Drugplain

Terbutaline Sulfate 5 mg/1

Terbutaline Sulfate · TABLET · ANI Pharmaceuticals, Inc.

No Recall History
Plain English

Terbutaline Sulfate is a tablet containing terbutaline sulfate at 5 mg/1, taken oral. Manufactured by ANI Pharmaceuticals, Inc..

Key Facts

Brand Name
Terbutaline Sulfate
Generic Name
Terbutaline Sulfate
NDC Code (Product)
62559-722
Manufacturer
ANI Pharmaceuticals, Inc.
Strength
5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA017849
Marketing Start
10/16/2018

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

Dosage & Administration

DOSAGE AND ADMINISTRATION Adults The usual oral dose of terbutaline sulfate for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg. Children Terbutaline sulfate is not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12-15 years of age. The total dose within 24 hours should not exceed 7.5 mg. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.

Warnings

WARNINGS Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of terbutaline sulfate than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. Cardiovascular Effects Terbutaline sulfate, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of terbutaline sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and S…

Contraindications

CONTRAINDICATIONS 1. Tocolysis Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. [see Boxed Warning: Tocolysis . ] 2. Hypersensitivity Terbutaline sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

Drug Interactions

Drug Interactions The concomitant use of terbutaline sulfate with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. However, this does not preclude the use of an aerosol bronchodilator of the adrenergic-stimulant type for the relief of an acute bronchospasm in patients receiving chronic oral therapy with terbutaline sulfate.

Adverse Reactions

ADVERSE REACTIONS Adverse reactions observed with terbutaline sulfate are similar to those commonly seen with other sympathomimetic amines. All of these reactions are generally transient in nature and usually do not require treatment. The frequency of these side effects appears to diminish with continued therapy. The following table lists the adverse reactions seen in 199 patients treated with terbutaline sulfate tablets during six double-blind crossover studies and four double-blind parallel studies (short- and long-term) performed in the United States. Percent Incidence of Adverse Reactions (Total Daily Dosage Range 5 to 15 mg) Terbutaline N=199 Reaction % Nervous System Nervousness 35.0 Tremor 15.0 Somnolence 5.5 Dizziness 3.5 Anxiety 1.0 Insomnia 1.5 Cardiovascular Palpitations 5.0 Tachycardia 3.5 Extrasystoles ventricular 1.5 Vasodilations 1.0 Digestive Nausea 3.0 Dry mouth 1.5 Body as a Whole Headache 7.5 Asthenia 2.0 Skin and Appendages Sweating 1.0 The following adverse effects each occurred in fewer than 1% of patients: hallucinations, rash, paresthesia, hypertonia, (muscle cramps), vomiting. There have been rare reports of elevations in liver enzymes and of hypersensitivi…

Frequently Asked Questions

What is Terbutaline Sulfate used for?

Terbutaline Sulfate contains Terbutaline Sulfate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Terbutaline Sulfate a controlled substance?

Terbutaline Sulfate is not classified as a controlled substance by the DEA.

What is the generic name for Terbutaline Sulfate?

The generic name for Terbutaline Sulfate is Terbutaline Sulfate. There are 1 other brand versions of Terbutaline Sulfate.

What is the NDC code for Terbutaline Sulfate 5 mg/1?

The NDC (National Drug Code) for Terbutaline Sulfate 5 mg/1 is 62559-722, listed by ANI Pharmaceuticals, Inc..

Product NDC

62559-722

Package NDC

62559-722-01

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)