Standardized Orchard Grass Pollen

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Overview

What is Standardized Orchard Grass Pollen?

Standardized Grass Pollen Extracts include: Orchard , Perennial Rye , Timothy , Redtop , Kentucky (June) Bluegrass , Bermuda , Meadow Fescue , Sweet Vernal . The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% NaHPO, 0.036% KHPO, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection.

Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts.

Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.

What does Standardized Orchard Grass Pollen look like?

What are the available doses of Standardized Orchard Grass Pollen?

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What should I talk to my health care provider before I take Standardized Orchard Grass Pollen?

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How should I use Standardized Orchard Grass Pollen?

Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration)

The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.

It is imperative that the physician determine a safe initial dose. Patients being switched from one lot of Standardized Pollen to another lot of Standardized Pollen (from the same or different manufacturers) should have the initial dose from the new lot reduced by 75%. For patients being switched from non-standardized extract to a standardized extract, the selection of dose needs to be based on the dose of the extract currently administered and the relative potency with regards to the standardized extract. Side by side comparison of wheal and erythema by skin testing of standardized and non-standardized extract can be carried out to determine comparability of doses selected.

For safe and effective use of allergenic extracts, sterile solutions, vials, syringes, etc. should be used and aseptic precautions followed when making dilution's and giving injections. The usual precautions to be observed in administering extracts are necessary. A sterile tuberculin syringe graduated in 0.1mL units to measure each dose for the prescribed dilution should be used.

After therapeutic injections patients should always be observed for at least 30 minutes. If adverse reactions appear, the next therapeutic injection of extract should be reduced to the dose which does not elicit a reaction and subsequent doses increased more slowly.

Recommended dosage and range: (Scratch or Prick tests)

The general method of making a scratch test is to first scarify the skin and then apply a drop of extract to the scratch. Make scarifications at least 2.5 cm apart. Hold the scarifier between thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt the outer layers of epidermis but should not produce immediate oozing of blood. One drop (0.05mL) of extract is rubbed or applied into each scratch. Always apply a control scratch with each test set. Sterile Diluent is used in exactly the same way as an active test extract. Histamine may be used as a positive control. Scratch or prick test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction.

The concentration of Standardized Pollen extract for Scratch or Prick-puncture testing is prepared using 10,000 BAU/mL. If negative, 100,000 BAU/mL can be used to determine sensitivity of the patient.

Recommended dosage and range:

Patients with a negative scratch or prick-puncture test:

Patients who do not react to a valid scratch or prick- puncture test should be tested intradermally with 0.05mL of a 50 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 100 BAU/mL extract dilution. The negative puncture test control must be diluted appropriately for intradermal use.

To prepare a 50 BAU/mL dilution from Nelco's

10,000 BAU/mL vial:

Take 5.0 mL of the 10,000 BAU/mL + 5.0mL of diluent

equals Vial A at 5,000 BAU/mL.

Take 1.0 mL of Vial A + 9.0 mL diluent equals

Vial B at 500 BAU/mL.

Take 1.0 mL of Vial B + 9.0 mL diluent equals

Vial C at 50 BAU/mL.

Patients tested only by the intradermal method:

Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes. Wheal and erythema size may be recorded by actual measurement as compared with positive and negative controls.

Preparation Instructions:

Recommended dosage and range: (Therapeutic)

Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, the clinical response and tolerance to the extract administered during the injection regimen. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be 0.05mL of 5 BAU/mL which results in a dosage of 0.25 BAU. Patients with lesser sensitivity may be started using 1 BAU/mL. The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount, and the next increment is governed by the response to the last injection. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. Any evidence of a local or generalized reaction requires a reduction in dosage. After therapeutic injections, patients should always be observed for at least 20 minutes. If adverse reactions appear, the next therapeutic injection of extract should be reduced to the dose which dose not elicit a reaction and subsequent doses increased more slowly. The upper limits of dosage have not been established. Doses larger than 0.2 mL of 10,000 BAU/mL may be painful due to glycerin content. Dosage use of up to 100,000 BAU/mL is determined by patient response and administered at the discretion of the physician.

Suggested Dosage Charts

*(Note Disclaimer)

*

This is a suggested dose chart only. Dose regimen has not been subjected to adequate and well controlled studies to determine safety and efficacy.

Please read entire instructions before commencing immunotherapy. Observe patients for 30 minutes after an injection. Note: Certain individuals may not tolerate this suggested schedule. The physician may need to adjust both the dosage and interval accordingly.

Note: Maintenance dose is that dose which provides symptomatic relief or the strongest dose that can be tolerated by the patient. Therefore, a physician must determine each patient's maintenance dose.

Intervals between doses:

Duration of Treatment:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

What interacts with Standardized Orchard Grass Pollen?

Standardized Pollen extract should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergy to Pollen is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Pollen extract is not indicated for use in patients who are not clinically allergic to pollen or who are not skin reactive to pollen. Limitations on treatment should be considered when treating the very young, or geriatric patients or those suffering from auto-immune disorders or severe and unstable allergic disorders.

What are the warnings of Standardized Orchard Grass Pollen?

Allergenic extracts should be used with caution in patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease.

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.

DO NOT INJECT INTRAVENOUSLY.

All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients.

Standardized Pollen extracts should be used with caution when treating patients who exhibit hypersensitivity to standardized pollen extracts as confirmed by diagnostic testing.

An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.

What are the precautions of Standardized Orchard Grass Pollen?

General:

To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing. Patients should be observed for 30 minutes after any test.

Information for Patients:

Drug Interactions:

Extreme caution should be taken when using allergenic extracts in patients who are taking beta-blockers. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodialators.

Carcinogenesis, mutagenesis, impairment of fertility.

Long term studies in animals have not been conducted with allergenic extracts, including Pollen extracts, to determine their potential carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy: Category C.

Nursing Mothers:

Pediatric Use:

What are the side effects of Standardized Orchard Grass Pollen?

Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause anaphylaxis or shock and loss of consciousness. In rare instances this may result in death.

The treatment of systemic allergic reactions is dependent upon the system complex. Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.

Local Reactions

Serious adverse reactions

MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, MD 20852-9787, call 1-800-FDA-1088.

What should I look out for while using Standardized Orchard Grass Pollen?

Standardized Pollen extract should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergy to Pollen is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Pollen extract is not indicated for use in patients who are not clinically allergic to pollen or who are not skin reactive to pollen. Limitations on treatment should be considered when treating the very young, or geriatric patients or those suffering from auto-immune disorders or severe and unstable allergic disorders.

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.

DO NOT INJECT INTRAVENOUSLY.

All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients.

Standardized Pollen extracts should be used with caution when treating patients who exhibit hypersensitivity to standardized pollen extracts as confirmed by diagnostic testing.

An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.

What might happen if I take too much Standardized Orchard Grass Pollen?

An overdose can cause both local and systemic reactions. An overdose is prevented by careful observation and questioning the patient about reactions to previous extract injections.

If systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5mL of 1:1000 epinephrine hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes. The epinephrine hydrochloride 1:1000 dose for infants to 2 years is 0.05 to 0.1mL, for children 2 to 6 years it is 0.15mL, for children 6-12 years it is 0.2mL. Patients unresponsive to epinephrine may be treated with intravenous bronchodilators. Studies on asthmatic subjects reveal that plasma concentrations of theophylline of 5 to 20 µg/mL are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 µg/mL. A loading dose of aminophylline of 5.8 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 µg/mL for patients not previously receiving theophylline. (Mitenko, Ogilive 1973; Nicholoson, Chick 1973)

Other beta-adrenergic drugs such as Isoproterenol, Isoetharine, or Albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5mL of the 0.5% solution for Isoproterenol HCl. The Albuterol inhaler delivers approximately 90mcg of Albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4-6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340mcg Isoetharine. The average dose is one to two inhalations. Persistent wheezing may necessitate intravenous aminophylline treatment. For profound shock and hypotension, intravenous fluids, vasopressors and oxygen may also be needed. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require oxygen, intubation and the use of life support systems.

How should I store and handle Standardized Orchard Grass Pollen?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials. Diagnostic Allergens:Scratch or Prick test: 10,000 BAU/mL or 100,000 BAU/mL contained in 50% glycerin (v/v) in 5mL dropper vials.Intradermal test: 100 BAU/mL in 5mL or 10mL sterile multiple dose vials.Concentrate of Extract for Therapeutic Use Allergens:10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The mode of action of allergenic extracts is still under investigation. The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergenic extracts are used for therapeutic immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergic response. Although immunotherapy may be considered as immunosuppression, in which the production of allergen-specific antibody is inhibited, the mechanism of the clinical effectiveness of immunotherapy remains under investigation. Assignment of BAU/mL potency designation was determined based on Puncture and Intradermal Data with CBER Grass References.

Puncture & Intradermal Data with CBER Grass References

A. Puncture Data with 10,000 BAU/mL Grass Extracts

B. Intradermal Dose (BAU) of CBER Grass References for 50 mm Sum of Erythema

C. Potency of Selected Glycerinated Non-Standardized Grasses distributed by Nelco Laboratories, Inc.

The potency of the glycerinated non-standardized grass extracts are equivalent to or exceed the potency for standardized grass pollen extract (Range for equivalence to CBER reference labeled 100,000 BAU/mL is 67,300 to 148,600, and range for equivalence to CBER reference labeled 10,000 BAU/mL is 6,730 to 14,860).

Non-Clinical Toxicology

Standardized Pollen extract should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergy to Pollen is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Pollen extract is not indicated for use in patients who are not clinically allergic to pollen or who are not skin reactive to pollen. Limitations on treatment should be considered when treating the very young, or geriatric patients or those suffering from auto-immune disorders or severe and unstable allergic disorders.

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.

DO NOT INJECT INTRAVENOUSLY.

All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients.

Standardized Pollen extracts should be used with caution when treating patients who exhibit hypersensitivity to standardized pollen extracts as confirmed by diagnostic testing.

An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.

Drug Interactions:

It has been reported that ZYLOPRIM prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when ZYLOPRIM is given to patients already on dicumarol therapy.

Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and ZYLOPRIM has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with ZYLOPRIM alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on ZYLOPRIM alone or in combination with uricosuric agents, the possibility should be kept in mind.

The reports that the concomitant use of ZYLOPRIM and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of ZYLOPRIM was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and ZYLOPRIM even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.

An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with ZYLOPRIM compared to patients who are not receiving both drugs. The cause of the reported association has not been established.

Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of ZYLOPRIM. However, in a well-controlled study of patients with lymphoma on combination therapy, ZYLOPRIM did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.

Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.

Chlorpropamide's plasma half-life may be prolonged by ZYLOPRIM, since ZYLOPRIM and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if ZYLOPRIM and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with ZYLOPRIM. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

General:

To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing. Patients should be observed for 30 minutes after any test.

Information for Patients:

Drug Interactions:

Extreme caution should be taken when using allergenic extracts in patients who are taking beta-blockers. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodialators.

Carcinogenesis, mutagenesis, impairment of fertility.

Long term studies in animals have not been conducted with allergenic extracts, including Pollen extracts, to determine their potential carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy: Category C.

Nursing Mothers:

Pediatric Use:

Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause anaphylaxis or shock and loss of consciousness. In rare instances this may result in death.

The treatment of systemic allergic reactions is dependent upon the system complex. Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.

Local Reactions

Serious adverse reactions

MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, MD 20852-9787, call 1-800-FDA-1088.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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