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DRUGS & SUPPLEMENTS
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Intal Compound
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Intal Compound uses
Intal Compound consists of Cromolyn Sodium, Isoproterenol Sulfate.Cromolyn Sodium:
- Active ingredient (per spray)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
Intal Compound (Cromolyn Sodium)
Drug Facts
Active ingredient
Intal Compound (Cromolyn Sodium) sodium 5.2mg
Purpose
Nasal allergy symptom controller
Uses
to prevent and relieve nasal symptoms of hay fever and other nasal allergies:
- runny/itchy nose
- sneezing
- allergic stuffy nose
Warnings
Do not use
- if you are allergic to any of the ingredients
Ask a doctor before use if you have
- fever
- discolored nasal discharge
- sinus pain
- wheezing
When using this product
- it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
- brief stinging or sneezing may occur right after use
- do not use it to treat sinus infection, asthma, or cold symptoms
- do not share this bottle with anyone else as this may spread germs
Stop use and ask a doctor if
- shortness of breath, wheezing, or chest tightness occurs
- hives or swelling of the mouth or throat occurs
- your symptoms worsen
- you have new symptoms
- your symptoms do not begin to improve within two weeks
- you need to use for more than 12 weeks
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- see package insert on how to use pump
- parent or care provider must supervise the use of this product by young children
- adults and children 2 years and older:
- spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.
- use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)
- to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.
- if desired, you can use this product with other medicines, including other allergy medicines.
- children under 2 years: Do not use unless directed by a doctor
Other information
- store between 20°-25°C (68°-77°F)
- protect from light
- keep carton and package insert. They contain important instructions.
- do not use if imprinted plastic bottle wrap is broken or missing
- see bottom panel for lot number and expiration date
Inactive ingredients
benzalkonium chloride, edetate disodium, purified water
Questions or comments?
call 1-877-9-ALLERGY (1-877-925-5374)
Isoproterenol Sulfate:
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
Intal Compound (Isoproterenol Sulfate) hydrochloride injection is indicated:
- For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
- For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation).
- For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available.
- For bronchospasm occurring during anesthesia.
- As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock.
CONTRAINDICATIONS
Use of Intal Compound (Isoproterenol Sulfate) hydrochloride injection is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; and angina pectoris.
WARNINGS
Intal Compound (Isoproterenol Sulfate) hydrochloride injection, by increasing myocardial oxygen requirements while decreasing effective coronary perfusion, may have a deleterious effect on the injured or failing heart. Most experts discourage its use as the initial agent in treating cardiogenic shock following myocardial infarction. However, when a low arterial pressure has been elevated by other means, Intal Compound (Isoproterenol Sulfate) hydrochloride injection may produce beneficial hemodynamic and metabolic effects.
In a few patients, presumably with organic disease of the AV node and its branches, Intal Compound (Isoproterenol Sulfate) hydrochloride injection has paradoxically been reported to worsen heart block or to precipitate Adams-Stokes attacks during normal sinus rhythm or transient heart block.
PRECAUTIONS
General
Intal Compound hydrochloride injection should generally be started at the lowest recommended dose. This may be gradually increased if necessary while carefully monitoring the patient. Doses sufficient to increase the heart rate to more than 130 beats per minute may increase the likelihood of inducing ventricular arrhythmias. Such increases in heart rate will also tend to increase cardiac work and oxygen requirements which may adversely affect the failing heart or the heart with a significant degree of arteriosclerosis.
Adequate filling of the intravascular compartment by suitable volume expanders is of primary importance in most cases of shock and should precede the administration of vasoactive drugs. In patients with normal cardiac function, determination of central venous pressure is a reliable guide during volume replacement. If evidence of hypoperfusion persists after adequate volume replacement, Intal Compound (Isoproterenol Sulfate) hydrochloride injection may be given.
In addition to the routine monitoring of systemic blood pressure, heart rate, urine flow, and the electrocardiograph, monitor the response to therapy by frequent determination of the central venous pressure and blood gases. Closely observe patients in shock during Intal Compound (Isoproterenol Sulfate) hydrochloride injection administration. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease the infusion rate or temporarily discontinue the infusion. Determinations of cardiac output and circulation time may also be helpful. Take appropriate measures to ensure adequate ventilation. Pay attention to acid-base balance and to the correction of electrolyte disturbances.
Drug Interactions
Intal Compound (Isoproterenol Sulfate) hydrochloride injection and epinephrine should not be administered simultaneously because both drugs are direct cardiac stimulants and their combined effects may induce serious arrhythmias. The drugs may, however, be administered alternately provided a proper interval has elapsed between doses.
Avoid Intal Compound (Isoproterenol Sulfate) when potent inhalational anesthetics such as halothane are employed because of potential to sensitize the myocardium to effects of sympathomimetic amines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate the carcinogenic potential of Intal Compound hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that Intal Compound (Isoproterenol Sulfate) hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with Intal Compound (Isoproterenol Sulfate) hydrochloride. It is also not known whether Intal Compound (Isoproterenol Sulfate) hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Intal Compound (Isoproterenol Sulfate) hydrochloride should be given to a pregnant woman only if clearly needed.
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 Compound hydrochloride injection is administered to a nursing woman.
Pediatric Use
Safety and efficacy of Intal Compound (Isoproterenol Sulfate) in pediatric patients have not been established.
Intravenous infusions of Intal Compound (Isoproterenol Sulfate) in refractory asthmatic children at rates of 0.05-2.7 mcg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. The risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients. If I.V. Intal Compound (Isoproterenol Sulfate) is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including CPK-MB.
Geriatric Use
Clinical studies of Intal Compound (Isoproterenol Sulfate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. There are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. In general, dose selection for elderly patients should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.
ADVERSE REACTIONS
The following reactions to Intal Compound (Isoproterenol Sulfate) hydrochloride injection have been reported:
CNS: Nervousness, headache, dizziness, nausea, visual blurring.
Cardiovascular: Tachycardia, palpitations, angina, Adams-Stokes attacks, pulmonary edema, hypertension, hypotension, ventricular arrhythmias, tachyarrhythmias.
In a few patients, presumably with organic disease of the AV node and its branches, Intal Compound (Isoproterenol Sulfate) hydrochloride injection has been reported to precipitate Adams-Stokes seizures during normal sinus rhythm or transient heart block.
Respiratory: Dyspnea.
Other: Flushing of the skin, sweating, mild tremors, weakness, pallor.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
The acute toxicity of Intal Compound (Isoproterenol Sulfate) hydrochloride in animals is much less than that of epinephrine. Excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis.
In case of accidental overdosage as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, reduce rate of administration or discontinue Intal Compound (Isoproterenol Sulfate) hydrochloride injection until patient’s condition stabilizes. Blood pressure, pulse, respiration, and ECG should be monitored.
It is not known whether Intal Compound (Isoproterenol Sulfate) hydrochloride is dialyzable.
The oral LD50 of Intal Compound (Isoproterenol Sulfate) hydrochloride in mice is 3,850 mg/kg ± 1,190 mg/kg of pure drug in solution.
DOSAGE AND ADMINISTRATION
Start Intal Compound (Isoproterenol Sulfate) injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.
| Route of Administration | Preparation of Dilution | Initial Dose | Subsequent Dose Range |
| Bolus intravenous injection | Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP | 0.02 mg to 0.06 mg (1 mL to 3 mL of diluted solution) | 0.01mg to 0.2 mg (0.5 mL to 10 mL of diluted solution) |
| Intravenous infusion | Dilute 10 mL (2 mg) in 500 mL of 5% Dextrose Injection, USP | 5 mcg/min. (1.25 mL of diluted solution per minute) | |
| Intramuscular | Use Solution undiluted | 0.2 mg (1 mL) | 0.02 mg to 1 mg (0.1 mL to 5 mL) |
| Subcutaneous | Use Solution undiluted | 0.2 mg (1 mL) | 0.15 mg to 0.2 mg (0.75 mL to 1 mL) |
| Intracardiac | Use Solution undiluted | 0.02 mg (0.1 mL) |
There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.
| Route of Administration | Preparation of Dilution | Infusion Rate |
| Intravenous infusion | Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP | 0.5 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of diluted solution) |
Recommended dosage for adults with bronchospasm occurring during anesthesia:
| Route of Administration | Preparation of Dilution | Initial Dose | Subsequent Dose |
| Bolus intravenous injection | Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP | 0.01 mg to 0.02 mg (0.5 mL to 1 mL of diluted solution) | The initial dose may be repeated when necessary |
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.
HOW SUPPLIED
| NDC Number | Container | Concentration | Fill | Quantity |
| 0187-4330-01 | Ampul | 0.2 mg/mL | 1 mL | UNI-AMP pak of 25 |
| 0187-4330-05 | Ampul | 1 mg/5 mL (0.2 mg/mL) | 5 mL | 10 ampuls per carton |
Protect from light. Keep in opaque container until used.
Store at 20° to 25°C (68° to 77°F).
Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.
Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Hospira, Inc.
McPherson, KS 67460 USA
9445502
Rev. 08/2016
Intal Compound (Isoproterenol Sulfate) is a registered trademark of Hospira, Inc. used under license.
©Valeant Pharmaceuticals North America LLC
5 mL
NDC 0187-4330-05
Rx only
Isuprel®
Intal Compound (Isoproterenol Sulfate) HC1
Injection, USP
1 mg/5 mL (0.2 mg/mL)
Intravenous, Subcutaneous,
Intramuscular or Intracardiac Use Only.
Protect from light.
Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Valeant Pharmaceuticals North America LLC
Intal Compound pharmaceutical active ingredients containing related brand and generic drugs:
Intal Compound available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.