizer Solution »
This monograph has been modified to include the generic and brand name in many instances.

Indications

INTAL is a prophylactic agent indicated in the management of patients with bronchial asthma.

In patients whose symptoms are sufficiently frequent to require a continuous program of medication, INTAL is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION). The effect of INTAL is usually evident after several weeks of treatment, although some patients show an almost immediate response.

In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., INTAL should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION).

Dosage Administration

For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one ampule administered by nebulization four times a day at regular intervals.

Drug stability and safety of INTAL Nebulizer Solution (cromolyn sodium inhalation solution) when mixed with other drugs in a nebulizer have not been established.

Patients with chronic asthma should be advised that the effect of INTAL therapy is dependentupon its administration at regular intervals, as directed. INTAL should be introduced into the patient's therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately.

For the prevention of acute bronchospasm which follows exercise or exposure to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one ampule administered by nebulization shortly before exposure to the precipitating factor.

It should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route of administration.

For additional information, see the accompanying leaflet entitled "Living a Full Life with Asthma".

INTAL Therapy in Relation to Other Treatments for Asthma: Non-steroidal agents: INTAL should be added to the patient's existing treatment regimen (e.g., bronchodilators). When a clinical response to INTAL is evident, usually within two to four weeks, and if the asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually.

If concomitant medications are eliminated or required on no more than a prn basis, the frequency of administration of INTAL may be titrated downward to the lowest level consistent with the desired effect. The usual decrease is from four to three ampules per day. It is important that the dosage be reduced gradually to avoid exacerbation of asthma. It is emphasized that in patients whose dosage has been titrated to fewer than four ampules per day, an increase in the dose of INTAL and the introduction of, or increase in, symptomatic medications may be needed if the patient's clinical condition deteriorates.

Corticosteroids: In patients chronically receiving corticosteroids for the management of bronchial asthma, the dosage should be maintained following the introduction of INTAL. If the patient improves, an attempt to decrease corticosteroids should be made. Even if the corticosteroid-dependent patient fails to show symptomatic improvement following INTAL administration, the potential to reduce corticosteroids may nonetheless be present. Thus, gradual tapering of corticosteroid dosage may be attempted. It is important that the dose be reduced slowly, maintaining close supervision of the patient to avoid an exacerbation of asthma.

It should be borne in mind that prolonged corticosteroid therapy frequently causes an impairment in the activity of the hypothalamic-pituitary-adrenal axis and a reduction in the size of the adrenal cortex. A potentially critical degree of impairment or insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. Therefore, if a patient is subjected to significant stress, such as a severe asthmatic attack, surgery, trauma or severe illness while being treated or within one year (occasionally up to two years) after corticosteroid treatment has been terminated, consideration should be given to reinstituting corticosteroid therapy. When respiratory function is impaired, as may occur in severe exacerbation of asthma, a temporary increase in the amount of corticosteroids may be required to regain control of the patient's asthma.

It is particularly important that great care be exercised if, for any reason, INTAL is withdrawn in cases where its use has permitted a reduction in the maintenance dose of corticosteroids. In such cases, continued close supervision of the patient is essential since there may be sudden reappearance of severe manifestations of asthma which will require immediate therapy and possible reintroduction of corticosteroids.

How Supplied

INTAL Nebulizer Solution (cromolyn sodium inhalation solution) is a colorless solution supplied in a low density polyethylene plastic unit dose ampule with 12 ampules per foil pouch. Each 2 mL ampule contains 20 mg cromolyn sodium, USP, in purified water.

NDC 0585-0673-02.....................60 ampules x 2 mL
NDC 0585-0673-03.....................120 ampules x 2 mL

Store at Controlled Room Temperature 20 to 25ºC (68 to 77ºF) [see USP]. Protect from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready for use.

Distributed by: King Pharmaceuticals™, Inc. Bristol, TN 37620. Manufactured by: Aventis Pharma, 76580 Le Trait, France. FDA Rev date: 2/11/2004


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical experience with the use of INTAL suggests that adverse reactions are rare events. The following adverse reactions have been associated with INTAL

Nebulizer Solution: cough, nasal congestion, nausea, sneezing, and wheezing.

Other reactions have been reported in clinical trials; however, a causal relationship could not be established: drowsiness, nasal itching, nose bleed, nose burning, serum sickness, and stomachache.

In addition, adverse reactions have been reported with INTAL Capsules (cromolyn sodium for inhalation, USP). The most common side effects are associated with inhalation of the powder and include transient cough (1 in 5 patients) and mild wheezing (1 in 25 patients). These effects rarely require treatment or discontinuation of the drug.

Information on the incidence of adverse reactions to INTAL Capsules has been derived from U.S. postmarketing surveillance experience. The following adverse reactions attributed to INTAL, based upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness, dysuria and urinary frequency, nausea, cough, wheezing, headache, nasal congestion, rash, urticaria, and lacrimation.

Other adverse reactions have been reported in less than 1 in 100,000 patients, and it is unclear whether these are attributable to the drug: anaphylaxis, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, pulmonary infiltrates with eosinophilia, polymyositis, exfoliative dermatitis, hemoptysis, anemia, myalgia, hoarseness, photodermatitis, and vertigo.

Read the Intal Nebulizer Solution (cromolyn sodium inhalation solution) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.


This monograph has been modified to include the generic and brand name in many instances.

 

Warnings

INTAL has no role in the treatment of status asthmaticus.

Anaphylactic reactions with cromolyn sodium administration have been reported rarely.

 

Precautions

General: Occasionally, patients may experience cough and/or bronchospasm following INTAL inhalation. At times, patients who develop bronchospasm may not be able to continue INTAL administration despite prior bronchodilator administration. Rarely, very severe bronchospasm has been encountered.

Symptoms of asthma may recur if INTAL is reduced below the recommended dosage or discontinued.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous treatment at doses up to 75 mg/kg six days per week) showed no neoplastic effects. These doses correspond to approximately 1.0, 0.3, and 2 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis.

Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.

No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day in males and 100 mg/kg/day in females. These doses are approximately 18 and 10 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m2 basis.

Pregnancy: Pregnancy Category B. Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations. These doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m2 basis. Adverse fetal effects (increased resorptions and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Drug Interaction During Pregnancy: Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses up to 540 mg/kg (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m2 basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m2 basis) increased both resorptions and malformations. The addition of cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m2 basis) to isoproterenol (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m2 basis) appears to have increased the incidence of both resorptions and malformations.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when INTAL is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use: Clinical studies of INTAL 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.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

There is no clinical syndrome associated with an overdosage of cromolyn sodium. Acute toxicity testing in a wide variety of species has demonstrated that toxicity with cromolyn sodium occurs only with very high exposure levels, regardless of whether administration was parenteral, oral or by inhalation. Parenteral administration in mice, rats, guinea pigs, hamsters, and rabbits demonstrated a median lethal dose of approximately 4000 mg/kg. Intravenous administration in monkeys also indicated a similar pattern of toxicity. The highest dose administered by the oral route in rats and mice was 8000 mg/kg, (approximately 261 and 130 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis) and at this dose level no deaths occurred. By inhalation, even in long term studies, it proved impossible to achieve toxic dose levels of cromolyn sodium in a range of mammalian species.

ContrainDications

INTAL is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits sensitized mast cell degranulation which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of mediators from mast cells. Studies show that cromolyn sodium indirectly blocks calcium ions from entering the mast cell, thereby preventing mediator release.

Cromolyn sodium inhibits both the immediate and non-immediate bronchoconstrictive reactions to inhaled antigen. Cromolyn sodium also attenuates bronchospasm caused by exercise, toluene diisocyanate, aspirin, cold air, sulfur dioxide, and environmental pollutants. Cromolyn sodium has no intrinsic bronchodilator or antihistamine activity. After administration by inhalation, approximately 8% of the total cromolyn sodium dose administered is absorbed and rapidly excreted unchanged, approximately equally divided between urine and bile. The remainder of the dose is either exhaled or deposited in the oropharynx, swallowed and excreted via the alimentary tract.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

INTAL is to be taken as directed by the physician. Because it is preventive medication, it may take up to four weeks before the patient experiences maximum benefit.

INTAL Nebulizer Solution should be used in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece.

Drug stability and safety of INTAL Nebulizer Solution (cromolyn sodium inhalation solution) when mixed with other drugs in a nebulizer have not been established.

For additional information, see the accompanying leaflet entitled Living a Full Life with Asthma.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

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Consumer Overview Side Effect

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Consumer Overview Missed Dose

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Patient Detailed Side Effect

Brand Names: Intal, Intal Inhaler

Generic Name: cromolyn sodium (inhalation) (Pronunciation: KROE moe lin SOE dee um)

  • What is cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • What are the possible side effects of cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • What is the most important information I should know about cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • What should I discuss with my healthcare provider before using cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • How should I use cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • What happens if I miss a dose (Intal Nebulizer Solution)?
  • What happens if I overdose (Intal Nebulizer Solution)?
  • What should I avoid while taking cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • What other drugs will affect cromolyn sodium inhalation (Intal Nebulizer Solution)?
  • Where can I get more information?

What is cromolyn sodium inhalation (Intal Nebulizer Solution)?

Cromolyn sodium is an anti-inflammatory medication. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium inhalation is used to prevent asthma attacks in people with bronchial asthma. Cromolyn sodium is also used to prevent bronchospasm (wheezing, chest tightness, trouble breathing) caused by exercise, pollutants in the air, or exposure to certain chemicals.

Cromolyn sodium inhalation may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cromolyn sodium inhalation (Intal Nebulizer Solution)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe wheezing or chest tightness just after inhaling the medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • fever, swollen glands, rash or itching, joint pain, and a general ill feeling.

Less serious side effects may include:

  • dry or irritated throat, temporary or occasional cough;
  • sneezing, stuffy or itchy nose, watery eyes;
  • burning or bleeding of your nose;
  • nausea, heartburn, stomach pain;
  • urinating more or less than usual;
  • dizziness, drowsiness, headache; or
  • unusual or unpleasant taste in your mouth.

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.

Read the Intal Nebulizer Solution (cromolyn sodium inhalation solution) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about cromolyn sodium inhalation (Intal Nebulizer Solution)?

You should not use this medication if you are allergic to cromolyn sodium.

Before using cromolyn sodium inhalation, tell your doctor if you have heart disease or a heart rhythm disorder, coronary artery disease, kidney disease, or liver disease.

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Side Effects Centers

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Patient Detailed How Take

What should I discuss with my healthcare provider before using cromolyn sodium inhalation (Intal Nebulizer Solution)?

You should not use this medication if you are allergic to cromolyn sodium.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using cromolyn sodium inhalation, tell your doctor if you have:

  • heart disease or a heart rhythm disorder;
  • coronary artery disease;
  • kidney disease; or
  • liver disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cromolyn sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use cromolyn sodium inhalation (Intal Nebulizer Solution)?

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

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack.

Cromolyn sodium inhalation is given using a nebulizer or with a metered-dose inhaler. You will inhale the medication through a face mask or mouth piece. Do not swallow this medicine.

To prevent bronchial asthma attacks, cromolyn sodium inhalation is usually given 4 times daily. If you are using cromolyn sodium inhalation to prevent asthma caused by exercise, air pollutants, or exposure to chemicals, use the medicine 10 to 15 minutes (but not more than 1 hour) before exercising or exposure. Follow your doctor's instructions about your individual dosing schedule.

The instructions below are for standard use of the inhaler and nebulizer devices. Your doctor may want you to use your device differently. Be sure you understand all instructions that are specific to your use of this medication.

To use cromolyn sodium with a metered-dose inhaler:

  • Uncap the mouthpiece of the inhaler and shake the inhaler gently.
  • Breathe out fully. Put the mouthpiece into your mouth and close your lips. Do not block the mouthpiece with your tongue. Tilt your head back and breathe in slowly while pushing down on the top of the canister. Take the inhaler out of your mouth and hold your breath for several seconds, then breathe out slowly.
  • Clean your inhaler twice a week by removing the canister and rinsing the mouthpiece under warm running water. Allow the parts to dry before putting the inhaler back together. Never place the medicine canister in water.

To use cromolyn sodium inhalation solution with a nebulizer:

  • Break open the ampule and empty the medicine into the chamber of the nebulizer. Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor.
  • Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.
  • Breathe in slowly and evenly until you have inhaled all of the medicine. The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.
  • Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

It may take up to 4 weeks of using cromolyn sodium before you get the full effect. For best results, keep using the medication as directed. Call your doctor if your symptoms do not improve after 4 weeks of treatment, or if they get worse.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store this medication at room temperature away from moisture and heat. Keep the inhaler canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture an inhaler canister.

Keep track of the number of sprays you have used and throw away the canister after 112 sprays if you use the 8.1-gram inhaler, or 200 sprays if you use the 14.2-gram inhaler, even if it feels like there is still medicine in the canister.

Side Effects Centers
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Patient Detailed Avoid Taking

What happens if I miss a dose (Intal Nebulizer Solution)?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose (Intal Nebulizer Solution)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of cromolyn sodium inhalation is not likely to cause life-threatening symptoms.

What should I avoid while taking cromolyn sodium inhalation (Intal Nebulizer Solution)?

Avoid spraying the inhaler into your face or getting the medication in your eyes.

Do not mix cromolyn sodium inhalation with other medicines in a nebulizer.

What other drugs will affect cromolyn sodium inhalation (Intal Nebulizer Solution)?

There may be other drugs that can interact with cromolyn sodium inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about cromolyn sodium inhalation.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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